Ex Parte DeLuca et al

Patent Trial and Appeal Board

May 5, 2017

13485343 (P.T.A.B. May. 5, 2017)

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.
13/485,343 05/31/2012 Hector DeLuca 032026-1240 6922
81079 7590 05/09/2017
Wisconsin Alumni Research Foundation (WARF)
C/O Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
BADIO, BARBARA P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
05/09/2017 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):
ipdocketing @ foley. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HECTOR DeLUCA, RAFAL BARYCKI, LORI PLUM, and
MARGARET CLAGETT-DAME 1
Appeal 2016-005936
Application 13/485,343
Technology Center 1600
Before RICHARD J. SMITH, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to vitamin D
receptor (VDR) compounds. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Wisconsin Alumni
Research Foundation. (Appeal Br. 2.)
Appeal 2016-005936
Application 13/485,343
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—6, 16—22, and 31 are on appeal.2 (Claims Appendix, Appeal
Br. 16—23.) Claim 1 is illustrative and reads as follows:
1. A compound of formula I or a pharmaceutically acceptable salt
thereof
wherein
R1 and R2 are independently selected from H and hydroxy protecting
groups selected from silyl protecting groups; and
R3 is a straight or branched chain alkyl group with 1 to 8 carbon
atoms.
Examiner’s Rejections
1. Claims 1—6, 16—19, 21, 22, and 31 stand rejected under pre-AIA 35
U.S.C. § 103(a) as unpatentable over DeLuca.3 (Ans. 4—9.)
2. Claims 1—6, 16—19, 21, 22, and 31 stand rejected on the ground of
nonstatutory obviousness-type double patenting over claims 1, 2, 4—6, 9-11,
2 Claims 7—15, 24, and 28 are allowed. (Final Act. 1, dated Mar. 17, 2015.)
3 DeLuca et al., US 7,915,242 B2, issued Mar. 29, 2011 (“DeLuca”).
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Application 13/485,343
and 15—21 of DeLuca. {Id. at 2—3.)
3. Claims 1—3, 5, and 16—22 stand provisionally rejected on the ground
of nonstatutory obviousness-type double patenting over claims 1—20, 22—29,
31—38, 40-47, 49-57, 59-66, 68—75, and 77—87 of copending Application
No. 13/533,018.4 {Id. at 3-A)
FINDINGS OF FACT
FF 1. The Examiner finds that the compounds of claim 1 are a species
of the genus of compounds taught by DeLuca. (Ans. 8.) Appellants do not
dispute this finding. (Appeal Br. 10.)
FF 2. The Examiner finds that DeLuca exemplifies compounds such
as the following compounds 16 and 19:
O O OH O
(Ans. 13.)
FF 3. The Examiner finds that the compounds illustrated above in FF
2 differ only in a single position from the instantly claimed compounds, and
that the sole difference is within the teachings of DeLuca. (Ans. 13.) The
Examiner further finds that DeLuca “provides ample motivation to modify
the above mentioned prior art compounds [FF 2] by replacing the 24-
4 US Application No. 13/533,018, filed June 26, 2012 (“the ’018
application”).
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Application 13/485,343
hydroxyl with 24-oxo [compound 16] or the 25-dimethyl with 25-
cyclopropyl moiety [compound 19].” (Id.)
FF 4. The Examiner finds that DeLuca teaches the use of its disclosed
compounds in treating asthma. (Ans. 7, citing DeLuca claim 17.)
DISCUSSION
We adopt the Examiner’s findings, analysis, and conclusions as set
forth in the Final Action (Final Act. 2—3 and 5—7) and Examiner’s Answer
(Ans. 2—15). We discern no error in the Examiner’s rejections. We limit our
consideration to claim 1 because the claims were not separately argued.
Rejection No. 1
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under 35 U.S.C. § 103(a).
Analysis
Prima Facie Case
The Examiner finds that the compounds of claim 1 are encompassed
by the genus of compounds taught by DeLuca, and structurally similar to
embodiments exemplified in DeLuca. (Ans. 4—9 and 13; FF 1—3.) The
Examiner also finds that DeLuca teaches that its compounds are useful for
treating asthma. (FF 4.)
Appellants argue that the compounds of claim 1 are nonobvious
because they are vitamin D receptor (VDR) agonists, and that the DeLuca
compounds are VDR antagonists.5 (Appeal Br. 6—10.) Appellants support
5 According to Appellants, “[a]n agonist is a compound that binds to a
receptor and activates the receptor to produce a biological response, while an
antagonist blocks the action of agonist.” (Appeal Br. 6.)
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Application 13/485,343
this argument by reference to certain data from the Specification, addressed
below. (Id.) Appellants also argue that “both agonists and antagonists [are]
useful in treating asthma,” and refer to U.S. Patent No. 5,843,928, as
describing “VDR receptor agonists and their utility in treating asthma.” (Id.
at 8; see also Reply Br. 10—11.)
We find that the structural similarity between the compounds of claim
1 and the DeLuca compounds, as explained by the Examiner, along with a
reason or motivation to make the claimed compounds (FF 3), creates a prima
facie case of obviousness, with the burden then falling on Appellants to
rebut that prima facie case. See In re Dillon, 919 F.2d 688, 692—93 (Fed.
Cir. 1990). Moreover, with respect to reason or motivation to make the
claimed compounds, “it is sufficient to show that the claimed and prior art
compounds possess a ‘sufficiently close relationship ... to create an
expectation’. . . that the new compound will have ‘similar properties’ to the
old.” Aventis Pharma Deutschland GmbHv. Lupin, Ltd., 499 F.3d 1293,
1301 (Fed. Cir. 2007) (quoting In re Dillon, 919 F.2d at 692).
Appellants’ argument regarding the alleged agonist properties of the
claimed compounds is not persuasive because “the discovery that a claimed
composition possesses a property not disclosed for the prior art subject
matter, does not by itself defeat a prima facie case.” In re Dillon, 919 F.2d
at 693. Furthermore, the argument that both VDR agonists and VDR
antagonists are useful in treating asthma is consistent with the Examiner’s
position that species of the genus taught by DeFuca would have similar
properties and the same use (treating asthma) as the DeFuca compounds.
(Ans. 9.)
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Unexpected Results
Appellants seek to rebut the prima facie case of obviousness by
arguing that “the agonistic activity of the compounds at issue discovered by
the inventors is significant, surprising, and unexpected.” (Appeal Br. 7.) In
support of that argument, Appellants refer to test data and Table 1 from the
Specification comparing the antagonistic activity of claimed compound
example PP-48 to compounds CN-67 and OU-72 disclosed by DeLuca. {Id.
at 7—9; Spec. 96, 97, 99, 102, and Table 1.) Table 1 is illustrated below:
Working
Example1
Where Side chain
Competitive
VI) R Binding2
(Relative
Activity)'’
HL-60
Differentiation4
(Relative
Activity)3
240Hase
Transcription4
(Relative
Activity)3
PP-48 Present 0.6
(0.17)
30
(0.1)
2
(0.1)
AS-51 Present
OH 0 0.1
(1.0)
>1000
(0.002)
Antagonistic'
6
(0.02)
Antagonistic'
CN-67 US 7,915,242
'^^'0 0
1.5
(0.015)
3
(0.06)
Antagonistic1
5
(0.007)
Antagonistic5
OU-72 US 7,915,242
OH 0 0.023
(1.0)
5
(0.3)
Antagonistic'
3
(0.01)
Antagonistic'
(Spec. 49.)6
Appellants indicate that PP-48 corresponds to present claim 6
(formula IIIA). (Reply Br. 5.) Moreover, Appellants argue that, contrary to
6 Footnotes corresponding to Table 1 read as follows: lA\\ compounds are 2-
methylene 19-nor compounds. 2Ki, nM. 3Relative to native hormone,
l,25(OH)2D3 as measured in the same assay. Relative activity = (value
observed for native hormone) / (value observed for working example).
Ratios less than one indicate the working example is less active than the
native hormone. 4EC50, nM. 5When administered with l,25(OH)2D3. (Spec.
49.)
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DeLuca’s teachings, “PP-48 displays agonistic behavior” in both the HL-60
differentiation assay and the 24-OHase transcription assay. (Id. )
We do not find Appellants’ test data persuasive because it compares
only one species of the claimed compounds (PP-48), and the comparison is
not made to the closest prior art.
It is well settled that unexpected results must be shown to be
unexpected compared with the closest prior art, and the mere recognition of
latent properties in the prior art does not render nonobvious an otherwise
known invention. In re Baxter Travenol Labs, 952 F.2d 388, 392 (Fed. Cir.
1991) (citing cases). Here, the Examiner makes clear that DeLuca
compounds 16 and 19 (FF 2) are the closest prior art, not the compounds
tested and identified as CN-67 and OU-72 (Table 1). (Final Act. 6—7.)
Moreover, mere statements in DeLuca that its compounds are antagonists
does not take the place of objective evidence, such as test data comparing
the claimed compounds to the closest prior art. See, e.g., In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997). The Examiner explained to Appellants
that it was necessary for Appellants to compare their claimed compounds to
the closest prior art (Final Act. 6—7), a comparison which Appellants
characterized as a “demand” for additional data (Appeal Br. 9; Reply Br.
12—13).7 Accordingly, when weighed with the evidence of obviousness, we
do not find Appellants’ evidence of unexpected results sufficient to support a
conclusion of nonobviousness.
7 We also find no basis for Appellants’ contention that the Examiner ignored
Appellants’ evidence. (Reply Br. passim.)
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Conclusion of Law
A preponderance of evidence of record supports the Examiner’s
conclusion that claim 1 is unpatentable under pre-AIA 35 U.S.C. § 103(a).
Claims 2—6, 16—19, 21, 22, and 31 were not argued separately and fall with
claim 1.
Rejection No. 2
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection of claim 1 on the ground of nonstatutory obviousness-
type double patenting.
Analysis
Obviousness-type double patenting prohibits the issuance of claims in
a second patent that are “not patentably distinct from the claims of the first
patent.” In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985) (citations omitted).
An obviousness-type double patenting analysis is generally analogous to an
obviousness analysis under 35 U.S.C. § 103. See, e.g., Abbvielnc. v.
Mathilda and Terence Kennedy Institute of Rheumatology Trust, 764 F.3d
1366, 1378—79 (Fed. Cir. 2014) (citing cases). However, resolution of a
double patenting analysis is based on the claims at issue and the claims of
the reference patent. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955,
968 (Fed. Cir. 2001) (“A later patent claim is not patentably distinct from an
earlier patent claim if the later claim is obvious over, or anticipated by, the
earlier claim.”) (citations omitted).
Here, the Examiner concluded that claim 1 was not patentably distinct
from claims 1, 2, 4—6, 9—11, and 15—21 of DeFuca. (Ans. 2—3.) Appellants
contest that conclusion by relying on essentially the same arguments as
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advanced above; namely, that the claimed compounds are agonists, not
antagonists. (Appeal Br. 10-12.)
We find that the Examiner has the better position. Based on the
structural similarity between the compounds of claim 1 and the compounds
of the cited claims of Deluca, we find that the cited claims of DeLuca
provide the motivation to make the claimed compounds in the expectation
that they would have similar properties. See Dillon, 919 F.2d at 692—93.
Accordingly, we find that the Examiner has shown a sufficient structural
similarity and close relationship to establish a prima facie case of
obviousness-type double patenting. (Ans. 2—3.) Moreover, as discussed
above, Appellants have not provided persuasive evidence of unexpected
results to rebut the prima facie case of obviousness-type double patenting.
Conclusions of Law
A preponderance of evidence of record supports the Examiner’s
conclusion that claim 1 is unpatentable on the ground of nonstatutory
obviousness-type double patenting over the cited claims of DeLuca. Claims
2—6, 16—19, 21, 22, and 31 were not argued separately and fall with claim 1.
Rejection No. 3
The Examiner entered a provisional rejection of claims 1—3, 5, and
16—22 on the ground of nonstatutory double patenting over the cited claims
of the ’018 application based on a comparison of the respective claims.
(Ans. 3—4.) Appellants argue that “[bjecause the other rejections in the
present Application are overcome,” the provisional rejection should be
withdrawn because the present Application was filed prior to the ’018
application. (Appeal Br. 14—15; Reply Br. 13.) Accordingly, because the
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present rejections are not overcome, we summarily affirm the provisional
double patenting rejection.
SUMMARY
We affirm the rejections of all claims on appeal.
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
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