Ex Parte Cordle et al

Patent Trial and Appeal Board

May 11, 2018

13818486 (P.T.A.B. May. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/818,486 06/04/2013
106587 7590 05/15/2018
Abbott Laboratories
Department 108140, Bldg. RP3-2
3300 Stelzer Road
Columbus, OH 43219-3034
FIRST NAMED INVENTOR
Christopher T. Cordle
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.
10517US01 (35226/05237) 2373
EXAMINER
COX,AMBERM
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
05/15/2018 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):
ipdocket@calfee.com
AN_Patent_Docketing@abbott.com
wfrick@calfee.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte CHRISTOPHER T. CORDLE, STEVEN T. LUEBBERS,
LARRY W. WILLIAMS, JEFFREY HARRIS BAXTER, and
GERALYN DUSKA-MCEWEN
Appeal2017-008207
Application 13/818,486
Technology Center 1700
Before DONNA M. PRAISS, CHRISTOPHER C. KENNEDY, and
JEFFREY R. SNAY, Administrative Patent Judges.
SNAY, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellants2 appeal under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 16-20, 24, and 35-37. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 We cite to the Specification ("Spec.") filed February 22, 2013; Final Office
Action ("Final Act.") dated February 26, 2016; Appellants' Appeal Brief
("App. Br.") dated November 28, 2016; Examiner's Answer ("Ans.") dated
March 13, 2017, and Appellants' Reply Brief ("Reply Br.") dated May 12,
2017.
2 Appellants identify Abbott Nutrition Incorporated as the real party in
interest. App. Br. 4.
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Application 13/818,486
BACKGROUND
The invention relates to nutritional products containing pea protein
hydrolysates. Spec. i-f 1. Claim 16 is the sole independent claim on appeal:
16. A nutritional product for oral consumption by an
individual, the nutritional product comprising protein,
carbohydrate and optionally fat, wherein the protein
comprises 50-100% by weight of pea protein hydrolysate
and the pea protein hydrolysate meets at least one of the
following:
(a) has less than 15,000 µg of immunologically active pea
antigen per 1 gram of protein, and
(b) has an adjusted degree of hydrolysis of7-19%.
App. Br. 24 (Claims Appendix) (emphasis added to highlight the key
recitation in dispute).
REJECTIONS
I. Claims 16-20, 24, and 35-37 stand rejected under 35 U.S.C. § 112,
second paragraph.
II. Claims 16, 17, 24, and 37 stand rejected under 35 U.S.C. § 102(b) or,
in the alternative, § 103(a) as unpatentable over Eriksen3 as evidenced by
Boehm. 4
III. Claims 18-20, 35, and 36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Eriksen and Boehm.
3 US 5,520,935, issued May 28, 1996 ("Eriksen").
4 US 2008/0096794 Al, published April 24, 2008 ("Boehm").
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Application 13/818,486
Rejection I
OPINION
The Examiner finds that the phrase, "adjusted degree of hydrolysis,"
in claim 16 is indefinite because it is unclear what that parameter represents,
how it is measured, and how it can be obtained. Final Act. 3. Appellant
points to paragraph 19 of the Specification, where the phrase, "adjusted
degree of hydrolysis," is defined to mean the degree of hydrolysis of a
protein material "adjusted or corrected to account for the measurable amino
nitrogen content of the intact protein material." App. Br. 17 (quoting Spec.
i-f 19). Examples of such correction involve determining the amino nitrogen
content of unmodified protein and subtracting that value from a determined
degree of hydrolysis after subjecting the protein to a hydrolysis procedure.
Spec. i-fi-119, 125.
In the Answer, the Examiner adopts different reasoning to support the
indefiniteness finding. First, the Examiner contends that "if one of ordinary
skill in the art does not know the starting point or starting material, then they
will not be able to calculate the adjusted degree of hydrolysis and therefore
will not know if they are infringing." Ans. 12-13. However, as Appellants
correctly observe (Reply Br. 6), a need for routine experimentation to
practice an invention is not indicative of indefiniteness. W.L. Gore &
Associates, Inc. v. Garlock, Inc., 721F.2d1540, 1557 (Fed. Cir. 1983) ("[A]
patent is not invalid because of a need for experimentation."). Second, the
Examiner asserts that "the adjusted degree of hydrolysis varies depending on
the method used for determining the degree of hydrolysis," and that, absent
some specificity as to the method used, the scope of the recitations involving
a degree of hydrolysis are unclear. Ans. 13. However, the Examiner points
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to no evidence or credible technical reasoning to substantiate the assertion
that different measurement techniques would yield materially different
values for degree of hydrolysis on a given protein material.
For the foregoing reasons, we are persuaded that the Examiner erred
in finding Appellants' claims indefinite. Rejection I is not sustained.
Rejection II
With regard to Rejection II, Appellants argue the claims as a group.
App. Br. 19-21. We select the independent claim as representative, and
decide the appeal of Rejection II based on the representative claim alone.
The Examiner finds that Eriksen discloses a pea protein hydrolysate as
a nutritional additive to foods or beverages. Final Act. 5. The Examiner
further finds that Eriksen teaches that the pea protein is hydrolyzed to a
degree of hydrolysis (DH) in the range of 15-35%. Id. (citing Eriksen 2:4--
6). There, Eriksen discloses that the pea protein "is proteolytically
hydrolyzed by means of a non-pH-stat method to a DH of between 15 and
35%." Eriksen 2:5---6. Eriksen does not identify a degree of hydrolysation
of the intact protein prior to hydrolysis. However, pointing to Appellants'
identification of a degree of hydrolysis of 8.68 for a conventional intact pea
protein, and further noting that both Appellants and Eriksen concern pea
protein hydrolysates intended for use as a nutritional additive, the Examiner
infers that Eriksen's DH range of 15-35%, when adjusted for a reasonably
expected initial degree of hydrolysation, corresponds to an adjusted degree
of hydrolysation (ADH) range that overlaps the 7-19% range recited in
claim 16. Final Act. 6; Ans. 15-16. The Examiner additionally finds that
the specific DH value reported for each of Eriksen's examples 1--4, when
adjusted by subtracting 8.68 as a presumed DH for the corresponding intact
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protein, demonstrates an ADH value within the claimed range. Final Act. 6;
Ans. 15.
Appellants argue that the 8.68 value for pre-hydrolyzed pea protein
identified in the Specification cannot necessarily be applied to Eriksen's pea
protein because the initial degree of hydrolysation "can vary among different
protein sources." App. Br. 19. According to Appellants, it is impossible to
calculate an adjusted degree of hydrolysation for Eriksen's pea protein
because Eriksen does not identify the degree of hydrolysation of the intact
material. Id. at 19-20. On that basis, Appellant contends that Eriksen "lacks
a fundamental piece of information" necessary to determine the ADH
associated with any of Eriksen's described pea protein hydrolysates. Id.
We agree that the Examiner erred in finding that Eriksen's examples
necessarily possessed ADH values within the claimed range. Absent
evidence establishing a DH value for the specific corresponding intact
protein, the Examiner has not identified an express or implicit description in
Eriksen of a given ADH value for the hydrolyzed materials reported in the
examples. For that reason, we do not sustain the anticipation basis of
Rejection II.
However, with regard to the obviousness basis of Rejection II,
Appellants' argument is not persuasive of reversible error. There is no
dispute that Eriksen's disclosed DH range of 15-35% necessarily
corresponds to an ADH range, the values of which depend solely on the
degree of hydrolysation of the intact pea protein. Any initial DH value for
Eriksen's pea protein material would result in an ADH range that is less than
15-35%. Thus, Eriksen's disclosed DH range of 15-35% for hydrolyzed
pea protein necessarily corresponds to an ADH range that is equal to or less
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than 15-35%. As such, we are persuaded that the Examiner's finding that
Eriksen's disclosed DH range corresponds to an ADH range that overlaps
the claimed ADH range is supported by a preponderance of the evidence.
Because Appellants do not present evidence or argument to show
criticality of the claimed range, we agree with the Examiner's determination
that the claimed ADH range would have been obvious to one of ordinary
skill in light of the disclosure of Eriksen. See In re Geisler, 116 F.3d 1465,
1469 (Fed. Cir. 1997) ("[W]hen the difference between the claimed
invention and the prior art is the range or value of a particular variable, then
a prima facie rejection is properly established when the difference in range
or value is minor.") (quoting Haynes Int'!, Inc. v. Jessop Steel Co., 8 F.3d
1573, 1577 n.3 (Fed. Cir. 1993)); In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990) ("The law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other variable within
the claims. These cases have consistently held that in such a situation, the
applicant must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results relative to the
prior art range.") (internal citations omitted).
Appellants also dispute the Examiner's finding that the recited level of
immunologically active pea antigen would have been inherent in Eriksen's
pea protein material. App. Br. 20-21; Reply Br. 7-8. However, claim 16
recites that property only in the alternative. Particularly, Appellants' claim
requires, inter alia, that the hydrolysate "meets at least one of the
following:" (a) a range of active pea antigen and (b) a range of ADH. Claim
16 (emphasis added). Because we are not persuaded of error in the
Examiner's obviousness determination based on (b ), the recited ADH range,
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we need not reach Appellants' arguments concerning (a), the recited antigen
content.
For the foregoing reasons, we sustain the obviousness grounds set
forth in Rejection II.
Rejection III
Appellants contest Rejection III based on the same arguments
presented against Rejection II (App. Br. 21 ), which are not persuasive of
error in the Examiner's obviousness rationale for the reasons stated.
Appellants also argue that the Examiner fails to establish that the content of
protein, fat, and carbohydrate would have been recognized as result-effective
variables in a nutritional formula. Id. at 21-22. We disagree.
There is no dispute that Boehm discloses a nutritional formula
containing pea protein hydrolysate as well as desired amounts of fat and
carbohydrate. Compare Final Act. 9 (finding that Boehm teaches a
nutritional product containing hydrolyzed pea protein, a fat component, and
a carbohydrate component), with App. Br. 21-23. For formula food, Boehm
teaches a suitable carbohydrate content of 40 to 55 energy% and fat content
of 35 to 50 energy%. Boehm i-f 22. Appellants present no persuasive
evidence or technical reasoning to refute that one of ordinary skill would
have considered carbohydrate and fat content to be variables, the adjustment
and optimization of which would have been obvious based on the desired
nutrition and energy contribution of those ingredients in a given nutritional
formula.
Accordingly, Appellants do not persuade us of reversible error in
connection with Rejection III, which we also sustain.
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SUMMARY
The Examiner's rejection under 35 U.S.C. § 112 is not sustained.
The Examiner's rejection under 35 U.S.C. § 102(b) is not sustained.
The Examiner's rejections under 35 U.S.C. § 103(a) are sustained.
DECISION
The Examiner's decision rejecting claims 16-20, 24, and 35-37 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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