Petition for Writ of Certiorari — Hemphill v. McNeil-PPC, Inc., (2001) (No. 1770)

Supreme Court, U8.

FILED

~~

No. QO 1177 0 MAR 1 6 2002

OFFICE OF THE CLERK

In The

Supreme Court of the United States

@ctober Term, 2001

ALLEGRA D. HEMPHILL

fietitioner,

v.

MCNEIL-PPC, INC.,

despondent.

On Petition for Writ of Certiorari

to the United States Court of Appeals

for the Federal Circuit

PETITION FOR WRIT OF CERTIORARI

Allegra Hemphill, pro se

6217 Charnwood Drive

Rockville, Maryland 20852

(301) 897 - 2030

llpos

QUESTIONS PRESENTED FOR REVIEW.

1. By the omission of USPTO Examiner’s statements

regarding the structure in the prior art ‘567 patent, did the court

prejudice claim construction?

2. The term “vaginal swab” has more than one

meaning. Should the court construe the term as structural?

3. Claim 2 reads “core member being secured to said

housing means”. Is the court denying 35 U.S.C.§112 ?

4. For safety and effectiveness reasons, the claim 2

“secures”. The specification is ensuring security also.

A dictionary definition “attaches”. Does extrinsic evidence

(dictionary definition) limit the legally operative meaning in the

intrinsic evidence (the claim and specification)?

5. Serenity ®is an accused device. The Federal Circuit

forgets to construe an element. Will the Supreme Court

perform the literal patent infringement analysis for the asserted

claim 2, species #4 Fig. 8 and 9 in the ‘720 patent?

LIST OF PARTIES

[X ] All parties appear in the caption of the cover page.

Johnson & Johnson, One Johnson & Johnson Plaza

New Brunswick, New Jersey 08933 is the parent

company of McNeil-PPC, Inc.

{ ] All parties do not appear in the caption of the case on

the cover page. A list of all parties to the proceeding in the

court whose judgement is the subject of this petition is as

follows:

it.

TABLE OF CONTENTS

OPINIONS BELOW

U.S. Court of Appeals for the Federal Circuit,

before Clevenger, Gjarsa and Dyk Circuit Judges

U.S. District Court for the District of Maryland

before Judge Deborah K.Chasanow.............:-ssssessseeseenenenseness ]

JURISDICTION. .......0..ccccscccsssssscccsscsssccsssccssscsssssessoscssnncsenes 2

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED...............:ccccccecesseeeeereeeeeeeeeeneeees .

STATEMENT OF THE CASE.............:cc:cccsseessseeeeeeeeeeens 6

REASONS FOR GRANTING THE WRIT .................-+ 1]

SUPREME COURT RULE, RULE 10(a)

SUPREME COURT RULE, RULE 10(c)

PUBLIC CONCERN

PROOF EXPLANATION

CONCLUSION. ..........:cccccssscscssscssssccsrccserccssssscscssccosssesosees 30

-ili-

TABLE OF AUTHORITIES CITED

CASES PAGE NUMBER

Alpex Computer Corp. v. Nintendo Co.,

102 F.3d. 1214 (Fed. Cir. 1996) 1220 ..... ee eesseseeeees 11,14

Bell Comm. Research, Inc. v. Vitalink Corp.

3S F.3G. GIS, (FOR. Cap. TGS) OID = GID. .cqrccsrscinssscsscssncsorse 15

E.I]. DuPont De Nemours & Co. v. Phillips Petro.,

849 F.2d. 1430 (Fed. Cir.1988)1433,1434..... esses a» aa

Markman v. Westview Instruments, Inc.

52 F. 3d. 967 (Fed. Cir 1995)

978- 980, 988, 990, 1000, 1018-1019... 4, 6, 8, 14, 18

Maxwell v. J. Baker Inc.

OF. Si. BO Cl, Ce. FD Fi ccctctenscrnsenstnstsinnsiindetnan 17

-jV-

'

Multiform Desiccants, Inc. v. Medzam, LTD, 133 F. 3d.

1473 (Fed. Cir. 1998) 1476, 1477,1479........ esses 21. tds ae

Vitronics Corp. v. Conceptronic, Inc.,

90 F. 3d. 1576 (Fed. Cir. 1996) 1582...................e000 8, 16, 24

STATUTES AND RULES

35 USC. F928 incncictistinnnnansedinieae 4-5

AMERICAN HERITAGE COLLEGE DICTIONARY,

(3"ed., 1993)

“ORG” scncnocsenstubinananisisnsdidiambadaiabdilesdatmaantaae saa a 15

"OID aisnscsninsiininiatnisaniianauddasadamamsealammasandaadanuas ee 15

"SHIIIIIE sicnncnnscesncnsplansnianiinnnliidesensssnasdianesetakaannaataaa 15

INDEX TO APPENDIX

APPENDIX A Decision

U.S. Court of Appeals for the Federal Circuit....................... ]

APPENDIX B Reconsideration Denied

U.S. District Court for the District of Maryland ................. 22

APPENDIX C Decision

U.S. District Court for the District of Maryland ................. 29

APPENDIX D Order Denying Rehearing

U.S. Court of Appeals for the Federal Circuit..................... 64

APPENDIX E STATUTES CITATIONS ........................ 67

35 U.S.C. §102

35 U.S.C.§ 103

35 U.S.C. §112

-Vi-

35 U.S.C. §132

APPENDIX F OPINIONS,

United States Department of Commerce,

Patent and Trademark Office ............::ccccssseeeeeeeeeersneeneeeees 74

Request for Reexamination Re: McNair

Request for Reexamination Re: Srininvasan

Notice of Intent to Issue Certificate

Reexamination Certificate

APPENDIX G

.QHNSON & JOHNSON MOTION...........cccccseseeeeseenteees 90

APPENDIX H

JOHNSON & JOHNSON

LEGAL ANALYSIS OPINION. ............:cccccsesceseeeeeeesseeneneees 94

INDEX TO PETITIONER’S LODGING

UNITED STATES LETTERS PATENT 4,557,720.......... 401

Pe CR Ie Rp ictnncninnenicntiedcisnninsinnsnnnemscinnsanninnie 409 |

United States Department of Commerce

Patents and Trademarks Office

Patent Application Number 619,684

Hemphill United States Letters Patent #4,557,720

Pe PURE Ue TONNE BTS, FOE sagasnscncccnnscssrreccncsnosanss 570

REEXAMINATION CERTIFICATE ......... ce eeseeeeeesees 577

PAPERS SctPUDOUE. oF scsiesinhsnnceintinscenpinnnndnianiapinninniniiiaeniniiies 579

aN EE te icnniisccnianiieuiinniaesitsidasiitsiahaiiasiciapnabemnannnaunindsiiiiia 59]

American Heritage College Dictionary, 3 ed. 1993.

Brands and Their Companies, 23" ed. Vol. 2 S-Z,

2002.

IN THE

SUPREME COURT OF THE UNITED STATES

OCTOBER TERM 2001

PETITION FOR WRIT OF CERTIORARI

to the UNITED STATES COURT OF APPEALS

for the FEDERAL CIRCUIT

Petitioner, respectfully prays that a writ of certiorari

issue to review the judgement below.

OPINIONS BELOW

[X] For cases from federal courts:

The opinion of the United States court of Appeals for

the Federal Circuit appears at Appendix_A to the

petition and is

[]reportedat si; or

[ ] has been designated for publication but is not yet

reported; or

{X] unpublished, as of March 8, 2002.

The opinion of the United States district court for the

District of Maryland appears at Appendix B and Appendix C

to the petition and is

[X] reported at Hemphill v. McNeil-PPC, Inc., 134

F.Supp. 2d. 710 (D. Md. 2001);or,

[ ] has been designated for publication but is not yet

[ ] reported; or is unpublished.

JURISDICTION

[X] For cases from federal courts:

The date on which the United States Court of

Appeals for the Federai Circuit decided my case was

November 27, 2001.

[ ] No petition for rehearing was filed in my case.

[X] A timely petition for rehearing was denied by the

United States Court of Appeals for the Federal Circuit on

December 21, 2001, and a copy of the order denying

rehearing appears at Appendix D.

a.

cnniaboeuaeaallll

[ ] An extension of time to file the petition for a writ ;

of certiorari was granted to and including (date)

on ___(date) in Application No. A- ,

The jurisdiction of this Court is invoked under 28

U.S.C. §1254(1).

On petition for writ of certiorari, the captioned case

Hemphill v. McNeil-PPC, Inc., results from a literal patent

infringement suit. The United States District court for the

District of Maryland presided over jurisdiction pursuant to

28 U.S.C.§ 1338. The decision was on March 12, 2001 and

reconsideration was denied on May 11, 2001.

On appeal, in the United States Court of Appeals for

the Federal Circuit the decision was on November 27, 2001.

Rehearing was denied on December 21, 2001. Jurisdiction

in the U.S. Court of Appeals for the Federal Circuit for

Hemphill v. McNeil-PPC, Inc., No. 01-1391 was exercised

pursuant to 28 U.S.C. §1295(a)(1).

,

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED

A). 35.U.S.C.§ 112 SPECIFICATION,

SEE Appendix E, pg. 72-73.

(“[a]pplicants are now required by 35 U.S.C.§ 112

to particularly point out and distinctly claim

the subject matter the applicant regards as his [or her]

invention and this requirement applies with equal

force to claims having means-plus-function

limitations”). Markman v. Westview Instruments,

Inc. 52 F.3d. 967 (Fed. Cir 1995) 988.

(“Anyone who wants to know what a patent protects

must first read its claim, for they are the measure of its

scope”). Markman v. Westview Instruments Inc., 52 F. 3d,

967 (Fed. Cir. 1995), on page 990, I.

(“The claims of the patent provide the concise

formal definition of the invention. They are the

she

es rs a ee

| numbered paragraphs which ‘particularly [point] out

and distinctly [claim] the subject matter which the

applicant regards as his [or her] invention’.

35 U.S.C. §112. It is to these wordings that

one must look to determine whether there has

been infringement.”). E.]. DuPont De Nemours &

Co. v. Phillips Petro. 849 F2d. 1430 (Fed. Cir 1988), 1433.

B) SEVENTH AMENDMENT RIGHT

The pro se plaintiff's request for jury trial was usurped.

Appendix G, pg. 90-93.

. (“Jury trial in patent cases is protected by

Seventh Amendment. Elimination of the jury

is not this court’s choice to make. The

constitutional right alone bars the majority’s

: rule. The majority today denies 200 years of

jury trial on patent cases in the United

States,...by simply calling a question of fact a

question of law. The Seventh Amendment is

not so readily circumvented.”). Markman v.

Westview Instruments Inc., 52 F. 3d, 967

(Fed. Cir. 1995), on page 1000, at 3.

The Constitution.

STATEMENT OF THE CASE

Petitioner Allegra D. Hemphill (“Hemphill”) is the

inventor in the United States Letters Patent 4,557,720

(‘the 720 patent’) dated December 10, 1985. The title of the

‘720 patent is “Vaginal Applicator”. There are two

independent claims. Claim 2 is asserted. Claim 2 is

structural. Claim 2 entitles a vaginal swab. Claim 2 defines

the invention. Col. 7, 11.6 through Col. 8, 11.10. The elected

species is #4, Figures 8 and 9, in Col. 5, 11.27 through Col. 6,

1]. 58 . See the ‘720 Patent in Petitioner’s Lodging, “PL”,

pages 401-408.

Be ce TAS dla ahah

In 1998, Allegra Hemphill and Johnson & Johnson

agreed to terms in claim 2 with no factual dispute. The “720

patent underwent ‘reexamination’ in the United States Patent

and Trademark Office (the “USPTO).' The USPTO denied

their prior art McNair 4,285,343 Patent (the *343 patent”) as

not being relevant under 35 U.S.C.§ 102 and not relevant

under 35 U.S.C. §103 in April 1998. See Appendix F, pg.

75-77. The USPTO awarded the certificate of patentability

to the Hemphill ‘720 patent over the prior art of Srininvasan

et al. 3,973,567 Patent (the ‘567 patent) on January 26, 1999.

See Appendix F, pg. 78-89. Johnson & Johnson did not

contest any decision(s) by the USPTO. “There were no

amendments...”. See Appendix F, pg. 89.

‘Johnson & Johnson asserted two prior art patents against the

‘720 patent which warranted two ‘Requests for Reexamination’ in the

United States Patent and Trademark Office. See Appendix H, 94-106.

a

(“This undisputed public record of proceedings in

the Patents and Trademarks Office is of primary

significance in understanding claims.”). Markman v.

Westview Instruments, Inc., 52 F.3d. 967, (Fed. Cir.

1995) 980 at [13-15]. (“As such, the record before

the Patent and Trademark Office is often of critical

significance in determining the meaning of claims”).

Vitronics Corp. v. Conceptronic, Inc., 90 F. 3d. 1576

(Fed. Cir. 1996) 1582 at [9-11]. (“If the language of a

claim is not disputed, then the scope of the claim

may be construed as a matter of law.”). Markman v.

Westview Instruments, Inc., 52 F.3d. 967 (Fed. Cir

1995) 1018, 1019.

The accused devices are Stayfree®, Carefree®,

and Serenity®. *, Johnson & Johnson has a standard

See Serenity® in PL, pg. 602. See Stayfree® in Pl. pg. 603.

.

industrial code 2676. Therefore, in the District Court for

the District of Maryland, Hemphill sued Johnson & Johnson

One Johnson & Johnson Plaza, New Brunswick, New Jersey

08933 on March 8, 1999. On June 4, 1999, Defendant

Johnson & Johnson Motions before the district court to

substitute McNeil-PPC, Inc (SIC 2834) as the official

defendant.’ See Appendix G, pg.90-93.

On February 14, 2000, McNeil-PPC, Inc., was admitted

into DKC 99-CV-654 as the official defendant. *

‘Defendant Johnson & Johnson is “telling” the U.S. District

court for the District of Maryland: (“These products are not

manufactured or sold by Johnson & Johnson. They are products of a

different company called McNeil-PPC, Inc.”), See Paper No. 15 filed

in DKC 99-CV-654 at paragraph 1. Appendix G, pg. 91.

‘McNeil-PPC, Inc. is a company manufacturing

pharmaceuticals in Pennsylvania having an SIC 2834. McNeil-PPC,

Inc., was not a Delaware corporation. Division of McNeil-PPC, Inc is

not a company. McNeil-PPC, Inc. is a copyright on the packaging of

accused devices named above.

-9-

On June 2, 2000 McNeil-PPC, Inc. brought

summary judgement against Allegra D. Hemphill, pro se.

On March 12, 2001, the district court’s ruling is partial to the

- corporate defendant McNeil-PPC, Inc. On March 20, 2001,

Hemphill motions for reconsideration. On May 11, 2001,

the district court denied Hemphill’s motion. Hemphill

appealed on May 23, 2001.

On appeal in the U.S. Court of Appeals for the

Federal Circuit, the Federal Circuit affirmed on

November 27, 2001. Appendix A, pg. 1-21. The Federal

Circuit denied Rehearing on December 21, 2001.

Appendix D., pg. 64-66. The mandate issued on

December 28, 2001. On March 16, 2002, Allegra Hemphill

respectfully petitions for writ of certiorari in the Supreme

Court of the United States, within Supreme Court Rules,

Rule 10.

-10-

REASONS FOR GRANTING THE WRIT

Literal patent infringement is a federal question.

The reason for granting the writ of certiorari is to fulfill

claim construction for the asserted claim 2, species #4,

Ae Fe PO

Fig. 8 and 9 in the ‘720 patent. The Federal Circuit did not

: construe all elements in claim 2 in the ‘720 Patent. Rule

10(a). There is no claim construction for “an outer housing”

in the Federal Circuit opinion. Rule 10(c). See Appendix A,

tS da Dd i Oe

pg. 1-21.

| SUPREME COURT RULE 10(a).

: The Federal Circuit opinion cites: (“...it is proper for

the court to use [p]rosecution history to construe the

claim at issue if the prosecution history relates to the

same structure as the asserted claim”). Alpex

Computer Corp. v._ Nintendo Co., 102 F. 3d. 1214,

1220. See Appendix A, pg. 10-11.

The Federal Circuit focused only on prior art

. =

Gelardin 2393677 (the ‘677 patent”) which has structure as

‘a rotatable base by means of twisting a knob’. Appendix A,

pg. 15. Statements the court relied upon regarding the

Gelardin ‘677 patent are directed to a non-asserted canceled

claim #3. See PL, pg. 528. The Federal Circuit did not

review structure in prior art Srininvasan et.al. ‘567 patent.

Reexamination of the ‘720 patent proved structure in the

prior art Srininvasan ‘567 patent is relevant to the elected

species #4, Fig. 8 and 9. Appendix E, pg. 80. This structure

is readable on the asserted claim 2.°

* See “an outer housing” in the ‘567 Patent. It is a sheet of

flexible material in Col. 4, I!. 47 and Col. 5, Il. 57.

The ‘567 Patent has at least one layer of porous material:

(“...an absorbent core 14 ... made up of any suitable absorbent

material...”). (“...fluid pervious cover 16 which may be such sheet

material as gauze or non-woven fabrics”) Col. 4, ll. 1-5.

The *567 Patent teaches a core member: (“...may comprise a

fluid impermeable sheet material such as polyethylene or polypropylene

cellophane or other similar films”). Col. 4, ll. 5-12. See PL, pg. 574.

-12-

=". ~~ -orr.- 4 - ee . ce Delis Ab te ie el A th

we —= ars tt - - -

“so,

See Appendix E, pg.85 and 86. However, the Federal

Circuit would not review the structure in the ‘567 patent:

(“*...does not persuade us to construe the term ‘vaginal swab’

to cover wrapped napkins.”) See Appendix A, pg. 15.

The ‘720 Patent covers ‘a vaginal swab’ having four

component parts. In a patent claim 2 that is structural

(“...must have all component parts to be a vaginal swab”)

which is in accordance with the USPTO:

(“...Srininvasan does not disclose housing means of

Hemphill and does not disclose structure that could

be considered the equivalent to the housing means of

Hemphill.”). In re Donaldson Co., 16 F.3d. 1189.)

See Appendix F, pg.85-86.

Thus, if the Federal Circuit is not sure about

construing the claim 2 as structural, the court should look to

statements by Examiner’s in the USPTO. Statements by the

USPTO Examiners’ are relevant for understanding the

meaning and scope of claims, also. See Appendix F, pg. 80,

a.

85-86, and pg. 89. (“statements made during reexamination

“are relevant prosecution history when interpreting claims”,

quoting Hemphill v. McNeil-PPC, Inc. in Appendix A, on

pg. 11. By the omission of statements by Examiner’s in the

USPTO, the Federal Circuit is gainsaying the controlling law

they cited. (“It is well-settled that [p]rosecution history is

relevant ...also for construing the meaning and scope of the

claims”). Alpex Computer Corp. v. Nintendo Co., 102 F. 3d.

1214, 1220. See Appendix A, pg. 11.

Refusing to review the structure in the prior art ‘567

patent unfairly narrowed claim construction. Denying the

“USPTO” STATEMENTS and/or Decisions about the prior

art wrongfully limited the scope. Therefore, this dispute

calls for the supervisory power in the Supreme Court.

(“Time and again, the Supreme Court itself has resolved

disputes over construction of claims as a matter of law”).

Markman v. Westview Instruments, Inc. 52 F. 3d. 967 (Fed.

Cir. 1995) 978. The Petitioner appeals to the Supreme Court

-14-

to exercise their authority in this matter.

SUPREME COURT RULE 10(a)

(“Claim construction begins with reading the

words in the claim”). Bell Comm. Research, Inc. v.

Vitalink Corp. 55 F. 3d. 615, (Fed. Cir. 1995)619-620.

The word ‘vaginal’ is defined as:

1. Of or relating to the vagina

2. Relating to or resembling a sheath, quoting American

Heritage College Dictionary , 1488 (3 ed. 1993).° The

patent claim 2 is structural. See as claim 2 reads:

(“A vaginal swab comprising an outer housing including an

inner case member and an outer case member ...”’), the word

“case” appears in claim 2. The word “case” is defined as:

1. acontainer; areceptacle. 2. a container with its contents

*The word “sheath” is to encase or cover with, quoting

American Heritage College Dictionary 1254 (3 ed. 1993). PL, pg. 594.

24.

3. A decorative or protective covering or cover (quoting the

American Heritage College Dictionary 217 (3d ed. 1993).

The specification describes a container in Col.1, ll. 66

through Col. 2, Il. 4: (“My device is comprised of an outer

container,...which allow that container, or at least a part

thereof, ...”). The specification also describes “the cover

section 110 is preferably as a one-piece unit” in Col. 6, Il.

40-42. (“...the court has numerous sources that it may utilize

for guidance.”). Vitronics Corp. v. Conceptronic Inc., 90 F.

3d. 1576 (Fed. Cir. 1996) 1582.

The court did not observe the word “case” in claim 2

and thus, overlooks the term ‘vaginal’ pertaining to “an outer

housing”, cover or sheath in Col. 7, ll. 6-9. By choosing not

to interpret the term ‘vaginal’ in a patent claim 2 that is

structural, the Federal Circuit did not construe the term

-16-

“outer housing”. ’

SUPREME COURT RULE 10(c)

(“An infringement analysis requires two separate

steps. First the court must construe the claims to be

infringed as a matter of law in order to establish their

meaning and scope. Maxwell v. J. Baker Inc., 86 F. 3d.

1098 (Fed. Cir. 1996) 1105, A. Infringement [3-5].

The writ of certiorari should be granted because the Federal

Circuit did not construe an element, “outer housing”.

’ “An outer housing “ that is covering-over to better protect the

unit is seen in Figure 8 in the ‘720 patent. See PL, pg. 404.

The flexible sheet as “outer housing” in the prior art ‘567 patent left the

sides wide-open as shown in Figure 9 in the ‘720 patent.

(“Both this court and the Supreme Court have made clear

that all elements of a patent claim are material with no single

part of a claim being more important or ‘essential’ than

another”). Markman v. Westview Instruments, Inc., 52 F.

3d. 967 (Fed. Cir. 1995) 988.

Claim 2 reads: “an outer housing including

an inner case member and outer case member at least part

of which is connected to and overlies said inner case

member”’). Col. 7, 11.6 -9.

Claim construction by the court has mistaken the

term “outer housing” above, with the term “housing means”

below in Col. 7, ll.11 through Col. 8, ll. 10:

“and housing means for supporting

and enclosing said core member, said core member being

secured to said housing means, having at least two portions

movable relative to one another between first and second

positions for enclosing said core member when in said first

-18-

position and for both exposing said core member and the

said porous padding secured thereto and for forming a

handle for said swab when in said second position..”

The fact the court is forgetting to construe “an outer

housing” is evident on page 15 and certain on page 18:

(‘[t]he Accused Products lack an outer housing as

required ...and instead have an vioueen wiepelon...”)

See Appendix A. The ‘outer wrapping’ the court

disregarded, IS “an outer housing” in claim 2. Col. 7, Il. 6-9:

(“with segments 126 and 128 serving to provide...”),

- (“can be modified as desired so_that the resulting

shape of segments 126 and 128 can be varied”’.).

(“...when sections 126 and 128 are folded down...a

variety of handle structures could be formed.”). Col.

6, ll. 27-38. See Fig 9 in the ‘720 patent. PL, pg.404.

In other words, handle structures 126 and 128

(as outer housing side 1 and side 2) serves to provide

(the housing means) as band or sheet 106. The housing

means IS the handle structure required for using the swab

100. The “housing means” is “or at least a part thereof”

outer housing in Col.1, Il. 68 - Col.2, Il. 4:

(“ ...which allow that container or at least a

part thereof, to form the handle structure for

the swab, with that handle providing both the

protection for the swab while packaged and a

handle during use to provide better control

over swab during such use.”’).

“Housing means” is “a handle”. “Housing means” is at, or

around the base; “for supporting” the core member. Hence,

on page 15 and _ on page 16, the Federal Circuit is actually

construing the “housing means”. * See Appendix A.

*]) “functions as a handle for the use of the swab” 2) “not

designed to be removed or thrown away” 3) “to keep sticky fingers off

the fibers” 4) “an annular band” 5) “an outer diameter which is at least

equal to the inner diameter so that the two can fit thereby allowing the

-20-

Failure to read the words in claim 2 denies

35 U.S.C. §112. The Federal Circuit affirms: “.. core

member ...secured to the outer housing”, see Appendix A,

pg. 16. The court is mistaken. Claim 2 defines:

(“...core member being secured to said housing means...”’).

Col. 8, ll. 2-3. (“The claims are concise statements of the

subject matter for which the statutory right to exclude is

secured by the grant of the patent.”). Multiform Desiccants

Inc. v. Medzam, LTD. 133 F.3d. 1473 (Fed. Cir. 1998) 1476.

The claim defines the invention. 35 U.S.C. §112.

By granting the writ of certiorari , claim construction

will be clear and consistent with the distinctions in claim 2.

Claim 2 reads: “...at least one layer of porous material

secured to said core member, ...said core member being

secured to said housing means ...”. Col. 7, ll. 10 - Col.

core to be secured within the band by a suitable adhesive” . See

Appendix A, pg. 15 and 16.

-21-

8.11.2. In other words, claim 2 is first defined

with no extraneous property limitations. However,

the Federal Circuit agreed with McNeil-PPC, Inc.,

extraneous property limitations from the specification are

admissible. (“When the meaning of a term is sufficiently

clear in the specification, that meaning shall apply.”).

Multiform Desiccants, Inc. v. Medzam, Ltd. 133 F.3d. 1473

(Fed. Cir. 1998), 1477 at [6]. See Appendix A, pg 10.

In doing so, claim 2 is not limited by “fairly rigid core

member”, “annular band” or “adsorbent”, but rather, is

inclusive of the extraneous property limitations. In fact, the

Federal Circuit opinion in Appendix A on page 16 affirms:

(“The specification described the core member as “fairly

rigid”...”). In the specification, it is also understood:

“the invention is not to be limited to the disclosed

embodiment but on the contrary is intended to cover

various modifications and equivalent arrangements

-22-

included within the spirit and scope of the claims,

which scope is to be accorded the broadest

interpretation so as to encompass all such

modifications and equivalent structures.”

Col 6, ll. 51-58. Therefore, structure that is not extraneous is

first defined in the asserted claim 2. The writ of certiorari

should be granted to accomplish claim construction within

35 U.S.C.§ 112.

SUPREME COURT RULE 10(c)

The four portions in a vaginal swab share equally in

importance. The Federal Circuit affirms the word ‘swab’ via

‘

dictionary definition as: “...absorbent material attached to

the end of a stick or wire...’._ See Appendix A, pg. 12 and

pg. 14. The word ‘swab’ in the named vaginal swab also

reads to the unit in claim 2. See Col. 7, Il. 10 through Col.8,

11.10. ° The outer housing protects the unit from danger, risk

and loss. Together, a core member, at least one layer of

porous material and housing means are made safe within an

outer housing side 1 and side 2. In this way, all are essential.

All the portions are secured.

The Supreme Court is being petitioned for

clarification. Claim 2 established safety and effectiveness

for the unit with the words “secured to” and “secured

thereto”. It is not known whether or not the Federal Circuit

intended to replace the words already in the claim 2 with the

word “attached” via dictionary definition.

(“In most situations, an analysis of intrinsic evidence

alone will resolve any ambiguity in a disputed term”).

(“...intrinsic evidence is the most significant source of the

legally operative meaning of disputed claim language”.).

*Core member and its band are “preferably” ...a one-piece unit.

Col. 6, Il. 39-40.

-24-

Vitronics Corp. v. Conceptronic, Inc., 90 F. 3d. 1576 (Fed.

Cir. 1996) 1582. In this way, a dictionary definition can be

inclusive, but it should not limit the meaning and purpose in

the claim. The word “attached” is a limitation that is

not in the specification and it is not in claim 2.

(“[W]e know of no principle of law which

would authorize us to read into a claim an

element which is not present, for purpose of

making out a case of novelty or infringement.

The difficulty is that if we once begin to

include elements not mentioned in the claim

in order to limit such claim and avoid a

defense or anticipation, we should never

know where to stop.”). E.I. DuPont De

Nemours & Co. v. Phillips Petro. 840 F.2d.

1430 (Fed. Cir. 1988) 1433-1434.

PUBLIC CONCERN

Upholding and maintaining the integrity in our patent

system is with good — for granting the writ of certiorari.

In fact, every statement made by the patentee Hemphill was

reviewed by well-qualified Examiners in the United States

Patents and Trademarks Office (“the USPTO”). These

examiners acutely evaluated all statements under careful

scrutiny, first and before rendering their Decisions. The

public trusts the record in the USPTO as a reliable source.

“These documents have legal as well as

technological content, for they show not only

the framework of the invention as viewed by

the inventor, but also issues of patentability as

viewed by the patent examiner”). Multiform

Desiccants, Inc. v. Medzam, Ltd., 133 F. 3d.

1473 (Fed. Cir. 1998). 1477 at [5].

Therefore, in patent application 619,684, the election

of species #4 overcomes the prior art patents. See PL, pg.

534 at paragraph 4. The asserted claim 2 was not narrowed

by this election. The claims readable on species #4 were

claims 5 and claim 6. See PL, pg. 533. Quite simply, the

asserted claim 2 in the ‘720 patent was claim 6 in the patent

application 619,684. See PL, pg. 435. At no time, were any

amendments made to claim 6. See pg. 500 and pg. 516. In

fact, no amendments were made to the asserted claim 2

during reexamination.. '° Thus, statements in the Federal

Circuit opinion on page 7 and on page 12 :

(“Hemphill narrowed her claims...and further limited

the scope of her invention during two reexaminations

proceedings .”), (“she narrowed her claims to

overcome prior art.”), (“she further limited her

claims to convince the PTO to reissue...”)

"There is no change to the drawings. There is no change to the

specification. See Appendix F, pg. 83.

2.

are not true. The court did not look at the facts:

“NO AMENDMENTS HAVE BEEN MADE TO THE

PATENT AS A RESULT OF REEXAMINATION”,

January 26, 1999. See Appendix F, pg. 89. In other words,

despite any and all statements made by the patent owner,

she did not narrow claim 2 and did not limit the scope in

claim 2.

PROOF / EXPLANATION

A). Claims are written for those skilled in the art.

During reexamination, a sanitary napkin is the McNair

4,285,343 patent. A wrapped napkin is the Srininvasan

3,973,567 patent. Reexamination was proof clain. 2 is

inclusive of both “internal use” and “external use”.

Reexamination is proof claim 2 is not limited by the words

“fairly rigid” “adsorbent” or “annular band.” Proof claim 2

can be construed as structural is the fact the USPTO denied

the ‘343 patent with no outer housing, but granted (a core

-28-

member surround by a layer of porous material with

a flexible outer housing) in the ‘567 patent. Appendix F,

pg. 77 and pg. 80.

B) The ‘567 patent had “after use” and “thereafter

use” handling instructions. These instructions probably

disgusted the court which could explain as to why this prior

art ‘567 patent was not construed. The instructions were

directed to a “used” or “dirty” wrapped napkin with three

component parts like prior art ‘567 patent.'' However, claim

construction for the Hemphill ‘720 Patent should not be

“prejudged” because of outrageous handling instructions in

their ‘567 Patent. In point of fact, the three components of a

“wrapped napkin” in the ‘567 patent dated August 1976,

'' Read handling instructions in prior art ‘567 Patent Col. 6, Il.

49-68 and Col. 7, Il. 17-35 in PL, pg. 575-576. Their “outer housing” is

shown “folding-over” in Fig. 10, 11, and 14 in the ‘567 Patent. PL, pg.

572. Moreover, Johnson & Johnson agreed ‘folding over’ forms

‘a handle’ on accused devices; first and before reexamination in the

USPTO. See Appendix H, pg. 100 and 104.

29.

RMN oe aa AD REE HE Sa

cannot cover the accused devices. The accused devices have

the four component parts to be ‘a vaginal swab’.

In the second step of an infringement analysis, the

accused “reads-on” the asserted claim 2. See PL, pg. 579-

590. (“it is important the device be extremely compact, and

easily manufactured so as to be both portable and disposable

rendering it easily carriable and usable.”’) Col. 3, Il. 15-18.

(“The improvements on a vaginal swab are made known

through structural components to become a vaginal swab and

the way the consumer makes use of the device is entirely up

to them.”). It is literal patent infringement.

CONCLUSION

The petition for a writ of certiorari should be granted.

Respectfully submitted,

Allegra Hemphill, pro se

6217 Charnwood Drive

Rockville, Maryland 20852

301 897 - 2030

Date: March 16, 2002

-30-

APPENDIX A

In the

UNITED STATES COURT of APPEALS

for the FEDERAL CIRCUIT

ALLEGRA D. HEMPHILL Plaintiff-Appellant,

V.

MCNEIL-PPC, INC., Defendant -Appellee.

No. 01-1391

DECIDED NOVEMBER 27, 2001.

Before CLEVENGER, GAJARSA, and DYK,

Circuit Judges. DYK, Circuit Judge.

APPENDIX A

NOTE: Pursuant to Fed. Cir. R. 47.6, this disposition

is not citable as precedent. It is a public record. This

disposition will appear in tables published periodically.

United States Court of Appeals for the Federal Circuit

ALLEGRA D. HEMPHILL Plaintiff-Appellant,

v.

MCNEIL-PPC, INC., Defendant -Appellee.

No. 01-1391

DECIDED NOVEMBER 27, 2001.

Before CLEVENGER, GAJARSA, and DYK,

Circuit Judges. DYK, Circuit Judge.

Allegra Hemphill (“Hemphill”) appeals the decision

of the United States District Court of Maryland granting

McNeil-PPC Inc.’s (“McNeil”) motion for summary

judgement that McNeil-s sanitary napkin products do not

infringe Hemphill’s U.S. Patent No. 4,557,720 (the “720

patent”). Hemphill v. McNeil-PPC, Inc., 134 F. Supp. 2d.

719 (D. Md. 2001). Because the district court properly

construed the asserted claim of the ‘720 patent and properly

determined that McNeil’s sanitary napkin products do not

infringe that claim as matter of law, we affirm.

BACKGROUND

Hemphill is the inventor and patentee of the ‘720

patent, which relates to a “Vaginal Applicator”. The patent

describes a disposable vaginal swab or refresher meant either

to cleanse or to treat the vaginal area with fragrances,

medications, germicides, or deodorants. Col. 1, ll. 34-38.

The ‘720 patent has two independent claims, but only claim

2 is at issue on appeal. Claim 2 of the ‘720 patent reads as

follows:

2. A vaginal swab comprising an outer housing

including an inner case member and outer case

member at least part of which is connected to and

overlies inner case member;

a core member at least one layer of porous material

secured to said core member, and housing means for

supporting and enclosing said core member, said core

member being secured to said housing means, having

at lest two portions movable relative to one another

between first and second positions for enclosing said

core member when in said first position and for both

exposing said-core member and the said porous

padding secured thereto and for forming a handle for

said swab when in said second position.

*720 patent, col. 7, 1. 6-col.8, 1.10.

McNeil manufactures and sells several families of

sanitary napkin products including Stayfree sanitary napkins,

Carefree, sanitary napkins. Serenity adult napkins. For

purposes of determining infringement. McNeil’s Stayfree,

Carefree, Serenity products (the “Accuse Products”) are

nearly identical in design. Hemphill, 134 F. Supp. 2d. At

723. The following description of the Accused Products is

undisputed:

The Accused [Products] are sold in multiple units in

large plastic bags, inside of which are individual

napkins packaged in plastic wrappers. Each of these

individual units is composed of absorbent material

with a flexible thin porous membrane that is attached

on one side to a flexible plastic sheet that has an

adhesive on the other side. In its packaging, the side

of the plastic sheet containing the adhesive is

attached to a thin paper sheet.

In order to use the napkin, the consumer removes the

plastic packaging, and peels off the thin paper sheet.

Then, the consumer presses the side with the

adhesive to the undergarment in order to attach the

napkin to the undergarment. The napkin is intended

to passively collect fluid during use. After use the

consumer pulls on the napkin to peel it off of the

undergarment, and then discards it, either directly or

by first inserting the napkin into the plastic wrapper

of the next napkin. The Accused [Products] are not

designed to be used of placed internally in the

vagina. They do not have handles, and do not have

adsorbent material.

Id. At 723-34 (emphasis added) (citations omitted).

Hemphill sued McNeil in the United States District

Court for the District of Maryland, alleging that several

families of McNeil’s sanitary napkin product lines infringe

the ‘720 patent. McNeil moved for summary judgement of

noninfringement at the close of discovery.

The district court first construed claim2 of the ‘720

patent. Looking to the intrinsic evidence, the district court

construed the claim language in light of the specification and

prosecution history. Hemphill, 134 F. Supp. 2d. At 725-27.

For example, the district court found that during the

prosecution phase, Hemphill narrowed her claims to

distinguish her invention from prior art. And further limited

the scope of her invention during two re-examination

proceedings. Jd. At 721-722. On the basis of this intrinsic

evidence, the district court interpreted claim 2 to require a

“vaginal swab” to be used within the vaginal canal and to be

comprised of four component parts: (1) an outer housing; (2)

a core member; (3) at Jeast one layer of porous material; and

(4) a housing means. Id. At 728.

The district court then compared claim 2 as construed

to the Accused Products, and concluded that the Accused

Products, as a matter of law, did not infringe the ‘720 patent.

Id. At 729. As for literal infringement, the district court

found that “the structure of [Hemphill’s] invention differs

vastly from the accused devices on each element.” Id. At

728. As for infringement under the doctrine of equivalents,

the district court found that Hemphill “failed-to offer a single

assertion illustrating that the difference between the

elements of her invention and the accused devices is only

insubstantial. Rather, the evidence establishes [that] the

difference is vast.” Id. At 729.

Accordingly, the district court granted McNeil’s

motion for summary judgement of noninfringement .

Hemphill then filed a Motion for Reconsideration pursuant

to District Court of Maryland Local Rule 105.10 and Federal

Rule of Civil Procedure 60 seeking reconsideration of the

entry of summary judgement. The district court treated her

motion as Rule 59(e) Motion to Alter or Amend Judgement,

and denied the motion.

Hemphill filed a timely pro se appeal. We have

jurisdiction over this appeal pursuant to 28 U.S.C. 1295

(a)(1).

DISCUSSION

I. Claim Construction

Hemphill argues that the district court improperly

construed claim 2 by “reading into” claim 2 “extraneous

limitations from the specification”, and by reading

limitations into claim 2 that relate to claim1. McNeil

responds that the district court properly looked to the

specification and prosecution history to construe claim 2.

We agree.

In interpreting claim, a court “should look first to the

intrinsic evidence of record, i.e. the patent itself, including

the claims, the specification and, if in evidence the

prosecution history.” Vitronics Corp. v. Conceptronic, Inc.,

90 F3d. 1576, 1582, 39 USPQ2d 1573, 1576 (Fed. Cir.

1996). It is well-settled that for purposes of claim

construction, the specification may act as a sort of dictionary

that explains the invention and may define terms used in

claims. Markman v. Westview Instruments, Inc., 52 F.3d.

967, 979, 34 USPQ2d 1321, 1330 (Fed. Cir. 1995) (en

banc), afffd., 517 U.S. 370 (1996). When the meaning of a

term used in a claim is sufficiently clear from its definition

in the specification, that meaning shall apply. Multiform

Desiccants, Inc. v. Medzam, Ltd., 133 F.3d. 1473, 1477, 45

USPQ2d 1429, 1432 (Fed. Cir. 1998). In this case, the

district court properly looked to the specification for

clarification of several terms which were not wholly defined

in the claim language.

Similarly, the district court properly looked to the

prosecution history of the ‘720 patent. Hemphill argues that

“the district court construed] the wrong. .claim” by reading

into claim 2 limitations relating to claim 1. But even where

the prosecution history does not relate to the particular itis

at issue, it is proper for the district court to use that

prosecution history to construe the claim at issue if the

10

prosecution history relates to the same structure as the

asserted claim. Alpex Computer v. Nintendo Co., 102 F.3d.

1214, 1220 40 USPQ2d 1667, 1662 (Fed. Cir. 1996) (“[W]e

discern no reason why prosecution history relating to the

structure of...claim lis not pertinent to the same structure

...[in] claim 12 and 13".) It is well settled that “[p]rosection

history is relevant not only for purposes of prosecution

history estoppel but also for construing the meaning and

scope of the claims.” Id. At 1220, 40 USPQ2d at 1671.

Thus, like the specification, the prosecution history can act

like a dictionary, Hoechst Celanese Corp. v. BP Chems. Ltd.,

78 F.3d. 1575, 1578, 38 USPQ2d 1126, 1129 (Fed. Cir.

1996), cert. denied, 519 U.S. 911 (1996), and statements

made during reexamination proceedings “are relevant

prosecution history when interpreting claims.” E.]. DuPont

de Nemours & Co. v. Phillips Petroleum Co.. 849 F.2d.

1430, 1439 TUSPQ2d 1129, 1136 (Fed. Cir. 1988), cert.

1]

denied, 488 U.S. 986 (1988). In this case, in construing

claim 2, the district court relied on statements Hemphill

made during prosecution of the ‘720 patent in which she

narrowed her claims to overcome prior art. The district

court also relied on Hemphill’s statements, described below,

that she made during two reexmaintion proceedings in which

she further limited her claims to convince the PTO to reissue

them. The district court properly relied on Hemphill’s

statements made during prosecution and during the

reexamination proceedings, even though some of those

statements related to the unasserted claim 1.

The district court construed the term “swab” to mean

“a small piece of absorbent material attached to the end of a

stick or wire and used for cleansing or applying medicine.”

Hemphill, 134 F. Supp. 2d. At 727. (Quoting American

Heritage Dictionary 1810 (3d ed. 1992). Hemphill argues

that the term “vaginal” does not limit her invention to a swab

12

meant for use inside the vaginal cavity, but instead “pertains

to the outer housing as a cover or sheath”. We agree with

the district court. After determining that claim 2 “provides

little guidance as to the terms ‘vaginal’ and ‘swab,’ the

district court found that the “specification clarifies that

[Hemphill] designed the ‘vaginal swab’ to enter into the

vaginal cavity”, and that the “specification defines the

purpose of the invention as ‘a truly portable, convenient, and

disposable internal vaginal cleaning device or refresher.” Id.

At 726. Thus, the district court found that the specification

limits the term “vaginal” to a “swab entering into the vaginal

canal.” Id, The district court also found that Hemphill

distinguished her invention from prior art during prosecution

by stating that the prior art lacked “an elongated structure for

the swabbing element to be introduced into the vaginal

cavity.” Id. The district court accordingly precluded

Hemphill from “claiming] that her invention is not meant to

=

13

enter into the vaginal cavity,” and construed the term

“vaginal” to mean “ a swab entering into the vaginal canal”.

Id.

Finally, the district court relied on the following

dictionary definitions to determine the plain meaning of the

term “swab”; American Heritage Dictionary, 1810 (3d ed.

1992) (defining “swab” as [a] small piece of absorbent

material attached to the end of a stick or wire and used for

cleansing or applying medicine”); Dorland’s Medical

Dictionary 1617 (28" ed. 1994) (defining “swab” as “a wad

of cotton or other absorbent material firmly attached to the

end of a wire or stick, used for apply medication, removing

material, collecting bacteriological material, etc.”). The fact

that the PTO granted Hemphill’s request for reexamination

in light of a patent for wrapped sanitary napkins (U.S. Patent

No. 3,973,567) (the “Srininvasan” patent) and reissued her

patent over Srininvasan does not alter the proper

14

construction of the term “vaginal swab,” and does not

persuade us to construe the term “vaginal swab” to cover

wrapped sanitary napkins. We find that the district court

properly construed the term “vaginal swab.”

Next, the district court construed the term “outer

housing” to require an outer housing that “functions as a

handle for the use of the swab,” and is “not designed to be

removed and thrown away”. Hemphill, 134 F. Supp. 2d at

727. Specifically, the district court found that during

prosecution of the ‘720 patent, Hemphill distinguished her

invention from U.S. Patent No. 2,393,677 (the ‘677 patent),

noting that her “outer housing” transformed into a “handle

structure”, a metamorphosis absent from the invention of the

‘677 patent. Id. We find that the district court properly

construed the term “outer housing.”

The district court then construed the term “core

member” to require “a fairly rigid core member with an

15

age

annular band or ring at its base that can fit into the band or

ring of the outer housing.” Id. The district court looked to

Hemphill’s statements during prosecution of the ‘720 patent

to determine that the purpose of the “annular band” is “to

keep sticky fingers off the fibers,” and to possess “an outer

diameter which is at least equal to the inner diameter” of the

band attached to the outer housing, “so that the two can fit

thereby allowing the core to be secured within the band by a

suitable adhesive.” Id. The specification described the core

member as “fairly rigid,” and secured to the outer housing.

Id. We find that the district court properly construed the

term “core member.”

We agree with McNeil that the district court properly

construed all terms of claim 2, as a matter of law.

II. Infringement

Hemphill’s pro se appeal implicitly challenges the

16

district court’s grant of summary judgement of

noninfrignement. To prove literal infringement, Hemphill

must establish that the Accused Products contain each and

every limitation of the asserted claim. See e.g., Maxwell v.

J. Baker. Inc., 86 F.3d. 1098, 1105, 39 USPQ2d. 1001, 1004

(Fed. Cir. 1996), cert. denied, 520 U.S. 1115 (1997).

Hemphill’s sole discernible argument regarding infringement

is based on an advertisement describing certain features of

the Accused Products. Hemphill, 134 F. Supp. 2d. At 728.

After comparing claim 2 to the Accused products, the district

court found that the limitations in claim 2 were not satisfied

by the Accused Products.

First, as noted above, the-district court found that the

term “vaginal swab” limited the invention to “a small piece

of absorbent material attached to the end of a stick or wire

and used for cleansing or applying medicine,” and meant to

be used inside the vaginal canal. Jd. At 727. The district

17

court found that the Accused Products are not designed for

use within the vaginal canal, and that a sanitary napkin is

neither the size nor shape to allow for internal use. Id. At

728.

Second, as noted above, the district court found that

the term “outer housing” limited the invention to a swab

with a housing that “functions as a handle for the use of the

swab,” and is “not designed to be removed and thrown

away.” Id. At 727. The district court found that the Accused

Products lack an outer housing as required by the ‘720

patent, and instead have an “outer wrapping that is discarded

once the sanitary napkin is utilized.” Id, At 728.

Finally, as noted above, the district court found that

the term “core member” required a “fairly rigid core member

with an annular band or ring at its base that can fit into the

band or ring of the outer housing.” Id. At 721. The district

court found that the Accused Products lack both a rigid core

18

and an annular band. Id. At 728.

We agree with the district court that no reasonable

jury could find that these limitations recited in claim 2 are

found in the Accused Products.

To prove infringement under the doctrine of

equivalents, Hemphill must show “equivalence” between the

elements of the Accused Products and the claimed elements

of the ‘720 patent, Warner-Jenkinson, Co. v. Hilton Davis

Chem. Co., 520 U.S. 17, 21 (1997, by showing that the

Accused Products “perform[ ] substantially the same

function in substantially the same way to obtain the same

result” as the claimed elements of the ‘720 patent. Graver

Tank & Mfg. Co. v. Linde Air Prods. Co.. 339 U.S.

605, 608 (1950). Noting that Hemphill “failed to offer a

single assertion illustrating that the difference between the

elements of her invention and the accused devices is only

insubstantial,” the district court found that “no reasonable

19

jury could find there to be equivalence between the elements

of [Hemphill’s] invention and the accused devices.”

Hemphill 134 F. Supp. 2d, at 729. There are simply no

genuine issues of material fact regarding infringement, either

literally or under the doctrine of equivalents.

IlI._ Motion for Reconsideration

Hemphill also argues that the district court

erroneously considered her Motion for reconsideration as a

Rule 59(e) Motion to Alter or Amend Judgement. We do

not understand how the district court’s treatment of her

motion as a motion under Rule 59(e) could possibly

constitute prejudicial error. Because the district court’s

decision to treat the motion as a Rule 59(e) motion did not

prejudice Hemphill, we need not further address this issue,

and we affirm the district court’s dismissal of Hemphill’s

motion.

CONCLUSION

Because the district court’s claim construction was

not Jegally erroneous, and its infringement analysis was

proper, the district court’s grant of summary judgement of

noninfringement is

AFFIRMED.

APPENDIX B

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARYLAND

ALLEGRA D. HEMPHILL

v.

MCNEIL-PPC, INC.

Civil Action No. DKC 99-654

Date of Entry May 11, 2001

APPENDIX B

22

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARYLAND

ALLEGRA D. HEMPHILL v. MCNEIL-PPC, INC.

Civil Action No. DKC 99-654

Date of Entry May 11, 2001

MEMORANDUM OPINION

Presently pending is Plaintiff Allegra Hemphill’s

Motion for Reconsideration brought pursuant to Federal

Rule of Civil Procedure 60(b) and Local Rule 105.10.

Plaintiff, proceeding pro se, contests this court’s order issued

March 12, 2001. Paper No. 60. She primarily asserts that

this court erred in construing claim 2 of her patent, United

States Patent No. 4,557,720. The court rejects this

contention and stands by its prior ruling. Accordingly,

Plaintiff's ee for Reconsideration shall be DENIED.

Motions for reconsideration are typically treated as

Rule 59(e) motions to alter or amend judgement when filed

23

lo

within ten days from entry of judgement and as a Rule 60(b)

motion if it is served more than ten days after the court’s

ruling. See Dove v. CODESCO, 569 F.3d. 807, 809 (4 Cir.

1978) (construing motion for reconsideration asa Rule 59(e)

motion because the motion was served within ten days of

entry of judgement and calls into question the correctness of

that judgement; In re Burnley, 988 F.2d. 1,3,(4th Cir. 1992)

(finding that a motion for reconsideration not filed within ten

days of the entry of judgement must be construed as a

motion under 60(b) rather than 59(e). In the instant case,

this court entered judgement on March 12, 2001, and

Plaintiff filed this motion for reconsideration on March 20,

2001, well within the ten day limit. Thus, it appears this

motion is governed by Rule 59(e) rather than Rule 60(b).’

! Even if the court construed this as a Rule 60(b) motion, it

would fail. Plaintiff fails to offer any evidence supporting a basis for

reconsideration as specified in Rule 60(b), such as mistake,

inadvertence, excusable neglect, newly discovered evidence, or fraud.

Fed. R. Civ. P. 60(b).

24

The Fourth Circuit has identified three grounds for

amending a prior judgement pursuant to Rule 59(e): 1) to

accommodate an intervening change in controlling law; 2) to

account for new evidence not available at trial; or 3) to

correct a clear error or prevent manifest injustice. E.E.0.C.

v. Lockheed Martin Corp., 116 F.3d. 110, 112 (4" Cir 1997)

(citing Hutchinson v. Staton 994 F.2d. 1076, 1081 (4 Cir.

1993)). It is undisputed there has been no intervening

change in the law and that no new evidence has been set

forth. Plaintiff's primary contention is that this court erred

in construing her patent claim.

Claim construction is properly a matter of law before

the court. Markman v. Westview Instruments, Inc. 52 F.3d.

967, 979 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370

(1996). When construing a claim, the court examines “the

claims themselves, the written description portion of the

specification, and the prosecution history.” Bell & Howell

25

Doc. Mgmt. Co. v. Altek Sys., 132 F. 3d. 701,705 (Fed. Cir.

1997), reh’g denied Jan. 6, 1998; Vitronics Corp. v.

Conceptronic, Inc., 90 F.3d. 1576, 1581-82 (Fed. Cir. 1996)

(“The claims, specification, and file history...constitute the

public record of the patentee’s claim, a record on which the

public is entitled to rely.”). In construing claim 2, this court

followed this procedure by looking at the claims themselves,

the specification,, and the prosecution history.

Plaintiff contends that the court did not look to the

words of the claim. However, this is simply not true as

evidenced in the court’s detailed opinion. Paper No. 60 at

14-18. Plaintiff also argues that the literal words of the claim

should be compared to the accused devices prior to the

court’s construction of the claim. Courts, however, have

been instructed first, to construe the claim and then, to

determine whether the claim reads on the accused device.

Markman, 52 F.3d. At 976. Thus, the court properly

26

construed the claim before comparing the claim to the

accused devices. ?

Additionally, a motion for reconsideration that

merely revisits the same arguments already considered and

rejected should be denied. CNF Constructors, Inc. v.

Donohoe Constr. Co., 57 F.3d. 395, 400 (4" Cir. 1995)

(when “the motion seeks reconsideration of legal issues

already addressed in an earlier ruling there are no grounds

for relief); Jnt’l Longhoremen’s Assoc., AFL-CIO v. Cataneo

Inc., 990 F.2d. 794, 801 (4" Cir. 1993) (denying motion for

reconsideration brought by party “rehashing” the same

. Moreover, Plaintiff's various arguments within her :notion for

reconsideration directly contradict each other. For example, she begins

by asserting that the term “vaginal swab” was adequately defined within

the words of the claim itself. Paper No. 61 at 8. She then argues that a

different dictionary definition should have used in the determination of

the meaning of the term “vaginal swab”. Id. At 18. F inally, she claims

that the term “vaginal swab” is simply a title without its own significant

meaning. Id. At 20.

27

arguments the court had rejected). Plaintiffs motion, in

large part, simply reiterates arguments this court has

addressed. Consequently, this court shall DENY Plaintiffs

motion for reconsideration and a separate Order will be

entered.

“o/

DEBORAH K. CHASANOW

United States District Judge

May 11, 2001. ©

28

>

&

est

#, i

Ei

B

3

APPENDIX C

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARYLAND

ALLEGRA D. HEMPHILL

v.

MCNEIL-PPC, INC.

Civil Action No. DKC 99-654

Date of Entry March 12, 2001

APPENDIX C

29

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARYLAND

ALLEGRA D. HEMPHILL v. MCNEIL-PPC, INC.

Civil Action No. DKC 99-654

Date of Entry March 12, 2001

MEMORANDUM OPINION

Plaintiff Allegra Hemphill, proceeding pro se, alleges

that Defendant Johnson & Johnson, Inc. (Johnson and

Johnson) manufactures and districts products which infringe

on her patent, U.S. Patent 4,557,720 (“the ‘720 patent”).

Presently pending and ready for resolution are three motions.

Johnson & Johnson Consumer Companies, Inc. (JJCCT”’) has

filed a Motion for Leave to Permissively Intervene.

Defendant McNeil has filed both a Motion for Summary

| On February 14, 2000, this court ordered that McNeil-PPC,

Inc. (“McNeil”) replace Johnson & Johnson as party defendant because

McNeil is the entity responsible for the manufacture and distribution of

the Stayfree, Carefree, and Serenity products at issue in this case. Paper

No. 36.

30

KOT EAP A Oe CTO RS RG AER RR CMSA RN

a SEs

Judgement for Noninfringement and a Motion to Bifurcate. 2

The issues are fully briefed and no hearing is deemed

necessary. Local Rule 105.6 For the following reasons, the

court shall deny JJCCI’s Motion for Leave to Permissively

Intervene and grant McNeil’s Motion for Summary

Judgement. 3

I. Background

Ms. Hemphill filed her application for the ‘720 patent

with the Patent and Trademarks Office (“PTO”) on June 11,

1984, and her patent was subsequently issued on December

10, 1985. Paper No. 46, Ex. D1. Bearing the title “vaginal

Applicator”, the ‘720 patent describes a disposable vaginal

swab or refresher meant either to cleanse or to treat the

!

. The issue of non-infringement is the sole issue in McNeil’s

summary judgment motion because Defendant does not argue the

validity or unenforceability of Plaintiff's patent. Paper No. 57, 2 n.2.

3 In light of this court’s decision to grant McNeil’s Motion for

Summary Judgement, Defendant’s Motion to Bifurcate is no longer

applicable, and thus, the motion will be denied as moot.

3]

SMART aT eR So

vaginal area with fragrances, medications, germicides, or

deodorants. Id., Col. 1, lines 33-38. The ‘720 Patent has two

independent claims, but only claim 2 is at issue in this

litigation. Id., Ex. B. Deposition of Allegra Hemphill

(“Hemphill Depo”), 10. The description contained in claim 2

of the Applicator is as follows:

a vaginal swab comprising an outer housing including

an inner case member and an outer case member at

least part of which is connected to and overlies inner

case member;

a core member, at least one layer of porous material

secured to said core member, and housing means for

supporting and enclosing said core member, said core

member being secured to said housing means, having

at least two portions movable relative to one another

between first and second positions for enclosing said

core member when in said first position and for both,

32

i a

- oe ms er nn tT eee

SiC ARE ie ana apa NG i a i a

exposing said core member and the porous padding

secured thereto and for forming a handle for said

swab when in said second position.

Id. Ex. D1, Col. 7-8, lines 1-10.

A. Prosecution of the ‘720 Patent.

During the prosecution phase, Plaintiff narrowed her

claims to distinguish her invention from prior art cited by the

Examiner. For example, Plaintiff clarified the distraction

between her invention and a patent awarded to M. Alvarez

by explaining that:

[t]he Alvarez device does not allow for an elongated

structure for the swabbing element to be introduced into the

vaginal cavity nor does it provide a sufficient handle

structure.

Id., Ex. D10, PTO 00313. She also differentiated between

the porous material specified in the respective patents.

Alvarez teaches that a moisture absorbent layer is

33

RARER 0s oh he

exposed after the protective covering is removed. There is a

distinct difference between Absorbent and Adsorbent, to ab

as in Alvarez, absorb is to take in, suck up, swallow, engross

wholly, to take up or receive by chemical or actions as of

gases or liquids, and to ad as in Hemphill to adsorb is to take

up and hold, to gather gas or liquid or dissolved material on a

surface. -

Id., Ex. D6, PTO 000336 (emphasis added).

Additionally, Plaintiff distinguished the “housing” in

her invention from the “housing” in the patent issued to

Albert Gelardin for a Cosmetic Holder. Plaintiff noted:

[t]he Hemphill device, after removing the outer

housing serves as a handle structure, and still serves as a

function for the device, unlike Gelardin that states that the

cover is completely removed.

Id., Ex. D6 PTO 00342.

B. Reexamination of the ‘720 patent

34

OE EE SME i OE ATT UR ON ote HAR aT aod 8

On February 2, 1998, Plaintiff asked the PTO to re-

examine her patent in light of the McNair patent (“McNair”)

for a Sanitary Napkin. With wings. The description of the

McNair patent states as follows:

The central element and side elements have fluid-

impervious backing upon which is placed a thin layer

adhesive which will not penetrate the absorbent materials

placed thereon. The central element has a highly absorptive

pad means whereas the absorptive means on the side panels

may be minimal. The backing element of the central potion

of the invention contains a strip of adhesive covered by a

protective tape until use.

Id., ex. E2, AH 0222. Plaintiff differentiated her invention

from McNair by stating that “Hemphill [vaginal swab]

improves absorbing on the McNair cover sheet because of an

absorbency characteristic”. Id., Ex. El, AH 0230. Thus, the

McNair patent required an absorbent porous sheet, whereas

35

Plaintiff's patent specified adsorbent porous material.

Ultimately, the PTO denied Plaintiff's request for

reexamination after finding that McNair patent “did not raise

a substantial new question of patentability.” Id., E4, AH

0227. Specifically, the PTO stated that the McNair patent

“discloses non of the structural features recited (on Plaintiff's

claims)” in light of Plaintiff's invention having a particular

core member and housing. Id.

Plaintiff also applied for reexamination of her patent

on May 20, 1998, this time over a patent held by Srininvasan

et al. Id., Ex. F2, U.S. Letters Patent No. 3,973,567 (“the

Srininvasan patent). The Srininvasan patent describes a

“wrapped” sanitary napkins that includes plastic outer

packaging and a napkin that affixes to an undergarment using

adhesive. The patent contains this description of the

invention:

A sanitary napkin having an adhesive element thereon

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for attaching to an undergarment is provided with

means for protecting the napkin and the adhesive

element prior to use and for disposing of the napkin

’ after use. The means comprise providing the napkin

with a wrapper sheet of flexible material overlying

one major surface, and the sides of the napkin and at

least partially Overlapping-on the second major

surface of the napkin. The sheet is releasably adhered

to and held in place by the adhesive element.

Id., Ex. Fl, PTO 00509.

The PTO granted Plaintiff’ s request for

reexamination, finding that “[a] substantial new question of

patentability affecting Claim 2" was raised by the Srininvasan

E patent. Id., Ex. F3, PTO 0048]. Agreeing to compare claim

: 2 and the Srininvasan patent more closely, the PTO

acknowledged the possibility that Srininvasan had the

claimed structure, such as “a core member surrounded by a

37

layer of porous material, an outer housing, and housing

means with 2 positions (one position that protects the core

member and another position that exposes the core member

for use).” Id.

In an effort to get her claimed reissued, Plaintiff

stated the Srininvasan patent lacked both the “housing

means” and “a band” at the base of the core member, found

in her invention. Id., Ex. F4, PTO 00484. Plaintiff

emphasized that the missing band was particularly significant

to her invention because “[t]he band is the means or

intermediary in both Positions from the closed location to

the open state”, Id., Ex. F4, PTO 00486 (emphasis in

original), allowing users “to keep sticky fingers off the

fibers.” Id., Ex. F2, PTO 00447. Furthermore, Plaintiff

distinguished her vaginal swab by stating : [i]t should be well

understood that Hemphill does not behave, operate or

function like a sanitary napkin. Srininvasan does not

38

have the components or parts to be a vaginal swab. Id.,

Ex. F2, PTO 00451. (emphasis in original.)

On January 26, 1999, the PTO issued a reexamination

certificate for the ‘720 Patent over Srininvasan for the

following reasons:

Claim 1 of the patent to Hemphill (4557720) is

considered patentable over the patent to Srininvasan,

et al. (3973567) because Srininvasan simply does not

disclose the claimed structure, such as an open end

Opposite a closed end, an annular band, and frangible

seams.

Claim 2 of the patent to Hemphill (4557720) is

considered patentable over the patent to Srininvasan,

et al. (3973567) because Srininvasan does not

disclose the housing means of Hemphill and does not

disclose a structure that could be considered

equivalent to housing means of Hemphill. Id., Ex. Ff,

39

PTO 00490. :

According to Defendant, beginning in 1994 and

continuing for the next four years, Plaintiff sent letters to

Johnson & Johnson executives alleging that the company’s

sanitary and adult napkins incorporate her patented

technology. Specifically, Plaintiff has alleged that the

Stayfree sanitary napkin, Carefree sanitary napkin , and

Serenity adult napkin product lines infringe upon her patent.‘

Moreover, Plaintiff testified that she considers these

respective product lines to be structurally equivalent to each

other. Id., Ex. B, 363, 368, 372-74, 376077.

Defendant agrees that the three different product lines

are nearly identical in design. Id., Ex. A, McCoy Decl., 95.

Defendant has provided the following undisputed description

' Although Plaintiff mentions in her deposition testimony that

Band Aid brand adhesive bandage products also infringe upon her

patent, she never actually argues this contention. This court construes

Plaintiff's complaint as limited to products from the Stayfree, Carefree,

and Serenity product lines.

40

of these products:

side. Id., 7. In its packaging, the side of the plastic

| The Accused Napkins are sold in multiple units in

' large plastic bags, inside of which are individual

napkins packaged in plastic wrappers. (Ex. A,

] McCoy., 96). Each of these individual units is

: composed of absorbent material with a' flexible thin

porous membrane that is attached on one side to a

4

: flexible plastic sheet that has as adhesive on the other

sheet containing the adhesive is attached to a thin

; paper sheet. Id.,] 7. In order to use the napkin, the

consumer removes the plastic packaging, and peels

off the thin paper sheet. Id., ] 9. The, the consumer

presses the side with the adhesive element to the

undergarment in order to attach the napkin to the

undergarment. Id. The napkin is intended to

passively collect fluid during use. Id., 410. After use,

41

the consumer pulls on the napkin and then discards it,

either directly or by first inserting the napkin into the

plastic wrapper of the next napkin. Id., 911. The

Accused Napkins are not designed to be used or

placed internally in the vagina. Id.,J12. They do not

have handles, and do not have adsorbent material. Id.,

q 13. Paper No. 46, 5.

II. Motion to Intervene

JJCCI has filed a motion for leave to permissively

intervene pursuant to Rule 24(b). See Fed. R. Civ. P. 24(b).

In October 1999 at her deposition, Plaintiff suggested that

Band-Aid brand adhesive bandage products may also infringe

upon her patent. These bandages are manufactured and/or

distributed by JJCCI, another subsidiary of Johnson &

Johnson, not by McNeil- the current party Defendant.

A. JJCCI’s Motion for Leave to Permissively

Intervene

42

Rule 24(b) (2) provides, in pertinent part:

Upon timely application anyone may be permitted to

intervene in an action...when an applicant’s claim or

defense and the main action have a question of law or

fact in common...In exercising its discretion, the court

shall consider whether the intervention will unduly

delay or prejudice the adjudication of the nights of the

Original parties.

Fed. R.Civ. P. 24(b)(2). Thus, permissive intervention is

appropriate in circumstances in which 1) the applicant is

timely; 2) the moving party’s claim or defense and the main

action have a common question of law or fact; and 3) the

proposed intervention will not unduly delay or prejudice the

adjudication of the original parties’ nghts. Hill v. W.

Electronic Co., 672 F2d. 381, 386 (4" Cir. 1982): 6 James

Wm. Moore et al. Moore's Federal Practice $ 24.10 (3ed.

1997).

43

ESP ee ee

B. Analysis

Although Plaintiff identify Band Aid brand adhesive bandages

at her deposition taken October 18, 1999 as a product line

allegedly infringing upon her patent, she never made this

assertion again. Paper No. 53. Exhibit A, Hemphill Depo.,

375-376. In fact, both Plaintiff's response tp JJCI’s motion

for leave to permissively intervene and her opposition

memorandum to McNeil’s motion for summary aihemiiin

contains assertions that Stayfree, Carefree and Serenity

product lines are the sole product lines she is litiga6ting in

this lawsuit. Paper NO. 48 at 5, Paper No. 55 at 1. Plaintiff

does not assert that Ban Aid products are within the

identified accused products in her complaint or in any or her

papers, thus, this court will not force her to litigate an issue

she has not asserted.

Moreover, JJCI provides absolutely no explanation

for the eight moth time lapse between receiving notice

44

a

through Plaintiff's deposition testimony in October 1999

and filing the motion in May 2000. Plaintiff also asserts that

JJCT’s motion is untimely, Particularly, in light of discovery

closing on March 13, 2000. Thus, the court shall deny JJCI’s

motion for leave to permissively intervene. |

Il. McNeil-s Motion for Summary Judgement

A. Summary Judgement Standard

In patent cases, as well as in other cases, a motion for

summary judgement will be granted only if there exists no

genuineissue as to any material fact and the moving party is

entitled to judgement as a matter of law. Fed. R. Civ. P.

56(c); Anderson v, Liberty Lobby, Inc.,/477 U.S. 242, 250

(1986); Celotex Corp. v. Catrett, 477 US. 317, 322 ( 1986):

Clark v. Alexander, 85 F.3d. 146, 150 (4 Cir. 1996). The

moving party bears the burden of Showing that there is no

genuine ssue of material fact. Fed. R.Civ. P. 56(c); Pulliam

810 F.2d At 1286 (citing Charbonnages de France v. Smith

45

597 F.2d. 406, 414 (4 Cir. 1979)).

When ruling on a motion for summary judgement,

the court must draw all reasonable inferences in favor of and

construe the facts in the light most favorable to the non-

moving party. Tinsley v. First Union Nat'l Bank, 155 F. 3d.

435, 437 (4 Cir. 1998). A properly supported motion for

summary judgement may not be defeated by “the mere

existence of some alleged factual dispute between the

parties.” Anderson, 477 U.S. at 247-48. Further, while the

court is charged with liberally construing a complaint filed by

a pro se litigant to allow the development of a potentially

meritorious case, the requirement of liberal construction does

not mean that the court can assume the existence of a

genuine issue of material fact where none exists. Weller v.

Dep't of Social Services, 901 F.2d. 387, 391 (4" Cir. 1990):

Beaudett v. City of Hampton, 775 F.2d. 1274, 1277 (4* Cir

1985).

46

Although an infringement analysis usually involves

both questions of fact and law, summary judgement of

noninfringement may still be proper. Nike Inc., v. Wolverine

Worldwide Inc. 43 F.3d. 644, 646 (Fed. Cir. 1994),

Chemical Eng’g Corp. v. Essef Indus. Inc., 795 F2d. 1565,

1571 (Fed. Cir. 1986). A good faith dispute about the

meaning and scope of asserted claims does not, in and of

itself, create a genuine dispute to preclude summary

judgement in patent cases. Lantech, Inc. vy. Kelp Mach. Co.,

32 F. 3d. 542, 546 (Fed. Cir. 1994).

B. Analysis

Plaintiff alleges that McNeil’s Stayfree, Carefree and

Serenity product lines literally infringe her ‘720 patent.

Defendant objects to this characterization by Stating that the

original design for these products existed prior to Hemphill’s

patent and that these products vary in both design and

purpose compared to Hemphill’s vaginal applicator. *

In order to assess this motion, the court must engage

in a two-step infringement analysis. “The first step is

determining the meaning and scope of the patent claims

asserted to be infringed. The second step is comparing the

properly construed claims to the device accused of

infringing.” Markman v. Westview Instruments, Inc., 52

F.3d. 967, 979 (Fed, Cir. 1995) (en banc), aff'd, 517 U.S.

370 (1996). Claim construction is correctly a matter of law

for the court to decide. Id. When construing a claim, a court

should look to the intrinsic evidence, i.e., the patent itself, its

claims, wnitten description and tthe prosecution history.

> Defendant asserts that all of the accused products arise from

a Stayfree sanitary napkin sold in 1981, prior to the existence of the

‘720 patent. See Paper No. 46. Exhilbit L, Stayfree Sanitary Napkin

Manufacturing Specifications. Plainitiff, however, contends that the

design of these accused products changed after she sent samples of her

patented invention to Defendant ‘s parent company in an attempt to

distribute her product commercially. Without reaching the question of

whether the accused products were sold in the same form prior 10 the

filing of the “720 patent, this court will analyze whether the products in

their present form infringe Plaintiff's “720 patent.

48

Vitronics Corp. v. Conceptronic, Inc., 90 F.3d. 1576, 1582

(Fed. Cir 1996). Additionally, statements made during the

reissue [reexamination] proceeding “are relevant prosecution

history when interpreting claims,” E.J. DuPont de Nemours

& Co. v. Phillips Petroleum Co., 849 F.2d. 1430, 1439 (Fed.

Cir. 1988).

1. Claim Construction

Claim construction begins with the words of the

Claim. Bell Comm. Research, Inc. v. Vitalink Comm. Corp.,

55 F.3d. 615, 619-620. (Fed. Cir. 1995). Moreover, claim

terms are given their plain meaning unless the inventor :

“choosing to be his or her own lexicographer,” uses terms in

a manner other than their ordinary meaning and clearly

discloses these special or alternative meanings in the patent

specification or file history. Vitronics, 90 F.3d. At 1582;

Beachwood v. Wiledwood Creative Products, Inc., 31 F.3d

1154, 1158 (Fed. Cir. 1994). Courts may rely on dictionary

49

definitions when construing claim terms “so long as the

dictionary definition does not contradict any definition found

or ascertained by a reading of the patent documents.”

Vitronics, 90 F.3d. At 1582.

The parties agree that only claim 2 of the ‘720 patent

is at issue. Claim 2 provides in pertinent part as follows:

A vaginal swab compnising an outer housing

including an inner case member and outer case

member at least part of which is connected to and

overlies inner case member;

a core member at least one layer of porous

material secured to said core member, and housing

means for supporting and enclosing said core

member, said core member being secured to said

housing means, having at lest two portions movable

relative to one another between first and second

positions for enclosing said core member when in said

50

first position and for both exposing said core member

and the said porous padding secured thereto and for

forming a handle for said swab when in said second

position.

Plaintiff has specifically identified the four component parts

to the vaginal swab as : 1) outer housing: 2) core member, 3)

at least one layer of porous material; and 4) a housing means.

Paper No. 46, Ex. G.

a. Vagina Swab

Plaintiff asserts that the term “vaginal” refers to the

outer housing as the cover or Sheath, and, “swab” refers to

the unit being used as either a swab to dry or absorb or an

applicator to hold or apply treatment. Paper No. 55, 3. By

contrast, Defendant offers a narrower definition that a

“vaginal swab” is a stick or wire with a small piece of

absorbent material attached the end of it, which is of a size

and structure for cleansing or applying medicine within the

51

vaginal canal.

While the claim provides little guidance as to the

terms “vaginal” and “swab”, the ‘720 patent specification

clarifies that Plaintiff designed the “vaginal swab” to enter

into the vaginal cavity. For an example, the specification

defines the purpose of the invention as “a truly portable,

convenient, and disposable internal vaginal cleansing device

or refrehner.” Paper No. 46, Exhibit Fl, Col. 1, lines 46-48.

Moreover, the invention in the ‘720 Patent is designed to dry

or absorb material in the internal vaginal area. Id., Col. 3,

lines 5-6. In fact, the length of the average vaginal cavity

establishes the approximate length of the swab, including the

core and gauze material. Id., Col. 3, lines 50-54. From the

prosecution history, Plaintiff also distinguished her invention

on this particular point by statement that the invention

Alvarez lacked “an elongated structure for the swabbing

element to be introduced into the vaginal cavity.” Id., Ex.

52

D10, PTO 00313.

In the face of all of this evidence, Plaintiff will not be

allowed to claim that her invention is not meant to enter into

the vaginal cavity. After all, “a patentee may not construe a

claim term one way during prosecution in order to obtain

allowances of the patent and then in a different way during

litigation in order to obtain a finding of infringement.”

Knorr Bremse Systeme Fuer Nutzfahrzeuge GMBH v. Dana

Corp., No. CIV. A. 00-803-A, 2001 WL 179815m at 4 *4

(E. D. Va. 2001) citing Southwall Ti echnologies, Inc. v.

Cardinal IG Co., 54 F.3d. 157-, 1579 (fed. Cir. 1995). Thus,

the ‘720 patent limits the term “vaginal” to a swab entering

into the vaginal canal.

As for “swab”, the ‘720 patent states that a vaginal

swab should preferably be “comprised of fairly rigid core

member constructed either in segments of as a one piece unit,

over which a thick gauze type absorbent pad or layer is

53

secured”. Paper Nol. 46, Ex. D1, Col. 2, lines 5-9. The

plain meaning of the term “swab” is “a small piece of

absorbent material attached to the end of a stick or wire and

used for cleansing or applying medicine.” American

Heritage Dictionary 1810 (3d.ed. 1992): Dorland’s Medical

Dictionary 1617 (28* ed. 1994).

B. Outer Housing & Housing Means

Plaintiff asserts that “outer housing” is the “packaging

that protects [the swab] from danger, risk or

loss in an enclosing or protecting relationship and the

“housing means” is a part of the outer housing. Paper No.

55, 2. In claim 2, she states that the outer housing must have

“an inner case member and an outer case member,” must be

secured to the core member and must have at least two

portions movable relative to one another.” Paper No. 46,

D1, Col. 7-8, line 1-10. Moreover, the ‘720 Patent

specification states that the “outer housing” is comprised of

54

“an external cover, an internal tubular member, and rotatable

base.” Id., Col. 1 lines 19-22. During the prosecution

process. Plaintiff, further clarified the housing structure in

order to distinguish her invention from Gelardin’s patent

She explained:

[t]he Hemphill device, after removing the outer

housing serves as handle Structure, and still serves as

a function for the device, unlike Gelardin...that states

that the cover is completely removed.

Thus, the outer housing is not designed to be removed and

thrown away but actually functions as a handle for the use of

the swab. Plaintiff's suggestion that the outer housing is only

equivalent to protective packaging is clearly at odds with

both the terms of the patent as well as the Plaintiff's own

assertions during the prosecution phase.

C. Core Member

Plaintiff claims that having an accused device with a

55

core member, whether flexible or rigid, is enough to infringe

upon her patent. However, according to the’720 patent

specifications, the core member should be fairly rigid, Id. ,

Col. 7, lines 10, and have an “annular band or ring” at the

base, Id., Col. 5, lines, 31 - 33. Furthermore, the core

member is secured to the outer housing “can be formed either

as a solid structure preferably with a hollow interior.”

Id., Col. 5, lines 33-35. The purpose of the “annular band” is

two-fold: 1) “to keep sticky fingers off the fiber,” Id., Ex. F2.

PTO 00447, and 2) to possess “an outer diameter which is at

least equal to the inner diameter of the band attached to the

outer housing, “so that the two can fit thereby allowing the

core to be secured within the band by a suitable adhesive.”

Id., Ex. D1, Col. 5, line 45-48. Thus, consistent with the

patent specifications, claim 2 require a fairly ngid core

member with an annular band or ring at its base that can fit

into the band or ring of the outer housing.

56

D. Layer of porous material

Plaintiff identified the layer of porous material as a

critical element of her invention. Paper No. 46, Ex. G. In

prior documentation, including the patent itself, Plaintiff

provided a much more specified for the layer of porous

material. In fact, the ‘720 patent specification dictates that

the porous material should be “secured about the interior

surface [the] core.” Id., Ex. D1, Col. 5, line 35-37.

Moreover, the porous material should be a “which gauze

type adsorbent pad or layer.” Id., Col. 2, lines 7-8. During

the reexamination proceedings, Plaintiff emphasized that the

absorbency of her invention distinguished it from McNair’s

absorbent invention. Id., Ex. El, AH 0229 (“Hemphill

improves absorbing on the McNair cover sheet because of an

absorbency characteristic”). According to the patent

specification and Plaintiff's Previous assertions, the porous

material should be secured to the exterior surface of the core

57

member and be composed of adsorbent material.

2. Comparison to Accused Device

After the claims are properly construed, then the

terms “must be compared to the accused device or process.”

Carroll Touch Inc., v. Electro Mechanical Systems, Inc 15 F.

3d, 1573, 1576 (Fed. Cir. 1993). “In order for there to be

infringement each and every limitation set forth in a patent

claim must be found in the accused device, either literally or

doctrine of equivalents.” Bell Atlantic Network Services v.

Covad Comm. Group, Inc. 92 F.Supp. 2d. 483, 498 (E.D.

Va. 2000) (citing Lemelson v. United States, 752 F2d.

1538,1551 (Fed. Cir. 19985)).

a. Literal Infringement

Plaintiff offers an advertisement for the accused

devices as evidence the Defendant has literally infringed her

patent. The advertisement contains these assertions : 1) “an

absorbent core pulls fluid-in and locks it away”, and 2) “the

58

silky clean cover draws fluid away and helps keep it below

the surface to help you feel clean and dry.” Paper No. 52,

Ex.2. Despite Plaintiff's attempts to portray the elements of

her invention in a manner to the quoted advertisement she is

unable to prove that each element of her patented invention

can be found in the accused devices. A claim of literal

infringement requires proof that the accused devices meet

every limitation of the Properly construed claims, Gentry

Gallery, Inc. v, Berkline Corp., 134 F. 3d. 1473, 1476 (Fed.

Cir. 1998). “If even one limitation is missing and not met as

claimed, there is no literal infringement. Mas-Hamiilton

Group v. LaGard, Inc., 156 F3d. 1206 » 1211 (Fed. Cir.

1998).

First, and foremost, Plaintiff has stated that her

vaginal swab does not resemble, behave or function like a

Sanitary napkin. Each of the accused products is a type of

sanitary napkin which lacks the rigid core required in a swab

59

and is not designed for use within the vaginal canal. The

accused products are designed “to cover a substantial portion

of an undergarment in order to passively collect fluid that

flows onto them.” Paper No. 46 Ex. B, 4] 12.

Second, the structure of Plaintiff's invention differs

vastly from the accused devices on each element. Plaintiff's

vaginal swab is comprised of an outer housing structure that

encloses a core member in first position and exposes the core

member and forms a handle for the swab in the second

position. The accused devices has an outer wrapping that is

discarded once the sanitary napkin is utilized. At most, the

discarded wrapper covers the used and soon- to- be

discarded napkin. The protective packaging of the accused

devices is in no way equivalent to the handle function of the

“outer housing” in Plaintiff's invention.

Moreover, Plaintiff asserts that because the accused

products have a core pad, they infringe upon her invention.

60

However, the ‘720 patent clearly specifies that the core

member be “fairly rigid” and have an annular band at its base

that can fit into the band of the outer housing. The accused

products do not have such a structure.

Finally, Plaintiff went to great lengths during the

reexamination phase to distinguish the absorbency

characteristics of the porous material used in her invention

versus the absorbeny characteristic of the McNair patent.

Plaintiff, herself asserts that McNeil’s products have an

absorbent core yet, offers absolutely no explanation as to

how the porous material can possibly be the same between

Plaintiff's invention and the accused devices. Accordingly,

Plaintiff has failed to establish that the accused products

literally infringe upon her ‘720 patent.

B. Doctrine of Equivalents

Under this doctrine, a product which does not literally

infringe upon the express terms of a patent may nonetheless

61

infringe if there is “equivalence” between the elements of the

accused products and the claimed elements of the patent.

Zelinski v. Brunswick Corp., 185 F3d. 1311, 1316 (Fed. Cir.

1999) (citing Warner-Jenkinson, Inc. v, Hilton Davis Chem

Co. 520 U.S. 17, 21, (1997)). Infringement occurs under

this doctrine or equivalents if the difference between the

particular element and the claim limitation are “insubstantial”.

Id. A test to determine “insubstantially” is whether “the

element performs substantially the same function in

substantially the same way to obtain substantially the same

result as the claim limitation.” Id. At 1316-1317 (citing

Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S.

605, 608 (1950).

Once again, Plaintiff has admitted that her invention,

a vaginal swab, “does not look or behave like a sanitary

napkin” or even “function like a sanitary napkin” Paper No.

46, Ex. E3, AH 0245. Moreover, Plaintiff has failed to offer

62

a single assertion illustrating that the difference between the

elements of her invention and the accused devices is only

insubstantial. Rather, the evidence establishes the difference

is vast. Accordingly, the court shall find that no reasonable

jury could find there to be equivalence between the elements

of Plaintiff's invention and the accused devices.

IV. Conclusion

For the foregoing reasons, this court shall GRANT

McNeil’s Motion for Summary Judgement for

Noninfringement.

A separate Order will be entered .

“s/

DEBORAH K. CHASANOW

United States District Judge

March 12, 2001.

63

APPENDIX D

UNITED STATES COURT of APPEALS

for the FEDERAL CIRCUIT

ALLEGRA D. HEMPHILL, Plaintiff-Appellant,

v.

MCNEIL-PPC, INC., Defendant -Appellee.

No. 01-1391

Date of entry December 21, 2001.

ORDER DENYING REHEARING

APPENDIX D

UNITED STATES COURT of APPEALS

for the FEDERAL CIRCUIT

ALLEGRA D. HEMPHILL, Plaintiff-Appellant,

V.

MCNEIL-PPC, INC., Defendant -Appellee.

No. 01-139]

Date of entry December 21, 2001.

ORDER

Before CLEVENGER, GAJARSA, and DYK, Circuit

Judges.

A petition for rehearing having been filed by the

APPELLANT, UPON CONSIDERATION THEREOF, it is

ORDERED that the petition for rehearing be, and the same

hereby is, DENIED.

The mandate of the court will issue on December 28,

2001.

65

FOR THE COURT

Dated: December 21, 2001

cc: Allegra Hemphill

George F. Pappas

HEMPHILL V. MCNEIL-PPC, 01-1391

(DCT -99-CV-654)

FILED

U.S. COURT OF APPEALS FOR

THE FEDERAL CIRCUIT

DEC 21 2001

JAN HORBALY

Note: Pursuant to Fed. Cir. R. 47.6, this order is not citable

as precedent. It is a public record.

APPENDIX E

STATUTES

35 U.S.C.§ 102

35 US.C.§ 103

35 U.S.C. §112

35 US.C.§ 132

67

APPENDIX E

35 U.S.C. 102 . Conditions for patent ability; novelty

and loss of right to patent

A person shall be entitled to a patent unless —

(a) ihe invention was known or used by others in this

country, or patented or described in a printed publication in

this or a foreign country, before the invention thereof by the

applicant for patent, or

(b) the invention was patented or scribed in a printed

publication in this or a foreign country or in public use or on

sale in this country, more than one year prior to the date of

the application for patent in the United States, or

(c) he [or she] has abandoned the invention, or

(d) the invention was first patented or caused to be patented

by the applicant or his [or her] legal representatives or

assigns in a foreign country prior to the date of application

for patent in this country on a application filed more that

twelve months before the filing of the application in the

68

United States, or

(e) the invention was described in a patent granted on an

application for patent by another filed in the United States

before the invention thereof by the applicant for patent, or

(f) he [or she] did not himself [or herself] invent the subject

matter sought to be patented, or

(g) before the applicant’s invention thereof the invention was

made in this country by another who had not abandoned,

Suppressed, or concealed it. In determining priority of

invention there shall be considered not only the respective

dates of conception and reduction to practice of the

invention, but also the reasonable diligence of one who was

first to conceive and last to reduce to practice, from a time

prior to conception by the other. (R.S. 4886, 4887, 4923: 35

U.S.C., 1946 ed., 3] 32, 72).

Notes- Section 4(b) of the Act of July 19, 1952

provides:

69

Ra Mcnine SM

DE

“Section 102(d) of title 35, as enacted by section 1 hereof,

shall not apply to existing patents and pending applications,

but the law previously in effect, namely the first paragraph of

R.S. 4887 (U.S. Code, title 35, sec. 32, first paragraph, 1946

ed.), shall apply to such patents and applications.”

Section 4(d) of the Act of July 19, 1952 provides:

“The period of one year specified in section 102(b) of |

Title 35 as enacted by section 1 hereof shall not apply in the

case of applications filed before August 1940, and patents

granted on such applications, and with respect to such

applications and patents, said period is two years instead of

one year.”

70

35 U.S.C. 103. Conditions for patent ability’ non-

obvious subject matter

A patent may not be obtained through the invention is

not identically disclosed or described as set forth in section

102 of this title, if the differences between the subject matter

sough to be patented and the prior art are such that the

subject matter as a whole would have been obvious at the

time the invention was made to a person having ordinary skill

in the art to which said subject matter pertains. Patent ability

shall not be negatived by the manner in which the invention

was made.

=

35 U.S.C. §112 Specification:

The specification shall contain a written description

of the invention, and of the manner and process of making

and using it, in such full, clear, concise, and exact terms as to

enable any person skilled in the art to which it pertains, or

with which it is most nearly connected, to make and use the

same, and shall set forth the best mode contemplated by the

inventor of carrying out his [or her] invention.

The specification shall conclude with one or more

claims particularly pointing out and distinctly claiming the

subject matter which the applicant regards as his [or her]

invention.

An element in a claim for combination may be

expressed as a means or step for performing a specified

function without the recital of structure, matenal, or acts in

support thereof, and such claim shall be construed to cover

the corresponding structure, material, or acts described in the

72

specification and equivalents thereof. (R.S. 4888; 35 U.S.C.,

1946 ed., 33.).

35 U.S.C. 132. Notice of rejection; reexamination

Whenever, on examination, any claim for a patent is

rejected, or any objection or requirement made, the

Commissioner shall notify, the applicant thereof, stating the

reasons for such rejection, or objection or requirement,

together with such information of the propriety of continuing

the prosecution of his [or her] application; and if after

receiving such notice, the applicant persists in his [or her]

claim for a patent, with or without amendment, the ~

_ application shall be reexamined. No amendment shall

introduce new matter into the disclosure of the invention.

(RS. 4903; 35 U.S.C., 1946 ed., 51),

SE AS ST aa

APPENDIX F

UNITED STATES DEPARTMENT OF COMMERCE

Patents and Trademark Office

APPENDIX F

74

Patents and Trademark Office

ORDER GRANTING/DENYING REQUEST

FOR REEXAMINATION

ReExamination No. 90/004,908

Date mailed 04/] 5/98

The request for reexamination is DENIED.

In due course, a refund under CFR 1.26(c) will be made to

requester (listed below if not Patent owner) by Treasury

check.

ReExamination No. 90/004,908

Art Unit 3734

Decision

No substantial new question of patent ability is raised

by the request for reexamination and prior art cited therein

for the reasons set forth below.

The newly cited U.S. patent 4,285,343 issued to

McNair does not raise a substantial new question of

patent ability as to claims 1 and 2 of the requesters U.S.

Patent 4,557,720 issued to Hemphill.

The claims of the Hemphill patent for which

reexamination is requested , require “A vaginal swab

comprised of...a pair of hinged housing segments defined by

a plurality of frangible seams...in which an absorbent member

is enclosed therein.” And in claim 2, “a vaginal

swab...including a moveable inner and outer case member;” a

core member...including at least one layer of porous material

76

secured to a core member, and housing means for Supporting

and enclosing said core member, said core member being

secured to said housing means, having at least two portions

moveable relative to one another between first and second

positions for enclosing said core member when is said first

position and for both exposing said core member and the said

porous material secured thereto and for forming a handle for

said swab when in said second position.”

The U.S. patent to McNair discloses none of the

structural features recited, Supra. Further, the McNair patent

is neither relevant under 35 U.S.C. 102 nor U.S.C. 103.

Accordingly, since the newly submitted prior art McNair

presents no substantial new question of patent ability, the

request for reexamination is DENIED.

J. Yasko:lf (“s/ )

703 308-2986

April 3, 1998

77

UNITED STATES DEPARTMENT OF COMMERCE

Patents and Trademark Office

ORDER GRANTING/DENYING REQUEST

FOR REEXAMINATION

Serial Number 90/004987

Patent under reexamination : 4,557,720

Date mailed 07/06/98

Art Unit 3735

The request for reexamination has been considered.

Identification of the claims, the references relied on, and the

rationale supporting the determination are attached.

Attachment(s); PTO-892.

The request for reexamination is GRANTED.

78

Serial Number 90/004987

Art Unit 3735

A substantial new question of patent ability affecting

claim 2 of United States Patent Number 4,557,720 is raised

_ by the request for reexamination.

Extensions of time under 37 CFR 1.136(a) will not be

permitted in these proceedings because the provisions of 37

CFR 1,136 apply only to “an applicant” and not to parties in

a reexamination proceeding. Additionally, 35 U.S.C. 305

requires that reexamination proceedings “will be conducted

with special dispatch” (37 CFR 1.550 (a)). Extensions of

time in reexamination proceedings are provided for in 37

CFR 1,550(c). :

The request for re-examination indicates that the

patent to Srnininvasan Et al. . (39735567) may be relevant to

claim 2 and the examiner feels that further consideration of

79

se

this reference is warranted as it was not considered during

prosecution of patent #4,557,720. The request also presents

arguments as to why claim 2 is patent able over the patent to

Srininvasan et al. . (3973567).

It is agreed that the reference to Srininvasan et. al.

raises a substantial new question of patent ability with

respect to claim 2. Srininvasan et al.., has structure that may

read on claim 2 such as a core member surrounded by

a layer of porous material, an outer housing, and housing

means with 2 positions (one position that protects the core

member and another posiiion that exposes the core member

for use). For these reasons the examiner considers that there

is a substantial new question of patent ability with respect to

claim 2 versus the patent to Srininvasan et. al.

(“s/ _)

John G. Weiss

Supervisory Patent Examiner

80

Group 3700

D.R. (Initials)

Assistant Examiner, Sector 3700

Notice of References Cited

Document 3,973,567

Date 8-1976

Srinvasan et al.

Class 604

Subclass 386

82

UNITED STATES DEPARTMENT OF COMMERCE

Patents and Trademark Office

NOTICE OF INTENT TO ISSUE

REEXAMINATION CERTIFICATE

Examination has been terminated in this reexam

proceeding and a certificate will be issued in due course in

view of patent owner’s communication filed on 7/14/98;

7/11/98 and 7/24/98.

The Reexamination Certificate will indicate the

following::

Change in the Specification : No

Change in the Drawings: No

Status of the Claims - Patent claims confirmed 1,2.

Note attached statements of reasons for patentabilityand/or

confirmation. Any comments considered necessary by patent

83

owner regarding reasons for patentability and/or confirmation

must be submitted promptly to avoid processing delays.

Such submissions should be labeled: “Comments on

Statement of Reasons for Patentability and/or Confirmation”.

(“s/ )

John G. Weiss

Supervisory Patent Examiner

Group 3700

cc. Requestor

84

Re-exam no. 90/004987 Date mailed 10/07/98

Art Unit 3735

1. STATEMENT OF REASONS FOR

PATENTABILITY AND/OR CONFIRMATION

The following is an examiner’s Statement of reasons

for patentability and/or confirmation of the claims found

patent able in this reexamination proceeding:

Claim 1 of the patent to Hemphill (4557720) is considered

patent able over the patent to Srininvasan et al. (3973567)

because Srininvasan simply does not disclose the Claimed

structure, such as an open end Opposite a closed end, an

annular band, and frangible seams.

Claim 2 of the patent to Hemphill (4557720) is

considered patent able over the patent to Srininvasan et al.

(3973567) because Srininvasan does not disclose the housing

means of Hemphill and does not disclose structure that could

be considered equivalent to the housing means of Hemphill.

85

In re Donaldson Co., 16 F.3d. 1189, 29 USPQ2d 1845 (Fed.

Cir. 1994).

Any comments considered necessary by PATENT

OWNER regarding the above statement must be submitted

promptly to avoid processing delays. Such submission by the

patent owner should be labeled: “Comments on Statement of

reasons for Patent ability and/or Confirmation “ and will be

placed in the reexamination file.

a Any inquiry concerning this communication or

earlier communications from the examiner should be directed

to Dennis Ruhl whose telephone number is

(703) 308-22-62.

(“s/ )

Johnson G. Weiss

Supervisory Patent Examiner

Group 3700

D.R. (Initials)September 1, 1998

86

REEXAMINATION CERTIFICATE (3712")

United States Patent [ 19]

Hemphill

[54] VAGINAL APPLICATOR

[76]Inventor Allegra D. Hemphill, 6217 Charnwood Dr.,

Rockville, Md. 20852

Reexamination Request: No. 90/004.987. May 22, 1998

Reexamination Certificate for:

Patent No. 4,557,720

Issued: Dec. 10. 1985

Appl. No. 619,684

Filed: Jun. 11, 1984

Related U.S. Application Data

[62] Division of Ser. Bo. 434,828 Oct. 18, 1982, abandoned.

OST) Int. Ch eee. A61B 10/00

87

[11] B1 4,557,720

[45] Certificate Issued Jan. 26,1999

bari CLs @ + SReeeeeneee 604/1; 401/77; 401/78

[56] References Cited

U.S. PATENT DOCUMENTS

3,973,567 8/1976 Srininvasan et al. .............. 604/386

Primary Examiner -John Weiss

[57] ABSTRACT

A disposable vaginal refresher or swab comprised of an outer

container for enclosing an inner, fairly ngid core member

on which an adsorbent layer is secured. The outer

container when removed exposes the adsorbent covered

member or allows that member to be moved out of the

cine Siti an operable position. The outer container also

forms the handle of the disposable swab element.

B1 4,557,720

REEXAMINATION CERTIFICATE ISSUED

UNDER 35 U.S.C. 307

NO AMENDMENTS HAVE BEEN MADE TO

THE PATENT AS A RESULT OF REEXAMINATION.

IT HAS BEEN DETERMINED THAT:

The patentability of claims 1 and 2 is confirmed.

* * * x »

APPENDIX G

JOHNSON & JOHNSON’S MOTION

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARYLAND

SOUTHERN DIVISION

ALLEGRA D. HEMPHILL Plaintiff,

V.

JOHNSON & JOHNSON , Defendant

Civil Action No. DKC 99CV654

Date: June 4, 1999

APPENDIX G

90

DEFENDANT JOHNSON & JOHNSON’S

MOTION TO SUBSTITUTE DEFENDANT

Defendant Johnson & Johnson, by its undersigned

attorneys, moves to dismiss Johnson & Johnson a party to

the instant lawsuit, and moves to substitute McNeil-PPC,

Inc., and for reason states as follows:

1. In her Complaint and discovery responses,

plaintiff Allegra D. Hemphill (“Hemphill) has alleged that

various products infringe upon United States Patent No.

4,557,720, her patent for a vaginal applicator. Although her

theories of infringement remain obscure and difficult to

comprehend, the brand name products she has accused of

infringement are Stayfree®, Serenity®, Sure & Natural®,

and Carefree® sanitary napkins. These products are not

manufactured, marketed or sold by Johnson & Johnson.

They are products of a different company called

McNeil-PPC, Inc.

2. Johnson & Johnson, the original party Defendant,

the parent company of McNeil-PPC, Inc is a Delaware

corporation with its principal place of business in New

Jersey. McNeil-PPC, Inc., a subsidiary of Johnson & —

Johnson, is also a Delaware corporation with its principal

place of business in New Jersey. |

3. At all times material hereto, McNeil-PPC, Inc was

and is subject to jurisdiction in the courts of the state of

Maryland.

4. Accordingly, defendant Johnson & Johnson

requests that McNeil-PPC, Inc be substituted as the correct

party defendant in this case. Plaintiff will not be prejudiced

by this substitution since McNeil-PPC, Inc waives any

defects in service arising out of the incorrect designation.

Respectfully submitted,

(“s/ )

George F. Pappas

Tern L. Turner

92

cues:

Pe ERR aR RGU LAS Mra eats Be

Venable, Baejter, Howard &

Civiletti, LLP.

1201 New York Avenue, N.W.

Suite 1000

Washington, DC 20005

(202) 962-4800

Attomeys for Defendant

Johnson & Johnson and

McNeil-PPC, Inc.

93

ST

—$——$

APPENDIX H

JOHNSON & JOHNSON LEGAL ANALYSIS /OPINION

JOHNSON & JOHNSON

Office of General Counsel

One Johnson & Johnson Plaza

New Brunswick, N.J. 08933-7003

Tel. (732) 524-2826

Fax: (732) 524-2808

January 6, 1998

APPENDIX H

94

Johnson & Johnson

Office of General Counsel

One Johnson & Johnson Plaza

New Brunswick, N.J. 08933-7003

Tel. (732) 524-2826

Fax: (732) 524-2808

January 6, 1998

This is in response to your letters of December

11,23,29 to the Chief Executive Officer of Johnson &

Johnson.

We have carefully reviewed your allegation that

McNeil-PPC’s STAYFREE Maxi sanitary napkin infringes

claim 2 of your U.S. Patent No. 4,557,720, in particular the

opinion letter of April 29, 1997 from Mr. Sheldon H. Parker

from the law firm of Parker and DeStephano. While we

disagree with your as well as Mr. Parker’s opinion regarding

95

the scope of your patent and its relevance to our

STAYFREE sanitary napkins, we have nevertheless provided

you with an analysis (as Mr. Parker has interpreted the

claims) of a sanitary napkin having an outer wrapper which

was disclosed in our U.S. Patent No. 3,973,567 (copy

enclosed). Our patent issued more than one year prior to the

filing date of your patent application. As you will note, all of

the elements (in accordance with Mr. Parker’s interpretation)

which you allege exist in our present STAYFREE sanitary

napkin are also disclosed in this earlier patent. Thus, to the

extent that you allege that our current STAYFREE sanitary

napkins read on the claims in your patent, these claims

cannot be considered to be valid.

96

CLAIM 2

A vaginal swab comprising an outer housing including an

inner case member and outer case member at least part of

which is connected to and overlies inner case member

STAYFREE**

plastic wrapper side one side two

U.S. PATENT 3,973,567

sheet 20 of flexible material side one and side two

97

CLAIM 2

a core member, at least one layer of porous material secured

to said core member and housing means for supporting and

enclosing said core member, said core member being secured

to said housing means

STAYFREE

inner pad with absorbent core

cottony dry cover of STAYFREE

‘567 PATENT

absorbent core 14 with fluid pervious cover to core via

envelope formed with cover 16 and fluid. impermeable sheet

98

a

a EE RR OEY TTI

CLAIM 2

having at least two portions movable relative to one another

between first and second positions

STAYFREE

fold over STAYFREE unit as for disposal .

‘567 PATENT

fold over napkin unit

CLAIM 2

for enclosing said core member when in said first position

STAYFREE

as for disposal

‘567 PATENT

Figures 10, 11, 14 show ends folded over for disposal

CLAIM 2

sod for both exposing said core member and the said porous

padding secured thereto and for forming a handle for said

swab when in said second position

STAYFREE

folded over for disposal forms handle for disposal

‘567 PATENT

folded over for disposal forms handle for disposal

Figures 10, 11 and 14 show ends folded over for disposal

100

( it Nr a seis

abi ee 8 bana dead

***Hemphill interpretation of STAYFREE

The following is an alternate comparison of the product and

CLAIM 2.

A vaginal swab comprising an outer housing including an

inner case member and outer case member at least part of

which is connected to and overlies inner case member

STAYFREE

outer housing

inner porous sheet

‘567 PATENT

outer housing

fluid pervious cover 16

101

CLAIM 2

and outer case member at least part of which is connected to _

and overlies inner case member

STAYFREE

outer plastic layer

‘567 PATENT

fluid impermeable sheet overlying bottom major surface

CLAIM 2

a core member, at least one

layer of porous material secured to said core member

STAYFREE

inner absorbent pad cottony dry cover STAYFREE.....

‘567 PATENT

Absorbent core 14 with fluid pervious cover 16 secured to

core via envelope formed with cover 16 and fluid

impermeable sheet

102

CLAIM 2

and housing means for supporting and enclosing said core

member ,

STAYFREE

outer shell

‘567 PATENT

outer shell

CLAIM 2

said core member being secured to said housing means

having at least two portions movable relative to one another

between first and second positions

STAYFREE absorbent core is secured to cottony dry layer

and to plastic layer

‘$67 PATENT

absorbent core 14 is secured to core via envelope formed by

fluid pervious cover and fluid impermeable sheet

103

ee

CLAIM 2

for enclosing said core member when in said first position

STAYFREE

fold over two ends of STAYFREE unit as for disposal

‘567 PATENT

Figures 10, 11, 14 show ends folded over for disposal

CLAIM 2

and for both exposing said core member and the said porous

padding secured thereto and for forming a handle for said

swab when in said second position

STAYFREE

folded over for disposal forms handle for disposal

‘567 PATENT |

folded over for disposal forms handle for disposal

**Hemphill interpretation of STAYFREE

We have carefully considered and addressed all of the

104

issues raised in your letters and have now provided you with

a copy of the Johnson & Johnson patent which issued before

Hemphill, as you requested. Accordingly, as we previously

advised, our STAYFREE sanitary napkins do not infringe

any valid claim of your patent and we consider this matter to

be closed.

We note from your correspondence that you are now

represented by legal counsel. Since the current matter

concerns legal issues, it would be unethical for us to continue

to correspond directly with you. Accordingly, in the unlikely

event that you have any further questions or issues regarding

the foregoing claim analysis, please direct these to your

attorney and we will be happy to discuss these issues with

him.

Sincerely,

(‘s/ ”)

James P. Barr

JPB

Enclosure

cc. Sheldon Parker

106