Guidelines for the Examination of Claims Directed to Species of Chemical Compositions Based Upon a Single Prior Art Reference

DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. 970129014-8206-02]

RIN 0651-XX09

Guidelines for the Examination of Claims Directed to Species of

Chemical Compositions Based Upon a Single Prior Art Reference

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice.

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SUMMARY: The Patent and Trademark Office (PTO) is publishing the final

version of guidelines to be used by Office personnel in reviewing a

certain type of patent application for compliance with 35 U.S.C. 103.

The guidelines are to be used when examining claims directed to a

species or subgenus of chemical compositions when: (1) the claims have

been rejected based upon a single prior art reference, and (2) the

single prior art reference discloses a genus embracing the claimed

species or subgenus but does not expressly describe the particular

claimed species or subgenus. Because these guidelines govern internal

practices, they are exempt from notice and comment rulemaking under 5

U.S.C. 553(b)(A).

DATES: The guidelines are effective September 3, 1998.

FOR FURTHER INFORMATION CONTACT: Linda Moncys Isacson, Office of the

Solicitor, P.O. Box 15667, Arlington, Virginia 22215 or Linda S.

Therkorn, Box Comments, Assistant Commissioner for Patents, Washington,

D.C. 20231, or by facsimile transmission to (703) 305-9373 or by

electronic mail over the Internet to [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 47001]]

Discussion of Public Comments

Comments were received by the PTO from two different individuals

and one organization in response to the Request for Comments on the

Interim Guidelines for the Examination of Claims Directed to Species of

Chemical Compositions Based Upon a Single Prior Art Reference published

February 11, 1997 (62 FR 6217). All comments have been carefully

considered.

The following comments have been substantively adopted to effect

changes in the guidelines:

(1) A suggestion to annotate the flowchart with references to

corresponding sections of text in the guidelines was adopted.

(2) One comment suggested that the guidelines inappropriately

focussed solely on the number of possible members of a prior art genus

to determine whether the prior art genus anticipated a claimed species

or subgenus. Attention was drawn to the discussion of In re Petering,

301 F.2d 676, 133 USPQ 275 (CCPA 1962) in the text at section II.A.4.a

and note 22, which seemed to suggest that size of the genus alone was

sufficient to support a finding of anticipation. These portions of the

guidelines have been modified to indicate that size of the genus is

only one factor to be considered in determining anticipation.

(3) One comment suggested that the guidelines be supplemented to

direct Office personnel to consider the sufficiency of the preparative

methods disclosed in the cited reference. Failure of a prior art

reference to disclose or render obvious a method for making any

composition of matter may preclude a conclusion that the composition

would have been obvious if the disclosure is not enabling. However,

once a prima facie case of obviousness is made out by the PTO, the

initial burden of going forward with evidence to show that no process

was known in the art for preparing the compound is on the applicant.

Accordingly, the guidelines have been changed at section II.B to

include consideration of sufficiency of disclosure of preparative

methods as rebuttal evidence to overcome a prima facie case of

obviousness.

(4) One comment suggested that the language in section II.A.2 of

the guidelines and in corresponding portions of the flowchart

instructing Office personnel to make explicit findings on the

similarities and differences between ``the closest prior art

reference'' and the claimed species or subgenus be changed to direct

findings to be made between the ``closest disclosed species or

subgenus'' and the claimed species or subgenus for accuracy and

clarity. This change has been made in the text.

(5) One comment suggested that section II.A.4.d be clarified to

indicate that the utility disclosed in a reference need not be the same

as the stated utility of the claimed compound. Language has been added

to indicate that any useful property may be the basis of a finding of

motivation.

(6) One comment suggested that language in section II.B. stating

that evidence of an unexpected property may not be sufficient to

overcome a prima facie case of obviousness, regardless of the scope of

the showing, is not accurate in view of the law. Language has been

added to the associated footnote to clarify that a showing of an

unexpected property is sufficient in most circumstances.

The following comments have been considered but have not been

adopted for the reasons discussed below:

(1) One comment suggested that more emphasis be placed on

additional references which may teach away from the claimed compound(s)

due to a disclosure of related compounds having or expected to have

disadvantages not possessed by the claimed compound(s). This comment

was not adopted because it focuses on ``additional references,''

whereas the scope of these guidelines is directed to situations

involving rejections over a single reference. The guidelines already

clearly instruct Office personnel that they must consider any

additional references or evidence of teaching away that are present.

(2) One comment suggested that the guidelines were too limited in

scope because they focused on rejections based on a single reference as

opposed to rejections based on more than one reference. The scope of

these guidelines is intended to address a specific issue, i.e., the

situation where only one reference disclosing a genus but not the

claimed species is found. Although the principles discussed in these

guidelines are generally applicable to all rejections under 35 U.S.C.

103, the explicit scope of these guidelines will not be changed.

(3) One comment suggested that section II.A.4.f of the guidelines

inappropriately instructs Office personnel to focus only on evidence

supporting a rejection rather than making a complete analysis. Section

II.A.4.f of the guidelines additionally instructs Office personnel to

consider the totality of the evidence in each case. Furthermore, Office

personnel are instructed in section II.B to consider whether rebuttal

evidence overcomes a prima facie case of obviousness and in section III

to reconsider all evidence in reaching a conclusion. Thus, the

guidelines presently clearly require all evidence to be considered, not

only evidence supporting a rejection.

(4) One comment suggested that the last sentence of section

II.A.4.c assumes that a generic teaching in a reference, by itself, is

never enough to make out a prima facie case of obviousness. The

referenced language does not suggest this, but rather it merely states

the general proposition that in most cases, additional teachings of

structural similarity to the disclosed species or subgenus are

necessary. Accordingly, no change has been made.

(5) One comment suggested that the guidelines address the

significance of the type of reference involved, i.e. whether there is a

difference between a journal publication, a U.S. Patent, a foreign

patent, etc. This suggestion has not been adopted, because for

substantive analysis under 35 U.S.C. 103, each reference should be

considered for all of its teachings, regardless of its form.

(6) One comment suggested that the guidelines address the

significance of the presence or absence of any activity testing of

disclosed species in the reference. The guidelines already instruct

Office personnel to consider any teachings of similar properties or

uses, predictability of the technology, and any other teachings present

in the reference that would support selection of the claimed compound.

Consideration of any disclosed testing data is subsumed in these

considerations.

I. Guidelines for the Examination of Claims Directed to Species of

Chemical Compositions Based Upon a Single Prior Art Reference

These ``Genus-Species Guidelines'' are to assist Office personnel

in the examination of applications which contain claims to species or a

subgenus of chemical compositions for compliance with 35 U.S.C. 103

based upon a single prior art reference which discloses a genus

encompassing the claimed species or subgenus but does not expressly

disclose the particular claimed species or subgenus. Office personnel

should attempt to find additional prior art to show that the

differences between the prior art primary reference and the claimed

invention as a whole would have been obvious. Where such additional

prior art is not found, Office personnel should follow these guidelines

to determine whether a single reference 35 U.S.C. 103 rejection would

be appropriate. The guidelines are based on the Office's

[[Page 47002]]

current understanding of the law and are believed to be fully

consistent with binding precedent of the Supreme Court, the Federal

Circuit, and the Federal Circuit's predecessor courts.

The analysis of the guidelines begins at the point during

examination after a single prior art reference is found disclosing a

genus encompassing the claimed species or subgenus. Before reaching

this point, Office personnel should follow appropriate antecedent

examination procedures. Accordingly, Office personnel should first

analyze the claims as a whole in light of and consistent with the

written description, considering all claim limitations.1

Next, Office personnel should conduct a thorough search of the prior

art and identify all relevant references.2 If the most

relevant prior art consists of a single prior art reference disclosing

a genus encompassing the claimed species or subgenus, Office personnel

should follow the guidelines set forth herein.*

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\*\ Footnotes at end of docket.

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These guidelines do not constitute substantive rulemaking and hence

do not have the force and effect of law. Rather, they are to assist

Office personnel in analyzing claimed subject matter for compliance

with substantive law. Thus, rejections must be based upon the

substantive law, and it is these rejections which are appealable, not

any failure by Office personnel to follow these guidelines.

Office personnel are to rely on these guidelines in the event of

any inconsistent treatment of issues between these guidelines and any

earlier provided guidance from the Office.

II. Determine Whether the Claimed Species or Subgenus Would Have

Been Obvious to One of Ordinary Skill in the Pertinent Art at the

Time the Invention Was Made

The patentability of a claim to a specific compound or subgenus

embraced by a prior art genus should be analyzed no differently than

any other claim for purposes of 35 U.S.C. 103.3 A

determination of patentability under 35 U.S.C. 103 should be made upon

the facts of the particular case in view of the totality of the

circumstances.4 Use of per se rules by Office personnel is

improper for determining whether claimed subject matter would have been

obvious under 35 U.S.C. 103.5 The fact that a claimed

species or subgenus is encompassed by a prior art genus is not

sufficient by itself to establish a prima facie case of

obviousness.6

A proper obviousness analysis involves a three step process. First,

Office personnel should establish a prima facie case of unpatentability

considering the factors set out by the Supreme Court in Graham v. John

Deere.7 If a prima facie case is established, the burden

shifts to applicant to come forward with rebuttal evidence or argument

to overcome the prima facie case.8 Finally, Office personnel

should evaluate the totality of the facts and all of the evidence to

determine whether they still support a conclusion that the claimed

invention would have been obvious to one of ordinary skill in the art

at the time the invention was made.9

A. Establishing a Prima Facie Case of Obviousness

To establish a prima facie case of obviousness in a genus-species

chemical composition situation, as in any other 35 U.S.C. 103 case, it

is essential that Office personnel find some motivation or suggestion

to make the claimed invention in light of the prior art

teachings.10 In order to find such motivation or suggestion

there should be a reasonable likelihood that the claimed invention

would have the properties disclosed by the prior art

teachings.11 These disclosed findings should be made with a

complete understanding of the first three ``Graham factors.''

12 Thus, Office personnel should (1) determine the ``scope

and content of the prior art''; (2) ascertain the ``differences between

the prior art and the claims at issue''; and (3) determine ``the level

of ordinary skill in the pertinent art.'' 13

1. Determine the Scope and Content of the Prior Art

As an initial matter, Office personnel should determine the scope

and content of the relevant prior art. Each reference must qualify as

prior art under 35 U.S.C. 102,14 and should be in the field

of applicant's endeavor, or be reasonably pertinent to the particular

problem with which the inventor was concerned.15

In the case of a prior art reference disclosing a genus, Office

personnel should make findings as to (1) the structure of the disclosed

prior art genus and that of any expressly described species or subgenus

within the genus; (2) any physical or chemical properties and utilities

disclosed for the genus, as well as any suggested limitations on the

usefulness of the genus, and any problems alleged to be addressed by

the genus; (3) the predictability of the technology; and (4) the number

of species encompassed by the genus taking into consideration all of

the variables possible.

2. Ascertain the Differences Between the Closest Disclosed Prior Art

Species or Subgenus of Record and the Claimed Species or Subgenus

Once the structure of the disclosed prior art genus and that of any

expressly described species or subgenus within the genus are

identified, Office personnel should compare it to the claimed species

or subgenus to determine the differences. Through this comparison, the

closest disclosed species or subgenus in the prior art reference should

be identified and compared to that claimed. Office personnel should

make explicit findings on the similarities and differences between the

closest disclosed prior art species or subgenus of record and the

claimed species or subgenus including findings relating to similarity

of structure, chemical properties and utilities.16

3. Determine the Level of Skill in the Art

Office personnel should evaluate the prior art from the standpoint

of the hypothetical person having ordinary skill in the art at the time

the claimed invention was made.17 In most cases, the only

facts of record pertaining to the level of skill in the art will be

found within the prior art reference. However, any additional evidence

presented by applicant should be evaluated.

4. Determine Whether One of Ordinary Skill in the Art Would Have Been

Motivated To Select the Claimed Species or Subgenus

In light of the findings made relating to the three Graham factors,

Office personnel should determine whether one of ordinary skill in the

relevant art would have been motivated to make the claimed invention as

a whole, i.e., to select the claimed species or subgenus from the

disclosed prior art genus.18 To address this key issue,

Office personnel should consider all relevant prior art teachings,

focusing on the following, where present.

a. Consider the size of the genus. Consider the size of the prior

art genus, bearing in mind that size alone cannot support an

obviousness rejection.19 There is no absolute correlation

between the size of the prior art genus and a conclusion of

obviousness.20 Thus, the mere fact that a prior art genus

contains a small number of members does not create a per se rule of

obviousness. Some motivation to select the claimed species or subgenus

must be taught by the prior art.21 However, a genus may be

so small that, when considered in light of the totality of the

circumstances, it

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would anticipate the claimed species or subgenus. For example, it has

been held that a prior art genus containing only 20 compounds and a

limited number of variations in the generic chemical formula inherently

anticipated a claimed species within the genus because ``one skilled in

[the] art would . . . envisage each member'' of the genus.22

b. Consider the express teachings. If the prior art reference

expressly teaches a particular reason to select the claimed species or

subgenus, Office personnel should point out the express disclosure

which would have motivated one of ordinary skill in the art to select

the claimed invention.23

c. Consider the teachings of structural similarity. Consider any

teachings of a ``typical,'' ``preferred,'' or ``optimum'' species or

subgenus within the disclosed genus. If such a species or subgenus is

structurally similar to that claimed, its disclosure may motivate one

of ordinary skill in the art to choose the claimed species or subgenus

from the genus,24 based on the reasonable expectation that

structurally similar species usually have similar

properties.25 The utility of such properties will normally

provide some motivation to make the claimed species or

subgenus.26

In making an obviousness determination, Office personnel should

consider the number of variables which must be selected or modified,

and the nature and significance of the differences between the prior

art and the claimed invention.27 The closer the physical and

chemical similarities between the claimed species or subgenus and any

exemplary species or subgenus disclosed in the prior art, the greater

the expectation that the claimed subject matter will function in an

equivalent manner to the genus.28

Similarly, consider any teaching or suggestion in the reference of

a preferred species or subgenus that is significantly different in

structure from the claimed species or subgenus. Such a teaching may

weigh against selecting the claimed species or subgenus and thus

against a determination of obviousness.29 For example,

teachings of preferred species of a complex nature within a disclosed

genus may motivate an artisan of ordinary skill to make similar complex

species and thus teach away from making simple species within the

genus.30 Concepts used to analyze the structural similarity

of chemical compounds in other types of chemical cases are equally

useful in analyzing genus-species cases.31 Generally, some

teaching of a structural similarity will be necessary to suggest

selection of the claimed species or subgenus.32

d. Consider the teachings of similar properties or uses. Consider

the properties and utilities of the structurally similar prior art

species or subgenus. It is the properties and utilities that provide

real world motivation for a person of ordinary skill to make species

structurally similar to those in the prior art.33

Conversely, lack of any known useful properties weighs against a

finding of motivation to make or select a species or

subgenus.34 However, the prior art need not disclose a newly

discovered property in order for there to be a prima facie case of

obviousness.35 If the claimed invention and the structurally

similar prior art species share any useful property, that will

generally be sufficient to motivate an artisan of ordinary skill to

make the claimed species.36 For example, based on a finding

that a tri-ortho ester and a tetra-ortho ester behave similarly in

certain chemical reactions, it has been held that one of ordinary skill

in the relevant art would have been motivated to select either

structure.37 In fact, similar properties may normally be

presumed when compounds are very close in structure.38 Thus,

evidence of similar properties or evidence of any useful properties

disclosed in the prior art that would be expected to be shared by the

claimed invention weighs in favor of a conclusion that the claimed

invention would have been obvious.39

e. Consider the predictability of the technology. Consider the

predictability of the technology.40 If the technology is

unpredictable, it is less likely that structurally similar species will

render a claimed species obvious because it may not be reasonable to

infer that they would share similar properties.41 However,

obviousness does not require absolute predictability, only a reasonable

expectation of success, i.e., a reasonable expectation of obtaining

similar properties.42

f. Consider any other teaching to support the selection of the

species or subgenus. The categories of relevant teachings enumerated

above are those most frequently encountered in a genus-species case,

but they are not exclusive. Office personnel should consider the

totality of the evidence in each case. In unusual cases, there may be

other relevant teachings sufficient to support the selection of the

species or subgenus and, therefore, a conclusion of obviousness.

5. Make express fact-findings and determine whether they support a

prima facie case of obviousness. Based on the evidence as a

whole,43 Office personnel should make express fact-findings

relating to the Graham factors, focusing primarily on the prior art

teachings discussed above. The fact-findings should specifically

articulate what teachings or suggestions in the prior art would have

motivated one of ordinary skill in the art to select the claimed

species or subgenus.44 Thereafter, it should be determined

whether these findings, considered as a whole, support a prima facie

case that the claimed invention would have been obvious to one of

ordinary skill in the relevant art at the time the invention was made.

B. Determining Whether Rebuttal Evidence Is Sufficient To Overcome the

Prima Facie Case of Obviousness

If a prima facie case of obviousness is established, the burden

shifts to the applicant to come forward with arguments and/or evidence

to rebut the prima facie case.45 Rebuttal evidence and

arguments can be presented in the specification,46 by

counsel,47 or by way of an affidavit or declaration under 37

CFR Sec. 1.132.48 However, arguments of counsel cannot take

the place of factually supported objective evidence.49

Office personnel should consider all rebuttal arguments and

evidence presented by applicants.50 Rebuttal evidence may

include evidence of ``secondary considerations,'' such as ``commercial

success, long felt but unsolved needs, [and] failure of others,''

51 evidence that the claimed invention yields unexpectedly

improved properties or properties not present in the prior

art,52 or evidence that the claimed invention was copied by

others.53 It may also include evidence of the state of the

art, the level of skill in the art, and the beliefs of those skilled in

the art.54 For example, rebuttal evidence may include a

showing that the prior art fails to disclose or render obvious a method

for making the compound, which would preclude a conclusion of

obviousness of the compound.55

Consideration of rebuttal evidence and arguments requires Office

personnel to weigh the proffered evidence and arguments. Office

personnel should avoid giving evidence no weight, except in rare

circumstances.56 However, to be entitled to substantial

weight, the applicant should establish a nexus between the rebuttal

evidence and the claimed invention,57 i.e., objective

evidence of nonobviousness must be attributable to the claimed

invention.58 Additionally, the evidence must be reasonably

commensurate in scope with the claimed invention.59 However,

an exemplary showing may be sufficient to establish a reasonable

correlation

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between the showing and the entire scope of the claim, when viewed by a

skilled artisan.60 On the other hand, evidence of an

unexpected property may not be sufficient regardless of the scope of

the showing.61 Accordingly, each case should be evaluated

individually based on the totality of the circumstances.

Office personnel should not evaluate rebuttal evidence for its

``knockdown'' value against the prima facie case 62 or

summarily dismiss it as not compelling or insufficient. If the evidence

is deemed insufficient to rebut the prima facie case of obviousness,

Office personnel should specifically set forth the facts and reasoning

that justify this conclusion.

III. Reconsider All Evidence and Clearly Communicate Findings and

Conclusions

A determination under 35 U.S.C. Sec. 103 should rest on all the

evidence and should not be influenced by any earlier

conclusion.63 Thus, once the applicant has presented

rebuttal evidence, Office personnel should reconsider any initial

obviousness determination in view of the entire record.64

All the proposed rejections and their bases should be reviewed to

confirm their correctness. Only then should any rejection be imposed in

an Office action. The Office action should clearly communicate the

Office's findings and conclusions, articulating how the conclusions are

supported by the findings.

Where applicable, the findings should clearly articulate which

portions of the reference support any rejection. Explicit findings on

motivation or suggestion to select the claimed invention should also be

articulated in order to support a 35 U.S.C. Sec. 103 ground of

rejection.65 Conclusory statements of similarity or

motivation, without any articulated rationale or evidentiary support,

do not constitute sufficient factual findings.

VI. Endnotes

\1\ When evaluating the scope of a claim, every limitation in

the claim must be considered. E.g. , In re Ochiai, 71

F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995). However, the

claimed invention may not be dissected into discrete elements to be

analyzed in isolation, but must be considered as a whole. E.g., W.L.

Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1548, 220 USPQ

303, 309 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984); Jones

v. Hardy, 727 F.2d 1524, 1530, 220 USPQ 1021, 1026 (Fed. Cir.

1983)(''treating the advantage as the invention disregards the

statutory requirement that the invention be viewed 'as a whole''').

\2\ Both claimed and unclaimed aspects of the invention should

be searched if there is a reasonable expectation that the unclaimed

aspects may be later claimed.

\3\ ``The section 103 requirement of unobviousness is no

different in chemical cases than with respect to other categories of

patentable inventions.'' In re Papesch , 315 F.2d 381, 385, 137 USPQ

43, 47 (CCPA 1963).

\4\ E.g., In re Dillon , 919 F.2d 688, 692-93, 16 USPQ2d 1897,

1901 (Fed. Cir. 1990)(in banc).

\5\ E.g., In re Brouwer , 77 F.3d 422, 425, 37 USPQ2d 1663, 1666

(Fed. Cir. 1996); In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127,

1133 (Fed. Cir. 1995); In re Baird, 16 F.3d 380, 382, 29 USPQ2d

1550, 1552 (Fed. Cir. 1994).

\6\ In re Baird , 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed.

Cir. 1994)(''The fact that a claimed compound may be encompassed by

a disclosed generic formula does not by itself render that compound

obvious.''); In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943

(Fed. Cir. 1992)(Federal Circuit has ``decline[d] to extract from

Merck [& Co. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d

1843 (Fed. Cir. 1989)] the rule that . . . regardless of how broad,

a disclosure of a chemical genus renders obvious any species that

happens to fall within it.''). See also In re Deuel, 51 F.3d 1552,

1559, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995).

\7\ E.g., In re Bell, 991 F.2d 781, 783, 26 USPQ2d 1529, 1531

(Fed. Cir. 1993)(``The PTO bears the burden of establishing a case

of prima facie obviousness.''); In re Rijckaert, 9 F.3d 1531, 1532,

28 USPQ2d 1955, 1956 (Fed. Cir. 1993); In re Oetiker, 977 F.2d 1443,

1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992).

Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966), requires that

to make out a case of obviousness, one must: (1) determine the scope

and contents of the prior art; (2) ascertain the differences between

the prior art and the claims in issue; (3) determine the level of skill

in the pertinent art; and (4) evaluate any evidence of secondary

considerations.

\8\ E.g., Bell, 991 F.2d at 783-84, 26 USPQ2d at 1531;

Rijckaert, 9 F.3d at 1532, 28 USPQ2d at 1956; Oetiker, 977 F.2d at

1445, 24 USPQ2d at 1444.

\9\ Id.

\10\ E.g., In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, 1666

(Fed. Cir. 1996)(``[T]he mere possibility that one of the esters or

the active methylene group-containing compounds . . . could be

modified or replaced such that its use would lead to the specific

sulfoalkylated resin recited in claim 8 does not make the process

recited in claim 8 obvious ``unless the prior art suggested the

desirability of [such a] modification'' or replacement.'')(quoting

In re Gordon, 733 F.2d 900, 902, 221 USPQ 1125, 1127 (Fed. Cir.

1984); In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438, 1442 (Fed.

Cir. 1991)(``[A] proper analysis under Sec. 103 requires, inter

alia, consideration of . . . whether the prior art would have

suggested to those of ordinary skill in the art that they should

make the claimed composition or device, or carry out the claimed

process.'').

\11\ The prior art disclosure may be express, implicit, or

inherent. Regardless of the type of disclosure, the prior art must

provide some motivation to one of ordinary skill in the art to make

the claimed invention in order to support a conclusion of

obviousness. E.g., Vaeck, 947 F.2d at 493, 20 USPQ2d at 1442 (A

proper obviousness analysis requires consideration of ``whether the

prior art would also have revealed that in so making or carrying out

[the claimed invention], those of ordinary skill would have a

reasonable expectation of success.''); In re Dow Chemical Co., 837

F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988)(``The consistent

criterion for determination of obviousness is whether the prior art

would have suggested to one of ordinary skill in the art that this

process should be carried out and would have a reasonable likelihood

of success, viewed in the light of the prior art.''); Hodosh v.

Block Drug Co., 786 F.2d 1136, 1143 n.5, 229 USPQ 182, 187 n.5 (Fed.

Cir. 1986).

\12\ When evidence of secondary considerations such as

unexpected results is initially before the Office, for example in

the specification, that evidence should be considered in deciding

whether there is a prima facie case of obviousness. The

determination as to whether a prima facie case exists should be made

on the full record before the Office at the time of the

determination.

\13\ Graham v. John Deere, 383 U.S. 1, 17, 148 USPQ 459, 467

(1966). Accord, e.g., In re Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d

1671, 1676 (Fed. Cir. 1994).

\14\ E.g., Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561,

1568, 1 USPQ2d 1593, 1597 (Fed. Cir. 1987)(``Before answering

Graham's ``content'' inquiry, it must be known whether a patent or

publication is in the prior art under 35 U.S.C. Sec. 102.'').

\15\ In re Oetiker, 977 F.2d 1443, 1447, 24 USPQ2d 1443, 1445

(Fed. Cir. 1992). Accord, e.g., In re Clay, 966 F.2d 656, 658-59, 23

USPQ2d 1058, 1060 (Fed. Cir. 1992).

\16\ In Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1537,

218 USPQ 871, 877 (Fed. Cir. 1983), the Court noted that ``the

question under 35 U.S.C. Sec. 103 is not whether the differences

[between the claimed invention and the prior art] would have been

obvious'' but ``whether the claimed invention as a whole would have

been obvious.'' (emphasis in original).

\17\ See, Ryko Manufacturing Co. v. Nu-Star Inc., 950 F.2d 714,

718, 21 USPQ2d 1053, 1057 (Fed. Cir. 1991)(``The importance of

resolving the level of ordinary skill in the art lies in the

necessity of maintaining objectivity in the obviousness inquiry.'');

Uniroyal Inc. v. Rudkin-Wiley Corp., 837 F.2d 1044, 1050, 5 USPQ2d

1434, 1438 (Fed. Cir. 1988) (evidence must be viewed from position

of ordinary skill, not of an expert).

\18\ E.g., Ochiai, 71 F.3d at 1569-70, 37 USPQ2d at 1131; Deuel,

51 F.3d at 1557, 34 USPQ2d at 1214 (``[A] prima facie case of

unpatentability requires that the teachings of the prior art suggest

the claimed compounds to a person of ordinary skill in the art.''

(emphasis in original)); Jones, 958 F.2d at 351, 21 USPQ2d at 1943-

44 (Fed. Cir. 1992); Dillon, 919 F.2d at 692, 16 USPQ2d at 1901; In

re Lalu, 747 F.2d 703, 705, 223 USPQ 1257, 1258 (Fed. Cir.

1984)(``The prior art must provide one of ordinary skill in the art

[[Page 47005]]

the motivation to make the proposed molecular modifications needed

to arrive at the claimed compound.''). See also In re Kemps, 97 F.3d

1427, 1430, 40 USPQ2d 1309, 1311 (Fed. Cir. 1996)(discussing

motivation to combine).

\19\ See, e.g., Baird, 16 F.3d at 383, 29 USPQ2d at 1552

(observing that ``it is not the mere number of compounds in this

limited class which is significant here but, rather, the total

circumstances involved'').

\20\ Id.

\21\ See, e.g., Deuel, 51 F.3d at 1558-59, 34 USPQ2d at 1215

(``No particular one of these DNAs can be obvious unless there is

something in the prior art to lead to the particular DNA and

indicate that it should be prepared.''); Baird, 16 F.3d at 382-83,

29 USPQ2d at 1552; Bell, 991 F.2d at 784, 26 USPQ2d at 1531

(``Absent anything in the cited prior art suggesting which of the

10\36\ possible sequences suggested by Rinderknecht corresponds to

the IGF gene, the PTO has not met its burden of establishing that

the prior art would have suggested the claimed sequences.'').

\22\ In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA

1962)(emphasis in original). More specifically, the court in

Petering stated:

``A simple calculation will show that, excluding isomerism

within certain of the R groups, the limited class we find in Karrer

contains only 20 compounds. However, we wish to point out that it is

not the mere number of compounds in this limited class which is

significant here but, rather, the total circumstances involved,

including such factors as the limited number of variations for R,

only two alternatives for Y and Z, no alternatives for the other

ring positions, and a large unchanging parent structural nucleus.

With these circumstances in mind, it is our opinion that Karrer has

described to those with ordinary skill in this art each of the

various permutations here involved as fully as if he had drawn each

structural formula or had written each name.''

Id. (emphasis in original).

Accord In re Schaumann, 572 F.2d 312, 316, 197 USPQ 5, 9 (CCPA

1978)(prior art genus encompassing claimed species which disclosed

preference for lower alkyl secondary amines and properties possessed

by the claimed compound constituted description of claimed compound

for purposes of 35 U.S.C. Sec. 102(b)). C.f., In re Ruschig, 343

F.2d 965, 974, 145 USPQ 274, 282 (CCPA 1965)(Rejection of claimed

compound in light of prior art genus based on Petering is not

appropriate where the prior art does not disclose a small

recognizable class of compounds with common properties.).

\23\ An express teaching may be based on a statement in the

prior art reference such as an art recognized equivalence. For

example, see Merck & Co. v. Biocraft Labs., 874 F.2d 804, 807, 10

USPQ2d 1843, 1846 (Fed. Cir. 1989) (holding claims directed to

diuretic compositions comprising a specific mixture of amiloride and

hydrochlorothiazide were obvious over a prior art reference

expressly teaching that amiloride was a pyrazinoylguanidine which

could be co-administered with potassium excreting diuretic agents,

including hydrochlorothiazide which was a named example, to produce

a diuretic with desirable sodium and potassium eliminating

properties). See also, In re Kemps, 97 F.3d 1427, 1430, 40 USPQ2d

1309, 1312 (Fed. Cir. 1996)(holding there is sufficient motivation

to combine teachings of prior art to achieve claimed invention where

one reference specifically refers to the other).

24 E.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904.

See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214 (``Structural

relationships may provide the requisite motivation or suggestion to

modify known compounds to obtain new compounds. For example, a prior

art compound may suggest its homologs because homologs often have

similar properties and therefore chemists of ordinary skill would

ordinarily contemplate making them to try to obtain compounds with

improved properties.'').

25 E.g., Dillon, 919 F.2d at 693, 16 USPQ2d at 1901.

26 See id.

27 E.g., In re Jones, 958 F.2d 347, 350, 21 USPQ2d

1941, 1943 (Fed. Cir. 1992) (reversing obviousness rejection of

novel dicamba salt with acyclic structure over broad prior art genus

encompassing claimed salt, where disclosed examples of genus were

dissimilar in structure, lacking an ether linkage or being cyclic);

In re Susi, 440 F.2d 442, 445, 169 USPQ 423, 425 (CCPA 1971)(the

difference from the particularly preferred subgenus of the prior art

was a hydroxyl group, a difference conceded by applicant ``to be of

little importance.'').

In the area of biotechnology, an exemplified species may differ

from a claimed species by a conservative substitution (``the

replacement in a protein of one amino acid by another, chemically

similar, amino acid * * * [which] is generally expected to lead to

either no change or only a small change in the properties of the

protein.'' Dictionary of Biochemistry and Molecular Biology 97 (John

Wiley & Sons, 2d ed. 1989)). The effect of a conservative

substitution on protein function depends on the nature of the

substitution and its location in the chain. Although at some

locations a conservative substitution may be benign, in some

proteins only one amino acid is allowed at a given position. For

example, the gain or loss of even one methyl group can destabilize

the structure if close packing is required in the interior of

domains. James Darnell et al., Molecular Cell Biology 51 (2d ed.

1990).

28 E.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904

(and cases cited therein). C.f. Baird, 16 F.3d at 382-83, 29 USPQ2d

at 1552 (disclosure of dissimilar species can provide teaching

away).

29 Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552

(reversing obviousness rejection of species in view of large size of

genus and disclosed ``optimum'' species which differed greatly from

and were more complex than the claimed species); Jones, 958 F.2d at

350, 21 USPQ2d at 1943 (reversing obviousness rejection of novel

dicamba salt with acyclic structure over broad prior art genus

encompassing claimed salt, where disclosed examples of genus were

dissimilar in structure, lacking an ether linkage or being cyclic).

30 Baird, 16 F.3d at 382, 29 USPQ2d at 1552. See also

Jones, 958 F.2d at 350, 21 USPQ2d at 1943 (disclosed salts of genus

held not sufficiently similar in structure to render claimed species

prima facie obvious).

31 For example, a claimed tetra-orthoester fuel

composition was held to be obvious in light of a prior art tri-

orthoester fuel composition based on their structural and chemical

similarity and similar use as fuel additives. Dillon, 919 F.2d at

692-93, 16 USPQ2d at 1900-02.

Likewise, claims to amitriptyline used as an antidepressant were

held obvious in light of the structural similarity to imipramine, a

known antidepressant prior art compound, where both compounds were

tricyclic dibenzo compounds and differed structurally only in the

replacement of the unsaturated carbon atom in the center ring of

amitriptyline with a nitrogen atom in imipramine. In re Merck & Co.,

800 F.2d 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir. 1986).

Other structural similarities have been found to support a prima

facie case of obviousness. E.g., In re May, 574 F.2d 1082, 1093-95,

197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563

F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977)(adjacent homologs and

structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406,

409 (CCPA 1970)(acid and ethyl ester); In re Druey, 319 F.2d 237,

240, 138 USPQ 39, 41 (CCPA 1963)(omission of methyl group from

pyrazole ring).

32 Id.

33 Dillon, 919 F.2d at 697, 16 USPQ2d at 1905; In re

Stemniski, 444 F.2d 581, 586, 170 USPQ 343, 348 (CCPA 1971).

34 In re Albrecht, 514 F.2d 1389, 1392, 1395-96, 185

USPQ 585, 587, 590 (CCPA 1975)(The prior art compound so irritated

the skin that it could not be regarded as useful for the disclosed

anesthetic purpose, and therefore a person skilled in the art would

not have been motivated to make related compounds.); Stemniski, 444

F.2d at 586, 170 USPQ at 348 (close structural similarity alone is

not sufficient to create a prima facie case of obviousness when the

reference compounds lack utility, and thus there is no motivation to

make related compounds.).

35 Dillon, 919 F.2d at 697, 16 USPQ2d at 1904-05 (and

cases cited therein).

36 E.g., id.

37 Id. at 692, 16 USPQ2d at 1900-01.

38 Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901,

1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871

(Fed. Cir. 1985)(``When chemical compounds have `very close'

structural similarities and similar utilities, without more a prima

facie case may be made.'').

39 Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In

re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re

Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).

40 See, e.g., Dillon, 919 F.2d at 692-97, 16 USPQ2d

at 1901-05; In re Grabiak, 769 F.2d 729, 732-33, 226 USPQ 870, 872

(Fed. Cir. 1985).

41 See e.g.,In re May, 574 F.2d 1082, 1094, 197 USPQ

601, 611 (CCPA 1978)(prima facie

[[Page 47006]]

obviousness of claimed analgesic compound based on structurally

similar prior art isomer was rebutted with evidence demonstrating

that analgesia and addiction properties could not be reliably

predicted on the basis of chemical structure); In re Schechter, 205

F.2d 185, 191, 98 USPQ 144, 150 (CCPA 1953)(unpredictability in the

insecticide field, with homologs, isomers and analogs of known

effective insecticides having proven ineffective as insecticides,

was considered as a factor weighing against a conclusion of

obviousness of the claimed compounds).

42 See, e.g., In re O'Farrell, 853 F.2d 894, 903, 7

USPQ2d 1673, 1681 (Fed. Cir. 1988).

43 In re Bell, 991 F.2d 781, 784, 26 USPQ2d 1529,

1531 (Fed. Cir. 1993); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d

1056, 1057 (Fed. Cir. 1990).

44 Kulling, 897 F.2d at 1149, 14 USPQ2d at 1058;

Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1579 n.42, 1

USPQ2d 1593, 1606 n.42 (Fed. Cir. 1987).

45 E.g., Dillon, 919 F.2d at 692, 16 USPQ2d at 1901.

46 In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687

(Fed. Cir. 1995).

47 In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-

95 (Fed. Cir. 1995).

48 E.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In

re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir.

1984).

49 E.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d

1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222

USPQ 191, 196 (Fed. Cir. 1984).

50 E.g., In re Soni, 54 F.3d 746, 750, 34 USPQ2d

1684, 1687 (Fed. Cir. 1995) (error not to consider evidence

presented in the specification). C.f., In re Alton, 76 F.3d 1168, 37

USPQ2d 1578 (Fed. Cir. 1996)(error not to consider factual evidence

submitted to counter a section 112 rejection); In re Beattie, 974

F.2d 1309, 1313, 24 USPQ2d 1040, 1042-43 (Fed. Cir. 1992)(Office

personnel should consider declarations from those skilled in the art

praising the claimed invention and opining that the art teaches away

from the invention.); Piasecki, 745 F.2d at 1472, 223 USPQ at 788

(``[Rebuttal evidence] may relate to any of the Graham factors

including the so-called secondary considerations.'').

51 Graham v. John Deere Co., 383 U.S. at 17, 148 USPQ

at 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223

USPQ 785, 788 (Fed. Cir. 1984) (commercial success).

52 Rebuttal evidence may consist of a showing that

the claimed compound possesses unexpected properties. Dillon, 919

F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results

must be based on evidence, not argument or speculation. In re Mayne,

104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir.

1997)(conclusory statements that claimed compound possesses

unusually low immune response or unexpected biological activity that

is unsupported by comparative data held insufficient to overcome

prima facie case of obviousness).

53 E.g., In re GPAC, 57 F.3d 1573, 1580, 35 USPQ2d

1116, 1121 (Fed. Cir. 1995); Hybritech Inc. v. Monoclonal

Antibodies, 802 F.2d 1367, 1380, 231 USPQ 81, 90 (Fed. Cir. 1986),

cert. denied, 480 U.S. 947 (1987).

54 E.g., In re Oelrich, 579 F.2d 86, 91-92, 198 USPQ

210, 214 (CCPA 1978) (Expert opinions regarding the level of skill

in the art were probative of the nonobviousness of the claimed

invention.); Piasecki, 745 F.2d at 1471, 1473-74, 223 USPQ at 790

(Evidence of non-technological nature is pertinent to the conclusion

of obviousness. The declarations of those skilled in the art

regarding the need for the invention and its reception by the art

were improperly discounted by the Board); Beattie, 974 F.2d at 1313,

24 USPQ2d at 1042-43 (Seven declarations provided by music teachers

opining that the art teaches away from the claimed invention must be

considered, but were not probative because they did not contain

facts and did not deal with the specific prior art that was the

subject of the rejection.).

55 A conclusion of obviousness requires that the

reference(s) relied upon be enabling in that it put the public in

possession of the claimed invention. The court in In re Hoeksema,

399 F.2d 269, 274, 158 USPQ 596, 601 (CCPA 1968), stated:

``Thus, upon careful reconsideration it is our view that if the

prior art of record fails to disclose or render obvious a method for

making a claimed compound, at the time the invention was made, it

may not be legally concluded that the compound itself is in the

possession of the public. [footnote omitted.] In this context, we

say that the absence of a known or obvious process for making the

claimed compounds overcomes a presumption that the compounds are

obvious, based on close relationships between their structures and

those of prior art compounds.''

The Hoeksema court further noted that once a prima facie case of

obviousness is made by the PTO through citation of references, the

burden is on the applicant to produce contrary evidence establishing

that the reference being relied on would not enable a skilled

artisan to produce the different compounds claimed. Id. at 274-75,

158 USPQ at 601. See also Ashland Oil, Inc. v. Delta Resins &

Refractories, Inc., 776 F.2d 281, 295, 297, 227 USPQ 657, 666, 667

(Fed. Cir. 1985) (citing Hoeksema for the proposition above); In re

Grose, 592 F.2d 1161, 1168, 201 USPQ 57, 63-64 (CCPA 1979) (``One of

the assumptions underlying a prima facie obviousness rejection based

upon a structural relationship between compounds, such as adjacent

homologs, is that a method disclosed for producing one would provide

those skilled in the art with a method for producing the other. * *

* Failure of the prior art to disclose or render obvious a method

for making any composition of matter, whether a compound or a

mixture of compounds like a zeolite, precludes a conclusion that the

composition would have been obvious.'')

56 Id. See also In re Alton, 76 F.3d 1168, 1174-75,

37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996).

57 The Federal Circuit has acknowledged that

applicant bears the burden of establishing nexus, stating:

``In the ex parte process of examining a patent application,

however, the PTO lacks the means or resources to gather evidence

which supports or refutes the applicant's assertion that the sales

constitute commercial success. C.f. Ex parte Remark, 15 USPQ2d 1498,

1503 ([BPAI] 1990)(evidentiary routine of shifting burdens in civil

proceedings inappropriate in ex parte prosecution proceedings

because examiner has no available means for adducing evidence).

Consequently, the PTO must rely upon the applicant to provide hard

evidence of commercial success.''

In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir.

1996). See also GPAC, 57 F.3d at 1580, 35 USPQ2d at 1121; In re

Paulsen, 30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed. Cir. 1994).

58 E.g., Paulsen, 30 F.3d at 1482, 31 USPQ2d at 1676.

(Evidence of commercial success of articles not covered by the

claims subject to the 35 U.S.C. Sec. 103 rejection was not probative

of nonobviousness).

59 E.g., In re Kulling, 897 F.2d 1147, 1149, 14

USPQ2d 1056, 1058 (Fed. Cir. 1990); In re Grasselli, 713 F.2d 731,

743, 218 USPQ 769, 777 (Fed. Cir. 1983). In re Soni, 54 F.3d 746, 34

USPQ2d 1684 (Fed. Cir. 1995) does not change this analysis. In Soni,

the Court declined to consider the Office's argument that the

evidence of non-obviousness was not commensurate in scope with the

claim because it had not been raised by the Examiner. 54 F.3d at

751, 34 USPQ2d at 1688.

When considering whether proffered evidence is commensurate in

scope with the claimed invention, Office personnel should not

require the applicant to show unexpected results over the entire

range of properties possessed by a chemical compound or composition.

E.g., In re Chupp, 816 F.2d 643, 646, 2 USPQ2d 1437, 1439 (Fed.

Cir. 1987). Evidence that the compound or composition possesses

superior and unexpected properties in one of a spectrum of common

properties can be sufficient to rebut a prima facie case of

obviousness. Id.

For example, a showing of unexpected results for a single member

of a claimed subgenus, or a narrow portion of a claimed range would

be sufficient to rebut a prima facie case of obviousness if a

skilled artisan ``could ascertain a trend in the exemplified data

that would allow him to reasonably extend the probative value

thereof.'' In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296

(CCPA 1980) (Evidence of the unobviousness of a broad range can be

proven by a narrower range when one skilled in the art could

ascertain a trend that would allow him to reasonably extend the

probative value thereof.). But see, Grasselli, 713 F.2d at 743, 218

USPQ at 778 (evidence of superior properties for sodium containing

composition insufficient to establish the non-obviousness of broad

claims for a catalyst with ``an alkali metal'' where it was well

known in the catalyst art that different alkali metals were not

interchangeable and applicant had shown unexpected results only for

sodium containing materials); In re Greenfield, 571 F.2d 1185, 1189,

197 USPQ 227, 230 (CCPA 1978)(evidence of superior properties in one

species insufficient to establish the nonobviousness of a subgenus

containing hundreds of compounds); In re

[[Page 47007]]

Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972)(one test

not sufficient where there was no adequate basis for concluding the

other claimed compounds would behave the same way).

60. E.g., Chupp, 816 F.2d at 646, 2 USPQ2d at 1439;

Clemens, 622 F.2d at 1036, 206 USPQ at 296.

61. Usually, a showing of unexpected results is

sufficient to overcome a prima facie case of obviousness. See, e.g.,

In re Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975).

However, where the claims are not limited to a particular use, and

where the prior art provides other motivation to select a particular

species or subgenus, a showing of a new use may not be sufficient to

confer patentability. See Dillon, 919 F.2d at 692, 16 USPQ2d at

1900-01.

62. Piasecki, 745 F.2d at 1473, 223 USPQ at 788.

63. E.g., Piasecki, 745 F.2d at 1472-73, 223 USPQ at

788; In re Eli Lilly & Co., 902 F.2d 943, 945, 14 USPQ2d 1741, 1743

(Fed. Cir. 1990).

64. E.g., Piasecki, 745 F.2d at 1472, 223 USPQ at

788; Eli Lilly, 902 F.2d at 945, 14 USPQ2d at 1743.

65. Dillon, 919 F.2d at 693, 16 USPQ2d at 1901; In re

Mills, 916 F.2d 680, 683, 16 USPQ2d 1430, 1433 (Fed. Cir. 1990).

Dated: August 26, 1998.

Bruce A. Lehman,

Assistant Secretary of Commerce and Commissioner of Patents and

Trademarks.

[FR Doc. 98-23681 Filed 9-2-98; 8:45 am]

BILLING CODE 3510-16-P