Petition for Writ of Certiorari — Nigel Parker, et al., Petitioners v. Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director, Patent and Trademark Office

No. 18In the

Supreme Court of the United States

________________________

NIGEL R. PARKER AND SEPPO YLÄHERTTUALA,

Petitioners

-againstThe Honorable ANDREI IANCU, in his official

capacity as Under Secretary of Commerce for

Intellectual Property and Director of the United

States Patent and Trademark Office,

Respondent

________________________

ON PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

J. MARK POHL

Counsel of Record

PHARMACEUTICAL PATENT

ATTORNEYS, LLC

55 Madison Avenue, 4th fl.

Morristown, New Jersey 07960

(973) 984-6159 x304

Mark.Pohl@LicensingLaw.Net

September 21, 2018

Attorneys for Petitioners

i

Question Presented

In Dickinson v. Zurko, 527 U.S. 150 (1999), this

Court held that The United States Patent Office

must support rejection with substantial evidence.

See Dickinson at 152, citing 5 U.S.C. § 706(2)(E).

In the instant case, The Patent Office rejects

Petitioners’ patent claims based on either of two

alleged antedating publications. Neither document,

however, is of record. This appeal thus raises simple

yet fundamental questions of agency overreach:

Whether the “substantial” evidence required to

support agency action under 5 U.S.C. §

706(2)(E) must be evidence of record?

Whether agency rejection is “arbitrary” or

“capricious” under 5 U.S.C. § 706(2)(A) if

supported only by alleged evidence which is

not of record and which the agency has not in

fact considered?

Whether a document which is not publicly

available is a “publication” under 35 U.S.C. §

102(b)?

ii

Rule 14(b) Statement

A list of all parties to the proceeding in the court

whose judgment is sought to be reviewed:

Nigel R. Parker Ph.D. and Seppo Ylä-Herttuala M.D.,

Petitioners. The real party in interest is the assignee

of the instant patent applications, FKD Therapies Oy.

The Honorable Andrei Iancu, in his official capacity

as Under Secretary of Commerce for Intellectual

Property and Director of the United States Patent

and Trademark Office, Respondent.

iii

Corporate Disclosure Statement

The real party in interest, FKD Therapies Oy, a

Finnish company, hereby identifies The Frederick

Paulsen Foundation, a privately-held Swiss

foundation, as its ultimate parent company indirectly

owning 100% of Petitioner’s stock.

iv

Table of Contents

QUESTION PRESENTED ....................................... I

RULE 14(B) STATEMENT .................................... II

CORPORATE DISCLOSURE STATEMENT .... III

TABLE OF CONTENTS ........................................ IV

TABLE OF AUTHORITIES ................................... V

TABLE OF APPENDIXES .................................... VI

OPINIONS BELOW ................................................. 1

JURISDICTION ....................................................... 2

STATUTORY PROVISION INVOLVED ............... 3

STATEMENT OF THE CASE ................................. 4

STERMAN (DEC. 15, 2011) DOES NOT QUALIFY AS

PRIOR ART UNDER 35 U.S.C. § 102(B)...................... 4

DIGITAL FILE DOI NO. 10:1164/ RCCM.2011030554CR WAS CREATED ON 11/24/2011.................... 5

THE BOARD CORRECTLY DISTINGUISHED BETWEEN

STERMAN (DEC. 15, 2011) AND THE DIGITAL (DOI)

FILE ......................................................................... 8

THE BOARD’S EX PARTE INVESTIGATION CONFIRMS

THAT THERE IS NO “EARLIER MANUSCRIPT” .......... 10

THE ALLEGED MANUSCRIPT IS NOT A “PUBLICATION”

............................................................................... 11

ROUTINE BUSINESS PRACTICE CAN SHOW THE DATE

OF PUBLICATION, BUT NOT THE SUBSTANCE OF THE

PUBLICATION.......................................................... 12

THE FEDERAL CIRCUIT AFFIRMED PER CURIAM ..... 13

ARGUMENT ............................................................ 13

v

THE DOI FILE DOES NOT QUALIFY AS ANTEDATING

PRIOR ART .............................................................. 14

NEITHER THE DOI FILE NOR THE ALLEGED

MANUSCRIPT ARE OF RECORD ............................... 15

THE ALLEGED MANUSCRIPT IS NOT A “PUBLICATION”

............................................................................... 16

THE AGENCY’S REJECTION IS ARBITRARY AND

CAPRICIOUS BECAUSE IT IS NOT SUPPORTED BY ANY

EVIDENCE OF RECORD ............................................ 16

CONCLUSION ........................................................ 17

vi

Table of Appendixes

Appendix 1a – Decision of the United States Court of

Appeals for the Federal Circuit, docket 2018-1088

(July 17, 2018)

Appendix 3a – Decision Of The Patent Trial &

Appeal Board, docket 2016-008089 (Sept. 27, 2017)

Appendix 11a - Decision of the United States Court

of Appeals for the Federal Circuit, docket 2017-2244

(July 17, 2018)

Appendix 13a - Decision Of The Patent Trial &

Appeal Board, docket 2016-003044 (May 24, 2017)

vii

Table of Authorities

Cases

Chicago Firefighters Local 2 v. City of Chicago, 249

F.3d 649 (7th Cir. 2001)......................................... 15

Citizens to Preserve Overton Park v. Volpe, 401 U.S.

402 (1971) .......................................................... 9, 14

Dickinson v. Zurko, 527 U.S. 150 (1999)............. 9, 11

Eisenstadt v. Centel Corp., 113 F.3d 738 (7th Cir.

1997) ...................................................................... 14

In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000) ........ 15

In re Hall, 781 F.2d 897 (Fed. Cir. 1986) ........... 11, 16

Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545

F.3d 1340 (Fed. Cir. 2008) .............................. 12, 16

Roberts v. City of Shreveport, 397 F.3d 287 (5th Cir.

2005) ...................................................................... 15

Verdegaal Bros. v. Union Oil Co. of California, 814

F.2d 628 (Fed. Cir. 1987) .................................. 6, 17

Statutes

28 U.S.C. § 1254(1) ..................................................... 2

35 U.S.C. § 134(a) ....................................................... 2

35 U.S.C. § 141 ............................................................ 2

5 U.S.C. § 706(2) ................................................. 11, 17

Rules

Fed. R. Evid. Rule 803 .............................................. 12

1

Petitioners here petition for a writ of certiorari to

review the two judgments of The United States Court

of Appeals for the Federal Circuit entered on July 17,

2018 in Petitioners’ two patent applications.

Opinions Below

Regarding

patent

application

serial

No.

13/932202, the opinion of The Court of Appeals for

the Federal Circuit (docket 2018-1088) is not

reported and is reproduced in the Appendix at 1a.

The underlying opinion of The Patent Trial & Appeal

Board (docket 2016-008089) is not reported and is

reproduced in the Appendix at 3a.

Regarding

patent

application

serial

No.

14/030399, the opinion of The Court of Appeals for

the Federal Circuit (docket 2017-2244) is not

reported and is reproduced in the Appendix at 11a.

The underlying opinion of The Patent Trial & Appeal

Board (docket 2016-003044) is not reported and is

reproduced in the Appendix at 13a.

2

Jurisdiction

The Patent Trial & Appeal Board enjoyed

jurisdiction to hear an appeal of the rejection of the

instant patent applications under 35 U.S.C. § 6(b).

The Court of Appeals for the Federal Circuit enjoyed

jurisdiction to hear an appeal of The Patent Trial &

Appeal Board under 35 U.S.C. § 141.

The judgments of the Court of Appeals were entered

on July 17, 2018. No petition for rehearing was

entered. This Court therefore enjoys jurisdiction

under 28 U.S.C. § 1254(1).

3

Statutory Provision Involved

This case concerns the Federal Administrative

Procedure Act, 5 U.S.C. § 706(2):

“The reviewing court shall … (2) hold

unlawful and set aside agency action,

findings, and conclusions found to be (A) arbitrary, capricious, an abuse of

discretion, or otherwise not in

accordance with law; [or]

***

(E) unsupported by substantial

evidence in a case subject to sections

556 and 557 of this title or otherwise

reviewed on the record of an agency

hearing provided by statute.

4

Statement of the Case

The relevant facts are undisputed.

Sterman (Dec. 15, 2011) Does Not Qualify As

Prior Art Under 35 U.S.C. § 102(b)

Petitioners filed two utility patent applications,1 each

asserting an effective filing date as of July 11, 2012.

One cannot patent something which is fully taught in

an earlier publication. See pre-AIA 35 U.S.C. §

102(b).

The Examiner accordingly began examination by

entering into the record a journal article, Daniel H.

Sterman et al., A Trial of Intrapleural AdenoviralMediated Interferon-α2b Gene Transfer for Malignant

Pleural Mesothelioma, 184 AMER. J. RESPIRATORY &

CRITICAL CARE MED. 1395 (Dec. 15, 2011). The

Examiner argued that Petitioners’ patent claims

were barred under pre-AIA 35 U.S.C. § 102(b) by

Sterman et al. (Dec. 15, 2011).

The statute then in effect, however, afforded patent

applicants a grace period. The statute said that to

antedate, a prior publication must have been

published “more than one year prior to the date of the

application for patent.” See pre-AIA 35 U.S.C. §

102(b). In the instant case, Petitioners’ patent

applications assert an effective filing date of July 11,

2012. Therefore, to antedate, a publication must

have been published before July 11, 2011.

1

Patent Application Serial Nos. 13/932202 and 14/030399.

5

Sterman (Dec. 15, 2011), however, says on its face

that it was published on December 15, 2011:

See Appx30.2 Sterman (Dec. 15, 2011) was published

five months after the July 11 cut-off date. Sterman

(Dec. 15, 2011) therefore does not qualify as an

antedating publication. 3 See pre-AIA 35 U.S.C. §

102(b).

Digital File DOI No. 10:1164/ rccm.2011030554CR Was Created On 11/24/2011

Petitioners explained this to the Examiner. In

response, the Examiner conceded that Sterman (Dec.

15, 2011) does not qualify as a prior art.

“Appx” refers to the Appendix of record before the Court of

Appeals below.

In contrast, “__a” refers to the instant

Appendix.

2

Pre-AIA 35 U.S.C. § 102 has seven subsections, (a)

through (g). The Examiner correctly recognized that of these

seven subsections, six do not apply here. The Examiner thus

rejected the claims under only one subsection - subsection (b).

Thus, for simplicity I here say “does not qualify as prior art”

rather than a more verbose “does not qualify as prior art under

subsection (b)” because only subsection (b) is at issue. The

Board commented that Sterman (Dec. 15, 2011) might qualify

as prior art under subsection (a). That commentary, however,

is dicta because no rejection under subsection (a) was at issue

below.

3

6

The Examiner, however, raised a new argument.

Sterman (Dec. 15, 2011) says that it was published

Dec. 15, 2011. It also says, “Originally Published in

Press as DOI 10:1164/rccm.201103-0554CR on June

3, 2011. Internet address: www.atsjournals.org”:

See Appx31.

The Examiner thus shifted position

and rejected the patent applications not on Sterman

(Dec. 15, 2011), but on the “DOI” digital file referred

to in it.4

The Examiner, however, omitted from his rejection

two critical pieces of evidence.

First, the Examiner did not make the DOI digital file

of record. This is important because to reject a

patent claim under 35 U.S.C. § 102(b), the

antedating publication must show each and every

limitation of the patent claim, and must do so in

detail adequate to enable the skilled artisan to

practice the claimed invention. See e.g., Verdegaal

Bros. v. Union Oil Co. of California, 814 F.2d 628,

631 (Fed. Cir. 1987). In the instant case, however,

the digital DOI file is not of record. We thus cannot

determine whether it teaches each limitation of these

“DOI” means Digital Object Identifier. A DOI number

functions like an ISBN number does for books. A DOI number

identifies a specific digital file (e.g., a specific photograph or a

particular Adobe Acrobat™ file). This is useful because the

same digital file may be found in many different places on the

internet. The DOI number indicates that all of these copies are

identical.

4

7

patent claims. We thus cannot determine whether or

not the DOI file anticipates these patent claims. See

Verdegall Bros.

Second, the Examiner did not make of record

evidence showing when the DOI file was in fact

published.

To address this evidentiary void,

Petitioners obtained a copy of the DOI file from the

publisher and examined the file’s metadata. The

metadata shows that the DOI file was created on

Nov. 24, 2011 at 11:07 p.m. Appx62. The cut-off

date for antedating publications, however, is July 11,

2011. See pre-AIA 35 U.S.C. § 102(b). The DOI file

cannot possibly have been published before July 11,

2011 because it was not even created until the

following November 24th. This metadata thus shows

that the DOI file does not qualify as an antedating

publication. See pre-AIA 35 U.S.C. § 102(b).

Petitioners made of record the DOI file metadata.5

In response, the Examiner obtained a copy of the

DOI file and examined its metadata. Based on his

investigation, the Examiner agreed that the DOI file

was first created Nov. 24, 2011. The Examiner

(correctly) says:

“Appellant is relying upon the ‘metadata’

contained within the PDF file which can be

downloaded from the publishers website to

indicate that PDF file was created on

11/24/2011. The Examiner does agree that the

PDF file containing the work of Sterman,

downloaded from the publisher’s website, is a

PDF file created on 11/24/2011.”

N.B.: Petitioners made of record the metadata for the

DOI file. Neither party has made of record the DOI file itself.

5

8

Appx72. The 11/24/2011 creation date disqualifies

the DOI file as § 102(b) prior publication. The

Examiner correctly recognized this. The Examiner

thus did not bother to make the DOI file of record

because it does not qualify as prior art. See pre-AIA

§ 102(b).

The Examiner nonetheless reiterated that he was

rejecting the applications as anticipated by the DOI

file. That rejection is legally flawed because it is

based on a DOI file which the Examiner expressly

found does not qualify as antedating § 102(b) prior

art.6

The Board Correctly Distinguished Between

Sterman (Dec. 15, 2011) and the Digital (DOI)

File

The Examiner rejected Petitioners’ patent claims as

anticipated by digital file number 10:1164/

rccm.201103-0554CR. The Examiner, however, also

found that the digital file was created on Nov. 24,

2011. Appx72. The DOI file thus does not qualify as

antedating prior art as a matter of law. See pre-AIA

35 U.S.C. § 102(b).

Furthermore, assuming the DOI file qualified as

antedating prior art, it does not support rejection

because it is not of record.

Petitioners accordingly appealed to The Patent Trial

& Appeal Board. The Board correctly found that the

Dec. 15 publication (Appx31-32) “was published in

the issue … dated Dec. 15, 2011, which is less than a

6

The Examiner’s rejection appears based on pecuniary self-interest.

The Patent Office is self-funding. It retains applicants’ filing fees for its

own budget. The Examiner here raised a legally-flawed rejection and

refuses further work unless Petitioners pays further fees.

9

year before the provisional filing dates” for

Petitioners’ applications. 5a. The Board correctly

found that Sterman (Dec. 15, 2011) does not qualify

as antedating prior art. See 35 U.S.C. § 102(b).

The Board correctly found that the Dec. 15

publication and the digital file (DOI number 10:1164/

rccm.201103-0554CR) “are not the same.” 9a. The

Examiner correctly found that the DOI file “was

created on 11/24/2011.” Appx72. The Board did not

dispute this.

The Board nonetheless affirmed

rejection based on the DOI file. To support rejection,

the Board disregarded the metadata. In so doing,

the Board made two legal errors.

First, an agency cannot simply ignore adverse

evidence. Rather, an agency’s review must be on the

“full” administrative record.”

See Citizens to

Preserve Overton Park v. Volpe, 401 U.S. 402, 420

(1971) (emphasis mine). In the instant case, the

metadata is of record, the Examiner reviewed it, and

the Examiner made an undisputed factual finding

that the DOI file “was created on 11/24/2011.”

Appx72. The agency’s own Examiner having made

this factual finding, the Board cannot simply ignore

it. See Overton Park.

Second, assuming that the DOI file was published

before the critical date, the DOI file nonetheless

cannot support rejection because the DOI file is not

of record.7 The Patent Office must support rejection

with substantial evidence. See Dickinson v. Zurko,

527 U.S. 150, 152 (1999), citing 5 U.S.C. § 706(2)(E).

In the instant case, the DOI file cannot constitute

N.B.: The DOI file metadata is of record. In contrast,

the DOI file itself is not of record.

7

10

substantial evidence because it is not in evidence.

See id.

The Board’s Ex Parte Investigation Confirms

That There Is No “Earlier Manuscript”

The Examiner found that the DOI file was created on

11/24/2011. The DOI file thus does not qualify as

antedating prior art. See pre-AIA 35 U.S.C. § 102(b).

This is fatal to the Examiner’s rejection.

The Board tacitly recognized this. To rehabilitate

the rejection, the Board of Appeals contacted the

publisher ex parte to obtain a copy of an earlier

publication. See 7a n.3. The Board, however,

declines to make of record its ex parte

communications with the publisher.8

As a threshold issue, you may find the Board’s ex

parte investigation troubling because the Board is an

appellate panel, not an investigator, and agency

regulations forbid the parties from entering new

evidence on appeal. Furthermore, the Board of

Appeal is supposed to be impartial, not an advocate

for the Examiner.

The Board’s pursuit of an ex parte fact-finding

investigation implies that the Board disregarded its

limited and ostensibly impartial role. The Board

nonetheless came up empty-handed. Despite

contacting the publisher directly, the Board failed to

obtain any earlier manuscript.

The Board failed to obtain any earlier manuscript,

despite contacting the publisher directly. The Board

nonetheless says, “an earlier manuscript was

8

N.B.: The Board refers to an “attached email,” see 7a n.3, yet its

opinion does not in fact include any attached emails, see 10a.

11

published online on June 4, 2011.” See 9a. The

Board thus rejects the patent claims based on that

alleged “earlier manuscript.”

The alleged

manuscript, however, is not of record and, in light of

the publisher’s inability to provide a copy to the

Board, apparently does to not exist.

The Board here errs as a matter of law by ignoring

this Court’s mandate.

This Court requires the

agency to support rejection with substantial evidence.

See Dickinson v. Zurko, 527 U.S. 150, 152 (1999),

citing 5 U.S.C. § 706(2)(E). In the instant case, the

Board’s alleged manuscript is not of record. It is

thus not in evidence. It cannot constitute substantial

evidence because it is not even evidence. See id.

Indeed, the publisher’s inability to provide a copy of

it implies that the Board’s alleged manuscript does

not exist.

Furthermore, an agency cannot reject arbitrarily or

capriciously. See 5 U.S.C. § 706(2)(A). In the instant

case, the Board does not have a copy of its alleged

manuscript. The Board thus apparently never read

it. The Board nonetheless rejected based on an

alleged manuscript which the Board never in fact

read. This is the epitome of arbitrary or capricious

action. See id.

In response, the Board speculates that its alleged

manuscript should be similar to Sterman (Dec. 15,

2011).

The Board says, “it is reasonable [to

speculate] that the phrase ‘Originally Published’

refers to this complete article.” See 6a. Without a

copy of that alleged manuscript, however, that is

mere speculation. And speculation is not evidence.

Speculation thus cannot constitute the substantial

evidence this Court requires. See Dickinson.

12

The Alleged Manuscript Is Not a “Publication”

The proponent of an antedating publication must

show that prior to the critical date, the reference was

accessible to the artisan using reasonable diligence.

In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986);

Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545

F.3d 1340, 1350 (Fed. Cir. 2008).

In the instant case, if the Board’s manuscript was

accessible to the artisan, the artisan would be able to

find it in the National Library of Medicine and on the

publisher’s website. Neither, however, provides the

alleged manuscript. Indeed, the Board could not get

a copy despite contacting the publisher directly.

The artisan cannot obtain the alleged manuscript

with reasonable diligence.

It thus is not a

“publication” under the statute. See Kyocera, Hall.

Routine Business Practice Can Show The Date

of Publication, But Not the Substance of the

Publication

The Board found that currently, the publisher

publishes manuscripts on line as soon as they are

accepted for publication. The Board thus argues that

its alleged early manuscript was likely published on

June 4, 2011. The Board here makes three legal

errors.

First, the publisher’s current business practices fail

to evince the publisher’s routine practices in June

2011.

Second, routine business practice may be used to

establish the date a manuscript was published, but

13

cannot establish the contents of that manuscript. See

Fed. R. Evid. Rule 803(6).9

Third, the absence of a transaction from routine

business records tends to show that an alleged

transaction did not occur. See Fed. R. Evid. Rule

803(7). In the instant case, the Board is unable to

produce its alleged early manuscript, despite

contacting the publisher directly. See 7a n.3. This

implies that the alleged manuscript does not exist.

See Fed. R. Evid. Rule 803(7).

The Federal Circuit Affirmed Per Curiam

The Board rejected based on digital DOI file and an

alleged “earlier manuscript.” Neither document,

however, is of record. The Board did not in fact have

either document. The Board thus did not in fact read

either document. The Board thus bases its rejection

on evidence which is not of record, and which the

Board did not read.

Further, the Examiner found that the DOI file was

created on Nov. 24, 2011. It therefore does not

qualify as antedating § 102(b) prior art as a matter of

law. The Board’s inability to obtain its alleged

earlier manuscript from the publisher implies that

the manuscript does not exist. It also shows that the

manuscript as a matter of law is not a “publication’

under the statute. See Kyocera.

The Court of Appeals enjoyed jurisdiction to hear an

appeal from The Patent Trial & Appeal Board under

35 U.S.C. § 141. The Court of Appeals affirmed.

Perhaps recognizing that its decision is not

N.B.: While the Board’s argument echoes Fed. R. Evid. Rule

803, the Board did not expressly cite any authority for its

position.

9

14

supported by any evidence of record, the Court

declined to provide an opinion explaining its

rationale.

Argument

Neither the DOI file nor the Board’s alleged “earlier

manuscript”

constitutes

substantial

evidence

supporting rejection.

The DOI File Does Not Qualify As Antedating

Prior Art

The Examiner considered the metadata for digital

DOI file number 10:1164/rccm.201103-0554CR.

Based on that evidence, the Examiner found the DOI

file was “created on 11/24/2011.” Appx72. The

Examiner’s undisputed factual finding, based on

evidence of record, shows that the DOI file does not

qualify as an antedating publication. See pre-AIA §

102(b).

The Board responds by disregarding both the

metadata and the Examiner’s resulting finding.

Rather, the Board argues that the DOI file was

published on June 3, 2011 because Sterman (Dec. 15,

2011) says so. The Board here commits two legal

errors.

First, an agency’s review must be on the “full”

administrative record.

See Citizens to Preserve

Overton Park v. Volpe, 401 U.S. 402, 420 (1971). An

agency can weigh conflicting evidence. An agency

cannot, however, simply ignore adverse evidence. In

the instant case, the Board ignores the metadata,

and ignores its own Examiner’s finding that that the

DOI file was “created on 11/24/2011.” This is legal

error. See id.

15

Second, even if we ignore the metadata, the DOI file

as a matter of law does not support rejection because

the Board commits a law student’s error, basing it

rejection on uncorroborated hearsay. A newspaper

article can be used to prove the existence of the

article. In contrast, using a newspaper article to

prove the truth of its contents is hearsay. See e.g.,

Eisenstadt v. Centel Corp., 113 F.3d 738, 742 (7th Cir.

1997) (Posner, C.J.); Chicago Firefighters Local 2 v.

City of Chicago, 249 F.3d 649, 654 (7th Cir. 2001)

(same); Roberts v. City of Shreveport, 397 F.3d 287,

295 (5th Cir. 2005) (same).

In the instant case, the Board tries to prove the DOI

file publication date by relying on Sterman (Dec. 15,

2011). The board thus cites Sterman (Dec. 15, 2011)

not to prove the existence of Sterman (Dec. 15, 2011),

but to prove the truth of its contents, i.e., to prove

that digital file No. 10:1164/rccm.201103-0554CR

was in fact published on June 3. The Board’s use of

Sterman (Dec. 15, 2011) is therefore hearsay. See id.

Further, the agency has not made the alleged June 3

document of record. The Board’s hearsay evidence is

thus uncorroborated.

Uncorroborated hearsay is not substantial evidence.

See Consolidated Edison Co. v. NLRB, 305 U.S. 197,

229-30 (1938); In re Gartside, 203 F.3d 1305, 1312

(Fed. Cir. 2000). Uncorroborated hearsay thus fails

as a matter of law to support rejection.

See

Dickinson v. Zurko, 527 U.S. 150, 152 (1999), citing 5

U.S.C. § 706(2)(E). The Board’s rejection fails as a

matter of law because it is based solely on

uncorroborated hearsay.

16

Neither The DOI File Nor the Alleged

Manuscript Are Of Record

The agency must support rejection with substantial

evidence. See Dickinson v. Zurko, 527 U.S. 150, 152

(1999), citing 5 U.S.C. § 706(2)(E). In the instant

case, neither the DOI file nor the Board’s alleged

manuscript is in evidence.

Because neither is

evidence, neither can be the substantial evidence this

Court requires. Furthermore, the Board’s inability

to obtain a copy of the alleged manuscript - despite

asking the publisher directly - implies that the

alleged manuscript does not exist.

In response, the Board speculates that the DOI file

and its alleged manuscript should be similar to the

Dec. 15 document. The Board says, “it is reasonable

[to speculate] that the phrase ‘Originally Published’

refers to this complete article.” See 6a. Without

having copies of the DOI file nor the Board’s

manuscript, however, we cannot see whether those

documents are the same or not.

The Board’s

allegation here is baseless speculation. And

speculation is not evidence. It thus cannot constitute

the substantial evidence this Court requires.

The Alleged Manuscript Is Not a “Publication”

The proponent of an antedating publication must

show that prior to the critical date, the reference was

accessible to the artisan using reasonable diligence.

In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986);

Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545

F.3d 1340, 1350 (Fed. Cir. 2008).

In the instant case, neither the Examiner nor the

Board nor the Petitioner can get a copy of the Board’s

alleged manuscript. The artisan thus cannot obtain

17

it with reasonable diligence.

It thus is not a

“publication” as a matter of law. See Kyocera, Hall.

The Agency’s Rejection is Arbitrary and

Capricious Because It is Not Supported By Any

Evidence of Record

To reject a patent claim under 35 U.S.C. § 102(b), the

antedating prior art publication must show each and

every limitation of the patent claim, and must do so

in detail adequate to enable the skilled artisan to

practice the claimed invention. See e.g., Verdegaal

Bros. v. Union Oil Co. of California, 814 F.2d 628,

631 (Fed. Cir. 1987).

In the instant case, the agency cannot explain where

each limitation of Petitioner’s patent claims is taught

in the DOI file, nor in its alleged “earlier manuscript.”

The agency cannot do so because the agency has not

made either document of record. Not having either

document, the Board apparently never read either

document. The Board thus rejects based on alleged

documents it apparently never read. This is the

epitome of arbitrary or capricious agency action. See

5 U.S.C. § 706(2)(A).

Conclusion

The DOI file and the Board’s alleged “early

manuscript” are not of record. Further, the alleged

manuscript is not cataloged, nor available directly

from the publisher, and apparently does not even

exist. Petitioner respectfully asks this Court to grant

certiorari to clarify that evidence which is not of

record, and which may not in fact exist, is not the

“substantial” evidence this Court requires.

See

Dickinson v. Zurko, 527 U.S. 150, 152 (1999), citing 5

U.S.C. § 706(2)(E).

18

Respectfully submitted,

/s/

J. MARK POHL

Counsel of Record

PHARMACEUTICAL PATENT ATTORNEYS, LLC

55 Madison Avenue, 4th floor

Morristown, New Jersey 07960

(973) 984-6159 x304

Attorneys for Petitioner

APPENDIX

1a

NOTE: This disposition is nonprecedential.

United States Court of Appeals

for the Federal Circuit

______________________

IN RE: NIGEL PARKER, SEPPO YLAHERTTUALA,

Appellants

______________________

2018-1088

______________________

Appeal from the United States Patent and

Trademark Office, Patent Trial and Appeal Board in

No. 13/932,202.

______________________

JUDGMENT

______________________

J. MARK POHL, Pharmaceutical Patent Attorneys,

LLC, Morristown, NJ, argued for appellants.

MARY BETH WALKER, Office of the Solicitor,

United States Patent and Trademark Office,

Alexandria, VA, argued for appellee Andrei Iancu.

Also represented by NATHAN K. KELLEY,

THOMAS W. KRAUSE, WILLIAM LAMARCA.

______________________

2a

THIS CAUSE having been heard and considered, it

is ORDERED and ADJUDGED:

PER CURIAM (PROST, Chief Judge, NEWMAN and

LINN, Circuit Judges).

AFFIRMED. See Fed. Cir. R. 36.

ENTERED BY ORDER OF THE COURT

July 17, 2018

/s/ Peter R. Marksteiner

Date

Peter R. Marksteiner

Clerk of Court

3a

UNITED STATES PATENT AND TRADEMARK

OFFICE

BEFORE THE PATENT TRIAL AND APPEAL

BOARD

Ex parte NIGEL PARKER and SEPPO YLAHERTTUALA

Appeal 2016-008089

Application 13/932,2021,2

Technology Center 1600

Before RICHARD M. LEBOVITZ, ULRIKE W.

JENKS, and RICHARD J. SMITH, Administrative

Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL

This appeal involves claims directed to methods of

treating a cancerous organ comprising administering

a chemotherapeutic agent and a recombinant virus,

where the recombinant virus comprises a

homeomimetic transgene. The Examiner rejected the

claims under 35 U.S.C. §§ 102(b) and 103. We have

jurisdiction under 35 U.S.C. § 6(b). The rejections are

affirmed.

The Appeal Brief ("Appeal Br.") identifies FKD Therapies as

the real party-in-interest.

1

2

"The '202 Application."

4a

STATEMENT OF THE CASE

The claims stand rejected by the Examiner as

follows:

1. Claims 1-9, 11-19 and 21-30 under pre-AlA 35

U.S.C. § 102(b) as anticipated by Sterman (A Trial of

Intrapleural Adenoviral-mediated Interferon-a2b

Gene Transfer for Malignant Pleural Mesothelioma,

184 AM. J. RESPIR. CRIT. CARE MED. 1395-99

(2011)); issue of Dec. 15, 2011). Ans. 2.

The Examiner found that Sterman was originally

published as DOl: 10.1164/rccm.201103-0554CR on

June 3, 2011, which is more than a year before the

provisional application 61/670,330 filing date of July

11, 2012, and the provisional application 61/692,828

filing date of August 24, 2012, to which the '202

Application claims benefit.

2. Claim 10 under pre-AlA 35 U.S.C. § 103(a) as

obvious over Sterman in view of Giaccone (Pleural

mesothelioma: combined modality treatments 13,

Suppl. 4 EUR. SOC. MED. ONCOL. 217-25, (2002)).

Ans. 3-4.

3. Claims 11, 12 and 20 under pre-AlA 35 U.S.C. §

103(a) as obvious over Sterman in view of Lengyel

(Ovarian Cancer Development and Metastasis 177(3)

AMER. J. PATHOL. 1053-64. (Sep. 2010)). Ans. 5.

The '202 Application is the parent application of

continuation application 14/030,399 which was the

subject of Appeal 2016-003044 to the PTAB. A

decision on the appeal was decided on May 24, 2017,

affirming the Examiner's rejection. The decision has

been appealed to the Federal Circuit Court of

5a

Appeals. Appellants did not list this related appeal in

their Appeal Brief.

CLAIMED SUBJECT MATTER

Independent claim 1 is representative and reads as

follows:

1. In a method of treating a human diagnosed as

having cancerous organ by administering

chemotherapeutic agent, the improvement

comprising administering to said human a

recombinant virus, said recombinant virus

comprising a homeomimetic transgene.

REJECTIONS

Appellants contend that Sterman "does not qualify as

prior art" because it was published December 15,

2011, which "is less than one year before the priority

date of the instant application." Appeal Br. 1.

Appellants have presented no other patentability

argument for Rejections 1, 2, and 3. Consequently,

the appeal from all three rejections turns on the

issue of whether Sterman is prior art to the rejected

claims.

The '202 Application in this appeal claims benefit to

a provisional applications filed July 11, 2012 and

August 24, 2012, respectively. Sterman was

published in the issue of American Journal of

Respiratory and Critical Care Medicine dated Dec. 15,

2011, which is less than a year before the provisional

filing dates and thus constitutes prior art under preAlA 35 U.S.C. § 102(a) ("(a) the invention was known

or used by others in this country, or patented or

described in a printed publication in this or a foreign

6a

country, before the invention thereof by the applicant

for a patent"). Because Appellants did not establish

that the authors of Sterman were not "others,"

Appellants' statement that Sterman "does not qualify

as prior art" is not factually correct. A rejection

under § 102(a), however, was not made by the

Examiner. The Examiner found that Sterman is

prior art under pre-AlA 35 U.S.C. § 102(b) based on

the statement in Sterman that it was "Originally

Published in Press as DOl: 10.1164/rccm.2011030554CR on June 3, 2011" which is more than a year

before the July 11, 2012 provisional application filing

date. Final Act. 6. Because the complete journal

article was published in December of 2011, it is

reasonable that the phrase "Originally Published"

refers to this complete article, rather than just a part

of it, such as an abstract only. We find that such

statement constitutes sufficient evidence that the

manuscript and the experiments therein relied upon

by the Examiner to establish unpatentability of the

claimed subject matter was available on June 3, 2011.

Appellants argue that the only material from

Sterman that was published on June 3, 2011 was the

abstract. Reply Br. 4. Appellants contend that the

Examiner conceded that only the abstract was

available. Id., 5.

The Examiner made no such concession. Rather, the

Examiner directed Appellants' attention to the

publisher's guidelines which expressly states

"Manuscripts

accepted

for

publication

will

immediately (within 48 hours of acceptance) be

published online in the Articles in Press section of

the A.JRCCM." Ans. 8. Appellants contend that the

"publisher's previous publication guidelines could

7a

potentially be legally relevant here. In contrast, the

publisher's current guidelines provide no information

on how the publisher in fact treated the Sterman

manuscript six years ago." Reply Br. 5. We disagree.

There is no evidence that the policy has changed.3

The journal guidelines reproduced by the Examiner

stating that manuscripts are "published online in the

Articles in Press section" is fully consistent with the

statement in Sterman, published Dec. 15, 2011, that

the complete journal article was "Originally

Published in Press ... on June 3, 2011" containing the

experiments relied upon by the Examiner to

establish unpatentability. Appellants have not

provided evidence that the statement in the Dec. 15,

2011 journal article about being originally published

in press on June 3, 2011 is any less than what it says

to be true.

3 It seemed rather simple to confirm with the publisher of the

journal that the manuscript was available as indicated in the

printed statement that accompanied the publication on

December 15, 2011. We did just that, and as indicated in the

attached email, the publisher advised us that 'just abstracts"

are not posted. However, it is unnecessary to rely on this email

because, as explained in this Decision, Appellants did not

establish that the statement "Originally Published in Press ...

on June 3, 2011" means that only the abstract of the journal

article was published.

8a

Appellants' allegation that the guidelines are not of

record is not persuasive. The Examiner's citation to

the guidelines is responsive to the new argument

made by Appellants in the Appeal Brief for

apparently the first time concerning the editing and

creation of the PDF file for the Dec. 15 2011 journal

article. See Ans. 7-8. We could not find this argument

made earlier, e.g., in Appellants' Remarks filed July

13, 2015.

The Examiner clearly identified where the

information concerning the guidelines appeared. Ans.

8. Appellants had the opportunity to respond to the

Examiner's finding in their Reply Brief, and did.

Reply Br. 5. Appellants did not explain why

Examiner's response to Appellants' new argument is

improper and should be ignored when it is of record

in the Answer and Appellants are on notice of it.

Indeed, Appellants introduced new evidence in this

appeal regarding the creation of the Sterman pdf file.

Under 37 C.R.F. § 41.37(c)(2), the "brief shall not

include any new or non-admitted amendment, or any

new or non-admitted affidavit or other Evidence."

Appellants further argue that the pdf of the Sterman

publication is freely available to download from the

publisher's website and that "[t]he 'Document

Properties' for that pdf file says the file was created

on Nov. 24, 2011 - shortly before the Dec. 15 edition

was published." Appeal Br. 3. Based on this date,

Appellants contend

the metadata on the article pdf file shows that

publisher created that file on Nov. 24, 2011,

after the critical date. That file could not

9a

possibly have been published before the

critical date because it did not exist before the

critical date.

Id., 6.

We do not see the relevance of the date of when the

final publication was created to the finding by the

Examiner that an earlier manuscript was published

online on June 4, 2011. To the contrary, the fact that

the final version was created months later is

consistent with the statement in the Sterman

publication that an earlier manuscript was available

online after acceptance. Appellants appear to have

confused the pdf available today with the online

manuscript availability on June 4, 2011; these are

not the same.

Appellants also contend:

What was published on June 3, 2011, however,

appears to have been merely the Abstract only,

not the entire paper. Searching "Sterman

2011" on the www.atsjoumals.org website

identifies six articles, including the instant

one.

Clicking

on

the

link

to

"10.1164/rccm.201103-0554CR" leads to a page

with only the Abstract:

Id., 7.

Appellants' argument is not persuasive. The "link"

directs to a page with the abstract and tabs for "Full

Text", "References", "Suppl. Materials", "Cited by",

and "PDF." Consequently, we find Appellants'

argument that the aforementioned "link" establishes

that only the abstract was available on the disputed

10a

date is unavailing because the link contains the

complete publication as published on Dec. 15, 2011.

There is no evidence that this is the same link

available on June 3, 2011.

In sum, there is no persuasive evidence before us

that the disclosure in Sterman's December 15, 2011

publication indicating it was "Originally Published in

Press as DOl: 10.1164/rccm.201103-0554CR on June

3, 2011" was not the complete, albeit unedited for

publication, manuscript and the disclosure of the

experiments relied by the Examiner to reject the

claims. To the extent we have considered Appellants'

new argument and new evidence regarding the

creation of the December 15, 2011 pdf file, we find it

unpersuasive because such argument and new

evidence do not rebut the finding that an earlier

manuscript was publicly available on the journal

website at the cited DOl number.

SUMMARY

For the foregoing reasons, Rejections 1, 2, and 3 of all

pending claims are affirmed. No time period for

taking any subsequent action in connection with this

appeal may be extended under 37 C.F.R. §

1.136(a)(1)(iv).

AFFIRMED

11a

NOTE: This disposition is nonprecedential.

United States Court of Appeals

for the Federal Circuit

______________________

IN RE: NIGEL PARKER, SEPPO YLAHERTTUALA,

Appellants

______________________

2017-2244

______________________

Appeal from the United States Patent and

Trademark Office, Patent Trial and Appeal Board in

No. 14/030,399.

______________________

JUDGMENT

______________________

J. MARK POHL, Pharmaceutical Patent Attorneys,

LLC, Morristown, NJ, argued for appellants.

MARY BETH WALKER, Office of the Solicitor,

United States Patent and Trademark Office,

Alexandria, VA, argued for appellee Andrei Iancu.

Also represented by NATHAN K. KELLEY,

THOMAS W. KRAUSE, WILLIAM LAMARCA.

______________________

12a

THIS CAUSE having been heard and considered, it

is ORDERED and ADJUDGED:

PER CURIAM (PROST, Chief Judge, NEWMAN and

LINN, Circuit Judges).

AFFIRMED. See Fed. Cir. R. 36.

ENTERED BY ORDER OF THE COURT

July 17, 2018

/s/ Peter R. Marksteiner

Date

Peter R. Marksteiner

Clerk of Court

13a

UNITED STATES PATENT AND TRADEMARK

OFFICE

BEFORE THE PATENT TRIAL AND APPEAL

BOARD

Ex parte NIGEL PARKER and SEPPO YLAHERTTUALA

Appeal 2016-003044

Application 14/030,3991,2

Technology Center 1600

Before RICHARD M. LEBOVITZ, ULRIKE W.

JENKS, and RACHEL H. TOWNSEND,

Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL

This appeal involves claims directed to methods of

treating a cancer comprising administering a

chemotherapeutic agent and a recombinant virus,

where the recombinant virus comprises a

homeomimetic transgene. The Examiner rejected the

claims under 35 U.S.C. §§ 102(b). We have

jurisdiction under 35 U.S.C. § 6(b). The rejections are

affirmed.

1 The Appeal Brief ("Appeal Br.") identifies FKD Therapies Oy,

Kuopio Finland, as the real-party-in-interest.

2 "The '399 Application."

14a

STATEMENT OF THE CASE

Appellants appeal from the Examiner’s final

rejection of claims 1-9, 11-19, and 21-30 under preAIA 35 U.S.C.§ 102(b) as anticipated by Sterman

(Am. J. Respir. Crit. Care Med., 184: 1395-99, 2011;

issue of Dec. 15, 2011). Final Action (“Final Act.”;

Jan. 14, 2015) 2.

The Examiner found that Sterman was originally

published as DOI: 10.1164/rccm.201103-0554CR on

June 3, 2011, which is more than a year before the

provisional application 61/670,330 filing date of July

11, 2012 to which the ‘399 Application claims benefit.

Id. at 2-3.

CLAIMED SUBJECT MATTER

Independent claim 1 is representative and reads as

follows:

1. In a method of treating a human diagnosed

as having cancerous organ by administering

chemotherapeutic agent, the improvement

comprising administering to said human a

recombinant virus, said recombinant virus

comprising

a

homeomimetic

[spelled

throughout

the

'399

Application

as

"homomimetic"] transgene, said recombinant

virus administered to a site remote from said

cancerous organ.

CLAIM INTERPRETATION

There are four independent claims. Claims 1 and 11

are directed to methods of treating a human that has

a "cancerous organ." Claim 21 is directed to a method

of treating "organ cancer." Claim 30 is directed to a

15a

method of treating "cancer." The interpretation of

"cancerous organ" and "organ cancer" are in dispute.

The Examiner construed "cancerous organ" and

"organ cancer" as cancer involving the tissues of an

organ ("malignant pleural mesothelioma is a

malignant cancer which in later stages involves the

lung tissue and as such qualifies as a 'lung cancer''').

Final Act. 4. Appellants contend "internal organs

derive from embryonic endoderm. . . . Organ cancer is

cancer of an organ, i.e., endoderm-derived tissue."

Appeal Br. 7.3 Appellants distinguish an "organ

cancer" from a cancer of a mesothelioma which is a

sac which covers internal organs. Id. Appellants

argue that an organ cancer must arise from

cancerous cells of the organ ("Lung cancer is a

different [sic, cancer?], arising not from cancerous

mesothelium cells, but from cancerous lung cells.").

Id. at 8. See also Reply Br. 1-2.

Appellants did not provide adequate factual support

for the argument that an organ is derived from

endodermal cells. It is well-known that not all organs

derive from the endoderm. For example, the brain is

an organ and it arises from the ectoderm and the

spleen and heart, also organs, arise from the

mesoderm.4

3 Appellants did not number the pages of the Appeal Brief.

The

numbering used throughout this Decision begins with the title

page of the Appeal Brief numbered as page 1.

4 http://discovery.lifemapsc.com/library/review-of-medical-

embryology/chapter-25-germ-layers-and-their-derivatives.

Accessed April 2, 2017.

16a

Nonetheless, regardless of the embryonic origin of an

"organ," the issue is whether the terms "cancerous

organ" or "organ cancer" require the cancer to have

originated in the organ.

During patent examination proceedings, claim terms

are given "the broadest reasonable meaning ... in

their ordinary usage as they would be understood by

one of ordinary skill in the art, taking into account

whatever enlightenment by way of definitions or

otherwise that may be afforded by the written

description

contained

in

the

applicant's

specification." In re Morris, 127 F.3d 1048, 1054

(Fed. Cir. 1997).

The Specification does not provide a definition of

either term. Thus, we turn to the ordinary usage of

these terms.

In the term "organ cancer," "organ" is used as an

adjective to describe the type of cancer, namely, the

cancer is associated with an organ, namely, the

organ has cancerous cells present in it. Neither word

requires the cancer of the organ to have originated in

the organ. For example, the cancer could have

metastasized to, or invaded a particular organ, and

the cancerous cells would still would be present in

the organ.

In the term "cancerous organ," "cancerous" is an

adjective and thus describes the organ as being

"affected" with a cancer.5 Again, neither word in the

5 http://www.thefreedictionary.com/cancerous. Accessed April 2,

2017.

17a

term "cancerous organ" requires the cancer to have a

specific history; a "cancerous organ" can result from

cells that originated in the organ, or, from cells

originating from another location in the body that

subsequently invaded the organ.

We have not been directed to a definition in the

Specification, or an extrinsic definition, that would

guide us to a narrower interpretation, particularly

the interpretation urged by Appellants that cancer

must originate in the organ to qualify as an organ

cancer or cancerous organ. Consequently, we adopt

the Examiner's claim construction as the broadest

reasonable interpretation of the disputed terms and

construe "organ cancer" and "cancerous organ" to

mean that cancer is present in the organ.

REJECTION

The claims are directed to methods of treating cancer

comprising administering 1) a chemotherapeutic

agent and 2) a recombinant virus to a human, where

the recombinant virus comprises a homeomimetic

transgene. Appellants elected lFN-alpha as the

species of the homeomimetic transgene6 and lung as

the species of cancerous organ. Ans. 2.

6 A homomimetic transgene is defined in the '399 Application as

"a transgene which codes for a polypeptide which mimics an

effect of a naturally-occurring human polypeptide." '399

Application 2:18-20.

18a

The Examiner found that Sterman teaches "methods

of treating malignant pleural mesothelioma (MPM)

in human patients by intrapleural catheter infusion

of a saline solution comprising an adenoviral vector

encoding interferon-alpha 2b, wherein patients

receiving the treatment exhibited antitumor immune

responses and in some cases stable disease or even

tumor regression .... " Id. at 3. The patients had also

received a chemotherapeutic agent. Id. Because the

Examiner found that all limitations of the claim are

described by Sterman, the Examiner concluded the

claim is anticipated. Id.

Appellants contend that mesothelioma is not an

organ cancer or a cancerous organ. Appeal Br. 7-8.

Appellants state:

Organ cancer is cancer of an organ, i.e.,

endoderm-derived

tissue.

In

contrast,

mesothelioma is, as the name implies, cancer of

the mesothelium-derived sac that covers many

internal organs. The two types of cancers differ in

location (one occurs in the organ, the other in the

surrounding sac) and biology (endoderm and

mesoderm cells differ).

Id.

Appellants also contend that lung cancer must arise

from cancerous lung cells, not mesothelioma cells

which migrate into the lung. Id. at 9.

Discussion

The broadest reasonable interpretation of "organ

cancer" and

"cancerous organ" is of a cancer that is present in an

organ, which in this case would be the elected organ,

the lung. Contrary to Appellants' interpretation, the

19a

claims do not require the cancer to originate from the

cells of the organ. Accordingly, the issue in the

anticipation rejection is whether the mesothelioma

described by Sterman is present in lung tissue.

The Examiner relied upon an online publication (at

https://www.pleuralmesothelioma.com/cancer/

staging. php) ("pleuralmesothelioma.com") describing

the staging of mesothelioma to establish that the

lung contains mesothelioma cells in Stage T2. Final

Act. 4; Ans. 5. According to this publication, at Stage

T2:

The tumor involves the pleural lining of the chest

wall on one side of the chest, as well as the

pleural lining of the diaphragm, mediastinum and

the lung. The cancer has also grown into at least

one of the following:

• The diaphragm muscle

• Tissue of the lung itself

Stage T2 occurs in Stages II through IV of

mesothelioma (pleuralmesothelioma.com). Sterman

specifically discloses that several of the treated

patients were in Stages III and IV (Sterman 1396,

Table 1). Stage III and Stage IV patients would have

Stage T2 cancer where the mesothelioma is in the

lung tissue. Thus, the Examiner had sufficient

factual basis to conclude that Sterman treated lung

cancer. Final Act. 4; Ans. 5. Appellants have not

provide adequate arguments or evidence to rebut this

fact-based determination.

Appellants contend that the migration of cells into

the lung is not a lung cancer. Appeal Br. 8. However,

such claim construction is not the broadest

reasonable interpretation of the claim. Accordingly,

20a

this argument does not persuade us that the

Examiner erred.

Remote

Claim 1 requires that the "recombinant virus [is]

administered to a site remote from said cancerous

organ .... " Appeal Br. 7. The Examiner found that

Sterman describes "intrapleural catheter infusion of

a saline solution comprising an adenoviral vector

encoding interferon-alpha 2b." Ans. 3. The Examiner

also found that "intrapleural catheter infusion

involves the delivery of the vector to the intrapleural

space, the space between the mesothelium and the

lung, and as such qualifies as a site 'remote' from a

cancerous [lung] organ." Id. Appellants respond that

"Sterman's mesothelium is cancerous, so Sterman

teaches administration directly onto cancerous tissue,

not 'remote' from it." Reply Br. 5.

This argument does not demonstrate error because

the rejection is based on administration of the

transgene to the intrapleural space which is at a

remote location to the lung.

Is Sterman prior art?

Appellants contend that "Sterman (Dec. 15, 2011)

was first published in December 2011 and therefore

does not qualify as prior art." Reply Br. 7.

The '399 Application in this appeal claims benefit to

a provisional application filed July 11, 2012. Sterman

was published in the issue of American Journal of

Respiratory and Critical Care Medicine dated Dec. 15,

2011, which is less than a year before the provisional

filing date and thus constitutes prior art under preAlA 35 U.S.C. § 102(a). Consequently, Appellants'

21a

statement that Sterman "does not qualify as prior

art" has no factual support in this record.

The Examiner found that Sterman is prior art under

pre-AlA 35 U.S.C. § 102(b) based on the statement in

Sterman that it was "Originally Published in Press

as DOl: 10.1164/rccm.201103-0554CR on June 3,

2011" which is more than a year before the July 11,

2012 provisional filing date.

See Ans. 2. Appellants argue, without providing the

Board with any evidence in this proceeding, that the

only material published was the abstract. Reply Br. 7.

Appellants contend that the DOI document is of

record "in the parent case," but did not identify the

"parent case" nor provide the Board, as a courtesy,

with such document. Id.

Sterman clearly states "Originally Published in

Press," indicating that the article was itself

published.

Appellants

had

the

opportunity

throughout this proceeding to provide evidence to the

Examiner that it was only the abstract which was

published, but did not. For example, the Sterman

rejection was made by the Examiner in a non-final

Office Action entered June 11, 2014. Appellants

responded to the rejection on Sept. 10, 2014 without

making the allegation that Sterman is not prior art

to their application and without providing evidence

that the Examiner erred in finding Sterman's

publication date to be June 3, 2011.

Nonetheless, Sterman is prior art under pre-AlA 35

U.S.C. § 102(a). Consequently, even if Sterman was

not published more than before the provisional filing

date of the '399 Application, it is still prior art to the

application.

22a

SUMMARY

For the foregoing reasons, the anticipation rejection

of independent claims 1, 11, 21, and 30 is affirmed.

Dependent claims 2-9, 12-19, and 22-29 were not

argued separately and fall with the independent

claims. 37 C.F.R. § 41.37(c)(iv)(1)

TIME PERIOD

No time period for taking any subsequent action in

connection with this appeal may be extended under

37 C.F.R. § 1. 136(a)(1)(iv).

AFFIRMED