KUCHIPUDI, LAKSHMI SAMYUKTA. et al.

Patent Trials and Appeals Board

Jun 22, 2020

14327875 - (D) (P.T.A.B. Jun. 22, 2020)

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.
14/327,875 07/10/2014 LAKSHMI SAMYUKTA KUCHIPUDI 1114.109 9080
37761 7590 06/22/2020
Erickson Kernell IP, LLC
8900 State Line Road
Suite 500
Leawood, KS 66206
EXAMINER
SATANOVSKY, ALEXANDER
ART UNIT PAPER NUMBER
2863
NOTIFICATION DATE DELIVERY MODE
06/22/2020 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):
ekdkdocket@kcpatentlaw.com
kre@kcpatentlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte LAKSHMI SAMYUKTA KUCHIPUDI, CURTIS PARVIN, and
JOHN YUNDT-PACHECO1
____________

Appeal 2019-000848
Application 14/327,875
Technology Center 2800
____________

Before MICHAEL P. COLAIANNI, CHRISTOPHER C. KENNEDY, and
LILAN REN, Administrative Patent Judges.

KENNEDY, Administrative Patent Judge.

DECISION ON APPEAL
This case is an appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1–17. We have jurisdiction under 35 U.S.C.
§ 6(b). We AFFIRM.
BACKGROUND
The subject matter on appeal relates to “clinical diagnostic processes,
and more particularly to a system and method for spot-checking small out-of

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. The Appellant identifies the real party in interest as Bio-Rad
Laboratories, Inc. Appeal Br. 2.
Appeal 2019-000848
Application 14/327,875

2
control conditions in such processes.” Spec. ¶ 4; claim 1. Claim 1 is
reproduced below from page 16 (Claims Appendix) of the Appeal Brief:
1. A method for analyzing at least one specimen in a clinical
diagnostic process, the method comprising:
analyzing at least one specimen using at least one laboratory
instrument;
spot-checking the results of the analysis by the at least one
laboratory instrument to determine the existence of a small out-
of-control condition which renders only a fraction of specimens
evaluated by the at least one laboratory instrument during the
existence of the condition to be unreliable;
upon receiving notification of an out-of-control condition from
the at least one laboratory instrument; analyzing specimen test
data from the at least one laboratory instrument using a processor
to determine a scope of potential error caused by the out-of-
control condition by predicting the number of unreliable patient
specimen results since the last known good quality control
evaluation;
identifying by the processor specimens to be re-evaluated based
on the analyzing step; and
re-evaluating the identified specimens using the at least one
laboratory instrument after the out-of-control condition is
resolved.
ANALYSIS
Claims 1–17 stand rejected under 35 U.S.C. § 101 as directed to
patent-ineligible subject matter. The Appellant argues the claims as a group.
We address claim 1 below, and the remaining claims will stand or fall with
claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
After review of the cited evidence in the appeal record and the
opposing positions of the Appellant and the Examiner, we determine that the
Appellant has not identified reversible error in the Examiner’s rejection.
Appeal 2019-000848
Application 14/327,875

3
Accordingly, we affirm that rejection for reasons set forth below, in the
Final Action, and in the Examiner’s Answer.
Determining whether a claimed invention is directed to patent-eligible
subject matter is a two-step process that requires (1) evaluating whether the
claim is directed toward a patent-ineligible concept, i.e., a law of nature,
natural phenomenon, or abstract idea; and, if so, (2) determining whether the
claim’s elements, considered both individually and as an ordered
combination, transform the nature of the claim into a patent-eligible
application. See Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217–18
(2014).
As to step (1) of Alice, the Examiner determines in the Final Action
that claim 1 is directed to abstract ideas and identifies several claim
recitations that encompass abstract ideas. See Final Act. 1–4. Specifically,
the Examiner finds that the “spot-checking . . . to determine the existence of
a small out-of-control condition” recitation, the “identifying by the
processor” recitation, and the “re-evaluating the identified specimens”
recitation “are similar to ‘organizing information through mathematical
correlations [as in] Digitech Image Tech., LLC v. Electronics for Imaging,
Inc. (758 F.3d 1344).” Id. at 2. The Examiner finds that the “analyzing”
recitations and the “receiving notification of an out-of-control condition”
recitation concern data collection, comparison, and analysis. Id. at 3.
In the Answer, the Examiner elaborates on step (1) of Alice and
further explains that the Federal Circuit has “treated analyzing information
by steps people go through in their minds, or by mathematical algorithms,
without more, as essentially mental processes within the abstract-idea
category.” Ans. 5 (citing Electric Power Grp., LLC v. Alstom S.A., 830 F.3d
Appeal 2019-000848
Application 14/327,875

4
1350, 1354 (Fed. Cir. 2016)). The Examiner also cites In re Grams, 888
F.2d 835 (Fed. Cir. 1989), for the proposition that claims directed to testing
a system to diagnose the existence of an abnormality may involve abstract
ideas. Ans. 6.
As to step (2) of Alice, the Examiner determines that the remaining
elements of claim 1, “such as a processor (computer), laboratory instrument,
and not defined specimens . . . are well-understood, purely conventional or
routine in the relevant field.” Final Act. 3; Ans. 7–9 (citing evidence).
Relevant to step (1) of Alice, the Appellant argues that claim 1 is not
directed to an abstract idea because it requires “the physical processing” of
an “analyte or specimen . . . through the physical interaction of those
analytes with various sensors.” Appeal Br. 10. The Appellant asserts that
“[s]uch testing thus implicitly requires a physical transformation and/or
interaction of the analyte or specimen with various reagents and the
subsequent measurement thereof.” Id.
Relevant to step (2) of Alice, the Appellant argues that claim 1
satisfies the “significantly more” criteria of Alice:
[T]he claims improve the technology of clinical diagnostic
processes by providing for spot checking small out-of-control-
conditions in a clinical diagnostic process, the claims add
specific limitations providing for specific retesting of specific
specimens in the event of a small out-of-control condition, and
the claims directed to the detection and retesting of specimens in
a clinical diagnostic process are targeted to a particular useful
application.
Id. at 13.
Appeal 2019-000848
Application 14/327,875

5
Legal Framework
In determining whether a claim falls within a category excluded from
eligible subject matter, our inquiry focuses on the Supreme Court’s two-step
framework described in Mayo and Alice, set forth above. Alice, 573 U.S. 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. Concepts determined
to be abstract ideas, and thus patent ineligible, include, e.g., mathematical
concepts, e.g., Parker v. Flook, 437 U.S. 584, 594–95 (1978), and mental
processes, e.g., Gottschalk v. 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)).
Not every claim that recites a mathematical concept is patent
ineligible. 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
mathematical formula.” 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.”). 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
Appeal 2019-000848
Application 14/327,875

6
laws . . . and this principle cannot be circumvented by attempting to limit the
use of the formula to a particular technological environment.” Id. (citing
Flook and Gottschalk v. Benson, 409 U.S. 63 (1972)); see also, 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 turn 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.
The USPTO published revised guidance on the application of § 101.
2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50
(Jan. 7, 2019) (“Guidance”). Under the 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 activity such as a fundamental economic practice, or mental
processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th ed.
2018)).
Appeal 2019-000848
Application 14/327,875

7
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 is not
“well-understood, routine, conventional” in the field (see MPEP
§ 2106.05(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.
See Guidance 52, 55–56.
Judicial Exception (Guidance step (1))
Consistent with the Examiner’s analysis, claim 1 recites steps of
(1) obtaining data by “analyzing” generically recited “specimen[s]” using
generically recited “laboratory instrument[s],” (2) “spot-checking” the data
to “determine the existence of” abnormalities (“out-of-control condition”),
(3) “analyzing” the data to “determine a scope of potential error” caused by
the abnormality, (4) “identifying” specimens to be re-evaluated, and (5) “re-
evaluating” the specimens after fixing the abnormality. See Appeal Br. 16
(claim 1). As set forth above, the claim recites steps of evaluating data to
identify abnormalities, and then evaluating data to identify samples that were
affected by the abnormality and that therefore need to be retested after the
abnormality is fixed. Claim 1 concerns error identification and correction.
We agree with the Examiner that, under the broadest reasonable
interpretation of the claim, the “spot-checking,” “analyzing . . . to determine
a scope of potential error,” and “identifying” recitations could be carried out
in the human mind as a mental process.
We also agree with the Examiner that In re Grams is instructive. In
Grams, the claim at issue concerned “[a] method of diagnosing an abnormal
Appeal 2019-000848
Application 14/327,875

8
condition in an individual” and recited, inter alia, steps of
(1) “performing . . . clinical laboratory tests on [an] individual,”
(2) comparing measured values to reference values to “produc[e] . . . a first
quantity representative of the condition of the individual,” (3) “comparing”
data “to determine whether the individual’s condition is abnormal,” and
(4) upon identifying an abnormal condition, running “successive[] testing.”
Grams, 888 F.2d at 836–37. The Federal Circuit determined that the recited
steps “are in essence a mathematical algorithm.” Id. at 837. We agree with
the Examiner that the subject matter of claim 1 is sufficiently similar to that
of the claims at issue in Grams to determine that the subject matter of
claim 1 encompasses mathematical algorithms or concepts. Cf. Spec. ¶ 21
(“Application module 20 may execute any sequence of diagnostic steps or
one or more diagnostic algorithms in conjunction with implementing any
clinical diagnostic process . . . .”).
The Appellant does not persuasively contend otherwise. The
Appellant does not address Grams. In accordance with the Guidance,
step (1), we determine that claim 1 recites both mathematical concepts and
mental processes, and thus recites an abstract idea.
Integration into a Practical Application (Guidance step (2))
Turning to step (2) of the Guidance, we determine that claim 1, as a
whole, does not integrate the judicial exception into a practical application.
Integration into a practical application requires an additional element or a
combination of additional elements in the claim to “apply, rely on, or use the
judicial exception in a manner that imposes a meaningful limit on the
judicial exception, such that the claim is more than a drafting effort designed
to monopolize the judicial exception.” Guidance 53–54; see also id. at 55
Appeal 2019-000848
Application 14/327,875

9
(setting forth exemplary considerations indicative that an additional element
or combination of elements may have integrated the judicial exception into a
practical application).
As noted above, the Appellant does not persuasively assert that
claim 1 does not recite abstract ideas; rather, the Appellant argues that
claim 1 is not “directed to” to those abstract ideas because of the physical
elements of the claim such as the “specimen” and the “laboratory
instrument.” Appeal Br. 9–12.
That argument is not persuasive because the presence of physical
elements in a claim is not dispositive of whether a claim is directed to
abstract ideas. See, e.g., Grams, 888 F.2d at 836–37 (holding ineligible a
claim that recited performing laboratory tests on an individual (i.e., a
specimen) despite acknowledging that the claim includes a “physical process
step” of “performing clinical tests on individuals”). As noted above, the
Appellant does not address Grams, which also included physical elements.
The Appellant also argues that the claims “improve the technology of
clinical diagnostic processes by providing for spot checking small out-of-
control conditions in a clinical diagnostic process.” Appeal Br. 13. That
argument is not persuasive because it does not persuasively identify an
actual improvement to a process or technology. On the contrary, it appears
that claim 1 essentially takes the concept of error identification (by spot-
checking) and correction in the context of a clinical diagnostic laboratory
and performs certain aspects of the process on a computer. See Alice, 573
U.S. at 222 (“[T]he mere recitation of a generic computer cannot transform a
patent-ineligible abstract idea into a patent-eligible invention.”).
Appeal 2019-000848
Application 14/327,875

10
The Appellant also asserts, without significant explanation, that In re
Abele, 684 F.2d 902 (CCPA 1982), supports a conclusion that the claims are
directed to patent-eligible subject matter. Appeal Br. 14.
We are not persuaded that Abele supports the Appellant’s position. In
Grams, the Federal Circuit stated, “[i]n Abele . . . the algorithm served to
improve the CAT-scan process.” Grams, 888 F.2d at 835 (emphasis added).
In In re Bilski, 545 F.3d 943, 962–63 (Fed. Cir. 2008), aff’d sub nom. Bilski
v. Kappos, 561 U.S. 593 (2010), the Federal Circuit also discussed Abele and
explained that “the transformation of that raw data into a particular visual
depiction of a physical object on a display was sufficient to render that more
narrowly-claimed process patent-eligible” (emphasis added). Thus, the
claims at issue in Abele were eligible because they recited an improvement
to a technical process and because they transformed raw data into a visual
depiction of a physical object.
The Appellant does not persuasively identify any such technical
improvement or transformation that claim 1 implicates, see Grams, 888 F.2d
at 835; Bilski, 545 F.3d at 963, sufficient to integrate the judicial exception
into a practical application. We are not persuaded that laboratory testing of
a specimen using a laboratory instrument, see Appeal Br. 10–12, is the type
of “transformation” that supports patent eligibility under Abele/Bilski. See
Grams, 888 F.2d at 836–37 (holding claims ineligible despite recitation of
“clinical laboratory tests which measure the levels of chemical and
biological constituents of the individual”).
On this record, we are not persuaded that claim 1 integrates the
judicial exception into a practical application. Thus, claim 1 is directed to
the recited abstract ideas.
Appeal 2019-000848
Application 14/327,875

11
Inventive Concept (Guidance steps (3) and (4))
Turning to steps (3) and (4) of the Guidance, the Appellants have not
shown error in the Examiner’s determination that the limitations of claim 1
beyond the abstract idea itself are well understood, routine, and
conventional. The Appellant does not attempt to specifically identify any
claim element that is not well understood, routine, and conventional.
The Appellant, however, argues that “the claims add specific
limitations providing for specific retesting of specific specimens in the event
of a small out-of-control condition.” Appeal Br. 13. That argument is
unpersuasive because the Appellant does not adequately explain, with
citation to applicable case law, how the “re-evaluating” step renders the
claims patent eligible, or how it amounts to anything more than routine
postsolution activity. See Mayo, 566 U.S. at 79 (citing Bilski and Diehr for
the proposition that “the prohibition against patenting abstract ideas ‘cannot
be circumvented by’ . . . adding ‘insignificant post-solution activity.’”).
Similar to the re-evaluating step at issue in this case, the claim at issue in
Grams, discussed above, included a “successive[] testing” step after an
abnormal condition was identified from the first testing step, but was
nevertheless held to be ineligible. Grams, 888 F.2d at 836–37. We also
observe that, to the extent that the claim is directed to an abstract algorithm
(a series of steps to achieve error identification and correction), the “re-
evaluating” step appears to simply be part of the algorithm. See id. at 837
(identifying the “successive[] testing” step as part of a mathematical
algorithm). The Appellant does not address Grams or otherwise
persuasively explain how the re-evaluating step prevents the claim from
being “directed to” the abstract ideas encompassed by the claims; nor does
Appeal 2019-000848
Application 14/327,875

12
the Appellant persuasively explain how or why that step should be
considered an “improvement” to any existing process. Cf. BSG Tech LLC v.
BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018) (“It has been clear
since Alice that a claimed invention’s use of the ineligible concept to which
it is directed cannot supply the inventive concept that renders the invention
‘significantly more’ than that ineligible concept.”).
The Appellant also argues that “the claims directed to the detection
and retesting of specimens in a clinical diagnostic process are targeted to a
particular useful application.” Appeal Br. 13. We, however, do not discern
how claim 1 is “targeted” to a limited application. As set forth above,
claim 1 generically recites analyzing a “specimen” using a “laboratory
instrument,” and using a generic “processor” to determine the scope of error
and to identify specimens to be re-evaluated. The “spot-checking” recitation
appears to be broad and generic. On this record, we are not persuaded that
the claim 1 is “targeted to a particular useful application” in a way that
would render it patent eligible. Appeal Br. 13.
On this record, having considered the limitations individually and in
combination, we are not persuaded that any step of claim 1 beyond those
encompassing the abstract idea itself recites subject matter that is not well
understood, routine, and conventional, or that claim 1 otherwise amounts to
“significantly more” than the abstract ideas to which it is directed.
We have carefully considered the Appellants’ arguments but are not
persuaded of reversible error in the Examiner’s rejection of claim 1 under
§ 101.
Appeal 2019-000848
Application 14/327,875

13
CONCLUSION
In summary:
Claims
Rejected 35 U.S.C. § Basis Affirmed Reversed
1–17 101 Eligibility 1–17
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED