Ronald Biediger et al.

Patent Trials and Appeals Board

Jul 14, 2020

2019006528 (P.T.A.B. Jul. 14, 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.
15/497,414 04/26/2017 Ronald J. Biediger D7397 1071
27851 7590 07/14/2020
BENJAMIN A. ADLER
8011 CANDLE LANE
HOUSTON, TX 77071
EXAMINER
O DELL, DAVID K
ART UNIT PAPER NUMBER
1625
NOTIFICATION DATE DELIVERY MODE
07/14/2020 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):
Ben@adlerandassociates.com
Colleen@adlerandassociates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RONALD J. BIEDIGER, MICHELE A. BENISH, LINDSAY
BONNER HARDY, VINCENT A. BOYD, ROBERT V. MARKET,
THOMAS P. THRASH, and BRANDON M. YOUNG
____________

Appeal 2019-006528
Application 15/497,414
Technology Center 1600
____________

Before ERIC B. GRIMES, ELIZABETH A. LAVIER, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to certain chemical compositions. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Herein, we refer to the Response to Restriction
Requirement filed October 31, 2017 (“Response”); Final Action mailed June
13, 2018 (“Final Act.”); Appellant’s Appeal Brief filed May 7, 2019
(“Appeal Br.”); and Examiner’s Answer mailed June 14, 2019 (“Ans.”).
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STATEMENT OF THE CASE
Claims 1–8, 14, 15, 21, and 22 are on appeal and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 reads as follows:
1. A compound of formula I having a chemical structure of

wherein R1 is

R2 and R3 are independently hydrogen or C1-4
alkyl;
R4 is H or C1-4 alkyl;
R5 is phenyl, or aryl, any of which is substituted
with one or more of hydrogen, C1-4 alkyl, alkoxy, oxo,
halogen, haloalkoxy, -CF3, hydroxyl, -OCF3, aryl,
-OCF2H, -OCF2CF2H, -O(C3-6 cycloalkyl), -OCH2CF3,
thioalkoxy, dialkylamino, C3-6 cycloalkyl or haloalkyl;
R6 is phenyl, or aryl, any of which is substituted
with one or more of hydrogen, C1-4 alkyl, alkoxy,
halogen, oxo, acetyl, haloalkoxy, -CF3, hydroxyl, -OCF3,
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aryl, -OCF2H, -OCF2CF2H, -O(C3-6 cycloalkyl),
-OCH2CF3, thioalkoxy, dialkylamino, C3-6 cycloalkyl or
haloalkyl;
R7 is H or C1-4 alkyl;
R8 and R9 are independently hydrogen, C1-4 alkyl,
or hydroxyl;
R10 is hydroxyl;
or a pharmaceutically acceptable salt or
stereoisomer thereof.
Appeal Br. 14–15. Dependent claim 8 recites the formula of claim 1
wherein the R1 group corresponds to that in the elected species.2 Claim 8
reads as follows.
8. The compound of claim 1, wherein the compound of
formula I is the compound of formula I A having a chemical
structure of

wherein, R2, R3, R4, R5, R6, R7, R8, R9 and R10 are as
defined in claim 1; or a pharmaceutically acceptable salt or
stereoisomers thereof.
Id. at 15–16. As shown in claim 8, the recited compounds have a pyridine
ring on the left-hand side with a variable group (R7) attached to the nitrogen
in the pyridine ring. Appellant’s claims limit the R7 group to either
hydrogen or a relatively short (i.e., 1–4 carbons) alkyl group.

2 In response to Examiner’s species election requirement, Appellant selected
(S)-3-(5-fluoro-2’,6’-dimethylbiphenyl-3-yl)-3-(3-(4-hydroxy-1,6-dimethyl-
2-oxo-1,2-dihydropyridin-3-yl)ureido)propanoic acid. Response 2.
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Appellant seeks review of Examiner’s rejection of claims 1–8, 14, 15,
21, and 22 under 35 U.S.C. § 103 as obvious over Biediger.3 The issue
before us is whether the preponderance of the evidence supports Examiner’s
conclusion that Appellant’s claims are obvious over the genus of compounds
taught in Biediger.
Analysis
Examiner determines that “Biediger teaches a genus encompassing the
elected species” recited in Appellant’s claims. Final Act. 5. Specifically,
Examiner relies on Formula V of Biediger, which is reproduced below. Id.

Biediger, 7:30–40. As shown above, Formula V of Biediger discloses a
generic chemical structure with a pyridine ring on the left-hand side that
corresponds to the R1 group of Appellant’s elected species. The nitrogen in
the pyridine ring of Formula V is connected to variable group R18, which
corresponds to the R7 group in Appellant’s claims. Examiner finds that
Biediger defines R18, and the various other variable groups in Formula V,
such that the genus of compounds described by Formula V encompasses
Appellant’s elected species. Final Act. 5.
Examiner acknowledges that Biediger does disclose any particular
“species reading on the instantly claimed genus,” but determines that the

3 US 6,972,296 B2, issued Dec. 6, 2005 (“Biediger”).
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elected species would have been obvious in light of Biediger based on
certain fact findings. Id. First, Examiner determines that Biediger teaches
that the compounds in Formula V have “the same utility,” i.e., as integrin
inhibitors, as the compounds in Appellant’s claim. Id. at 6. Second,
Examiner finds that the level of skill is “high” and “[s]omeone preparing
these compounds . . . would recognize the very close structural similarity
and would expect them to have similar properties.” Id. Based on these
findings, Examiner determines Appellant’s claims would have been obvious
because “[t]he generic claims and species compounds of the instant claims
are described by the prior art genus. One of ordinary skill would be
motivated to make the compounds of the invention because he would expect
the compounds to have similar properties.” Id.
Appellant argues that the genus taught in Biediger Formula V does
not render the compounds recited in its claims obvious. See Appeal Br. 6–
10. Appellant contends that “the genus that is taught by the Biediger
reference is . . . extremely large” and “the only embodiments preferred and
exemplified” in Biediger are those in which the R18 group of Formula V is
“benzylic in nature or bulkier.” Id. at 6. Appellant points out that
“teachings of preferred species of a complex nature within a disclosed genus
may motivate an artisan of ordinary skill to make similar complex species
and also teach away from making simple species within the genus.” Id. at 7
(citing MPEP § 2144.08). Thus, urges Appellant, “replacing the more
complex substituted or unsubstituted aralkyl R18 group” that Biediger
teaches is preferred with the “hydrogen or alkyl” group recited at the
corresponding position in Appellant’s claims “produces a simpler species,”
whereas one following the teachings in Biediger would be motivated to
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make more complex changes at that position. Id. at 10. According to
Appellant, “[n]othing in the Biediger [reference] would suggest selecting
from among the at least hundreds of thousands of possibilities Applicant’s
substituents, particularly hydrogen or alkyl for R18.” Id. at 9.
Based on the current record, we determine that Appellant has the
better argument. The generic chemical structure in Formula V of Biediger
has ten variable groups, each of which is “independently selected” from
large groups of widely–variable chemical substituents. See Biediger, 7:44–
8:44. For example, R6, R7, and R18 are described as being “independently
selected from the group consisting of alkyl, alkenyl, alkynyl, hydroxyalkyl,
aliphatic acyl, alkynylamino, alkoxycarbonyl, heterocycloyl, -CH=NOH,
haloalkyl, alkoxyalkoxy, carboxaldehyde, carboxamide, cycloalkyl,
cycloalkenyl, cycloalkynyl, cycloalkylalkyl, aryl, aroyl, aryloxy, arylamino,
biaryl, thioaryl, diarylamino, heterocyclyl, alkylaryl, aralkenyl, aralkyl,
alkylheterocyclyl, heterocyclylalkyl, carbamate, aryloxyalkyl, hydrogen and
–C(O)NH(benzyl) groups.” Id. at 8:16–25. Given the number, breadth, and
possible permutations of these variable groups, we agree with Appellant that
the genus taught in Biediger is “extremely large.” Appeal Br. 6.
We are also persuaded by Appellant’s argument that Biediger
expresses a preference for more complex substituents at the R18 position in
Formula V. See Appeal Br. 6–9. Biediger teaches that “[p]resently
preferred compounds of Formula V” have a “substituted or unsubstituted
aralkyl” at R18. Biediger, 8:45–47. In addition, Biediger describes the
synthesis of a multitude of compounds. See id. at 26:1–53:10 (describing
synthetic schemes); Table 1 (listing H1 NMR spectra for synthesized
compounds). Appellant “submits that all of the[se] compounds . . . have
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bulky groups (unsubstituted aralkyl or substituted aralkyl) at [the] R18
position.” Appeal Br. 9; see also id. at 10 (“[T]he compounds synthesized in
Biediger are preferred species.”). Examiner does not dispute that
Appellant’s characterization is accurate. Accordingly, we agree with
Appellant that Biediger expresses a clear preference for R18 substituents
other than the hydrogen or relatively short alkyl group recited in Appellant’s
claims.
Examiner’s other findings concerning shared utility and the level of
skill in the art (see Final Act. 5–6) are insufficient to support a rejection on
the record here. Teachings of similar uses and the relative level of skill in
the art are relevant considerations in assessing whether a species or subgenus
would have been obvious over the disclosure of a genus in the prior art. See
MPEP § 2144.08. However, the MPEP makes clear that the rejection must
also “consider the size of the genus” and “any teaching or suggestion in the
reference of a preferred species or subgenus that is significantly different in
structure from the claimed species or subgenus.” Id. In this case, Examiner
has not sufficiently articulated why one of ordinary skill in the art would
have been motivated to use the relatively simple substituents in Appellant’s
claims at the R18 position given Biediger’s clear preference for more
complex groups at that position, particularly given the enormous breadth of
the genus encompassed by the generic structure in Formula V.
For these reasons, Examiner’s rejection is not supported by the
preponderance of the evidence. Therefore, we reverse.

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–8, 14, 15,
21, 22
103 Biediger 1–8, 14,
15, 21, 22

REVERSED