Ex Parte Dale

Patent Trial and Appeal Board

Nov 30, 2016

11833192 (P.T.A.B. Nov. 30, 2016)

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.
11/833,192 08/02/2007 Mark Dale CTS-0110-US 7460
65449 7590 12/02/2016
PATENT INGENUITY, P.C.
9701 Wilshire Boulevard
Suite 1000
Beverly Hills, CA 90212
EXAMINER
PATEL, NEHA
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
12/02/2016 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):
ssimpson@patentingenuity.com
patents@patentingenuity.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK DALE
Appeal 2014-003673
Application 11/833,1921
Technology Center 3600
Before JOSEPH A. FISCHETTI, BIBHU R. MOHANTY, and
BART A. GERSTENBLITH, Administrative Patent Judges.
FISCHETTI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant seeks our review under 35 U.S.C. § 134 of the Examiner’s
rejection of claims 1-7, 9-14, 16-23, and 25-34 in the Office Action mailed
on May 10, 2013 (hereinafter “Non-Final Action).2 We have jurisdiction
under 35 U.S.C. § 6(b).
SUMMARY OF DECISION
We AFFIRM.
1 Appellant identifies Clinisafe LTD as the real party in interest. (Appeal
Br. 2).
2 Claims 8, 15, and 24 are canceled. (Appeal Br. 2, 20, 21, 24 (Claims
App.)).
Appeal 2014-003673
Application 11/833,192
THE INVENTION
Appellant’s claims relate to “a method of screening a candidate for a
clinical trial.” (Spec. para. 2).
Claims 1, 22, 23, 28, 29, and 31—34 are the independent claims on
appeal. Claim 1, reproduced below, is representative of the subject matter
on appeal.
1. A computer implemented method of screening a
candidate for a clinical trial utilizing a computer comprising a
processor and a memory, the method comprising:
processing, with the processor, a drug rule stored in the
memory and a candidate drug list, the drug rule being indicative
of a criteria associated with at least one drug, the candidate drug
list comprising a list of drugs taken by the candidate; and
generating an output indicative of suitability of the
candidate for the clinical trial based upon the processing.
(Appeal Br. 19 (Claims App.)).
THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Michelson US 2002/0002474 A1 Jan. 3, 2002
Gogolak US 2002/0188465 A1 Dec. 12, 2002
Henderson US 2003/0236683 A1 Dec. 25, 2003
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Application 11/833,192
The following rejections are before us for review.
Claims 1-7, 9-14, 16-21, and 31-343 are rejected under 35 U.S.C.
§101 because the claimed invention is directed to non-statutory subject
matter.
Claims 1, 3-7, 9-13, 19, 21-23, 25, 26, and 28-33 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Henderson in view of
Michelson.
Claims 2, 14, 16-18, 20, 27, and 34 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Henderson in view of Michelson and
further in view of Gogolak.
FINDINGS OF FACT
1. We adopt the Examiner’s findings as set forth on pages 2—18 of the
May 10, 2013, Non-Final Action.
ANALYSIS
35 U.S.C. § 101 REJECTION
The Examiner has rejected claims 1-7, 9-14, 16-21, and 31-34 under
35 U.S.C. § 101 because the claimed invention is directed to non-statutory
subject matter. (Answer 3, supra note 3).
3 In the Answer, the Examiner indicates that although claim 34 was
inadvertently omitted from the statement of the rejection, claim 34 was
rejected under 35 U.S.C. § 101. See Answer 3. The body of the rejection
addresses claim 34 (see Non-Final Action 3 (mailed May 10, 2013)), and
Appellant recognizes that the Examiner’s rejection under § 101 applied to
claim 34 (see Appeal Br. 11 (addressing claim 34 under this rejection)).
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Application 11/833,192
Our analysis will address the patent ineligibility of all independent
claims 1, 22, 23, 28, 29, and 31—34 given each of these claims cover the
subject matter of using a drug rule to generate an output indicative of
suitability of the candidate for the clinical trial.
The Supreme Court has:
set forth a framework for distinguishing patents that claim laws
of nature, natural phenomena, and abstract ideas from those that
claim patent-eligible applications of those concepts. First, . . .
determine whether the claims at issue are directed to one of
those patent-ineligible concepts. If so, we then ask, “[w]hat
else is there in the claims before us?” To answer that question,
. . . 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. [The Court] 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.”
Alice Corp. Pty. Ltd. v. CLS Bank Inti, 134 S. Ct. 2347, 2355 (2014)
(citations omitted) (citing Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 132 S. Ct. 1289, 1294, 1297 (2012)).
To perform this test, we must first determine whether the claims at
issue are directed to a patent-ineligible concept.
The preamble of claim 1 recites that it is for a method of screening a
candidate for a clinical trial. The steps in claim 1 result in an output
indicative of suitability of the candidate for the clinical trial based upon a
processing of information. Thus, claim 1 is directed to generating output
indicative of suitability of the candidate data for a clinical trial.
It follows from prior Supreme Court cases, and Gottschalk v. Benson,
409 U.S. 63 (1972), in particular, that the claims at issue here are directed to
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Application 11/833,192
an abstract idea. Like the algorithm in Gottschalk, a method of screening a
candidate for a clinical trial is a mathematical algorithm that preempts all
implementations and uses. At its core, the method goes to fundamental
economic practice, e.g., insuring that the clinical trial of a drug receives an
unbiased run so that the trial drug can be sold on the open market. Thus,
determining an output indicative of suitability of candidate data for a clinical
trial is an “abstract idea” beyond the scope of § 101. See Alice Corp. Pty.
Ltd., 134 S. Ct. at 2356.
As in Alice Corp. Pty. Ltd., we need not labor to delimit the precise
contours of the “abstract ideas” category in this case. It is enough to
recognize that there is no meaningful distinction in the level of abstraction
between the concept of performing a mathematical algorithm in Gottschalk
and the concept of determining the suitability of the candidate for the
clinical trial based on a drug rule at issue here. Both are squarely within the
realm of “abstract ideas” as the Court has used that term. See Alice Corp.
Pty. Ltd., 134 S. Ct. at 2357. The independent claims no more recite what
pharmacists have been mentally thinking through for hundreds of years, how
one drug interacts with another. That the thought process should occur in
the environment of a clinical drug trial does not render the abstraction
eligible, because the environment does not alter the thought process.
The introduction of a computer into certain of the claims does not
alter the analysis at Mayo step two:
the mere recitation of a generic computer cannot transform a
patent-ineligible abstract idea into a patent-eligible invention.
Stating an abstract idea “while adding the words ‘apply it’” is
not enough for patent eligibility. Nor is limiting the use of an
abstract idea “‘to a particular technological environment.’”
Stating an abstract idea while adding the words “apply it with a
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Application 11/833,192
computer” simply combines those two steps, with the same
deficient result. Thus, if a patent’s recitation of a computer
amounts to a mere instruction to “implement^]” an abstract
idea “on ... a computer,” that addition cannot impart patent
eligibility. This conclusion accords with the pre-emption
concern that undergirds our § 101 jurisprudence. Given the
ubiquity of computers, wholly generic computer
implementation is not generally the sort of “additional
feature[e]” that provides any “practical assurance that the
process is more than a drafting effort designed to monopolize
the [abstract idea] itself.”
Alice Corp. Pty. Ltd., 134 S. Ct. at 2358 (alterations in original) (citations
omitted).
“[T]he relevant question is whether the claims here do more than
simply instruct the practitioner to implement the abstract idea ... on a
generic computer.” Alice Corp. Pty. Ltd., 134 S. Ct. at 2359. Here, they do
not.
Taking the claim elements separately, the function performed by the
computer at each step of the process is purely conventional. Using a
computer to process data by comparing one data value to another in a drug
rule is one of the most basic functions of a computer. All of these computer
functions are well-understood, routine, conventional activities previously
known to the industry. In short, each step does no more than require a
generic computer to perform generic computer functions.
Considered as an ordered combination, the computer components of
Appellant’s method add nothing that is not already present when the steps
are considered separately. Viewed as a whole, Appellant’s claims simply
recite the concept of using a rule as a filter as performed by a generic
computer. The claims do not, for example, purport to improve the
functioning of the computer itself. Nor, do they effect an improvement in
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Application 11/833,192
any other technology or technical field. Instead, the claims at issue amount
to nothing significantly more than an instruction to apply the abstract idea of
filtering data from base data which shows a conflict with the base data.
Under our precedents, that is not enough to transform an abstract idea into a
patent-eligible invention. See Alice Corp. Pty. Ltd., 134 S. Ct. at 2360.
Because we find that all independent claims, and those claims
dependent thereon, are patent ineligible because each is based on the abstract
idea of determining the suitability of the candidate for the clinical trial based
on a drug mle, we need not decide on the transient signal issue raised in this
35 U.S.C. § 101 rejection pertaining to claims 31 and 32. See Non-Final
Action 3^4.
35 U.S.C. § 103(a) REJECTION
Appellant argues claim 1 as the representative independent claim of
this appeal. (Appeal Br. 11). Appellant argues that the remaining claims
(2—7, 9-14, 16—23 and 25—34) rise and fall with arguments made for
independent claim 1. (Appeal Br. 14-17). Thus, independent claim 1 is the
representative claim for this appeal with all claims standing or falling with
claim 1.
Appellant argues that:
claim 1 provides that the suitability output is based upon
the particular processing of a drug rule and a candidate
drug list. Michelson does not mention that the query
utilizes a drug rule and a candidate drug list. Michelson
simply provides for a query without teaching a query that
is based upon a drug rule and a candidate drug list.
Michelson does not teach determining subject eligibility
based upon a drug rule and a candidate drug list.
(Appeal Br. 12).
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That argument is not well taken because the Appellant is attacking the
Michelson reference individually when the rejection is based on a
combination of references, and the Examiner found that Henderson at
paragraphs 10, 16 and 86, and not Michelson (Non-Final Act. 6—7), discloses
processing using a drug rule and a drug list, e.g., paragraph 86, and
searching strings for “potential conflicts between any medication patient is
currently taking, which is received from the patient information DB 20.” Id.
at 6. See In re Keller, 642 F.2d 413, 426 (CCPA 1981); In re Young, 403
F.2d 754, 757-58 (CCPA 1968). That Henderson discloses searching “any
medication” as opposed to searching the claimed “list,” is not of
consequence because “any medication” is taken to be a list of all known
medications.
Appellant further argues that:
The distinction between the rule in Henderson and claim 1 is
that Henderson is patient centric whereas claim 1 is drug
centric. Henderson is directed toward monitoring a variety of
conditions of a patient whereas claim 1 is directed toward
determining eligibility of a candidate for a particular drug
clinical trial.
(Appeal Br. 13).
We disagree with Appellant. As found supra, Henderson explicitly
discloses searching for “potential conflicts between any medication patient is
currently taking, which is received from the patient information DB 20.”
(Henderson, para. 86). We find that one having ordinary skill in the art in
looking at the drug rule disclosed by Henderson in the context of the clinical
study of Michelson would have known to account for all drugs taken by the
patient because, by definition, the trial is taken subject to the conditions in
which the candidate would normally be found.
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Application 11/833,192
Appellant’s arguments alleging of commercial success likewise fail to
be persuasive. Appellant asserts that:
Mark Dale explains the relationship between various
claim elements and CLINISAFE’S LTD’s Interactive
Web-Based Concomitant Medication Management
System that was the recipient of “Best Technological
Development in Clinical Trials” as described by the “The
Scrip Awards Review of the Night” attached as Exhibit A
to the Dale Declaration.
(Appeal Br. 14).
We recognize that evidence of secondary considerations, such as that
presented by the Appellant (Appeal Br. 14), must be considered in route to a
determination of obviousness/nonobviousness under 35 U.S.C. § 103.
Accordingly, we consider anew the issue of obviousness under 35 U.S.C.
§103, carefully evaluating and weighing both the evidence relied upon by
the Examiner and the objective evidence of nonobviousness provided by
Appellant.
We have reviewed the 37 C.F.R. § 1.132 Declaration dated
January 12, 2010 and a second 37 C.F.R. § 1.132 Declaration dated October
8, 2011,4 and find no evidence establishing a nexus between the alleged
commercial success and the merits of the claimed invention. For objective
evidence to be accorded substantial weight, an Applicant must establish a
nexus between the evidence and the merits of the claimed invention. In re
GPAC, 57 F.3d 1573, 1580 (Fed. Cir. 1995) (citations omitted).
4 We have reviewed the papers in the record dated March 28, 2012 and
thereabouts, and find no Declaration submitted. We have further reviewed
the Remarks in the Response to Final Office Action filed March 28, 2012 at
page 10 and find no reference to an appended Declaration, except to a
reference to paragraph 6 of the October 8, 2011 Declaration.
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Appellant asserts that “Appellant respectfully submits that an expert
panel’s recognition that the system is ‘valuable for many studies, especially
for early phase’ as indicated by paragraph] 10 of the 37 CFR 1.132
declaration [dated January 10, 2010] is evidence of commercial success.”
(Appeal Br. 14).
We disagree with Appellant because we find the declaration fails in its
purpose because it recites conclusions and few facts to buttress those
conclusions. In re Brandstadter, 484 F.2d 1395, 1406 (CCPA 1973). The
CLINISAFE LTD article only discusses problems in the industry and does
not show how the claimed system overcomes these problems. We find no
evidence of gross numbers for company growth, nor does the declaration
discuss in any cogent manner, or rely on, relevant matters, such as,
(1) accounting ledgers of sales comparing year by year advances in the sales
of the product, (2) the nature and extent of advertising, (3) pricing (e.g.,
Were trial systems sold at a low price to gain market share), and/or (4) data
showing how the product outperformed other like products. Thus, the
declarations fail to provide any credible nexus between the novel features of
the claimed invention and the alleged commercial sales. In re Fielder, 471
F.2d 640, 642 (CCPA 1973). Nothing in the rules or in jurisprudence
requires the fact finder to credit unsupported or conclusory assertions. Rohm
and Haas Co. v. Brotech Corp., Ill F.3d 1089, 1092 (Fed. Cir. 1997).
CONCLUSIONS OF LAW
We conclude the Examiner did not err in rejecting claims 1-7, 9-14,
16-21, and 31-34 under 35 U.S.C. § 101.
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We conclude the Examiner did not err in rejecting claims 1-7, 9-14,
16-23, and 25-34 under 35 U.S.C. § 103(a).
DECISION
The decision of the Examiner to reject claims 1-7, 9-14, 16-23, and
25-34 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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