Ex Parte Ni et al

Patent Trial and Appeal Board

Feb 12, 2016

11282963 (P.T.A.B. Feb. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111282,963 11/18/2005
45458 7590 02/17/2016
SCHWEGMAN LUNDBERG & WOESSNER/BSC
POBOX2938
MINNEAPOLIS, MN 55402
Quan Ni
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.
279.N04US1 1024
EXAMINER
MALAMUD, DEBORAH LESLIE
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/17/2016 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):
uspto@slwip.com
SLW@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte QUAN NI, DOUGLAS DAUM, JEFFREY E. STAHMANN,
KENT LEE, and JESSE HARTLEY
Appeal2013---004109
Application 11/282,963 1
Technology Center 3700
Before JILL D. HILL, THOMAS F. SMEGAL, and
LISA M. GUIJT, Administrative Patent Judges.
SMEGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Quan Ni et al. (Appellants) seek our review under 35 U.S.C. § 134 of
the Examiner's Final Rejection of claims 32-53.2 We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is Cardiac Pacemakers,
Inc. Appeal Br. 1.
2 Claims 1-31 were canceled. Final Act. 2
Appeal2013---004109
Application 11/282,963
CLAIMED SUBJECT MATTER
Claims 32 and 41 are independent claims. Claim 32 is reproduced
below and illustrates the claimed subject matter, with disputed limitations
emphasized.
32. An implantable medical device, comprising:
a housing configured for implantation in a patient;
a lead system comprising an electrode arrangement and
coupled to the housing; and
a processor provided in the housing and coupled to the
lead system, the processor configured to:
detect presence of sleep disordered breathing;
detect a cardiac dyssynchrony at least one of within and
between cardiac chambers of the patient, the cardiac
dyssynchrony being indicative of mild heart failure; and
initiate cardiac resynchronization therapy for the patient
based on the combined detection of the sleep disordered
breathing and the cardiac dyssynchrony.
REJECTIONS
The following Examiner's rejections are before us for review.
1. Claims 32-53 are rejected under 35 U.S.C. § 112, first paragraph,
as failing to comply with the enablement requirement.
2. Claims 32, 33, 36-38, 40-44, 51, and 53 are rejected under 35
U.S.C. § 102(b) as anticipated by Cho (US 2004/0138719 Al, pub. July 15,
2004). Final Act. 6.
3. Claims 34 and 52 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Cho and Benser (US 7,519,425 B2, iss. Apr. 14, 2009).
4. Claims 35, 39, and 45-50 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Cho.
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Application 11/282,963
ANALYSIS
First Ground of Re} ection: Lack of Enablement of Claims 3 2-5 3
Insofar as the enablement requirement is concerned, the dispositive
issue is whether Appellants' disclosure, considering the level of ordinary
skill in the art as of the filing date, would have enabled a person of such skill
to make and use the invention without undue experimentation. In re
Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982). When rejecting a claim for
lack of enablement, the PTO bears the initial burden of setting forth a
reasonable explanation as to why the scope of the claim is not adequately
enabled by the description provided in the specification. In re Wright, 999
F.2d 1557, 1561-62 (Fed. Cir. 1993).
The Examiner first explains that "the Disclosure contains no mention
of CRT therapy in the case of 'mild heart failure' or in the presence of 'mild
symptoms of heart failure' as claimed." Final Act. 2. The Examiner also
observes that the Specification discloses "that previous studies showed that
CRT is not indicated for mild heart failure." Id. at 3; see Spec. 12, 11. 18-21.
While agreeing that the Specification provides "support for identifying a
'subset of patients who are like[ly] positive responders to CRT' and[]
'likely to benefit from CRT,"' the Examiner determines that the
Specification does not "provide evidence that this subset of patients are
those that suffer from mild heart failure or mild symptoms of heart failure,
as implied by [Appellants]." Id. From the foregoing, the Examiner
concludes that there is no "evidence that [Appellants were] in possession of
this claimed subject matter in the enclosed Disclosure." Id.
Appellants contend that "[ o ]ne skilled in the art would recognize that
a patient who is likely to be a positive responder to CRT is one for whom
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Application 11/282,963
CRT is designed to treat, namely, a patient with heart failure (CHF)," and
that "[ o ]ne skilled in the art would further understand that if a CHF patient
was not a Class III or IV patient, this CHF patient must be in a lower class,
which includes Classes II and I." Appeal Br. 13-14. Appellants also argue
from the foregoing that "the [S]pecification provides the requisite disclosure
for the claimed subject matter in compliance with 35 U.S.C. § 112, first
paragraph." Id. at 14. See also Reply Br. 8-12.
The Examiner responds by again pointing out that although "the
paragraphs of the instant application cited [by Appellants] provide support
for identifying a 'subset of patients who are like[ly] positive responders to
CRT,"' that is not "evidence that this subset of patients are those that suffer
from mild heart failure or mild symptoms of heart failure, as implied by
[Appellants]." Ans. 15-16. We agree with the Examiner that Appellants
have failed to identify where in the Specification there is a disclosure that
would enable a person of ordinary skill in the art to detect a "cardiac
dyssynchrony being indicative of mild heart failure," as recited by claim 32,
without undue experimentation. In re Mayhew, 527 F.2d 1229, 1232-33
(CCP A 1976). Thus, we reject claims 32-53 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.
Second Ground of Re} ection: Anticipation of Claims 3 2, 3 3, 3 6--3 8,
40--44, 51, and 53 by Cho
We are persuaded by Appellants' arguments that the Examiner failed
to establish a prima facie showing of anticipation in rejecting claims 32, 33,
36-38, 40-44, 51, and 53 over Cho.
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Application 11/282,963
The Examiner finds that Cho anticipates claim 32, inter alia, because
paragraph 27 of Cho discloses:
detecting the presence of sleep disordered breathing; detecting a
cardiac dyssynchrony at least one of within and between cardiac
chambers of the patient, the cardiac dyssynchrony being
indicative of mild heart failure (e.g., detection of Cheyne-Stokes
breathing); and initiating cardiac resynchronization therapy for
the patient based on the combined detection of the sleep
disordered breathing and the cardiac dyssynchrony.
Final Act. 6.
Appellants point out that "Cho fails to describe an implantable
medical device that both internally detects and internally initiates CRT
based on the combined detection of sleep disordered breathing (SDB) and
cardiac dyssynchrony as alleged in the Office Action." Appeal Br. 5. In
particular, Appellants explain that because "Cho teaches two modalities: a
system that consists of either external monitoring with an implantable
medical device for delivering SRDB therapy, or internal monitoring with an
external medical device for delivering SRDB therapy," that "Cho does not
teach both internal monitoring and an implantable medical device for
delivering therapy in response to the internal monitoring." Id. at 6.
The Examiner responds that claim 32 "requires only an 'implantable
medical device' comprising a housing 'configured for implantation,"' and
"[s]ince all components of Cho ... are capable of being implanted, the
Examiner considers them to be 'implantable' and 'configured for
implantation' as claimed." Ans. 9.
However, we agree with Appellants that "[n]owhere does Cho teach
or suggest that all the components of their system are implantable," and that
"throughout the specification, Cho makes it clear that its various
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Application 11/282,963
embodiments include an external apparatus and an implantable medical
device." Reply Br. 2. 3 We disagree with the Examiner's finding that
anything disclosed as external is necessarily capable of being implanted.
Thus, we find the determinations made by the Examiner to be an arbitrary
(and therefore unreasonable) interpretation of Cho.
[U]nless a reference discloses within the four comers of the
document not only all of the limitations claimed but also all of
the limitations arranged or combined in the same way as recited
in the claim, it cannot be said to prove prior invention of the thing
claimed and, thus, cannot anticipate under 35 U.S.C. § 102.
Net MoneyIN, Inc., v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
The error we identify above also applies to claims 33, 36-38, and 40
that depend from claim 32, independent claim 41 - a method claim having a
similar limitation to that discussed above, and claims 42--44, 51, and 53 that
depend from claim 41. See Appeal Br., Claims App.
For the foregoing reasons, we do not sustain the Examiner's rejection
of claims 32, 33, 36-38, 40-44, 51, and 53 as anticipated by Cho.
Third Ground of Rejection: Obviousness of Claims 34 and 52 over
Cho and Benser
The Examiner's rejection of claims 34 and 52 over Cho and Benser is
based on the same erroneous findings discussed above with respect to the
3 "If it is necessary to reach beyond the boundaries of a single reference to
provide missing disclosure of the claimed invention, the proper ground is not
§ 102 anticipation, but § 103 obviousness." Scripps Clinic & Research
Found. v. Genentech, Inc., 927 F.2d 1565, 1577 (Fed. Cir. 1991).
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disclosure of Cho. Final Act. 7-9. The addition of Benser does not remedy
the deficiencies of Cho, as discussed supra.
Accordingly, for similar reasons as discussed above for independent
claims 32 and 41, we do not sustain the Examiner's rejection of claims 34
and 52, which depend from claims 32 and 41, over Cho and Benser.
Fourth Ground of Rejection: Obviousness of Claims 35, 39, and 45-
50 over Cho
This rejection is directed to claims 35 and 39, which depend from
claim 32, and claims 45-50, which depend from claim 41. Final Act. 9-10.
We reverse the rejection of claims 32 and 41 above as anticipated by Cho,
and thus we do not sustain the rejection of claims 35, 39, and 45-50 as
obvious over Cho.
DECISION
The rejection of claims 32-53 under 35 U.S.C. § 112, first paragraph,
is AFFIRMED.
The rejection of claims 32, 33, 36-38, 40-44, 51, and 53 under 35
U.S.C. § 102(b) as anticipated by Cho is REVERSED.
The rejection of claims 34 and 52 under 35 U.S.C. § 103(a) as
unpatentable over Cho and Benser is REVERSED.
The rejection of claims 35, 39, and 45-50 under 35 U.S.C. § 103(a) as
unpatentable over Cho is REVERSED.
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)(l )(iv).
AFFIRMED
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