Ex Parte Graf et al

Patent Trial and Appeal Board

Aug 10, 2016

11577680 (P.T.A.B. Aug. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111577,680 11130/2007
20995 7590 08/12/2016
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
Federico Graf
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.
KLAUS8.001APC 7078
EXAMINER
LANDAU, SHARMILA GOLLAMUDI
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
08/12/2016 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FEDERICO GRAF, PHILIPP GROB,
and DOMINIQUE BRASSART
Appeal2014-001962
Application 11/577 ,680
Technology Center 1600
Before JEFFREY N. FRED MAN, DEBORAH KATZ, and
RICHii .. RD J. S1\1ITH, Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2014-001962
Application 11/577 ,680
Appellants 1 seek our review, under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 22, 25-28, and 32-33, all of the
pending claims.2 (App. Br. 5.) We have jurisdiction under 35 U.S.C.
§ 6(b ). We REVERSE. We also enter a NEW GROUND OF REJECTION
under 35 U.S.C. § 101.
Appellants claim a strain of a bacteria, Lactobacillus gasseri, reciting
several characteristics, such as antibacterial activity and the ability or
inability to metabolize different carbohydrates. Claim 32, the only
independent claim recited by Appellants, recites:
A strain of Lactobacillus gasseri, wherein said strain:
(a) is gram positive,
(b) has antibacterial activity that is resistant to catalase,
( c) produces lactic acid and hydrogen peroxide,
( d) is positive for metabolism of GAL, GLU, PRU, MNE,
AMY, ESC, SAL, CEL, MAL, LAC, SAC, TRE and AMD, as
determined by an API 50 CHL test; and
(e) is negative for metabolism of KON, GLY, ERY, DARA,
LARA, RIB, DXYL, LXYL, ADO, MDX, SBE, RHA, DUL, INO,
MAN, SOR, MDM, MDG, NAG, ARB, MEL, INU, MLZ, RAF,
GLYG, XLT, GEN, TUR, LYX, TAG, DFUC, LFUC, DARL, LARL,
GNT, 2KG and 5KG, as determined by an API 50 CHL test;
wherein said strain kills urogenital and/or gastrointestinal
pathogens.
(App. Br. 23, Claims App'x.)
1 The real party-in-interest is Frederico Graf. (App. Br. 3.)
2 Although Appellants state that claims 22 and 25-33 are the subject of their
appeal, they also acknowledge that method claims 29-31 were previously
withdrawn. (See App. Br. 5.) Accordingly, we do not consider claims 29-
31 in our analysis.
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Appeal2014-001962
Application 11/577 ,680
Rejections on Appeal
The Examiner made the following rejections of Appellants' claims:
Claims 35 U.S.C. Prior Art Answer
22, 26-28, 32 and 33 § 102(b) /§103(a) Samuelsson 3 pp.2-3
22, 26-28, 32 and 33 § 102(b) /§103(a) Mastromarino 4 pp. 3--4
22, 26-28, 32 and 33 § 102(b) /§103(a) De Simone5 pp. 5---6
22, 32, and 33 § 102(b) /§103(a) Itoh6 pp.4--5
22, 26, 28, 32 and 33 § 103(a) Itoh pp. 9-10
25 § 103(a) Samuels son, pp. 6-9
Mastromarino,
or De Simone in
view of Reid7
The Examiner's rejections under 35 U.S.C. § 102(b), or§ 103(a) in
the alternative, over Samuelsson, Mastromarino, De Simone, or Itoh are
similar. In each rejection the Examiner finds that the cited prior art teaches a
3 Sameulsson et al., International Patent Application Publication WO
03/038068, published May 8, 2003.
4 Mastromarino, et al., "Characterization and selection of vaginal
Lactobacillus strains for the preparation of vaginal tablets," 93 J. Applied,
Microbiol. 884--93 (2002).
5 DeSimone, U.S. Patent Application Publication 2004/0071679, published
April 15, 2004.
6 Itoh et al., "Inhibition of food-borne pathogenic bacteria by bacteriocins
from Lactobacillus gasseri," 21 Lett. in Applied Microbiol. 137--41 (1995).
7 Reid and Bruce, U.S. Patent Application Publication 2003/0118571,
published June 26, 2003.
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Appeal2014-001962
Application 11/577 ,680
strain of L. gasseri useful for treating vaginal and/or urogenital infections.
(See Ans. 2, citing Sanmelsson at pp. 16-19; Ans. 3, citing Mastromarino at
abstract and p. 891; Ans. 5, citing DeSimone at i-fi-13 and 7; Ans. 4--5, citing
Itoh at p. 139, Table 1, and p. 140.) In each rejection, the Examiner also
finds:
The cited art taken as a whole demonstrates a reasonable
probability that [the prior art's] composition is either identical to
Appellants' or sufficiently similar to the claimed composition
that whatever differences exist are not patentably significant.
Therefore, the burden of establishing novelty or unobviousness
by objective evidence is shifted to Appellants.
(Ans. 3, 4, 5, and 6.) Thus, even though the cited prior art does not
expressly recite limitations of Appellants' claims, such as the carbohydrate
metabolism profile, the Examiner finds that they are inherently taught. See
In re Best, 562 F.2d 1252, 1254--55 (CCPA 1977) (holding that the burden
to show the prior art does not possess a claimed characteristic was properly
shifted to appellant where there was sufficient evidence to show that the
characteristic would be inherently possessed by other products).
A reference may be silent about a specific limitation and still anticipate
a claimed product, if the limitation is inherently taught. "Inherency ... may
not be established by probabilities or possibilities. The mere fact that a
certain thing may result from a given set of circumstances is not sufficient."
In re Oelrich, 666 F.2d 578, 581(CCPA1981). According to the Examiner,
the usefulness in treating vaginal and urogenital infections is a sufficient
basis on which to find that the bacterial strains in the prior art are inherently
the same as the bacterial strains Appellants claim.
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Application 11/577 ,680
To counter the Examiner's rejection, Appellants point to the
characteristics of several different L. gasseri strains reported in their
Specification. (See App. Br. 8-11.) Specifically, Appellants direct us to
pages 4---6 (i-fi-f 29-31 and 46---50), which report that different L. gasseri
strains have different carbohydrate metabolism profiles. Appellants note
that though the claimed L. gasseri strain is positive for AMY metabolism,
three other L. gasseri strains (KS114.1, 123.1, and 124.3) are negative.
(App. Br. 10.) Appellants argue that this result shows that L. gasseri strains
can have different metabolism capacities due to the unique genetic profile of
each strain. Appellants argue that therefore the L. gasseri strains reported in
the prior art are not necessarily or inherently the same strains as those
claimed. (App. Br. 11.)
We agree with Appellants that in light of these differences, the
Examiner's finding that the strains taught in Samuelsson, Mastromarino, De
Simone, and Itoh are necessarily the same as ii~ppellants' claimed strains is
not supported by evidence. (See Reply 5.) Without further evidence that the
strains taught in the prior art have the recited characteristics of the claimed
strain we are persuaded that the Examiner erred in rejecting Appellants'
claims under 35 U.S.C. § 102. Accordingly, we reverse these rejections.
The Examiner also fails to persuade us that the strains of L. gasseri
recited in Appellants' claims would have been obvious to those of skill in
the art under 35 U.S.C. § 103. The Examiner does not make findings about
how or why those of skill in the art would have modified the L. gasseri
strains of Samuelsson, Mastromarino, or De Simone to obtain the claimed
characteristics. Therefore, we have no basis on which to sustain the
Examiner's rejections. See In re Kahn, 441F.3d977, 986, 988 (Fed. Cir.
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Appeal2014-001962
Application 11/577 ,680
2006) ("[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.").
We are also not persuaded by the Examiner's separate rejection
under 35 U.S.C § 103 over Itoh. (See Ans. 9-10.) The Examiner
finds that one of ordinary skill in the art would have had a reasonable
expectation of success in substituting the L. gasseri strains taught in
Itoh for L. acidophilus in known fermented milk formulations because
both are lactic acid bacteria. (Ans. 10.) This finding addresses only
the limitations of Appellants' dependent claims and fails to provide a
reason why it would have been obvious to modify the bacterial strains
in Itoh to obtain the specific limitations recited in Appellants' claim
32. Accordingly, we are not persuaded that the L. gasseri strain
recited in 1A .. ppellants' independent claim 32 or the claims that depend
on it would have been obvious.
Because we have no basis on which to find that those of skill in
the art would have obtained an L. gasseri strain with the limitations
recited in Appellants' claims, we reverse the Examiner's rejection of
claims under 35 U.S. C. § 103.
New Ground of Rejection
Within our authority under 37 C.F.R. § 41.50(b), we enter a new
ground of rejection for Appellants' claims 22, 25-28, 32, and 33 under 35
U.S.C. § 101.
Appellants disclose several specific bacterial strains in its
specification, including L. gasseri KS 120.1, which is representative of the
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Application 11/577 ,680
strains they claim. (See Spec., i-fi-127-56; Brief, 9-10, table.) Appellants
state that "[m]ost of these strains are ... representative of the healthy human
vaginal micro flora." (See Spec., i127.) Thus, the bacterial strains recited in
Appellants' claim 32 are products of nature. We do not find any information
in Appellants' Specification to indicate that the claimed strains were
manipulated or otherwise engineered to be more than the "handiwork of
nature." See Funk Bros. Seed Co. v. Kala Inoculant Co., 333 U.S. 127, 131
( 1948) (holding that a combination of certain strains of bacteria is
unpatentable where "[i]t is no more than the discovery of some of the
handiwork of nature and hence is not patentable.").
As products of nature, Appellants' claimed bacterial strains fall
within the exceptions to the categories of patentable subject matter provided
in 35 U.S.C. § 101. That is, though they are a composition of matter, they
are natural phenomena and, thus, patent ineligible. See Mayo Collaborative
Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012) "The Court
has long held that [35 U.S.C. § 101] contains an important implicit
exception. '[L]aws of nature, natural phenomena, and abstract ideas' are not
patentable."); see also Ass 'n for Molecular Pathology v. Myriad Genetics,
Inc., 133 S. Ct. 2107, 2117 (2013) (holding isolated genomic DNA to be
unpatentable under § 101 where, in contrast to bacteria that had been
engineered to include additional plasmids and to degrade oil, "markedly
different characteristics from any found in nature," the genomic DNA had
only been separated from its surrounding genetic material, citing Diamond v.
Charkarbarty, 447 U.S. 303, 310 (1980)).
Appellants claim no more than the recited bacterial strains. We find
no evidence that the natural product has been transformed into eligible
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Application 11/577 ,680
subject matter or is markedly different from those found in nature. See
Mayo, 132 S.Ct. at 1294 (providing for a two-step analysis to determine
patent eligibility of subject matter excepted from the categories of§ 101,
wherein an "inventive concept" or other "additional features" may
"transform" a claim to be drawn to eligible subject matter). Accordingly, we
enter a new grounds of rejection for claim 32 under 35 U.S.C. § 101 for the
failure to claim patentable subject matter.
Appellants' dependent claims 22, 26-28, and 33 recite either a species
of the bacterial strains recited in claim 32 (claim 33) or compositions
comprising the bacterial strains and a "support or carrier." (See App. Br.
23-24, Claims App'x.) Appellants' Specification does not provide for
specific supports or carriers that are more than those known to be available.
(See e.g. Spec. i-f 60: "The corresponding therapeutic or prophylactic
treatments are performed by administering an effective amount of the
selected strain or strains of this invention in combination \'l1ith a suitable, if
ever necessary food grade, delivery system, support or carrier which has
been designed therefor.") Thus, this additional element does not recite
additional features that render the bacterial strain of claim 32 patent eligible.
We enter a new grounds of rejection under 35 U.S.C. § 101 for claims 22,
26-28, and 33, as well.
Similarly, Appellants' dependent claim 25 recites a composition
comprising the bacterial strain of claim 32 and "lactic acid bacteria (LAB)
growth factors and/or prebiotic ingredients." (See App. Br. 23, Claims
App'x.) Appellants' Specification does not indicate these were previously
unknown ingredients that transform the bacterial strain of claim 32 into
patent eligible subject matter. (See Spec. i-f 61: "Probiotic compositions
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Application 11/577 ,680
according to this invention can further comprise usual LAB growth factors
or prebiotics, e.g. dedicated natural growth factors like skim milk powder
(MSK).") We also enter a new grounds of rejection under 35 U.S.C. § 101
for claim 25.
Summary
We do not sustain the Examiner's rejections under 35 U.S.C. § 102
and§ 103 of claims 22, 25-28, 32, and 33.
We enter a new ground of rejection, pursuant to 37 C.F.R. § 41.50(b)
of claims 22, 25-28, 32, and 33 under 35 U.S.C. § 101 as being drawn to a
product of nature.
37 C.F.R. § 41.50(b) provides that the Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the examiner, in
which event the proceeding will be remanded to the examiner.
2) Request rehearing. Request that the proceeding be reheard
under§ 41.52 by the Board upon the same record.
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)(l)(iv).
REVERSED; 37 C.F.R. § 41.50(b)
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