Ex Parte Khatib

Patent Trial and Appeal Board

Dec 14, 2018

14074685 (P.T.A.B. Dec. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/074,685 11/07/2013 Hasan Khatib
39290 7590 12/14/2018
DUANE MORRIS LLP - DC
505 9th Street
Suite 1000
WASHINGTON, DC 20004-2166
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
153629-00030 1040
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
MAIL DATE DELIVERY MODE
12/14/2018 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HASAN KHATIB
Appeal 2017-011299
Application 14/074,685
Technology Center 1600
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
method of genetically selecting cattle for increasing milk fat yield or milk fat
percentage. The Examiner rejected the claims as indefinite, directed to non-
statutory subject matter, and anticipated. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
1 Appellant identifies the Real Party in Interest as the Wisconsin Alumni
Research Foundation (see App. Br. 2).
2 We have considered and herein refer to the Specification of Aug. 28, 2015
("Spec."); Final Office Action of Sept. 12, 2016 ("Final Act."); Appeal Brief
of Mar. 1, 2017 ("App. Br."); Examiner's Answer of July 6, 2017 ("Ans.");
and Reply Brief of Sept. 4, 2017 ("Reply Br.")
Appeal2017-011299
Application 14/074,685
Statement of the Case
Background
"Dairy cows are significant investments for dairy farmers, and ...
systematic animal breeding programs and artificial insemination, have been
and continue to be invested in ensuring that the ... milk produced is of high
quality or has desired composition" (Spec. ,r 4). "[S]election based purely
on phenotypic characteristics does not efficiently take into account genetic
variability caused by complex gene action and interactions, and the effect of
environmental and developmental variants" (Spec. ,r 6). "Marker-assisted
selection can lower the high cost and reduce the extended time commitment .
. . [ t ]herefore, there is [] a need for genetic markers for improved milk
production traits" (Spec. ,r 7).
The Claims
Claims 20-26, 29, and 30 are on appeal. The Examiner has
withdrawn the rejections of claims 20-26 (Final Act. 2; Ans. 11 ). Claims 29
and 30 remain under review (Reply Br. 2).
Independent claim 29 is representative and reads as follows:
29. A method for increasing milk fat yield or milk fat
percentage of dairy cattle, the method comprising determining
the nucleotide identity of position 213 of the bovine signal
transducer and activator of transcription (ST AT 1) gene of a
cow, wherein the STATl gene comprises a nucleotide sequence
of SEQ ID NO: 2, and using a cow which has cytosine at the
position for milk production.
The Issues
A. The Examiner rejected claims 29 and 30 under 35 U.S.C. § 112 (pre-
AIA), second paragraph as being indefinite (Final Act. 4--6; Ans. 2).
2
Appeal2017-011299
Application 14/074,685
B. The Examiner rejected claim 29 under 35 U.S.C. § 102(e) as being
anticipated by Raadsma3 (Final Act. 14--17; Ans. 8-11).
C. The Examiner rejected claims 29 and 30 under 35 U.S.C. § 101, as
being directed to non-statutory subject matter (Final Act. 8-13; Ans. 3-8).
A. 35 U.S.C. § 112, second paragraph
The Examiner finds the recitation of "using a cow which has cytosine
at the position for milk production" in claim 29 "vague and unclear" (Ans.
3). In particular, the Examiner finds that "[i]t is unclear if merely breeding
[a] cow is considered using it for milk production or if it requires something
in addition to breeding" (id.).
Appellant further contends that "claim 29 does not recite a breeding
step" and that "there is simply nothing unclear to one of ordinary skill[] in
the art in regard to using a cow for milk production" (App. Br. 8).
Appellant's position is consistent with the claim language. Claim 29
is directed to a method for increasing milk fat yield or milk fat percentage of
dairy cattle including the step of using a cow for milk production. The plain
meaning of the claim requires the production of milk, i.e., milking, as would
be recognized by one of ordinary skill in the art. While the scope of the
claim allows for a broad range of activities, "breadth is not to be equated
with indefiniteness." In re Miller, 441 F.2d 689, 693 (CCPA 1971).
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that claim 29 is indefinite.
3 Raadsma et al., WO 2007/050735 A2, published May 3, 2007.
3
Appeal2017-011299
Application 14/074,685
B. 35 U.S.C. § 102(e) over Raadsma
The Examiner finds "Raadsma teaches the 200 nucleotide sequence of
SEQ ID NO 14915 [page 8] which comprises a portion of the claimed SEQ
ID NO 2 with a Y at position 213 which encompasses a T, U, or C" (Ans. 9).
The Examiner further finds "Raadsma teaches selecting an animal for milk
fat yield, which anticipates the breadth of the using step of the claim ...
[ abstract, page 7]" (Ans. 11; see also Ans. 16, citing Raadsma abstract,
pages 2, 7, 8).
The issue with respect to the rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that Raadsma
anticipates claim 29?
Findings of Fact
1. Raadsma teaches a method for
managing an animal, wherein said animal is selected according
to the method of any one of the first to twentieth aspects.
The management of the animal may comprise
determining whether the animal is to be used for breeding
purposes or production purposes .... This determination may
be made in the context of any one of the traits selected from ...
milk fat yield
(Raadsma 7: 4--10).
2. Raadsma teaches "[t]he methods of the invention are applicable
to animals including but not limited to cattle" (Raadsma 7:32-33).
3. Raadsma teaches a "second aspect" as:
a method for selecting an animal for milk fat yield, wherein said
method comprises:
(a) analyzing a nucleic acid sample from said animal
for a polymorphism in at least one genetic marker selected from
the group set out in Table 2; and
4
Appeal2017-011299
Application 14/074,685
(b) selecting the animal based on the presence or
absence of the polymorphism in the at least one genetic marker,
wherein the polymorphism is predictive of milk fat yield.
(Raadsma 2: 11-1 7).
4. Raadsma teaches: "a sequence listing of SEQ ID NOS: 1-
15380 reflecting the identity of the genetic markers referred to herein,
including details of relevant polymorphisms and flanking sequence of [the]
same" (Raadsma 8: 11-14).
5. Raadsma teaches SEQ ID NO. 14915 as a genetic marker
having a positive value for fat yield in Table 2 (see Raadsma 16:2-11;
108:1; 118,col.6).
Principles of Law
The Examiner bears the initial burden of establishing a prima facie
case of anticipation. In re King, 801 F.2d 1324, 1326-27 (Fed. Cir. 1986).
Anticipation under 35 U.S.C. § 102 requires that "each and every element as
set forth in the claim is found, either expressly or inherently described, in a
single prior art reference." In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
1999).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 8-11; FF 1-5) and agree that the
claim is anticipated by the prior art. We address Appellant's arguments
below.
Appellant contends
[t]here is ... no mention whatsoever in Raadsma that a
particular SNP is correlated with desired high milk fat content .
. . . Raadsma does not in any way teach or suggest that the
5
Appeal2017-011299
Application 14/074,685
sequence has any biological meaning, not to mention a milk
production method based thereupon
(Reply Br. 9).
We find this argument unpersuasive because Raadsma teaches
selecting cattle for milk fat yield (FF 1-3) wherein specific genetic markers,
such as SEQ ID NO. 14915, which includes a cytosine at position 213 of the
STATl gene, are correlated with a positive value for milk fat yield (FF 5).
Appellant contends that "the 'using a cow for milk production'
recitation is not indefinite," and is therefore, a required element of the claim.
(App. Br. 12). As part of this discussion, Appellant argues that as long as
the steps of claim 29 are performed, "the resultant cows will necessarily
have the trait of improved or increased milk yield production" (App. Br. 7).
As discussed above, we agree with Appellant that the recitation is not
indefinite; however, we find that this element is taught in the prior art.
In particular, Raadsma teaches managing cattle by "determining
whether the animal is to be used for breeding purposes or production
purposes" based on genetic traits, including milk fat yield (FF 1, 2).
Because Raadsma teaches using a cow for milk production based on genetic
traits, including the cytosine substitution at position 213 of the STATl gene,
any resulting increase in milk fat yield is an inherent result of the known use.
"'Newly discovered results of known processes directed to the same purpose
are not patentable because such results are inherent."' In re Montgomery,
677 F.3d 1375, 1381 (Fed. Cir. 2012).
Conclusions of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that claim 29 is anticipated.
6
Appeal2017-011299
Application 14/074,685
C. 35 U.S.C. § 101, non-statutory subject matter
The Examiner finds that claim 29 is directed to "a naturally occurring
correlation between a cytosine at a position corresponding to position 213 of
SEQ ID NO 2 with improving milk fat yield or milk fat percentage" (Ans.
4). The Examiner finds "[ w ]hile this correlation was identified by applicants
in the accompanying specification, the correlation existed in nature prior to
the discovery of the claimed correlation or judicial exception by applicants"
(Ans. 5). The Examiner further finds
the claim provides routine, conventional, well understood steps
[in] addition to the natural correlation or judicial exception.
These steps are generic as they provide no specific reagents,
conditions, or guidance such [that] these additional steps fail to
provide a further inventive concept.
Further, the claims do not recite any elements or steps
that do more than describe the judicial exceptions with
instructions for applying it.
(Ans. 6). The Examiner concludes "the claims are not considered to recite
something significantly different than a judicial exception and thereby are
not directed to patent eligible subject matter" (Ans. 8).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that claim 29 is directed to non-
statutory subject matter?
Findings of Fact
6. The Specification teaches "[t]he present invention relates to a
method of cattle progeny testing using molecular genetic methods by
assaying for the presence of at least one genetic marker which is indicative
of ... milk fat content" (Spec. ,r 3).
7
Appeal2017-011299
Application 14/074,685
7. The Specification teaches "[b ]y direct sequencing of genomic
DNA, a single nucleotide polymorphism (SNP) in the EST corresponding to
STAT] (GenBank accession number A W289395) at position 213 was
identified" (Spec. ,r 80).
8. The Specification teaches that prior art data was used to
conduct an analysis of milk properties, specifically "[ d]aughter yield
deviations (DYD) data for milk yield, milk protein and fat yields, milk
protein and fat percentages, ... were obtained from the Animal
Improvement Programs Laboratory" and "[ w ]eighted least squares analysis
was employed to study the effects of STAT] variants on production and
function traits" (Spec. ,r,r 80, 81 ).
9. The Specification teaches that "[t]he observed effects of the
bovine STAT] on milk composition ... was not surprising because" of prior
art associations of STATl with the hormone prolactin (Spec. ,r,r 83-85).
10. The Specification teaches "a significant association between
different haplotypes of the protease inhibitor gene and several production
traits in Holstein dairy cattle including milk yield, milk fat yield ... was
found (Khatib et al. 2005). Using this approach STAT] was chosen as a
candidate gene affecting milk production traits" (Spec. ,r 87).
Principles of Law
[W]e set forth a framework for distinguishing patents that claim
laws of nature, natural phenomena, and abstract ideas from
those that claim patent-eligible applications of those concepts.
First, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts. If so, we then ask,
"[w]hat else is there in the claims before us?" To answer that
question, we consider the elements of each claim both
individually and "as an ordered combination" to determine
whether the additional elements "transform the nature of the
8
Appeal2017-011299
Application 14/074,685
claim" into a patent-eligible application. We have described
step two of this analysis as a search for an "inventive concept"
-i.e., an element or combination of elements that is "sufficient
to ensure that the patent in practice amounts to significantly
more than a patent upon the [ineligible concept] itself."
Alice Corp. Pty. Ltd. v. CLS Banklnt'l, 134 S. Ct. 2347, 2355 (2014).
We agree with and adopt the Examiner's findings of fact and
reasoning regarding the conclusion that claim 29 is unpatentable as being
directed to non-statutory subject matter consistent with binding precedent
(Ans. 4--8; FF 1-10). We address Appellant's arguments below.
Appellant contends
even though the two claims under review recite a naturally
occurring phenomenon ( a correlation between a particular SNP
and the milk production ability of the dairy cow having such a
SNP), they also recite additional elements or steps, which, when
viewed as a whole, add meaningful limits on the use of the
correlation. The totality of these steps integrates the correlation
into the claimed methods, and amounts to more than merely
detecting the SNP, and instructing a breeder or a dairy farmer to
"apply it."
(Reply Br. 7).
We do not find this argument persuasive because Appellant fails to
identify how the additional steps, when viewed as a whole, add meaningful
limits on the use of the correlation. Applying the first step of the two step
test in Mayo and Alice, we agree with the Examiner that the correlation
between cytosine at position 213 of the STATl gene and increased milk fat
yield/percentage is directed to a patent ineligible concept, specifically
natural laws regarding genetic information that controls milk production in
cows. The method of increasing (i.e., optimizing) milk fat yield/percentage
by identifying a natural correlation is factually similar to Mayo, where the
9
Appeal2017-011299
Application 14/074,685
"method of optimizing therapeutic efficacy" was a based on identifying
naturally occurring levels of thioguanine. See Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 566 U.S. 66, 74 (2012). Like Mayo, the relation
between the naturally occurring SNP and increased milk production "exists
in principle apart from any human action" and is a consequence of "entirely
natural processes." Id. at 77.
Appellant contends that "the combination of steps, when viewed as a
whole, is not routine and conventional, and ensures that the selected dairy
cattle [] possess unexpected, inventive characteristics, as opposed to dairy
cattle not subjected to such selection" (Reply Br. 7-8).
We do not find Appellant's argument persuasive. "Mayo demanded
that, when a claim involves ... a law of nature ... eligibility under section
101 requires that the claim involve 'enough' else-applying the idea in the
realm of tangible ... physical actions (for process claims}--that is beyond
'well-understood, routine, conventional activity."' SmartGene, Inc. v.
Advanced Biological Laboratories, SA, 555 F. App'x 950, 955 (Fed. Cir.
2014).
Under the second step of the two-step test, we find that claim 29 does
not add "significantly more" to the natural law of milk production in dairy
cattle. Each step of claim 29 is a routine, prior art, conventional activity as
acknowledged by Appellant's own Specification and evidenced by Raadsma.
For example, the step of determining the nucleotide identify uses known
sequencing techniques (FF 3, 7). The step of correlating the effects of
STATl variants relies on known statistical techniques and a prior art dataset
(FF 3-5, 8). The "selecting" step of using a cow which has cytosine at the
position for milk production simply refers to the conventional process of
10
Appeal2017-011299
Application 14/074,685
using cattle based on phenotypes that had already been catalogued in the
prior art dataset (FF 3-5, 8). Thus, Appellant does not identify an inventive
concept that is more than applying routine, conventional steps to a natural
phenomenon specified at a high level of generality. See Ariosa Diagnostics,
Inc. v. Sequenom, Inc., 788 F.3d 1371, 1378 (Fed. Cir. 2015).
Appellant contends that "[ c ]laim 29 recites a milk production method,
and is only one of the many possible aspects of how the correlation can be
applied, thus does not preempt its application. Claim 30 further limits the
use [to] homozygous cows" (Reply Br. 8).
We find this argument unpersuasive because "[ w ]hile preemption may
signal patent ineligible subject matter, the absence of complete preemption
does not demonstrate patent eligibility." Ariosa, 788 F.3d at 1379.
Importantly, the preemption concern is addressed by the two-part test
considered above. See id. After all, every patent "forecloses ... future
invention" to some extent, Mayo, 566 U.S. at 86, and, conversely, every
claim limitation beyond those that recite the abstract idea limits the scope of
the preemption.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that claim
29 is directed to non-statutory subject matter.
SUMMARY
In summary, we reverse the rejection of claims 29 and 30 under
35 U.S.C. § 112, second paragraph.
We affirm the rejection of claim 29 under 35 U.S.C. § 102(e) as
anticipated by Raadsma.
11
Appeal2017-011299
Application 14/074,685
We affirm the rejection of claim 29 under 35 U.S.C. § 101, as being
directed to non-statutory subject matter. Claim 30 falls with claim 29.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a).
AFFIRMED
12