Robert E. Heinz et al.

Patent Trials and Appeals Board

Aug 1, 2019

14222180 - (D) (P.T.A.B. Aug. 1, 2019)

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.
14/222,180 03/21/2014 Robert E. HEINZ 2599-226.DIV2 8880
17427 7590 08/01/2019
Richard Wydeven
RFEM/ Genprobe
607 Fourteenth Street, NW
Suite 800
Washington, DC 20005
EXAMINER
DEJONG, ERIC S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
08/01/2019 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):
patentdept@hologic.com
pto-pat-email@rfem.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROBERT E. HEINZ, DENNIS NEWELL,
DAVID OPALSKY, and JASON RHUBOTTOM
(APPLICANTS: GEN-PROBE INCORPORATED)
____________

Appeal 2018-005267
Application 14/222,1801
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1–3 (App. Br.
3; see also Final Act. 2).2, 3 Examiner entered a rejections under 35 U.S.C.
§ 101 and obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 Appellants identify Gen-Probe Incorporated and its parent Hologic, Inc. as
the real party in interest (Appellants’ August 14, 2017 Appeal Brief (App.
Br.) 1).
2 Examiner’s January 12, 2017 Final Office Action.
3 Appellants’ pending claims 4–6, 8, and 9 stand withdrawn from
consideration (App. Br. 3; see generally Ans. 2).
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STATEMENT OF THE CASE
Appellants’ disclosure “relates to systems and methods for performing
multiple diagnostic assays simultaneously, and more particularly to systems
and methods for distinguishing different measured emission signals based on
the modulation frequencies of the corresponding excitation signals that
generated the emission signals” (Spec. ¶ 4). Appellants’ claim 1 is
representative and reproduced below:
1. A method for determining a concentration of an analyte of
interest in a sample contained in a receptacle by detecting an
optical signal emitted from the contents of the receptacle in the
presence of multiple, different optical signals originated from
the same receptacle or a different receptacle, said method
comprising:
(a) forming amplification products from the analyte of interest
contained within the receptacle;
(b) hybridizing a detectibly labeled probe to the amplification
products;
(c) generating an optical excitation signal, wherein the optical
excitation signal has a predetermined excitation wavelength that
excites an emission moiety of the probe, which emits an optical
emission signal that is associated with the excitation
wavelength and wherein the optical excitation signal is
modulated at a predetermined modulation frequency;
(d) while forming the amplification products, directing the
optical excitation signal at the contents of the receptacle;
(e) with a signal detecting device, detecting an optical signal
including an optical emission signal emitted from the contents
of the receptacle and converting the detected optical signal to an
analog detection signal;
(f) digitizing the analog detection signal using a computer-
implemented signal-digitizing algorithm to generate digitized
detection data;
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(g) determining the amplitude of the digitized detection data
that is at the predetermined modulation frequency by
mathematically processing the digitized detection data using a
computer-implemented digital signal processing technique for
determining the amplitude of the optical signal at the
predetermined modulation frequency to thereby ascertain the
portion of the detected optical signal that corresponds to the
associated optical emission signal; and
(h) determining the concentration of an analyte present within
the receptacle by executing a computer-implemented algorithm
for processing data relating to the portion of the detected optical
signal that corresponds to the associated optical emission signal
determined in step (g).
(App. Br. 15.)

Grounds of rejection before this Panel for review:
Claims 1–3 stand rejected under 35 U.S.C. § 101.
Claims 1–3 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over the claims of
Heinz.4

Subject Matter Eligibility:
ISSUE
Does the preponderance of evidence of record support Examiner’s
finding that Appellants’ claimed invention is directed to patent ineligible
subject matter?

4 Heinz et al., US 8,718,948 B2, issued May 6, 2014.
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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. The
Supreme Court, however, has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. See e.g., Alice Corp. Pty. Ltd. v. CLS Bank
International, 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. Kappos, 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 (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.
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252, 267–68 (1853))); and manufacturing flour (Gottschalk, 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
mathematical formula.” Diehr, 450 U.S. at 176, and 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.” Diehr, 450 U.S. at 176 (citing Gottschalk and Parker); 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 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.
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The PTO recently published revised guidance on the application of
§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 50 (January 7, 2019) (“Revised Guidance, 84 Fed. Reg.”).
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 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)).
See Revised Guidance, 84 Fed. Reg. 54–55. 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 Revised Guidance, 84 Fed. Reg. 51.
ANALYSIS
Applying the Revised Guidance to the facts on this record, we find
that Appellants’ claims are directed to patent-eligible subject matter. In this
regard, we recognize Appellants’ Supplemental Briefing filed in response to
the Revised Guidance (see Supp. Br. 1).5
The Revised Guidance instructs us first to determine whether any
judicial exception to patent eligibility is recited in the claim. The Revised

5 Appellants’ June 25, 2019 Supplemental Brief (Supp. Br.).
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Guidance identifies three judicially-excepted groupings identified by the
courts as abstract ideas: (1) mathematical concepts; (2) certain methods of
organizing human behavior such as fundamental economic practices; and (3)
mental processes.
On this record, Appellants claim a “method for determining a
concentration of an analyte of interest in a sample contained in a receptacle
by detecting an optical signal emitted from the contents of the receptacle in
the presence of multiple, different optical signals originated from the same
receptacle or a different receptacle” (see App. Br. 15; see generally Ans. 3).
A method of deriving an analyte’s concentration in a sample by detecting an
optical signal emitted from a receptacle’s contents is an abstract idea,
specifically a mental process, because it is a correlation between an optical
signal and an analyte concentration. As Appellants explain:
In the present application, although claim 1 does not recite any
specific mathematical formula, equation, or relationship, it does
recite steps — i.e., steps (f), (g), (h) — that involve
mathematical computations and manipulations, such as
“digitizing the analog detection signal,” “mathematically
processing the digitized detection data using a computer-
implemented digital signal processing technique for
determining the amplitude of the optical signal at the
predetermined modulation frequency,” and “executing a
computer-implemented algorithm.”
(Supp. Br. 1–2.)
Having determined that Appellants’ claim 1 is directed to a mental
process, a judicial exception, the Revised Guidance directs us to next
consider whether the claims integrate the judicial exception into a practical
application. On this record, we find that Appellants’ claimed method
includes additional elements sufficient to integrate the judicial exception into
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a practical application. Specifically, as Appellants’ explain, “the additional
elements(s) [of their claimed invention, inter alia,] reflects an improvement
to technology or a technical field,” specifically, when viewed as a whole,
Appellants’ claimed invention, inter alia, “improves the accuracy and
efficiency of analyte detection technology by reducing inaccuracies
introduced by optical cross-talk and ambient light without the need for an
analog demodulator or filter circuit” (Supp. Br. 2–4). As Appellants explain,
this is an improvement to “[p]rior art systems for applying synchronous
detection[, which] relied upon analog filtering circuits to filter a signal from
the signal detecting device” (id. at 3).
Because Appellants’ claimed method includes additional elements
that implement the judicial exception in conjunction with “a particular
machine or manufacture that is integral to the claim,” see Revised Guidance,
84 Fed. Reg. 55, we are persuaded that Appellants’ claimed method
integrates the judicial exception into a practical application. As Appellants
explain, Appellants’ “claim 1 integrates the mathematical concepts into a
practical application, so claim 1 is not directed to an abstract idea. Claim 1
is therefore eligible at Prong Two, and this concludes the eligibility
analysis” (Supp. Br. 5 (citing Revised Guidance, 84 Fed. Reg. 54)).6 We
agree.
For the foregoing reasons, we find that Appellants’ claimed invention
is patent eligible.

CONCLUSION

6 Appellants’ claims 2–3 depend ultimately from Appellants’ claim 1 (see
App. Br. 15–16).
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The preponderance of evidence of record fails to support Examiner’s
finding that Appellants’ claimed invention is directed to patent ineligible
subject matter. The rejection of claims 1–3 under 35 U.S.C. § 101 is
reversed.

Obviousness-type Double Patenting:
ISSUE
Did Examiner properly present the obviousness-type double patenting
rejection for review in this Appeal?
FACTUAL FINDINGS (FF)
FF 1. Examiner’s Final Office Action: (1) rejected Appellants’ “[c]laims
1-3 . . . on the ground of nonstatutory double patenting as being unpatentable
over claims 1-20 of U.S. Patent No. 8,718,948” and (2) provisionally
rejected Appellants’ “[c]laims 1-3 . . . on the ground of nonstatutory double
patenting as being unpatentable over claims 1-10 of copending Application
No. 14/222,160,” now U.S. Patent No. 9,915,613 (Final Act. 8).
FF 2. Examiner and Appellants held an interview on April 28, 2017,
wherein Examiner’s Interview Summary states “the [E]xaminer agreed that
the Obviousness Double Patenting rejection in the instant application is
improper and will be withdrawn in view of the restriction set forth in the
parent application [(Application No. 13/404,437, now U.S. Patent No.
8,718,948)].”
FF 3. Appellants’ subsequently confirmed that “[p]er the Interview
Summary of May 4, 2017, [Appellants] understand[] that the double
patenting rejection has been withdrawn” (Appellants’ May 12, 2017 Request
for Pre-Appeal Brief Review 5).
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FF 4. The Pre-Appeal Brief Review Decision does not dispute Examiner’s
statement of the status, or Appellants’ understanding, of the status of the
obviousness-type double patenting rejections on this record (see June 8,
2017 Notice of Panel Decision from Pre-Appeal Brief Review).
FF 5. Appellants’ Appeal Brief confirms that the “obvious-type double
patenting rejection . . . has been withdrawn per the Interview Summary
issued May 4, 2017” (App. Br. 14, n. 1; see also Reply Br. 1 (“[A]s noted in
the footnote on page 14 of the Brief, the obvious-type double patenting
rejections were withdrawn per the Interview Summary issued May 4,
2017”); see also Reply Br. 2 (Examiner’s Interview Summary made “no
indication that one of the obviousness type double patenting rejections was
withdrawn and the other was not”)).
FF 6. Examiner’s Answer withdrew the provisional rejection of
Appellants’ “[c]laims 1-3 . . . on the ground of nonstatutory double patenting
as being unpatentable over claims 1-10 of copending Application No.
14/222,160,” now U.S. Patent No. 9,915,613 (Ans. 2).
FF 7. Examiner’s Answer maintained the rejection of Appellants’ claims
1-3 “on the ground of nonstatutory double patenting as being unpatentable
over claims of U.S. Patent No. 8,718,948,” for the “reasons of record,” and
asserted that “Appellant has not presented any traversal argument specific to
[this] ground[] of rejection” (Ans. 5, 8).
ANALYSIS
The evidence of record establishes that Examiner withdrew the
obviousness-type double patenting rejections set forth in Examiner’s January
12, 2017 Final Office Action (see FF 2; cf. FF 1; see also FF 4). The
evidence of record establishes that Appellants repeatedly stated their
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understanding that Examiner withdrew the obviousness-type double
patenting rejections on this record (see FF 3 and 5). Nonetheless, although
given the opportunity, Examiner did not correct Appellants’ understanding
or identify that an obviousness-type double patenting rejection was
maintained prior to Examiner’s Answer and then incorrectly asserts that
“Appellant has not presented any traversal argument specific to [this]
ground[] of rejection” (see FF 4, 6, and 7; cf. FF 2, 3, and 5).
Given the foregoing, we find that Examiner withdrew the obviousness
rejections on this record after the Final Office Action. We find no evidence
on this record that Examiner re-opened prosecution on this record to enter a
rejection of claims 1–3 under the judicially created doctrine of obviousness-
type double patenting as being unpatentable over the claims of Heinz, which
would have necessarily included an appropriate time period for response.
Therefore, we find that Examiner fails to properly present the
obviousness-type double patenting rejection for review on this record.
CONCLUSION
Examiner failed to properly present the obviousness-type double
patenting rejection for review in this Appeal. The rejection of claims 1–3
under the judicially created doctrine of obviousness-type double patenting as
being unpatentable over the claims of Heinz is reversed.

REVERSED