Ex Parte Mullen et al

Patent Trial and Appeal Board

May 9, 2017

13610163 (P.T.A.B. May. 9, 2017)

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.
13/610,163 09/11/2012 Thomas J. Mullen P0025111.USC2/LG10126.L33 4567
27581 7590 05/11/2017
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/11/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS J. MULLEN, JOHN E. BURNES, and
ALEKSANDRE T. SAMBELASHVILI
Appeal 2015-007367
Application 13/610,163
Technology Center 3700
Before LYNNE H. BROWNE, ERIC C. JESCHKE, and
GORDON D. KINDER, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Thomas J. Mullen et al. (“Appellants”) seek review under 35 U.S.C.
§ 134(a) of the Examiner’s decision, as set forth in the Final Office Action
dated August 1, 2014 (“Final Act.”), and as further explained in the
Advisory Action dated November 6, 2014 (“Adv. Act.”), rejecting claims
10-12 and 14.1 We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE, pro forma, and enter NEW GROUNDS OF
REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b).
1 Appellants identify Medtronic, PLC as the real party in interest.
Appeal Br. 3.
Appeal 2015-007367
Application 13/610,163
BACKGROUND
The disclosed subject matter “relates to apparatus and methods for
automatically adjusting an AV interval during single ventricle pacing to
efficiently deliver fusion-based cardiac resynchronization therapy (CRT) via
ventricular pre-excitation.” Spec. 2,11. 7—10. Claim 10, the sole
independent claim, is reproduced below, with emphasis added:
10. A method of ventricular pacing including
automated adjustment of atrio-ventricular (AV)
pacing delay intervals and intrinsic AV nodal
conduction testing comprising performing the
following steps:
(a) measuring an intrinsic atria-ventricular
(PR) interval based upon timing of atrial
depolarizations and depolarizations of a first
ventricular chamber;
(b) responsive to the measured intrinsic PR
interval falling within a defined range for said
ventricular chamber, storing the measured intrinsic
PR interval in a memory structure; and
(c) decrementing the stored intrinsic PR
interval to define pre-excitation intervals (PEI)
following subsequent atrial depolarizations;
(d) delivering fusion pacing pulses to a
second ventricle on expirations of the PEI;
(e) detecting loss of capture of the second
ventricle; and responsive to the detected loss of
capture, repetition of steps a), b), c) and d).
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REJECTIONS
1. Claims 10 and 14 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Van Gelder (US 2005/0209650 Al, published Sept. 22,
2005), or, in the alternative, under 35 U.S.C. § 103(a) as unpatentable over
Van Gelder.2
2. Claims 11 and 12 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Van Gelder and Stahmann (US 2005/0080461 Al,
published Apr. 14, 2005).
DISCUSSION
Rejections 1 and 2
For the reasons discussed below, certain language in independent
claim 10 renders indefinite that claim (and, therefore, dependent claims 11,
12, and 14 as well). The prior art rejections of those claims must fall, pro
forma, because they are based on speculative assumption as to the meaning
of the claims.3 See In re Steele, 305 F.2d 859, 862-63 (CCPA 1962); Ex
parte Miyazaki, 89 USPQ2d 1207, 1221 (BPAI 2008) (precedential).
2 The Examiner refers to this reference as both “Van Gelder” and
“Gelder.” See, e.g., Ans. 2.
3 See, e.g., Ans. 2 (“The examiner notes that the lack of clarity
mentioned in the remarks is not based on a lack of understanding of the prior
art, but rather is derived from the fact that the present application fails to
accurately define/describe a ‘defined range’ to support the line of argument
presented in the remarks.”).
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Application 13/610,163
New Grounds of Rejection
A. Under 35U.S.C. § 112, second paragraph
We enter a new ground of rejection of claims 10-12 and 14 under
35 U.S.C. § 112, second paragraph, for failing to particularly point out and
distinctly claim the subject matter regarded as the invention. A claim fails to
comply with 35 U.S.C. § 112, second paragraph, “when it contains words or
phrases whose meaning is unclear.” In re Packard, 751 F.3d 1307, 1310,
1314 (Fed. Cir. 2014) (approving, for pre-issuance claims, the standard from
MPEP § 2173.05(e)). Claim 10 recites “responsive to the measured intrinsic
PR interval falling within a defined range for said ventricular chamber,
storing the measured intrinsic PR interval in a memory structure.” Appeal
Br. 9 (Claims App.) (emphasis added).4
The Specification does not use the phrase “defined range.” In the
Reply Brief, Appellants take the position that “defined range” means “the
range of physiologically acceptable PR interval durations.” Reply Br. 4.
Even applying this proposed construction, however, the scope of the
limitation at issue remains unclear. The phrase “physiologically acceptable”
is a term of degree. See, e.g., Interval Licensing LLC v. AOL, Inc., 766 F.3d
1364, 1370 (Fed. Cir. 2014) (identifying “unobtrusive manner” as a term of
degree); Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357,
1372 (Fed. Cir. 2008) (“Here, the term ‘anaerobic condition’ is in effect a
term of degree because its bounds depend on the degree of oxygen
deficiency.”). Our reviewing court has reaffirmed that terms of degree are
not “inherently indefinite” and that “[cjlaim language employing terms of
degree has long been found definite where it provided enough certainty to
4 We will refer to this as the “limitation at issue.”
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Application 13/610,163
one of skill in the art when read in the context of the invention.” Interval
Licensing, 766 F.3d at 1370 (citations omitted). We view this guidance as
applicable either when the term of degree is recited in the claim at issue or,
as here, when present in the proposed construction of language in the claim.
To satisfy the statute, “[t]he claims, when read in light of the specification
and the prosecution history, must provide objective boundaries for those of
skill in the art.” Id. at 1371 (citing Nautilus, Inc. v. Biosig Instruments, Inc.,
134 S. Ct. 2120, 2130 & n.8 (2014) (additional citation omitted).
The Specification uses “physiologically acceptable” in one sentence:
“Thus, in the event that the AV conduction test reveals a physiologically
acceptable intrinsic PR interval then storing the physiologically acceptable
PR interval in a memory structure (e.g., a median P-R from one or more
cardiac cycles).” Spec. 10,11.26—29. The Specification also provides “In
the event that the AV conduction test reveals an AV conduction block
condition or if unacceptably long PR intervals are revealed then a pacing
mode-switch to a bi-ventricular (Bi-V) pacing mode occurs and the
magnitude of the AVEI is increased.” Id. at 10,1. 29 — 11,1. 3.5 In the
“Summary of Claimed Subject Matter” section of the Appeal Brief,
Appellants provide an exemplary citation for the limitation at issue: “See,
e.g. Appellants’] Disclosure, last paragraph on page 23, lines 22—29 and
lines 1—16 of page 24, block 402, FIG. 4, block 502, FIG. 5, and FIG. 3.”
Appeal Br. 3 n.l. We determine that none of these cited disclosures
demonstrates that the limitation at issue provides “objective boundaries for
5 “AVEI” refers to atrio-ventricular Evaluation Interval. See Spec. 10,
11. 20-23.
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Application 13/610,163
those of skill in the art” in light of the Specification and prosecution history.
See Interval Licensing, 766 F.3d at 1371.
After proposing to construe “defined range” as “the range of
physiologically acceptable PR interval durations,” Appellants state:
While the specific endpoints of this range may vary from patient
to patient and the physician programming the device may choose
different endpoints for different patients, there is no doubt that
any physician using the disclosed device would be able to
determine appropriate endpoints. Similarly, even if the device
does not have the defined range programmable for each
individual patient, the physiology of the heart is well enough
known to cardiac pacemaker manufacturers that any
manufacturer could pre-select a range corresponding to the
physiologically acceptable range of PR intervals.
Reply Br. 4 (emphasis added). Appellants identify no evidence, however, to
support these positions. See In re Pearson, 494 F.2d 1399, 1405 (CCPA
1974) (“Attorney’s argument in a brief cannot take the place of evidence.”).
Although the Examiner does, as noted by Appellants, use the phrase
“physiologically acceptable” in the Final Office Action and the Answer (see
Reply Br. 4), we do not view that as necessarily demonstrating that “defined
range” is not indefinite. Here, the Examiner uses “physiologically
acceptable” in the context of the stated position that “a patient who is alive
. . . necessarily ha[s PR interval duration] values in a physiologically
acceptable range.” Ans. 3; see also Final Act. 4 (“Regardless, the examiner
interprets the ‘defined range’ as being equivalent to the ‘physiologically
acceptable’ range of the PR interval. The prior art of [Van] Gelder measures
the cardiac intervals from a patient which is alive and functioning,
necessarily requiring that their PR interval is ‘physiologically acceptable.’”).
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In response, Appellants do not clarify the scope of “physiologically
acceptable,” but rather, argue that the Examiner’s position is incorrect. See
Appeal Br. 5; Reply Br. 5; see also Ans. 3 (stating that, in the Appeal Brief,
Appellants “are simply attacking the prior art and the examiner’s
interpretation, without presenting any concrete, valid, or convincing
arguments as to how the ‘defined range’ of the present invention is to be
interpreted or what it actually is”). In the end, “[i]t is the applicants’ burden
to precisely define the invention, not the PTO’s.” In re Morris, 111 F.3d
1048, 1056 (Fed. Cir. 1997) (also stating that § 112, second paragraph “puts
the burden of precise claim drafting squarely on the applicant”).
For these reasons, we conclude that claim 10 is indefinite. Dependent
claims 11, 12, and 14 fail to provide additional clarity as to the scope of the
“defined range” recited in claim 10, and therefore are also indefinite.
B. Under 35 U.S.C. § 112, first paragraph
We enter a new ground of rejection of claims 10—12 and 14 under
35 U.S.C. § 112, first paragraph, based on a lack of enablement. “[T]o be
enabling, the specification of a patent must teach those skilled in the art how
to make and use the full scope of the claimed invention without ‘undue
experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)
(quoting In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991)). Our reviewing
court has set forth factors to be considered in determining whether a
disclosure satisfies the enablement requirement:
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth of
the claims.
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In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Having considered the evidence as a whole in light of all of these
factors, we conclude that the Specification does not teach one skilled in the
art how to make and use the full scope of the claimed invention without
undue experimentation. Specifically, the Specification does not enable the
limitation requiring “responsive to the measured intrinsic PR interval falling
within a defined range for said ventricular chamber, storing the measured
intrinsic PR interval in a memory structure.” Appeal Br. 9 (Claims App.).
We now highlight certain factors from In re Wands.
We first address factors 2 and 7: the amount of direction or guidance
presented and the predictability or unpredictability of the art (respectively).
Although we see no evidence that the relevant art is unpredictable, as
discussed above (see infra § A), the Specification here provides insufficient
direction or guidance regarding the “defined range.” Moreover, even
applying Appellants’ proposed construction of “defined range”—“the range
of physiologically acceptable PR interval durations” (Reply Br. 4)—for the
reasons discussed above (see infra § A), the Specification also provides
insufficient direction or guidance regarding that phrase. See also Union Pac.
Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 690—91 (Fed. Cir.
2001) (affirming determination of a lack of enablement where the
Specification did not disclose certain programming details used to perform
the claimed method, and the record showed that a person of ordinary skill in
the art would not understand how to perform certain aspects of the method).
We turn now to factor 3: the presence or absence of working
examples. Based on our review of the Specification, we do not discern
evidence of any working examples that teach one skilled in the art how to
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make and use the full scope of the claimed invention (including the
limitation at issue) without undue experimentation.
We turn now to factors 5 and 6: the state of the prior art and the
relative skill of those in the art (respectively). Although a patent need not
teach, and preferably omits, what is well known in the art (see In re
Buchner, 929 F.2d 660, 661 (Fed. Cir. 1991)), as discussed above (see infra
§ A), Appellants identify no evidence of record to support the assertions
that, as of the filing date, one of ordinary skill in the art would have
understood the scope of the “defined range” and been able to make and use
the claimed invention. See Reply Br. 4.
In view of the lack of direction or guidance provided by the
Specification, the quantity of experimentation necessary to make and use the
invention (factor 1) cannot be determined.
Weighing the Wands factors against Appellants’ assertion that one of
ordinary skill in the art would understand how to make and use the invention
(Reply Br. 4), we determine that the factors demonstrating lack of
enablement outweigh Appellants’ arguments. For these reasons, we
conclude that claim 10, and claims 11, 12, and 14, which depend from claim
10, are invalid for lack of enablement.
DECISION
We (1) REVERSE, pro forma, the decision to reject claims 10 and 14
under 35 U.S.C. § 102(b) as anticipated by Van Gelder, (2) REVERSE, pro
forma, the decision to reject claims 10 and 14 under 35 U.S.C. § 103(a) as
unpatentable over Van Gelder, and (3) REVERSE, pro forma, the decision
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to reject claims 11 and 12 under 35 U.S.C. § 103(a) as unpatentable over
Van Gelder and Stahmann.
We enter (1) a NEW GROUND OF REJECTION for claims 10-12
and 14 under 35 U.S.C. § 112, second paragraph, for failure to particularly
point out and distinctly claim the subject matter regarded as the invention
and (2) a NEW GROUND OF REJECTION for claims 10-12 and 14 under
35 U.S.C. § 112, first paragraph, based on a lack of enablement.
FINALITY OF DECISION
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
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Application 13/610,163
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
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).
REVERSED; 37 C.F.R, $ 41.50(b)
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