Ex Parte Sogard et al

Patent Trial and Appeal Board

Sep 12, 2016

13243134 (P.T.A.B. Sep. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/243,134 09/23/2011
121974 7590 09/14/2016
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
David Sogard
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.
8150BSC0146 2833
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
09/14/2016 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):
kddocketing@cpaglobal.com
Docketing@kdbfirm.com
bbonneville@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID SOGARD, SCOTT SMITH, and MARK L. JENSON
Appeal2014-008585
Application 13/243,134
Technology Center 3700
Before JAMES P. CALVE, BEVERLY M. BUNTING, and
SEAN P. O'HANLON, Administrative Patent Judges.
O'HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
David Sogard et al. (Appellants) 1 appeal under 35 U.S.C. § 134 from
the Examiner's decision rejecting claims 1, 8-12, and 18-23.2 We have
jurisdiction over this appeal under 35 U.S.C. § 6(b ).
SUMMARY OF DECISION
We REVERSE.
1 According to Appellants, the real party in interest is Boston Scientific
Scimed, Inc. App. Br. 3.
2 Claims 2-7 and 13-17 are canceled. Id. at 12, 13 (Claims Appendix).
Appeal2014-008585
Application 13/243,134
SUMMARY OF INVENTION
Appellants' disclosure is directed to methods and apparatus
configured for inserting a flexible medical device into a patient's body via a
natural orifice and delivering energy to innervated tissue. Spec. 1. Claim 1,
reproduced below from page 12 (Claims Appendix) of the Appeal Brief, is
illustrative of the claimed subject matter:
1. A method, comprising:
inserting an elongated flexible medical device into a
patient's body via a natural orifice;
wherein the natural orifice includes a urethra;
advancing the medical device through the urethra,
through the bladder, and through a ureter to a location
proximate innervated tissue that influences renal sympathetic
nerve activity; and
delivering energy from a distal end of the medical device
to one or both of image and ablate the innervated tissue.
Independent claim 12 is directed to an apparatus and contains similar
recitations as claim 1. See App. Br. 13 (Claims Appendix).
REJECTIONS
Claims 1, 8, 9, 11, 12, 18-20, and 23 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Zarins (US 2008/0255642 Al, pub. Oct.
16, 2008) and Huang (US 2006/0122566 Al, pub. June 8, 2006).
Claims 10, 21, and 22 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Zarins, Huang, Panescu (US 2003/0208123 Al, pub. Nov.
6, 2003), and Marilla (US 2007 /0208256 Al, pub. Sept. 6, 2007).
Claims 1 and 12 are provisionally rejected on the ground of non-
statutory obviousness-type double patenting as being unpatentable over
claims 1 and 23 of copending US Application No. 13/227,446.
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Application 13/243,134
Claims 1 and 12 are provisionally rejected on the ground of non-
statutory obviousness-type double patenting as being unpatentable over
claims 1, 16, and 24 of copending US Application No. 13/299,932.
Claims 1 and 12 are provisionally rejected on the ground of non-
statutory obviousness-type double patenting as being unpatentable over
claims 1, 14, and 18 of copending US Application No. 13/280,784.
Claims 1 and 12 are provisionally rejected on the ground of non-
statutory obviousness-type double patenting as being unpatentable over
claims 1, 2, 11, and20 ofcopendingUS Application No. 13/188,677.
ANALYSIS
Obviousness Rejection Based on Zarins and Huang
The Examiner finds that Zarins discloses an apparatus substantially as
claimed in independent claim 12, but "does not explicitly disclose insert[ing]
the device into the body via a natural orifice urethra and advanc[ing] the
device through a bladder and ureter to treatment area." Final Act. 5 (citing
Zarins, Abstract, i-fi-136 and 54, Fig. 13). The Examiner finds that Huang
teaches this feature, and reasons that it would have been obvious to a skilled
artisan to use the Zarins apparatus in the manner set forth by Huang
"because this is an effective and common way to insert device into the body
to perform treatment." Id. (citing Huang i-fi-f 10 and 41, Fig. 4). For the same
reasons, the Examiner further finds that the combination of Zarins and
Huang satisfies the method recited in independent claim 1. Id. at 6. The
Examiner elaborates that:
Huang discloses treatment of [the] kidney by insert[ion of a]
catheter [through] the urethra. The renal nerve is in the kidney.
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Application 13/243,134
Zarins discloses treating [the] kidney by treating [the] renal
nerve in the kidney. Zarins in view of Huang discloses treating
[the] renal nerve by insert[ ion of a] device through the urethra.
Adv. Act. 2.
With respect to claim 1, Appellants traverse the Examiner's proffered
reason to modify the renal treatment method and apparatus of Zarins using
the insertion technique of Huang, arguing, inter alia, that because "Zarins
appears to focus on a method of treating the renal nerves in which the
treatment catheter is inserted vascularly to a site within the renal artery" and
because "Huang appears to teach systems and methods of introducing an
instrument through the urethra and into the kidney for treatment in the
urinary tract," the motivation to combine the references "is found only in
[Appellants'] [S]pecification and thus is not appropriately applied to the
cited references." App. Br. 7-8. Appellants also disagree with the
Examiner's assertion that the renal nerve is in the kidney, instead asserting
that the renal nerves extend along the renal artery and that a skilled artisan
would understand "that treating the renal nerves adjacent the kidney is not a
treatment of the kidney per se, but rather a treatment of the sympathetic
nerves." Id. at 8 (referencing Zarins if 50, Figs. 1 and 2). The Examiner
answers that the "renal nerve extends longitudinally along the ... renal
artery, which is not only adjacent to the kidney, but also extends into the
kidney." Ans. 9.
We are persuaded by Appellants' arguments. It is not sufficient
merely to demonstrate that each of the components is known. See KSR Int 'l
Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ("a patent composed of
several elements is not proved obvious merely by demonstrating that each of
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Appeal2014-008585
Application 13/243,134
its elements was, independently, known in the prior art"). The Examiner
must also explain how a person of ordinary skill in the art would combine
those embodiments, and why such a person would be motivated to do so.
See, e.g., In re Chaganti, 554 F. App'x 917, 922 (Fed. Cir. 2014) ("It is not
enough to say that ... to do so would 'have been obvious to one of ordinary
skill.' Such circular reasoning is not sufficient-more is needed to sustain
an obviousness rejection."). Indeed, this articulated reasoning must include
some rational underpinning to support the legal conclusion of obviousness.
See KSR, 550 U.S. at 418 (citing In re Kahn, 441F.3d977, 988 (Fed. Cir.
2006)).
As noted by Appellants, Zarins discloses reducing renal sympathetic
nerve activity via neuromodulation by inserting a probe to a position
adjacent the interior or exterior surface of a patient's renal artery, renal vein,
or other vessel to a position proximate the renal nerves (see, e.g., Zarins
i-fi-135, 50, 62, 69, 70), but does not suggest that the disclosed methodology
could be performed with the treatment catheter positioned in the ureter or
kidney. App. Br. 7. Appellants argue convincingly that the Examiner's
reliance on Huang's disclosure of inserting a lumen system through a
patient's urethra, bladder, and ureter to the interior of the kidney as
establishing "an effective and common way to insert [a] device into the body
to perform treatment" (Final Act. 5) does not have a sufficient rationale
underpinning. For example, the assertion that the Zarins probe could be
inserted via the Huang lumen system does not establish why a skilled artisan
would so insert the Zarins probe, or that the Zarins probe would be effectual
for its treatment methodology from such a position. The Examiner's
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Application 13/243,134
assertion that the renal nerves extend within the kidney (Ans. 9-10) does not
satisfy these shortcomings, as the Examiner has not established that any
innervated tissue within the kidney influences renal sympathetic nerve
activity or, moreover, how the Zarins probe---even if inserted via the ureter
to the kidney interior-would be able to bypass the kidney components
intermediate the ureter and renal artery (nephron, tubules, ducts, etc.) to a
position proximate such innervated tissue.
Appellants also traverse the Examiner's findings regarding
independent claim 12, arguing, inter alia, that the Examiner "has not
provided any reasoned statement as to why one of ordinary skill in the art
would have been motivated to modify Zarins and Huang to achieve the
claimed structure." App. Br. 10. We are persuaded by this argument for the
same reasons as set forth above regarding claim I-namely, the Examiner's
proffered reason as to why a skilled artisan would attempt to modify the
Zarins device using the insertion method of Huang does not have a sufficient
rational underpinning to support the legal conclusion of obviousness.
Accordingly, for the foregoing reasons, we reverse the Examiner's
rejection of independent claims 1 and 12, as well as their dependent claims
8, 9, 11, 18-20, and 23, as being obvious over Zarins and Huang.
Obviousness Rejection Based on Zarins, Huang, Panescu, and Marilla
Panescu and Marilla are not relied upon by the Examiner in any
manner that would remedy the deficiencies noted above with respect to the
proposed combination of Zarins and Huang in rendering obvious the subject
matter of claims 1 and 12. Therefore, we also reverse the rejection of claims
10, 21, and 22.
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Application 13/243,134
Provisional Double Patenting Rejections
The Examiner provisionally rejects independent claims 1 and 12 over
various claims of four then-pending patent applications. Final Act. 3--4.
Appellants make conclusory arguments that the rejections are in error. App.
Br. 5---6. However, we do not sustain the double patenting rejection based on
claims 1 and 23 of US Application No. 13/227,446 because that application
was abandoned. We do not reach the merits of the Examiner's provisional
double patenting rejection based on claims 1, 16, and 24 of US Application
No. 13/299,932 because that application is still pending and thus it would be
premature to do so at this time, consistent with the holding of Ex Parte
Moncla, 95 USPQ2d 1884, 1885 (BP AI 2010) (precedential). We do not
reach the merits of the Examiner's provisional double patenting rejection
based on claims 1, 14, and 18 of US Application No. 13/280,784 and claims
1, 2, 11, and 20 of US Application No. 13/188,677 because each of those
applications have or will issue as United States patents. Moreover, claims 1,
14, and 18 of Application No. 13/280,784 were amended after the date of the
Final Action in this case and claims 1 and 2 of Application No. 13/188,677
were cancelled.
DECISION
The Examiner's decision to reject claims 1, 8-12, and 18-23 under 35
U.S.C. § 103(a) is reversed.
We do not sustain the Examiner's provisional obviousness-type
double patenting rejection of claims 1 and 12 over claims 1 and 23 of
copending US Application No. 13/227,446.
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Application 13/243,134
We do not reach the Examiner's other provisional obviousness-type
double patenting rejections of claims 1 and 12.
REVERSED
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