University of Georgia Research Foundation, Inc.

Patent Trials and Appeals Board

Aug 5, 2020

15411083 - (D) (P.T.A.B. Aug. 5, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/411,083 01/20/2017 Donald A. Harn 0235.000184US21 4864
26813 7590 08/05/2020
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
EXAMINER
LYONS, MARY M
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
08/05/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ptodocketing@mrgs.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DONALD A. HARN, RAFAELLA QUEIROZ,
LISA SHOLLENBERGER, and EMILY-JOY FARAH SAMLI
__________

Appeal 2020-000013
Application1 15/411,083
Technology Center 1600
__________

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods of administering one or more antigens and a self-assembling
peptide comprising the sequence RADARADARADARADA, which have
been rejected as obvious and for obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as University
of Georgia Research Foundation, Inc. (Appeal Br. 3.)
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STATEMENT OF THE CASE
According to Appellant’s Specification: “The goal of vaccine delivery
is to present vaccine antigens in a manner that enhances antigen presenting
cell activation, uptake of antigen and processing.” (Spec. 1.) Appellant’s
Specification states that “[t]here is a need for improved delivery modes and
adjuvants that are safe for use in vaccine formulations.” (Id.) Appellant’s
invention is directed to a method of delivering one or more immunogenic
antigens to a subject. (Id. at 2.)
Claims 12–15, 21, 26–30, and 34–47 are on appeal. Claim 12 is
representative and reads as follows:
12. A method of producing an increased titer of both IgG1 and
IgG2b antigen-specific antibodies in a subject, the method
comprising administering to the subject a composition that is a
liquid at room temperature and forms a peptide hydrogel at
physiological pH, physiological salt concentrations, and/or
physiological temperatures, the composition comprising:
one or more isolated antigens; and
a self-assembling peptide comprising
RADARADARADARADA (SEQ ID NO:2);
wherein the one or more isolated antigens comprises a
bacterial antigen, a viral antigen, a parasitic antigen, or a tumor
associated antigen;
wherein the self-assembling peptide and the one or more
isolated antigen are mixed together in the composition; and
wherein the titer of both IgG1 and IgG2b antigen-specific
antibodies in the subject is increased compared to a subject
administered a composition comprising a similar amount of
antigen alone without the self-assembling peptide or a similar
amount of antigen and alum adjuvant.
(Appeal Br. Claims Appendix 1.)

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The prior art relied upon by the Examiner is:
Name Reference Date
Irvine et al. US 2005/0053667 A1 Mar. 10, 2005
Genove et al. US 2005/0181973 A1 Aug. 18, 2005
Vincent F. M. Segers & Richard T. Lee, Local delivery of proteins and
the use of self-assembling peptides, 12(13/14) Drug Discovery Today
561–68 (2007)
S. Koutsopoulos et al., Controlled release of functional proteins through
designer self-assembling peptide nanofiber hydrogel scaffold, 106(12)
PNAS 4623–28 (2009)

The following grounds of rejection by the Examiner are before us on
review:
Claims 12, 13, 15, 21, 26–30, 34–36, and 38–47 under 35 U.S.C.
§ 103(a) as unpatentable over Irvine and Koutsopoulos.
Claims 12–15, 21, 26–30, and 34–47 under 35 U.S.C. § 103(a) as
unpatentable over Segers, Irvine, and Genove.
Claims 12–15, 21, 26–30, and 34–47 on the ground of non-statutory
obviousness-type double patenting as being unpatentable over claims 15–20
of U.S. Patent No. 9,566,338.
DISCUSSION
Obviousness: Irvine and Koutsopoulos
The Examiner finds that Irvine teaches a method of modulating
immune responses by administering a composition that includes a hydrogel
polymer and an immunogen, and can also include a ligand such as CpG.
(Final Action 6; Ans. 16.) The Examiner finds further that “Irvine et al.
teach slow and controlled release of the antigen of interest from the
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composition comprising a hydrogel (e.g.[, ]see [0030, 0054]).” (Ans. 4;
Ans. 16.)
The Examiner finds that Koutsopoulos teaches “peptide hydrogels
provide a platform that makes them ideal for nanomedical applications
because they are easy to use, nontoxic, non-immunogenic, non-
thrombogenic, biodegradable and applicable to localized therapies through
injection into particular tissue.” (Final Action 8 (citing Koutsopoulos 4623,
right column).) The Examiner finds that Koutsopoulos teaches such peptide
hydrogels include “those comprising RADA, (e.g., (RADA)4; which is
RAD16-1 and RADARADARADARADA; and thus matches instant SEQ
ID NO:2)” and that they “have all the advantages of traditional hydrogels
but do not use harmful materials such as potentially toxic cross-linkers to
initiate the solution-gel transformation.” (Id. at 7–8 (citing Koutsopoulos
4623, Introduction).) The Examiner further finds that Koutsopoulos teaches
these hydrogels are biodegradable and thus release their entire load into the
host tissue. Id. at 8 (citing Koutsopoulos 4624, left column).) In addition,
the Examiner notes that
Koutsopoulos et al. teach these self-assembling peptides are
mixed with proteins of interest and applied to a specific tissue[]
such that the peptide hydrogel subsequently releases its protein
load slowly to the local area over time thereby yielding an
efficient and controlled delivery and release system (e.g.[,] page
4626-27, bridging paragraph).
(Ans. 5; Ans. 16.)
In light of these teachings, the Examiner finds that it would have been
prima facie obvious at the time the invention was made to substitute the self-
assembling peptide hydrogel taught by Koutsopoulos for the hydrogel taught
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for use in Irvine. In particular, the Examiner states the modification would
have been obvious
because peptide hydrogels did not use harmful, potentially
toxic, cross-linkers to initiate the solution-gel transformation
and because peptide hydrogels released the entire load of the
hydrogel locally into the host tissue in an efficient and
controlled manner, as taught by Koutsopoulos et al.
(Ans. 5–6; Final Action 8.) The Examiner further states with respect to
motivation to combine:
The person of ordinary skill in the art would have been
motivated to make the modification because the (RADA)4
peptide hydrogels (i.e.[,] SEQ ID NO: 2) were recognized as
easy to use, nontoxic, non-immunogenic, non-thrombogenic,
biodegradable and applicable to localized therapies through
injection into particular tissue, as taught by Koutsopoulos et al.
In addition, the (RADA)4 peptide hydrogel was more efficient
than non-peptide hydrogels, as taught by Koutsopoulos et al.
Thus, the combination is also desirable; see MPEP [§]
2144(11).
(Ans. 6; Advisory Action at Continuation Sheet 12; Final Action 8–9.) The
Examiner further explains with respect to a reasonable expectation of
success that
The person of ordinary skill in the art would have had a
reasonable expectation of success because Irvine et al. already
taught methods to modulate an immune response against a
specific antigen by using hydrogel-based delivery platforms
comprising a non-peptide hydrogel, antigen and CpG ligand;
and Koutsopoulos et al. already taught the advantages of using
a self-assembling, RADA-comprising peptide hydrogel over the
more traditional type of hydrogels (i.e.[,] less harmful and more
efficient). Therefore, the combination leads to expected results

2 We refer to the Advisory Action dated Dec. 3, 2018.
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because each element performs the same function as it does
individually.
(Ans. 6; Final Action 9.) The Examiner explains that
Irvine et al. contains a “base” method of modulating an immune
response comprising the use of a non-peptide hydrogel; and
Koutsopoulos et al. contains a similar method wherein the
technique of using the (RADA)4 peptide hydrogels (i.e.[,] SEQ
ID NO: 2) is taught as advantageous. Thus, one of ordinary
skill in the art would have recognized that applying the known
technique taught by Koutsopoulos et al. would have yielded
predictable results (i.e.[,] the same advantages) and an
improved system.
(Ans. 7; Final Action 8.)
The Examiner recognizes that the reason to combine may not “suggest
the combination to achieve the same advantage or result discovered by
Appellant,” i.e., the increased antibody titer, but that such is not necessary,
where, as here, that advantage is simply an intended result of the positively
recited method step of administering the claimed composition, and there is a
reason to substitute the hydrogel of Irvine with that of Koutsopoulos that
arises from the teaching of Koutsopoulos. (Ans. 15–16.)
We agree with the Examiner’s factual findings and conclusion of
obviousness. Appellant does not dispute the Examiner’s characterization of
the teachings of Irvine or Koutsopoulos and we adopt the Examiner’s
characterization as set forth above. Moreover, we agree with the Examiner
that there would have been good reason to substitute the (RADA)4 hydrogel
of Koutsopoulos in the Irvine method with a reasonable expectation of
success in delivering an antigen to a tissue to modulate an immune response
to the antigen, including dendritic cell activation. Irvine teaches, the “delay
in release [of the antigen from the hydrogel particles] into the local
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microenvironment will limit nonspecific removal of the particles by tissue
macrophages and allow time for DC recruitment to the vaccine site.” (Irvine
¶ 66.) And, as the Examiner explained (Ans. 5), Koutsopoulos teaches (1)
that the (RADA)4 hydrogels will allow for the entire load of the hydrogel to
be released into the host tissue because of its biodegradability, whereas other
hydrogel systems rarely reach 100% protein release (Koutsopoulos 4624 left
column), and (2) that the peptide hydrogel subsequently releases its protein
load slowly to the local area over time (id. at 4626–27.)
Appellant argues that the Examiner’s rejection is in error because “a
person of ordinary skill in the art at the time of the invention could have had
no recognition that substituting the self-assembling peptide
RADARADARADARADA (SEQ ID NO:2) (as taught by Koutsopoulos)
into the general method of generating antibody responses to an antigen (as
taught by Irvine) would result in an increased titer of both IgG1 and IgG2b
antigen-specific antibodies.” (Appeal Br. 9.)
To address the foregoing, we first address a claim construction issue
as to the three “wherein” clauses recited in claim 12. The first two recite
conditions for the composition used in the positively recited administration
step. In particular, the first is a requirement as to what the antigen in the
composition must be. The second is a requirement of how the parts of the
composition are provided in the composition, namely they are mixed
together. Such claim clauses are deemed to recite a positive limitation of the
claim. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329–30 (Fed.
Cir. 2005). The third “wherein” clause, unlike the first two that recite
conditions required to be implemented to carry out the process, simply
recites an intended result of the positively recited method step, namely that
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the titer of the IgG1 and IgG2b antigen-specific antibodies is increased in
comparison to one of two control administrations. Consequently, we
determine that this third “wherein” clause is not given any patentable
weight. See, e.g., Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d
1373, 1381 (Fed. Cir. 2003) (A “whereby clause in a method claim is not
given weight when it simply expresses the intended result of a process step
positively recited.”). Consequently, a prior art teaching or suggestion of
administering the recited composition would be sufficient to establish
obviousness of the claimed invention. See, e.g., Alcon Research, Ltd. v.
Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012) (finding in an
obviousness setting that the method limitation “stabilizing conjunctival mast
cells” to be met inherently by a prior art teaching of administering a
concentration of the claimed compound in an amount that overlapped with
amounts recited in the claim). As discussed above, we find that Irvine in
combination with Koutsopoulos provides that suggestion. Thus, the
teachings of the prior art render the administration of the recited composition
obvious, and the recited effect “adds nothing of patentable consequence.” In
re Kao, 639 F.3d 1057, 1070 (Fed. Cir. 2011). The Examiner has not
improperly “relied on an unknown property of prior art for a teaching.” Id.
Furthermore, even if this limitation were given weight, Appellant
concedes that the claimed increased titer “does indeed result” from
“administering ‘a composition . . . comprising: one or more isolated
antigens; and a self-assembling peptide comprising
RADARADARADARADA (SEQ ID NO:2).’” (Appeal Br. 8.) In other
words, Appellant concedes that the intended result necessarily follows from
the positively recited method step, i.e., it is an inherent result, whether
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recognized or not by the prior art. It is appropriate to rely on such a
concession as evidence the intended results necessarily occur from the
administration of the composition. In re Kao, 639 F.3d at 1070
(“Substantial evidence supports the Board’s finding, based upon the
specification, which confirms that the claimed ‘food effect’ is an inherent
property of oxymorphone itself, present both in controlled release and
immediate release formulations of that drug”). “[M]erely discovering and
claiming a new benefit of an old process cannot render the process again
patentable.” King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267,
1275–76 (Fed. Cir. 2010) (citations omitted)).
Appellant’s argument that “inherent properties of a new combination
are only unpatentable if those properties were not unexpected at the time of
the invention” (Appeal Br. 9 (citing PAR Pharm., Inc. v. TWI Pharm., Inc.,
773 F.3d 1186 (Fed. Cir. 2014)), is not the law. In PAR Pharmaceutical, the
Federal Circuit stated only that “inherency must be limited when applied to
obviousness, and is present only when the limitation at issue is the ‘natural
result’ of the combination of prior art elements,” not probably or possibly
the result, but necessarily the result. PAR Pharm., 773 F.3d at 1195. The
Federal Circuit did not require that the prior art recognize a recited property
for inherency to be found, just that evidence establish the property would
necessarily be present or be the natural result of the combination of
elements. Id. (citing In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009)
(“Even if no prior art of record explicitly discusses the [limitation],
[applicant’s] application itself instructs that [the limitation] is not an
additional requirement imposed by the claims on the [claimed invention],
but rather a property necessarily present in [the claimed invention].”).
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Even if we were to give patentable weight to the intended effect
limitation, here, as we noted, Appellant has conceded the increased antibody
titer is an inherent property of the administration of the claimed
composition. (Appeal Br. 8 (“the administration of this composition does
indeed result in an increased ‘titer of both IgG1 and IgG2b antigen-specific
antibodies in the subject . . . compared to a subject administered a
composition comprising a similar amount of antigen alone without the self-
assembling peptide or a similar amount of antigen and alum adjuvant.’”).)
Thus, because there is sufficient evidence to establish the substitution of the
hydrogel of Koutsopoulos would have been prima facie obvious in the
method of Irvine, and the evidence establishes the intended result necessarily
occurs, MPEP § 2145 (9th ed. Nov. 2015) (“Attorney argument is not
evidence unless it is an admission, in which case, an examiner may use the
admission in making a rejection.”), we conclude that the claimed method
would have been obvious.
Appellant’s argument that there would have been no reasonable
expectation of success when combining the teachings of Irvine and
Koutsopoulos (Appeal Br. 11–12, Reply Br. 6) is unavailing. Appellant
argues first that it has provided evidence of unexpectedly superior results.
(Id. at 11 (referring to evidence discussed id. at 10).) Appellant’s evidence,
as the Examiner explained, does not compare administration of the hydrogel
plus antigen and CpG described in Irvine. (Ans. 17–18.) Instead, there is a
comparison of the administration of antigen alone, to antigen plus alum, and
to the claimed composition (i.e., antigen, claimed hydrogel, and CpG). (Id.
(referring to Spec. Figure 27(c).) Bristol-Myers Squibb Co. v. Teva Pharms.
USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014) (“To be particularly probative,
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evidence of unexpected results must establish that there is a difference
between the results obtained and those of the closest prior art.”) Thus, we
agree with the Examiner that unexpected results have not been established.
Second, Appellant’s position that the prior art must establish that an
increase in antibody titer would have been expected (Appeal Br. 11) is
erroneous. All that the Examiner had to establish was a reasonable
expectation of achieving delivery of the antigen over an extended period of
time. For a prima facie case of obviousness to be established, the references
need not recognize the problem solved by the Appellant. See In re Kemps,
97 F.3d 1427, 1430 (Fed. Cir. 1996); In re Lintner, 458 F.2d 1013, 1016
(CCPA 1972) (“The fact that appellant uses sugar for a different purpose
does not alter the conclusion that its use in a prior art composition would be
prima facie obvious from the purpose disclosed in the references.”). Our
reviewing court has “repeatedly held that the motivation to modify a prior
art reference to arrive at the claimed invention need not be the same
motivation that the patentee had.” Alcon Res. Ltd., 687 F.3d at 1368.
Irvine teaches that the antigen delivery will stimulate immune
response to the antigen (Irvine ¶ 12) and that “delay in release into the local
microenvironment will limit nonspecific removal of the particles [that
include compound capable of attracting immature DCs and DC precursors,
such as CpG; id. ¶ 62] by tissue macrophages and allow time for DC
recruitment to the vaccine site.” (Irvine ¶ 66.) Koutsopoulos teaches the
claimed (RADA)4 hydrogel releases proteins of different molecular mass,
isoelectric points, and morphologies slowly over time. (Koutsopoulos
4627.) Thus, we find there is sufficient evidence to establish a reasonable
expectation of success in substituting the hydrogel of Koutsopoulos in the
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method of Irvine. In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988)
(“Obviousness does not require absolute predictability of success . . . all that
is required is a reasonable expectation of success.”).3
Thus, we affirm the Examiner’s rejection of claim 12 as being obvious
over Irvine and Koutsopoulos.
Appellant’s arguments of error regarding independent claims 13 and
43 are similar to those noted above for claim 12. (See Appeal Br. 12 (claim
13: the combined teachings “provide no hint of a method of producing
increased mucosal IgA antigen-specific antibody titers in the lungs); id. at 14
(claim 43: the combined teachings “provide no hint of a method of
producing a mixed T helper 1 (TH1) and T helper 2 (TH2) antigen-specific
response”).) Each of the limitations that Appellant argues are not hinted at
are intended results of administering the claimed composition recited in
wherein clauses and for the reasons discussed above are not given patentable
weight. And, even if they were given weight, there is sufficient evidence of

3 In the Reply Brief, the Appellant argues for the first time, that the
hydrogel of Koutsopoulos and the hydrogel of Irvine do not have the same
function, and that “Koutsopoulos et al. make it clear that not every hydrogel
in combination with every protein” results in delayed release from an
encapsulated hydrogel particle as in Irvine. (Reply Br. 3–4.) According to
Appellant, these argument are made in response to the Examiner’s position
regarding the substitution of a self-assembling peptide taught by
Koutsopoulos for the hydrogel taught by Irvine would have been a
predictable use of prior art elements. (Reply Br. 3.) This is not a new
position by the Examiner; it was articulated in the Final Action. (See Final
Action 8). Consequently, these new arguments by Appellant are not timely,
and we do not address them. Ex parte Borden, 93 USPQ2d 1473, 1474
(BPAI 2010) (informative) (“the reply brief [is not] an opportunity to make
arguments that could have been made in the principal brief on appeal to
rebut the Examiner’s rejections, but were not.”).
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record to establish a prima facie case that the intended result would
necessarily occur. That is because Appellant’s Specification teaches that the
administration of a composition of the antigen with the claimed hydrogel
with CpG is all that is necessary to achieve increased IgA (see, e.g., Spec.
32) and a mixed TH1 and TH2 response (see, e.g., Spec. 46). We do not
find Appellant’s arguments directed to these intended effects to be
persuasive of non-obviousness for the reasons discussed above.
Thus, we affirm the Examiner’s rejection of claims 13 and 43 as being
obvious over Irvine and Koutsopoulos.
Claims 15, 21, 26–30, 34–36, 38–42, and 44–47 have not been argued
separately from claims 12, 13, and 43 and therefore fall with claims 12, 13,
and 43. 37 C.F.R. § 41.37(c)(1)(iv).

Obviousness: Segers, Irvine, and Genove
The teachings of Irvine are discussed above. Among other things, the
Examiner finds Segers teaches the administration of self-assembling
peptides including RADARADARADARADA, that these compositions can
be mixed with proteins, the self-assembling peptide forms a hydrogel, and
the compositions can be injected. (Final Action 11–12.) The Examiner
further finds that Segers teaches advantages of these hydrogels include
“stab[ility] across a wide range of temperatures, pH and concentrations of
otherwise denaturing agents (page 563, right column) and allow the
controlled, slow release of therapeutics (page 562, left column).” (Id. at 12.)
The Examiner finds that Genove “teach[es] similar methods
comprising administration of self-assembling peptides including RAD16-1
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(i.e.[,] RADARADARADARADA; e.g.[,] [0010, 0017, 0068, 0073,
0206]).” (Id. at 13.)
The Examiner finds:
it would have been prima facie obvious, before the effective
filing date of the claimed invention, to a person of ordinary skill
in the art, to modify therapeutic methods comprising
administration of self-assembled peptides, including the
sequence RADARADARADARADA, mixed together with a
protein of interest, as taught by Segers et al., by using a protein
antigen and CpG, as taught by Irving et al., in order to produce
a tailored immune response including local delivery, slow
release, targeting to DCs, and maturation of DCs once
internalized, as taught by Segers et al. and Irving et al. Thus,
each and every element is taught in the prior art and the
combination has a beneficial result. However, the combination
amounts to no more than a predictable use of prior art elements
according to their established functions.
(Id. at 14–15.)
We agree with the Examiner that the claimed invention would have
been obvious from the teachings of Irvine, Segers, and Genove. “[W]here a
rejection is predicated on two references each containing pertinent disclosure
which has been pointed out to the applicant, we deem it to be of no
significance, but merely a matter of exposition, that the rejection is stated to
be on A in view of B instead of on B in view of A, or to term one reference
primary and the other secondary.” In re Bush, 296 F.2d 491, 496 (CCPA
1961). As discussed above, Irvine teaches a method of delivering an antigen
to a tissue where a hydrogel plus antigen and CpG are provided as the
composition to be administered to modulate an immune response to the
antigen including dendritic cell activation. Similar to Koutsopoulos, Segers
teaches the advantages of self-assembling peptides for slow release of
proteins (see, e.g., Segers 565) and suggests using RADA self-assembling
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peptides, such as RADA 16-I and RADA 16-II, in combination with an
antigen in immunotherapy (id. at Figure 1, 562).
We conclude that it would have been obvious to substitute the
hydrogels discussed in Segers, and Genove, in the method of Irvine with a
reasonable expectation of success. Appellant’s arguments against this
rejection are the same as set forth above (Appeal Br. 15–16), which we do
not find persuasive of non-obviousness for the reasons discussed above.
Thus, we affirm the Examiner’s rejection of claims 12, 13, and 43 as
being obvious over Segers, Irvine, and Genove.
Claims 14, 15, 21, 26–30, 34–42, and 45–47 have not been argued
separately from claims 12, 13, and 43 and therefore fall with claims 12, 13,
and 43. 37 C.F.R. § 41.37(c)(1)(iv).

Obviousness-Type Double Patenting
The Examiner finds that claims 15–20 of the ’338 patent are drawn to
the same method of producing an immune response by administering a
composition within the scope of the claimed invention on appeal. (Final
Action 5.) The Examiner finds the difference to be that the patented claims
require a very specific antigen, and a more specific subject of administration
than that which is recited by the claims on appeal. (Id.) The Examiner
concludes that the patented claims are a species which anticipate the claimed
invention. (Id.)
We agree with the Examiner’s findings and conclusion that the claims
on appeal are not patentably distinct from the patented invention recited in
claims 15–20 of the ’338 patent.
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As discussed above, the wherein clause reciting the intended effect of
the claimed method is not given patentable weight. Thus, we do not find
persuasive Appellant’s argument that the patented method which requires
“generically ‘producing an immune response’” after administration of the
particular antigen in a bovoid and not the specific immune response claimed
(Appeal Br. 16). We agree with the Examiner that the patented claims are a
species of the broader genus recited in the claims on appeal. “A patentable
distinction does not lie where a later claim is anticipated by an earlier one.
That is, a later patent claim that fails to provide novel invention over an
earlier claim is not patentably distinct from the earlier claim.” Eli Lilly &
Co. v. Barr Labs., Inc., 251 F.3d 955, 971 (Fed. Cir. 2001).
Moreover, even if the last wherein clause was given some patentable
weight, as discussed above, Appellant has conceded the administration of an
antigen mixed with a hydrogel will necessarily result in the antibody
response recited in claim 12. (Appeal Br. 8.) Moreover, Appellant’s
Specification discloses that the administration of antigen plus CpG in
combination with a hydrogel will necessarily result in the antibody response
recited in claims 13 and 43. (See, e.g., Spec. 32 and 46.) Thus, we conclude
the method recited in the patented claims will result in the intended results
recited in the claims on appeal. In re Best, 562 F.2d 1252, 1254–55, (CCPA
1977) (quoting In re Swinehart, 439 F.2d 210, 212–13 (CCPA 1971)) (“‘[I]t
is elementary that the mere recitation of a newly discovered function or
property, inherently possessed by things in the prior art, does not cause a
claim drawn to those things to distinguish over the prior art. Additionally,
where the Patent Office has reason to believe that a functional limitation
asserted to be critical for establishing novelty in the claimed subject matter
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may, in fact, be an inherent characteristic of the prior art, it possesses the
authority to require the applicant to prove that the subject matter shown to be
in the prior art does not possess the characteristic relied on.’”)
In light of the foregoing, we affirm the Examiner’s rejection of claims
12–15, 21, 26–30, and 34–47 on the ground of non-statutory obviousness-
type double patenting.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
12, 13, 15,
21, 26–30,
34–36, 38–
47
103 Irvine,
Koutsopoulos
12, 13, 15,
21, 26–30,
34–36, 38–
47

12–15, 21,
26–30, 34–
47
103 Segers, Irvine,
Genove
12–15, 21,
26–30, 34–
47

12–15, 21,
26–30, 34–
47
Non-statutory
Double Patenting:
US 9,566,338
12–15, 21,
26–30, 34–
47

Overall
Outcome
12–15, 21,
26–30, 34–
47

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED