Ex Parte Heinrich et al

Patent Trial and Appeal Board

Feb 27, 2018

13476940 (P.T.A.B. Feb. 27, 2018)

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.
13/476,940 05/21/2012 Stephen D. Heinrich P008967.USC14 4288
99661 7590 03/01/2018
SHUMAKER & SIEFFERT, P.A.
1625 RADIO DRIVE
SUITE 100
WOODBURY, MN 55125
EXAMINER
EVANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
03/01/2018 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):
pairdocketing @ ssiplaw.com
medtronic_crdm-docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN D. HEINRICH and WARD M. BROWN
Appeal 2016-002486
Application 13/476,940
Technology Center 3700
Before CHARLES N. GREENHUT, PATRICK R. SCANLON, and
MICHELLE R. OSINSKI, Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Stephen D. Heinrich and Ward M. Brown (Appellants)1 appeal under
35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1, 2, 4-6,
11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111,
116, and 120-128.2 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as Medtronic, Inc. Appeal Br,
3.
2 Claims 3 and 10 are cancelled, and claims 7-9, 12-14, 36, 38-41, 52-59,
61, 62, 72, 73, 75-78, 85-89, 93-99, 101, 105-109, 112-115, and 117-119
are withdrawn from consideration. Amendment (Aug. 19, 2014), 2-29.
Appeal 2016-002486
Application 13/476,940
THE CLAIMED SUBJECT MATTER
Claims 1, 11, 15-23, 37, 120, and 123-128 are independent. Claim 1,
reproduced below, is illustrative of the claimed subject matter on appeal.
1. A system for providing arrhythmia therapy to a. patient,
comprising:
a can having a surface to deliver high voltage shocks;
an implantable pulse generator housed in the can and
configured to generate electrical therapy including high voltage
shocks;
a sensing circuit coupled to the implantable pulse
generator and configured to sense arrhythmia; and
a subcutaneous electrode array coupled to the implantable
pulse generator to deliver electrical therapy to the patient without
a transvenous, intracardiac, or epicardial electrode upon
detection by the sensing circuit of an arrhythmia.
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Dahl
Fischell
Bardy
US 5,342,407
US 6,272,379 B1
US 6,721,597 B1
Aug. 30, 1994
Aug. 7, 2001
Apr. 13, 2004
THE PRIORITY ISSUE3
The Examiner determines that prior-filed Application Nos.
11/981,410; 10/949,877; 09/990,045; and 60/252,811 fail to provide
3 The Examiner’s determination that prior-filed Application Nos.
11/981,410; 10/949,877; 09/990,045; and 60/252,811 fail to provide
adequate written descriptive support or enablement for the limitations
relating to “a ‘substantially’ pliant and directable cannula/means/lead” and
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Application 13/476,940
adequate written descriptive support or enablement for one or more of the
present claims, namely, those that include (i) ‘“without a transvenous,
intracardiac, or epicardial electrode’ or similar limitation”; (ii) “sensing
electrodes interfacing with low voltage and high impedance circuitry”; and
(iii) “a concentrated electrically conductive surface defined about a surface
of the housing adapted to face the heart,” such that these claims are not
entitled to the benefit of the filing date of the prior-filed applications. Final
Act. 2—4.
THE REJECTIONS* * 4
I. Claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92,
100, 102-104, 110, 111, 116, and 120-128 stand rejected under
35 U.S.C. § 112, second paragraph, as indefinite for failing to
particularly point out and distinctly claim the subject matter which the
applicant regards as the invention. Id. at 4-5.
II. Claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92,
100, 102-104, 110, 111, 116, and 120-128 stand rejected under
35 U.S.C. § 102(e) as anticipated by Bardy. Id. at 7.
III. Claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92,
100, 102-104, 110, 111, 116, and 120-128 stand rejected under
“an electrically isolated connector block on a proximal end of the housing”
(Non-Final Act. 3) is withdrawn (Ans. 2).
4 The Examiner’s rejection of claims 123-128 under 35 U.S.C. § 101 as
directed to non-statutory subject matter appears to be moot in view of the
indication in the Advisory Action mailed August 26, 2014 that Appellants
Reply filed August 19, 2014 has overcome this rejection. Adv. Act. (Aug.
26, 2014), 1.
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35 U.S.C. § 102(f) because Appellants did not invent the subject
matter claimed. Id.
IV. Claims 1, 2, 5, 11, 16-18, 37, 42, 43, 48, 51, 79, 80, 84, 90-92, 100,
103, 104, 111, 120, and 123-128 stand rejected under 35 U.S.C.
§ 102(e) as anticipated by Fischell. Id. at 8.
V. Claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92,
100, 102-104, 110, 111, 116, 120 and 123-128 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Fischell and Dahl. Id. at 9-
14.
VI. Claims 121 and 122 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Bardy or Fischell, either alone or in view of Dahl.
Id. at 14.
OPINION
The Priority Issue
“without a transvenous, intracardiac, or epicardial electrode ”
or similar limitation
The Examiner finds that prior-filed Application Nos. 11/981,410;
10/949,877; 09/990,045; and 60/252,811 fail to provide adequate written
descriptive support or enablement for the limitation “without a transvenous,
intracardiac, or epicardial electrode” or similar limitation, such that one or
more of the present claims5 are not entitled to the benefit of the filing date of
the earlier filed applications. Final Act. 3.
5 The Examiner does not identify which claims are not entitled to the benefit
of the filing date of the prior-filed applications because of the identified
language, but it appears that claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-
71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, and 121-125 are
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As we sustain the Examiner’s rejection of claims 1, 2, 4-6, 11, 15-35,
37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, and
121-125 under 35 U.S.C. § 112, second paragraph, as indefinite based on
the inclusion, either directly or indirectly, of the phrase “transvenous,
intracardiac, or epicardial electrode” or similar limitation (see infra), we find
it imprudent to speculate as to whether the prior-filed Application Nos.
11/981,410; 10/949,877; 09/990,045; and 60/252,811 provide adequate
written descriptive support or enablement for the limitation “without a
transvenous, intracardiac, or epicardial electrode” or similar limitation so as
to entitle the relevant claims to the benefit of the filing date of the prior-filed
applications. See In re Steele, 305 F.2d 859, 862-63 (CCPA 1962) (holding
that the Board erred in affirming a rejection of indefinite claims because the
rejection was based on speculative assumptions as to the meaning of the
claims). We find the reasoning in In re Steele to be applicable because
reaching a decision regarding the priority claim requires that we first
understand the metes and bounds of the claims. Cf. In re Moore, 439 F.2d
1232, 1235 (CCPA 1971) (One is not in a position to determine whether a
claim is enabled under the first paragraph of 35 U.S.C. § 112 until the metes
and bounds of that claim are determined under the second paragraph of this
section of the statute.).
Because we do not know the metes and bounds of the claims reciting
“without a transvenous, intracardiac, or epicardial electrode” or similar
limitation, we cannot determine if the subject matter of these claims is
implicated by virtue of their inclusion, either directly or indirectly, of
“without a transvenous, intracardiac, or epicardial electrode” or similar
limitation.
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disclosed in prior-filed Application Nos. 11/981,410; 10/949,877;
09/990,045; and 60/252,811 in the manner provided by 35 U.S.C. § 112,
first paragraph, so as to entitle the claims to the benefit of the prior-filed
applications’ filing dates. See AriadPharm., Inc. v. EliLilly and Co., 598
F.3d 1336, 1351 (Fed. Cir. 2010) (“[T]he test for sufficiency is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date.”).
Consequently, we are constrained to find that the Examiner has failed
to adequately show that claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71,
74, 79-84, 90-92, 100, 102-104, 110, 111, 116, and 121-125 are not
entitled to the priority of the filing dates of Application Nos. 11/981,410;
10/949,877; 09/990,045; and 60/252,811 based on lack of support for a
system “without a transvenous, intracardiac, or epicardial electrode” or
similar limitation. We emphasize, however, that our decision in this regard
is based solely on the indefmiteness of the claimed subject matter, and does
not reflect on the adequacy of the evidence or reasoning applied by the
Examiner.
“sensing electrodes interfacing with low voltage
and high impedance circuitry ”
The Examiner finds that prior-filed Application Nos. 11/981,410;
10/949,877; 09/990,045; and 60/252,811 fail to provide adequate written
descriptive support or enablement for “sensing electrodes interfacing with
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low voltage and high impedance circuitry” “[i]n regards to claims 49 and
50.” Final Act. 3.6
As we sustain the Examiner’s rejection of claim 50 under 35 U.S.C.
§112, second paragraph, as indefinite based on the phrase “high voltage and
low impedance circuitry” being inferentially included (see infra), we find it
imprudent to speculate as to whether the prior-filed Application Nos.
11/981,410; 10/949,877; 09/990,045; and 60/252,811 provide adequate
written descriptive support or enablement for the this limitation so as to
entitle claim 50 to the benefit of the filing date of the prior-filed
applications.
Because we do not know the metes and bounds of claim 50 reciting
“high voltage and low impedance circuitry,” we cannot determine if the
subject matter of this claim is disclosed in prior-filed Application Nos.
11/981,410; 10/949,877; 09/990,045; and 60/252,811 in the manner
provided by 35 U.S.C. § 112, first paragraph, so as to entitle claim 50 to the
benefit of the prior-filed applications’ filing dates.
6 Dependent claim 49 recites that the “electrode [for delivering an electrical
therapy to the heart of a patient in a cardioverter-defibrillator] interfaces
with high voltage and low impedance circuitry.” Appeal Br. 67 (Claims
App.). We agree with Appellants that “claim 49 does not recite sensing
electrodes interfacing with low voltage and high impedance circuitry” and
that “[t]he Examiner has not asserted . . . that a person skilled in the art
would not recognize in Appellants’ disclosure a description of the . . .
recitation of claim 49.” Id. at 41 n. 142. Consequently, we find that the
Examiner has failed to adequately show that claim 49 is not entitled to the
priority of the filing dates of Application Nos. 11/981,410; 10/949,877;
09/990,045; and 60/252,811 based on lack of “support for sensing electrodes
interfacing with low voltage and high impedance circuitry.” Final Act. 3.
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Consequently, we are constrained to find that the Examiner has failed
to adequately show that claim 50 is not entitled to the priority of the filing
dates of Application Nos. 11/981,410; 10/949,877; 09/990,045; and
60/252,811 based on lack of “support for sensing electrodes interfacing with
low voltage and high impedance circuitry.” We emphasize, however, that
our decision in this regard is based solely on the indefmiteness of the
claimed subject matter, and does not reflect on the adequacy of the evidence
or reasoning applied by the Examiner.
“a concentrated electrically conductive surface defined about a surface of
the housing adapted to face the heart ”
Dependent claim 92 recites “[a] subcutaneous cardioverter-
defibrillator . . . further comprising: a concentrated electrically conductive
surface defined about a surface of the biocompatible housing [enclosing and
containing cardioversion-defibrillation circuitry] adapted to face the heart.”
Appeal Br. 70-71 (Claims App.). The Examiner finds that prior-filed
Application Nos. 11/981,410; 10/949,877; 09/990,045; and 60/252,811 fail
to provide adequate written descriptive support or enablement for “a
concentrated electrically conductive surface defined about a surface of the
housing adapted to face the heart” “[i]n regards to claim 92.” Final Act. 3.
Appellants argue that:
the prior-filed applications disclose that the surface of the can or
housing of the implantable pulse generator may be divided into
different portions, including a shocking surface on one side of
the housing that faces muscle tissue, and a different surface
including sensing electrodes on the opposite side of the housing,
which faces subcutaneous tissue. Because the housing is
configured to be implanted subcutaneously between the muscle
and subcutaneous tissue, the shocking surface that faces muscle
tissue, and is opposite the other surface that faces subcutaneous
tissue, is necessarily defined about a surface of the housing that
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is adapted to face the heart. Additionally, the shocking surface
is concentrated relative to the housing as a whole, because the
shocking surface is a defined portion of the housing, electrically
isolated from other portions of the housing, such that electrical
energy is concentrated or focused at the shocking surface of the
housing.
Appeal Br. 34 (citing Application No. 60/252,811, Figs. 1—4; 3:19-26, A-6).
The Examiner replies that “the claimed phrase ... is not directed to
how the electrical energy is concentrated, but directed to the electrically
conductive surface.” Ans. 6. We find Appellants’ argument to be
persuasive in that the concentration of electrical energy at a particular
defined portion of the surface of the housing, relative to the housing as a
whole, makes it reasonable for that portion of the surface of the housing to
be considered a concentrated electrically conductive surface.
Consequently, we find that the Examiner has failed to adequately
show that claim 92 is not entitled to the priority of the filing dates of
Application Nos. 11/981,410; 10/949,877; 09/990,045; and 60/252,811
based on lack of “support for a concentrated electrically conductive surface
defined about a surface of the housing adapted to face the heart.” Final
Act. 3.
Rejection I
Indefiniteness
The Examiner rejects claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-
71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, and 120-128 under 35
U.S.C. § 112, second paragraph, as indefinite for failing to particularly point
out and distinctly claim the subject matter which the applicant regards as the
invention. Final Act. 4-5. In determining whether a claim is definite under
35 U.S.C. § 112, second paragraph, “[t]he USPTO, in examining an
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application, is obliged to test the claims for reasonable precision.” In re
Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014). “[A] claim is indefinite
when it contains words or phrases whose meaning is unclear.” Id. at 1322
(citing MPEP § 2173.05(e)).
Claims 1, 2, 4 6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100,
102-104, 110, 111, 116, and 120-122
The Examiner finds that “it is unclear what a ‘transvenous,
intracardiac, or epicardiaf electrode exactly is, since all electrodes are
conductive pieces of material.” Final Act. 4.7 Appellants argue that the
identified phrase is “no less definite, nor less able to particularly point out
and distinctly claim the subject matter which Appellants regard as the
invention than [it was] in the applications that granted as the Bardy . . .
patent[]” from which the claims were copied. Appeal Br. 47 (citing Andrew
Corp. v. Gabriel Electronics, 847 F.2d 819, 822 (Fed. Cir. 1988)).
We understand the problem with the identified language of the claims
to be that it is unclear, for example, in the context of independent claims 1
and 11, whether the subcutaneous electrode array coupled to the implantable
pulse generator to deliver electrical therapy to the patient without a
transvenous, intracardiac, or epicardial electrode is intended to be a specific
structural limitation on the electrode array (e.g., the subcutaneous electrode
array lacks a structurally unique electrode used exclusively for transvenous,
intracardiac, or epicardial placement) or a functional limitation of the
7 The Examiner does not identify which claims are rendered indefinite
because of the identified phrase, but it appears that claims 1, 2, 4-6, 11, 15-
35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116,
121, and 122 are implicated by virtue of their inclusion, either directly or
indirectly, of the identified phrase (or similar phrase).
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electrode array, (e.g., the subcutaneous electrode array is functional to
deliver electrical therapy to the patient without the need to place any
electrode transvenously, intracardially, or epicardially). Similar problems
arise with respect to independent claims 15-23 and 37, which recite “the
absence of a transvenous, intracardiac, or epicardial electrode”; or “without
a transvenous, intracardiac or epicardial electrode.” Stated differently, it is
not clear on the evidentiary record before us precisely why or when an
electrode may be characterized as a “subcutaneous electrode” as compared
to a “transvenous, intracardiac, or pericardial electrode.” One possibility is
that an electrode may be characterized as being of one of the mentioned
types based on its placement in the patient. In such a case the potential
infringer would not know whether the claim is infringed until the method of
using the system is practiced. Including what effectively amounts to a
requirement to practice a particular method in a system claim seemingly
directed to a machine, a different statutory class of subject matter, obfuscates
the scope of the claim and renders it unclear to the potential infringer
precisely when the claim is infringed. Another possible interpretation of the
language in question is that there are some inherent structural meanings that
are implied by using terms like “subcutaneous,” “transvenous,”
“intracardiac,” and “pericardial” when those terms modify the term
“electrode.” The problem with this possibility is that, on the record
presently before us, no such meanings are evident. See Final Act. 15 (Where
the Examiner is unable to discern what structurally distinguishes electrodes
for transvenous, intracardiac, and epicardial placement from electrodes for
subcutaneous placement, stating, “both are merely conductive pieces of
metal.”) (emphasis omitted). Further clarification of the meaning of these
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terms is required before we can proceed to analyze this limitation for
purposes of satisfying the disclosure requirements.
As to the case law cited by Appellants, that case dealt with different
claim language and is not dispositive on the issue before us. Andrew Corp.,
847 F.2d at 821 (court finding that the terms “substantially equal” and
“closely approximate” were “ubiquitous in patent claims”). Moreover,
Andrew Corp. was a patent infringement case, where claims are entitled to a
presumption of validity, whereas no such presumption attaches in
prosecution of patent applications before the U.S. Patent and Trademark
Office. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). “An essential
purpose of patent examination is to fashion claims that are precise, clear,
correct, and unambiguous. Only in this way can uncertainties of claim scope
be removed, as much as possible, during the administrative process.” In re
Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
Accordingly, we do not find that the Examiner erred in finding that
the scope of the claim is not reasonably ascertainable by those skilled in the
art. We sustain the rejection of claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60,
63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, 121, and 122 under
35 U.S.C. § 112, second paragraph, based on the inclusion of the phrase
“transvenous, intracardiac, or epicardial electrode” either directly or
indirectly.
The Examiner further determines that “[i]n claim 120, ‘without
venous or epicardial access’ is vague since this is directed to how the lead is
implanted and not directed to a[] particular structure of the lead.” Final Act.
4. The Examiner also finds the phrases (i) “electrical therapy” in claims 16,
17, 19, 21, 22, 37, 90, 120; (ii) “an electrically isolated connector block” in
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claims 17, 19, 20-22, 120; (iii)“intemal interfacing means” of claim 18; (iv)
“anti-arrythmic waveform” of claim 20; (v) “sensing circuitry” of claims 21,
22, 91; and (vi) “high voltage and low impedance circuitry” of claims 49, 50
to be vague and/or inferentially included. Id. at 5. The Examiner also finds
the phrases (i) “an autonomously detected arrhythmic condition” of claims
18, 20-22 and (ii) “upon detection of a certain event” of claims 45, 46, 82,
83, to make the claim incomplete for omitting an element to do this. Id.
Despite differences in the limitations in question, Appellants rely on
the same argument based on Andrew Corp. case law that we found
unpersuasive in connection with the rejection based on the inclusion of the
phrase “transvenous, intracardiac, or epicardial electrode.” Appeal Br. 45-
47. It is noted that arguments must address the Examiner’s action with
particularity. 37 C.F.R. § 41.37(c)(l)(iv)(“The arguments shall explain why
the examiner erred as to each ground of rejection contested by appellant”).
The Board will not advocate for Appellants by scouring the record to see if
the Board can identify some flaw in the Examiner’s findings of fact,
articulated reasoning, or legal conclusions. See, e.g., Halliburton Energy
Services, Inc. v. M-ILLC, 514 F.3d 1244, 1250 n.2 (Fed. Cir. 2008).
Accordingly, we do not find that the Examiner erred in finding that the
scope of the claim is not reasonably ascertainable by those skilled in the art,
and we sustain the rejection of claims 16-22, 37, 45, 46, 49, 50, 82, 83, 90,
91, 120 under 35 U.S.C. § 112, second paragraph, based on the inclusion of
the various phrases identified above.
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Claims 123—125
Claims 123-125 recite “the absence of a transvenously-implanted
electrode, an intracardially-implanted electrode, or an epicardially-implanted
electrode.” Appeal Br. 73-75 (Claims App.). The Examiner determines that
“claims 123-12[5] have limitations directed to ‘implanted’ electrodes and
how the lead is implanted and not to a particular structural limitation.” Final
Act. 5. Appellants argue that “claim language that is not a structural
limitation is not per se indefinite.” Appeal Br. 48. Appellants further argue
that the applicable standard is not whether “the Examiner believes the claim
could be more clear,” but rather whether the claim is reasonably precise. Id.
Similar to analysis of the phrase “transvenous, intracardiac, or
epicardial electrode,” we find it unclear whether the phrase “the absence of a
transvenously-implanted electrode, an intracardially-implanted electrode, or
an epicardially-implanted electrode” is intended to be a specific structural
limitation on the cardioverter-defibrillator (e.g., it lacks a structurally unique
electrode used exclusively for transvenous, intracardiac, or epicardial
implantation) or a functional limitation of the cardioverter-defibrillator (e.g.,
it is functional to deliver electrical cardioversion-defibrillation energy
without the need to implant any electrode transvenously, intracardially, or
epicardially).
Accordingly, we do not find that the Examiner erred in concluding
that the scope of the claim is not reasonably ascertainable by those skilled in
the art. We sustain the rejection of claims 123-125 under 35 U.S.C. § 112,
second paragraph, based on the inclusion of the phrase “the absence of a
transvenously-implanted electrode, an intracardially-implanted electrode, or
an epicardially-implanted electrode.”
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Claims 126—128
Claim 126 recites that “each electrode of the subcutaneous
implantable cardioverter-defibrillator ... is configured to be implanted
subcutaneously on one of the chest, left chest, back, or side of a patient.”
Appeal Br. 75 (Claims App.). Claims 127 and 128 recite similar limitations.
Id. at 75-76. The Examiner determines that “claims 12[6]—128 have
limitations directed to ‘implanted’ electrodes and how the lead is implanted
and not to a particular structural limitation.” Final Act. 5. Appellants argue
that “the configuration of the electrodes to be implanted as recited in claims
126-128 is a structural limitation of the electrodes.” Appeal Br. 48^19.
We agree that the phrase “configured to” denotes a state of
configuration that makes possible the subcutaneous implantation on one of
the chest, left chest, back, or side of patient. We do not consider the
identified claim phrasing to raise the same questions regarding the scope of
the claim as the related previously-identified phrasing of the earlier claims.
Accordingly, we find that the Examiner erred in concluding that the
scope of the claim is not reasonably ascertainable by those skilled in the art.
We do not sustain the rejection of claims 126-128 under 35 U.S.C. § 112,
second paragraph, based on the inclusion of the phrase “electrode . . .
configured to be implanted subcutaneously on one of the chest, left chest,
back, or side of a patient.”
Rejection II
Anticipation by Bardy
Claims 1, 2, 4 6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100,
102-104, 110, 111, 116, and 120-125
Claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92,
100, 102-104, 110, 111, 116, and 120-125 stand rejected under 35 U.S.C.
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§ 102(e) as anticipated by Bardy. Final Act. 7. We do not sustain the
Examiner’s rejection of these claims. For the reasons discussed above,
claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100,
102-104, 110, 111, 116, and 120-125 are indefinite. Before a proper review
of this rejection can be performed, the subject matter encompassed by the
claims on appeal must be reasonably understood without resort to
speculation. Therefore, since these claims fail to satisfy the requirements of
35 U.S.C. § 112, second paragraph, we are constrained to reverse the prior
art rejection because it necessarily is based on speculative assumptions as to
the scope of the claims. See In re Steele, 305 F.2d at 862-63 (CCPA 1962).
We emphasize, however, that our decision in this regard is based solely on
the indefiniteness of the claimed subject matter, and does not reflect on the
adequacy of the prior art evidence applied in support of the rejection.
Claims 126—128
Claims 126-128 also stand rejected under 35 U.S.C. § 102(e) as
anticipated by Bardy. Final Act. 7. These claims do not include any of the
phrasing that the Examiner found lacked support in the prior-filed
applications. See Final Act. 2-3; Appeal Br. 75-76 (Claims App.). Because
the Examiner has failed to adequately show that claims 126-128 are not
entitled to the priority of the filing dates of Application Nos. 11/981,410;
10/949,877; 09/990,045; and 60/252,811, the Examiner has failed to show
that Bardy qualifies as prior art under 35 U.S.C. § 102(e). Therefore, we
cannot sustain the rejection of claims 126-128 as anticipated by Bardy.
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Appeal 2016-002486
Application 13/476,940
Rejection III
Derivation
Claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92,
100, 102-104, 110, 111, 116, and 120-128 stand rejected under 35 U.S.C.
§ 102(f) because Appellants did not invent the subject matter claimed. Final
Act. 7. The basis for the Examiner’s rejection is that Bardy has an earlier
effective filing date and meets the limitations of the claims. Id.
Our finding that the Examiner has failed to adequately show that
claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100,
102-104, 110, 111, 116, and 120-125 are not entitled to the priority of the
filing dates of Application Nos. 11/981,410; 10/949,877; 09/990,045; and
60/252,811 because of the indefmiteness of the claimed subject matter also
constrains us to reverse the rejection of these claims under 35 U.S.C.
§ 102(f) because it necessarily is based on speculative assumptions as to the
scope of the claims when analyzing priority.
As to claims 126-128, the Examiner has failed to adequately show
that these claims are not entitled to the priority of the filing dates of
Application Nos. 11/981,410; 10/949,877; 09/990,045; and 60/252,811
because these claims do not include any of the phrasing that the Examiner
found lacked support in the prior-filed applications. See Final Act. 2-3;
Appeal Br. 75-76 (Claims App.). This is dispositive as to the rejection of
these claims under 35 U.S.C. § 102(f).
Rejections IV VI
Anticipation by, or Obviousness over, Fischell
(Either Alone or With Other References)
The Examiner rejects claims 1, 2, 5, 11, 16-18, 37, 42, 43, 48, 51, 79,
80, 84, 90-92, 100, 103, 104, 111, 120, and 123-128 under 35 U.S.C.
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Application 13/476,940
§ 102(e) as anticipated by Fischell. Final Act. 8. The Examiner also rejects
claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100,
102-104, 110, 111, 116, and 123-128 under 35 U.S.C. § 103(a) as
unpatentable over Fischell and Dahl. Id. at 9-14. The Examiner rejects
claims 121 and 122 under 35 U.S.C. § 103(a) as unpatentable over Bardy or
over Fischell, either alone or in view of Dahl. Id. at 14.
We do not sustain the Examiner’s rejections of claims 1, 2, 4-6, 11,
15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111,
116, and 120-125. For the reasons discussed above, these claims are
indefinite. Before a proper review of these rejections can be performed, the
subject matter encompassed by the claims on appeal must be reasonably
understood without resort to speculation. Therefore, since these claims fail
to satisfy the requirements of 35 U.S.C. § 112, second paragraph, we are
constrained to reverse the prior art rejections because they necessarily are
based on speculative assumptions as to the scope of the claims. See In re
Steele, 305 F.2d at 862-63 (CCPA 1962). We emphasize, however, that our
decision in this regard is based solely on the indefiniteness of the claimed
subject matter, and does not reflect on the adequacy of the prior art evidence
applied in support of the rejections.
With respect to claims 126-128, we are not precluded from
addressing the prior art rejections because we do not sustain the rejection of
claims 126-128 under 35 U.S.C. § 112, second paragraph, as indefinite.
Thus, we need not speculate about the meaning of the language of the claims
to consider the merits of the rejections under 35 U.S.C. § 102(b) and
35 U.S.C. § 103(a). Appellants’ sole argument as to the prior art rejection is
that the “claims are no less novel when presented in the present application
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Application 13/476,940
by Appellants . . . than they were when presented in the . . . granted Bardy
. . . patents” from which they were copied. Appeal Br. 51, 52. The
allowability of other patents is irrelevant to the merits of the Examiner’s
rejection in this case and does not persuade us of error by the Examiner.
See, e.g., In re Gyurik, 596 F.2d 1012, 1016 n. 15 (CCPA 1979) (“Each case
is determined on its own merits. In reviewing specific rejections of specific
claims, this court does not consider allowed claims in other applications or
patents.”).
For the foregoing reasons, we do not find that the Examiner erred in
finding that Fischell anticipates claims 126-128 or in concluding that
Fischell and Dahl render obvious claims 126-128. We sustain the rejection
of claims 126-128 under 35 U.S.C. § 102(b) as anticipated by Fischell and
the rejection of claims 126-128 under 35 U.S.C. § 103(a) as unpatentable
over Fischell and Dahl.
DECISION
The Examiner’s decision that prior-filed Application Nos. 11/981,410;
10/949,877; 09/990,045; and 60/252,811 do not provide adequate written
descriptive support or enablement for the claimed invention such that one or
more of the present claims are not entitled to the benefit of the filing date of
the prior-filed applications is reversed.8
8 The Examiner does not identify which claims purportedly are not entitled
to the benefit of the filing date of the prior-filed applications, but it appears
that claims 1, 2, 4-6, 11, 15-35, 37, 42-51, 60, 63-71, 74, 79-84, 90-92,
100, 102-104, 110, 111, 116, and 121-125 are implicated by virtue of their
inclusion, either directly or indirectly, of the language identified as lacking
support in the Priority Section of the Final Action (i.e., ‘“without a
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The Examiner’s decision to reject claims 1, 2, 4-6, 11, 15-35, 37, 42-
51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, and 120-125
under 35 U.S.C. § 112, second paragraph, as indefinite for failing to
particularly point out and distinctly claim the subject matter which the
applicant regards as the invention is affirmed.
The Examiner’s decision to reject claims 126-128 under 35 U.S.C.
§112, second paragraph, as indefinite for failing to particularly point out
and distinctly claim the subject matter which the applicant regards as the
invention is reversed.
The Examiner’s decision to reject claims 1, 2, 4-6, 11, 15-35, 37, 42-
51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, and 120-128
under 35 U.S.C. § 102(e) as anticipated by Bardy is reversed.
The Examiner’s decision to reject claims 1, 2, 4-6, 11, 15-35, 37, 42-
51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, and 120-128
under 35 U.S.C. § 102(f) because Appellants did not invent the subject
matter claimed is reversed.
The Examiner’s decision to reject claims 1, 2, 5, 11, 16-18, 37, 42,
43, 48, 51, 79, 80, 84, 90-92, 100, 103, 104, 111, 120, and 123-125 under
35 U.S.C. § 102(e) as anticipated by Fischell is reversed.
The Examiner’s decision to reject claims 126-128 under 35 U.S.C.
§ 102(e) as anticipated by Fischell is affirmed.
The Examiner’s decision to reject claims 1, 2, 4-6, 11, 15-35, 37, 42-
51, 60, 63-71, 74, 79-84, 90-92, 100, 102-104, 110, 111, 116, 120, and
transvenous, intracardiac, or epicardial electrode’ or similar limitation”;
“sensing electrodes interfacing with low voltage and high impedance
circuitry”; or “a concentrated electrically conductive surface defined about a
surface of the housing adapted to face the heart”). Final Act. 3.
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Application 13/476,940
123-125 under 35 U.S.C. § 103(a) as unpatentable over Fischell and Dahl is
reversed.
The Examiner’s decision to reject claims 126-128 under 35 U.S.C.
§ 103(a) as unpatentable over Fischell and Dahl is affirmed.
The Examiner’s decision to reject claims 121 and 122 under 35 U.S.C.
§ 103(a) as unpatentable over Bardy or over Fischell, either alone or in view
of Dahl 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)(l)(iv).
AFFIRMED9
9 “The affirmance of the rejection of a claim on any of the grounds specified
constitutes a general affirmance of the decision of the examiner on that
claim, except as to any ground specifically reversed.” 37 C.F.R.
§ 41.50(a)(1).
21