Ex Parte Uchiyama et al

Patent Trial and Appeal Board

Mar 12, 2018

14034824 (P.T.A.B. Mar. 12, 2018)

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.
14/034,824 09/24/2013 Shigeto UCHIYAMA Q206859 9942
23373 7590 03/14/2018
SUGHRUE MION, PLLC
2100 PENNSYLVANIA AVENUE, N.W.
SUITE 800
WASHINGTON, DC 20037
EXAMINER
MARX, IRENE
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
03/14/2018 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):
PPROCESSING@SUGHRUE.COM
sughrue@sughrue.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHIGETO UCHIYAMA, TOMOMIUENO,
and TOSHIMI SUZUKI1
Appeal 2017-005387
Application 14/034,824
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
composition comprising a specific strain of bacteria, which have been
rejected for lack of adequate description in the Specification and for being
directed to a product of nature. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as Otsuka Pharmaceutical
Co., Ltd. (Br. 2.)
Appeal 2017-005387
Application 14/034,824
STATEMENT OF THE CASE
The Specification states that “it is reported that equol as the active
metabolite of soy isoflavone is a key factor in the expected efficacies in
clinical application.” (Spec. 1.) “The present invention relates to equol-
producing lactic acid bacterial strain [and] a composition comprising said
lactic acid bacterial strain.” (Id.) “A specific example of said lactic acid
bacterial strain is Lactococcus 20-92 (FERM BP-10036).” (Id. at 4.)
Claims 1 and 7—9 are on appeal.2 Claims 1 and 9 are illustrative and
reads as follows:
1. A composition comprising Lactococcus garvieae 20-92
deposited under accession number FERM BP-1003 6, and an
effective amount of an added preservative.
9. A composition comprising Lactococcus garvieae 20-92
deposited under accession number FERM BP-1003 6, wherein
said composition is in the form of fermented milk or fermented
soy milk, said fermented milk or fermented soy milk having
been fermented by said Lactococcus garvieae 20-92.
The claims stand rejected as follows:
Claims 1, 7, and 8 under 35 U.S.C. § 112, first paragraph, for failing
to comply with the written description requirement (Final Action3 3), and
Claims 1 and 7—9 under 35 U.S.C. § 101 as being directed to a natural
product (Final Action 4—5).
2 Claims 2 and 4 are also pending; the Examiner has indicated that these
claims are allowable. (Ans. 2.)
3 Office Action mailed March 3, 2016.
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I
The Examiner has rejected claims 1,7, and 8 under 35U.S.C. § 112,
first paragraph, for failing to comply with the written description
requirement. The Examiner finds that the insertion of‘“an effective amount
of an added preservative’ is considered to be the insertion of new matter”
because
[i]t neither has literal support in the as-filed specification by
way of generic disclosure, nor are there specific examples of
the newly limited genus which would show possession of the
concept of the use of “an effective amount of an added
preservative”. There is no indication as to the intended
effectiveness, for example.
(Final Action 4.)
Appellants argue that “persons of skill in the art would understand,
from the explicit disclosure in the specification that a ‘preservative’ may be
added . . . that the inventors were in possession of the concept of using an
‘effective amount’ of the preservative.” (Br. 7.)
We agree with Appellants that the Specification adequately describes
a composition comprising Lactococcus garvieae 20-92 and an effective
amount of a preservative. The Specification states that “[t]he equol-
producing lactic acid bacteria-containing composition of the invention can
be processed into pharmaceutical preparations.” (Spec. 23:20—22.) The
Specification also states that “where necessary, colorant, preservative,
flavoring, corrigent, sweetener, and other drugs can be incorporated into the
pharmaceutical product of the invention.” {Id. at 25:4—6.) The Specification
states that “[o]n ingestion (administration) of the composition of the
invention, the microorganism in the composition finds its way alive into the
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lower digestive tract or settles there as part of the intestinal flora, whereby
the expected efficacy is expressed.” {Id. at 25:26—29.)
“In the prosecution of a patent, the initial burden falls on the PTO to
set forth the basis for any rejection, i.e., a prima facie case.” Hyatt v. Dudas,
492 F.3d 1365, 1369 (Fed. Cir. 2007). “In the context of the written
description requirement, an adequate prima facie case must. . . sufficiently
explain to the applicant what, in the examiner’s view, is missing from the
written description.” Id. at 1370. “[T]he test for sufficiency is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date.” AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010).
In this case, we conclude that the Specification’s disclosure of
pharmaceutical preparations comprising the lactic acid bacterium
Lactococcus garvieae 20-92 and a preservative would have been recognized
by those skilled in the art as showing possession of the claimed composition.
We agree with Appellants (Br. 7—8) that the Specification’s description of
including a preservative in the disclosed composition would have been
recognized as describing a composition comprising an effective amount of a
preservative, because an effective amount would be required to achieve the
function of preserving the viability of the bacteria in the composition, as
intended.
The Examiner reasons that “[tjhere is no evidence of record to show
that a composition comprising L. garvieae 20-92 is preserved by any
preservative whatsoever, what amount would be ‘effective’ for this purpose,
or for how long the composition is preserved without loss of viability and
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under which conditions.” (Ans. 3.) As discussed above, however, the test
for adequate written description is whether the Specification shows that the
inventors were in possession of what is later claimed, and in this case the
Specification shows constructive possession of a composition comprising
Lactococcus garvieae 20-92 and an effective amount of a preservative.
II
The Examiner has rejected claims 1 and 7—9 under 35 U.S.C. § 101 as
being directed to a natural product. The Examiner finds that “the
Lactococcus garviae [sic] strain isolated from nature is not markedly
different from the Lactococcus garviae [sic] as it is found in nature and it is
naturally found in milk.” (Final Action 4.) The Examiner also finds that
“there is no evidence of record that addition of any preservative in ‘an
effective amount’ results in a markedly different property for the material.
. . . Therefore, the claims as a whole do not recite something markedly
different than the judicial subject-matter eligibility exception of natural
products.” {Id. at 5.)
We agree with the Examiner that claim 1 encompasses a product that
is not markedly different from naturally occurring bacteria, and therefore is
directed to patent-ineligible subject matter.
Even before the Supreme Court’s recent decision in Association
for Molecular Pathology v. Myriad Genetics, Inc., [569] U.S.
[576], 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013), the Court’s
opinions in Chakrabarty and Funk Bros. Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127, 68 S.Ct. 440, 92 L.Ed. 588 (1948),
made clear that naturally occurring organisms are not patentable.
In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336 (Fed. Cir. 2014).
The Roslin Institute court explained that the mixture of naturally occurring
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bacteria claimed in Funk Bros, was held to be “not patent eligible because
the patentee did not alter the bacteria in any way.” Id. “Thus, while the
method of selecting the strains of bacteria might have been patent eligible,
the natural organism itself—the mixture of bacteria—was unpatentable
because its ‘qualities are the work of nature’ unaltered by the hand of man.”
Id.
By contrast, “[t]he patent at issue in Chakrabarty claimed a
genetically engineered bacterium that was capable of breaking down various
components of crude oil.” Id. “[T]he Court held that the modified
bacterium was patentable because it was ‘new’ with ‘markedly different
characteristics from any found in nature and one having the potential for
significant utility.’” Id. (emphasis added by the Roslin Institute court).
“Accordingly, discoveries that possess ‘markedly different characteristics
from any found in nature,’ are eligible for patent protection. In contrast, any
existing organism or newly discovered plant found in the wild is not
patentable.” Id. (citation omitted).
Here, the Specification states that Lactococcus garvieae 20-92 is a
naturally occurring strain of bacteria. (Spec. 4:31—33.) The composition of
claim 1 combines the naturally occurring bacteria with “an effective amount
of an added preservative.” (Claim 1.) In the context of the claimed
composition, we interpret “an effective amount” to be one that preserves the
viability of the bacteria, because the Specification states that, on ingestion,
“the microorganism in the composition finds its way alive into the lower
digestive tract or settles there as part of the intestinal flora.” (Spec. 25:26—
29.)
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However, the Specification provides no guidance, by way of
definition or otherwise, regarding how much viability is required for a given
amount of a given preservative to be considered “effective,” or how long
viability must be maintained in order for a given amount of a preservative to
be considered an “effective amount,” or under what circumstances the
viability must be maintained. The claimed bacterial strain was “isolated
from human stools,” and grown in vitro, demonstrating that the isolated, but
naturally occurring, bacteria were viable. (Spec. 4:29 to 5:10.)
Appellants have not pointed to evidence showing that the viable
bacteria in the claimed composition are “markedly different,” Diamond v.
Chakrabarty, 447 U.S. 303, 310 (1980), from the viable bacteria naturally
found in human stools. We therefore conclude that the evidence of record
supports the Examiner’s position that the composition of claim 1
encompasses patent-ineligible subject matter and is unpatentable under
35U.S.C. § 101.
Appellants argue that the patentability of the claimed composition is
supported by “the revised § 101 Guidance issued December 16, 2014” and
“[specifically, Example 2 of the ‘Nature-Based Products Examples’ sheet
(which accompanied the December 16, 2014, Guidance).” (Br. 8.)
Appellants argue that this example included a hypothetical claim to pomelo
juice and an effective amount of an added preservative, which was found to
confer a property that was markedly different from the juice itself, because
adding the preservative resulted in the juice spoiling “in a few weeks” rather
than “in a few days.” (Id. at 9.) Appellants argue that “the preserving
effects of a preservative constitute a markedly different property — in much
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the same way as a preservative that prevents spoiling of a fruit juice does.”
(Id.)
This argument is not persuasive, because it is not supported by
evidence showing that an “effective amount” of a preservative, in the
context of claim 1, would result in the bacteria of the claimed composition
having a markedly different rate of losing viability than the bacteria in their
natural state. The facts of the hypothetical example cited by Appellants state
that the pomelo juice mixed with an effective amount of a preservative
spoils in a few weeks rather than a few days. Here, by contrast, and as
pointed out by the Examiner (Final Action 5), the evidence of record does
not show that an effective amount of a preservative changes the properties of
the claimed bacteria in a manner comparable to the weeks-versus-days
change posited by the cited hypothetical example.
We therefore affirm the rejection of claim 1 under 35 U.S.C. § 101.
Claims 7 and 8 have not been argued separately and therefore fall with claim
1. 37C.F.R. §41.37(c)(l)(iv).
With regard to claim 9, Appellants argue that
this fermented diary product, which has been fermented by the
specific bacteria recited in the claim, does not occur in nature,
and is not merely a mixture of otherwise naturally-occurring
products (since the microorganism acts, e.g., enzymatically, to
change the structure and properties of the dairy product (pre- and
post-fermentation). Additionally, the Examples in the present
specification convey that storing this bacteria in soymilk
fermented with the bacteria results in an extended shelf life, with
retention of equol-producing activity, which is a “markedly
different” functional property.
(Br. 10.)
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Application 14/034,824
We will reverse the rejection of claim 9. As Appellants point out, the
Specification’s examples show that fermenting milk or soy milk with
Lactococcus garvieae 20-92 results in properties in the resulting product that
are different from those of the natural products themselves. For example,
the Specification states that in both daidzein-supplemented basal medium
and in soy milk, “the production of equol began to be noticed at hour-48
following the start of incubation” and that, with soy milk, “at the inoculation
level of 4.00%, the production of equol was as large as 57.0 pg/mL at hour-
96 of incubation.” (Spec. 32:22 to 33:2.) In the daidzein-supplemented
basal medium, by contrast, production of equol did not exceed about 10
pg/mL during the course of the experiment. (See Fig. 3.)
The Specification also states that,
as far as cow’[s] milk is concerned, the equol-producing ability
(activity) is sustained to week-4 of low-temperature storage at
4°C after completion of culture in both cases of 1L and 2L.
Moreover, in the case of 2L of cow’s milk, the activity was found
to be sustained to day-51, that was the last day of monitoring of
the storage stability at 4°C. In the case of 1L of commercial skim
milk, too, the equol-producing ability (activity) was apparently
sustained to day-34, the last day of monitoring of the low-
temperature storage stability at 4°C after completion of culture.
(Id. at 35:5—15.) The Specification states that “equol as the active
metabolite of soy isoflavone is a key factor in the expected efficacies in
clinical application,” including “in breast cancer, carcinoma of the prostate,
and climacteric and postmenopausal osteoporosis.” (Id. at 1.)
Thus, the evidence supports Appellants’ position that fermenting
either milk or soy milk with Lactococcus garvieae 20-92 results in a product
that has properties that are markedly different from any of the naturally
occurring products by themselves; specifically, an enhanced amount of
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equol, which is disclosed to have clinical application in disorders such as
breast cancer, prostate cancer, and postmenopausal osteoporosis. The
resulting product therefore would be expected to have applications that are
not shared by milk, soy milk, or Lactococcus garvieae 20-92 by themselves.
In response to Appellants’ argument, the Examiner cited evidence to
show that L. garvieae “naturally occurs in fermented milk.” (Ans. 4.) The
Examiner concludes that the cited evidence “clearly demonstrate[s] that at
least cow’s milk naturally contains L. garvieae, which milk would be
naturally fermented at room temperature and comprise the strain.” (Id. at 5.)
Claim 9, however, is not directed to a product comprising L. garvieae,
generally, but to the specific strain of L. garvieae that Appellants refer to as
Lactococcus garvieae 20-92. The Specification makes clear that “[f]rom
[its] cultural and biochemical characteristics, the strain of the invention is
classified into Lactococcus garvieae which is a gram-positive coccus but
differs from its type strain ... in the utilization of starch.” (Spec. 6:14 to
7:2.) Thus, the fact that some strain(s) of L. garvieae are naturally found in
cow’s milk is not adequate to establish that the fermented product of claim 9
is naturally occurring.
SUMMARY
We reverse the rejection of claims 1,7, and 8 under 35U.S.C. § 112,
first paragraph.
We affirm the rejection of claims 1, 7, and 8 under 35 U.S.C. § 101.
We reverse the rejection of claim 9 under 35 U.S.C. § 101.
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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-IN-PART
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