Valio Ltd

Patent Trials and Appeals Board

Aug 4, 2020

14353718 - (D) (P.T.A.B. Aug. 4, 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.
14/353,718 04/23/2014 Kirsi Rajakari Q211565 5656
23373 7590 08/04/2020
SUGHRUE MION, PLLC
2000 PENNSYLVANIA AVENUE, N.W.
SUITE 900
WASHINGTON, DC 20006
EXAMINER
TURNER, FELICIA C
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
08/04/2020 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):
PPROCESSING@SUGHRUE.COM
USPTO@sughrue.com
sughrue@sughrue.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KIRSI RAJAKARI, KAI HOTAKAINEN
and PAIVI MYLLARINEN

Appeal 2019-004870
Application 14/353,718
Technology Center 1700
____________

Before KAREN M. HASTINGS, MICHAEL G. McMANUS, and
JANE E. INGLESE, Administrative Patent Judges.

McMANUS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 seeks review of the
Examiner’s decision to reject claims 1–4, 6–14, and 16–20. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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 Valio Ltd.
Appeal Brief dated Feb. 19, 2019 (“Appeal Br.”) 2.
Appeal 2019-004870
Application 14/353,718

2
CLAIMED SUBJECT MATTER

The present application generally relates to a stable liquid enzyme
formulation comprising a milk protein crosslinking enzyme and/or a milk
protein modifying enzyme. Specification filed April 23, 2014 (“Spec.”) ¶ 1.
The Specification teaches that milk protein crosslinking and/or
modifying enzymes are useful in the manufacture of “processed fish, meat
and egg products, pastes and [pâté]s, fruits, berries and vegetables, soy
products, cereal products, bread and bakery products.” Id. ¶ 12. The
Specification further teaches that a problem associated with milk protein
crosslinking and modifying enzyme formulations is the lack of stability of
the formulation. Id. ¶ 4. The Specification additionally provides that
The invention is based on the finding that when a
transglutaminase, tyrosinase or protein glutaminase is stored in
a suspension of a polyol, such as glycerol or sorbitol, and water
in the pH range from 4.4 to 5.1, its activity is remained
moderately during storage at room temperature and excellently
during storage in the temperatures of a refrigerator and/or a
freezer.

Id. ¶ 23.
Claim 1 is illustrative of the subject matter on appeal and is
reproduced below with certain limitations bolded for emphasis:

Appeal 2019-004870
Application 14/353,718

3
1. A liquid enzyme formulation comprising at least one
milk protein crosslinking and/or modifying enzyme selected
from transglutaminase, protein glutaminase and tyrosinase in
polyol-water suspension comprising from 25% to 100% (w/w)
polyol and having pH value within the range from 4.4 to 5.1,
wherein the at least one milk protein crosslinking and/or
modifying enzyme selected from transglutaminase, tyrosinase
and protein glutaminase maintains its activity in the
formulation.
Appeal Br. 22 (Claims App.) (emphasis added).
REFERENCES
The Examiner relies upon the following prior art:
Name Reference Date
Schooneveld-Bergmans US 2003/0190399 Al Oct. 9, 2003
Chou US 2003/0219853 Al Nov. 27, 2003
Parkhideh US 2005/0008581 A1 Jan. 13, 2005
Miwa US 2011/0064847 A1 Mar. 17, 2011
Bodo US 2011/0189344 Al Aug. 4, 2011

REJECTIONS
The Examiner maintains the following rejections:
1. Claims 1–4, 6, 8–10, 12–14, 16, and 18 are rejected under pre-
AIA 35 U.S.C. § 103(a) as being unpatentable over
Schooneveld-Bergmans in view of Miwa. Final Action dated
May 15, 2018 (“Final Act.”) 2–5.
2. Claims 7 and 17 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over Schooneveld-Bergmans
in view of Miwa and further in view of Chou. Id. at 5–6.
3. Claim 11 is rejected under pre-AIA 35 U.S.C. § 103(a) as
Appeal 2019-004870
Application 14/353,718

4
being unpatentable over Schooneveld-Bergmans in view of
Miwa and further in view of Bodo. Id. at 6.
4. Claims 19 and 20 are rejected under pre-AIA 35 U.S.C. §
103(a) as being unpatentable over Schooneveld-Bergmans in
view of Miwa and further in view of Parkhideh. Id. at 6–7.
DISCUSSION
Rejection 1. The Examiner rejects claims 1–4, 6, 8–10, 12–14, 16
and 18 as obvious over Schooneveld-Bergmans in view of Miwa. Id. at 2–5.
In support of the rejection, the Examiner finds that Schooneveld-Bergmans
teaches a liquid enzyme formulation including polyol and having a pH from
4 to 5. Id. at 2. The Examiner further finds that Schooneveld-Bergmans
discloses utilizing protein modifying enzymes in its liquid enzyme
formulation. Id. at 8. The Examiner finds, however, that Schooneveld-
Bergmans does not explicitly teach that the enzyme is a milk protein
modifying enzyme. Id. at 2.
The Examiner finds that Miwa teaches the use of protein glutaminase
and transglutaminase as protein modifying enzymes that can modify milk
proteins. Id. (citing Miwa ¶ 51). The Examiner determines that one of
ordinary skill in the art would have had reason to modify the formulation of
Schooneveld-Bergmans to include protein glutaminase and transglutaminase
(as taught by Miwa) in order to store such enzymes. Id. at 2–3, 8.
Appellant alleges error on several bases. First, Appellant argues that
“the presently claimed invention is different from Schooneveld-Bergmans
and Miwa.” Appeal Br. 8; see id. 8–11.
Appeal 2019-004870
Application 14/353,718

5
Appellant argues that Schooneveld-Bergmans does not teach or
suggest a stable liquid protein modifying enzyme composition. Id. at 9.
Appellant contends that the focus of Schooneveld-Bergmans is carbohydrase
enzymes. Id. Appellant directs us to differences in the reported stability of
various carbohydrases as showing that “the activity of different enzymes
differ considerably even under the same storage conditions.” Id.
Appellant asserts that Schooneveld-Bergmans does not teach that the
pH of the formulation is adjusted to a range of 4 to 5. Id. at 10. In this
regard, Appellant states that one of skill in the art would recognize that
Schooneveld-Bergmans teaches the use of ascorbic acid in high quantities
such that “ascorbic acid is not used to adjust the pH of the composition, but
rather, is used in order to improve the flour and dough.” Id. Appellant
further asserts that ascorbic acid would be unstable in the claimed
formulation. Id. Appellant additionally asserts that the activity (after a
period of storage) of the enzymes of Schooneveld-Bergmans was measured
at a pH outside the claimed range. Last, Appellant cites to a treatise
indicating that “[o]ptimal conditions for storage are distinctive to each
protein.” Id. at 11 (underscoring omitted) (citing Pierce Biotechnology,
Protein Stability and Storage, TR0043.1, hereafter “Pierce”). In the Reply,
Appellant argues that Pierce indicates that “persons of ordinary skill in the
art would have understood that stability properties of the protein modifying
enzyme can be significantly different from those of carbohydrases.” Reply
Brief dated June 5, 2019 (“Reply Br.”) 6.
The foregoing is not persuasive. Appellant may be correct that the
primary thrust of Schooneveld-Bergmans concerns carbohydrase enzymes.
Precedent, however, requires that “all disclosures of the prior art, including
Appeal 2019-004870
Application 14/353,718

6
unpreferred embodiments, must be considered.” See Merck & Co., Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Accordingly, the
Examiner may rely on Schooneveld-Bergmans’ teaching that “[l]iquid
compositions according to the invention comprise one or more enzymes that
may be selected from the group consisting of . . . a protein modifying
enzyme.” Schooneveld-Bergmans ¶ 13.
Appellant asserts that Schooneveld-Bergmans does not teach the
claimed pH range. Appeal Br. 10–11; Reply Br. 5–6. Appellant, however,
does not squarely address Schooneveld-Bergmans’ teaching that “an
aqueous solution of ascorbic acid with a pH preferably from 4 to 5
(obtainable by adding buffer salts)” may be used in making the formulation.
Schooneveld-Bergmans. The Examiner finds that this teaches a formulation
having a pH within the claimed range. Final Act. 2. Appellant does not
specifically rebut such finding. Appellant’s factual assertion that “ascorbic
acid is not used to adjust the pH of the composition” is not supported by
evidence of record nor directly contrary to the Examiner’s finding.
Similarly, Appellant’s assertion regarding the stability of ascorbic acid is not
supported by citation to evidence of record.
Appellant further asserts that the examples of Schooneveld-Bergmans
were measured at a pH outside the claimed range. In this regard, the
Examiner finds that the “tests were conducted after the enzymes were
stabilized for different periods of up to 26 weeks.” Answer 11 (emphasis in
original). The tests were conducted at the optimal pH for enzyme activity,
not the optimal pH for storage. Id.
There is some ambiguity as to whether Appellant relies on Pierce to
indicate 1) that the formulation of the Examiner’s hypothetical combination
Appeal 2019-004870
Application 14/353,718

7
would not have the claimed stability or 2) that a person of ordinary skill
would not have had a reasonable expectation of success in preserving protein
modifying enzymes according to Schooneveld-Bergmans. Appeal Br. 10–
11. Neither point is persuasive. Pierce is insufficient to overcome the plain
teaching of Schooneveld-Bergman that it is applicable to “a protein
modifying enzyme.” Schooneveld-Bergmans ¶ 13. Further, the portion of
Pierce quoted by Appellant (“[o]ptimal conditions for storage are distinctive
to each protein”) is immediately followed by “nevertheless, it is possible to
suggest some general guidelines for protein storage and stability.” Pierce 1.
There is some lack of congruence between the omitted portion and the
quoted portion.
In view of the foregoing, we determine Appellant has failed to show
error in the Examiner’s findings regarding the content of the prior art.
Second, Appellant argues that a person of ordinary skill in the art
would not have had a reasonable expectation of success that the formulation
of Schooneveld-Bergmans could be used to preserve a milk protein
modifying enzyme. Appeal Br. 11–14. Appellant argues that each enzyme
has “its own unique structure and conditions for stability” thus, one of skill
in the art would not regard the conditions of Schooneveld-Bergmans as
broadly applicable to the storage of other enzymes. Id. at 11.
An invention is obvious if “a skilled artisan would have been
motivated to combine the teachings of the prior art references to achieve the
claimed invention, and that the skilled artisan would have had a reasonable
expectation of success in doing so.” Proctor & Gamble Co. v. Teva Pharm.
USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009). “[O]bviousness cannot be
avoided simply by a showing of some degree of unpredictability in the art so
Appeal 2019-004870
Application 14/353,718

8
long as there was a reasonable probability of success.” Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Similarly,
“[o]bviousness does not require absolute predictability of success. . . . For
obviousness under § 103, all that is required is a reasonable expectation of
success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)
Appellant has not shown evidence sufficient to rebut the plain
meaning of Schooneveld-Bergmans. As above, Schooneveld-Bergmans
teaches that “[l]iquid compositions according to the invention comprise one
or more enzymes that may be selected from the group consisting of . . . a
protein modifying enzyme.” Schooneveld-Bergmans ¶ 13 (emphasis
added). Pierce teaches that “it is possible to suggest some general guidelines
for protein storage and stability.” Pierce 1. Given such teachings, the
Examiner’s finding that one of skill in the art would have had a reasonable
probability of success that the formulation of Schooneveld-Bergmans could
be used to preserve a milk protein modifying enzyme is supported and has
not been shown to be in error.
Third, Appellant argues that the formulation of the claims exhibits
unexpected benefits. Appeal Br. 14–16. Appellant asserts that its
formulation “unexpectedly retains its enzyme activity to a significant extent
during storage at room temperature; and unexpectedly retains its enzyme
activity excellently during storage at lower temperatures (e.g., when
refrigerated or frozen[)].” Appeal Br. 14. Appellant argues that, “[i]n
contrast, Schooneveld-Bergmans emphasizes the need to refrigerate the
carbohydrases (4 °C) - and not to store them at room temperature (25 °C).”
Id. at 14–15.
Appeal 2019-004870
Application 14/353,718

9
An applicant may overcome a prima facie case of obviousness by
establishing that the claimed composition is “critical,” generally by showing
that the claimed composition “achieves unexpected results relative to the
prior art.” In re Geisler, 116 F.3d 1465, 1469–70 (Fed. Cir. 1997) (citation
omitted).
Appellant may show that the claimed invention has an unexpected
property over the prior art “with evidence that the claimed invention exhibits
some superior property or advantage that a person of ordinary skill in the
relevant art would find surprising or unexpected.” In re Mayne, 104 F.3d
1339, 1343 (Fed. Cir. 1997); see also Forest Labs., LLC v. Sigmapharm
Labs., LLC, 918 F.3d 928, 937 (Fed. Cir. 2019). An examination for
unexpected results is a factual, evidentiary inquiry. Id.
Here, the Examiner finds that Appellant errs in asserting that
Schooneveld-Bergmans emphasizes the need to refrigerate enzymes. The
Examiner cites to Schooneveld-Bergmans’ Table 1 which gives results for
enzymes “stored at 25° C.” The results found in Schooneveld-Bergmans’
Table 1 are generally consistent with those provided in the examples
described in the Specification.
In both the Appeal Brief and the Reply Brief, Appellant refers to its
Example 13. Appeal Br. 15; Reply Br. 11. Example 13 describes the
activity of a transglutaminase enzyme refrigerated at 4° C for 26 weeks. The
Specification states that “[a]fter 26 weeks storage, 89% of the activity of the
enzyme was left.” Spec. ¶ 84. This is comparable to Schooneveld-
Bergmans’ reported results at 26 weeks. See Schooneveld-Bergmans, Table
1. It is not apparent why one of ordinary skill in the art would see this result
as surprising.
Appeal 2019-004870
Application 14/353,718

10
Appellant correctly asserts that the unexpected benefit need not be
specifically claimed to show criticality. Appeal Br. 15–16. Nonetheless,
Appellant has not carried its burden of showing that the claimed benefit
(stability of milk protein crosslinking and/or modifying enzyme
formulations) is “surprising or unexpected” when compared to the closest
prior art. Accordingly, Appellant has not shown error in the rejection of
claims 1–4, 6, 8–10, 12–14, 16, and 18 as obvious over Schooneveld-
Bergmans in view of Miwa.
Rejections 2–4. The Examiner rejects claims 7, 11, 17, 19, and 20
over Schooneveld-Bergmans in view of Miwa and certain tertiary
references. Final Act. 5–7.
On appeal, Appellant relies on the arguments discussed above in
asserting that the claims are rejected in error. As we have not found such
arguments to be persuasive, we determine that Appellant has not shown
error in the rejections of these claims.

Appeal 2019-004870
Application 14/353,718

11
CONCLUSION

For the reasons set forth in the Final Action, the Examiner’s Answer,
and above, the Examiner’s rejections are affirmed.
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–4, 6, 8–
10, 12–14,
16, 18
103(a) Schooneveld-
Bergmans, Miwa
1–4, 6, 8–
10, 12–14,
16, 18

7, 17 103(a) Schooneveld-
Bergmans, Miwa, Chou
7, 17
11 103(a) Schooneveld-
Bergmans, Miwa, Bodo
11
19, 20 103(a) Schooneveld-
Bergmans, Miwa,
Parkhideh
19, 20
Overall
Outcome
1–4, 6–14,
16–20

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