Deffez, Karine et al.

Patent Trials and Appeals Board

Jan 30, 2020

15054899 - (R) (P.T.A.B. Jan. 30, 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.
15/054,899 02/26/2016 Karine Deffez 298046-19 5327
3705 7590 01/30/2020
ECKERT SEAMANS CHERIN & MELLOTT LLC
U.S. Steel Tower
600 Grant Street, 44th Floor
Pittsburgh, PA 15219
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
01/30/2020 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):
ipmail@eckertseamans.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KARINE DEFFEZ and JEAN-PIERRE CASSIERE
Appeal 2019-004972
Application 15/054,899
Technology Center 1600

Before ERIC B. GRIMES, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellant requests rehearing of the Decision entered November 7,
2019 (“Decision”). The request for rehearing is denied.
Appellant argues that the Decision improperly interprets the claim
language as being open to a swellable clay disintegrant, in addition to one or
more of the disintegrants expressly recited in the claims. Req. Reh’g 2.
Appellant argues that
[t]he prosecution history shows that through the series of
amendments, Appellant limited the scope of the claims to
exclude any disintegrant beyond those specifically recited in the
claims. Specifically, . . . Appellant amended claim 16 to recite
“consisting of” with reference to the closed Markush group of
disintegrants. Appellant’s prosecuting attorney advised the
examiner that the amendment expressly distinguished the cited
reference by stating, “[i]n contrast to the subject matter of the
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instant claims, Patel ’221 teaches a particularly soluble CNS
compound and requires swellable clay as a disintegrating
agent.”
Id. at 4 (footnotes omitted). Appellant asserts that “[t]he prosecution
record clearly and unambiguously illustrates the fact that Appellant’s
claims expressly exclude swellable clay as a disintegrant.” Id. at 5.
This argument is unpersuasive. “[T]he PTO gives a disputed claim
term its broadest reasonable interpretation during patent prosecution.” In re
Bigio, 381 F.3d 1320, 1324 (Fed. Cir. 2004). “Absent claim language
carrying a narrow meaning, the PTO should only limit the claim based on
the specification or prosecution history when those sources expressly
disclaim the broader definition.” Id. at 1325.
Here, the statement made during prosecution and cited by Appellant
simply notes that Patel’s composition differs from the claimed tablets in two
respects: (a) it has a different active agent and (b) it includes a swellable clay
disintegrant. See Req. Reh’g 4. The statement does not expressly disclaim
compositions comprising a swellable clay disintegrant or, more broadly,
compositions comprising any disintegrant that is not expressly recited in the
claims.
“The ‘broadest reasonable interpretation’ rule recognizes that ‘before
a patent is granted the claims are readily amended as part of the examination
process.’ Thus, a patent applicant has the opportunity and responsibility to
remove any ambiguity in claim term meaning by amending the application.”
In re Bigio, 381 F.3d at 1324 (citation omitted). Appellant retains the ability
to amend the claims to unambiguously limit their scope, if that is desired.
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Appellant also argues that a narrow interpretation of the claims is
supported by Shire Development LLC v. Watson Pharms. Inc., 848 F.3d 981
(Fed. Cir. 2017). Req. Reh’g 5. According to Appellant, claim 16 on appeal
is directly analogous to the claims at issue in Shire, in which
[t]he Federal Circuit held that, “[h]ere, claim 1’s (a) and (b)
limitations use the phrase “consisting of,” or “consists of,” to
characterize the matrix, and “consisting of” to define the
groups, which “creates a very strong presumption that that
claim element is ‘closed’ and therefore ‘exclude[s] any
elements, steps, or ingredients not specified in the claim.”
Overcoming this presumption requires “the specification and
prosecution history” to “unmistakably manifest an alternative
meaning,” such as when the patentee acts as its own
lexicographer.
Id. at 7.
We disagree that Shire supports interpreting the claims to exclude
disintegrants other than those expressly recited. In Shire, the relevant
limitations recited “a) an inner lipophilic matrix consisting of substances
selected from the group consisting of” certain compounds, and “b) an outer
hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer
hydrophilic matrix consists of compounds selected from the group consisting
of” certain polymers. Shire, 848 F.3d at 983 (emphasis omitted).
The court noted that “claim 1’s (a) and (b) limitations use the phrase
‘consisting of,’ or ‘consists of,’ to characterize the matrix, and ‘consisting
of’ to define the groups.” Id. at 984 (emphasis added). Appellant’s claims,
by contrast, do not use “consisting of” to characterize either the claimed
tablet or a specific structural component that would be comparable to the
matrices in Shire’s composition. Thus, the Shire court’s claim interpretation
does not apply here.
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The court recently considered claims that are similar to Appellant’s in
Amgen Inc. v. Amneal Pharms. LLC, 2020 WL 62012 (Fed. Cir. Jan. 7,
2020). Claim 1 in that case recited “[a] pharmaceutical composition
comprising . . . (d) from about 1% to 10% by weight of at least one
disintegrant selected from the group consisting of crospovid[o]ne, sodium
starch glycolate, croscarmellose sodium, and mixtures thereof.” Id. at *1–2.
The court considered the argument that Shire required interpreting the
claim language to exclude any unrecited disintegrants, but concluded that the
argument “read more into . . . Shire than is properly found there.” Id. at *6.
In Shire, “the issue presented to and decided . . . was framed solely in terms
of interpreting element (b) [the outer matrix], without any reliance on the
‘comprising’ language of the general transition phrase of claim 1.” Id. at *8.
By contrast, the issue in Amgen was
[w]hether all binders or disintegrants in the claimed formulation
are subject to the specific binder or disintegrant limitations. The
answer, we conclude, is no. There is no language in Amgen’s
claim indicating that every binder or disintegrant in the claimed
formulation must be within the Markush groups. Instead, the
claim recites “at least one” binder or disintegrant “selected from
the group consisting of” various excipients.
Id. The court concluded that “[t]he plain language of this claim requires ‘at
least one’ of the Markush members and certainly does not indicate that the
only binders and disintegrants in the claimed formulation are those listed in
the groups.” Id.
The court went on to note that,
[i]mportantly, we also have the “comprising” language. . . .
[T]he language of the binder and disintegrant limitations is not
inconsistent with the presence of binders and disintegrants
beyond those identified in those limitations. Amgen’s use of the
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“comprising” transition phrase reinforces the conclusion that
the language of those limitations is best construed not to
foreclose such additional binders and disintegrants. Thus,
optional additional binders and disintegrants not recited in the
Markush group may be included in the claimed formulation.
Id.
The Amgen court’s claim interpretation is directly applicable to the
very similar language of Appellant’s claims. Thus, we conclude the similar
language of the claims here require one or more of the recited disintegrants,
but do not exclude the presence of Patel’s swellable clay disintegrant.
Appellant also argues that the record shows a nexus between the
evidence of secondary considerations, which relates to EXJADE®, and the
claimed invention. Req. Reh’g 9. Appellant points to “Statement[s] of Fact
throughout the prosecution history and record of this case . . . that
EXJADE® is the commercial embodiment of the claimed subject matter.”
Id. at 10 (emphasis omitted). Specifically, Appellant points to statements
made in remarks filed January 12, 2018, and in the Appeal Brief, stating that
EXJADE® is the commercial embodiment of the claimed subject matter,
that EXJADE® is “[t]he current subject matter,” or that EXJADE® “is the
invention disclosed and claimed.” Id. at 10–11. Appellant also “chooses at
this time to state the fact, in no uncertain terms, that Example 2 of the
specification is the RLD [reference-listed drug] formulation of EXJADE®,
per se.” Id. at 17 (emphasis omitted).
These arguments are unpersuasive because they are simply that:
arguments, not evidence. Relying on attorney argument as evidence to
establish a factual matter is erroneous. See Worlds Inc. v. Bungie, Inc., 903
F.3d 1237, 1246 (Fed. Cir. 2018) (“[W]e have some concern that the Board
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may have relied on attorney argument as evidence that Activision was not
controlling or funding these IPRs. See . . . Icon Health & Fitness, Inc. v.
Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017) (‘Attorney argument is
not evidence.’). . . . In light of these concerns, we find it appropriate to
remand this case to the Board for further consideration.”).
To be clear, we agree with Appellant that, if the evidence of record
indicated that the components labeled “1.1” are fillers, components “1.2” are
disintegrants, and components “1.3” are binders, the compositions described
in the Specification’s Example 2 would appear to meet the limitations of the
claims on appeal. Evidence supporting the argument in the Request for
Rehearing that Example 2 of the Specification is the formulation of
EXJADE® thus would be one way to establish a nexus between the claimed
invention and the evidence pertaining to EXJADE®. Other evidence could
also establish the required nexus; e.g., a declaration under 37 C.F.R. § 1.132
that includes a factual basis for concluding that EXJADE® meets the
limitations of the claims. The current record, however, lacks such evidence.
Appellant has submitted the “list of inactive ingredients that . . . exists
on the original NDA 21-882 FDA-approved EXJADE® label.” Req. Reh’g
12 (emphasis omitted), citing Exhibit I. Appellant’s Exhibit I includes a
description of EXJADE® that lists inactive ingredients including
“crospovidone (NF)” and “microcrystalline cellulose (NF).” Req. Reh’g,
Exhibit I, at 1. Crospovidone is cross-linked polyvinylpyrrolidone. Spec. 4.
Thus, Appellant’s evidence shows that EXJADE® includes at least one of
the compounds recited as disintegrants in the claims. However, the evidence
does not show that the total amount of the recited disintegrant(s) in
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EXJADE® is “about 5 to 40% by weight based on the total weight of the
tablet,” as required by the claims. The EXJADE® label therefore is
insufficient to establish a nexus between the claimed invention and the
evidence pertaining to EXJADE®.
Appellant cites In re DBC, 545 F.3d 1373 (Fed. Cir. 2008), as
supporting its position that the EXJADE® label shows that EXJADE® falls
within the scope of the claims. Req. Reh’g 13–14. The record in DBC,
however, included “three declarations pursuant to 37 C.F.R. § 1.132 . . .
describ[ing], among other things, the ingredients in XanGo™ juice and the
process for making it.” In re DBC, 545 F.3d at 1383. In one declaration, the
declarant “aver[red] personal knowledge of the contents of XanGo™ juice,
based on discussions with employees, contractors, and officers of DBC.” Id.
The court held that “[u]nder the circumstances of th[at] case, no more is
required to demonstrate that the XanGo™ juice falls within the scope of the
claims, particularly when the product label itself demonstrates as much.” Id.
Here, by contrast, the record does not include a declaration under 37
C.F.R. § 1.132 showing that EXJADE® falls within the scope of the instant
claims, and the submitted product label does not show as much. Thus, In re
DBC does not support reversal on the facts of this case.
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DECISION SUMMARY
Outcome of Decision on Rehearing:
Claims 35 U.S.C. § Reference(s)/Basis Denied Granted
16, 27–31 103(a) Lattmann, Patel 16, 27–31

Final Outcome of Appeal after Rehearing:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
16, 27–31 103(a) Lattmann, Patel 16, 27–31

REHEARING DENIED