Philippe Pierre

Patent Trials and Appeals Board

Aug 18, 2021

2021000641 (P.T.A.B. Aug. 18, 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.
14/969,798 12/15/2015 Philippe Pierre 11450109B2 4290
30743 7590 08/18/2021
W&C IP
11491 SUNSET HILLS ROAD
SUITE 340
RESTON, VA 20190
EXAMINER
EWOLDT, GERALD R
ART UNIT PAPER NUMBER
1644
MAIL DATE DELIVERY MODE
08/18/2021 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PHILIPPE PIERRE
____________

Appeal 2021-000641
Application 14/969,798
Technology Center 1600
____________

Before DONALD E. ADAMS, DEBORAH KATZ, and
TIMOTHY G. MAJORS, 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 16–22, 25–31, 34, and 35 (see Final Act.2 2). 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. Appellant identifies the real party in interest as “INSTITUT
NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
(INSERM) of Paris, France; UNIVERSITE D'AIX-MARSEILLE of
Marseille, France; and CENTRE NATIONAL DE LA RECHERCHE
SCIENTIFIQUE (CNRS) of Paris, France” (Appellant’s May 19, 2020,
Appeal Brief (Appeal Br.) 3).
2 Examiner’s October 30, 2019 Final Office Action.
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to the general field of the treatment
and prevention of diseases involving an inflammatory condition, namely
sepsis or infectious or viral diseases as well as diseases requiring for the . . .
treatment [of] an immunosuppressive activity namely autoimmune diseases
and graft rejection” (Spec. 1:7–10). Appellant’s claims 16 and 17 are
reproduced below:
16. A method of treating inflammation in patient in need
thereof, comprising the step of
administering to said patient a therapeutic amount of an
inhibitor of activity or formation of a PP1/GADD34 complex
sufficient to reduce inflammation in said patient, wherein said
inhibitor is not salubrinal and wherein said inflammation is a
response in said patient selected from the group consisting of
activation of dendritic cells, activation of the complement
system, release of inflammatory cytokines, cytokine storm,
hyperproduction of inflammatory mediators, production of
chemokines, and leukocyte migration.
(Appeal Br. 21.)
17. The method of claim 16, wherein said inflammation is
resultant from inflammatory bowel disease.
(Id.)

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Grounds of rejection before this Panel for review:3
Claims 16, 18–22, 25, and 34 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Roca4 and Kroemer.5, 6
Claims 17, 26–31, and 35 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Roca and Sun.7

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Roca
relates to a cell comprising an Endoplasmic Reticulum (ER)
stress element operably linked to a reporter element and an
exogenous gene encoding a protein that induces ER stress.
Methods of screening using the modified cell, constructs used
in the modified cell, the candidate agents identified by the
screen and uses thereof.
(Roca, Abstr.)

3 Appellant canceled claims 23, 24, 32, and 33 (see Appellant’s October 17,
2019, Amendment 5). Therefore, Appellant’s recitation of claims 23, 24,
and 32 as included in the grounds of rejection on this record is incorrect (see
Appeal Br. 14). We find these typographical errors harmless on this record.
4 Roca et al., US 8,236,490 B2, issued Aug. 7, 2012.
5 Kroemer et al., US 8,129,340 B2, issued Mar. 6, 2012.
6 In contrast to Examiner’s Final Action, Examiner’s June 15, 2020, Answer
(Ans.) fails to include Appellant’s pending claim 25 in the statement of this
rejection. Appellant, however, confirms that its claim 25 should have been
included in this ground of rejection (see Ans. 3; cf. Final Act. 2; Appeal Br.
14). We find this typographical error harmless on this record
7 Sun et al., US 8,802,721 B2, issued Aug. 12, 2014.
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FF 2. Roca discloses “[i]n one embodiment, the candidate agents are for
use in treating ER stress-related diseases or disorders. An ER stress-related
disease or disorder is a disease or disorder caused by or contributed to be ER
stress levels. For example, . . . inflammation” (Roca 9:19–34; see Ans. 3).
FF 3. Roca discloses that “[c]ompounds already proven to be capable of
alleviating ER stress were chosen as controls” for its screening method, such
as “salubrinal, identified as an inhibitor of phosphatases that act on the
eukaryotic translation initiation factor 2 subunit (eIF2α),” wherein “[t]he
resulting maintenance of protein phosphorylation results in enhanced
protection from the adverse effects of ER stress, mainly because eIF2α
phosphorylation causes a halt in protein synthesis” (Roca 13:34–47; see
generally Ans. 3).
FF 4. Examiner finds that Roca differs from Appellant’s “claimed
invention only in that it does not teach the administration of an inhibitor that
is not salubrinal” and relies on Kroemer to make up for this deficiency (Ans.
3).
FF 5. Kroemer
relates to the use of a protein phosphatase inhibitor selected
from an inhibitor of the catalytic subunit of the protein
phosphatase I (PP1), an inhibitor of GADD34 and an inhibitor
of the PP1/GADD34 complex to prepare a pharmaceutical
composition to prevent or treat a cancer in a mammal, wherein
the pharmaceutical composition is intended for administration
in combination with a product used in a treatment of a cancer.
(Kroemer, Abstr.)
FF 6. Kroemer discloses inhibitors of PP1/GADD34, “namely tautomycin,
calyculin A (which both inhibit the catalytic subunit of PP1)” and
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“salubrinal (which inhibits the PP1/GADD34 complex)” (Kroemer 32:32–
37).
FF 7. Examiner finds that Roca differs from Appellant’s “claimed
invention only in that it does not teach the treatment of the specific
inflammatory conditions of inflammatory bowel disease (IBD), asthma, and
psoriasis” and relies on Sun to make up for this deficiency (Ans. 4).
FF 8. Sun “relates to biologically active chemical compounds, namely
thiophenyl derivatives that may be used for immunosuppression or to treat or
prevent inflammatory conditions, allergic disorders and immune disorders”
(Sun 1:13–16).
FF 9. Sun discloses that the biologically active chemical compounds,
namely thiophenyl derivatives, of its invention “can be used to prevent or to
treat subjects with inflammatory disorders,” such as inflammatory bowel
disease (IBD), asthma, and psoriasis (see Sun 15:7–38; see also id. at ll. 8–
12 (Sun discloses that “an ‘inflammatory disorder’ means a disease, disorder
or condition characterized by inflammation of body tissue or having an
inflammatory component. These include local inflammatory responses and
systemic inflammation.”)).
ANALYSIS
The rejection over the combination of Roca and Kroemer:
Based on the combination of Roca and Kroemer, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious to substitute “calyculin A or tautomycin for salubrinal in the
method of” Roca, because “the substitution of known equivalents, in this
case PP1/GADD34 inhibitors, for the same purpose, has long been held
obvious” (Ans. 3–4). We are not persuaded.
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Roca discloses the identification of candidate agents “for use in
treating ER stress-related diseases or disorders. An ER stress-related
disease or disorder is a disease or disorder caused by or contributed to be
ER stress levels. For example, . . . inflammation” (FF 2 (emphasis added)).
Although Roca discloses the use of salubrinal as a control, Roca discloses
that in the context of its disclosure salubrinal is “an inhibitor of phosphatases
that act on the eukaryotic translation initiation factor 2 subunit (eIF2α),”
wherein “[t]he resulting maintenance of protein phosphorylation results in
enhanced protection from the adverse effects of ER stress, mainly because
eIF2α phosphorylation causes a halt in protein synthesis” (FF 3).
As Appellant makes clear, however, the evidence of record establishes
that “salubrinal modulates pathways that are independent of eIF2α . . . such
as the NF-κB and p38 signaling pathways” (Appeal Br. 17 (citing Matsuoka8
16282–83)). Thus, as Appellant explains, “even if one were to consider that
Roca makes the treatment of inflammation with salubrinal obvious . . . one
of ordinary skill in the art would not assume that the treatment of
inflammation is correlated to salubrinal’s effect on PP1/GADD34” (id.). As
Appellant further explains, “Roca is completely silent regarding an inhibitor
of activity or formation of a PP1/GADD34 complex” (Appeal Br. 15).
Thus, we agree with Appellant’s contention that “one of ordinary skill
in the art would not recognize that inhibition of the PP1/GADD34 pathway
in particular was necessary or sufficient for treatment of inflammation”
(Appeal Br. 18). Thus, we find Examiner’s reliance on Kroemer misplaced

8 Matsuoka et al., Experimental Evidence Shows Salubrinal, an eIF2α
Dephosphorylation Inhibitor, Reduces Xenotoxicant-Induced Cellular
Damage, 16 Ind. J. Mol. Sci. 16275–87 (2015).
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on this record. Stated differently, absent improper hindsight reconstruction,
Examiner failed to establish a nexus between Roca and Kroemer’s
disclosure. Indeed, Kroemer
relates to the use of a protein phosphatase inhibitor selected
from an inhibitor of the catalytic subunit of the protein
phosphatase I (PP1), an inhibitor of GADD34 and an inhibitor
of the PP1/GADD34 complex to prepare a pharmaceutical
composition to prevent or treat a cancer in a mammal, wherein
the pharmaceutical composition is intended for administration
in combination with a product used in a treatment of a cancer.
(FF 5 (emphasis added).) As Appellant explained:
Examiner has failed to indicate where in the prior art it is taught
that tautomycin and calyculin A are ER stress inhibitors.
Indeed, Roca is silent regarding tautomycin and calyculin A (or
PP1/GADD34 complex inhibitors in general) and Kroemer only
mentions that tautomycin and calyculin A may be useful for the
treatment of cancer (ER stress modulation is not mentioned).
Thus, it could not be obvious to substitute such compounds if
they were not known to modulate ER stress.
(Reply Br. 4.) We agree.

The rejection over the combination of Roca and Sun:
Based on the combination of Roca and Sun, Examiner concludes that,
at the time Appellant’s invention was made, it would have been prima facie
obvious
to treat the inflammatory diseases including inflammatory
conditions of IBD, asthma, and psoriasis through the method
of . . . [Roca] given the teachings of . . . [Sun] that these
diseases are essentially equivalent in the context of treating
inflammation and would be expected to be treatable by similar
anti-inflammatory methods.
(Ans. 4.) We are not persuaded.
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Sun, as relied upon by Examiner, at best establishes that IBD, asthma,
and psoriasis are inflammatory conditions (see FF 8–9). As Appellant
explains, Sun fails to make up for the deficiencies in Roca alone, or in
combination with Kroemer9 (see Appeal Br. 18). We agree.
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 16, 18–22, 25, and 34 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Roca and Kroemer is
reversed.
The rejection of claims 17, 26–31, and 35 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Roca and Sun is reversed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
16, 18–22,
25, 34
103(a) Roca, Kroemer 16, 18–22,
25, 34
17, 26–31,
35
103(a) Roca, Sun 17, 26–31,
35
Overall
Outcome
16–22, 25–
31, 34, 35

REVERSED

9 Although Examiner does not rely upon Kroemer to support this rejection,
Appellant contends that the rejection should have further relied upon
Kroemer (Appeal Br. 14).