Robert Davis et al.

Patent Trials and Appeals Board

May 21, 2021

2020002946 (P.T.A.B. May. 21, 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.
13/203,365 08/25/2011 Robert Davis IT-44-US 6759
50446 7590 05/21/2021
HOXIE & ASSOCIATES LLC
75 MAIN STREET
SUITE 203
MILLBURN, NJ 07041
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
05/21/2021 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):
HoxiePatentMail@gmail.com
HoxiePatentMail@hoxpat.com
file@hoxpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte ROBERT DAVIS and ALLEN FIENBERG
____________________

Appeal 2020-002946
Application 13/203,365
Technology Center 1600
____________________

Before DEBORAH KATZ, JON M. JURGOVAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

JURGOVAN, Administrative Patent Judge.

DECISION ON APPEAL

Appellant1 seeks review under 35 U.S.C. § 134(a) from a Final
Rejection of claims 2, 7, and 56–58, constituting all of the claims pending in
the application.2 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.3

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. According to Appellant, the real party in interest is Intra-
Cellular Therapies, Inc. Appeal Br. 2.
2 Claims 1, 5, 6, 8–26, and 29–55 were canceled, and claims 3–4, 27–28, and
59–60 were withdrawn following a restriction requirement. These claims
are thus not before us in this appeal.
3 Our Decision refers to the Specification (“Spec.”) filed August 25, 2011;
the Final Office Action (“Final Act.”) mailed April 22, 2019; the Appeal
Brief (“Appeal Br.”) filed September 26 2019; the Examiner’s Answer
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CLAIMED INVENTION
The claims recite a method of treatment of glaucoma or elevated
intraocular pressure by administering an effective amount of
phosphodiesterase (PDE) 1. Spec. Abstract. The PDE 1 may be
administered as a monotherapy or in combination with one or more
additional intraocular pressure-lowering agents. Id.
Claim 2 is independent, and claims 7 and 56–58 are dependent
therefrom. Claim 2, reproduced below, is representative of the claimed
subject matter.
2. A method of treatment of glaucoma or elevated
intraocular pressure comprising administering an effective
amount of a PDE 1 inhibitor, or a combination of a PDE 1
inhibitor and an intraocular pressure-lowering agent, to a
patient in need thereof wherein the PDE 1 inhibitor is a
compound of the formula (IV):

Formula IV

(“Ans.”) mailed January 10, 2020; and the Reply Brief (“Reply Br.”) filed
March 10, 2020.
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wherein
R2 is H and R3 and R4 together form a tri- or tetra-
methylene bridge; or at least one of R2 and R3 is methyl,
isopropyl or arylalkoxy and R4 is H; or R2 and R3 are H
and R4 is a C1-4 alkyl;
R6 is phenylamino or benzylamino;
R10 is phenyl, pyridyl, or thiadiazolyl;
wherein
phenyl is optionally substituted with C1-4 alkyl, halogen,
haloC1-4 alkyl, hydroxyl, C1-4carboxy or an additional
aryl or heteroaryl; or
pyridyl or thiadiazolyl is optionally substituted with
C1-4alkyl, halogen, haloC1-4alkyl, hydroxyl or
C1-4carboxy;
in free, salt or prodrug form.

Appeal Br. 12 (Claims App.).

REJECTIONS
Claims 2 and 7 stand rejected under pre-AIA 35 U.S.C. § 103 as
unpatentable over Li (WO 2006/133261 A2, published December 14, 2006)
and Gupta (N. Gupta et al., Glaucoma as a neurodegenerative disease, 18(2)
CURRENT OPIN. OPTHALMOL., 110–114 (2007),
http://www.ncbi.nlm.nih.gov/pubmed/17301611 (12/1/2014)). Final Act. 6–
9.
Claims 56–58 stand rejected under pre-AIA 35 U.S.C. § 103 as
unpatentable over Li, Gupta, and Orzalesi (N. Orzalesi, Comparison of the
effects of latanoprost, travoprost, and bimatoprost on circadian intraocular
pressure in patients with glaucoma or ocular hypertension, 113(2)
OPTHALMOLOGY, 239–46 (2006) , https://www.ncbi.nlm.nih.gov/
pubmed/16458092 (4/16/2019)). Final Act. 9–10.
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Claims 2 and 7 stand rejected under pre-AIA 35 U.S.C. § 103 as
unpatentable over Li and Bell (US 6,235,742 B1, issued May 22, 2001).
Final Act. 11–14.
Claims 56–58 stand rejected under pre-AIA 35 U.S.C. § 103 as
unpatentable over Li, Bell, and Orzalesi. Final Act. 14–16.
Claims 2 and 7 stand rejected under pre-AIA 35 U.S.C. § 103 as
unpatentable over Li and Bhushan (US 2004/0137068 A1, published
July 15, 2004). Final Act. 16–21.
Claims 56–58 stand rejected under pre-AIA 35 U.S.C. § 103 as
unpatentable over Li, Bhushan, and Orzalesi. Final Act. 21–22.
Claims 2 and 7 stand rejected for nonstatutory double patenting over
claims 6 and 9–10 of Hendrick ’132 (US 9,849,132 B2, issued Dec. 26,
2017). Final Act. 22–23.
Claims 56–58 stand rejected for nonstatutory double patenting over
claims 6 and 9–10 of Hendrick ’132 in view of Orzalesi. Final Act. 23–24.

ANALYSIS
Standard of Review
We undertake a limited de novo review of the appealed rejection for
error based upon the issues identified by Appellant, and in light of the
arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d
1072, 1075 (BPAI 2010) (precedential).
1. Obviousness
Legal Principles
Title 35, section 103, provides
A patent for a claimed invention may not be obtained,
notwithstanding that the claimed invention is not identically
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disclosed as set forth in section 102, if the differences between
the claimed invention and the prior art are such that the claimed
invention as a whole would have been obvious before the
effective filing date of the claimed invention to a person having
ordinary skill in the art to which the claimed invention pertains.
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) any differences between the claimed subject matter and the prior art;
(3) the level of ordinary skill in the art; and (4) where present, objective
evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18
(1966).
Independent Claim 2
The Examiner finds that Li teaches PDE 1 inhibitors including the
elected species of
Cis-(6aR*,10aS*)-2-(4-(Pyridin-2yl)benzyl)-5,6a,7,8,9,10,10a-
heptahydro-5-methyl-3-(phenylamino)cyclohex[4,5]
imidazo[l,2-a]pyrazolo[4,3-e]pyrimidin-4(2H)-one

Li’s Example 8, shown above, depicts the chemical formula
for a PDE 1 inhibitor for treatment of neurodegenerative diseases.
for the treatment and prophylaxis of PDE 1 related disorders, including
neurodegenerative diseases like Alzheimer’s and Parkinson’s. Final Act. 6
(citing Li ¶¶ 61, 65, 68, 96–Example 8). The Examiner acknowledges that
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Li does not teach treatment of glaucoma, but finds that Gupta “teaches that
glaucoma is a neurodegenerative disease and that there are numerous
similarities between glaucoma and other neurodegenerative diseases like
Alzheimer’s and Parkinson’s.” Id. at 7. The Examiner finds it prima facie
obvious that one would use Li’s compounds to treat glaucoma with a
reasonable expectation of success absent evidence of criticality for the
elected compound considering Gupta’s teaching that glaucoma has
“numerous similarities” with the neurodegenerative diseases, Alzheimer’s
and Parkinson’s, which are described in Li as treatable using Li’s compound.
Id.
Appellant disagrees with the Examiner’s rejection. Appeal Br. 4–5.
Appellant argues that “Gupta does not mention the effectiveness of a PDE
inhibitor to treat glaucoma” and that the Examiner has “not demonstrated
that the Gupta abstract teaches or suggests that treatment for diseases such as
Alzheimer’s or Parkinson’s could be similarly applied to glaucoma.” Id.;
see also Reply Br. 2. However, the Examiner did not rely on Gupta alone to
teach this feature, but on the combination of Li and Gupta. As the Examiner
notes, Appellant’s argument attacks Gupta individually and does not
consider what a person of ordinary skill in the art would have understood
from the combination of Li and Gupta. Final Act. 8. This is an improper
approach to the obviousness inquiry. In re Merck & Co., 800 F.2d 1091,
1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981))
(“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references.”). Also, Appellant’s argument against Gupta
alone does not address the Examiner’s rejection as applied. See 37 C.F.R.
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§ 41.37(c)(1)(iv) (“The arguments shall explain why the examiner erred as
to each ground of rejection contested by appellant.”) (Emphasis added).
Appellant argues that “Gupta also does not draw any inference
whatsoever as to the role of PDE 1 in any of Parkinson’s Disease,
Alzheimer’s Disease or glaucoma.” Appeal Br. 4. Appellant does not
explain why Gupta must teach the role of PDE 1 in order to support the
rejection. In any case, Li describes the role of PDE 1 as a selective inhibitor
in treatment of neurodegenerative diseases. Li ¶¶ 1, 61.
Appellant further argues that “Gupta only names a few symptoms
common to Parkinson’s Disease, Alzheimer’s Disease or glaucoma.”
Appeal Br. 4. Appellant’s argument overlooks that the Examiner relies on
Gupta’s teaching that “[n]umerous similarities exist between glaucoma and
neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases.”
Gupta 1 (emphasis added); Final Act. 7. Gupta provides the specific
examples of selective loss of neuron populations, transsynaptic
degeneration, and common mechanisms of cell injury and death, but a
person of ordinary skill would have understood that Gupta’s “numerous
similarities” implies more than just a few similarities, which would have led
one to consider using treatments known to be effective for
neurodegenerative diseases on glaucoma. Id. Accordingly, we do not find
Appellant’s argument persuasive.
Appellant next asserts that “Gupta’s failure to acknowledge PDE1
inhibitors in any way would lead one to assume that glaucoma should be
treated with any of the normal avenues of treatment on the market.” Appeal
Br. 5. This argument again attacks Gupta individually and does not consider
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what a person or ordinary skill in the art would have understood from the
combined teachings of Li and Gupta. See Merck, supra.
Appellant argues that Example 10 of Appellant’s application
WO 201849417 A1 shows that PDE1 inhibitory compound substantially
increased survival of retinal ganglion cells in mice. Appeal Br. 9. Appellant
emphasizes that treatment of glaucoma through increasing survival of optic
neurons or through axonal regeneration were not known mechanisms in the
art, and that this result was highly unexpected. Reply Br. 4. But using Li’s
PDE 1 inhibitor compound to treat glaucoma, as suggested by Li and Gupta,
would achieve the same results, even if one would not have recognized from
their teachings the specific mechanisms by which the combination of Li and
Gupta is effective.
Appellant further argues that data submitted in the Appeal Brief, taken
together with the Declaration submitted September 5, 2017 (Appeal Br. 9–
10, Appendix B), shows that the claimed compounds, applied topically to
rabbits, achieve the unexpected result of penetrating ocular tissue and
treating glaucoma. Appeal Br. 9–10. We agree with the Examiner that the
Appellant’s data and Declaration are not commensurate in scope with the
claim. Ans. 4–6. Specifically, the claim is not restricted to topical
application of the claimed PDE 1 inhibitor compound.
For the foregoing reasons, we sustain the Examiner’s rejection of
claim 2 for obviousness over the combination of Li and Gupta.
Dependent Claims 7 and 56–58
Appellant presents no separate arguments for claim 7, which falls for
the reasons stated for claim 2. See 37 C.F.R. § 41.37(c)(1)(iv) (“[T]he
failure of appellant to separately argue claims which appellant has grouped
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together shall constitute a waiver of any argument that the Board must
consider the patentability of any grouped claim separately.”).
For claims 56–58, Appellant contends that Orzalesi fails to provide a
rationale that would guide one to treat glaucoma with the claimed
compounds, or account for the unexpected results obtained by Appellant, or
account for the alleged deficiencies of Li, Gupta, Bell, and Bhushan. Appeal
Br. 10–11. The Examiner explained how one would be guided to use Li’s
compound to treat glaucoma based on Li’s and Gupta’s teachings. Final
Act. 9–10. Appellant does not explain why the result of using Li’s PDE 1
inhibitor compound to treat glaucoma, as suggested by Li and Gupta, would
not achieve the same result of optic neuron survival and axonal regeneration
observed in Appellant’s testing of its compound. Furthermore, Appellant
has not identified any deficiencies in the combination of Li and Gupta that
Orzalesi was needed to cover.
Consequently, the dependent claims fall for the same reasons as
independent claim 2.
Remaining Obviousness Rejections
As we sustain the Examiner’s rejections of claims 2 and 7 over Li and
Gupta, and of claims 56–58 over the combination of Li, Gupta, and Orzalesi,
we do not reach the remaining obviousness rejections.
2. Obviousness-Type Double Patenting
Legal Principles
The doctrine of double patenting seeks to prevent the unjustified
extension of patent exclusivity beyond the term of a patent. In re
Zickendraht, 319 F.2d 225, 232 (CCPA 1963); In re Van Ornum, 686 F.2d
937 (CCPA 1982). In obviousness-type double patenting, the examiner
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normally applies the one-way test, which requires a showing that an
application’s claims are obvious in view of a patent’s. MPEP § 806. In
unusual circumstances, such as when an application for an improvement
issues before a basic invention through no fault of the applicant, the
examiner applies a two-way test, which requires, in addition, a showing that
the patent’s claims are obvious in view of the application’s. In re Janssen
Biotech, Inc., 880 F.3d 1315 (Fed. Cir. 2018); In re Berg, 140 F.3d 1428
(Fed. Cir. 1998).
Claims 2, 7, and 56–58
The Examiner applies the one-way test for obviousness-type double
patenting, finding that, although not identical, claims 2 and 7 for a PDE 1
inhibitor are not patentability distinct from claims 6, 9, and 10 of
Hendrik ’132 for the combination of a PDE 1 inhibitor and a PDE 2
inhibitor. Final Act. 22–23.
Appellant argues that it “would not have been obvious to treat
glaucoma or elevated intraocular pressure with a PDE1 inhibitor as presently
claimed in light of the ’132 patent’s combination of a PDE1 and PDE2
inhibitor.” Appeal Br. 11.
We find the Examiner’s analysis to be conclusory. It does not explain
why one would have used a PDE 1 inhibitor alone to treat glaucoma when
Hendrik ’132 teaches that the combination of PDE 1 and PDE 2 inhibitors
has “more than an additive effect” on the nitric oxide signaling in the brain,
thereby increasing cGMP levels. Hendrik ’132 3:18–22. In other words,
one would have understood Hendrik ’132 to teach that the PDE1 and PDE2
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inhibitors should be used together. The Examiner has not shown why one
would seek to use the PDE 1 inhibitor alone from Hendrik ’132’s teachings.
Accordingly, we do not sustain the obviousness-type double patenting
rejection of claims 2, 7, and 56–58.

CONCLUSION
We affirm the Examiner’s rejections of claims 2 and 7 over Li and
Gupta, and of claims 56–58 over Li, Gupta, and Orzalesi, for obviousness
under 35 U.S.C. § 103. We do not reach the remaining obviousness
rejections.
We reverse the rejections of claims 2, 7, and 56–58 for obviousness-
type double patenting over Hendrik.
In summary:
Claim(s)
Rejected
35 U.S.C.
§4
Reference(s)/Basis Affirmed Reversed
2, 7 103 Li, Gupta 2, 7
56–58 103 Li, Gupta, Orzalesi 56–58
2, 7 103 Li, Bell
56–58 103 Li, Bell, Orzalesi
2, 7 103 Li, Bhushan
56–58 103 Li, Bhushan, Orzalesi
2, 7 Nonstatutory Double
Patenting
2, 7
56–58 Nonstatutory Double
Patenting
56–58
Overall
Outcome
2, 7, 56–
58

4 Since we affirm the obviousness rejections of claims 2 and 7 based on Li
and Gupta, and of claims 56–58 based on Li, Gupta, and Orzalesi, we do not
reach the remaining obviousness rejections.
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Because we have affirmed at least one ground of rejection with
respect to each claim on appeal, the Examiner’s decision is affirmed. See
37 C.F.R. § 41.50(a)(1).
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)(1)(iv). See
37 C.F.R. § 41.50(f) (2019).

AFFIRMED