Trizell Ltd.

Patent Trials and Appeals Board

Jan 11, 2021

2020003431 (P.T.A.B. Jan. 11, 2021)

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.
15/754,598 02/23/2018 Nigel PARKER Trizell - 62/218810 6776
24280 7590 01/11/2021
CHOATE, HALL & STEWART LLP
TWO INTERNATIONAL PLACE
BOSTON, MA 02110
EXAMINER
CHEN, STACY BROWN
ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
01/11/2021 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):
jnease@choate.com
patentdocket@choate.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NIGEL PARKER, HANNA P. LESCH, JENNI MYKKANEN,
SARA PAULO, MINNA HASSINEN, and ROBERT SHAW
Appeal 2020-0034311
Application 15/754,598
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims related to
an assay to determine the infectivity of a recombinant viral vector. The
Examiner rejected the claims as patent ineligible under 35 U.S.C. § 101,
anticipated under 35 U.S.C. § 102(a)(1), and obvious under 35 U.S.C. § 103.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Trizell
Limited. Appeal Br. 1.
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CLAIMED SUBJECT MATTER
Claims 1–9, 12–15, and 35–37 are on appeal, of which claims 1, 12,
and 35–37 are independent. Final Act. 2; Appeal Br. 27–30 (Claims
Appendix). Claim 1 is illustrative:
1. An assay to determine the infectivity of a recombinant viral
vector, the assay comprising:
a. obtaining a recombinant viral vector; and
b. obtaining cells that support replication of said viral vector and
then dividing said cells into a first cell culture and a second cell
culture; and then
c. contacting each of said first cell culture and said second cell
culture with said recombinant viral vector, whereby the vector
particles per cell contacted to said first cell culture is different
from the vector particles per cell contacted to said second cell
culture; and then
d. measuring the total number of cells in each cell culture,
measuring the number of cells in each cell culture that have been
infected with the viral vector, and determining the percentage of
cells in each cell culture which have been infected with the viral
vector; and then
e. calculating a linear response curve to measure relative
infectivity using the Slope Ratio method.
Appeal Br. 27 (Claims Appendix).

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REFERENCES
The Examiner relied upon the following prior art:
Name Reference Date
Weaver et al., Evaluation of Adenoviral Vectors by Flow Cytometry,
21 Methods 297–312 (2000) (“Weaver”)
Candolfi et al., Optimization of adenoviral vector-mediated transgene
expression in the canine brain in vivo, and in canine glioma cells in vitro,
9 Neuro-Oncology 245–58 (2007) (“Candolfi”)
REJECTIONS
Claims Rejected 35 U.S.C. § Reference(s)/Basis
1–9, 35–37 101 Patent Eligibility
1–6 102(a)(1) Weaver
7–9 103 Weaver
12–15, 35–37 103 Weaver, Candolfi
OPINION
Rejection Under 35 U.S.C. § 101
Principles of Law
1. Section 101
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 U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract 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 Court’s two-part framework, described in Mayo and Alice.
Id. at 217–18; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566
U.S. 66, 75–77 (2012). In accordance with that framework, we first
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determine what concept the claim is “directed to.” 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, 67 (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
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 187; 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 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
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formula to a particular technological environment.” Id. (citation omitted)
(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 a 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 (internal 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. (alterations in original) (quoting Mayo, 566 U.S. at 77).
2. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (“USPTO”)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“Guidance”).2 “All USPTO personnel are, as a matter of internal agency
management, expected to follow the guidance.” Id. at 51; see also October
2019 Update at 1.
Under the Guidance and October 2019 Update, we first look to
whether the claim recites:

2 In response to public comments, the Office issued further guidance on
October 17, 2019, clarifying the Guidance. USPTO, October 2019 Update:
Subject Matter Eligibility (“October 2019 Update”) (available at
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019
_update.pdf).
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(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) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial
exception into a practical application (see MPEP §§
2106.05(a)–(c), (e)–(h) (9th ed. Rev. 08.2017, Jan. 2018))
(“Step 2A, Prong Two”).
Guidance at 51–55. The evaluation under Step 2A, Prong Two is performed
by (a) identifying whether there are any additional elements recited in the
claim beyond the judicial exception, and (b) evaluating those additional
elements individually and in combination to determine whether the claim as
a whole integrates the exception into a practical application. See id. at 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, under
Step 2B, 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.
Id. at 52–56.
Analysis
Appellant separately argues independent claims 1 and 35–37. See
Appeal Br. 8, 11, 13. Accordingly, we focus our analysis on these claims.
37 C.F.R. § 41.37(c)(1)(iv). For the reasons explained below, we are not
persuaded that the Examiner erred in finding the claimed subject matter
patent ineligible.
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Claims 1 and 35–37 generally relate to processes or methods of
assessing the infectivity of a viral vector. Appeal Br. 27, 29–30 (Claims
Appendix). A process (or method) is one of the four categories of patent-
eligible subject matter enumerated in 35 U.S.C. § 101. We thus proceed to
Step 2A, Prong 1 of the Guidance.
Guidance Step 2A, Prong 1
Pursuant to Step 2A, Prong 1, we analyze whether the claims recite
any judicial exception(s) to patent eligibility. Guidance at 54.
The Examiner found that the claims describe a correlation between the
presence of infected cells and the presence of infectivity of the viral vector,
which the Examiner found is a consequence of natural processes, “similar to
the naturally occurring correlation found to be a law of nature by the
Supreme Court in Mayo.” Final Act. 5. The Examiner also found that the
steps of “determining percentage of infected cells, calculating a linear
response curve, comparing levels of infectivity, determining infectivity
based on infectivity measurements, could all be performed by a human using
mental steps or basic critical thinking, which are types of activities that have
been found by the courts to represent abstract ideas.” Id.
We agree with the Examiner that the appealed claims recite abstract
ideas. First, the claims recite mental processes. Claim 1, limitation (d)
recites, in relevant part, “determining the percentage of cells in each cell
culture which have been infected with the viral vector,” while limitation (e)
recites “calculating a linear response curve to measure relative infectivity
using the Slope Ratio method.” Appeal Br. 27 (Claims Appendix). Claim
35, step (3) recites “comparing” two levels of infectivity, and step (4) recites
“determining a linear response curve using the Slope Ratio method.” Id. at
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30. Claim 36 recites “calculating by the Slope Ratio method a linear
response curve.” Id. Claim 37 recites “determining the infectivity . . . based
on infectivity measurements.” Id. We agree with the Examiner that these
steps “could all be performed by a human using mental steps or basic critical
thinking.” Final Act. 5. Thus, these limitations fall within at least the
“mental processes” grouping of abstract ideas set forth in the Guidance.
Guidance at 52 (abstract ideas include “(c) Mental processes—concepts
performed in the human mind (including an observation, evaluation,
judgment, opinion”)).
We also agree with the Examiner that the claims recite natural
processes or correlations. For example, step (d) of claim 1 recites:
“determining the percentage of cells in each cell culture which have been
infected with the viral vector.” Appeal Br. 27 (Claims Appendix). Claims
35–37 recite similar steps of determining the level of infectivity of the viral
vector in cell populations. Id. at 29–30. The percentage of cells that have
been infected with viral vector is a consequence of a natural process, which
is a category of judicial exceptions to patentable subject matter. Guidance at
51; see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376
(Fed. Cir. 2015) (finding claims reciting a method of detecting fetal DNA in
a maternal blood sample to be directed to a natural phenomenon).
We additionally find that the steps (i) in claim 1 reciting “determining
a percentage” and “calculating a linear response curve . . . using the Slope
Ratio method,” (ii) in claim 35 reciting “determining a linear response curve
using the Slope Ratio method,” and (iii) in claim 36 reciting “calculating by
the Slope Ratio method a linear response curve,” recite mathematical
calculations and mathematical formulas (the “Slope Ratio method”), and
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thus these limitations fall within at least the “mathematical concepts”
grouping of abstract ideas set forth in the Guidance. Guidance at 52.
Appellant does not appear to dispute that the claims recite mental
processes and natural correlations. See generally Appeal Br. Additionally,
Appellant appears to concede that the claims recite an algorithm, which is a
mathematical concept. See, e.g., Reply Br. 1 (“Mayo thus confirms that the
instant claims are not unpatentable simply because they contain an
algorithm.”). Appellant instead argues that the Examiner has “ignore[d] the
applicable legal standard,” including by failing to consider the claimed
subject matter as a whole. Appeal Br. 6. We are not persuaded by this
argument. Instead, we agree with the Examiner that “the analysis for 101
requires the initial identification of the judicial exception, followed by
analysis of whether the judicial exception is incorporated into a practical
application, and whether there are additional elements that add significantly
more.” Final Act. 7. The Examiner’s rejection follows the prescribed
analysis. We find that the Examiner considered the claims as a whole, e.g.,
by examining the interplay between the judicial exceptions and the
additional elements in the claims, in connection with at least the Step 2A
Prong 2 and Step 2B analyses. Id. at 6–7.
Having found that the claims recite abstract ideas, we proceed to
analyze the claims under Step 2A, Prong 2 of the Guidance.
Guidance Step 2A, Prong 2
“[M]ere recitation of a judicial exception does not mean that the claim
is ‘directed to’ that judicial exception under Step 2A Prong Two.” October
2019 Update at 10. Instead, if the claim as a whole integrates the judicial
exception into a practical application, the claim is not “directed to” a judicial
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exception. Guidance at 54; October 2019 Update at 10. As in the
Mayo/Alice framework, we must look at the claim elements individually and
as an ordered combination to determine whether the additional elements
integrate the recited abstract idea(s) into a practical application, such as an
improvement to technology or to a technical field. Guidance at 54–55. This
analysis is performed “without reference to what is well-understood, routine,
conventional activity.” October 2019 Update 12.
We agree with the Examiner that the judicial exceptions are not
integrated into a practical application. Final Act. 6. The additional elements
of the claim are directed to performing a viral vector assay, e.g., “obtaining a
recombinant viral vector, obtaining cells for a first and second cell culture,
contacting each culture the viral vector (in differing amounts), and
measuring total cells/infected cells, respectively.” Id. These steps involve
mere data gathering, which is not sufficient to integrate the recited judicial
exceptions into a practical application. See Guidance at 55 n.31 (additional
element that merely adds insignificant extra-solution activity to a judicial
exception includes “mere data gathering such as a step of obtaining
information about credit card transactions so that the information can be
analyzed in order to detect whether the transactions were fraudulent”).
Looking at the claimed subject matter as a whole, the limitations reciting the
mental processes, natural correlation, and mathematical concepts do not
refine or limit the assay steps. Rather, the assay steps involve either the
natural correlation itself (measuring total cells/infected cells) or are merely
gathering data for the mental processes and/or mathematical calculations.
See, e.g., In re Grams, 888 F.2d 835, 840 (Fed. Cir. 1989) (finding claims
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directed to performing clinical tests on individuals to obtain input for an
equation to be patent ineligible).
Appellant argues that the Examiner ignores the applicable legal
standard, i.e., Diamond v. Diehr, 450 U.S. 175 (1981). Appeal Br. 6. We
disagree. The Examiner appropriately analyzed the claims pursuant to the
Guidance, which, as noted above, is binding on all Office personnel. See
generally Final Act. 5–7 (evaluating whether claims recite any judicial
exceptions to patentability, whether the judicial exceptions are integrated
into a practical application, and whether the claims include additional
elements sufficient to amount to significantly more than the judicial
exception); Ans. 14–15. The Guidance, in turn, expressly considers, and is
consistent with, Diehr. See, e.g., Guidance 52 n.12, 53 n.16, 55 n.28, 56
n.34 (setting forth analytical framework consistent with Diehr).
Appellant also asserts that Diehr “addressed a fact pattern nearly
identical to the instant case,” because both cases “involve[] an industrial
manufacturing process.” Appeal Br. 6. In particular, Appellant argues that
claim 1 requires “physical actions performed on physical things,” which
“achieves a previously-unattainable goal: industrial-scale manufacture of
recombinant viruses for gene therapy.” Id. at 8. Appellant also argues that
the Examiner’s reliance on cases like Mayo and Grams “is misplaced
because none of those cases involved a physical, industrial manufacturing
process.” Id. at 9–10. Appellant also argues that the method of claim 35 is
integrated into a practical application because the Specification “explains in
detail how the gene therapy industry has suffered from manufacturing-
capacity constrains [sic] due to the lack of an efficient infectivity test, and
how the inventors solved this.” Id. at 12.
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We are not persuaded by these arguments, because they
mischaracterize Appellant’s claims. The claimed processes are directed to
assays to determine the infectivity of a recombinant viral vector. Even if the
claimed assays in turn permit industrial-scale manufacturing of vectors by
“assur[ing] the quality of viral vector produced by large-scale vector
manufacturing processes,” Spec. 1:20, the claims themselves are directed to
the assays, not the vector manufacturing process. See, e.g., October Update
at 12 (“[I]f the specification sets forth an improvement in technology, the
claim must be evaluated to ensure that the claim itself reflects the disclosed
improvement.”). Appellant has not persuasively established that the claims
define an “industrial manufacturing process” like that in Diehr. Cf. Diehr,
450 U.S. at 192–93 (finding that respondents’ claims applied a mathematical
formula in a process of molding rubber products).
Appellant also argues that the Examiner disregards the claimed
physical steps because they “take place prior to the recitation of the judicial
exception,” and “Diehr requires us to consider every claimed step, no matter
when it takes place.” Appeal Br. 10. We are not persuaded that the
Examiner disregarded the claimed physical steps. Rather, as discussed
above, the Examiner appropriately examined the interplay between the
judicial exceptions and the additional elements in the claims. See, e.g., Final
Act. 6–7. When viewed in context, the claimed physical steps merely
involve observing a natural correlation and/or gathering data for the mental
processes and mathematical calculations.
For the above reasons, we determine that the claims do not integrate
the judicial exceptions into a practical application, and therefore the claims
are “directed to” the judicial exceptions themselves.
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Guidance Step 2B
We next determine whether the claims add specific limitation(s)
beyond the judicial exceptions that are not “well-understood, routine,
conventional activity in the field” (see MPEP § 2106.05(d)), or whether they
simply append well-understood, routine, conventional activities previously
known to the industry, specified at a high level of generality, to the judicial
exception. See Guidance at 56.
Here, the additional limitations recited in claim 1 beyond the judicial
exceptions are directed to a viral vector assay. These limitations include:
(a) obtaining a recombinant viral vector; (b) obtaining cells that support
replication of the viral vector, and dividing those cells into two cell cultures;
and (c) contacting each cell culture with different amounts of the viral
vector. Appeal Br. 27 (Claims Appendix). The additional steps of claim 35
are similarly directed to a viral vector assay, comprising determining the
level of infectivity of a viral vector infected in two cell populations at two
ratios. Id. at 29–30. The same is true of claim 36, which recites “exposing
to a viral vector having an expressible transgene, cells that support
replication of said viral vector, the cells exposed to the viral vector in a
particular ratio.” Id. at 30. Finally, the same is true of claim 37, which
involves “infectivity measurements from two cell cultures infected by said
viral vector respectively at a lower viral particle per cell ratio and a higher
viral particle per cell ratio.” Id.
We agree with the Examiner that these additional elements,
considered individually and as an ordered combination, are not sufficient to
transform the judicial exceptions into a patent-eligible invention. See, e.g.,
Bascom Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed.
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Cir. 2016) (“An inventive concept that transforms the abstract idea into a
patent-eligible invention must be significantly more than the abstract idea
itself.”). The steps of the viral vector assays set forth in claims 1 and 35–37
are well-understood, routine, conventional activities known in the art, as
supported by Weaver. Final Act. 6–7. We also agree with the Examiner that
“[s]ince the additional elements are recited at a high level of generality, there
is no meaningful limitation, such as a particular or unconventional reagent
or assay that distinguishes it from well-understood, routine and conventional
reagents/assays known in the art, as seen in Weaver.” Id. at 7.
Appellant does not dispute the Examiner’s findings that the additional
physical steps of the claims are “well-understood, routine, conventional
activities known in the art,” but rather argues that it is irrelevant if they are,
because “Diehr requires us to consider every claimed step, even those that
are conventional.” Appeal Br. 10. This argument does not persuade us of
Examiner error, because the Examiner in fact considered every claimed step.
Moreover, evaluating whether the additional claimed steps are well-
understood, routine, conventional activities known in the art is fully
consistent with Supreme Court precedent. See, e.g., Mayo, 566 U.S. at 79
(“Purely ‘conventional or obvious’ ‘[pre]-solution activity’ is normally not
sufficient to transform an unpatentable law of nature into a patent-eligible
application of such a law.”) (quoting Flook, 437 U.S., at 590); Bilski, 561
U.S., at 610 (“[T]he prohibition against patenting abstract ideas ‘cannot be
circumvented by’ . . . adding ‘insignificant post-solution activity.’”) (quoting
Diehr, 450 U.S. at 191–92).
Appellant additionally argues that claims 35–37 are “modeled” on
claims of issued U.S. patents, and because the Office has “already found”
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that the issued claims comply with Section 101, it would be “arbitrary or
capricious for the agency to find the opposite” here.3 Appeal Br. 11; see
also id. at 11–13. We are not persuaded by this argument. First, every
application is treated on its own merits and treated on its individualized
facts. We are not bound by an Examiner’s findings in a different
application, which may be based on facts not applicable here. Second, the
cited patent claims are not related to viral vector assays, and Appellant does
not explain in what ways the appealed claims purportedly parallel the issued
claims.
In sum, based on the record before us, we are not persuaded that the
Examiner erred in finding the claims to be directed to patent-ineligible
subject matter. Accordingly, we affirm the rejection of claims 1–9 and 35–
37 under 35 U.S.C. § 101.
Anticipation Rejection
The Examiner rejects claims 1–6 under 35 U.S.C. § 102(a)(1) as
anticipated by Weaver. Final Act. 8. The Examiner finds that in claim 1, a
portion of step (d) and step (e) “are steps that can be performed in the human
mind, the results of which are not tied to any tangible method steps.” Id.
The Examiner thus bases the anticipation rejection only on “the active
method steps recited.” Id.
We determine that the Examiner has not established a prima facie case
of anticipation. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). A
patent claim is anticipated “if each and every limitation is found either

3 Appellant argues that (i) claim 35 is modeled on claim 1 of US 10,309,964;
(ii) claim 36 is modeled on claim 1 of US 10,303,846; and (iii) claim 37 is
modeled on claim 22 of US 6,474,159.
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expressly or inherently in a single prior art reference.” King Pharms., Inc. v.
Eon Labs., Inc., 616 F.3d 1267, 1274 (Fed. Cir. 2010). Here, the Examiner
effectively sets aside claim step (e) and a portion of step (d), reasoning that
they are mental processes not tied to any tangible method step. Final Act. 8.
The Examiner, however, provides no persuasive rationale for setting aside
these steps. Cf. id. at 10 (distinguishing claimed steps from printed matter).
The Examiner also supports her anticipation rejection by arguing that
the data shown in Weaver Fig. 1 would inherently result in a linear response
curve. Ans. 8. This is not sufficient to establish anticipation of claims 1–6.
Independent claim 1 recites a particular method, which involves calculating
a linear response curve in a specific manner, i.e., “using the Slope Ratio
method.” Appeal Br. 27 (Claims Appendix). The Examiner does not assert
that Weaver teaches this particular method. That is, even if the data in
Weaver Fig. 1 could result in a linear response curve, the Examiner has not
established that Weaver teaches generating such a curve using the Slope
Ratio method.
Accordingly, because the Examiner has not demonstrated that Weaver
expressly or inherently discloses each and every limitation of claims 1–6, we
reverse the anticipation rejection.
Obviousness Rejections
The Examiner rejected (i) claims 7–9 as obvious over Weaver, and (ii)
claims 12–15 and 35–37 as obvious over Weaver and Candolfi. Final Act.
10, 12. In connection with these rejections, the Examiner has similarly set
aside the mental process steps, and thus has not articulated how Weaver (or
Candolfi) teach or suggest calculating or determining a linear response curve
using the Slope Ratio method, or provided a persuasive rationale for setting
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aside these steps. See id. at 14 (noting that “the claims are rejected on the
basis of the active method steps”); 15 (noting that “[T]he Office is not
asserting that one would have been motivated to calculate a linear response
curve based on Weaver’s teachings.”). Accordingly, we reverse the
obviousness rejection with respect to independent claims 12, 35, and 36, and
claims 13–15, which depend from claim 12, because the Examiner has not
established a prima facie case with respect to the how the prior art teaches or
suggests at least the claims steps directed to calculating or determining a
linear response curve using the Slope Ratio method. We also reverse the
obviousness rejection of claims 7–9, which depend from claim 1, for the
same reasons.
Claim 37 is differently-situated, because it does not require generating
a linear response curve using the Slope Ratio method. Claim 37 recites:
37. A method comprising determining the infectivity of a
recombinant viral vector having an expressible transgene,
relative to a population of cells that support replication of said
viral vector, based on infectivity measurements from two cell
cultures infected by said viral vector respectively at a lower viral
particle per cell ratio and a higher viral particle per cell ratio.
Appeal Br. 30 (Claims Appendix).
The Examiner finds that Weaver discloses “a method that examined
the dose effect of adenovirus on target cells,” where cells were infected with
different m.o.i. (multiplicity of infection), and amounts of hexon protein
were compared between the different m.o.i. in the cell cultures. Final Act.
14–15 (citing Weaver 299, 300, Fig. 1). The Examiner finds that in this
experiment of Weaver, the vector does not include a transgene. Id. at 15.
The Examiner finds, however, that “it would have been obvious to have
performed the same experiment with an adenovirus expressing a transgene,
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since adenovirus is used as a vector,” and that Candolfi “discloses the
production and optimization of adenoviral vectors expressing a transgene.”
Id. (citing Candolfi Abstract). The Examiner also notes that “Weaver
discloses the production of an adenoviral vector carrying a transgene on two
different cell lines with different m.o.i., and detection of infectivity of the
adenoviral vector via hexon protein detection using flow cytometry.” Id. at
13 (citing Weaver 303–04), 15 (citing same portion of Weaver).
We adopt the Examiner’s findings of fact, and agree that claim 37
would have been obvious over Weaver and Candolfi for the reasons the
Examiner articulated. See, e.g., id. at 14–15; Ans. 18–19. We address
Appellant’s arguments below.
Appellant argues that there is no transgene in Weaver, and that the
Examiner found as much. Appeal Br. 23–24 (citing Final Act. 15). The
Examiner did find that the experiment described on page 300 of Weaver had
no transgene, but the Examiner also found that the experiment described on
pages 303–04 of Weaver involved an adenoviral vector carrying a transgene.
See Final Act. 15, 13. Additionally, the Examiner found that Candolfi
motivates inclusion of a transgene in an adenoviral vector. Accordingly, we
find that the Examiner has sufficiently addressed the transgene limitation in
claim 37.
Appellant also argues that Candolfi cannot be combined with Weaver,
because “Weaver’s intended purpose is to provide a generally-applicable
assay that is ‘independent of the particular transgene contained in the
vector,’” whereas Candolfi “teaches to use assays that are transgene-
specific.” Appeal Br. 21–22, 24. We are not persuaded by this argument,
because claim 37 does not require determining infectivity based on
Appeal 2020-003431
Application 15/754,598

19
expression of the transgene. Rather, the claim requires determining
infectivity based on “infectivity measurements from two cell cultures.”
Appeal Br. 30 (Claims Appendix). Nothing in the claim requires that these
measurements be related to transgene expression. Thus, Appellant has not
persuasively established that combining Candolfi and Weaver would “render
the combination unsuitable for Weaver’s intended purpose.” Appeal Br. 22.
CONCLUSION
We affirm the Examiner’s rejection of claims 1–9 and 35–37 under
35 U.S.C. § 101 as patent ineligible.
We reverse the Examiner’s rejection of claims 1–6 under 35 U.S.C.
§ 102(a)(1) as anticipated by Weaver.
We reverse the Examiner’s rejection of claims 7–9 under 35 U.S.C.
§ 103 as obvious over Weaver.
We reverse the Examiner’s rejection of claims 12–15, 35, and 36
under 35 U.S.C. § 103 as obvious over Weaver and Candolfi, but affirm this
rejection with respect to claim 37.
Appeal 2020-003431
Application 15/754,598

20
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–9, 35–37 101 Patent eligibility 1–9, 35–37
1–6 102(a)(1) Weaver 1–6
7–9 103 Weaver 7–9
12–15, 35–
37
103 Weaver, Candolfi 37 12–15, 35,
36
Overall
outcome:
1–9, 35–37 12–15
TIME PERIOD FOR RESPONSE
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)(1)(iv).
AFFIRMED-IN-PART