Ex Parte Brandt et al

Patent Trial and Appeal Board

Feb 28, 2019

14317848 (P.T.A.B. Feb. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/317,848 06/27/2014
23517 7590 03/04/2019
MORGAN, LEWIS & BOCKIUS LLP (BO)
1111 PENNSYLVANIA A VENUE, N.W.
WASHINGTON, DC 20004
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
William Andrew Brandt
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
RPN-033/7316442001 9413
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
03/04/2019 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):
kcatalano@morganlewis.com
patents@morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM ANDREW BRANDT, JILIAN KA VAZOV,
DAVID MATHEW WESSEL, and ANDREW DUNN
Appeal 2018-003766
Application 14/317,848
Technology Center 3700
Before ANNETTE R. REIMERS, JEFFREY A. STEPHENS, and
ALYSSA A. FINAMORE, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
William Andrew Brandt et al. ("Appellants") appeal under 35 U.S.C.
§ 134(a) from the Examiner's decision to reject under 35 U.S.C. § 103
claims 1-15. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
Appeal 2018-003766
Application 14/317 ,848
CLAIMED SUBJECT MATTER
The claimed subject matter relates to "an implantable device for
administering a liquid." Spec. ,r 7, Figs. 1-3.
Claim 1, the sole independent claim on appeal, is representative of the
claimed subject matter and recites:
1. An implantable device for administering a liquid, the
device comprising:
an outer shell defining an interior volume;
within the interior volume, a pump assembly including a
reservoir having an inner shell, a gas-driven forcing mechanism
and a passage for conducting liquid from the reservoir to an
ejection site outside the shell in response to pressure applied by
the forcing mechanism; and
a refill port assembly comprising:
an orifice through a surface of the outer shell for
receiving a refill needle;
a first housing defining a first chamber having first
and second open ends and fluidly coupled, via at least
one bore through the first housing, to a ventable interior
portion, the ventable interior portion having boundaries
defined by the outer and inner shells;
a second housing defining a second chamber
having an open end and fluidly coupled, via at least one
bore through the second housing, to the drug reservoir;
and
first and second needle-penetrable septums,
wherein the orifice, the first and second housings and the
first and second septums are arranged in series with the first
septum disposed between, and penetrably sealing, the orifice
and the first open end of the first housing, and the second
septum disposed between, and penetrably sealing, the second
open end of the first housing and the open end of the second
housing.
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Application 14/317 ,848
REJECTIONS
I. Claims 1, 5-8, 14, and 15 stand rejected under 35 U.S.C. § 103 as
unpatentable over Enegren (US 4,955,861, issued Sept. 11, 1990)
and Fischell (US 4,571,749, issued Feb. 25, 1986).
II. Claims 2 and 9 stand rejected under 35 U.S.C. § 103 as
unpatentable over Enegren, Fischell, and Gibson (US
2003/0050626 Al, published Mar. 13, 2003).
III. Claim 3 stands rejected under 35 U.S.C. § 103 as unpatentable
over Enegren, Fischell, and Giebmeyer (US 2005/0015076 Al,
published Jan. 20, 2005).
IV. Claims 4, 10, and 12 stand rejected under 35 U.S.C. § 103 as
unpatentable over Enegren, Fischell, and McEntee (US 6,648,853
Bl, issued Nov. 18, 2003).
V. Claim 11 stands rejected under 35 U.S.C. § 103 as unpatentable
over Enegren, Fischell, and Nelson (US 6,013,051, issued Jan. 11,
2000).
VI. Claim 13 stands rejected under 35 U.S.C. § 103 as unpatentable
over Enegren, Fischell, 1 and Idriss (US 5,176,641, issued Jan. 5,
1993).
1 The Fischell reference is omitted in the header of this rejection. See Non-
Final Office Action 8 ("Non-Final Act."), dated Jan. 12, 2017. Because claim
13 depends from claim 1 (Appeal Brief 13 ("Appeal Br."), Claims Appendix
("Claims App."), filed Sept. 7, 2017), and because the Examiner refers to
claim 1 in the rejection of claim 13 (see Non-Final Act. 8), we understand this
rejection to rely on Fischell as well.
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Application 14/317 ,848
ANALYSIS
Obviousness over Enegren and Fischel!
Claims 1, 5---8, 14, and 15
Appellants do not present arguments for claims 5-8, 14, and 15
separate from those presented for claim 1. See Appeal Br. 5-10. We select
claim 1 as the representative claim, and claims 5-8, 14, and 15 stand or fall
with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
Independent claim 1 is directed to an implantable device including a
refill port assembly having "a first housing defining a first chamber having
first and second open ends and fluidly coupled, via at least one bore through
the first housing, to a ventable interior portion, the ventable interior portion
having boundaries defined by ... outer and inner shells." Appeal Br. 11,
Claims App. The Examiner finds although Enegren substantially discloses
the implantable device as claimed, including an interior portion 28 having
boundaries defined by outer and inner shells, Enegren "does not disclose the
first housing fluidly coupled, via at least one bore through the first housing,
to the interior portion, and the interior portion being ventable." Non-Final
Act. 2-3. The Examiner finds "Fischell discloses a refill port assembly
similar to that of Enegren, but [Fischell] includes three housings so that the
pressure inside the system may be adjusted." Id. at 3, 9 ("Fischell is used in
a similar way [ to Enegren] but [Fischell] discloses the chamber is accessible
and ventable only as part of adjustment in the event the pressure inside the
chamber is too high or too low."); Fischell 9:56-10:6. The Examiner
concludes it would have been obvious to modify the first housing of Enegren
by adding an additional chamber and septum, which is fluidly coupled to
interior portion 28 ofEnegren to allow a user to adjust the pressure within
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Application 14/317 ,848
interior portion 28, as taught by Fischell, in the event the pressure within
interior portion 28 is too high or too low. See Non-Final Act. 4, 9-10; see
also Ans. 8-11. 2
Appellants contend:
[I]f Enegren's compartment 42 (which the Examiner equates to
the recited first chamber) were fluidly coupled to the interior
chamber 28 (which the Examiner equates to the recited ventable
interior portion) as proposed, injection of the infusate from
Enegren's needle into the compartment 42 would mean that the
infusate necessarily enters the interior chamber 28.
Appeal Br. 6-7; id. at 7 ("[F]luidly coupling Enegren's interior chamber 28
to the compartment 42 would deleteriously mix the infusate with the two-
phase fluid.").
In the Answer, the Examiner clarifies it was "never suggested [by the
Examiner to] fluidly coupl[e] chamber 42 and interior portion 28." Ans. 9.
Rather, the Examiner "stated it would have been obvious to add an
additional chamber and septum [to Enegren] which would be fluidicly
coupled to interior portion 28"; thus, in the Examiner's proposed
modification of Enegren, "the infusate of chamber 42 and delivery path 74
would not mix with the two-phase fluid of the new chamber and interior
portion 28." Ans. 9; see also id. (The Examiner "stated it would have been
obvious to add another septum and chamber to Enegren as taught by
Fischell, this new chamber is the claimed first chamber. The [E]xaminer
never stated chamber 42 would be placed into communication with interior
portion 28."); Non-Final Act. 4.
2 Examiner's Answer ("Ans."), dated Dec. 22, 2017.
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Application 14/317 ,848
Appellants contend "an additional chamber would cause the proposed
configuration to fall outside claim 1, which requires the ventable interior
portion to be fluidly coupled to the first chamber." Appeal Br. 7 ( emphasis
omitted). However, the Examiner points out "there is no claim language
preventing another chamber [in Enegren ], nor is the [E]xaminer required to
interpret chamber 42 [ of Enegren] as the first chamber; the additional
chamber in the combination is Appellant[s'] claimed first chamber." Ans.
10. In addition, the presence of additional structures in Enegren does not
undermine a rejection where the claim defines the invention using the open-
ended term "comprising." See Exergen Corp. v. Wal-Mart Stores, Inc., 575
F.3d 1312, 1319 (Fed. Cir. 2009) ("The claim uses the term 'comprising,'
which is well understood in patent law to mean 'including but not limited
to."' (quoting CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360
(Fed. Cir. 2007))).
Appellants contend "Enegren's chamber 28 cannot be modified to be
ventable using Fischell's approach, as the proposed modification would ...
render Enegren unsatisfactory for its intended purpose." Appeal Br. 7. In
particular, Appellants contend "the vaporization pressure generated by the
two-phase fluid in the interior chamber 28 would be significantly reduced if
the chamber 28 were ventable. Consequently, the critical ability for the
chamber 28 to expel the infusate from the bellow chamber 26 would be
defeated." Appeal Br. 7-8; see also id. at 8-9 ("Because venting gas out of
the chamber 28 would prevent [the vapor in Enegren's chamber 28 from
condensing into a liquid,] which Enegren's recharging mechanism depends
on, one of ordinary skill in the art would not and could not modify Enegren's
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Application 14/317 ,848
chamber 28 to be ventable."); Reply Br. 43 ("[V]enting gas out of
[Enegren's] chamber 28 would reduce pressure therein, thereby preventing
recharging of the fluid power cell taught by Enegren as well as resulting in
(at best) inefficient delivery of the infusate from ... infusate chamber 26 to
the patient's body.").
Appellants' argmnent is unpersuasive because it fails to point to
evidence or provide sound technical reasoning to establish that a skilled
artisan would recognize the identified possible disadvantage would outweigh
the benefit identified by the Examiner, such that the proposed modification
would not have been obvious. Even if the Examiner's proposed
modification would not permit Enegren' s design to operate in the same
manner or as well, "[a] known or obvious [product] does not become
patentable simply because it has been described as somewhat inferior to
some other product for the same use." In re Gurley, 27 F.3d 551, 553 (Fed.
Cir. 1994). "The fact that the motivating benefit comes at the expense of
another benefit ... should not nullify its use as a basis to modify the
disclosure of one reference with the teachings of another. Instead, the
benefits, both lost and gained, should be weighed against one another."
Winner Int'! Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir.
2000). Although tradeoffs rnay be required in balancing the benefits and
drawbacks of Enegren's chamber 28 being ventable, such tradeoffs do not
necessarily prevent the proposed combination or negate the obviousness of
the claimed subject matter. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d
1157, 1165 (Fed. Cir. 2006) ("[A] given course of action often has
3 Reply Brief ("Reply Br."), filed Feb. 22, 2018.
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Application 14/317 ,848
simultaneous advantages and disadvantages, and this does not necessarily
obviate motivation to combine.").
In this case, the Examiner notes an advantage to modifying Enegren's
chamber 28 to be ventable --------namely, to allow a user to adjust the pressure
within interior portion/chamber 28 in the event the pressure is too high or
too low. See Non-Final Act. 4, 9--10; see also Ans. 8-11. Appellants have
not shown that the alleged disadvantage-namely, decreased efficiency in
delivery of the infusate from chamber 26 to the patient's body--------0utweighs
the advantage identified by the Examiner.
Appellants contend the motivation of Enegren is to "maintain the
integrity of ... interior portion 28" and this motivation would not be
maintained if interior portion 28 were ventable. Reply Br. 4 ( emphasis
omitted). However, the Examiner establishes that the "integrity" of interior
portion 28 of Enegren would be maintained if interior portion 28 were
ventable. In particular, the Examiner states "[ o ]ther than being accessible
via the needle (which may perform a venting function), the space [of
interior portion/chamber 28] remains a closed space (fluid may not enter or
exit)." Ans. 10.
We disagree with Appellants that the Examiner fails "to provide any
realistic reason or motivation for the proposed modification of Enegren by
Fischell." Reply Br. 7. To the contrary, the Examiner provides a reason
with rational underpinnings for combining the teachings of Enegren and
Fischell, namely, to allow a user to adjust the pressure within interior
portion/chamber 28 of Enegren in the event the pressure within the interior
portion/chamber is too high or too low. See Non-Final Act. 4, 9--10; see also
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Application 14/317 ,848
Ans. 8-11. Appellants do not provide persuasive evidence or argument
apprising us of error.
Appellants contend the Examiner "does not articulate any reasons
why one of skill in the art would even want to adjust the delivery rate of the
infusate." Reply Br. 8; see also id. at 7-8 ("In his Answer, the Examiner
argues that by making Enegren's interior portion 28 ventable as taught by
Fischell, the delivery rate of the infusate to the patient's body can be
adjusted."). However, in the portion of the Answer identified by Appellants,
(i.e., page 10 of the Answer (see Reply Br. 8, n.13)), the Examiner refers to
adjustment of the delivery rate of fluid via venting or filling interior
portion/chamber 28 of Enegren not to adjustment of the delivery rate of the
infusate to the infusion site, as proposed by Appellants. See Ans. 1 O; see
also Reply Br. 7-8. Thus, Appellants do not apprise us of error.
We also are not persuaded the Examiner engages in impermissible
hindsight in combining the teachings of Enegren and Fischell. See Reply Br.
8. The Examiner cites specific teachings in the references themselves, not
Appellants' disclosure, in support of the Examiner's articulated reasoning
for combining the references as proposed in the rejection. See Non-Final
Act. 2--4; In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (viewing
an argument regarding "impermissible hindsight" as "essentially a
repackaging of the argument that there was insufficient evidence of a
motivation to combine the references" and holding that this argument was
addressed by showing that a proper motivation to combine the references in
fact existed).
Appellants contend "the Examiner equates Enegren's interior chamber
28 with the gas-driven forcing mechanism and the ventable interior portion.
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Application 14/317 ,848
Thus, the Examiner has cited the same element in the prior art (i.e., the
interior chamber 28) for two distinct claim elements (i.e., the gas-driven
forcing mechanism and the ventable interior portion)." Appeal Br. 9
(footnote omitted). However, in the Answer, the Examiner clarifies element
28 of Enegren is cited "as the interior chamber, but ... Col.4 11 40-42 [ of
Enegren is cited] for the gas-driven forcing mechanism, said citation is
drawn to the two-phase fluid which, while located within interior chamber
28, is not the same structure as interior chamber 28." Ans. 11.
In the Reply Brief, Appellants argue for the first time that Enegren
and Fischell are not analogous art. Reply Br. 5-7. Normally, we do not
consider new arguments presented in a Reply Brief that are not accompanied
by a showing of good cause why they could not have been presented in the
Appeal Brief. 37 C.F.R. § 41.41(b)(2); Ex Parte Borden, 93 USPQ2d 1473,
1476-77 (BPAI 2010) (informative). Nonetheless, we address the analogous
art argument below.
Appellants contend (1) Enegren and Fischell are "in different fields of
endeavor"; and (2) "Enegren and Fischell pertain to completely different
problems and different solutions." Reply Br. 5-7. However, Appellants are
comparing the relevance of Enegren and Fischell to each other, which is not
the required legal test and is not persuasive of error.
The established precedent of our reviewing Court sets up a two-fold
test for determining whether art is analogous: "(1) whether the art is from the
same field of endeavor, regardless of the problem addressed and, (2) if the
reference is not within the field of the inventor's endeavor, whether the
reference still is reasonably pertinent to the particular problem with which
the inventor is involved." In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011)
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Application 14/317 ,848
(quoting In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)). The "field of
endeavor" prong asks if the structure and function of the prior art is such that
it would be considered by a person of ordinary skill in the art because of the
similarity to the structure and function of the claimed invention as disclosed
in the application. Bigio, 381 F.3d at 1325-27.
In this case, the subject invention is directed to "an implantable device
for administering a liquid." Spec. ,r 7. Similarly, Enegren discloses an
implantable apparatus that "enables one to introduce [fluids] into or
withdraw [fluids] from the apparatus, after it is implanted" (Enegren,
Abstract), and Fischell discloses an implantable apparatus that "can be filled
with fluid, or the fluid pressure can be reset, after implantation without
necessitating a surgical procedure" (Fischell, Abstract). As both Enegren
and Fischell are directed to implantable medical devices for administering a
liquid, they are within the field of Appellants' endeavor and are analogous
art.
In summary, and based on the record presented, we are not persuaded
the Examiner erred in rejecting independent claim 1 as unpatentable over
Enegren and Fischell. Accordingly, we sustain the Examiner's rejection of
claim 1. We further sustain the rejection of claims 5-8, 14, and 15, which
fall with claim 1.
Obviousness over Enegren, Fischel!, and any of Gibson, Giebmeyer,
McEntee, Nelson, or Idriss
Claims 2-4 and 9-13
Appellants do not present arguments for claims 2--4 and 9-13 separate
from those presented for claim 1. See Appeal Br. 5-10. As we find no
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Application 14/317 ,848
deficiencies in the Examiner's rejection of independent claim 1 as
unpatentable over Enegren and Fischell for the reasons discussed above, we
likewise sustain the Examiner's obviousness rejections of claims 2--4 and 9--
13.
DECISION
We AFFIRM the decision of the Examiner to reject claims 1-15 under
35 U.S.C. § 103.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv).
AFFIRMED
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