Kristian Str¿mgaard et al.

Patent Trials and Appeals Board

Oct 15, 2019

15100687 - (D) (P.T.A.B. Oct. 15, 2019)

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.
15/100,687 06/01/2016 Kristian Strømgaard HOI-54102/16 5151
25006 7590 10/15/2019
DINSMORE & SHOHL LLP
900 Wilshire Drive
Suite 300
TROY, MI 48084
EXAMINER
REYNOLDS, FRED H
ART UNIT PAPER NUMBER
1654
NOTIFICATION DATE DELIVERY MODE
10/15/2019 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):
MichiganPatTM@dinsmore.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KRISTIAN STRØMGAARD,
ANDERS BACH, and KLAUS BERTRAM NISSEN
(APPLICANT: UNIVERSITY OF COPENHAGEN)
____________

Appeal 2018-007255
Application 15/100,687
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
RYAN H. FLAX, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3, 4, 25, 26, 28–31, and 34–37.2 We
have jurisdiction under 35 U.S.C. § 6(b).
This Appeal under 35 U.S.C. § 134(a) involves claims (Appeal Br. 4).
Examiner entered rejections under the written description provision of

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 Copenhagen (Appellant’s April 3, 2018 Appeal Brief (Appeal Br.) 2).
2 Pending claims 27, 32, 38, 42, 43, 47, and 53–56 stand withdrawn from
consideration (see Appeal Br. 4).
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35 U.S.C. § 112(a), 35 U.S.C. § 103, and obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellant’s disclosure “relates to compounds capable of binding to
the PDZ domains of PSD-95 and their medical use as inhibitors of protein-
protein interaction mediated by PSD-95” (Spec.3 1: 6–8). Appellant’s only
independent claim, claim 1, is representative and reproduced below:
1. A dimeric ligand of PDZI-2 of PSD-95 comprising a first
peptide (P1) and a second peptide (P2), wherein
P1 and P2 individually comprise at least two proteinogenic or
non-proteinogenic amino acid residues,
both P1 and P2 are conjugated to a first linker L1 via their N-
termini,
L1 comprises polyethylene glycol (PEG) wherein at least one
oxygen atom of said PEG is substituted with a nitrogen atom to
give NPEG,
an albumin binding moiety is linked to the nitrogen atom of the
NPEG by an amide bond, or via second linker L2,
the albumin binding moiety is a fatty acid (FA),
and wherein said dimeric ligand has the generic structure of
formula (II), wherein L2 is a nullity or comprises a nitrogen
atom:

(Appeal Br. 19.)

3 Appellant’s June 1, 2016 Specification.
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Grounds of rejection before this Panel for review:
Claims 1, 3, 4, 25, 26, 34, 35, and 37 stand rejected under the written
description provision of 35 U.S.C. § 112(a).
Claims 1, 3, 4, 25, 26, 28–31, and 34–37 stand rejected under
35 U.S.C. § 103 as unpatentable over the combination of Bach,4 Kabanov,5
Sjong,6 Dragulescu-Andrasi,7 and Gorris.8
Claims 1, 3, 4, 25, 26, 28–31, and 34–37 stand rejected under
35 U.S.C. § 103 as unpatentable over the combination of Bach ’615,9
Kabanov, Sjong, Dragulescu-Andrasi, and Gorris.
Claims 1, 3, 4, 25, 26, 28–31, and 34–37 stand rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over the claims of Bach ’615, Kabanov, Sjong, Dragulescu-
Andrasi, and Gorris.

4 Bach et al., A high-affinity, dimeric inhibitor of PSD-95 bivalently interacts
with PDZ1-2 and protects against ischemic brain damage, 109 PNAS 3317–
22 (2012).
5 Kabanov et al., New Technologies for Drug Delivery across the Blood
Brain Barrier, 10 Curr. Pharm. Des. 1355–63 (2004).
6 Sjong et al., US 2013/0260404 A1, published Oct. 3, 2013.
7 Dragulescu-Andrasi et al., Cell-permeable GPNA with appropriate
backbone stereochemistry and spacing binds sequence-specifically to RNA,
Chem. Commun. 244–46 (2005).
8 Gorris et al., Pushing Antibody-Based Labeling Systems to Higher
Sensitivity by Linker-Assisted Affinity Enhancement, 22 Bioconjugate Chem.
1619–24 (2011).
9 Bach et al., US 9,139,615 B2, issued Sept. 22, 2015.
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Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 1. “Postsynaptic density protein-95 (PSD-95) . . . is a member of the
membrane-associated guanylate kinase (MAGUK) family and is together
with PSD-93 recruited into the same NMDA receptor and potassium channel
clusters” (Spec. 1: 12–15).
FF 2. PSD-95 comprises “three PDZ domains . . . PDZ1-3, [which] bind
peptide ligands with similar consensus sequence such as Ser/Thr-X-
Val/Ile/Leu-COOH” (id. at 2: 3–4).
FF 3. Appellant discloses a compound having the structure of Formula (II),
wherein:
P1 comprises the amino acid sequence X4X3X2X1 (SEQ ID
NO: 1), and
P2 comprises the amino acid sequence Z4Z3Z2Z1 (SEQ ID
NO: 2),
wherein
a) X1 and/or [Z1] is an amino acid residue selected
from I, L and V,
b) X2 and/or Z2 is an amino acid residue selected
from A, D, E, Q, N, S, V, N-Me-A, N-Me-D, N-Me-E,
N-Me-Q, N-Me-N, N-Me-S and N-Me-V,
c) X3 and/or Z3 is an amino acid residue selected
from S and T,
d) X4 and/or Z4 is an amino acid residue selected
from E, Q, A, N and S,
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wherein X1 and Z1 both individually represent the
ultimate C-terminal amino acid residue comprising a free
carboxylic acid.
(id. at 22: 27 – 23: 7; see also id. at 42–43.)
FF 4. Appellant exemplifies two compounds within the scope of Formula
(II), wherein P1 and P2 each have the sequence IETAV (see id. at 34: 27 – 35:
4 and 37: 7 – 38: 3 (emphasis added to highlight Appellant’s disclosed P1
and P2 consensus sequence (see FF 2))).
ANALYSIS
Appellant discloses a three amino acid P1 and P2 consensus sequence
(FF 2). Appellant further discloses four amino acid P1 and P2 sequences that
fulfill the requirements of the P1 and P2 consensus sequence (see FF 3–4; cf.
FF 1). Thus, Appellant’s Specification provides written descriptive support
for a dimeric ligand of PDZ1-2 of PSD-95 comprising first (P1) and second
(P2) sequences that are each at least three amino acids in length (FF 2–4).
Appellant’s claim 1, however, requires that the claimed dimeric ligand
comprising first peptide (P1) and second (P2) sequences that are each at least
two amino acid residues in length (see Appeal Br. 19; see also Final Act.10 5
(“the only limitation on [Appellant’s claimed ligand is that its] length is ‘at
least two’ [amino acids]”); Ans.11 6). For the reasons set forth above,
Appellant’s Specification fails to provide written descriptive support for a
dimeric ligand of PDZ1-2 of PSD-95 comprising first (P1) and second (P2)
sequences that are each at least two amino acids in length.
We are not persuaded by Appellant’s reference to their “Formulas III
and IV,” as well as, “[t]welve specific compounds along with physical

10 Examiner’s October 5, 2017 Final Office Action.
11 Examiner’s May 16, 2018 Answer.
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characterization data . . . in Tables 1 and 2 of [their] [S]pecification” and “a
large number of peptide species . . . described on pages 24, 42, and 43 of
[Appellant’s] [S]pecification” (Appeal Br. 6; see also Reply Br. 3).
Appellant does not identify, nor do we find, a disclosure in Appellant’s
Specification of a dimeric ligand of PDZ1-2 of PSD-95 that is two amino
acids in length, i.e., a length that is smaller than Appellant’s disclosed
consensus sequence. Thus, Appellant’s Specification fails to provide written
descriptive support for a dimeric ligand of PDZ1-2 of PSD-95 that is
commensurate in scope with Appellant’s claim 1.
CONCLUSION
The preponderance of evidence on this record supports Examiner’s
finding that Appellant’s Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 1 under the written
description provision of 35 U.S.C. § 112(a) is affirmed. Claims 3, 4, 25, 26,
34, 35, and 37 are not separately argued and fall with claim 1.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 5. Bach discloses “[a] high-affinity, dimeric inhibitor of PSD-95 [that]
bivalently interacts with PDZ1-2 and protects against ischemic brain
damage” (Bach, Title; see also Final Act. 6; Ans. 9).
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FF 6. Bach discloses a dimeric inhibitor that comprises two IETDV, or
IETAV, moieties linked through a NPEG linker (Bach 3317; see also Final
Act. 6; Ans. 9).
FF 7. Bach discloses that “[i]n order to improve permeability across the
blood-brain barrier, [Bach] attached the cell-penetrating peptide sequences,
Tat and its inverse D-amino acid-containing version Retroinverso-D-Tat . . .,
to the linker nitrogen” of its dimeric inhibitor (Bach 3317; see also Final
Act. 6–7; Ans. 9).
FF 8. Examiner finds that Bach’s dimeric inhibitor differs from
Appellant’s claimed dimeric ligand by using “TAT instead of a fatty acid
with an optional linker” (Final Act. 7; Ans. 10).
FF 9. Kabanov discloses that “artificial hydrophobization of peptides and
proteins . . . facilitates the delivery of these peptides and proteins across [the
blood brain barrier (BBB)]” (Kabanov, Abstract (emphasis added); id. at 8
(Kabanov discloses “a new promising strategy for the brain delivery of
peptides and proteins is emerging, which involves artificial
hydrophobization of the protein (peptide) molecule with fatty acid residues”
(emphasis added)); see generally Final Act. 7, 10, and 13; Ans. 10, 16–17,
and 20).
FF 10. Kabanov discloses that “artificial hydrophobization . . . technology
involves [the gentle modification of protein or peptide molecules, wherein
the] introduction of a very small number of residues of a fatty acid (e.g.
stearic, palmitic, oleic) into the protein molecules, specifically, 1 to 2
residues per protein globule” (Kabanov 6; see generally Final Act. 7, 10, and
13; Ans. 10, 16–17, and 20; cf. Spec. 22 (“The fatty acid of [Appellant’s]
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invention may be . . . a fatty acid selected from the group consisting of [inter
alia] . . . palmitic acid, stearic acid, [and] . . . oleic acid”)).
FF 11. Sjong discloses linkers, such as “4-aminobutanoic acid,
5-aminopentanoic acid, 6-aminohexanoic acid, 7-aminoheptanoic acid,
8-aminooctanoic acid, or an N-protected derivative of any of the foregoing”
(Sjong 37; Final Act. 7, 10, and 13; Ans. 10, 17, and 20).
FF 12. Dragulescu-Andrasi discloses an aminobutanoic acid linker
(Dragulescu-Andrasi 245; Final Act. 7, 10, and 13; Ans. 10, 17, and 20–21).
FF 13. Gorris discloses an aminobutanoic acid linker (Gorris, Abstract;
Final Act. 7, 10, and 13; Ans. 10, 17, and 21).
FF 14. Bach ’615 discloses:
A compound comprising a first peptide linked to a
second peptide by a linker, wherein the first and the second
peptide comprise at least four amide-bonded residues having a
sequence YTXV (SEQ ID NO: 5) or YSXV (SEQ ID NO: 6),
wherein
a. Y is selected from among E, Q, and A, and
b. X is selected from among A, Q, D, N, N-Me-A, N-Me-
Q, N-Me-D, and N-Me-N, and
wherein the linker comprises PEG and, wherein at least one
oxygen atom of the PEG is substituted with a nitrogen atom
to give NPEG,
wherein a Cell Penetrating Peptide (CPP) is linked to the
nitrogen atom of the linker by an amide bond, and
wherein the CPP comprises at least 4 amino acid residues
selected from arginine and/or lysine.
(Bach ’615 45: 54–67 (Claim 1); see id. 47: 27–48: 55 (Claim 14); see also
Final Act. 9–10 and 12–13; Ans. 16 and 19–20.)
FF 15. Bach ’615 discloses “[a] pharmaceutical composition comprising a
compound according to [Bach ’615’s] claim 1 [(see FF 14)]” and a “method
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of treatment of an excitotoxic-related disease in a subject, . . . comprising
administering to [the] subject a therapeutically effective amount of the
pharmaceutical composition . . . wherein the disease is ischemic or traumatic
injury of the CNS” (Bach ’615 47: 11–20 (Claims 10–12); see Final Act. 9–
10 and 12–13; Ans. 16).
ANALYSIS
The rejection over the combination of Bach, Kabanov, Sjong, Dragulescu-
Andrasi, and Gorris:
Based on the combination of Bach, Kabanov, Sjong, Dragulescu-
Andrasi, and Gorris, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious “to substitute
the TAT of Bach . . . with the stearic acid described by Kabanov . . . as a
simple substitution of one known element for another yielding expected
results” (Final Act. 7; see also Ans. 11). In this regard, Examiner reasons
that because “the two compounds (TAT and stearic acid) are both known in
the art for the same purpose, an artisan in this field would attempt this
substitution with a reasonable expectation of success” (Final Act. 7; see also
Ans. 11).
Examiner further concludes that, at the time Appellant’s invention
was made, it would have been prima facie “obvious to attach the fatty acid
via an aminobutanoic acid linker, as a combination of known elements
yielding expected results” (Final Act. 8; see also Ans. 11). In this regard,
Examiner reasons that because aminobutanoic acid “is a common linker in
the art, an artisan in this field would attempt this modification with a
reasonable expectation of success” (Final Act. 8; see also Ans. 11).
We find no error in Examiner’s prima facie case of obviousness.
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Appellant contends that Egleton12 discloses that “increased
lipophilicity . . . [deters] BBB crossing by peptides” and, therefore,
“modification of the peptide of Bach with the fatty acid of Kabanov would
be expected to decrease the ability to cross the BBB in direct contrast with
the goal of Bach, thus rendering the [modified Bach] peptide unsuitable for
its intended purpose” (Appeal Br. 9–10 (citing Egleton 48: left column)
(emphasis omitted); see generally Appeal Br. 8–9; Reply Br. 4–5). We are
not persuaded.
Egleton discloses that “[h]ighly lipophilic drugs tend to be extensively
plasma bound, may increase affinity for efflux transporters at the BBB,
resulting in intraendothelial sequestration and are readily taken up in the
periphery” (Egleton 48: left column). In contrast, Kabanov discloses the
gentle modification of peptide molecules, wherein “a very small number of
residues of a fatty acid (e.g. stearic, palmitic, oleic),” i.e. 1–2 fatty acid
residues are introduced into the peptide molecule (see FF 9–10). Kabanov
discloses that it is this gentle modification, as opposed to Egleton’s
extensive modification, of peptides with fatty acid residues that is “a new
promising strategy for the brain delivery of peptides” (FF 9). Appellant
failed to establish an evidentiary basis on this record to support a finding that
Kabanov’s gentle modification technique results in the creation of a highly
lipophilic drug discussed by Egleton.
Bach discloses attaching a molecule that facilitates BBB permeation
to the NPEG component of its dimeric inhibitor (FF 5–7). Therefore, we are

12 Egleton et al., Development of Neuropeptide Drugs that Cross the Blood-
Brain Barrier, 2 THE JOURNAL OF THE AMERICAN SOCIETY FOR
EXPERIMENTAL NEUROTHERAPEUTICS, 44–53 (2005).
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not persuaded by Appellant’s contention that “[t]here is no teaching or
suggestion that provides a motivation to connect a fatty acid[, as disclosed
by Kabanov to facilitate BBB permeation,] to any other molecule, let alone
to attach a fatty acid to a NPEG linker as claimed (Appeal Br. 10 (emphasis
omitted)).
Because Kabanov discloses the use of a fatty acid as an alternative to
Bach’s TAT moiety, we find no error in Examiner’s conclusion that a person
of ordinary skill in this art would have found it prima facie obvious to
substitute Kabanov’s fatty acid for Bach’s TAT moiety to achieve the same
purpose (see Final Act. 7; see also Ans. 11; FF 5–10). Therefore, we are not
persuaded by Appellant’s contention that “there is nothing in the references
that would lead one of ordinary skill in the art to replace the TAT of Bach
with the fatty acid of Kabanov instead of merely adding the fatty acid of
Kabanov” (Appeal Br. 10 (emphasis omitted); see also id. at 11). It is
proper to “take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S.
398, 418 (2007); see also id. at 421 (“A person of ordinary skill is also a
person of ordinary creativity, not an automaton.”).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Examiner’s conclusion is based on improper hindsight
reconstruction (Appeal Br. 10–11; see Reply Br. 5).
On this record, we find that the preponderance of the evidence falls in
favor of Examiner’s conclusion that it would have been prima facie obvious
to substitute Kabanov’s fatty acid, i.e. stearic acid, for Bach’s TAT to
facilitate BBB permeation. In this regard, although Appellant’s claim 1 does
not require any degree of stability, we find that such a modification would
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result in at least the same degree of stability as Appellant’s claimed dimeric
ligand. Therefore, to the extent that Appellant discovered that replacing
Bach’s TAT for Kabanov’s fatty acid, as suggested by the combination of
references relied upon by Examiner, will result in increased plasma
concentration, we find that such a discovery does not distinguish over the
prior art (cf. Appeal Br. 11). See e.g., Atlas Powder Co. v. Ireco Inc., 190
F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of a previously
unappreciated property of a prior art composition, or of a scientific
explanation for the prior art's functioning, does not render the old
composition patentably new to the discoverer). For the foregoing reasons,
we are not persuaded by Appellant’s contentions regarding unexpectedly
improved properties (Reply Br. 5–6). “Evidence of secondary
considerations, including evidence of unexpected results and commercial
success, are but a part of the ‘totality of the evidence’ that is used to reach
the ultimate conclusion of obviousness.” Richardson-Vicks Inc. v. Upjohn
Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997).
Further, we limit our analysis to the arguments presented in
Appellant’s Brief. Therefore, additional arguments and new arguments in
Appellant’s Reply Brief that were not presented in Appellant’s Brief, were
not considered (see generally Reply Br. 5–6 (citing Example 3, Example 7,
Table 1, and ¶¶ 137 and 156 of Appellant’s Specification)). See Ex parte
Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (Appellant fails
to “explain what ‘good cause’ there might be to consider the new argument.
On this record, Appellant’s new argument is belated.”).
We recognize Appellant’s arguments based on “the supplementary
data attached [to Appellant’s Appeal Brief] as Appendix B,” but find that
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this “data” is not in the form of a publication or declaration and, thus, is
considered attorney argument (see Appeal Br. 12). See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take
the place of evidence.”).

The rejection over the combination of Bach ’615, Kabanov, Sjong,
Dragulescu-Andrasi, and Gorris:
Based on the combination of Bach ’615, Kabanov, Sjong, Dragulescu-
Andrasi, and Gorris, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious “to substitute
[Bach ’615’s CPP] TAT . . . with the stearic acid described by Kabanov . . .
as a simple substitution of one known element for another yielding expected
results” (Final Act. 10–11; see also Ans. 17). In this regard, Examiner
reasons that because “the two compounds ([CPP] TAT and stearic acid) are
both known in the art for the same purpose, an artisan in this field would
attempt this substitution with a reasonable expectation of success” (Final
Act. 11; see also Ans. 17).
Examiner further concludes that, at the time Appellant’s invention
was made, it would have been prima facie “obvious to attach the fatty acid
via an aminobutanoic acid linker, as a combination of known elements
yielding expected results” (Final Act. 11; see also Ans. 18). In this regard,
Examiner reasons that because aminobutanoic acid “is a common linker in
the art, an artisan in this field would attempt this modification with a
reasonable expectation of success” (Final Act. 11; see also Ans. 18).
We find no error in Examiner’s prima facie case of obviousness.
Appellant contends that Egleton discloses that “increased
lipophilicity . . . [deters] BBB crossing by peptides” and, therefore,
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“modification of the peptide of Bach with the fatty acid of Kabanov would
be expected to decrease the ability to cross the BBB in direct contrast with
the goal of Bach ’615, thus rendering the [modified Bach] peptide unsuitable
for its intended purpose” (Appeal Br. 14 (citing Egleton 48: left column)
(emphasis omitted); see generally Appeal Br. 13–14). We are not
persuaded.
Egleton discloses that “[h]ighly lipophilic drugs tend to be extensively
plasma bound, may increase affinity for efflux transporters at the BBB,
resulting in intraendothelial sequestration and are readily taken up in the
periphery” (Egleton 48: left column). In contrast, Kabanov discloses the
gentle modification of peptide molecules, wherein “a very small number of
residues of a fatty acid (e.g. stearic, palmitic, oleic),” i.e., 1–2 fatty acid
residues are introduced into the peptide molecule (see FF 9–10). Kabanov
discloses that it is this gentle modification, as opposed to Egleton’s
extensive modification, of peptides with fatty acid residues that is “a new
promising strategy for the brain delivery of peptides” (FF 9). Appellant
failed to establish an evidentiary basis on this record to support a finding that
Kabanov’s gentle modification technique results in the creation of a highly
lipophilic drug discussed by Egleton.
Because Kabanov discloses the use of a fatty acid as an alternative to
Bach’s TAT moiety, we find no error in Examiner’s conclusion that a person
of ordinary skill in this art would have found it prima facie obvious to
substitute Kabanov’s fatty acid for Bach’s TAT moiety to achieve the same
purpose (see Final Act. 7; see also Ans. 11; FF 5–10). Therefore, we are not
persuaded by Appellant’s contention that “there is nothing in the references
that would lead one of ordinary skill in the art to replace the TAT of Bach
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’615 with the fatty acid of Kabanov instead of merely adding the fatty acid
of Kabanov to the molecule of Bach ’615” (Appeal Br. 14 (emphasis
omitted); see also id. at 15–16). It is proper to “take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ.” KSR, 550 U.S. at 418; see also id. at 421 (“A person of ordinary
skill is also a person of ordinary creativity, not an automaton.”).
On this record, we find that the preponderance of the evidence falls in
favor of Examiner’s conclusion that it would have been prima facie obvious
to substitute Kabanov’s fatty acid, i.e. stearic acid, for Bach ’615’s CPP to
facilitate BBB permeation. In this regard, although Appellant’s claim 1 does
not require any degree of stability, we find that such a modification would
result in at least the same degree of stability as Appellant’s claimed dimeric
ligand. Therefore, we are not persuaded by Appellant’s contention that
“absent impermissibly using hindsight reconstruction, one of ordinary skill
in the art would not be led to remove the CPP of Bach ’615 and add the fatty
acid of Kabanov, particularly when seeking to improve stability in plasma,
as Appellant did” (Appeal Br. 15 (emphasis omitted)). Therefore, to the
extent that Appellant discovered that replacing Bach ’615’s CPP for
Kabanov’s fatty acid, as suggested by the combination of references relied
upon by Examiner, will result in increased plasma concentration, we find
that such a discovery does not distinguish over the prior art (cf. Appeal Br.
15–16). See e.g., Atlas Powder, 190 F.3d at 1347 (“[T]he discovery of a
previously unappreciated property of a prior art composition, or of a
scientific explanation for the prior art’s functioning, does not render the old
composition patentably new to the discoverer). For the foregoing reasons,
we are not persuaded by Appellant’s contentions regarding unexpectedly
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improved properties (Reply Br. 5–6). “Evidence of secondary
considerations, including evidence of unexpected results and commercial
success, are but a part of the ‘totality of the evidence’ that is used to reach
the ultimate conclusion of obviousness.” Richardson-Vicks, 122 F.3d at
1483.
Further, we limit our analysis to the arguments presented in
Appellant’s Brief. Therefore, additional arguments and new arguments in
Appellant’s Reply Brief that were not presented in Appellant’s Brief, were
not considered (see generally Reply Br. 5–6 (citing Example 3, Example 7,
Table 1, and ¶¶ 137 and 156 of Appellant’s Specification)). See Ex parte
Borden, 93 USPQ2d at 1474 (Appellant fails to “explain what ‘good cause’
there might be to consider the new argument. On this record, Appellant’s
new argument is belated.”).
For all of the foregoing reasons we are not persuaded by Appellant’s
contention that Examiner’s conclusion is based on improper hindsight
reconstruction (Appeal Br. 14–15).
We again recognize Appellant’s arguments based on the
supplementary data attached to Appellant’s Appeal Brief as Appendix B, but
find that this “data” is not in the form of a publication or declaration and,
thus, is considered attorney argument (see Appeal Br. 16). See In re
Pearson, 494 F.2d at1405 (“Attorney’s argument in a brief cannot take the
place of evidence.”).

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CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103 as unpatentable over
the combination of Bach, Kabanov, Sjong, Dragulescu-Andrasi, and Gorris.
Claims 3, 4, 25, 26, 28–31, and 34–37 are not separately argued and fall with
claim 1.
The rejection of claim 1 under 35 U.S.C. § 103 as unpatentable over
the combination of Bach ’615, Kabanov, Sjong, Dragulescu-Andrasi, and
Gorris. Claims 3, 4, 25, 26, 28–31, and 34–37 are not separately argued and
fall with claim 1.

Obviousness-type Double Patenting:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
ANALYSIS
Having found no deficiency in the foregoing rejection of claim 1
under 35 U.S.C. § 103 as unpatentable over the combination of Bach ’615,
Kabanov, Sjong, Dragulescu-Andrasi, and Gorris, we are not persuaded by
Appellant’s contention that the obviousness-type double patenting rejection
on this record fails for reasons “[a]s per above and incorporated herein by
reference and extendible to the subject rejection, there is no motivation or
reasonable expectation of success to substitute a fatty acid for the CPP of
Bach ’615” (Appeal Br. 17; see Reply Br. 6).

Appeal 2018-007255
Application 15/100,687

18
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting.
The rejection of claim 1 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over the claims of
Bach ’615, Kabanov, Sjong, Dragulescu-Andrasi, and Gorris. Claims 3, 4,
25, 26, 28–31, and 34–37 are not separately argued and fall with claim 1.

SUMMARY
In summary,
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1, 3, 4, 25,
26, 34, 35,
37
112(a) Written
Description
1, 3, 4, 25,
26, 34, 35,
37

1, 3, 4, 25,
26, 28–31,
34–37
103 Bach, Kabanov,
Sjong, Dragulescu-
Andrasi, Gorris
1, 3, 4, 25,
26, 28–31,
34–37

1, 3, 4, 25,
26, 28–31,
34–37
103 Bach ’615,
Kabanov, Sjong,
Dragulescu-
Andrasi, Gorris
1, 3, 4, 25,
26, 28–31,
34–37

1, 3, 4, 25,
26, 28–31,
34–37
Judicially
created doctrine
of obviousness-
type double
patenting
Bach ’615 claims
1, 11, 12, and 14,
Kabanov, Sjong,
Dragulescu-
Andrasi, Gorris
1, 3, 4, 25,
26, 28–31,
34–37

Overall
Outcome
1, 3, 4, 25,
26, 28–31,
34–37

Appeal 2018-007255
Application 15/100,687

19
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).

AFFIRMED