AMGEN INC.

Patent Trials and Appeals Board

Mar 19, 2021

2020005948 (P.T.A.B. Mar. 19, 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.
15/047,815 02/19/2016 Francisca Tan-Malecki 32263/46430ACON4 5415
109438 7590 03/19/2021
Marshall, Gerstein & Borun LLP (Amgen)
233 South Wacker Drive
6300 Willis Tower
Chicago, IL 60606-6357
EXAMINER
SEIF, DARIUSH
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/19/2021 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):
EFRHelp@amgen.com
mgbdocket@marshallip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte FRANCISCA TAN-MALECKI, RONALD FORSTER,
SCOTT M. NUNN, SON C. TRAN,
SHELDON MOBERG, and
MARK D. HOLT
____________

Appeal 2020-005948
Application 15/047,815
Technology Center 3700
____________

Before EDWARD A. BROWN, MICHELLE R. OSINSKI, and
WILLIAM A. CAPP, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
STATEMENT OF THE CASE
Appellant1 filed a request for rehearing under 37 C.F.R. § 41.52
(hereinafter “Request” or “Req. Reh’g”), dated January 22, 2021, of our
Decision on Appeal (hereinafter “Decision” or “Dec.”), dated November 27,
2020. In the Decision, we affirmed the Examiner’s decision to reject, under
35 U.S.C. § 103(a): (i) claims 1–4, 10, 12, and 14–22 as unpatentable over

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as AMGEN, INC.
Appeal Br. 3.
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Application 15/047,815

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Shue (US 2007/0276338 A1; pub. Nov. 29, 2007), Smith (US 2008/0097306
A1; pub. Apr. 24, 2008), Gross (US 6,824,529 B2; iss. Nov. 30, 2004), and
Badia (US 4,919,658; iss. Apr. 24, 1990); (ii) claims 5 and 13 as
unpatentable over Shue, Smith, Gross, Badia, and Appellant’s Admitted
Prior Art (“AAPA”)2; (iii) claims 6, 7, and 9 as unpatentable over Shue,
Smith, Gross, Badia, and Py (US 2006/0191594 A1; pub. Aug. 31, 2006);
and (iv) claim 8 as unpatentable over Shue, Smith, Gross, Badia, Tachikawa
(WO 2010/098323 A1; pub. Sept. 2, 2010), and Py. Dec. 14. Rehearing is
limited to matters overlooked or misapprehended by the Board in rendering
the initial decision.
OPINION
Appellant states that, contrary to the Board’s assertion on page 8 of
the Decision, “the Examiner’s rejection is not based on Shue rendering
obvious the sequence of filling a container prior to the container’s
attachment to a fluid delivery system.” Req. Reh’g 2–3. Appellant states
that “[r]ather, the Examiner’s rejection is based on the assertion that Shue’s
carpule 3 in Fig. 22 is filled with a drug and therefore must be filled prior to
its attachment to Shue’s alleged fluid delivery system (i.e., the assembly
including the needle cannula 23 in Fig. 22).”
We agree with Appellant that the Examiner’s position is more
properly characterized as Shue disclosing, by a preponderance of the
evidence or by inherency, a container that is filled prior to being attached to
a delivery device. Final Act. 3, 15. Our reference in the Decision to the

2 The Examiner refers to paragraph 55 of the Specification as AAPA. Final
Act. 12.
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Examiner’s rejection being based on Shue “rendering obvious filling the
container prior to the container’s attachment to the fluid delivery system”
(Dec. 8), as opposed to a finding by the Examiner that Shue fills the
container prior to the container’s attachment to the fluid delivery system, is
not a precise characterization of the Examiner’s position. We, however, do
not view such imprecision to be a basis compelling us to modify the
outcome of our Decision.
Appellant also argues that “Shue is silent as to whether or not the
carpule 3 in Fig. 22 is filled with a drug.” Req. Reh’g. 2; see also id. at 3
(“Shue is silent about the sequence in which its carpule 3 is filled with a
drug and attached to the alleged fluid delivery system.”). Appellant argues
that “[a]s explained by Appellant in the Reply Brief at pg. 3, the incorrect
assumption that the carpule 3 in Fig. 22 of Shue is filled with a drug leads
the Examiner, and now also the Board, to misapply what is taught by
Gross.” Id. at 3. Appellant’s statement regarding Shue’s silence about the
sequence in which its carpule is filled with a drug (raised for the first time in
the Reply Brief), did not address with sufficient particularity the Examiner’s
position (Final Act. 3, 15) so as to explain adequately why the Examiner did
not establish, by a preponderance of the evidence or by inherency, that Shue
discloses a carpule filled with a drug prior to the attachment of the carpule to
a fluid delivery system. See Final Act. 3 (emphasis omitted) (stating that
paragraph 43 of Shue “describes [reservoir] 31 [of carpule 3] hold[ing] a
liquid medicament which must have been filled at some point); id. at 15
(“Applicant appears to be suggesting that Shue . . . may suggest attaching
the fluid delivery system to the container before filling the container with a
drug product. However, in view of Shue FIGS. 4 and 5, this would appear
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highly counter-intuitive since it would dramatically increase the complexity
of the filling process. As envisaged in the FIG. 22/23 embodiment of Shue,
the container (31) is filled prior to being attached to the delivery device
(22/23). A person having ordinary skill in the art would recognize that this
order of operations would obviously apply to the FIG. 5 embodiment as
well.).
Appellant next argues that “Gross teaches one to fill a container after
or contemporaneous with attaching a fluid delivery system to the container”
and “[t]hus, the logical application of Gross to Shue is that Shue’s carpule 3
should be filled with a drug after or contemporaneous with attaching Shue’s
alleged fluid delivery system to the container.” Req. Reh’g 3. Appellant
takes the position that
if a person of ordinary skill in the art had looked to Gross for a
sequence to be used in filling Shue’s carpule 3 and attaching it to
Shue’s alleged fluid delivery system, the skilled person
following Gross would understand that Shue’s carpule 3 should
be filled with a drug after or contemporaneous with attaching
Shue’s alleged fluid delivery system to the carpule 3, so as to
avoid having to operate the environment where Shue’s carpule 3
is attached to the alleged fluid delivery system under sterile
conditions.
Id. We are not persuaded by Appellant’s argument because it does not
address the rejection as articulated by the Examiner. The Examiner turns to
Gross, not for a sequence to be used in filling Shue’s carpule and attaching it
to a fluid delivery system, but rather for teaching the sterility conditions
under which a medical device can be filled and assembled. Final Act. 4–5;
Ans. 5, 7. That Gross suggests filling of a carpule after or
contemporaneously with attachment to a fluid delivery system does not take
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away from the Examiner’s reliance on Shue for the sequence of filling a
carpule and attaching it to a fluid delivery system. Final Act. 3, 15.
Appellant next argues that “[t]o the extent that the Board believes that
a person of ordinary skill in the art would have ignored what is taught by
Gross in choosing a sequence for filling Shue’s carpule 3 and attaching it to
the alleged delivery system, Appellant notes that the record is devoid of
prior art evidence supporting such a belief.” Req. Reh’g 4. We reiterate the
Examiner’s reliance on Shue for the sequence of filling a carpule and
attaching a carpule to a fluid delivery system (Final Act. 3, 15), and that the
Examiner’s position was not responded to with sufficient particularity in the
briefing so as to apprise us of error in the Examiner’s position.
We acknowledge Appellant’s arguments in the Request that the
Examiner does not provide “prior art evidence supporting the assertion” that
attachment of Shue’s fluid delivery system to Shue’s carpule before filling
the carpule with a drug would “dramatically increase the complexity of the
filling process.” Req. Reh’g 4 (quoting Dec. 5 (quoting Final Act. 15)). We
also acknowledge Appellant’s argument in the Request that there is no “prior
art evidence indicating . . . that this purported complexity would have caused
a person of ordinary skill in the art to assume that Shue’s carpule 3
necessarily must be filled with a drug prior to the carpule’s attachment to
Shue’s alleged fluid delivery system.” Id. We, however, have not found
where any such argument was made previously in the briefing. The Board
could not have overlooked or misapprehended arguments that were not
before it. These arguments are untimely when made for the first time in a
request for reconsideration. See Hyatt v. Dudas, 551 F.3d 1307, 1313–14
(Fed. Cir. 2008); see also Cooper v. Goldfarb, 154 F.3d 1321, 1331 (Fed.
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Cir. 1998) (citing Moller v. Harding, 214 USPQ 730, 731 (BPAI 1982),
aff’d, 714 F.2d 160 (Fed. Cir. 1983) (table)) (“A party cannot wait until after
the Board has rendered an adverse decision and then present new arguments
in a request for reconsideration.”) and 37 C.F.R. § 41.52(a)(1) (“Arguments
not raised, and [e]vidence not previously relied upon, pursuant to §§ 41.37,
41.41, or 41.47 are not permitted in the request for rehearing except as
permitted by paragraphs (a)(2) through (a)(4) of this section.”).
Appellant additionally argues that “[t]he takeaway from Gross is that
certain steps of assembly can take place in a different room than where
filling has occurred only if the container was previously filled and attached
to a sealed off fluid delivery system under sterile conditions,” and “Gross
does not stand for the proposition that any post-filling assembly steps can
take place in a different room than where filling occurred, as the Board
seems to believe.” Req. Reh’g. 5. Appellant adds that “the implication in
Gross is that if the fluid delivery system has not previously been attached to
the container and sealed off, performing further assembly steps under non-
sterile (or what Gross calls ‘clean room’) conditions involves an
unacceptable risk of contamination.” Id. at 5–6 (citing Gross 10:42–45).
We have reconsidered Appellant’s argument, but remain unpersuaded that
Gross’s teaching is inapplicable in the context of the Examiner’s articulated
rejection. As explained in the Decision, the Examiner’s articulated rejection
relies on “the sterilization of Shue’s container and fluid delivery systems
while they are separated” as rendered obvious by Smith. Dec. 9 (citing Final
Act. 4). In conjunction with this sterilization step, the Decision then points
to Shue’s teaching of
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end caps 6, 7 for ‘shielding the communicating end 231 of the
[fluid delivery system] 23’ and ‘the [container] 3’ (Shue ¶ 58),
such that the parts of the fluid path in Shue are shielded so as to
be kept under sterile conditions for later attachment of the fluid
delivery system to the filled container in a clean room.
Id. Thus, we do not view the Examiner’s reliance on Gross in the articulated
rejection to be contrary to the teachings of Gross because sterilization and
shielding of the fluid path is explicitly contemplated, prior to the later
assembly step of attaching the filled container to the fluid delivery system, in
the Examiner’s cited combination of references.
For the above reasons, we are unpersuaded that the Board
misapprehended or overlooked Appellant’s arguments or otherwise erred in
sustaining the rejections of claims 1–10 and 12–22 under
35 U.S.C. § 103(a). Accordingly, Appellant’s Request is denied with
respect to our making any modification to the Decision.
CONCLUSION
In summary:
Outcome of Decision on Rehearing:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Denied Granted
1–4, 10,
12, 14–22
103(a) Shue, Smith, Gross,
Badia
1–4, 10, 12,
14–22

5, 13 103(a) Shue, Smith, Gross,
Badia, AAPA
5, 13
6, 7, 9 103(a) Shue, Smith, Gross,
Badia, Py
6, 7, 9
8 103(a) Shue, Smith, Gross,
Badia, Tachikawa,
Py
8
Overall
Outcome
1–10, 12–22
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Final Outcome of Appeal after Rehearing:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–4, 10, 12,
14–22
103(a) Shue, Smith, Gross,
Badia
1–4, 10, 12,
14–22

5, 13 103(a) Shue, Smith, Gross,
Badia, AAPA
5, 13
6, 7, 9 103(a) Shue, Smith, Gross,
Badia, Py
6, 7, 9
8 103(a) Shue, Smith, Gross,
Badia, Tachikawa, Py
8
Overall
Outcome
1–10, 12–22

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
DENIED