Chr. Hansen A/S

Patent Trials and Appeals Board

Dec 8, 2020

2020003750 (P.T.A.B. Dec. 8, 2020)

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.
14/396,249 10/22/2014 Eric Johansen 030427-0219 3882
22428 7590 12/08/2020
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
PROUTY, REBECCA E
ART UNIT PAPER NUMBER
1652
NOTIFICATION DATE DELIVERY MODE
12/08/2020 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC JOHANSEN, KIM IB SOERENSEN,
MIRJANA CURIC-BAWDEN, and METTE PIA JUNGE
Appeal 2020-0037501
Application 14/396,249
Technology Center 1600
Before JEFFREY N. FREDMAN, DAVID COTTA, 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 to a
method for producing a fermented milk product. The Examiner rejected the
claims as obvious under 35 U.S.C. § 103(a). We heard oral argument on
December 1, 2020. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

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 Chr. Hansen
A/S. Appeal Br. 3.
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Application 14/396,249

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CLAIMED SUBJECT MATTER
Claims 3, 4, 13, 33, and 34 are on appeal. Ans. 3. Claim 13,
reproduced below, is the only independent claim, and is illustrative of the
claimed subject matter:
13. A method for producing a fermented milk product,
comprising inoculating and fermenting a milk substrate with at
least one mutant galactose-fermenting Streptococcus
thermophilus strain obtained by a process comprising:
(a) selecting and isolating from a pool of Streptococcus
thermophilus strains derived from a galactose-fermenting
Streptococcus thermophilus mother strain, a pool of
Streptococcus thermophilus strains which are resistant to 2-
deoxyglucose; and
(b) selecting from the pool of 2-deoxyglucose resistant
Streptococcus thermophilus strains as the mutant Streptococcus
thermophilus strain, a strain that is able to grow to a colony when
streaked on a plate with (i) M17 medium + 2% lactose or M17
medium + 2% galactose and (ii) 20 mM 2-deoxyglucose, and
incubated at 40 °C for 20 hours,
wherein the mutant strain carries a mutation in the DNA
sequence of the glcK gene encoding a glucokinase protein,
wherein the mutation inactivates the glucokinase protein or has a
negative effect on expression of the gene as compared to the
mother strain, and wherein the mutant strain (i) is resistant to 2-
deoxyglucose, (ii) ferments lactose and/or excretes glucose when
grown on a milk substrate, and (iii) is capable of acidifying milk
to pH 5.
Appeal Br. 29–30 (Claims Appendix).

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REFERENCES
The Examiner relied upon the following prior art references:
Name Reference Date
Janzen WO 2011/026863 A1 Mar. 10, 2011
Pool et al., Natural sweetening of food products by engineering
Lactococcus lactis for glucose production, 8 Metabolic Engineering 456–
464 (2006) (“Pool”)
REJECTION
Claims Rejected 35 U.S.C. § Reference(s)/Basis
3, 4, 13, 33, 34 103(a) Janzen, Pool
OPINION
Examiner’s Findings
The Examiner finds that Janzen discloses galactose-fermenting
Streptococcus thermophilus strains for fermenting milk products, but does
not teach that the strains have an inactivating mutation of the glucokinase
(glcK) gene. Final Act. 3. The Examiner finds that Pool teaches
Lactococcus lactis strains having inactivating mutations in the glcK gene
and glucose/mannose phosphotransferase system, which strains secrete
glucose and enhance removal of lactose when grown on milk. Id. The
Examiner find that because both S. thermophilus and L. lactis are well
known bacteria used to produce fermented milk products, it would have
been obvious to one of ordinary skill in the art to make Pool’s inactivating
mutations in the corresponding genes of Janzen’s S. thermophilus strains,
with the expectation that the resulting strain would secrete glucose and
enhance removal of lactose when grown on milk. Id. at 4. The Examiner
acknowledges that Pool does not teach that its mutant strains are 2-
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deoxyglucose resistant, but asserts that this “would be an inherent feature of
the genetic modifications of Pool.” Id.
The Examiner finds that the appealed claims “recite that the mutant
Streptococcus thermophilus strains have not been modified by recombinant
DNA technology and do not carry a mutation induced by a chemical
mutagen or UV or gamma radiation,” and are thus product-by-process
claims. Id. at 5. The Examiner finds that the patentability of such claims is
“determined by the structure of the products produced not by the method of
making.” Id. The Examiner finds that Pool’s recombinant methods do not
leave any exogenous DNA sequences in the mutated strains, and thus Pool’s
strains “are indistinguishable structurally from a strain which was created by
processes as claimed.” Id. As such, the Examiner finds that “it is
completely irrelevant whether the combination of references would provide
a reasonable expectation that a strain with the recited properties could be
obtained by the selection method recited in the claims as the selection
method is NOT being examined and is NOT a step of the recited methods.”
Ans. 9.
Analysis
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We conclude that on this
record, the Examiner has not satisfied this burden.
We begin by considering claim scope. In relevant part, claim 13
recites a process of obtaining a mutant S. thermophilus strain by a process
comprising (a) selecting and isolating from a pool of certain mother strains,
a pool of S. thermophilus strains that are resistant to 2-deoxyglucose, and (b)
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selecting from that pool of 2-deoxyglucose-resistant strains a mutant strain
that is able to grow under certain conditions and has certain recited
properties. Appeal Br. 29–30 (Claims Appendix). The Specification defines
“mutant strain” in terms of how it is made, i.e., “mutant strain” means “a
natural (spontaneous, naturally occurring) mutant bacterium or an induced
mutant bacterium comprising one or more mutations in its genome (DNA)
which are absent in the wild type DNA” that is a “non-GMO (non-
genetically modified organism), i.e. not modified by recombinant DNA
technology.” Spec. 13:19–26.
The definition of “mutant strain” in the Specification is consistent
with the language of claim 13, which recites a nested product-by-process
limitation (for obtaining a mutant S. thermophilus strain via selection),
within a claim directed to a method for producing a fermented milk product
using that mutant strain. Cf. Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d
1326, 1334 (Fed. Cir. 2020) (“The nesting of the product-by-process
limitation within a method of treatment claim does not change the proper
construction of the product-by-process limitation itself.”). “A product-by-
process claim is ‘one in which the product is defined at least in part in terms
of the method or process by which it is made.”’ SmithKline Beecham Corp.
v. Apotex Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006) (quoting Bonito
Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 158 (1989)).
Product-by-process claims are directed to the ultimate product, not the
underlying process. Id. at 1317. “[O]nce a product is fully disclosed in the
art, future claims to that same product are precluded, even if that product is
claimed as made by a new process.” Id. at 1315.
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On this record, the Examiner has not established that the product
referenced in the claim – a mutant galactose-fermenting Streptococcus
thermophilus strain having certain properties – is fully disclosed in the art.
More particularly, the Examiner has not established that strains made by
Pool’s recombinant methods would be, as the Examiner contends,
“indistinguishable structurally” from a mutant strain created by the claimed
process. Final Act. 5. Pool’s methods resulted in a triple deletion mutant,
but as indicated by Dr. Neves (one of Pool’s authors), non-GMO methods
such as direct selection using 2-deoxyglucose would not be expected to
result in a triple deletion mutant, “because the probability of rare mutations
occurring simultaneously in even two genes would be exceedingly low (<1
in 1012 cells, assuming mutation rates of 1 in 106 for each target gene).”
Neves Decl. ¶ 9. This supports that the claimed method produces a different
strain than would be produced following Pool’s method.
The Examiner counters that selection for 2-deoxyglucose resistance is
capable of producing strains having deletion mutations, as disclosed in Pool.
Ans. 12 (citing Gauthier2 1106); see also id. at 24 (“[T]he triple deletion
mutant of Pool et al. could be produced by the claimed selection method as
selection for 2-deoxyglucose resistance is capable of producing all of point
mutations, insertions, and deletions in genes which will confer the resistant
phenotype.”). However, while it may be true that the claimed method can
result in deletion mutations, we agree with Appellant that “Gauthier does not

2 Gauthier et al., Positive selection for resistance to 2-deoxyglucose gives
Rise, in Streptococcus salivarius, to seven classes of pleiotropic mutants,
including ptsH and ptsl missense mutants, 13(6) Molec. Microbiol. 1101–09
(1994).
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support the premise underlying the rejection that selection pressure would
result in the same extensive deletions taught by Pool.” Reply Br. 11.
Indeed, the Examiner concedes that “[i]t is clearly true that production of the
specific mutant of Pool et al. using the method of the claims would be a very
rare event and thus use of . . . the claimed method to produce a mutant
having the specific modifications of Pool et al. would not be obvious.”
Ans. 24.
Because there is no persuasive evidence of record supporting the
Examiner’s finding that a strain having the extensive deletions taught by
Pool would be “indistinguishable structurally” from a strain encompassed by
the recited product-by-process language, the rejection is improper, and we
reverse. Final Act. 5.
CONCLUSION
We reverse the Examiner’s rejection of claims 3, 4, 13, 33, and 34
under 35 U.S.C. § 103(a) as obvious over Janzen and Pool.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
3, 4, 13, 33,
34
103(a) Janzen, Pool 3, 4, 13, 33,
34
REVERSED