Ex Parte Hurst

Patent Trial and Appeal Board

Jun 12, 2017

13344752 (P.T.A.B. Jun. 12, 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.
13/344,752 01/06/2012 Katherine L. Hurst 36407-0002 7663
46273 7590 06/12/2017
KIRK HAHN
14431 HOLT AVENUE
SANTA ANA, CA 92705
EXAMINER
COBANOGLU, DILEK B
ART UNIT PAPER NUMBER
3686
MAIL DATE DELIVERY MODE
06/12/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KATHERINE L. HURST
Appeal 2016-002210
Application 13/344,752
Technology Center 3600
Before JEAN R. HOMERE, DEBRA K. STEPHENS, and
JON M. JURGOVAN, Administrative Patent Judges.
HOMERE, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from a Final Rejection of
claims 1—18 and 22, which are all of the pending claims.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies the real party in interest as Katherine L. Hurst. App.
Br. 2.
2 Claims 20 and 21 are cancelled, and claims 19 and 23 are withdrawn. See
App. Br. 4 (Status of Claims).
Appeal 2016-002210
Application 13/344,752
Introduction
Appellant’s invention relates to a method for determining a dose of
anticoagulant drug for a patient to thereby obtain a specific International
Normalized Ratio (INR) for the patient. In particular, upon receiving the
patient’s responses to a questionnaire including the patient’s health factors
(e.g., vitals, illness and drug history), a health professional enters
corresponding values into a computer containing a mathematical model
program, to generate an equation of a line representing the relationship
between the anticoagulant dosage and the INR. The health professional
subsequently uses the generated equation to calculate the daily dosage
corresponding to the desired therapeutic INR score. Spec. 9—10.
Representative Claim
Independent claim 1 is representative, and reads as follows:
1. A method of determining a dose of anti-coagulant
drug for a patient in need of anti-coagulant therapy to obtain
a specific International Normalized Ratio (INR) comprising
the steps of:
a) conducting a patient intake by a health care
professional comprising questions concerning health
factors[:]
current average daily dose of anti-coagulant drug in
milligrams,
current international normalized ratio value,
patient's weight in kilograms,
patient's temperature,
number of episodes of fevers,
number of episodes of diarrhea,
amount and type of alcohol ingested,
current prescription drugs, including dosage, frequency
and route of intake,
percent compliance of taking anti-coagulant drug,
kidney function,
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Appeal 2016-002210
Application 13/344,752
liver function,
amount and type of Vitamin K containing food eaten,
and any change in the intake of these foods,
number of bleeding episodes since last visit, and
number of clotting episodes since last visit;
b) recording the answers in step a) into a questionnaire to
obtain values representing each category of question in step
a);
c) entering the values from step b) into a computer with a
mathematical model program;
d) generating an equation of a line representing the
relationship between the dose amount of the anti-coagulant
drug and the INR in the patient; and
e) using the equation generated in step d) to calculate the
daily dose of the anti-coagulant drug to obtain the desired
therapeutic INR score.
Rejections on Appeal
Claims 1—18 and 22 stand rejected under 35 U.S.C. § 101 as being
directed to non-statutory subject matter because the claims as a whole,
considering all claim elements both individually and in combination, do not
amount to significantly more than an abstract idea. Final Act. 3^4.
Claims 1—8, 11, and 13—18 stand rejected under 35 U.S.C. § 102(e) as
being anticipated by Mayer. Final Act. 4—10.
Claims 9 and 10 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Mayer and Wikipedia. Final Act. 10—
11.
Claim 12 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Mayer and Official Notice. Final Act.
12.
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Appeal 2016-002210
Application 13/344,752
ANALYSIS
We consider Appellant’s arguments seriatim, as they are presented in
the Appeal Brief, pages 9-18, and the Reply Brief, pages 4—11,3 We are
unpersuaded by Appellant’s contentions. Except as otherwise indicated
hereinbelow, we adopt as our own the findings and reasons set forth in the
Final Action, and the Examiner’s Answer in response to Appellant’s Appeal
Brief. Final Act. 2—14, Ans. 2—15. However, we highlight and address
specific arguments and findings for emphasis as follows.
Non-Statutory Subject Matter Rejection
Appellant argues the Examiner erred in concluding that claims 1—18
and 22 are directed to the “abstract idea of a method of organizing human
activities”. App. Br. 9. According to Appellant, “Although there are always
‘human activities’ involved when a method requires a human to do some
‘actions’, it is not these actions that are important, but it is the process of
using the collected data and transformed values to generate an (sic) unique
equation for the individual patient.” Id. In particular, Appellant argues
because the claim recites a method that uses a particular machine
programmed with a mathematical model to transform a particular article
(collected data) to a different state or thing (an equation indicating the
anticoagulant dosage for a patient), the claim amounts to significantly more
than just an abstract idea. Id. at 10-16. These arguments are not persuasive.
3 Rather than reiterate the arguments of Appellant and the Examiner, we
refer to the Appeal Brief (filed June 14, 2015), the Reply Brief (filed
December 9, 2015), and the Answer (mailed December 21, 2015) (“Ans.”)
for the respective details. We have considered in this Decision only those
arguments Appellant actually raised in the Briefs. Any other arguments
Appellant could have made but chose not to make in the Briefs are deemed
to be waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2012).
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Application 13/344,752
The U.S. Supreme Court provides a two-step test for determining
whether a claim is directed to patent-eligible subject matter under 35 U.S.C.
§ 101. See Alice Corp. Pty. Ltd. v. CLS Bank Inti, 134 S. Ct. 2347 (2014).
First, we determine whether the claims at issue are directed to one of the
four statutory categories of invention (i.e., process, machine, article of
manufacture or composition of matter). Because claims 1—18 and 22 are
directed to a method, they satisfy the first prong of the test. Second, we
determine whether the claims are directed to one or more judicial exceptions
(i.e., law of nature, natural phenomenon, and abstract ideas). Id. at 2355
(citations omitted) (citing Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 132 S. Ct. 1289, 1296-97 (2012))(“Mayo”).4
4 The Supreme Court identifies laws of nature, physical phenomena,
and abstract ideas as three exceptions of subject matter ineligible for patent
protection. Bilski v. Kappos, 561 U.S. 593, 601 (2010). In Alice Corp. v.
CLS Banklnt 1, the Court provides the following framework for analysis:
First, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts. If so, we then ask,
“[wjhat else is there in the claims before us?” To answer that
question, we consider the elements of each claim both
individually and “as an ordered combination” to determine
whether the additional elements “transform the nature of the
claim” into a patent-eligible application. We have described
step two of this analysis as a search for an “‘inventive
concept’”—i.e., an element or combination of elements that is
“sufficient to ensure that the patent in practice amounts to
significantly more than a patent upon the [ineligible concept]
itself.”
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Application 13/344,752
We agree with the Examiner that under part 2 of the Alice analysis,
claim 1 is directed to the abstract idea of determining the anticoagulant
dosage for a patient, which is a mental process of administering medication
that could be performed in the human mind, or by a human using a pen and
paper. Ans. 12. We further agree with the Examiner that the recited steps
describe the concept of using answers to a questionnaire provided by the
patient to calculate the patient’s daily dosage of anticoagulant using a
mathematical equation. Id. We do not agree with Appellant’s contention
that the claimed method is different from the method of Mayo. App. Br. 12.
As in Mayo, such methods for determining dosage of medication for a
patient were well known in the art, and the claimed method simply tells
doctors to engage in a well-understood, routine, conventional activity
previously engaged in by scientists in the field. Such activity as recited in
the claim is normally not sufficient to transform an unpatentable law of
nature into a patent-eligible application of such a law. Mayo, at 1291 (citing
Parker v. Flook, 437 U.S. 584, 590). Although the claim recites “entering . .
. into a computer with a mathematical model program” values obtained from
the patient in response to a questionnaire, the claim does not require that the
computer perform any of the subsequent steps including generating/using the
equation. Because the claim does not require the use of a specially tailored
computer for implementing the method, the steps as an ordered combination
add nothing to the laws of nature that is not already present when the steps
are considered separately. Further, it has been held that the “prohibition
against patenting abstract ideas ‘cannot be circumvented by attempting to
limit the use of the formula to a particular technological environment.’”
Bilski, supra, at__957_ (slip op. at 14) (quoting Diehr, 450 U.S. at 191—
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Application 13/344,752
192). Moreover, it has been held that simply implementing a mathematical
principle on a physical machine, namely a computer, was not a patentable
application of that principle. For the mathematical formula had “no
substantial practical application except in connection with a digital
computer.” See Gottschalkv. Benson, 409 U.S. 63, 71 (1972).
Because the steps in the claimed process involve a well-understood,
routine, conventional activity previously engaged in by others in the field,
we agree with the Examiner that the steps recited in claim 1 do not amount
to “significantly more” than the abstract idea under part 2 of Alice. Ans. 12.
As discussed supra, “determining the anticoagulant dosage for a patient” as
recited “could be performed in the human mind, or by a human using a pen
and paper. The Federal Circuit recently reconfirmed “[w]e have held that
‘analyzing information by steps people [can] go through in their minds, or
by mathematical algorithms, without more . . . [are] mental processes within
the abstract-idea category.’” Coffelt v. NVIDIA Corp., 2017 WL 999217 *1
(Fed. Cir. 2017) (brackets in original) (quoting Synopsys, Inc. v. Mentor
Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016)).
Accordingly, we sustain the Examiner’s non-statutory subject matter
rejection of claim 1, as well as claims 2—18 and 22 not separately argued.
Prior Art Rejections
Appellant argues that Mayer does not quality as prior art against the
claims in the present application because of the declarations submitted by
the inventor of record (Dr. Hurst) and her representative (Dr. Hahn) on
March 25, 2015 to antedate the Mayer application. App. Br. 16. According
to Appellant, because the declarations substantiate that the claimed invention
was reduced to practice prior to the effective filing date (September 22,
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Application 13/344,752
2010) of the Mayer application, the latter reference does not qualify as prior
art. Id. This argument is moot because the Examiner did not enter the cited
declarations. In particular, the Examiner refused to enter the declarations
subsequent to the final rejection because Appellant has not shown good
cause as to why the declarations were not presented earlier. Advisory Act.
of April 13, 2015; Ans. 13. Because the declarations were not entered by the
Examiner, they are not before us for review. See MPEP § 715.09.5
Accordingly, we summarily sustain the Examiner’s prior art rejections of
claims 1—18 and 22.
DECISION
For the above reasons, we affirm the 35 U.S.C. §§ 101, 102, and 103
rejections of claims 1—18 and 22.
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
5 Review of an examiner’s refusal to enter an affidavit as untimely is by
petition and not by appeal to the Patent Trial and Appeal Board. In re
Deters, 515 F.2d 1152, 185 USPQ 644 (CCPA 1975); Ex parte Hale,
49 USPQ 209 (Bd. App. 1941). See MPEP § 715,08 regarding review of
questions of propriety of 37 CFR 1.131(a) affidavits and declarations.
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