Ex Parte Sarwal

Patent Trial and Appeal Board

Jan 18, 2017

13144047 (P.T.A.B. Jan. 18, 2017)

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.
13/144,047 11/02/2011 Minnie M. Sarwal STAN-612 1915
77974 7590 01/20/2017
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
PRIEST, AARON A
ART UNIT PAPER NUMBER
1637
NOTIFICATION DATE DELIVERY MODE
01/20/2017 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MINNIE M. SARWAL1
Appeal 2015-006659
Application 13/144,047
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN G. NEW,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a system
for monitoring a subject for an acute rejection response, which have been
rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellant discloses “[ajcute graft rejection (AR) of allograft tissue is
a complex immune response. . . . Early detection of AR is one of the major
clinical concerns in the care of transplant recipients, including kidney
1 Appellant identifies the Real Party in Interest as the Board of Trustees of
the Leland Stanford Junior University. (App. Br. 3.)
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transplant recipients.” (Spec. 1:17—23.) Appellant’s invention relates to
“[mjethods ... for monitoring a subject having a graft for an acute rejection
(AR) response, e.g., to predict, to diagnose, and/or to characterize an AR
response, including graft survival in a subject... [as well as] compositions,
systems, kits and computer program products that find use in practicing the
subject methods.” (Id. at 2:2—8.)
Claims 12, 13, 22—24, and 34^46 are on appeal. Claim 12 is
illustrative:
12. A system for monitoring a subject who has received an
allograft for an acute rejection (AR) response, said system
comprising:
(a) a gene expression evaluation element configured for
evaluating the expression level of a first gene and a second gene
in a sample from said subject to obtain a gene expression result,
wherein said first gene is RNF-130, wherein said second gene is
selected from the group consisting of NKTR, MAPK9, DUSP1,
PBEF1, PSEN1, CFLAR, IFNGR1, ITGAX and RYBP, and
wherein said gene expression evaluation element comprises a
collection of gene specific primers or probes designed to
selectively amplify said first gene and said second gene, wherein
at least one of the gene specific primers or probes comprises a
directly detectable label or a label selected from: biotin,
fluorescein, digoxigenin, an antigen, a polyvalent cation, and a
chelator group; and
(b) a phenotype determination element, wherein said
phenotype determination element is a reference expression
profile for said first gene and said second gene, wherein the
reference expression profile was obtained from a sample from a
patient with an AR response.
(App. Br. 22 (Claims App’x).)
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Application 13/144,047
The claims stand finally rejected by the Examiner as follows:
I. Claims 12, 13, 22, 23, 34-42, and 44-46 as anticipated under
35 U.S.C. § 102(b) by Gow.2 (Final Act. 11 and 13.)
II. Claims 12, 13, 22—24, and 34-46 as anticipated under 35
U.S.C. § 102(e) by Palucka.3 (Final Act. 11-13.)
REJECTION I
Issue
The Examiner rejected claims 12, 13, 22, 23, 34-42, and 44-46 as
being anticipated by Gow. Appellant argues the patentability of the claims
as a group. We select claim 12 as representative. 37 C.F.R.
§41.37(c)(l)(iv).
The Examiner finds that “GOW teaches an assay system [e.g.,
Affymetrix HU133A microarray] . . . which comprises: (a) probes to at least
RNF-130, DUSP1, PBEF1, NKTR, CFLAR, PSEN1, ITGAX and RYBP . . .
and (b) control expression profiles (control genes on Affymetrix chip and/or
control ‘normal/healthy controls’ samples with ‘expression profile’ for
claimed genes.” (Final Act. 11; see also Ans. 4.)
2 Gow et al., WO 2006/082390 Al, published Aug. 10, 2006. In the
Answer, the Examiner includes claims 24 and 43 in the heading concerning
claims anticipated by Gow. (Ans. 4.) This is, however, inconsistent with
the rejection in the Sept. 18, 2014 Final Action (Final Act. 11), which did
not identify those claims as anticipated by Gow. In neither the Answer nor
the Final Action did Examiner make findings that Gow disclosed the
elements of claims 24 and 43. We thus interpret their inclusion in the
rejection as inadvertent error and do not consider whether Gow anticipates
claims 24 or 43 as an issue before us.
3 Palucka et al., EP 2 080 140 Bl, published Apr. 24, 2013.
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According to the Examiner, “[t]he ‘phenotype determination element’
[limitation (b) of claim 12] does not receive weight in the claim because it
constitutes either of (a) merely an intended use; and/or (b) mere instructions
that do not add a new and unobvious functional relationship between the
printed matter and the substrate.” (Final Act. 13—14; see also Adv. Act. 2.)
The Examiner asserts “an intended use of a product receives no
weight where the body of a product claim sets forth the structural limits of
the product. . . [and Examiner finds] the only structure in the body of the
system/product claim constitutes the primers and/or probes of element (a).”
{Id. at 14.) Further, according to the Examiner, “the claims encompass a
primer and/or probe and a sheet of paper comprising an ‘expression profile.’
Hence, the claims encompass merely instructing an artisan who uses the
primers and/or probes of element (a) to compare an ‘expression profile’ to
(presumably) other expression profiles.” {Id. at 14—15; see also id. at 4 (“a
‘phenotype determination element’ ... is an abstract idea .... For example,
a person could look at the ‘expression profile’ of a gene from component (a)
and compare it in their mind to an ‘expression profile’ of the same gene
from any source (e.g., ‘reference or control expression profile’ created by
others)”); Ans. 8 (“the ‘phenotype determination element’ encompasses both
tangible, physical elements such as computers and databases and abstract
numbers (i.e., ‘values’)”).)
Appellant does not dispute that Gow discloses limitation (a) of claim
12. (App. Br. 17—18.) Appellant, instead, argues the “Examiner has erred
in giving no patentable weight to element (b)” of claim 12. (Id. at 5.)
According to Appellant, the Specification, which describes examples of
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expression profiles provided in databases and computer media, reveals that
the “the claimed phenotype determination element is far from an abstract
idea . . . but rather [is] a specific and tangible element of the claims which
has patentable weight.” (Id. at 5—6.) Appellant further argues the Examiner
is incorrect in asserting that limitation (b) is merely an intended use of
limitation (a) of claim 12. (Id. at 6 and 18.) Rather, according to Appellant,
“[ejlement (b) is a collection of values that can be used after one uses
element (a)” and thus provides a “standard” by which test values in element
(a) may be compared. (Id. at 18.) If limitation (b) is given patentable
weight, Appellant argues, Gow cannot anticipate claim 12 because Gow
“fails to teach a reference expression profile for RNF-130 (alone or in
combination with additional genes), where the reference expression profile
was obtained from a sample from a patient with an AR response.” (Id. at
18.)
On appeal, we determine whether the Examiner established by a
preponderance of the evidence that Gow anticipates claim 12.
Principles of Law
“Where the printed matter is not functionally related to the substrate,
the printed matter will not distinguish the invention from the prior art in
terms of patentability.” In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983);
see also In reNgai, 367 F.3d 1336, 1338 (Fed. Cir. 2004) (affirming the
PTO’s rejection under § 102 where “the only difference between the prior
art and [the claims] is the content of the [printed matter]” and where the
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“content of the [printed matter] was not ‘functionally related’ to the
[claimed] kit.”)
Analysis
We adopt the Examiners findings of fact concerning the scope and
content of Gow. (Final Act. 11 and 14; see also Ans. 4—6.)
We begin with claim construction because it is a necessary
prerequisite to comparing the claims to the prior art. During prosecution, we
give claim terms the broadest reasonable interpretation as understood by a
person of ordinary skill in the art in light of the specification. In re Morris,
127 F.3d 1048, 1054 (Fed. Cir. 1997); In re Am. Acad. OfSci. Tech. Ctr.,
367 F.1359, 1364 (Fed. Cir. 2004) (“Construing claims broadly during
prosecution is not unfair to the applicant. . . because the applicant has the
opportunity to amend the claims to obtain more precise claim coverage.”)
Fimitation (b) of claim 12 reads: “(b) a phenotype determination
element, wherein said phenotype determination element is a reference
expression profile for said first and said second gene, wherein the reference
expression profile was obtained from a sample from a patient with an AR
response.” We look to the Specification, which discloses:
The terms “reference” and “control” are used interchangebly to
refer to a known value or set of known values against which an
observed value may be compared. As used herein, known means
that the value represents an understood parameter, e.g., a level of
expression of a marker gene in a graft survival or loss phenotype.
(Spec. 8:13—17.) The Specification further discloses
[t]he terms “reference” and “control” as used herein mean a
standardized pattern of gene expression or levels of expression
of certain genes to be used to interpret the expression signature
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of a given patient with respect to an AR response. The reference
or control profile may be a profile that is obtained from a
cell/tissue known to have the desired phenotype, e.g., having an
AR phenotype, and therefore may be a positive reference or
control profile.
{Id. at 22:29-23:1; see also id. at 23:5—12.) Also, per the Specification,
[t]he subject systems and kits may also include a phenotype
determination element, which element is, in many embodiments,
a reference or control expression profile that can be employed,
e.g., by a suitable computing means, to make an AR phenotype
determination based on an “input” expression profile, e.g., that
has been determined with the above described gene expression
evaluation element. Representative phenotype determination
elements include databases of expression profiles, e.g., reference
or control profiles, as described above.
{Id. at 29:11—17.)
The Specification describes examples where “databases of expression
profiles of AR responses” are provided and discloses “[t]he expression
profiles and databases thereof may be provided in a variety of media to
facilitate their use (e.g., in a user-accessible/readable format),” such as
computer-readable optical or magnetic storage media. {Id. at 25:10-30.)
The Specification discloses, however, that the invention is not to be limited
to any recited examples or embodiments. {Id. at 51:4—19.)
Based on the claim language and the Specification, we thus interpret
limitation (b) of claim 12 as “a known value representing the expression
(e.g., level of expression) of said first gene and said second gene for an AR
phenotype/response.” Neither the claims nor the Specification restrict the
media or means by which this value may appear. Accordingly, although it
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could be stored in a computer database, claim 12 also encompasses, for
instance, a value written on a sheet of paper. (Final Act. 15; Ans. 8—11.)
We next turn to whether limitation (b), so construed, should be given
patentable weight in claim 12 as a whole. As noted above, the Examiner
determined that limitation (b) was printed matter or an intended use of the
structure recited in the claim, and thus did not distinguish over the prior art.
(Final Act. 13—15.) If, instead, limitation (b) is neither printed matter nor an
intended use, then limitation (b) will lend patentable weight and will
distinguish claim 12 over Gow. Although Gow discloses reference/control
profiles (Ans. 4), as Appellant points out, Gow relates to a genetic assay for
diagnosing a different condition — chronic fatigue syndrome — not acute
rejection (AR) response as recited in limitation (b) of claim 12. (App. Br.
17—18; Reply Br. 6.) Because there are no findings from the Examiner that
Gow teaches a system including a reference expression profile for an AR
response, resolution of the printed matter and intended use issues is decisive.
In addressing the printed matter issue, we look to the Federal Circuit’s
guidance. As that Court has explained, “if a limitation claims (a) printed
matter that (b) is not functionally or structurally related to the physical
substrate holding the printed matter, it does not lend any patentable weight
to the patentability analysis . . . [The printed matter] may not be the basis
for distinguishing prior art.” In re DiStefano, 808 F.3d 845, 848 (Fed. Cir.
2015) (citing In re Gulack). Accordingly, there are two questions before us
with respect to limitation (b) of claim 12: whether the limitation is printed
matter and, if it is, whether the limitation provides the necessary structural or
functional relationship with the substrate?
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We answer the first question in the affirmative. Limitation (b) is
printed matter because it claims the content of information — values that
represent genetic expression information for an AR phenotype. As
discussed above, claim 12 encompasses such values presented in any
tangible or intangible form, including on a sheet of paper.4
Regarding the second question, we agree with the Examiner that the
printed matter of limitation (b) does not have the required functional
relationship with the substrate. (Final Act. 13—14; see also Adv. Act. 2.)
Inasmuch as the value may be recorded on any substrate or medium,
including a piece of paper as discussed, we perceive no new or nonobvious
structural or functional relationship between the information and the
substrate. When we juxtapose with claims of other cases where the required
relationship between the printed matter and the substrate did exist,5
4 In DiStefano, the Federal Circuit reversed the Board’s determination that
the claimed “origin” of the web assets was printed matter. In re DiStefano,
808 F.3d at 851. According to the Court, “where the information came
from, its ‘origin,’ [i.e., from third-party authors] is not part of the
informational content at all.” (Id.) The present appeal is distinguishable.
Fimitation (b) of claim 12 recites that the “reference expression profile was
obtained from a sample from a patient with an AR response,” which might
be described as the “origin” of the expression values. Unlike DiStefano,
however, the source of the information (i.e., value(s)/expression profile) is
part of the content here. It is important that the values derived from a patient
with an AR response in order to associate the value with the AR phenotype.
Otherwise it would simply be a value of an unknown phenotype.
5 See, e.g., In re Gulack, 703 F.3d at 1386—87 (finding a functional
relationship where the claimed band physically supported the claimed digits
and the digits were uniquely positioned to exploit the endless nature of the
band); In re Lowry, 32 F.3d 1579, 1584 (Fed. Cir. 1994) (finding that printed
matter did not apply to data structures comprising a plurality of attribute data
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Appellant’s claim 12 falls short. The value is, at best, an instruction that
suggests how one might compare an expression profile of a subject with an
expression profile for an AR response. Yet limitation (b) encompasses
values without restricting the means by which the information is presented,
stored, or compared, such that a functional connection between limitation (b)
and the rest of the claim, assuming it did exist, could be nothing more than
review of information undertaken by the human mind. In sum, we are not
persuaded claim 12 in its present form properly defines the requisite
functional relationship.
For these reasons, we agree with the Examiner that limitation (b) is
printed matter that does not distinguish claim 12 over Gow.
We turn to the Examiner’s alternative determination that limitation (b)
of claim 12 is merely an intended use of limitation (a). The Examiner finds
that limitation (b) encompasses abstract numbers intended to be generated
using the primers or probes of element (a) in claim 12. (Ans. 12.) We are
not persuaded. Although we agree the skilled person could generate values
for limitation (b) by use of probes, limitation (b) requires a known value for
an AR phenotype. Moreover, as limitation (b) requires values — in
whatever printed matter form they may exist — limitation (b) does not
objects (ADO) that “contain both information used by application programs
and information regarding their physical interrelationships within a
memory” as “[Appellant’s] claims dictate how application programs manage
information . . . and define functional characteristics of the memory.”); In re
Miller, 418 F.2d 1392, 1395-96 (CCPA 1969) (finding a functional
relationship for the claimed spoon having printed volumetric units and a
legend (indicating correct ratio/volume) on the spoon).
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include the type of language that is characteristic of a limitation drawn to
intended use.
As to Appellant’s argument that limitation (b) is “a specific and
tangible element of the claims which has patentable weight” (Appeal Br. at
5—6), we agree in part. Limitation (b) does relate to specific values and, in
embodiments such as a value written on paper, may even be tangible. But
limitation (b) may still recite printed matter. For the reasons discussed
above, we conclude that it does and that the limitation, thus, does not
patentably distinguish over Gow.
In the Appeal Brief, Appellant contends its “arguments are not based
on the intended use of the claimed systems, but rather that element (b) is a
structural and tangible element that must be given weight.” (App. Br. 7.)
Further to this point, Appellant argued “prohibitions of importing
limitation[s] from the preamble that define an ‘intended use’ of the claims, is
simply not relevant to the presently claimed invention.” (Id.) In the Reply
Brief, Appellant offered a new argument: “that the invention as claimed is
limited to a system of monitoring AR” as recited in the preamble and that
“limitations within the claim preamble give[] necessary meaning to the
claim.” (Reply Br. 6—7.)
We are not persuaded. First, ordinarily, and absent a showing of good
cause, the Board does not consider new argument or evidence submitted for
the first time in the Reply Brief. 37 C.F.R. § 41.41(b)(1) & (2). But even
considering Appellant’s argument, claim 12 is directed to a system, not a
method. And the preamble reflects intended use language in the claim.
Whether that language is in the claim’s preamble or the body, we assess the
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patentability of the system based on structural differences, if any, between
the claim and the prior art. Catalina Mktg. Int’l, Inc. v. Coolsavings.com,
Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) (“[T]he patentability of apparatus or
composition claims depends on the claimed structure, not on the use or
purpose of that structure.”); Hewlett-Packard Co. v. Bausch & Lomb Inc.,
909 F.2d 1464, 1468 (Fed. Cir. 1990) (“[Ajpparatus claims cover what a
device is, not what a device does.”) To the extent there are differences
between the prior art and claim 12, it resides in the content of printed matter
as discussed.
Appellant’s argument that the reference expression profile provides a
necessary functional relationship such that it is not printed matter and thus
should be given patentable weight (Reply Br. 3—5) is unpersuasive for the
reasons provided above.
Conclusion of Law
We conclude that the Examiner established by a preponderance of the
evidence that claim 12 is anticipated by Gow. Claims 13, 22, 23, 34-42, and
44-46 have not been argued separately and fall with claim 12.
REJECTION II
The Examiner rejected claims 12, 13, 22—24, and 34-46 as being
anticipated by Palucka. (Final Act. 11—13; Ans. 5—6.) We adopt the
Examiner’s findings of fact concerning the scope and content of Palucka.
Appellant’s arguments concerning the rejection over Palucka are
substantially the same as its arguments concerning the rejection over Gow
(Rejection I). (Appeal Br. 18—19; Reply Br. 5—9.) Just as with Rejection I,
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Appellant argues that if limitation (b) of the claims is entitled to patentable
weight, then the claims are not anticipated by Palucka, which Appellant
contends “is concerned with patients having metastatic melanoma, not an
AR response.”6 (App. Br. 19.) Because limitation (b) recites printed matter
that is not entitled to patentable weight as previously discussed, we conclude
that the Examiner established that claims 12, 13, 22—24, and 34-46 are
anticipated by Palucka. Appellant’s arguments concerning the rejection over
Palucka are unpersuasive for the reasons provided concerning Rejection I.
SUMMARY
We affirm the rejection of claims 12, 13, 22, 23, 34-42, and 44-46 as
anticipated under 35 U.S.C. § 102(b) by Gow.
We affirm the rejection of claims 12, 13, 22—24, and 34-46 as
anticipated under 35 U.S.C. § 102(e) by Palucka.
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).
AFFIRMED
6 We note, however, that Palucka teaches “[ejxamples of diseases or
conditions for analysis using the present invention include, e.g., autoimmune
disease, a viral infection [or] bacterial infection, cancer and transplant
rejection.” (Palucka 112 (emphasis added).)
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