Ex Parte Rosenberg

Patent Trial and Appeal Board

Jan 28, 2019

12102992 (P.T.A.B. Jan. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/102,992 04/15/2008 Michael J. Rosenberg
28930 7590 01/29/2019
RONALD B GOLDSTEIN
18 LAKE DR
NORTH BRUNSWICK, NJ 08902
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. CONFIRMATION NO.
216.0001 1158
EXAMINER
NGUYEN, HIEP VAN
ART UNIT PAPER NUMBER
3686
MAIL DATE DELIVERY MODE
01/29/2019 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 MICHAEL J. ROSENBERG
Appeal2017-004890 1
Application 12/102,992
Technology Center 3600
Before HUBERT C. LORIN, MICHAEL W. KIM, and
NINA L. MEDLOCK, Administrative Patent Judges.
KIM, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is an appeal from the final rejection of claims 1, 3-9, 12-19, 21-
27, and 30-36. We have jurisdiction to review the case under 35 U.S.C.
§§ 134(a) and 6(b).
The invention relates generally to "collection of various types of data,
for being able to rapidly analyze and respond to such data ( as well as
corresponding meta-data), and to provide real-time reporting." Spec. 1: 11-
13.
1 The Appellant identifies "the estate of the inventor, Dr. Michael J.
Rosenberg (deceased)," as the real party in interest. Appeal Br. 2.
Appeal2017-004890
Application 12/102,992
Independent claim 1 is illustrative:
1. A computer-implemented method for centrally
managing data in an adaptive clinical trial or other adaptive
process that is conducted at a plurality of geographically remote
sites according to a set of procedures or parameters, said method
comprising the steps of:
(a) collecting data in the course of conducting said clinical
trial or other process at a remote site, wherein the data comprise
performance metrics with respect to said clinical trial or other
process;
(b) electronically transmitting the data from said remote
site to a processing location;
( c) checking the transmitted data at said processing
location, in automated fashion, to assess the consistency of the
data with respect to other collected data, to evaluate changes in
the data as compared with data collected previously, or to
monitor the data for trends over time;
( d) electronically reporting the data to a pre-programmed
computer module;
( e) determining, by use of said pre-programmed computer
module, whether procedures or parameters utilized in conducting
said clinical trial or other process require modification; and
(f) providing instructions, based on said determining, to
follow or modify the procedures or parameters utilized in
conducting said clinical trial or other process.
The Examiner rejected claims 1, 3-9, 12-19, 21-27, and 30-36 under
35 U.S.C. § 101 as directed to patent-ineligible subject matter.
We AFFIRM.
PRINCIPLES OF LAW
An invention is patent eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
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ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int '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.
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 that "[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
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Application 12/102,992
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.
ANALYSIS
The Examiner asserts the following:
Claims 1, 3-9, 12-19, 21-27, 30-36 are directed to an
abstract idea because an abstract idea is recited in the claims. The
abstract idea is identified as collecting clinical trial data to check
the data to evaluate changes in the data and monitor the data for
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Application 12/102,992
trends over time, determining if the data 's
parameters/procedures require modification and providing
instruction to follow or modify trial procedures or parameters.
Evaluating patient data and other data for providing instructions
to modify the procedures or parameters utilized in a clinical trial
is an abstract idea because it uses categories to organize, store
and transmit information (such as organizing types of patient and
rule data), compares new and stored information and uses rules
to identify options (such as to identify how to modify the trial or
not modify the trial).
The claims do not include additional elements that are
sufficient to amount to significantly more than the judicial
exception because the additional elements or combination of
elements in the claims, other than the abstract idea per se, amount
to no more than a recitation of
A) generic computer structure that serves to perform
generic computer functions that serve to merely link the abstract
idea to a particular technological environment (i.e. host
computer, central processing site computer . .. ). Applicant's
specification, [Page 9, lines 4--10 and lines 13-16] discloses
these items to include typical and conventional computers; and
B) functions that are well-understood, routine, and
conventional activities previously known to the pertinent
industry (i.e. collecting, transmitting, checking, assessing,
evaluating, comparing, monitoring, reporting, determining,
providing and modifying).
Ans. 2-3. We analyze independent claim 1 as representative. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
The Appellant asserts that the following limitations are not accounted
for adequately in the Examiner's analysis: "determining ... whether
procedures or parameters utilized in conducting said clinical trial or other
process require modification"; and "providing instructions, based on said
determining, to follow or modify the procedures or parameters utilized in
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conducting said clinical trial or other process." App. Br. 6-10. We address
each in tum.
We are unpersuaded that the Examiner has not accounted adequately
for "determining ... whether procedures or parameters utilized in
conducting said clinical trial or other process require modification." Indeed,
the Examiner has identified that limitation expressly as being part of the
abstract idea recited in the claims. Ans. 2-3; see also Ans. 6-7 (reciting
limitations that are part of the abstract idea). The Appellant asserts that the
Examiner has not accounted for the fact that the "determining" occurs while
the clinical trial is "ongoing" and "being conducted." App. Br. 6-7. The
assertion is misplaced, as the Appellant has not identified any claim
limitation that limits the above "determining" to the specified time period.
The Appellant make similar assertions for "providing instructions,
based on said determining, to follow or modify the procedures or parameters
utilized in conducting said clinical trial or other process," but replaces
"ongoing" /"being conducted" with "timely" /"adaptive" /"continuously."
App. Br. 7. The assertions are unpersuasive for the same reasons.
The Appellant also takes issue with the Examiner's comparison of the
above claim limitations with those found patent ineligible in SmartGene,
Inc. v. Advanced Biological Laboratories, 555 F. App'x 950 (Fed. Cir.
2014 ), which the Examiner cites for showing that
comparing new and stored information and uses rules to
identify options (such as checking the transmitted data consistent
to the data with respect to other data to evaluate the changes in
data and to monitor the data trends and using these data to
modify procedures and parameters utilized in conducting the
clinical trial
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is an abstract idea. Ans. 7. Specifically, the Appellant asserts that "[ u ]nlike
SmartGene' s simple organization and ranking of information from routine
lists of previously known data, the instant claims are directed to measuring
and analyzing performance metrics, and determining therefrom exactly how
to make 'real time' modifications to a ( clinical trial) process." App. Br. 11.
Again, the distinction identified by the Appellant, "real time," is inapposite
because it is not commensurate with the scope of the claim. Instead, we
agree with the Examiner that, like the claims in SmartGene, independent
claim 1 recites limitations that involve mental processes, specifically,
evaluating data and rendering a judgment or opinion as to how the trial
should or should not be modified based on the evaluation. See 2019 Revised
Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50, 52-53 (Jan. 7,
2019) (footnote 15).
The Appellant asserts additionally that the Examiner has not
accounted adequately for the recited "performance metrics." App. Br. 6, 10-
11; Reply Br. 2--4. We disagree, as we are unpersuaded that the
"performance metrics" are entitled to any substantively significant weight.
The method steps would be performed in the same manner whether the data
being evaluated were "performance metrics" or otherwise. See Praxair
Distrib., Inc. v. Mallinckrodt Hosp. Prod. IP Ltd., 890 F.3d 1024, 1032
(Fed. Cir. 2018) ("Claim limitations directed to the content of information
and lacking a requisite functional relationship are not entitled to patentable
weight because such information is not patent eligible subject matter under
35 U.S.C. § 101.").
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The Appellant further asserts the following:
Th[ e determining and providing steps] are meaningful
limitations that add more than generally linking the use of the
abstract idea (the general concept of organizing and comparing
data) to [conducting clinical trials], because they solve [a clinical
trial-] centric problem with a claimed solution that is necessarily
rooted in computer technology. . . . These limitations, when
taken as an ordered combination, provide unconventional steps
that confine the abstract idea to a particular useful application.
App. Br. 8; Reply Br. 6-7.
The claim does not merely recite [the steps] in isolation, but
integrates these ideas into the [ clinical trial] process . . . . The
totality of the steps act in concert to improve another technical
field, specifically the field of [ clinical trials, by enabling an
"adaptive" process]. In addition, the claimed steps taken as a
combination effect a transformation of the [ standard clinical
trial] into a different state or thing, i.e., [an adaptive clinical trial].
App. Br. 9; Reply Br. 6-7. We are unpersuaded that limiting the claims to
"clinical trials" is any more than a general field of use or technological
environment, which alone cannot confer subject matter eligibility. See
Manual of Patent Examining Procedure ("MPEP") § 2106.0S(h). We are
also unclear how an improvement to "clinical trials" is an improvement
rooted to computer technology, when we are unable to identify any
limitation that performs the above-identified mental processes (i.e.,
evaluating, and rendering a judgment or opinion) in a computer-specific
manner. See MPEP § 2106.0S(a), (f). Finally, the types of
"transformations" shown to be sufficient to confer subject matter eligibility
usually involve a "physical object or substance," of which a "clinical trial" is
not. See MPEP § 2106.0S(c).
The Appellant takes issue with the approach the Examiner has taken
as to whether certain claim limitations are "well-understood, routine, and
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conventional," in that the Examiner has primarily taken that approach only
for claim limitations that fall outside of the abstract idea itself. App. Br. 9--
10. Specifically, the Appellant asserts that such an approach has no basis in
case law. We disagree. The Federal Circuit has held that, after formulating
the concept the claims are "directed to," the inquiry under Alice step two is
to determine whether claim limitations other than the steps for executing the
formulated concept are "well-understood, routine, and conventional." BSG
Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018).
Accordingly, the Examiner's treatment of the aforementioned "determining"
and "providing" steps as part of the abstract idea identified above is proper,
and for the computer components the Examiner has identified as "well-
understood, routine, and conventional," the Examiner has provided adequate
support from the Specification (see, e.g., Ans. 7 (citing Spec. 1:20-26; 5: 16-
24, 19:4--10, 13-16) or case law (Ans. 8-9). The Appellant does not
challenge these citations with any specificity. Reply Br. 5-6.
We sustain the Examiner's rejection of claims 1, 3-9, 12-19, 21-27,
and 30-36 under 35 U.S.C. § 101 as directed to patent-ineligible subject
matter.
DECISION
We AFFIRM the rejection of claims 1, 3-9, 12-19, 21-27, and 30-36
under 35 U.S.C. § 101.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv).
AFFIRMED
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