Ex Parte Ohri et al

Patent Trial and Appeal Board

Mar 3, 2016

12724448 (P.T.A.B. Mar. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121724,448 03/16/2010
31554 7590 03/07/2016
CARTER, DELUCA, FARRELL & SCHMIDT, LLP
445 BROAD HOLLOW ROAD
SUITE420
MELVILLE, NY 11747
RachitOhri
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.
H-US-01804 (1603-63) 7350
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
03/07/2016 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):
docket@cdfslaw.com
tgiordano@cdfslaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RACHIT OHRI and PHILLIP BLASKOVICH
Appeal2013-002056
Application 12/724,448
Technology Center 3700
Before WILLIAM A. CAPP, THOMAS F. SMEGAL, and
JAMES J. MAYBERRY, Administrative Patent Judges.
MAYBERRY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Rachit Ohri and Phillip Blaskovich (Appellants) seek our review
under 35 U.S.C. § 134 of the Examiner's rejections of claims 1-23. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
CLAIMED SUBJECT MATTER
The claims are directed to delivery devices for pH dependent forming
materials that prevent premature gelling of those materials. Spec. i-f 2.
Claim 1, reproduced below, is the sole independent claim and is illustrative
of the claimed subject matter:
Appeal2013-002056
Application 12/724,448
1
1. A delivery device comprising:
at least one lumen;
a means for aiding in expelling pH dependent forming
materials from the lumen; and
an opening configured to expel the pH dependent
forming materials from the delivery device in vivo,
wherein at least a portion of a surface of the delivery
device has a surface functionality for modulating pH of a
microenvironment near the surface for minimizing premature
gelling of the pH dependent forming materials in contact with
the surface and minimizing clogging of the delivery device.
Appeal Br. 22, Claims App.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Capozzi
Reynolds
Yokoyama
Chinn
Parthasarathy
Latini
us 4,978,336
us 6, 123,685
US 7,914,484 B2
us 2006/0105012 1A..l
US 2007/0160504 Al
US 2009/0012465 Al
REJECTIONS
Dec. 18, 1990
Sept. 26, 2000
Mar. 29, 2011
l\1ay 18, 2006
July 12, 2007
Jan. 8,2009
I. Claims 1, 12, 15, 16, 18, and 21 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Capozzi.
II. Claims 2-11 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Capozzi and Parthasarathy.
III. Claims 2, 3, 5-7, and 9-11 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Capozzi and Chinn.
IV. Claims 13 and 14 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Capozzi and (Parthasarathy or Chinn) and Latini.
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Application 12/724,448
V. Claim 17 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Capozzi and Reynolds.
VI. Claims 19 and 20 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Capozzi and Yokoyama.
VII. Claims 22 and 23 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Capozzi.
ANALYSIS
Rejection I
Claim 1 recites, in relevant part, "wherein at least a portion of a
surface of the delivery device has a surface functionality for modulating pH
of a microenvironment near the surface for minimizing premature gelling of
the pH dependent forming materials in contact with the surface and
minimizing clogging of the delivery device." Appeal Br. 22, Claims App.
In rejecting claim 1 as anticipated by Capozzi, the Examiner finds that
Capozzi' s device includes space 84 and outlet 88, where the two different
constituents delivered by Capozzi's device are mixed. Final Act. 2
(referencing Capozzi's Figure 8). The Examiner finds that these internal
surface features would perform the function of modulating the pH of a
microenvironment represented by the combined components. Id.; see also
Answer 10-11 ("Capozzi fully discloses that the surfaces at the space 84
and/or outlet 88 pertaining of function for modulating pH of the
microenvironment near the surface, for minimizing premature gelling of the
pH dependent forming materials and clogging of the delivery device").
"A patent applicant is free to recite features of an apparatus either
structurally or functionally. Yet, choosing to define an element functionally,
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Application 12/724,448
i.e., by what it does, carries with it a risk." In re Schreiber, 128 F.3d 1473,
1478 (Fed. Cir. 1997) (citation omitted) (emphasis added). Functional
language is not given patentable weight if the prior art structure can
inherently perform the function. See id. The Examiner has the burden to
provide a "reason to believe that ... the claimed subject matter may, in fact,
be an inherent characteristic of the prior art." Id. at 1478. Once the
Examiner satisfies this burden, it shifts to Appellants to provide evidence to
the contrary. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990); see also
In re Swinehart, 439 F.2d 210, 213 (CCPA 1971) ("[W]here the Patent
Office has reason to believe that a functional limitation ... may, in fact, be
an inherent characteristic of the prior art, it possesses the authority to require
the applicant to prove that the subject matter shown to be in the prior art
does not possess the characteristic relied on.").
Here, the Examiner satisfies the initial burden of providing reasoning
on how Capozzi' s structure inherently performs the recited function, which
shifts the burden to Appellants to rebut this finding. See Final Act. 2;
Answer 10-11. In response, Appellants merely provide the conclusory
statement that Capozzi fails to disclose the functional claim limitation. See
Appeal Br. 8. This response is insufficient to rebut the Examiner's finding.
In their Reply Brief, Appellants further argue that, when read in light
of the Specification, the functional limitation at issue would be understood
to be more than just the surface of the device itself, as the Examiner finds.
Reply Br. 3--4. Specifically, Appellants quote the Specification that
indicates that the functional language of claim 1 may be achieved by
imparting a charge on the surface of the delivery device or providing
functional groups that modulate the pH on the surface. Id. at 3.
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Application 12/724,448
vV e are not persuaded by this argument---claim 1 does not require the
recited function be accomplished by a charge imparted on the surface of the
delivery device or the surface including certain functional groups.
Appellants' argument improperly attempts to read claim limitations from the
Specification into claim 1. See In re Van Geuns, 9 88 F .2d 1181, 1184 (Fed.
Cir. 1993) ("[L ]imitations are not to be read into the claims from the
specification.") (citation omitted). Indeed, claim 2, which depends from
claim 1, adds the additional limitation requiring the surface to comprise a
charged polymer. See Appeal Br. 22, Claims App.
As Appellants' arguments fail to rebut the Examiner's finding that
Capozzi' s structure would perform the recited functional limitation of
claim 1, we sustain the Examiner's rejection of claim 1 under 35 U.S.C.
§ 102(b) as anticipated by Capozzi. Appellants fail to provide any additional
arguments for the separate patentability of claims 12, 15, 16, 18, and 21.
Appeal Br. 8-9. Accordingly, we sustain the rejection of these claims as
anticipated by Capozzi as well.
Rejection II
Claim 2 depends from claim 1 and further recites "wherein the surface
of the delivery device comprises a charged polymer." Appeal Br. 22, Claims
App. The Examiner finds that Capozzi fails to disclose the subject matter of
claim 2. Final Act. 4. The Examiner further finds that Parthasarathy
discloses this subject matter. Id. The Examiner determines that:
It would have been obvious at the time the invention was
made to a person having ordinary skill in the art to modify the
device of Capozzi with a surface of the delivery device includes
a charge polymer, as taught by either Parthasarathy, in order to
improve the biological function of the article, the lubricity on
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Application 12/724,448
the surface and prevent clogging on the surface of the coated
delivery device.
Id.
Appellants argue that "one skilled in the art reviewing Parthasarathy
would have no reason to apply Parthasarathy's anion exchange materials to
the recited delivery device, and one skilled in the art reviewing
Parthasarathy would have no reason to expect to succeed in arriving at the
recited delivery device." Appeal Br. 10. We agree.
"Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
(citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Here, the
Examiner's reasoning lacks the requisite rational underpinning.
Parthasarathy teaches an anion exchange material used to remove negatively
charged molecules from biological material. Parthasarathy, Abstract. The
Examiner's reasoning fails to adequately explain why an artisan of ordinary
skill would include Parthasarathy' s ion exchange material on the surface of
Capozzi's device. That is, the Examiner fails to explain how Parthasarathy's
ion exchange material, which removes negatively-charged molecules from a
medium, would "improve the biological function of [Capozzi's device], the
lubricity on the surface and prevent clogging on the surface of [Capozzi's]
coated delivery device." See Final Act. 4.
Accordingly, we do not sustain the Examiner's rejection of claim 2
under 35 U.S.C. § 103(a) as being unpatentable over Capozzi and
Parthasarathy. We also do not sustain the rejection of claims 3-11, which
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Application 12/724,448
depend, directly or indirectly, from claim 2, as being unpatentable over
Capozzi and Parthasarathy.
Rejection III
Under Rejection III, the Examiner finds that Chinn discloses the
subject matter of dependent claim 2: "wherein the surface of the delivery
device comprises a charged polymer." Final Act. 5. The Examiner
determines that:
Id.
It would have been obvious at the time the invention was
made to a person having ordinary skill in the art to modify the
device of Capozzi with a surface of the delivery device includes
a charge polymer, as taught by Chinn, in order to improve the
biological function of the article, the lubricity on the surface
and prevent clogging on the surface of the coated delivery
device.
Appellants argue that "one skilled in the art would not look to
combine a pro-fibrotic coating, utilized to promote a local response leading
to thrombus formation, as in Chinn, with a syringe system for delivering an
adhesive, as in Capozzi." Appeal Br. 14. We agree.
Once again, the Examiner fails to provide a rational underpinning to
support the determination of obviousness. See KSR Int'! Co., 550 U.S. at
418. The Examiner's reasoning does not adequately explain why one of
ordinary skill in the art would employ the pro-fibrotic coating of Chinn on
Capozzi' s device or how a material disclosed to promote hemostasis in the
body when used to coat medical implants would "improve the biological
function [], the lubricity on the surface and prevent clogging on the surface
of' Capozzi's device. See Final Act. 5.
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Application 12/724,448
Accordingly, we do not sustain the Examiner's rejection of claim 2
under 35 U.S.C. § 103(a) as being unpatentable over Capozzi and Chinn.
We also do not sustain the rejection of claims 3, 5-7, and 9-11, which
depend, directly or indirectly, from claim 2, as being unpatentable over
Capozzi and Chinn.
Rejection IV
Claim 13 depends, indirectly, from claim 1 and further recites
"wherein the tip assembly comprises a charged polymer," that is, subject
matter similar to that recited in claim 2. Appeal Br. 24, Claims App.
Claim 14 depends from claim 13 and further recites "wherein the charged
polymer comprises a coating on the tip assembly." Id. at 25, Claims App.
In rejecting claims 13 and 14 as obvious over Capozzi and either
Parthasarathy or Chinn and Latini, the Examiner relies on the same rationale
for how Parthasarathy or Chinn disclose the subject matter of claim 13 as
discussed above in connection with our analysis of claim 2 under Rejections
II and III. Accordingly, for the reasons discussed above in our analysis of
Rejections II and III, we do not sustain the Examiner's rejection of claims 13
and 14 under 35 U.S.C. § 103(a) as being unpatentable over Capozzi and
(Parthasarathy or Chinn) and Latini.
Rejections V and VI
In traversing Rejections V and VI, Appellants argue that Reynolds
(Rejection V) and Yokoyama (Rejection VI) fail to cure the deficiency in the
Examiner's anticipation rejection of claim 1. Appeal Br. 18-19, 19-20. As
discussed above in connection with our analysis of Rejection I, we find no
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deficiency in the Examiner's rejection. Accordingly, we sustain the
Examiner's rejection of claim 17 under 35 U.S.C. § 103(a) as being
unpatentable over Capozzi and Reynolds and the Examiner's rejection of
claims 19 and 20 under 35 U.S.C. § 103(a) as being unpatentable over
Capozzi and Yokoyama.
Rejection VII
In traversing Rejection VII, Appellants do not provide any arguments
for the separate patentability of claims 22 and 23 but instead rely on their
arguments with respect to Rejection I. 1 As discussed above in connection
with our analysis of Rejection I, these arguments are unpersuasive of
Examiner error. Accordingly, we sustain the Examiner's rejection of claims
22 and 23 under 35 U.S.C. § 103(a) as being unpatentable over Capozzi.
DECISION
We affirm the Examiner's rejection of claims 1, 12, 15, 16, 18, and 21
under 35 U.S.C. § 102(b) as anticipated by Capozzi.
We reverse the Examiner's rejection of claims 2-11 under 35 U.S.C.
§ 103(a) as being unpatentable over Capozzi and Parthasarathy.
We reverse the Examiner's rejection of claims 2, 3, 5-7, and 9-11
under 35 U.S.C. § 103(a) as being unpatentable over Capozzi and Chinn.
1 Appellants do state that "nowhere does Capozzi disclose or suggest" the
subject matter of claims 22 and 23. Appeal Br. 20. This contention is
misplaced as these facts are not in dispute-the Examiner determines that
the subject matter of claims 22 and 23 would be obvious over Capozzi, not
that Capozzi anticipates these claims. See Final Act. 8.
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\Ve reverse the Examiner's rejection of claims 13 and 14 under
35 U.S.C. § 103(a) as being unpatentable over Capozzi and (Parthasarathy or
Chinn) and Latini.
We affirm the Examiner's rejection of claim 17 under 35 U.S.C.
§ 103(a) as being unpatentable over Capozzi and Reynolds.
We affirm the Examiner's rejection of claims 19 and 20 under
35 U.S.C. § 103(a) as being unpatentable over Capozzi and Yokoyama.
We affirm the Examiner's rejection of claims 22 and 23 under
35 U.S.C. § 103(a) as being unpatentable over Capozzi.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l)(iv) (2015).
AFFIRMED-IN-PART
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