Wisconsin Alumni Research Foundation

Patent Trials and Appeals Board

Sep 8, 2021

2021000676 (P.T.A.B. Sep. 8, 2021)

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.
15/596,529 05/16/2017 William L. Murphy P150263US02
(3004049-0049
1514
130832 7590 09/08/2021
Stinson LLP (WARF 3004049)
7700 Forsyth Blvd.
Suite 1100
St. Louis, MO 63105
EXAMINER
GARYU, LIANKO G
ART UNIT PAPER NUMBER
1658
NOTIFICATION DATE DELIVERY MODE
09/08/2021 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):
USpatent2@stinson.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WILLIAM L. MURPHY, MATTHEW BRIAN PARLATO,
JAMES A MOLENDA, and NGOC NHI LE
____________

Appeal 2021-000676
Application 15/596,529
Technology Center 1600
____________

Before DONALD E. ADAMS, DEBORAH KATZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–6, 8, and 10–20. 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
“Wisconsin Alumni Research Foundation” (Appellant’s June 23, 2020,
Appeal Brief (Appeal Br.) 1).
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2
STATEMENT OF THE CASE
Appellant’s disclosure “relates to hydrogel compositions and to
methods for using the hydrogel compositions to promote cell expansion and
cell differentiation” (Spec.2 ¶ 4). Claims 1, 3, 10, 12, and 16 reproduced
below:
1. A hydrogel composition comprising an 8-arm, 20 kDa
polyethylene glycol functionalized with norbornene, a
crosslinking peptide, at least 0.25 mM of a cell adhesion
peptide selected from the group consisting of CRGDS (SEQ ID
NO: 2), Acetylated-GCYGRGDSPG (SEQ ID NO:31), cyclic
RGD (SEQ ID NO:35), CRGD-(G)13-PHSRN (SEQ ID
NO:29), CPHSRN-(SG)5-RGD (SEQ ID NO:30) and IKVAV
(SEQ ID NO:38); an immobilized low molecular weight
heparin; and a cell selected from the group consisting of an
embryonic stem cell, an embryonic stem cell-derived neuron, an
embryonic stem cell-derived neural progenitor cell, an
embryonic stem cell-derived astrocyte, an embryonic stem cell-
derived microglial cell, an embryonic stem cell-derived
endothelial cell, an embryonic stem cell-derived retinal pigment
epithelial cell, an induced pluripotent stem cell, an induced
pluripotent stem cell-derived neural progenitor cell, an induced
pluripotent stem cell-derived astrocyte, an induced pluripotent
stem cell-derived microglial cell, an induced pluripotent stem
cell-derived endothelial cell, a mesenchymal stem cell, an
umbilical vein endothelial cell, an NIH 3T3 fibroblast, a
cardiomyocyte, an induced pluripotent stem cell-derived
cardiomyocyte, an endothelial progenitor cell, a circulating
angiogenic cell, a neuron, a pericyte, a hepatocyte, a pancreatic
beta cell, a pancreatic islet cell and combinations thereof.
(Appeal Br. 12.)
3. The hydrogel composition of claim 2 comprising a
shear modulus range of from about 2 kPa to about 12 kPa.
(Id.)

2 Appellant’s May 16, 2017, Specification.
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10. The hydrogel composition of claim 1, wherein the
crosslinking peptide is selected from the group consisting of
KCGGPQGIWGQGCK (SEQ ID NO:27),
KCGGPQGIAGQGCK (SEQ ID NO:28) and combinations
thereof.
(Id. at 13.)
12. A hydrogel composition comprising a polyethylene
glycol functionalized with norbornene, a crosslinking peptide,
at least 0.25 mM of a cell adhesion peptide selected from the
group consisting of CRGDS (SEQ ID NO: 2), Acetylated-
GCYGRGDSPG (SEQ ID NO:31), cyclic RGD (SEQ ID
NO:35), CRGD-(G)13-PHSRN (SEQ ID NO:29),
CPHSRN(SG)5-RGD (SEQ ID NO:30) and IKVAV (SEQ ID
NO:38), an immobilized low molecular weight heparin, and a
cell selected from the group consisting of an embryonic stem
cell, an embryonic stem cell-derived neuron, an embryonic stem
cell-derived neural progenitor cell, an embryonic stem cell-
derived astrocyte, an embryonic stem cell-derived microglial
cell, an embryonic stem cell-derived endothelial cell, an
embryonic stem cell-derived retinal pigment epithelial cell, an
induced pluripotent stem cell, an induced pluripotent stem cell-
derived neural progenitor cell, an induced pluripotent stem cell-
derived astrocyte, an induced pluripotent stem cell-derived
microglial cell, an induced pluripotent stem cell-derived
endothelial cell, a mesenchymal stem cell, an umbilical vein
endothelial cell, an NIH 3T3 fibroblast, a cardiomyocyte, an
induced pluripotent stem cell-derived cardiomyocyte, an
endothelial progenitor cell, a circulating angiogenic cell, a
neuron, a pericyte, a hepatocyte, a pancreatic beta cell, a
pancreatic islet cell and combinations thereof, wherein the
hydrogel composition comprises a shear modulus in the range
of about 1.8 kPa to about 33 kPa.
(Id. at 13–14.)
16. The hydrogel composition of claim 12, wherein the
crosslinking peptide is selected from the group consisting of
KCGGPQGIWGQGCK (SEQ ID NO:27),
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KCGGPQGIAGQGCK (SEQ ID NO:28) and combinations
thereof.
(Id. at 14.)

Grounds of rejection before this Panel for review:
Rejection 1: Claims 1, 2, 5, 6, and 17–19 stand rejected under
35 U.S.C. § 103 as unpatentable over the combination of Yang,3 Liang,4 and
Schwartz.5
Rejection 2: Claims 3, 4, 8, and 11 stand rejected under 35 U.S.C.
§ 103 as unpatentable over the combination of Yang, Liang, Schwartz, and
Ki.6
Rejection 3: Claims 12–15 stand rejected under 35 U.S.C. § 103 as
unpatentable over the combination of Yang, Liang, Schwartz, and Ki.

3 Yang et al., Development of an Osteogenic Scaffold for Human
Mesenchymal Stem Cells, 52 Polymer Preprints (American Chemical
Society, Division of Polymer Chemistry)/Polym. Prepr. (Am. Chem. Soc.,
Div. Polym. Chem.) 160–161 (2011).
4 Liang et al., Heparin-functionalized polymeric biomaterials in tissue
engineering and drug delivery applications, 10 Acta Biomaterialia 1588–
1600 (2014).
5 Schwartz et al., A Quantitative Comparison of Human HT-1080
Fibrosarcoma Cells and Primary Human Dermal Fibroblasts Identifies a
3D Migration Mechanism with Properties Unique to the Transformed
Phenotype, 8 PLoS ONE e81689, doi:10.1371/journal.pone.0081689, (2013)
6 Ki et al., Effect of 3D Matrix Compositions on the Efficacy of EGFR
Inhibition in Pancreatic Ductal Adenocarcinoma Cells, 14
Biomacromolecules 3017–3026 (2013).
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Rejection 4: Claims 10 and 20 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Yang, Liang, Schwartz,
and Gould.7
Rejection 5: Claim 16 stands rejected under 35 U.S.C. § 103 as
unpatentable over the combination of Yang, Liang, Schwartz, and Gould.

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Yang discloses a human mesenchymal stem cell (hMSC) based
therapeutic system in which hMSCs are encapsulated in a synthetic 3-
dimensional (3D) scaffold using thiolene chemistry (Yang 160: Introduction;
see generally Ans.8 3).
FF 2. Yang discloses a hydrogel system comprising a 20 kDa, 4 arm, PEG-
norbornene crosslinked with a matrix metalloproteinase (MMP)-degradable
peptide KCGPQGIAGQCK, with 1 mM CRGDS and various concentrations
of peptide tethered with dexamethasone incorporated into the gel (see Yang
160: Fig. 2, legend; see also Ans. 3).
FF 3. Yang discloses that “[f]unctionalization of the thiolene scaffold with
chemical osteogenic cues is able to promote the differentiation of hMSCs”
(Yang 161: Discussion; see id. at 160 (Yang discloses that hMSCs “are

7 Gould et al., Small peptide functionalized thol-ene hydrogels as culture
substrates for understanding valvular interstitial cell activation and de novo
tissue deposition, 8 Acta Biomaterialia 3201–3209 (2012).
8 Examiner’s September 4, 2020, Answer.
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commonly used in stem cell based bone regeneration therapies since they are
multipotent and can differentiate into osteoblasts under osteogenic signals,
such as dexamethasone”); Ans. 3 (Examiner finds that Yang “suggest[s]
incorporating biomolecules in the hydrogel to direct differentiation.”)).
FF 4. Examiner finds that Yang does not teach a hydrogel comprising a 20
kDa, 8-arm, polyethylene glycol functionalized with norbornene, and further
comprising an immobilized low molecular weight heparin (Ans. 3).
FF 5. Liang discloses:
Given its function as an anticoagulant, heparin can exhibit
undesirable side effects, such as hemorrhagic complications,
heparin-induced thrombocytopenia and/or low bioavailability,
when administered non-intravenously. As a result, low-
molecular weight heparin (LMWH), which has a better defined
chemical composition, has been developed to provide more
predictable anticoagulant dose, longer half-lives and reduced
side effects. Many studies have indicated that LMWH is more
effective in the inhibition of tumor growth via its regulation of
the binding of many angiogenic growth factors (e.g. FGF and
VEGF) when compared with unfractionated heparin. LMWH
can also interfere with tumor metastasis by reducing the activity
of heparanase and thus reducing tumor metastatic potential and
growth, or by competing with P-selectin binding, thereby
inhibiting the adhesion of tumor cells. More recent research
has suggested that heparin can also interact with transcription
factors to induce apoptotic cell death. Therefore, LMWH has
been widely explored as a component in tumor-targeted
delivery systems, and a few chemically modified LMWH
derivatives, such as LMWH-deoxycholic acid, have been
developed with reduced anticoagulant activity and high
antiangiogenic efficacy. Recent research has also suggested
that LMWH may be potentially used as an antifibrotic agent in
patients with chronic hepatitis B.
(Liang 1588: § 1 (endnotes omitted); see Ans. 4.)

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FF 6. Liang discloses:
Due to its advantageous biological activities, the incorporation
of heparin in biomaterials has been highly attractive. Heparin is
often physically encapsulated or covalently conjugated to
hydrogels to provide sustained release of the anticoagulant.
Also, heparin-containing hydrogels have been widely used for
the sequestration and controlled release of growth factors to
promote angiogenesis and bone regeneration. Heparin-
functionalized, naturally derived hydrogels have been
developed by taking advantage of their biocompatibility, low
toxicity, relatively low cost and benign gelation conditions
while heparin-synthetic polymer biohybrid hydrogels have been
studied to provide increased control over their mechanical and
chemical properties. Additionally, surfaces and scaffolds
modified with heparin have been explored to suppress non-
specific protein absorption and localize growth factors to
promote cell attachment and proliferation.
(Liang 1589: § 1 (endnotes omitted); see generally Ans. 4.)
FF 7. Liang discloses that “heparin-functionalized hydrogels support
hMSC viability . . . and induce osteogenic differentiation” (Liang 1591:
§ 2.2.1; see id. (Liang discloses that “heparin-functionalized PEG hydrogels
[are] capable of sequestering bFGF and releasing it in a controlled manner
over a 5-week time period, with zero-order release kinetics after an initial
burst. The bFGF-loaded hydrogels demonstrated enhanced stimulation of
the growth of . . . [hMSCs] compared to the controls”); see also Ans. 3).
FF 8. Examiner relies on Schwartz to disclose “a synthetic ECM composed
of 8-arm, 20 kDa polyethylene glycol functionalized with norbornene (8-arm
PEG-NB) . . ., wherein the 8-arm PEG-NB is crosslinked with MMP-
degradable peptide and the cell adhesive peptide CRGDS” (Ans. 4 (citing
Schwartz 17: Figure S5 legend; Schwartz 18: Figure S7, legend); see also
Ans. 4 (Examiner finds that Schwartz discloses that “the mechanical
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properties [of a 20 kDa, 8-arm, PEG-NB are] similar to a 4-arm PEG-
NB.”)).
FF 9. Examiner finds that the combination of Yang, Liang, and Schwartz
fails to disclose a “shear moduli in the range of about 1.8 kPa to about 33
kPa and the extent of crosslinking from about 35% to about 75%” as
required by Appellant’s claimed invention, and relies on Ki to make up for
this deficiency (see Ans. 5–6 (citing Ki 3022: Tables 1–2); see Ans. 6 (citing
Ki 3018) (Examiner finds that Ki discloses that “by manipulating the cross-
linking density the stiffness of the gel matrix can be easily controlled to
mimic tissues with certain mechanical property”); see also Ans. 9–10).
FF 10. Examiner finds that the combination of Yang, Liang, and Schwartz,
with or without Ki fails to disclose a “crosslinking peptide . . . selected from
the group consisting of [Appellant’s] SEQ ID NO: 27, SEQ ID NO: 28, and
combinations thereof” as required by Appellant’s claimed invention, and
relies on Gould to make up for this deficiency (Ans. 7 (citing Gould § 2.3
(disclosing Appellant’s SEQ ID NO: 27); see also Ans. 11).
ANALYSIS
Rejection 1:
Based on the combination of Yang, Liang, and Schwartz, Examiner
concludes that, before the effective filing date of Appellant’s claimed
invention, it would have been prima facie obvious “to substitute low
molecular weight heparin taught by Liang . . . for dexamethasone taught by
Yang” and “substitute the 8-arm, 20 kDa polyethylene glycol that is
functionalized with norbornene taught by Schwartz . . . for the 4-arm, 20
kDa polyethylene glycol functionalized with norbornene of Yang . . . to
arrive at the presently claimed invention” (Ans. 4). As Examiner explains,
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“[t]he artisan of ordinary skill would have been motivated to make the
substitution with a reasonable expectation of success because low molecular
weight heparin promotes differentiation of hMSCs and “the 8-arm PEG-NB
can be utilized as a synthetic ECM and the 8-arm PEG-NB have similar
mechanical properties to a 4-arm PEG-NB as taught by Schwartz” (Ans. 4–
5; see also FF 1–8).
Examiner relies on Liang to disclose the use of low molecular weight
heparin containing hydrogel to stimulate hMSCs and promote, inter alia,
bone regeneration and induce osteogenic differentiation (see FF 5–7; see
also FF 7 (Liang discloses that “heparin-functionalized hydrogels support
hMSC viability . . . and induce osteogenic differentiation.”)). Thus, we are
not persuaded by Appellant’s contention that Yang does not suggest “that
heparin would be successfully used in place of dexamethasone in its
hydrogel . . . to differentiate hMSCs into osteoblasts” (Appeal Br. 7).
Liang further discloses that low molecular weight heparin was
developed to overcome the deficiencies of heparin (see FF 5–7). Therefore,
we are not persuaded by Appellant’s contention that “there is nothing to
suggest using LMWH as dexamethasone does not have the side effects of
heparin as discussed in Liang” (Appeal Br. 7).
Appellant recognizes that Schwartz discloses that an 8-arm 20 kDa
PEG-functionalized with norbornene produced similar results to a 4-arm 20
kDa PEG-functionalized with norbornene (see Appeal Br. 7). Appellant,
however, contends that “there is simply no reason to modify the references
to use the 8-arm PEG as an alternative to the 4-arm PEG,” Examiner
“appears to completely ignore the requirement for some reason to make the
substitutions,” and “if equivalent, then why make the substitutions at all –
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unless you are using inadmissible hindsight” (id.; see also Reply Br.9 1).
We are not persuaded. See In re Fout, 675 F.2d 297, 301 (CCPA 1982)
(“Express suggestion to substitute one equivalent for another need not be
present to render such substitution obvious.”); see also In re Mayne, 104
F.3d 1339, 1340 (Fed. Cir. 1997) (“Because the applicants merely
substituted one element known in the art for a known equivalent, this court
affirms [the rejection for obviousness].”); KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 416 (2007) (“[W]hen a patent claims a structure already known in
the prior art that is altered by the mere substitution of one element for
another known in the field, the combination must do more than yield a
predictable result.”).

Rejection 2:
Based on the combination of Yang, Liang, Schwartz, and Ki,
Examiner concludes that, before the effective filing date of Appellant’s
claimed invention, it would have been prima facie obvious “to optimize the
shear moduli and percent crosslinking density to have any appropriate value
including the values of shear moduli and percent crosslinking density as
claimed to achieve the desired stiffness and other mechanical properties of
the hydrogel as taught by Ki” (Ans. 6; see also id. at 10).
Having found no deficiency in the combination of Yang, Liang, and
Schwartz, we are not persuaded by Appellant’s contention that Ki fails to
overcome Appellant’s alleged shortcomings in Yang, Liang, and Schwartz
(see Appeal Br. 8).

9 Appellant’s November 4, 2020, Reply Br.
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Further, we are not persuaded by Appellant’s contention that Ki “is
directed to a completely separate and distinct purpose as the hydrogels of
Yang” and provides no disclosure “that would provide any advantage to the
goal stated in Yang” (id. at 8–9; see also Reply Br. 1 (Appellant contends
that Ki “is used for a completely different purpose as the hydrogels of
Yang . . . and/or Schwartz”)). As Examiner explains, Yang, Schwartz,
Liang, Ki, and Appellant’s “claimed invention are concerned with the
material and mechanical properties of functionalized hydrogels utilized as
scaffolds for cells” and Ki discloses that
the mechanical properties, shear moduli and cross-linking
density, are dependent [on] the concentration of
PEG8NB . . . and further by manipulating the cross-linking
density the stiffness of the gel matrix can be easily controlled to
mimic tissues with certain mechanical propert[ies]. . . .
Therefore, the skilled artisan would have looked to the
teachings Ki . . . to consider the effects of 8-arm 20kDa PEG-
NB concentration on the shear moduli, cross-linking density
and stiffness of the hydrogel utilized as a cell scaffold and
adjusted the concentration accordingly to obtain the desired
mechanical and material properties.
(Ans. 16 (citing Ki 3018 and 3022 (Tables 1–2)).) We find no error in
Examiner’s rationale. See In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992)
(Discussing the criteria for determining whether prior art is analogous).
Therefore, we are not persuaded by Appellant’s contention that although
“stiffness may or may not be beneficial, there is simply no reason for one
skilled in the art to even look to Ki . . . when first looking at Yang and the
other prior art references” (Appeal Br. 9).

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Rejection 3:
Based on the combination of Yang, Liang, Schwartz, and Ki,
Examiner concludes that, before the effective filing date of Appellant’s
claimed invention, it would have been prima facie obvious “to optimize the
shear moduli and percent crosslinking density to have any appropriate value
including the values of shear moduli and percent crosslinking density as
claimed to achieve the desired stiffness and other mechanical properties of
the hydrogel as taught by Ki” (Ans. 10).
For the reasons set forth above, we are not persuaded by Appellant’s
contention that “there is nothing that reasonably suggests that Yang . . .
could be successfully modified with Lang . . . Schwartz . . ., and Ki . . . to
arrive at a hydrogel composition including a polyethylene functionalized
with norbornene and an immobilized low molecular weight heparin”
(Appeal Br. 10).

Rejection 4:
Based on the combination of Yang, Liang, Schwartz, and Gould,
Examiner concludes that, before the effective filing date of Appellant’s
claimed invention, it would have been prima facie obvious “to substitute the
amino acid sequence KCGGPQGIWGQGCK taught by Gould . . . for the
MMP degradable linker with the sequence KCGPQGIAGQCK of
Yang . . . because the amino acid sequence of Gould et al. is a MMP
degradable linker” (Ans. 7 (citing MPEP § 2144.06(II))). See also Fout, 675
F.2d at 301 (“Express suggestion to substitute one equivalent for another
need not be present to render such substitution obvious.”).
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Having found no deficiency in the combination of Yang, Liang, and
Schwartz, we are not persuaded by Appellant’s contention that Gould fails to
overcome Appellant’s alleged shortcomings in Yang, Liang, and Schwartz
(see Appeal Br. 9). For the reasons set forth above, we are not persuaded by
Appellant’s contention that Examiner’s relied upon improper hindsight (see
id. (Appellant contends that “without Applicant’s claimed invention, there is
simply no reason to . . . [combine Yang, Liang, Schwartz, and Gould] to
arrive at Appellant’s claimed invention”)).

Rejection 5:
Based on the combination of Yang, Liang, Schwartz, and Gould,
Examiner concludes that, before the effective filing date of Appellant’s
claimed invention, it would have been prima facie obvious “to substitute the
amino acid sequence KCGGPQGIWGQGCK taught by Gould . . . for the
MMP degradable linker with the sequence KCGPQGIAGQCK of
Yang . . . because the amino acid sequence of Gould et al. is a MMP
degradable linker” (Ans. 11 (citing MPEP § 2144.06(II))). See also Fout,
675 F.2d at 301 (“Express suggestion to substitute one equivalent for
another need not be present to render such substitution obvious.”).
For the reasons set forth above, we are not persuaded by Appellant’s
contention that
there is nothing that reasonably suggests that Yang . . . could be
successfully modified with Lang . . ., Schwartz . . ., Ki . . . and
Gould . . . to arrive at a hydrogel composition including a
polyethylene functionalized with norbornene and an
immobilized low molecular weight heparin.
(Appeal Br. 11.)

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CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
Rejection 1: The rejection of claim 1 under 35 U.S.C. § 103 as
unpatentable over the combination of Yang, Liang, and Schwartz is
affirmed. Claims 2, 5, 6, and 17–19 are not separately argued and fall with
claim 1.
Rejection 2: The rejection of claim 3 under 35 U.S.C. § 103 as
unpatentable over the combination of Yang, Liang, Schwartz, and Ki is
affirmed. Claims 4, 8, and 11 are not separately argued and fall with claim
3.
Rejection 3: The rejection of claim 12 under 35 U.S.C. § 103 as
unpatentable over the combination of Yang, Liang, Schwartz, and Ki is
affirmed. Claims 13–15 are not separately argued and fall with claim 12.
Rejection 4: The rejection of claim 10 under 35 U.S.C. § 103 as
unpatentable over the combination of Yang, Liang, Schwartz, and Gould is
affirmed. Claim 20 is not separately argued and fall with claim 10.
Rejection 5: The rejection of claim 16 under 35 U.S.C. § 103 as
unpatentable over the combination of Yang, Liang, Schwartz, and Gould is
affirmed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2, 5, 6,
17–19
103 Yang, Liang,
Schwartz
1, 2, 5, 6,
17–19

3, 4, 8, 11 103 Yang, Liang,
Schwartz, Ki
3, 4, 8, 11
12–15 103 Yang, Liang,
Schwartz, Ki
12–15
10, 20 103 Yang, Liang,
Schwartz, Gould
10, 20
16 103 Yang, Liang,
Schwartz, Ki,
Gould
16
Overall
Outcome
1–6, 8,
10–20

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) (2019).

AFFIRMED