Ex Parte Tikanmäki et al

Patent Trial and Appeal Board

Aug 29, 2017

14357354 (P.T.A.B. Aug. 29, 2017)

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.
14/357,354 05/09/2014 Reetta Tikanmaki GPK-227-197 9860
23117 7590 08/31/2017
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
HEGGESTAD, HELEN F
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
08/31/2017 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):
PTOMAIL@nixonvan.com
pair_nixon @ firsttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REETTA TIKANMAKI, MATTI ERKKI HARJU, and
OLLI TOSSAVAINEN
Appeal 2017-003202
Application 14/357,354
Technology Center 1700
Before DONNA M. PRAISS, WESLEY B. DERRICK, and
JEFFREY R. SNAY, Administrative Patent Judges.
SNAY, Administrative Patent Judge.
DECISION ON APPEAL1
Appellants2 appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 23—39, 45, and 46. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 We cite to the Specification (“Spec.”) filed May 9, 2014; Non-Final Office
Action (“Non-Final Act.”) dated January 26, 2016; Appellants’ Appeal Brief
(“App. Br.”) dated July 26, 2016; Examiner’s Answer (“Ans.”) dated
October 4, 2016, and Appellants’ Reply Brief (“Reply Br.”) dated December
5,2016.
2 Appellants identify Valio Ltd. as the real party in interest. App. Br. 3.
Appeal 2017-003202
Application 14/357,354
BACKGROUND
The subject matter on appeal relates to infant formula and its
production using membrane filtration. Spec. 1. Claims 23, 38, and 39—the
only independent claims on appeal—are reproduced from the Claims
Appendix of Appellants’ Appeal Brief below:
23. A method for producing an infant formula base,
the method comprising the following steps of:
a) subjecting a milk raw material to micro filtration to
provide a casein concentrate as a microfiltration retentate and a
microfiltration permeate containing whey proteins,
b) subjecting the microfiltration permeate to
ultrafiltration to provide a whey protein concentrate as an
ultrafiltration retentate and an ultrafiltration permeate
containing lactose and milk salts,
c) subjecting the ultrafiltration permeate to nano filtration
to provide a lactose concentrate as a nanofiltration retentate and
a nanofiltration permeate containing milk salts,
d) providing a liquid infant formula base having a total
protein concentration of about 1.0 to about 1.5% comprising the
whey protein concentrate of step b), and the lactose concentrate
of step c),
wherein the method does not include drying steps
between steps a) and b), b) and c), and c) and d).
38. A liquid infant formula base having a total protein
concentration of about 1.0 to about 1.5% of the total weight of
the liquid infant formula base and a P-casein concentration of at
least about 11 % of the total protein concentration.
39. A liquid infant formula base having a total protein
concentration of about 1.0 to about 1.5% of the total weight of
the liquid infant formula base and a P-casein concentration of at
least about 50% of the casein concentration.
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Application 14/357,354
REJECTION
The Examiner maintains the following grounds of rejection:3
I. Claims 23—31, 35—39,4 45, and 46 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Woychik,5 Pascale,6
Harju,7 and Appellants’ admitted prior art.
II. Claims 32—34stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Woychik, Pascale, Harju, Appellants’
admitted prior art, Shimamura,8 and Sibakov.9
OPINION
Rejection I
With regard to Rejection I, Appellants separately argue claims 23, 27,
38, 39, and 45. App. Br. 8—17. We limit our discussion to the separately
argued claims. Claims 24—26, 28—31, 35-37, 45, and 46 stand or fall with
claim 23.
Claim 23
3 Non-Final Act. 3—12; Ans. 4—13.
4 Claim 40 is canceled. See App. Br. 22 (Claims Appendix). The Examiner
incorrectly identifies canceled claim 40 as subject to Rejection I, but corrects
that error by omitting claim 40 in the Answer. Compare Non-Final Act. 3
with, Ans. 2.
5 US 5,169,666, issued December 8, 1992 (“Woychik”).
6 FR 2 809 595 Al, published December 7, 2001, (“Pascale”), as translated,
which English language translation’s use is not contested. In citing to the
translation, which lacks pagination, we refer to the pages sequentially from
the first page.
7 WO 2011/051557 Al, published May 5, 2011 (“Harju”).
8 US 5,744,179, issued April 28, 1998 (“Shimamura”).
9 US 2013/0230623 Al, published September 5, 2013 (“Sibakov”).
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As is relevant to Appellants’ arguments on appeal, the Examiner finds
that Woychik discloses modifying bovine milk by filtration to simulate
human milk for use in infant formulations. Non-Final Act. 4. The Examiner
further finds that Pascale discloses a multi-step milk filtration process
including, sequentially, microfiltration, ultrafiltration, and nanofiltration,
wherein a protein-rich ultrafiltration retentate is combined with a lactose-
rich nanofiltration retentate to produce a desired milk product. Id. at 5. In
light of these findings, the Examiner determines that it would have been
obvious to one of ordinary skill in the art to perform the steps recited in
claim 23 so as to produce an infant formulation having a protein and lactose
content that simulates human milk. Id. at 5—6. Regarding the total protein in
the formulation, the Examiner finds that the recited concentration range
corresponds to that which naturally is found in human milk, that Harju
recognizes use of filtration techniques to obtain a desired protein
concentration in milk, and that one of ordinary skill would have had a reason
to perform the filtration method suggested in light of Woychik and Pascale
so as to provide an infant formulation having a total protein content that
corresponds with that of human milk. Non-Final Act. 5—6; Ans. 6—7.
Appellants argue that Woychik fails to disclose ultrafiltration of the
microfiltration permeate, or nanofiltration of a microfiltration permeate.
App. Br. 7. Appellants also argue that Woychick teaches using the permeate
fraction to form an infant formula rather than a retentate fraction. Id. at 9.
These arguments are not persuasive because they focus solely on Woychik,
and do not address the combined teachings of Woychik and Pascale as relied
upon by the Examiner in connection with Rejection I. See In re Keller, 642
F.2d 413, 426 (CCPA 1981) (explaining that “one cannot show non-
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Application 14/357,354
obviousness by attacking references individually where, as here, the
rejections are based on combinations of references”).
Appellants also argue that Harju discloses a high protein product
designed for use by athletes, rather than an infant formulation which would
require a lower protein content. App. Br. 7, 12—14. However, the fact that
Harju provides a high protein concentration product for use by athletes fails
to negate Harju’s general recognition that a desired protein concentration
may be achieved through filtration techniques. Moreover, Pascale teaches
mixing retentate fractions “so as to adjust the protein content of the final
product,” which may be an “ingredient in the formulation of infant
formulas.” Pascale 8. Appellants’ argument neither addresses nor identifies
error in the Examiner’s findings that the recited protein concentrations
encompass that which exists in human milk, and that one skilled in the art
would have had sufficient reason to proportion the protein content in
Woychik and Pascale to simulate that of human milk when preparing an
infant formulation.
Citing Pascale’s Example 2, Appellants further argue that Pascale’s
process involves evaporation under vacuum which, according to Appellants,
constitutes an intermediate drying step that is precluded by claim 23. App.
Br. 8, 11; Reply Br. 3—5. However, Pascale merely teaches an optional
preconcentration step, which may be accomplished by vacuum evaporation
or reverse osmosis. Pascale 6 (“may optionally be concentrated prior to the
next treatment, for example by vacuum evaporation or by reverse osmosis”).
Figure 1 in Pascale is identified as one of two disclosed processes for
producing the milk derivative product and does not depict any step involving
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evaporation. Id. at 5, Fig. 1. On this record, Appellants do not persuade us
that Pascale requires an intermediate drying step.
For the foregoing reasons, we are not persuaded of reversible error in
the Examiner’s rejection of claim 23. Accordingly, we sustain Rejection I as
applied to claims 23—26, 28—31, 35-37, 45, and 46.
Claims 27 and 45
Each of claims 27 and 45 recites an additional pre-microfiltration step
of heating the milk raw material to a specified temperature for a specified
time. The Examiner finds that Appellants acknowledge the recited heat
treatment encompasses conventional temperatures and exposure times used
for pasteurization, and that Woychik teaches providing pasteurized milk as a
milk raw material for filtration. Final Act. 7; Ans. 8 (citing Woychik
Examples I, II).
Appellants contend that the Examiner’s reliance on Appellants’ own
teaching is improper because “[t]he Office Action does not cite any teaching
that the particularly recited heat treatment should be performed in
conjunction with the remaining method steps recited in claim 23.” App. Br.
15—16. We disagree. Appellants do not contest the Examiner’s finding that
the recited heat treatment conditions are satisfied by conventional
pasteurization. Woychik expressly teaches pasteurization prior to
micro filtration. See, e.g., Woychik 5:43—45 (“Fresh pasteurized skim milk
was equilibrated at 4° C for 6 hours prior to microfiltration . . .”). Thus, we
are not persuaded that the Examiner improperly relied on Appellants’
disclosure in determining that it would have been obvious to perform
conventional pasteurization prior to microfiltration.
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Accordingly, we also sustain Rejection I as applied to claims 27 and
45.
Claims 38 and 39
Each of claims 38 and 39 is directed to a liquid infant formula having
a specified total protein concentration and a specified P-casein/total protein
ratio. The Examiner finds that the recited values for these ingredients
correspond to those which ordinarily are found in human milk, such that
they would have been obvious to one of ordinary skill in the art in light of
Woychik’s teaching that infant formula ideally mimics human milk. Non-
Final Act. 11; Ans. 11—12 (citing Woychik 1:24—61). See Woychik 1:27—31
(“The use of modified or ‘humanized’ bovine milk in infant formulas
designed to simulate human milk as a substitute or supplement, has long
been a subject of continuing research.”).
Appellants do not dispute the Examiner’s finding that the recited
protein and P-casein concentration values correspond to those found in
human milk. Rather, Appellants argue that Woychik discloses a lyophilized
infant formula having 92—95% total protein, and Pascale fails to specify a P-
casein concentration. App. Br. 16—17; Reply Br. 1—2. Neither of these
arguments rebuts the Examiner’s finding that one of ordinary skill would
have had a reason to provide an infant formulation having total protein and a
P-casein/total protein ratio that correspond to what is found in human milk.
Moreover, Woychik’s reported protein content after lyophilization does not
preclude a lower protein content either before lyophilization or after
reconstitution. We add that Woychik also states a preference for increased
P-casein content. Woychik 4:36—39 (“Since the only apparent casein
component in human milk is P-casein-like, the resulting permeate product
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containing free P-casein, approximates human milk.”); id. 4:55—64
(identifying protein compositions that include up to 55% casein, of which
approximately 60% is P-casein). On this record, Appellants do not persuade
us of reversible error in the Examiner’s finding that a desire to simulate
human milk would have served as a sufficient reason for one skilled in the
art to provide total protein and P-casein with the recited concentration
ranges. Accordingly, we sustain Rejection I as applied to claims 38 and 39.
Rejection II
Appellants do not separately argue against Rejection II, other than an
implied reliance on the arguments made against Rejection I. Because
Appellants’ arguments against Rejection I are not persuasive, we sustain
Rejection II for the reasons set forth above.
DECISION
The Examiner’s rejection of claims 23—39, 45, and 46 under 35 U.S.C.
§ 103(a) is affirmed.
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
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