Ex Parte Giftakis et al

Patent Trial and Appeal Board

Jun 22, 2017

12359037 (P.T.A.B. Jun. 22, 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.
12/359,037 01/23/2009 Jonathon E. Giftakis 1023-811US01/P0033057.01 3649
71996 7590 06/26/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
NGUYEN, HUONG Q
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
06/26/2017 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):
pairdocketing @ ssiplaw.com
medtronic_neuro_docketing @ cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHON E. GIFTAKIS, NINA M. GRAVES,
JONATHAN C. WERDER, ERIC J. PANKEN, TIMOTHY J. DENISON,
KEITH A. MIESEL, and MICHELE H. HERZOG
Appeal 2015-007433
Application 12/359,037
Technology Center 3700
Before STEVEN D.A. McCARTHY, NATHAN A. ENGELS, and
ERIC C. JESCHKE, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jonathon E. Giftakis et al. (“Appellants”)1 seek review under
35 U.S.C. § 134(a) of the Examiner’s decision, as set forth in the Final
Office Action dated July 31, 2013 (“Final Act.”), and as further explained in
the Advisory Actions dated October 30, 2013, and January 16, 2014,
rejecting claims 1, 3—14, 17—20, 22—34, and 36-49. Claims 2 and 21 have
been cancelled. The Examiner objects to claims 15, 16, and 35 but indicates
that they would be allowable if rewritten in independent form. Final Act.
1 Appellants identify Medtronic, Inc. as the real party in interest.
Appeal Br. 3.
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Application 12/359,037
11. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm in part.
BACKGROUND
The disclosed subject matter “relates to patient monitoring, and, more
particularly, to collecting information to evaluate a patient condition.” Spec.
12. Claims 1, 20, and 39 are independent. Claim 1 is reproduced below,
with emphasis added:
1. A method comprising:
sensing intracranial pressure of a patient;
determining, with one or more processors, a
trend in the sensed intracranial pressure over time;
determining, with the one or more
processors, a change in a seizure disorder of the
patient based on the determined trend; and
generating, with the one or more processors,
an intracranial pressure indication in response to
determining the change in the seizure disorder.
REJECTIONS
1. Claims 6 and 24 stand rejected under 35 U.S.C. § 112, second
paragraph, as failing to particularly point out and distinctly claim the subject
matter regarded as the invention.
2. Claims 1, 3—14, 20, 22—34, 39, 40, and 42-49 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over Miesel ’080 (US 6,248,080
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Bl, issued June 19, 2001) and Dorfmeister (US 5,995,868, issued Nov. 30,
1999).2
3. Claims 17—19, 36—38, and 41 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Miesel ’080, Dorfmeister, and Miesel ’118
(US 2007/0255118 Al, published Nov. 1, 2007).
DISCUSSION
Rejection 1 — The rejection of claims 6 and 24
under 35 U.S.C. § 112, second paragraph
The Examiner rejected claims 6 and 24, stating that “the term ‘about’
is a relative term which renders the claim[s] indefinite.” Final Act. 3.3
According to the Examiner, “[t]he term ‘about’ is not defined by the claim,
the specification does not provide a standard for ascertaining the requisite
degree, and one of ordinary skill in the art would not be reasonably apprised
of the scope of the invention thus rendering the metes and bounds of the
invention unclear.” Id.
Appellants argue that the Examiner has “failed to provide any support
for the assertion that ‘one of ordinary skill in the art would not be reasonably
apprised of the scope of the invention [of claims 6 and 24]’” or the
“assertion that Appellants] must define the term ‘about’ in claims 6 and 24,
2 Although the Examiner listed claims 1—14 and 42 in the summary
paragraph for Rejection 2 (Final Act. 4,19), the Examiner discussed claims
1, 3—14, 20, 22—34, 39, 40, and 42-49 in the body of the Rejection. See id.
at 4—10. As such, we consider the list in the summary paragraph as a
typographical error.
3 Claims 6 and 24 depend from claims 42 and 45 respectively, with
each adding “wherein the threshold value is between about 15 millimeters of
mercury (mmHg) and about 20 mmHg.” Appeal Br. 28, 32 (Claims App.).
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or ‘provide a standard for ascertaining the requisite degree’ in the
specification in order for claims 6 and 24 to satisfy the requirements of 35
U.S.C. § 112, second paragraph.” Appeal Br. 6—7. Appellants argue that the
Court of Appeals for the Federal Circuit has “asserted that, like the term
‘about’ the term ‘substantially’ is a descriptive term commonly used in
patent claims to ‘avoid a strict numerical boundary to the specified
parameter.’” Id. at 7 (citing Pall Corp. v. Micron Separations, Inc., 66 F.3d
1211, 1217 (Fed. Cir. 1995)). Appellants also argue that claims 6 and 24
include the term “about” “in order to accommodate minor variations that
may be appropriate to secure Appellants’] invention.” Id.
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) (per curiam)
(approving, for pre-issuance claims, the standard from MPEP § 2173.05(e)).
If an examiner “has initially issued a well-grounded rejection that identifies
ways in which language in a claim is ambiguous, vague, incoherent, opaque,
or otherwise unclear in describing and defining the claimed invention, and
thereafter the applicant fails to provide a satisfactory response,” the
examiner “can properly reject the claim as failing to meet the statutory
requirements of § 112(b),” the successor to § 112, second paragraph. Id. at
1311.
To the extent Appellants contend that the Examiner failed to set forth
a prima facie case, we disagree. See, e.g., Appeal Br. 7 (arguing that “the
Examiner failed to meet the burden of establishing that claims 6 and 24 are
indefinite”). The Office establishes a prima facie case of indefmiteness by
adequately explaining why the metes and bounds of a pending claim are not
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clear, thereby providing an applicant proper notice and the ability to
respond. See Packard, 751 F.3d at 1312; see also MPEP § 2173.02(III)(B)
(9th ed., Rev. 07.2105, Nov. 2015) (“The Office action must set forth the
specific term or phrase that is indefinite and why the metes and bounds are
unclear. Since a rejection requires the applicant to respond by explaining
why claim language would be recognized by a person of ordinary skill in the
art as definite or by amending the claim, the Office action should provide
enough information for the applicant to prepare a meaningful response.”).
Here, the Examiner clearly identified the language at issue and adequately
explained the perceived lack of clarity. See Final Act. 2—3.
A “satisfactory response” to a rejection under 35 U.S.C. § 112, second
paragraph, “can take the form of a modification of the language identified as
unclear, a separate definition of the unclear language, or, in an appropriate
case, a persuasive explanation for the record of why the language at issue is
not actually unclear.” Packard, 751 F.3d at 1311. Here, Appellants did not
modify or define the term “about,” and, for the reasons below, did not
persuasively explain why the term is not unclear. See Appeal Br. 6—7.
As an initial matter, we agree with Appellants and the Examiner that
the term “about” does not necessarily render a claim indefinite. Appeal Br.
7; Ans. 2. Appellants have not, however, identified any aspect of the
Specification (i.e., the claims or written description) or any other evidence of
record to support the assertion that “[o]ne having ordinary skill in the art, in
view of Appellants’] use of the term ‘about’ and Appellants’]
[Specification, would be able to discern the meaning of a threshold value
between about 15 mmHg and about 20 mmHg.” Appeal Br. 7; see Ans. 2
(stating that “the specification does not expressly define within what range
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of value is considered ‘about’ the cited value”); see also Amgen,
Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1218 (Fed. Cir. 1991) (affirming
a determination that “at least about” rendered claims indefinite when the
claim language, written description, prosecution history, and prior art did not
indicate the scope of the numerical range covered). Because Appellants
have not rebutted the Examiner’s prima facie case, we sustain the rejection
of claims 6 and 24 as indefinite.
Rejection 2 — The rejection of claims 1, 3—14, 20, 22—34,
39, 40, and 42—49 under 35 U.S.C. § 103(a)
Independent claim 1 recites the step of “determining, with one or
more processors, a trend in the sensed intracranial pressure over time.”
Appeal Br. 28 (Claims App.). Independent claim 20 recites “a processor
configured to determine a trend in the sensed intracranial pressure over
time.” Id. at 31. Independent claim 39 recites “means for determining a
trend in the sensed intracranial pressure over time.” Id. at 35. The Examiner
found that Miesel ’080 discloses these limitations. See Final Act. 4, 7.
Appellants argue the patentability of the three independent claims
based on arguments addressing claim 1. See Appeal Br. 16—17 (claim 20),
21 (claim 39). Appellants note that claim 1 “does not merely recite sensing
intracranial pressure” but, rather, “recites determining a trend in the sensed
intracranial pressure over time.” Id. at 9. Appellants argue that “[t]he
Examiner failed to establish that the applied art discloses determining a trend
in the intracranial pressure over time.” Id. For the reasons below, we agree.
We first construe the term “trend.” The Examiner states, “the term
‘trend,’ ... in the broadest reasonable sense, is simply a group of at least two
values.” Ans. 2; see also id. at 3 (discussing “the interpretation of the term
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‘trend’ [as] simply meaning a set of values”). The Examiner also states, “the
claims do not specify what is meant by said trend or how it is determined,
i.e. using mathematical calculations, etc., and thus . . ., is interpreted in the
broadest reasonable sense as simply being a random grouping of values over
time.” Id. at 3. The Examiner states that “[t]he trend could be a random
grouping and does not have to indicate any sort of relationship within the
pressure values” and, “[t]hus, all pressure signals would necessarily be in the
form of a trend.” Id. at 2. Appellants reply that “the Examiner’s
interpretation of the term ‘trend’, and the conclusions reached based on the
overly broad interpretation by the Examiner are in error.” Reply Br. 3.
We agree with Appellants that the Examiner has applied an
unreasonably broad construction of “trend,” when considering that claim
language in light of the Specification. See In re Bond, 910 F.2d 831, 833
(Fed. Cir. 1990). In the context here, we agree with Appellants that “trend”
in the limitation at issue means a “relationship.” See Reply Br. 4 (arguing
that “even if claim 1 does not recite a specific relationship or correlation
between the sensed intracranial pressure readings over time, the relationship
or correlation between the at least two values over time must actually be
determined in order to determine a trend in the sensed intracranial pressure
over time”). The written description supports this construction, providing
the example of an “increase” in pressure values as a “trend.” See, e.g., Spec.
11 109, 122. Moreover, in one example, the written description draws a
distinction between a “trend” and the “intracranial pressure values” on
which the trend is based. See id. 1118 (discussing how “processor 60
determines a trend based on each of the intracranial pressure values”).
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Applying this construction, we agree with Appellants that “[t]he
portion of Miesel ’080 cited by the Examiner [for the limitation at issue in
claim 1 ] does not mention determining a trend in intracranial pressure” but,
rather, “discusses the generation of intracranial pressure time-modulated
intervals.” Appeal Br. 9 (citing Miesel ’080, col. 14,11. 20-44). In other
words, the relied-upon passage discloses values in sensed intracranial
pressure over time but does not disclose determining a trend (i.e., a
relationship) in those values.
In the alternative, the Examiner states “Miesel ’080 discloses
identification of pressure values of interest (Col. 16: 60—63) which is also
considered a trend.” Ans. 2. To the extent the cited passage discloses
identifying intracranial pressure values of interest, the Examiner has not
shown why that satisfies the limitation at issue, which requires determining a
trend (i.e., a relationship) in those values over time.4
The Examiner also states that Dorfmeister “teach[es] that it is well
known in the art to determine a change in a seizure disorder of the patient
based on intracranial pressure (Col.9: 40-53), wherein said intracranial
pressure signals would necessarily be in the form of a trend over time.'1'’
Final Act. 4 (emphasis added). To the extent that the Examiner relies on
Dorfmeister, in the alternative, to address the limitation at issue in claim 1,
we agree with Appellants that “Dorfmeister fails to disclose or suggest that
such a trend is actually determined.” Appeal Br. 9.
As to independent claims 20 and 39, the Examiner has not shown that
the additional passages cited in Miesel ’080 disclose the limitations at issue
4 The cited passage appears to relate to intracranial temperature data
rather than intracranial pressure data. See Miesel ’080, col. 16,11. 57—63.
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under the proper construction of “trend.” See Final Act. 7 (citing Miesel,
abstract, col. 15,11. 51—62, and col. 16,11. 43—56).
For these reasons, we do not sustain the rejection of independent
claims 1, 20, and 39, and we also do not sustain the rejection of claims 3—14
and 42-44 (which depend from claim 1), claims 22—34 and 45—48 (which
depend from claim 20), or claims 40 and 49 (which depend from claim 39).
Rejection 4—The rejection of claim 17—19, 36—38,
and 41 under 35 U.S.C. § 103(a)
Claims 17—19 depend from claim 1, claims 36—38 depend from claim
20, and claim 41 depends from claim 39. The Examiner’s reliance on
Miesel ’118 does not remedy the deficiencies in the combined teachings of
Miesel ’080 and Dorfmeister, discussed above (see supra Rejection 2).
Thus, for the same reasons discussed above, we do not sustain the rejection
of claims 17—19, 36—38, and 41.
DECISION
We affirm the decision to reject claims 6 and 24 under 35 U.S.C.
§112, second paragraph, and we reverse the decision to reject claims 1, 3—
14, 17-20, 22-34, and 36-49 under 35 U.S.C. § 103(a).
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).
AFFIRMED-IN-PART
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