Consideration of Applicant’s Rebuttal Arguments and Evidence

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USPTO MPEP › Chapter 2100 - Patentability › MPEP § 2145

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[Editor Note: This MPEP section is applicable regardless of whether an application

is examined under the AIA or under pre-AIA law. For applications subject to the first

inventor to file (FITF) provisions of the AIA, the relevant time is "before the

effective filing date of the claimed invention". For applications subject to

pre-AIA 35 U.S.C.

102

, the relevant time is "at the time of the invention". See

MPEP §

2150

et seq. Many of the court decisions discussed in this

section involved applications or patents subject to

pre-AIA 35 U.S.C. 102

. These court

decisions may be applicable to applications and patents subject to

AIA 35 U.S.C.

102

but the relevant time is before the effective filing date of

the claimed invention and not at the time of the invention.]

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. See, e.g.,

In re Dillon,

919

F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990)

(en banc).

Applicant may also present rebuttal evidence and arguments prior to an Office action in

anticipation of possible prior art rejections. Examiners should consider all evidence of

obviousness and nonobviousness of record before making a determination under

35 U.S.C.

103

Rebuttal evidence and arguments can be presented in the

specification,

In re Soni,

54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed.

Cir. 1995), by way of an affidavit or declaration under

37 CFR 1.132

, 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), or

otherwise presented during prosecution. See, e.g.,

MPEP §§ 714

716

et seq.

However, arguments presented by applicant cannot take the place

of factually supported objective evidence. See, e.g.,

In re Schulze,

346

F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965);

In re De Blauwe,

736 F.2d

699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)

ecki,

745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984), or

otherwise presented during prosecution. See, e.g.,

MPEP §§ 714

716

et seq.

However, arguments presented by applicant cannot take the place

of factually supported objective evidence. See, e.g.,

In re Schulze,

346

F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965);

In re De Blauwe,

736 F.2d

699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).

Office personnel should consider all rebuttal arguments and evidence

presented by applicants. See, e.g.,

Soni,

54 F.3d at 750, 34 USPQ2d at

1687 (error not to consider evidence presented in the specification). C.f.,

In re

Kao,

639 F.3d 1057, 1067, 98 USPQ2d 1799, 1807 (Fed. Cir. 2011) (“[W]hen

secondary considerations are present, though they are not always dispositive, it is error

not to consider them.”);

In re Alton,

76 F.3d 1168, 37 USPQ2d 1578 (Fed.

Cir. 1996) (error not to consider factual evidence submitted to counter a

35 U.S.C. 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.”). The Federal Circuit has “emphasized that

consideration of the objective indicia is part of the whole obviousness analysis, not just

an afterthought.”

Leo Pharm. Prod., Ltd. v. Rea,

726 F.3d 1346, 1357,

107 USPQ2d 1943, 1952 (Fed. Cir. 2013) (emphasis in original). Even though court decisions

“have used the ‘prima facie’ and ‘rebuttal’ language [the decisions have] generally have

made clear that a fact finder must consider

all

evidence of obviousness

and nonobviousness before reaching a determination.”

In re Cyclobenzaprine

Hydrochloride Extended- Release Capsule Patent Litig.,

676 F.3d 1063, 1077,

102 USPQ2d 1760, 1772 (Fed. Cir. 2012) (emphasis in the original)

though court decisions

“have used the ‘prima facie’ and ‘rebuttal’ language [the decisions have] generally have

made clear that a fact finder must consider

all

evidence of obviousness

and nonobviousness before reaching a determination.”

In re Cyclobenzaprine

Hydrochloride Extended- Release Capsule Patent Litig.,

676 F.3d 1063, 1077,

102 USPQ2d 1760, 1772 (Fed. Cir. 2012) (emphasis in the original).

Rebuttal evidence may include evidence of “secondary considerations,” such

as “commercial success, long felt but unsolved needs, [and] failure of others.”

Graham v. John Deere Co.,

383 U.S. 1, 148 USPQ 4459, 467. See also,

e.g.,

In re Piasecki,

745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir.

1984) (commercial success). Rebuttal evidence may also include evidence that the claimed

invention yields unexpectedly improved properties or properties not present in the prior

art. 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 regarding unusually low immune response or unexpected

biological activity that were unsupported by comparative data held insufficient to overcome

prima facie

case of obviousness). Rebuttal evidence may include

evidence that the claimed invention was copied by others. See, 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). 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

ess). Rebuttal evidence may include

evidence that the claimed invention was copied by others. See, 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). 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. See, 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

nontechnological 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.). 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. A conclusion of obviousness requires

that the reference(s) relied upon, together with the knowledge of a person skilled in the

art, be enabling in that it put the public in possession of the claimed invention.

In re Hoeksema,

399 F.2d 269, 273, 158 USPQ 596, 600 (CCPA 1968)

(citing

In re Le Grice,

301 F.2d 929, 936, 133 USPQ 365, 372 (CCPA

1962))

eclude a conclusion of obviousness of the compound. A conclusion of obviousness requires

that the reference(s) relied upon, together with the knowledge of a person skilled in the

art, be enabling in that it put the public in possession of the claimed invention.

In re Hoeksema,

399 F.2d 269, 273, 158 USPQ 596, 600 (CCPA 1968)

(citing

In re Le Grice,

301 F.2d 929, 936, 133 USPQ 365, 372 (CCPA

1962)). The

Hoeksema,

court 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.

See

Hoeksema

, 399 F.2d at 274, 158 USPQ at 601. The

Hoeksema

court further noted that once a

prima

facie

case of obviousness is made by the USPTO through citation of references,

the burden is on the applicant to produce contrary evidence. In

Hoeksema

, the contrary evidence was that the applied reference did not

disclose or render obvious a process for producing the claimed compounds.

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..

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.").

Consideration of rebuttal evidence and arguments requires Office personnel

to weigh the proffered evidence and arguments.

Id.;

see also

re Alton,

76 F.3d 1168, 1174-75, 37 USPQ2d 1578, 1582-83 (Fed. Cir. 1996).

Office personnel should avoid giving no weight to evidence submitted by applicant, except

in rare circumstances. However, to be entitled to substantial weight, the applicant should

establish a nexus between the rebuttal evidence and the claimed invention, i.e., objective

evidence of nonobviousness must be attributable to the claimed invention. 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

ppropriate 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) (Evidence

of commercial success of articles not covered by the claims subject to the

35 U.S.C.

103

rejection was not probative of nonobviousness.). Additionally,

the evidence must be reasonably commensurate in scope with the claimed invention. See,

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 nonobviousness was not commensurate in scope

with the claim because it had not been raised by the examiner.

Id.

F.3d at 751, 34 USPQ2d at 1688.

In other words, in order for evidence of secondary

considerations to be accorded substantial weight, there must be a nexus, i.e., a legally

and factually sufficient connection or correspondence between the submitted evidence and

the claimed invention.

Fox Factory, Inc. v. SRAM, LLC,

944 F.3d 1366,

1373, 2019 USPQ2d 483355 (Fed. Cir. 2019), cert. denied, 141 S.Ct. 373 (2020). “A

presumption of nexus requires both that the product embodies the invention and is

coextensive with it.”

Volvo Penta of the Americas, LLC v. Brunswick

Corp.,

81 F.4th 1202,1211-12, 2023 USPQ2d 1000 (Fed. Cir. 2023) (While Volvo

Penta provided insufficient evidence to show a presumption of nexus, they did provide

sufficient evidence to show nexus, independent of the presumption, through evidence of

commercial success and copying due to the unique features of the claimed invention.). See

MPEP §

716.01(b)

vo Penta of the Americas, LLC v. Brunswick

Corp.,

81 F.4th 1202,1211-12, 2023 USPQ2d 1000 (Fed. Cir. 2023) (While Volvo

Penta provided insufficient evidence to show a presumption of nexus, they did provide

sufficient evidence to show nexus, independent of the presumption, through evidence of

commercial success and copying due to the unique features of the claimed invention.). See

MPEP §

716.01(b)

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. See, 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

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 nonobviousness 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.)

rtisan “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 nonobviousness 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);

re 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). However, an exemplary showing may be sufficient to establish a

reasonable correlation between the showing and the entire scope of the claim, when viewed

by a skilled artisan. See, e.g.,

Chupp,

816 F.2d at 646, 2 USPQ2d at

1439;

Clemens,

622 F.2d at 1036, 206 USPQ at 296. On the other hand,

evidence of an unexpected property may not be sufficient regardless of the scope of the

showing. 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 alone may not

be sufficient to confer patentability

howing 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 alone may not

be sufficient to confer patentability. See

Dillon,

919 F.2d at 692, 16

USPQ2d at 1900-01. Accordingly, each case should be evaluated individually based on the

totality of the circumstances.

Evidence pertaining to secondary considerations must be taken into

account whenever it has been properly presented; however, it does not necessarily control

the obviousness conclusion. See, e.g.,

Pfizer, Inc. v. Apotex, Inc.,

480

F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007) (“the record establish[ed] such a

strong case of obviousness” that allegedly unexpectedly superior results were ultimately

insufficient to overcome obviousness conclusion);

Leapfrog Enterprises Inc. v.

Fisher-Price Inc.,

485 F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir. 2007)

(“given the strength of the

prima facie

obviousness showing, the

evidence on secondary considerations was inadequate to overcome a final conclusion” of

obviousness); and

Newell Cos., Inc. v. Kenney Mfg. Co.,

864 F.2d 757,

768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988). Office personnel should not evaluate rebuttal

evidence for its “knockdown” value against the

prima facie

case,

Piasecki,

745 F.2d at 1473, 223 USPQ at 788, or summarily dismiss it

as not compelling or insufficient. Office personnel should weigh all relevant evidence of

record in order to determine whether the claims would have been obvious based on a

preponderance (more likely than not) standard, and then explain their conclusions. See

MPEP §

716

§ 716.10

for additional information

pertaining to the evaluation of rebuttal evidence submitted under

37 CFR 1.132

dismiss it

as not compelling or insufficient. Office personnel should weigh all relevant evidence of

record in order to determine whether the claims would have been obvious based on a

preponderance (more likely than not) standard, and then explain their conclusions. See

MPEP §

716

§ 716.10

for additional information

pertaining to the evaluation of rebuttal evidence submitted under

37 CFR 1.132

The following cases exemplify the continued application of

the principle that when evidence has been presented to rebut an obviousness rejection, it

should not be evaluated simply for its “knockdown” value. Rather, all evidence must be

reweighed to determine whether the claims are nonobvious.

Example 1:

The claims at issue in

PharmaStem Therapeutics,

Inc. v. Viacell, Inc.,

491 F.3d 1342, 83 USPQ2d 1289 (Fed. Cir. 2007), were

directed to compositions comprising hematopoietic stem cells from umbilical cord or

placental blood, and to methods of using such compositions for treatment of blood and

immune system disorders. The composition claims required that the stem cells be present

in an amount sufficient to effect hematopoietic reconstitution when administered to a

human adult. The trial court had found that PharmaStem’s patents were infringed and not

invalid on obviousness or other grounds. On appeal, the Federal Circuit reversed the

district court, determining that the claims were invalid for obviousness.

The Federal Circuit discussed the evidence presented at

trial. It pointed out that the patentee, PharmaStem, had not invented an entirely new

procedure or new composition. Rather, PharmaStem’s own specification acknowledged that

it was already known in the prior art that umbilical cord and placental blood-based

compositions contained hematopoietic stem cells, and that hematopoietic stem cells were

useful for the purpose of hematopoietic reconstitution. PharmaStem’s contribution was to

provide experimental proof that umbilical cord and placental blood could be used to

effect hematopoietic reconstitution in mice

ledged that

it was already known in the prior art that umbilical cord and placental blood-based

compositions contained hematopoietic stem cells, and that hematopoietic stem cells were

useful for the purpose of hematopoietic reconstitution. PharmaStem’s contribution was to

provide experimental proof that umbilical cord and placental blood could be used to

effect hematopoietic reconstitution in mice. By extrapolation, one of ordinary skill in

the art would have expected this reconstitution method to work in humans as well.

The court rejected PharmaStem’s expert testimony that

hematopoietic stem cells had not been proved to exist in cord blood prior to the

experiments described in PharmaStem’s patents. The court explained that the expert

testimony was contrary to the inventors’ admissions in the specification, as well as

prior art teachings that disclosed stem cells in cord blood. In this case, PharmaStem’s

evidence of nonobviousness was outweighed by contradictory evidence.

Despite PharmaStem’s useful experimental validation of

hematopoietic reconstitution using hematopoietic stem cells from umbilical cord and

placental blood, the Federal Circuit found that the claims at issue would have been

obvious. There had been ample suggestion in the prior art that the claimed method would

have worked. Absolute predictability is not a necessary prerequisite to a case of

obviousness. Rather, a degree of predictability that one of ordinary skill would have

found to be reasonable is sufficient. The Federal Circuit concluded that “[g]ood science

and useful contributions do not necessarily result in patentability.”

Id.

at 1364, 83 USPQ2d at 1304.

Example 2:

It was found to be an error in

In re

Sullivan,

498 F.3d 1345, 84 USPQ2d 1034 (Fed. Cir. 2007), for the Board to

fail to consider evidence submitted to rebut a

prima facie

case of

obviousness.

The claimed invention was directed to an antivenom

composition comprising F(ab) fragments used to treat venomous rattlesnake bites

essarily result in patentability.”

Id.

at 1364, 83 USPQ2d at 1304.

Example 2:

It was found to be an error in

In re

Sullivan,

498 F.3d 1345, 84 USPQ2d 1034 (Fed. Cir. 2007), for the Board to

fail to consider evidence submitted to rebut a

prima facie

case of

obviousness.

The claimed invention was directed to an antivenom

composition comprising F(ab) fragments used to treat venomous rattlesnake bites. The

composition was created from antibody molecules that include three fragments, F(ab)2,

F(ab) and F(c), which have separate properties and utilities. There had been

commercially available antivenom products that consisted of whole antibodies and F(ab)2

fragments, but researchers had not experimented with antivenoms containing only F(ab)

fragments because it was believed that their unique properties would prevent them from

decreasing the toxicity of snake venom. The inventor, Sullivan, discovered that F(ab)

fragments are effective at neutralizing the lethality of rattlesnake venom, while

reducing the occurrence of adverse immune reactions in humans. On appeal of the

examiner’s rejection, the Board held that the claim was obvious because all the elements

of the claimed composition were accounted for in the prior art, and that the composition

taught by that prior art would have been expected by a person of ordinary skill in the

art at the time the invention was made (the case was examined under

pre-AIA 35 U.S.C.

103

) to neutralize the lethality of the venom of a rattlesnake.

Rebuttal evidence had not been considered by the Board

because it considered the evidence to relate to the intended use of the claimed

composition as an antivenom, rather than the composition itself. Appellant successfully

argued that even if the Board had shown a

prima facie

case of

obviousness, the extensive rebuttal evidence must be considered

ralize the lethality of the venom of a rattlesnake.

Rebuttal evidence had not been considered by the Board

because it considered the evidence to relate to the intended use of the claimed

composition as an antivenom, rather than the composition itself. Appellant successfully

argued that even if the Board had shown a

prima facie

case of

obviousness, the extensive rebuttal evidence must be considered. The evidence included

three expert declarations submitted to show that the prior art taught away from the

claimed invention, an unexpected property or result from the use of F(ab) fragment

antivenom, and why those having ordinary skill in the art expected antivenoms comprising

F(ab) fragments to fail. The declarations related to more than the use of the claimed

composition. While a statement of intended use may not render a known composition

patentable, the claimed composition was not known, and whether it would have been

obvious depends upon consideration of the rebuttal evidence. Appellant did not concede

that the only distinguishing factor of its composition is the statement of intended use

and extensively argued that its claimed composition exhibits the unexpected property of

neutralizing the lethality of rattlesnake venom while reducing the occurrence of adverse

immune reactions in humans. The Federal Circuit found that such a use and unexpected

property cannot be ignored – the unexpected property is relevant and thus the

declarations describing it should have been considered.

Nonobviousness can be shown when a person of ordinary

skill in the art would not have reasonably predicted the claimed invention based on the

prior art, and the resulting invention would not have been expected. All evidence must

be considered when properly presented.

Example 3:

The case of

Hearing Components, Inc. v. Shure

Inc.,

600 F.3d 1357, 94 USPQ2d 1385 (Fed. Cir. 2010), involved a disposable

protective covering for the portion of a hearing aid that is inserted into the ear

canal

sonably predicted the claimed invention based on the

prior art, and the resulting invention would not have been expected. All evidence must

be considered when properly presented.

Example 3:

The case of

Hearing Components, Inc. v. Shure

Inc.,

600 F.3d 1357, 94 USPQ2d 1385 (Fed. Cir. 2010), involved a disposable

protective covering for the portion of a hearing aid that is inserted into the ear

canal. The covering was such that it could be readily replaced by a user as needed.

At the district court, Shure had argued that Hearing

Components’ patents were obvious over one or more of three different combinations of

prior art references. The jury disagreed, and determined that the claims were

nonobvious. The district court upheld the jury verdict, stating that in view of the

conflicting evidence presented by the parties as to the teachings of the references,

motivation to combine, and secondary considerations, the nonobviousness verdict was

sufficiently grounded in the evidence.

Shure appealed to the Federal Circuit, but the Federal

Circuit agreed with the district court that the jury’s nonobviousness verdict had been

supported by substantial evidence. Although Shure had argued before the jury that the

Carlisle reference taught an ear piece positioned inside the ear canal, Hearing

Components’ credible witness countered that only the molded duct and not the ear piece

itself was taught by Carlisle as being inside the ear canal. On the issue of combining

references, Shure’s witness had given testimony described as “rather sparse, and lacking

in specific details.”

Id.

at 1364, 94 USPQ2d at 1397. In

contradistinction, Hearing Components’ witness “described particular reasons why one

skilled in the art would not have been motivated to combine the references.”

itself was taught by Carlisle as being inside the ear canal. On the issue of combining

references, Shure’s witness had given testimony described as “rather sparse, and lacking

in specific details.”

Id.

at 1364, 94 USPQ2d at 1397. In

contradistinction, Hearing Components’ witness “described particular reasons why one

skilled in the art would not have been motivated to combine the references.”

Id.

Finally, as to secondary considerations, the Federal Circuit

determined that Hearing Components had shown a nexus between the commercial success of

its product and the patent by providing evidence that “the licensing fee for a covered

product was more than cut in half immediately upon expiration” of the patent.

Although the

Hearing Components

case

involves substantial evidence of nonobviousness in a jury verdict, it is nevertheless

instructive for Office personnel on the matter of weighing evidence. Office personnel

routinely must consider evidence in the form of prior art references, statements in the

specification, or declarations under

37 CFR 1.130

(for cases examined

under the

AIA

35 U.S.C. 102

and

103

37 CFR 1.131

(for cases examined under

pre-AIA 35 U.S.C. 102

and

103

), or

1.132

(for cases examined either

under the AIA or under pre-AIA law). Other forms of evidence may also be presented

during prosecution. Office personnel are reminded that evidence that has been presented

in a timely manner should not be ignored, but rather should be considered on the record.

However, not all evidence need be accorded the same weight. In determining the relative

weight to accord to rebuttal evidence, considerations such as whether a nexus exists

between the claimed invention and the proffered evidence, and whether the evidence is

commensurate in scope with the claimed invention, are appropriate. The mere presence of

some credible rebuttal evidence does not dictate that an obviousness rejection must

always be withdrawn. See

MPEP § 2145

mining the relative

weight to accord to rebuttal evidence, considerations such as whether a nexus exists

between the claimed invention and the proffered evidence, and whether the evidence is

commensurate in scope with the claimed invention, are appropriate. The mere presence of

some credible rebuttal evidence does not dictate that an obviousness rejection must

always be withdrawn. See

MPEP § 2145

. Office personnel must consider the appropriate

weight to be accorded to each piece of evidence. An obviousness rejection should be made

or maintained only if evidence of obviousness outweighs evidence of nonobviousness. See

MPEP §

706

, subsection I. (“The standard to be applied in all cases

is the ‘preponderance of the evidence’ test. In other words, an examiner should reject a

claim if, in view of the prior art and evidence of record, it is more likely than not

that the claim is unpatentable.”).

MPEP § 716.01(d)

provides further

guidance on weighing evidence in making a determination of patentability.

Example 4:

Yita LLC, v MacNeil IP LLC,

69 F.4th

1356, 2023 USPQ2d 667 (Fed. Cir. 2023) involved consideration of Yita’s challenge to

MacNeil’s patent in two

inter partes

reviews (IPRs). In

IPR2020-01139, the Board found the patent claims nonobvious due to MacNeil’s “evidence

of secondary considerations [which was] compelling and indicative of non-obviousness.”

On appeal, the Federal Circuit reversed the Board’s final written decision.

MacNeil’s patent claims were directed to a vehicle floor

tray “closely conforming” to certain walls of the vehicle foot well, a feature that the

Board recognized was disclosed in one of the asserted prior art references (Rabbe). The

Board had found that MacNeil was entitled to a presumption of nexus because its marketed

vehicle trays embodied the claimed invention and were coextensive with the claims

Neil’s patent claims were directed to a vehicle floor

tray “closely conforming” to certain walls of the vehicle foot well, a feature that the

Board recognized was disclosed in one of the asserted prior art references (Rabbe). The

Board had found that MacNeil was entitled to a presumption of nexus because its marketed

vehicle trays embodied the claimed invention and were coextensive with the claims.

On appeal, the Federal Circuit determined that the

finding of nexus rested on two legal errors: (1) the finding that Rabbe’s disclosure

needed to but did not establish that close conformance was well-known; and (2) the

misapplication of

WBIP, LLC v. Kohler Co.,

829 F.3d 1317, 119 USPQ2d

1301 (Fed. Cir. 2016), which did not speak to the present situation where the secondary

consideration evidence is linked to an individual element of the claimed invention,

specifically the close-conformity element taught by Rabbe.

As to the first error, the court determined that their

previous case law made clear that “objective evidence of nonobviousness lacks a nexus if

it exclusively relates to a feature that was ‘known in the prior art’—not necessarily

well-known.”

Rambus Inc. v. Rea,

731 F.3d 1248, 1257, 108 USPQ2d 1400

(Fed. Cir. 2013) (emphasis in the original) (quoting

Ormco Corp. v. Align

Technology, Inc.,

463 F.3d 1299, 1312, 79 USPQ2d 1931 (Fed. Cir. 2006))

(internal quotation marks omitted). Additionally, the court noted that the finding of

coextensiveness is only relevant to the presumption of nexus and it alone does not

decide the overall nexus question.

As to the second error, the court determined the

secondary consideration evidence was related solely to the individual element of

close-conformance disclosed in the prior art to Rabbe. This circumstance was different

than the one present in

WBIP

in which no single feature (but only the

combination) was responsible for the secondary consideration evidence

does not

decide the overall nexus question.

As to the second error, the court determined the

secondary consideration evidence was related solely to the individual element of

close-conformance disclosed in the prior art to Rabbe. This circumstance was different

than the one present in

WBIP

in which no single feature (but only the

combination) was responsible for the secondary consideration evidence.

The secondary consideration evidence was the only

Graham

factor that the Board deemed to weigh in favor of

nonobviousness. Because the Board determined that an artisan of ordinary skill would

have been motivated to combine the teachings of the prior art references to arrive at

the claimed invention with a reasonable expectation of success, the court reversed the

final written decision.

MPEP § 716.01(b)

provides further

guidance on the nexus requirement and evidence of nonobviousness.

See

MPEP § 2155

regarding affidavits or

declarations under

CFR 1.130

to overcome prior art rejections.

See

MPEP §§ 715

et seq. and

2136.05(a)

regarding affidavits or declarations under

37 CFR

1.131

to overcome prior art rejections.

See

MPEP §§ 716

et seq. and

2136.05(b)

regarding affidavits or declarations under

37 CFR

1.132

to overcome prior art rejections.

ARGUMENT DOES NOT REPLACE EVIDENCE WHERE EVIDENCE IS NECESSARY

An argument by the applicant is not evidence unless it is an admission,

in which case, an examiner may use the admission in making a rejection. See

MPEP §

2129

and

§ 2144.03

for a discussion of

admissions as prior art.

Arguments presented by applicant cannot take the place of evidence in

the record. See

In re De Blauwe,

736 F.2d 699, 705, 222 USPQ 191, 196

(Fed. Cir. 1984);

In re

Schulze,

346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965);

In re Geisler,

116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An

assertion of what seems to follow from common experience is just attorney argument and

not the kind of factual evidence that is required to rebut a

prima

facie

case of obviousness.”)

e record. See

In re De Blauwe,

736 F.2d 699, 705, 222 USPQ 191, 196

(Fed. Cir. 1984);

In re

Schulze,

346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965);

In re Geisler,

116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An

assertion of what seems to follow from common experience is just attorney argument and

not the kind of factual evidence that is required to rebut a

prima

facie

case of obviousness.”). See

MPEP § 716.01(c)

for examples of

applicant statements which are not evidence and which must be supported by an

appropriate affidavit or declaration.

II.

ARGUING ADDITIONAL ADVANTAGES OR LATENT PROPERTIES

Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional

Advantages or Latent Properties Present But Not Recognized in the Prior

Art

Mere recognition of latent properties in the prior art does not

render nonobvious an otherwise known invention.

In re Wiseman,

596

F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc

brakes wherein the grooves were provided to vent steam or vapor during a braking

action. A prior art reference taught noncarbon disc brakes which were grooved for the

purpose of cooling the faces of the braking members and eliminating dust. The court

held the prior art references when combined would overcome the problems of dust and

overheating solved by the prior art and would inherently overcome the steam or vapor

cause of the problem relied upon for patentability by applicants. Granting a patent

on the discovery of an unknown but inherent function (here venting steam or vapor)

“would remove from the public that which is in the public domain by virtue of its

inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at

661.);

In re Baxter Travenol Labs.,

952 F.2d 388, 21 USPQ2d 1281

(Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a

blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any

prima facie

showing of obviousness

that which is in the public domain by virtue of its

inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at

661.);

In re Baxter Travenol Labs.,

952 F.2d 388, 21 USPQ2d 1281

(Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a

blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any

prima facie

showing of obviousness. However, the closest prior

art utilizing a DEHP plasticized blood collection bag inherently achieved same

result, although this fact was unknown in the prior art.).

“The fact that appellant has recognized another advantage which

would flow naturally from following the suggestion of the prior art cannot be the

basis for patentability when the differences would otherwise be obvious.”

parte Obiaya,

227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The

prior art taught combustion fluid analyzers which used labyrinth heaters to maintain

the samples at a uniform temperature. Although appellant showed that an unexpectedly

shorter response time was obtained when a labyrinth heater was employed, the Board

held this advantage would flow naturally from following the suggestion of the prior

art.). See also

Lantech Inc.

v. Kaufman Co. of Ohio Inc.,

878 F.2d 1446, 12 USPQ2d 1076, 1077

(Fed. Cir. 1989),

cert. denied,

493 U.S. 1058 (1990) (unpublished

— not citable as precedent) (“The recitation of an additional advantage associated

with doing what the prior art suggests does not lend patentability to an otherwise

unpatentable invention.”).

In re Lintner,

458 F.2d 1013, 173 USPQ 560 (CCPA 1972) and

In re Dillon,

919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990)

discussed in

MPEP

§ 2144

are also pertinent to this issue.

See

MPEP § 716.02

§ 716.02(g)

for a discussion of

declaratory evidence alleging unexpected results.

III

ciated

with doing what the prior art suggests does not lend patentability to an otherwise

unpatentable invention.”).

In re Lintner,

458 F.2d 1013, 173 USPQ 560 (CCPA 1972) and

In re Dillon,

919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990)

discussed in

MPEP

§ 2144

are also pertinent to this issue.

See

MPEP § 716.02

§ 716.02(g)

for a discussion of

declaratory evidence alleging unexpected results.

III.

ARGUING THAT PRIOR ART DEVICES ARE NOT PHYSICALLY COMBINABLE

“It is well-established that a determination of obviousness based on

teachings from multiple references does not require an actual, physical substitution of

elements.”

In re Mouttet,

686 F.3d 1322, 1332, 103 USPQ2d 1219, 1226

(Fed. Cir. 2012) (citing

In re Etter,

756 F.2d 852, 859, 225 USPQ 1,

6 (Fed. Cir. 1985) (

en banc

)) (“Etter's assertions that Azure cannot

be incorporated in Ambrosio are basically irrelevant, the criterion being not whether

the references could be physically combined but whether the claimed inventions are

rendered obvious by the teachings of the prior art as a whole.”). See also

re Keller,

642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981) (“The test for

obviousness is not whether the features of a secondary reference may be bodily

incorporated into the structure of the primary reference.... Rather, the test is what

the combined teachings of those references would have suggested to those of ordinary

skill in the art.”);

In re Sneed,

710 F.2d 1544, 1550, 218 USPQ 385,

389 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be

physically combinable to render obvious the invention under review.”); and

re Nievelt,

482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the

teachings

of references does not involve an ability to combine

their specific structures.”).

However, the claimed combination cannot change the principle of

operation of the primary reference or render the reference inoperable for its intended

purpose. See

MPEP

§ 2143.01

, subsection VI.

he invention under review.”); and

re Nievelt,

482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the

teachings

of references does not involve an ability to combine

their specific structures.”).

However, the claimed combination cannot change the principle of

operation of the primary reference or render the reference inoperable for its intended

purpose. See

MPEP

§ 2143.01

, subsection VI.

IV.

ARGUING AGAINST REFERENCES INDIVIDUALLY

One cannot show nonobviousness by attacking references individually where the

rejections are based on combinations of references

In re

Keller,

642 F.2d 413, 208 USPQ 871 (CCPA 1981);

In re Merck &

Co., Inc.,

800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection

of a claim is based on two or more references, a reply that is limited to what a subset

of the applied references teaches or fails to teach, or that fails to address the

combined teaching of the applied references may be considered to be an argument that

attacks the reference(s) individually. Where an applicant’s reply establishes that each

of the applied references fails to teach a limitation and addresses the combined

teachings and/or suggestions of the applied prior art, the reply as a whole does not

attack the references individually as the phrase is used in

Keller

and reliance on

Keller

would not be appropriate. This is because

“[T]he test for obviousness is what the combined teachings of the references would have

suggested to [a PHOSITA].”

In re Mouttet,

686 F.3d 1322, 1333, 103

USPQ2d 1219, 1226 (Fed. Cir. 2012).

ARGUING ABOUT THE NUMBER OF REFERENCES COMBINED

Reliance on a large number of references in a rejection does not,

without more, weigh against the obviousness of the claimed invention.

In re

Gorman,

933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991) (Court affirmed a

rejection of a detailed claim to a candy sucker shaped like a thumb on a stick based on

thirteen prior art references.).

Cir. 2012).

ARGUING ABOUT THE NUMBER OF REFERENCES COMBINED

Reliance on a large number of references in a rejection does not,

without more, weigh against the obviousness of the claimed invention.

In re

Gorman,

933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991) (Court affirmed a

rejection of a detailed claim to a candy sucker shaped like a thumb on a stick based on

thirteen prior art references.).

VI.

ARGUING LIMITATIONS WHICH ARE NOT CLAIMED

Although the claims are interpreted in light of the specification,

limitations from the specification are not read into the claims.

In re Van

Geuns,

988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a

superconducting magnet which generates a “uniform magnetic field” were not limited to

the degree of magnetic field uniformity required for Nuclear Magnetic Resonance (NMR)

imaging. Although the specification disclosed that the claimed magnet may be used in an

NMR apparatus, the claims were not so limited.);

Constant v. Advanced

Micro-Devices, Inc.,

848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed.

Cir.),

cert. denied,

488 U.S. 892 (1988) (Various limitations on

which appellant relied were not stated in the claims; the specification did not provide

evidence indicating these limitations must be read into the claims to give meaning to

the disputed terms.);

Ex parte McCullough,

7 USPQ2d 1889, 1891 (Bd.

Pat. App. & Inter. 1987) (Claimed electrode was rejected as obvious despite

assertions that electrode functions differently than would be expected when used in

nonaqueous battery since “although the demonstrated results may be germane to the

patentability of a battery containing appellant’s electrode, they are not germane to the

patentability of the invention claimed on appeal.”).

See

MPEP

§ 2111

§ 2116.01

, for additional case law

relevant to claim interpretation.

VII

assertions that electrode functions differently than would be expected when used in

nonaqueous battery since “although the demonstrated results may be germane to the

patentability of a battery containing appellant’s electrode, they are not germane to the

patentability of the invention claimed on appeal.”).

See

MPEP

§ 2111

§ 2116.01

, for additional case law

relevant to claim interpretation.

VII.

ARGUING ECONOMIC INFEASIBILITY

The fact that a "combination would not be made by businessmen for

economic reasons" does not mean that a person of ordinary skill in the art would not

make the combination because of some technological incompatibility.

In re

Farrenkopf,

713 F.2d 714, 718, 219 USPQ 1, 4 (Fed. Cir. 1983) (Prior art

reference taught that addition of inhibitors to radioimmunoassay is the most convenient,

but costliest solution to stability problem. The court held that the additional expense

associated with the addition of inhibitors would not discourage one of ordinary skill in

the art from seeking the convenience expected therefrom.).

VIII.

ARGUING ABOUT THE AGE OF REFERENCES

“The mere age of the references is not persuasive of the unobviousness

of the combination of their teachings, absent evidence that, notwithstanding knowledge

of the references, the art tried and failed to solve the problem.”

In re

Wright,

569 F.2d 1124, 1127, 193 USPQ 332, 335 (CCPA 1977) (100 year old

patent was properly relied upon in a rejection based on a combination of references.).