Ex Parte Giftakis et al

Patent Trials and Appeals Board

Jul 9, 2019

12236260 - (D) (P.T.A.B. Jul. 9, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/236,260 09/23/2008
71996 7590 07/11/2019
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Jonathon E. Giftakis
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.
1023-803US01 /
P0033524.0
CONFIRMATION NO.
7565
EXAMINER
PORTER, RACHELL
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
07/11/2019 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
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHON E. GIFTAKIS, PETER J. KOVACH,
WARREN W. BALL, JONATHAN C. WERDER, NINA M. GRAVES,
DAVID C. ULLESTAD, and SARAH B. ALME 1
Appeal2017-0035142
Application 12/236,260
Technology Center 3600
Before BIBHU R. MOHANTY, KENNETH G. SCHOPPER, and
MATTHEWS. MEYERS, Administrative Patent Judges.
MEYERS, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
Appellants filed a Request for Rehearing ("Request" or "Req.") under
37 C.F.R. § 41.52 for reconsideration of our Decision ("Decision" or
"Dec.") on Appeal mailed March 29, 2019. The Decision affirmed the
1 Appellants identify Medtronic, Inc. as the real party in interest. Appeal
Br. 3.
2 Our decision references Appellants' Appeal Brief ("Appeal Br.," filed
April 4, 2016) and Reply Brief ("Reply Br.," filed January 2, 2017), and the
Examiner's Answer ("Ans.," mailed November 2, 2016) and Final Office
Action ("Final Act.," mailed October 28, 2015).
Appeal2017-003514
Application 12/236,260
Examiner's rejection of claims 1-22 under 35 U.S.C. § 101 as directed to
non-statutory subject matter. 3
We have jurisdiction over the Request under 35 U.S.C. § 6(b).
APPELLANTS' ARGUMENT
Appellants request we reconsider our Decision affirming the
Examiner's rejection of claims 1-22 under 35 U.S.C. § 101 based on recent
relevant decisions by the Federal Circuit, as well as based on the 2019
REVISED PATENT SUBJECT MATTER ELIGIBILITY GUIDANCE, 84 Fed. Reg. 50
(Jan. 7, 2019) ("2019 Revised Guidance"). Req. 1-2. Appellants argue that
"even if the claims recite a judicial exception, which Appellant[ s] do[] not
concede, the claims are patent eligible because the claims integrate the
judicial exception identified by the Board in the Decision on Appeal into a
practical application." Id. at 4.
PRINCIPLES OF LAW
A. 35 U.S.C. § 101
We first note "[ w ]hether a [patent] claim is drawn to patent-eligible
subject matter is an issue of law that [is] review[ed] de nova." SiRF Tech.,
Inc. v. Int'! Trade Comm'n, 601 F.3d 1319, 1331 (Fed. Cir. 2010) (emphasis
added).
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.4
3 The Decision also reversed the Examiner's rejection of claims 1-22 under
35 U.S.C. § 103(a). Appellants have not requested reconsideration of the
rejection under§ 103(a).
4 This threshold analysis of whether a claim is directed to one of the four
statutory categories of invention, i.e., a process, machine, manufacture, or
2
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Application 12/236,260
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. E.g., Alice Corp. v. CLS Bankint'l, 573 U.S. 208,
216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework,
we first determine what concept the claim is "directed to." See Alice, 573
U.S. at 219 ("On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4
in petitioners' application explain the basic concept of hedging, or protecting
against risk.").
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611 );
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and
mental processes (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 191
(1981 )); "tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores" (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
composition of matter, is referred to as "Step l" in the patent-eligibility
inquiry under § 101.
3
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252, 267---68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held "[a] claim drawn to subject matter otherwise statutory
does not become nonstatutory simply because it uses a mathematical
formula." Diehr, 450 U.S. at 176; see also id. at 191 ("We view
respondents' claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula."). Having
said that, the Supreme Court also indicated that a claim "seeking patent
protection for that formula in the abstract ... is not accorded the protection
of our patent laws, ... and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment." Id. (citing Benson and Flook); see, e.g., id. at 187 ("It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.").
If the claim is "directed to" an abstract idea, we tum to the second
step of the Alice and Mayo framework, where "we must examine the
elements of the claim to determine whether it contains an 'inventive
concept' sufficient to 'transform' the claimed abstract idea into a patent-
eligible application." Alice, 573 U.S. at 221 ( quotation marks omitted). "A
claim that recites an abstract idea must include 'additional features' to
ensure 'that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea]."' Id. ( quoting Mayo, 566 U.S. at 77).
"[M]erely requir[ing] generic computer implementation[] fail[ s] to transform
that abstract idea into a patent-eligible invention." Id.
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B. USPTO Guidance
The PTO recently published revised guidance in the Federal Register
concerning the application of§ 101. 2019 Revised Guidance. Under that
Guidance, we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings
of abstract ideas (i.e., mathematical concepts, certain methods
of organizing human interactions such as a fundamental
economic practice, or mental processes); 5 and
(2) additional elements that integrate the judicial
exception into a practical application (see MPEP § 2106.0S(a}-
( c), (e }-(h)). 6
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look to
whether the claim:
(3) adds a specific limitation beyond the judicial
exception that are not "well-understood, routine, conventional"
in the field (see MPEP § 2106.0S(d)); or
( 4) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception. 7
See 2019 Revised Guidance.
5 Referred to as "Revised Step 2A, Prong l" in the Guidance (hereinafter
"Step 2A(i)").
6 Referred to as "Revised Step 2A, Prong 2" in the Guidance (hereinafter
"Step 2A(ii)").
7 Items (3) and (4) continue to be collectively referred to as "Step 2B" of the
Supreme Court's two-step framework, described in Mayo and Alice.
5
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Step 2A(i) ~ Abstract Idea
Informed by our judicial precedent, the recent 2019 Revised Guidance
extracts and synthesizes key concepts identified by the courts as abstract
ideas to explain that the abstract idea exception includes the following
groupings of subject matter, when recited as such in a claim limitation:
(a) Mathematical concepts-mathematical relationships,
mathematical formulas or equations, mathematical calculations;
(b) Certain methods of organizing human activity -
fundamental economic principles or practices (including
hedging, insurance, mitigating risk); commercial or legal
interactions (including agreements in the form of contracts;
legal obligations; advertising, marketing or sales activities or
behaviors; business relations); managing personal behavior or
relationships or interactions between people (including social
activities, teaching, and following rules or instructions); and
( c) Mental processes----concepts performed in the human
mind (including an observation, evaluation, judgment, opinion).
Under the 2019 Revised Guidance, if the claim does not recite a
judicial exception (a law of nature, natural phenomenon, or subject matter
within the enumerated groupings of abstract ideas above), then the claim is
patent-eligible at Step 2A(i). This determination concludes the eligibility
analysis, except in situations identified in the Guidance. 8
However, if the claim recites a judicial exception (i.e., an abstract idea
enumerated above, a law of nature, or a natural phenomenon), the claim
8 In the rare circumstance in which an Examiner believes a claim limitation
that does not fall within the enumerated groupings of abstract ideas should
nonetheless be treated as reciting an abstract idea, the procedure described in
the Guidance for analyzing the claim should be followed. See Guidance,
Section III.C.
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requires further analysis for a practical application of the judicial exception
in Step 2A(ii).
Step 2A(ii) ~ Practical Application
If a claim recites a judicial exception in Step 2A (i), we determine
whether the recited judicial exception is integrated into a practical
application of that exception in Step 2A(ii) by: (a) identifying whether there
are any additional elements recited in the claim beyond the judicial
exception( s ); and (b) evaluating those additional elements individually and
in combination to determine whether they integrate the exception into a
practical application.
The seven identified "practical application" sections of the MPEP, 9
cited in the 2019 Revised Guidance under Step 2A(ii), are:
(1) MPEP § 2106.05(a) Improvements to the Functioning of
a Computer or To Any Other Technology or Technical
Field
(2) MPEP § 2106.05(b) Particular Machine
(3) MPEP § 2106.05( c) Particular Transformation
(4) MPEP § 2106.05(e) Other Meaningful Limitations
(5) MPEP § 2106.05(±) Mere Instructions To Apply An
Exception
( 6) MPEP § 2106.05(g) Insignificant Extra-Solution Activity
(7) MPEP § 2106.05(h) Field of Use and Technological
Environment
If the recited judicial exception is integrated into a practical
application as determined under one or more of the MPEP sections cited
9 See MPEP § 2106.05(a}-(c), (e}-(h). Citations to the MPEP herein refer
to revision [R-08.2017].
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above, then the claim is not directed to the judicial exception, and the patent-
eligibility inquiry ends. If not, then analysis proceeds to Step 2B.
Step 2B - "Inventive Concept" or "Significantly More"
Under our precedent, it is possible that a claim that does not
"integrate" a recited judicial exception under Step 2A(ii) is nonetheless
patent eligible. For example, the claim may recite additional elements that
render the claim patent eligible even though a judicial exception is recited in
a separate claim element. 10 The Federal Circuit has held claims eligible at
the second step of the Alice/Mayo test (USPTO Step 2B) because the
additional elements recited in the claims provided "significantly more" than
the recited judicial exception ( e.g., because the additional elements were
unconventional in combination). 11 Therefore, if a claim has been
determined to be directed to a judicial exception under Revised Step 2A, we
must evaluate the additional elements individually and in combination under
Step 2B to determine whether they provide an inventive concept (i.e.,
whether the additional elements amount to significantly more than the
exception itself). 12
10 See, e.g., Diehr, 450 U.S. at 187.
11 See, e.g., Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841 F.3d 1288,
1300, 1304 (Fed. Cir. 2016); BASCOM Global Internet Services, Inc. v.
AT&T Mobility LLC, 827 F.3d 1341, 1349-52 (Fed. Cir. 2016); DDR
Holdings, LLC v. Hotels.com L.P., 773 F.3d 1245, 1257-59 (Fed. Cir. 2014).
12 We note the patent eligibility inquiry may contain underlying issues of
fact. Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F .3d 1314,
1325 (Fed. Cir. 2016). In particular, "[t]he question of whether a claim
element or combination of elements is well-understood, routine and
conventional to a skilled artisan in the relevant field is a question of fact."
Berkheimer v. HP Inc., 881 F.3d 1360, 1368 (Fed. Cir. 2018).
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Under the 2019 Revised Guidance, we must consider in Step 2B
whether an additional element or combination of elements: (1) "Adds a
specific limitation or combination of limitations that are not well-
understood, routine, conventional activity in the field, which is indicative
that an inventive concept may be present;" or (2) "simply appends well-
understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception,
which is indicative that an inventive concept may not be present." See 2019
Revised Guidance, III.B. 13
In the Step 2B analysis, an additional element ( or combination of
elements) is not well-understood, routine or conventional unless the
examiner finds an evidentiary basis, and expressly supports a rejection in
writing with, one or more of the following:
1. A citation to an express statement in the
specification or to a statement made by an applicant during
prosecution that demonstrates the well-understood, routine,
conventional nature of the additional element( s ).
2. A citation to one or more of the court decisions
discussed in MPEP § 2106.05( d)(II) as noting the well-
13 In accordance with existing Step 2B guidance, an Examiner's conclusion
that an additional element ( or combination of elements) is well understood,
routine, conventional activity must be supported with a factual
determination. For more information concerning evaluation of well-
understood, routine, conventional activity, see MPEP § 2106.05( d), as
modified by the USPTO Berkheimer Memorandum (USPTO Commissioner
for Patents Memorandum dated Apr. 9, 2018, "Changes in Examination
Procedure Pertaining to Subject Matter Eligibility, Recent Subject Matter
Eligibility Decision (Berkheimer v. HP, Inc.)" (hereinafter "Berkheimer
Memo").
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understood, routine, conventional nature of the additional
element( s ).
3. A citation to a publication that demonstrates the
well-understood, routine, conventional nature of the additional
element( s ).
4. A statement that the examiner is taking official
notice of the well-understood, routine, conventional nature of
the additional element( s).
See Berkheimer Memo.
The analysis in Step 2B further determines whether an additional
element or combination of elements:
(a) Adds a specific limitation or combination of
limitations that are not well-understood, routine, conventional
activity in the field, which is indicative that an inventive
concept may be present; or
(b) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception,
which is indicative that an inventive concept may not be
present.
2019 Revised Guidance, see Berkheimer Memo.
If the Examiner or the Board determines under Step 2B that the
element ( or combination of elements) amounts to significantly more than the
exception itself, the claim is eligible, thereby concluding the eligibility
analysis.
However, if a determination is made that the element and combination
of elements does not amount to significantly more than the exception itself,
the claim is ineligible under Step 2B, and the claim should be rejected for
lack of subject matter eligibility.
10
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ANALYSIS 14
In the Decision, with respect to Step 2A(i), we stated that
we agree with the Examiner that independent claim 1 is directed
broadly to "comparing new and stored information and using
rules to identify options and a formula for updating alarm limits"
(Final Act. 2; Ans. 21 ). And, when viewed through the lens of
the 2019 Revised Guidance, the Examiner's analysis depicts the
claimed subject matter as one of the ineligible "[ m ]ental
processes" that include "concepts performed in the human mind
(including an observation, evaluation, judgment, opinion)," and
thus an abstract idea. See 2019 Revised Guidance, 52; See also
Flook, 437 U.S. at 595 ("If a claim is directed essentially to a
method of calculating, using a mathematical formula, even if the
solution is for a specific purpose, the claimed method is
nonstatutory." (internal citations omitted)).
Dec. 8. And, with respect to Step 2A(ii), we concluded that exemplary
independent claim 1 failed to integrate the judicial exception into a practical
application of that exception. See id. at 8-14.
However, upon reconsidering our Decision regarding Step 2A(ii), we
agree with Appellants' that independent claim 1 does integrate the judicial
exception into a practical application at least because it includes "an
additional element that applies or uses a judicial exception to effect a
particular treatment or prophylaxis for a disease or medical condition." See
2019 Revised Guidance, 84 Fed. Reg. at 55. In this regard, we agree with
Appellants that
14 We selected independent claim 1 as representative for claims 1-10 in the
Decision. See Dec. 3. Although Appellants argued remaining claims 11-22
separately, Appellants' arguments were based on the same reasons put forth
with respect to independent claim 1. See id. at 16. We maintain that
independent claim 1 is representative.
11
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claim 1 applies or uses the alleged mental process to effect a
particular treatment or prophylaxis for a disease or medical
condition, such as by reciting "adjusting, with the processor,
therapy delivered by a medical device to the patient, ... wherein
adjusting therapy comprises: ... initiating the on-cycle if the
medical device is in the off-cycle at the time the event marker is
generated ... ; and with the processor, restarting the on-cycle if
the medical device is in the on-cycle at the time the event marker
is generated.
Req. 6.
Here, after further consideration, we disagree with the Examiner that
the claims are simply "directed to a process of treating a patient by receiving
information regarding event marker has been triggered, and adjusting
treatment or therapy/treatment based upon whether the received data
indicates that the patient was not receiving therapy (i.e. off-cycle) for
therapy." Final Act. 2; Ans. 21. Instead, we find the claims use the received
information, i.e., an "event marker," to direct subsequent operations-
namely, to control "whether a medical device is in an off-cycle or an on-
cycle of a therapy cycle implemented by the medical device at a time an
event marker is generated." Req. 3. We agree with Appellants that
"'initiating the on-cycle if the medical device is in the off-cycle at the time
the event marker is generated' and 'restarting the on-cycle if the medical
device is in the on-cycle at the time the event marker is generated' result in
different dosages of the therapy." Id. (citations omitted).
Thus, Appellants' claims are like those in Vanda. In Vanda, the court
distinguished claims involving using acquired patient information to modify
a drug administration regimen from the claims at issue in Mayo, which
involved acquiring patient information, but did not require any particular use
of the acquired information. Vanda Pharms. Inc. v. West-Ward Pharms.
12
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Int'! Ltd., 887 F.3d 117, 1134--35 (Fed. Cir. 2018). The court found the
claims in Vanda were not directed to an abstract idea, under Alice step one,
because they involved using the acquired data to direct a treatment program.
Similarly, in this case, the claims involve the use of acquired data, i.e., an
"event marker," to direct operation of a medical device. As such, these
claims are not directed to an abstract idea and, accordingly, the claims
survive Alice step one.
Thus, we conclude that there are meaningful limitations in the claims
that transform the judicial exception into a patent-eligible application such
that the claim amounts to significantly more than the judicial exception
itself.
CONCLUSION
In view of the above, we modify our Decision and reverse the
Examiner's rejection of claims 1-22 under§ 101.
DECISION
We grant Appellants' Request and modify our Decision with respect
to reversing the rejection under 35 U.S.C. § 101 of claims 1-22.
Our decision is final for purposes of judicial review. See 37 C.F.R.
§ 4I.52(a)(l).
REQUEST FOR REHEARING GRANTED
13