Ex Parte 8067381 et al

Patent Trial and Appeal Board

Jul 17, 2015

95002001 (P.T.A.B. Jul. 17, 2015)

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.
95/002,001 05/31/2012 8067381 028284.0105X7US 2667
127044 7590 07/17/2015
Porzio, Bromberg & Newman P.C.
1200 New Hampshire Ave., NW
Suite 710
Washington, DC 20036
EXAMINER
PONNALURI, PADMASHRI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
07/17/2015 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

WOODBOLT DISTRIBUTION, LLC.
Requester and Respondent

v.

NATURAL ALTERNATIVES INTERNATIONAL, INC.
Patent Owner and Appellant
____________

Appeal 2015–000225
Reexamination Control 95/002,001
Patent 8,067,381 B1
Technology Center 3900
____________

Before, RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Patent Owner from the Patent
Examiner’s decision to reject claims 1–14 and 32-34 in the above-identified inter
partes reexamination of United States Patent 8,067,381 B1. The Board’s
jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315 (pre–AIA).
We affirm.
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BACKGROUND
The patent in dispute is this appeal is United States Patent 8,067,381 B1
(“the ’381 patent”) which issued Nov. 29, 2011, based on Application No.
13/215,073 filed Aug. 22, 2011. There are two named inventors, Roger Harris and
Mark Dunnett. The patent is subject to a terminal disclaimer. The real party in
interest and owner of the ’381 patent is Natural Alternatives International, Inc.
(“Patent Owner”). Owner Appeal Brief 1, dated May 14, 2014 (“Owner Appeal
Br.”).
A request for inter partes reexamination of the ’381 patent was filed May
31, 2012 by Woodbolt Distributors, LLC (“Requester”) under 35 U.S.C. §§ 311–
318 and 37 C.F.R. §§ 1.902–1.997. Woodbolt is also the Respondent in this
proceeding. An oral hearing was held April 15, 2015. A transcript of the hearing
has been entered into the record (“Hearing Tr.”).
According to Patent Owner, there is a related inter partes reexamination
(95/002,048) and district court litigation. Owner Appeal Br. 1.
The ’381 patent teaches that anaerobic stress “can cause the onset of fatigue
and discomfort that can be experienced with intense exercise . . ., where oxygen
availability may be limited . . . and with aging.” ’381 patent, col. 1, ll. 53-58. The
claimed subject matter of the ’381 patent is directed to a human dietary supplement
that comprises beta-alanine or a derivative of it. Id., col. 3, ll. 4–9. Beta-alanine is
an amino acid. Id. According to the ’381 patent, administering beta-alanine and
glycine increases the anaerobic working capacity in a tissue. Id., col. 2, ll. 48–65.
The claims stand rejected by the Examiner as follows:
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1. Claim 1–14 and 32–34 under 35 U.S.C. § 102(b) as anticipated by Harris
1

(Ground Nos. 1 and 15; RAN p. 24).
2. Claim 1 under 35 U.S.C. § 102(b) as anticipated by each of Asatoor
2
and
Gardner
3
(Grounds Nos. 2, 4, 16 and 18; RAN pp. 24–25).
3. Claims 1–4 and 32–34 under 35 U.S.C. § 102(b) as anticipated by are
anticipated by EP ’593
4
(Grounds Nos. 3 and 17; RAN pp. 25–26).
4. Claim 1 under 35 U.S.C. § 102(b) as anticipated by DeLacharriere ’068
5

and ’559
6
(Ground No.5; RAN p. 26-27).
5. Claim 1 under 35 U.S.C. § 102(b) as anticipated by Wu
7
(Ground No.6;
RAN pp. 26–27).
6. Claims 1–5, 7, 8, 10–14 and 32–34 under 35 U.S.C. § 103(a) as obvious
in view of Setra
8
and Asatoor (Grounds Nos. 7 and 19; RAN pp. 27-28).
7. Claims 1–5, 7, 8, 10–14 and 32-34 under 35 U.S.C. § 103(a) as obvious in
view of Setra and Gardner (Grounds Nos. 8 and 20; RAN pp. 28).

1
Roger Harris, et al., US 5,965,596 (Oct. 12, 1999).
2
A.M. Asatoor et al., Intestinal Absorption of Carnosine and its Constituent
Amino Acids in Man, 11 Gut, 250 (1970).
3
Michael L. G. Gardner et al., Intestinal Absorption of the Intact Peptide
Carnosine in Man, and Comparison with Intestinal Permeability to Lactulose, 439
J. Physiology 411 (1991).
4
Andre Rougereau, EP 0 280 593 B1 (pub. June 12, 1991).
5
Olivier De Lacharriere et al., US 5,869,068 (Feb. 9, 1999).
6
Olivier De Lacharriere et al., US 5,976,559 (Nov. 2, 1999).
7
Hui-Chun Wu et al., Proximate Composition, Free Amino Acids and Peptides
Contents in Commercial Chicken and Other Meat Essences, 10(3) J. Food and
Drug Analysis 170 (2002).
8
Glan Paolo Negrisoli, EP 0 449 787 A2 (pub. October 2, 1991).
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8. Claim 6 under 35 U.S.C. § 103(a) as obvious in view of Setra, Asatoor,
and Biola;
9
or Setra, Gardner, and Biola (Grounds Nos. 9, 10, 21 and 22; RAN pp.
29–30).
9. Claim 9 under 35 U.S.C. § 103(a) as obvious in view of Setra, Asatoor,
and Casey;
10
or Setra, Gardner, and Casey (Grounds Nos. 11, 12, 23 and 24; RAN
p. 30).
10. Claims 32-34 under 35 U.S.C. § 112, first and second paragraph
(Grounds 13 and 14).
Claim 1 is the only representative claim on appeal and reads as follows:
A human dietary supplement comprising at least one of:
an amino acid wherein said amino acid is beta-alanine that is
not part of a dipeptide, polypeptide or oligopeptide;
an ester of beta-alanine that is not part of a dipeptide,
polypeptide or oligopeptide; or
an amide of beta-alanine that is not part of a dipeptide,
polypeptide or oligopeptide.

Additional evidence
The following additional evidence is cited:
1. Declaration under 37 C.F.R. § 1.132 of Roger C. Harris, Ph.D. (dated
Oct. 29
,
2012) (hereinafter, “Harris Decl.”). Dr. Harris is co-inventor of the ’381
patent.
2. Declaration of Roger C. Harris, Ph.D. (dated March 8, 2013) which was
prepared for the related litigation in District Court) (hereinafter, “Court Harris

9
Gianni Biolo et al., Insulin Action on Protein Metabolism, 7(4) Bailliere’s
Clinical Endocrinology and Metabolism (Oct. 1993).
10
A. Casey et al., Creatine Ingestion Favorably Affects Performance and Muscle
Metabolism During Maximal Exercise in Humans, 271 Am. J. Physiology E31
(1996).
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Decl.”)
3. Declaration under 37 C.F.R. § 1.132 of Craig Sale, Ph.D. (dated Oct. 10,
2012) (hereinafter, “Sale Decl.”). Dr. Sale testified that he has a Ph.D. in exercise
physiology and over 11 years of experience in this field when the declaration was
executed. Sale Decl. ¶ 2.
4. Declaration under 37 C.F.R. § 1.132 of Stephen G. Kunin (dated Aug. 21,
2013) (hereinafter, “Kunin Decl.”). Mr. Kunin is an expert in patent law and
procedure with considerable experience in the field. Kunin Decl. ¶¶ 4–16.
5. Tallon, Ph.D., Mark, “A New Science in Muscular Performance,”
Product Number 17805, iSatori Technologies (undated).
6. Balcombe, B.S.E., “Athletic Edge Nutrition Presents The Beta-Alanine
Revolution Featuring-IntraXCell®,” 2010.
PRIORITY
All the claims in the ’381 patent were found by the Examiner to be
anticipated by Harris. Patent Owner contends that Harris is not prior art to the
’381 patent, but rather the ’381 patent is entitled to the benefit of the application
from which the Harris patent arose. Accordingly, we need to address the priority
claim of the ’381 patent.
The application which led to the ’381 patent was filed on August 22, 2011 as
part of a family of continuation and continuation in-part applications (“application
chain”) as listed in the table below.
11
The bracketed numbers are for reference: [6]
means the “sixth application,” [5] means the “fifth application,” and so on. It is
not disputed each application was co-pending with the earlier-filed application at

11
“CON” is a continuation application; “PROV” is a provisional application:
“CIP” is a continuation-in-part application; “DIV” is a divisional application;
“UK” is a United Kingdom application.
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the time the priority claim was made at the PTO, as required under 35 U.S.C.
§ 120.
Type Application No. Filing Date Patent Issue Date
13/215,073 Aug. 22,
2011
8,067,381 B1 Nov. 29, 2011
CON 12/806,356 [7] 08/10/2010
10/717,217 [5] 09/2/2008 Amendment filed claiming priority of
only provisional application and
deleting benefit of application chain
CON 12/231,240 [6] 08/29/2008 7,825,084 11/2/2010
10/717,217 [5] 11/18/2003 Preliminary amendment filed
claiming priority of application chain
CIP 10/717,217 [5] 11/18/2003 7,504,376 03/17/2009
PROV 60/462,238 04/10/2003
CON 10/209,169 [4] 07/30/2002 6,680,294 1/20/2004
CON 09/757,782 [3] 01/09/2001 6,426,361 7/30/2002
DIV 09/318,530 [2] 05/25/1999 6,172,098 1/9/2001
08/909,513 [1] 08/12/1997 5,965,596 [Harris] 10/12/1999
UK 9621914.2 10/21/1996
UK 9616910.7 08/12/1996

The Application Data Sheet, filed August 22, 2011, and Bibliographic Data
Sheet, mailed October 17, 2011, of the ’381 patent list Application 10/717,217 (the
“fifth application”) as a continuation-in-part of Provisional application 60/462,238
and Application 10/209,169 (the “fourth application”), and so on, all the way back
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to the United Kingdom (UK) applications. However, when the ’381 patent was
filed on August 22, 2011, the fifth application no longer claimed priority to the
fourth application nor the parent applications of the fourth application. Rather, as
summarized in the table above, the priority claim of the fifth application was
amended on September 2, 2008 to assert benefit of the provisional application, and
to delete the priority claim to the first, second, third, and fourth US applications,
and the two UK applications.
Although the ’381 patent claims priority all the way back to the UK
applications, the Examiner denied the priority claim on the basis that the fifth
application, in the amendment dated September 2, 2008, deleted the claim to
benefit of the fourth, third, second, and first US applications, and the two UK
applications. Because priority to the earlier filed and predecessor applications had
been disclaimed in the fifth application on September 2, 2008, the Examiner
concluded that continuity had been broken, and the ’381 patent was only entitled to
claim benefit back to the filing date of the provisional application filed April 10,
2003 and the intervening applications. RAN 5–6.
Patent Owner argues that the amendment to the fifth application (10/17,217
[5]) took place on September 2, 2008 after the sixth application (12/231,240 [6])
had been filed on August 29, 2008, and that the sixth application’s priority was
established to the earlier filed applications (fourth application, third application,
and so on) on the date when it was filed. Owner Appeal Br. 3–4. Patent Owner
contends that sixth application, when it was filed August 29, 2008, had unbroken
continuity to the UK applications which could not be divested of it by a subsequent
change in priority to the fifth application. Id.
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The issue is whether deleting the benefit claim in the fifth application, after
the sixth application had been filed but during its pendency, broke continuity with
the earlier filed applications (fourth application and earlier filed applications), and
whether such break in continuity deprives the ’381 patent of the benefit of the
applications filed prior to the filing date of the provisional application.

Discussion
Patent Owner asserts “Because a priority claim is determined on the date of
filing, the September 2, 2008 amendment cannot retroactively alter the properly
claimed priority of the earlier filed ’240 application [the sixth application].”
Owner Appeal Br. 6. In support of this position, Patent Owner cited In re Hogan,
559 F.2d 595 (CCPA 1977) for its holding that compliance with 35 U.S.C. § 112 is
determined as of the application filing date, indicating that priority is established as
of this date, as well. Patent Owner also argued:
Britannica clearly held that “[l]ater applications cannot amend [an
earlier] application and restore its entitlement to priority.”
Encyclopaedia Britannica, Inc. v. Alpine Elc. of Am., Inc., 609 F.3d
1345, 1350-51 (Fed. Cir. 2010). Similarly, a later application cannot
remove an earlier application’s entitlement to priority. The Examiner's
conclusory determination to the contrary conflicts with the well-
settled case law.
Id.
Initially, when the sixth application was filed, it was correctly stated that the
sixth application is a continuation of the fifth application, and that the fifth
application is a continuation-in-part application of Application 10/209,169 (the
“fourth application”), and so on. However, during the pendency of the sixth
application, on September 2, 2008, the fifth application was intentionally amended
by Patent Owner to delete benefit to the earlier filed fourth application and its
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parent applications. Consequently, the subsequent amendment to the sixth
application dated April 19, 2010 making a priority claim to the earlier filed fourth
application was incorrect because the priority claim to the fourth application had
been deleted in the fifth application.
Patent Owner contends that the Examiner is attempting to retroactively
divest the sixth application of its priority, but Patent Owner ignores the fact that
Patent Owner intentionally deleted the priority benefit and broke the chain of
priority while the sixth application was still pending. It was Patent Owner’s
intentional action which broke priority, not an action by the Examiner or the PTO.
See MPEP § 211.02(a)III (“A cancellation of a benefit claim to a prior application
may be considered as a showing that the applicant is intentionally waiving the
benefit claim to the prior application in the instant application.”)
Patent Owner contends that once the priority of the sixth application had
been established, it cannot be changed or divested by a subsequent deletion of a
benefit claim by an intermediate application in the chain of priority. Patent Owner
relied on Britannica to support this position. In Britannica, a priority claim was
found to be defective because an intermediate application had failed to contain
specific reference to the earlier filed applications. Britannica, 609 F.3d at 1347–
48. Britannica had argued that subsequently filed patents claimed priority to the
intermediate and earlier filed applications and thus the public notice function
would have been served and no harm was done. Id. at 1351. The court rejected
this rationale, stating:
Later applications cannot amend the ’955 application and restore its
entitlement to priority. The ’955 application failed to claim priority to
the ’917 application. The applicants allowed the ’955 application to
go abandoned even after being informed by the PTO of its infirmities.
It makes no sense to allow the applicant to rewrite history and
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resurrect the ’955 application's priority claim. The ’955 application
did not contain a specific reference to the ’917 application. Therefore,
it failed to satisfy the requirements of § 120 and is not awarded the
benefit of the earlier filing date in the United States.
Id.
The decision in Britannica was based on the interpretation of 35 U.S.C.
§ 120, which specifies the conditions for obtaining benefit of an earlier filing date
in the United States. Section 120 (Nov. 29, 1999) reads as follows (emphasis
added):
An application for patent for an invention disclosed in the
manner provided by the first paragraph of section 112 of this title in
an application previously filed in the United States, or as provided
by section 363 of this title, which is filed by an inventor or inventors
named in the previously filed application shall have the same effect,
as to such invention, as though filed on the date of the prior
application, if filed before the patenting or abandonment of or
termination of proceedings on the first application or on an application
similarly entitled to the benefit of the filing date of the first
application and if it contains or is amended to contain a specific
reference to the earlier filed application.
Britannica found that the application “similarly entitled to the benefit of the
filing date of the application” must also contain a reference to any earlier filed
applications to which priority is sought – a condition found to be defective in the
intermediate application in Britannica which led to the break in priority.
Britannica, 609 F.3d at 1350. In other words, in this specific case, for the fifth
intermediate application to be accorded benefit of the filing dates of the earlier
filed applications, it needed a specific reference to them. However, such reference
was deleted by amendment. Patent Owner contends that such deletion cannot
divest the sixth application of its priority under Britannica, but Patent Owner skips
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over the fact that Britannica required all applications in the priority chain to
contain specific references to earlier filed applications.
Mr. Kunin, in his declaration, argues that a correction in inventorship does
not result in a loss of priority under § 120. Kunin Decl. ¶ 28. The circumstances,
however, provided by Mr. Kunin are different from here because they involve a
restriction requirement by the PTO under 37 C.F.R. § 1.142, not a deliberate action
by Patent Owner as is the case here.
Contrary to Patent Owner’s arguments, priority does not “vest” on the filing
date of an application merely because an assertion is made that the application is
entitled to priority of one or more earlier filed applications. See Kunin Decl. ¶¶
35–36. In order to be accorded priority under § 120 to an earlier filed application,
the “invention” must be “disclosed in the manner provided by the first paragraph
of section 112.” 35 U.S.C. § 120. The PTO is tasked with determining whether a
claimed invention complies with § 112. See MPEP § 201.07 (8
th
Edition; August
2001); §§ 2163 and 2164. Thus, at any time during the prosecution of an
application, the PTO may determine that a claim in an application is not entitled to
the claimed benefit of an earlier filed application because it was not described or
enabled in the application.
When the ’381 patent was filed, it claimed the benefit of the fourth
application as a parent of the fifth, sixth, and seventh applications. See
Specification, filed Aug. 22, 2011 in Application 13/215,073. This assertion was
not factually correct because the fifth application had deleted the benefit claim to
the earlier filed fourth application and its parents. Under Britannica, 609 F.3d at
1351, a priority claim cannot simply be resurrected by making an assertion of
priority to an earlier filed application, when such assertion is not compliant with
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§ 120 because the specific reference to the earlier filed application had been
deleted.
The theory Patent Owner has put forth to restore priority is that the sixth
application should not be deprived of claiming priority to the fourth application by
a change in a benefit claim in the fifth application. As we have already discussed,
Patent Owner intentionally deleted the benefit claim in the fifth application, while
the sixth application was pending. Section 120 specifically provides for an
amendment to be made to an application’s benefit claim (“and if it contains or is
amended to contain a specific reference to the earlier filed application”). Once this
amendment was made to the fifth application, the fifth application was entitled
only to the benefit of the provisional application to which it had been “amended to
contain a specific reference to.” Patent Owner cannot have it both ways, cutting
off the priority of the fifth application, while preserving the priority of its
descendent sixth, seventh, and eighth (the ‘381 patent) applications. In sum, the
fifth application failed to comply with § 120, which requires a specific reference to
earlier filed applications entitled to the benefit of § 120. The fifth application is
not entitled to the benefit of the fourth application since the specific reference to
the fourth application was deleted in the fifth application.

Support for fifth application claims
In the Request for Reexamination, Requester argued that the fifth
application, when filed, had claims to beta-alanine and glycine, and beta-alanine in
specific numerical dosages, which had no § 112 support in the earlier-filed first,
second, third, and fourth applications. Request 7. For this reason, Requester
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contended that the fifth application was not entitled to claim priority under § 120 to
any earlier filed application. Id. See also RAN 20.
Whether the fifth application was “entitled” to claim benefit to an earlier
application is not at issue in this appeal. As already stated, Patent Owner voluntary
amended the fifth application to disclaim benefit to the earlier filed application.
It is therefore moot whether Patent Owner was required to make such an
amendment, and certainly is not an appealable issue in this case.
Nonetheless, we observe that The Manual of Patent Examination and
Procedure (“MPEP”) § 2163.II.3(b) specifically instructs an examiner to determine
whether a claim asserting entitlement to an earlier filed application is described in
the earlier filed application or applications. An examiner is not instructed by the
MPEP to review every earlier filed application to determine if the claims of the
earlier filed application would be entitled to the asserted priority benefit. Section
120 does not expressly require such a determination either since it grants priority to
“an application similarly entitled to the benefit of the filing date of the first
application,” referencing the “application” rather than the invention of the
application. Rather, the focus is on continuity of disclosure, and whether every
application in the chain of priority applications to which benefit is sought describes
the later-filed claims. Consequently, Patent Owner’s argument is not consistent
with PTO procedure.
The case law is consistent with the MPEP.
12
In Hollmer v. Harari, 681 F.3d
1351, 1355 (Fed. Cir. 2012), the Federal Circuit held:

12
Under Requester’s theory, no continuation-in-part application with only claims
to the new subject matter could ever serve as intermediate application in a priority
benefit claim.
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“[T]o gain the benefit of the filing date of an earlier application under
35 U.S.C. § 120, each application in the chain leading back to the
earlier application must comply with the written description
requirement of 35 U.S.C. § 112.” Zenon Envtl., Inc. v. U.S. Filter
Corp., 506 F.3d 1370, 1378 (Fed. Cir. 2007) (quoting Lockwood v.
Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997)); see also In
re Hogan, 559 F.2d 595, 609 (CCPA 1977) (“[T]here has to be a
continuous chain of copending applications each of which satisfies the
requirements of § 112 with respect to the subject matter presently
claimed.” (quoting In re Schneider, 481 F.2d 1350, 1356 (CCPA
1973))) (alteration in original). Thus, if any application in the priority
chain fails to make the requisite disclosure of subject matter, the later
filed application is not entitled to the benefit of the filing date of
applications preceding the break in the priority chain. See Lockwood,
107 F.3d at 1571–72; Hogan, 559 F.2d at 609 . . . Whether the
intervening patents in a chain of priority maintain the requisite
continuity of disclosure is a question of law we review de novo.
Zenon, 506 F.3d at 1379.
In Kangaroos U.S.C., Inc., 778 F.2d 1571, 1574 (Fed. Cir. 1985), the court
also referred the continuity of disclosure:
The role of the parent application with respect to the divisional was
solely to provide the continuity of disclosure required by § 120,
thereby connecting the divisional through a chain of co-pendency
back to the design application. It is not material whether the parent
could have relied on a § 120 priority claim, because no intervening
reference was cited against the claims of the parent.
In sum, Patent Owner’s argument about entitlement to priority is not
consistent with either PTO procedure or the pertinent case law. In any
event, the Patent Owner intentionally cut off priority to the fifth application
and the Patent Owner’s conduct in doing so is not at issue in this appeal.

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Summary
In view of the foregoing discussion, we conclude that the Examiner correctly
denied priority past the fifth application. Accordingly, the earliest filing date of the
claims at issue in this appeal is April 10, 2003, the filing date of the provisional
application.

CLAIM INTERPRETATION
Claim 1 is directed to a “human dietary supplement” which comprises beta-
alanine, an ester of beta-alanine, or an amide of beta-alanine. The interpretation of
“human dietary supplement” is in dispute in this appeal. Patent Owner argues
“human dietary supplement,” when properly interpreted, has the following
meaning:
an addition to the human diet, ingested as a pill, capsule, tablet,
powder or liquid, which is not a natural or conventional food, meat or
food flavoring or extract, or pharmaceutical product and that increases
the function of tissues when consumed over a period of time.
Owner Appeal Br. 6.
The Examiner considered the disputed phrase not to limit the claimed
composition because “it states the purpose or intended use of the composition.”
RAN 7. The Examiner concluded that “any prior art composition containing beta-
alanine, even if not disclosed for use as a ‘human dietary supplement,’ is
anticipating prior art to the claims of the ’381 Patent, because ‘human dietary
supplement’ is only in the claim preamble.” Id. Requester contends that the
Examiner’s interpretation is the correct one. Req. Resp’t Br. 8.

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Discussion
During reexamination of an unexpired patent, claims are given their broadest
reasonable interpretation consistent with the patent specification. In re Suitco
Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir. 2010); In re Abbott Diabetes Care
Inc., 696 F.3d 1142, 1148 (Fed. Cir. 2012). The “PTO applies to the verbiage of
the proposed claims the broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may be
afforded by the written description contained in applicant’s specification.” In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
The ’381 patent describes “natural food supplements” as being “typically
designed to compensate for reduced levels of nutrients in the modern human and
animal diet.” ’381 patent, col. 1, ll. 40–42. Furthermore, the ’381 patent teaches
“useful supplements increase the function of tissues when consumed.” Id. at col. 1,
ll. 42–43. The ’381 patent also teaches that it is “important to supplement the diets
of particular classes of animals whose normal diet may be deficient in nutrients
available only from meat and animal products.” Id. at col. 1, ll. 44–46. The ’381
identifies natural food supplements which are said to improve athletic
performance. Id. at col. 1, ll. 48–52.
The invention of the ’381 patent is described, in one aspect, as administering
beta-alanine and other named compounds to increase the anaerobic working
capacity in a tissue. ’381 patent, col. 2, ll. 52–56, 60–63. The ’381 patent
describes a composition comprising beta-alanine or derivatives of it. Id. at col. 3,
ll. 6–8. The ’381 patent teaches that the composition can be a pharmaceutical
composition, a dietary supplement, or sports drink which is formulated for humans.
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Id. at col. 3, ll. 21–25. Furthermore, the ’381 patent teaches that the composition
“can be a dietary supplement that can be ingested, injected, or absorbed through
the skin.” Id. at col. 9, ll. 28–29. The ’381 patent provides examples in which
beta-alanine was administered to humans as a supplement. Id. at col. 14, ll. 17–20;
col. 15, ll. 47–51; col. 18, ll. 20–23. In Example 4, for instance, “three doses of 40
milligrams per kilogram body weight of beta-alanine per day (i.e., administered in
the morning, noon, and at night) for 2 weeks.” Id. at col. 16, ll. 29–31. The ’381
patent states that the effect of this supplementation on “carnosine content of
muscle and isometric endurance at 66% of maximal voluntary contraction force
was investigated.” Id. at col. 16, ll. 32–34.
It is stated in the ’381 patent:
Supplementation with beta-alanine or compounds delivering beta-
alanine on ingestion may have a positive effect on exercise capacity in
sports and those general daily activities leading to lactate
accumulation.
Id. at col. 20, l. 39–43
Based on this description in the ’381 patent, we interpret a “human dietary
supplement” comprising beta-alanine, or a derivative of it, is a composition that is
formulated for humans, and that when administered to the human, can have a
positive effect on a tissue function over time. While it is true that “[p]reamble
language that merely states the purpose or intended use of an invention is generally
not treated as limiting the scope of the claim” (Bicon, Inc. v. Straumann Co., 441
F.3d 945, 951 (Fed. Cir. 2006)), in this case it is clear from reading the ’381 patent
and the plain language of the claim that the “dietary supplement” must be in a form
that is administrable to a human.
The Examiner takes the position that the dietary supplement is not a
limitation because it is only recited in the preamble. “In considering whether a
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preamble limits a claim, the preamble is analyzed to ascertain whether it states a
necessary and defining aspect of the invention, or is simply an introduction to the
general field of the claim.” On Demand Mach. Corp. v. Ingram Indus., 442 F.3d
1331, 1343 (Fed. Cir. 2006). As held in On Demand, the “preamble serves to
focus the reader on the invention that is being claimed.” The court concluded “the
preamble in this case necessarily limits the claims, in that it states the framework
of the invention.” Id.
Here, the phrase “human dietary supplement” defines the invention and
states its “framework” because the only purpose of the claimed supplement
comprising beta-alanine disclosed in the ’381 patent is as a supplement to a
“normal diet” to “increase the function of tissues when consumed,” specifically a
tissue’s anaerobic and exercise capacity. ’381 patent, col. 1, ll. 40–43, 48–52; col.
2, ll. 52–56, 60–63. See discussion above.
However, we observe that the claim does not recite a specific amount of
beta-alanine. In Example 4 discussed above, the supplement was administered for
weeks. Consequently, we do not interpret the claim to require a specific amount,
nor a specific effect after a single administration, only that over time it would
increase tissue function.
Patent Owner argued that the statements in the preliminary amendment filed
August 22, 2011, in the application which led to the ’381 patent made it clear the
phrase “human dietary supplement” limits the claim. Owner Appeal Br. 13. The
statements made in the preliminary amendment are largely consistent with the
interpretation that we afforded the phrase. However, Patent Owner wrote:
By human dietary supplements the applicants mean an addition to the
human diet in a pill, capsule, tablet, powder, or liquid form, which is
not a natural or conventional food, and which effectively increases the
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function of tissues when consumed. This is supported by the
specification at Col. 1, ll.18–25; Col. 3, ll. 54–59 and Examples 1–4
of U.S. Patent No. 6,426,361, for example. To be clear, the term
“human dietary supplement”, as claimed, does not encompass, and
does not mean, a natural or conventional food, such as chicken or
chicken broth, for example.
Preliminary Amendment in Application 13/215,073, p. 5, dated Aug. 11, 2001.
With respect to claim construction, the Federal Circuit held:
this court gives primacy to the language of the claims, followed by the
specification. Additionally, the prosecution history, while not literally
within the patent document, serves as intrinsic evidence for purposes
of claim construction. This remains true in construing patent claims
before the PTO. See In re Morris, 127 F.3d 1048, 1056 (Fed. Cir.
1997).
Tempo Lighting, Inc. v. Tivoli, LLC, 742 F.3d 973, 977 (Fed. Cir. 2014)
This court also observes that the PTO is under no obligation to accept
a claim construction proffered as a prosecution history disclaimer,
which generally only binds the patent owner.
Id. at 978.
We are thus not bound to Patent Owner’s statements concerning the
construction of “human dietary supplement.” Specifically, Patent Owner stated
that “the term ‘human dietary supplement’, as claimed, does not encompass, and
does not mean, a natural or conventional food, such as chicken or chicken broth,
for example.” However, Example 2 in the ’381 patent described the “effect of
supplementation of a normal diet with single and multiple daily doses of beta-
alanine.” ’381 patent, col. 14, ll. 17–18. The supplement administered was chicken
broth. Id. at col. 14, ll. 20–37. See also col. 15, Table 15 listing “Broth” as a
source of beta-alanine supplementation. In view of this explicit disclosure in the
’381 of a chicken broth used as a supplement for beta-alanine, we find that Patent
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Owner’s attempt to exclude it from the claim is ineffective.

ANTICIPATION BY ASATOOR
Findings of Fact
A1. Asatoor is a scientific publication which describes the intestinal
absorption of carnosine and its constituents in humans. Asatoor 250.
A2. Carnosine is a dipeptide of beta-alanine covalently bonded to histidine.
Id.
A3. Asatoor describes the serum levels of beta-alanine and histidine after
ingestion of carnosine. Id. at 250–51.
A4. Asatoor teaches:
Histidine and β-alanine were taken together in an amount which
would be produced after hydrolysis of the above dose of carnosine.
Both the dipeptide and the amino acid mixture were taken dissolved in
500 ml water.
Id. at 251, col. 1, ll. 4–8.
A5. Asatoor teaches:
It can be concluded that absorption of both β-alanine and of histidine
is significantly more rapid after ingestion of the free amino acids than
after ingestion of the equivalent amount of carnosine.
Id. at 252.
Figures 1 and 2 depict the concentration of histidine and beta-alanine in
blood serum, showing that in each case the concentrations of the amino acids were
higher when the amino acids were administered as compared to carnosine.
A6. Asatoor describes the results in dogs of intestinal absorption and says
these results “may not be necessarily applicable to man.” Asatoor 254. Asatoor
next states: “Probably the main importance of this paper is to draw attention to the
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uncertainties which face any interpretation of tolerance tests as indices of intestinal
absorption in man.” Asatoor addresses the results of intestinal absorption of the
dipeptide and of free amino acids, discussing the fact there may be different
interpretations on whether the intact peptide (carnosine) is hydrolyzed prior to
absorption by the intestine or is absorbed by the intestine and then hydrolyzed
intracellularly. Id. Asatoor concludes: “Such results in isolation are, therefore,
speculative and any theoretical interpretation is completely speculative.” Id.

Discussion
Claim 1, as discussed already, is directed to a human dietary supplement.
We have interpreted the latter phrase to require that the supplement be
administrable to humans. Asatoor describes administering the beta-alanine to
humans, satisfying this aspect of the claim. A1. Because the administered
compositions increases the beta alanine serum levels (A5) and appears to be
identical to the claimed composition, there is reasonable basis to believe that it
would serve as a dietary supplement, e.g., by increasing tissue function, such as
anaerobic or exercise capacity.
13

Patent Owner contends the composition is not anticipatory to the claim
because Asatoor does “no more than teach that giving a single dose of beta-alanine
can increase the beta-alanine concentration in the blood and that this is rapidly
followed by excretion of beta-alanine by the kidneys.” Owner Appeal Br. 16.

13
Where, as here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes, the PTO
can require an applicant to prove that the prior art products do not necessarily or
inherently possess the characteristics of his claimed product. In re Best, 562 F.2d
1252, 1255 (CCPA 1977).
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Patent Owner also refers to the declarations by Dr. Harris and Mr. Sales, and
publications by Dr. Tallon and Mr. Balcombe. We have considered these
declarations, but find them unpersuasive for the following reasons.
Dr. Harris testified that a single dose of beta-alanine “would be unlikely to
have any measurable effect on fatigue. It is not clear that a single dose would even
be directed to the muscles and not some internal storage location in the body, such
as the liver where beta-alanine is made and regulated.” Harris Decl. ¶ 13. See also
¶ 22.
Dr. Harris has misconstrued the claim. The claim does not require an effect
on anaerobic or exercise capacity in a single dosage, or at all. The claim is not a
method claim, but is directed to a human dietary supplement product capable of
having such an effect when administered over time. Indeed, the examples in the
’381 patent involve administration of beta-alanine for a week or more. ’381 patent,
col. 15, ll. 47–51; col. 16, ll. 29–34; col.18, ll. 20–23. The ’381 patent teaches the
“composition can be given over a period of at least about 3 days to about two,
three, four or more weeks.” Id. at col. 4, ll. 1–3. Consequently, Dr. Harris’s
discussion about the deficiencies of a single dose of beta-alanine are inconsistent
with the scope of the claimed invention and the teachings in the ’381 patent.
The question is whether the beta-alanine composition in Asatoor, when
administered over a period of time, would be capable of affecting tissue function,
such as anaerobic and exercise capacity. This requirement is consistent with the
claim interpretation put forth by Patent Owner (“Here, the intended use affects the
amount that needs to be ingested as well as the fact that it must be used over a
period of time to be effective.” Owner Appeal Br. 14–15) and the teachings in the
’381 patent. Yet, Dr. Harris appears to focus his attention on the single dosage in
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Asatoor, describing the deficiencies of the single dosage when the same could have
been said for a single dosage in his own patent. Id. at 20–21.
The Sale declaration incorporates the statements in Dr. Harris’s declaration,
and discusses the failure of Asatoor to provide the “single amino acid beta-alanine
in doses over many days as taught by the patent.” Sale Decl. ¶ 8. This argument is
not persuasive since the claim is not a method claim, but is rather directed to a
human dietary supplement product that reads on the same product administered by
Asatoor.
We have also considered the publications by Dr. Tallon and Mr. Balcombe,
Exhibits 10 and 11, respectively. These publications appear to be sales brochures
for beta-alanine which describe its effect on muscle. Patent Owner contends that
these publications, as well as the declarations of Drs. Harris and Sale, establish that
large amounts of beta-alanine are necessary to achieve the effects on muscle
fatigue. Owner Appeal Br. 16–17. However, we have not been pointed to
persuasive evidence in the Harris declarations that the amount of beta-alanine in
Asatoor’s dosage would be insufficient to achieve an effect on tissue function
when administered over a period of days or weeks.
In a case such as this where patentability rests upon a property of the
claimed material not disclosed within the art, i.e., the effect on muscle fatigue over
time, the PTO has no reasonable method of determining whether there is, in fact, a
patentable difference between the prior art materials and the claimed material.
Therefore, when a claimed product appears to be substantially identical to a
product disclosed by the prior art, the burden is on the patent owner to prove that
the product of the prior art does not necessarily or inherently possess
characteristics or properties attributed to the claimed product. In re Spada, 911
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F.2d 705, 708 (Fed. Cir. 1990); In re Fitzgerald, 619 F.2d 67, 70 (CCPA 1980); In
re Best, 562 F.2d 1252, 1254-55 (CCPA 1977). Patent Owner has not met this
burden on the record before us.
In sum a preponderance of the evidence supports the determination that
Asatoor is anticipatory to the claimed subject matter.

ANTICIPATION BY EP ’593
Findings of Fact
14

EP1. “[0001] The present invention relates to novel composition for use in
therapy, particularly a combination of amino acid based on the one hand, and
vitamins, on the other hand, can be used in therapeutic oncology.”
EP2. “[00011] It has now been found that a composition containing [beta]-
alanine in combination with various vitamins, has properties allowing its
application in therapy for the treatment of cancer, whereas no comparable activity
is observed when is used in isolation each of these compounds.”
EP3. “[0012] The present invention thus provides a new composition based
on [beta]-alanine and vitamins, used to treat cancer.”
EP4. “[0015] [beta]-alanine can be used individually or, where appropriate,
in combination with one or more other amino acids, for example 5-alanine and
glycine, or [beta]-alanine, and taurine, can be combined.”
EP5. “[0018] . . . the amount of amino acid administered per day is between
50g and 200g for an etching treatment and between 10 and 50g for maintenance
therapy in adult men.”

14
Facts EP1-EP6 are from the English translation of EP ’593; EP7 is from the
French document. The brackets appear in the English translation only.
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EP6. “[0022] The experimental results showed that the composition of the
invention does not destroy cancer cells, but inhibits cell division.”

Discussion
EP ’593 describes a composition comprising beta-alanine which is
administrable to a human (EP1-EP4) and which contains an amount of beta-alanine
that is within the effective range described in the ’381 patent. EP5; ’381 patent,
col. 3, l. 64-66 (“7.0 or more grams”).
Patent Owner contends that “dietary supplements” do not encompass the
pharmaceutical compositions disclosed in EP ’593. Owner Appeal Br. 17–18.
Patent Owner also argues that the cell division inhibiting activity described in EP
’593 (EP6) is not the same activity described in the ’381 patent. Id. at 17
(“Inhibiting tumor cell division is not the same as increasing the function of tissues
when consumed.”) Furthermore, Patent Owner argues that the preliminary
amendment removed pharmaceuticals from the claims. Id. at 18.
Patent Owner’s arguments are not persuasive. The beta-alanine composition
described in EP ’593 contains all the characteristics of the claimed human dietary
supplement, anticipating it. Patent Owner did not explain how a “pharmaceutical
composition” would be any different in its components than a dietary supplement.
Dr. Harris’s declaration does not provide evidence that the composition in EP ’593
is different from a dietary supplement, but merely states that EP ’593 does not
disclose the same activity described in the ’381 patent. Harris Decl. ¶¶ 25–30.
However, such disclosure in EP ’593 is not necessary since the compositions are
the same, and the claims do not require the composition to have a specific activity.
See Spada, 911 F.2d at 708; Best, 562 F.2d at 1254-55.
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ANTICIPATION BY HARRIS
Patent Owner contends only that Harris (US 5,965,596) is a priority
application to the ’381 patent and cannot be prior art that anticipates the claims.
Owner Appeal Br. 16. Because we have determined that the ’381 patent’s earliest
filing date is Apr. 10, 2003, US 5,965,596, which issued Oct. 12, 1999, Harris is
prior art under 35 U.S.C. § 102(b). Thus, we affirm the Examiner’s decision that
Harris anticipates the claimed subject matter, claims 1–14, and 32–34 for the
reason given by the Examiner and as set forth in the Request.

ANTICIPATION BY GARDNER, DELACHARRIERE, WU
The anticipation rejection of claim 1 has been affirmed on other grounds.
Consequently, we do not reach the issue of whether each of Gardner,
DeLacharriere, and Wu anticipate claim 1.

OBVIOUSNESS IN VIEW OF SETRA AND ASATOOR
Findings of Fact
Setra
S1. Setra teaches that after increased muscular or cerebral activity,
“uncontrolled proton release” occurs which “would cause an intracellular pH drop”
and “muscle fatigue.” Setra 2: 8–13.
S2. Setra teaches that dipeptides containing histidine, such as carnosine, can
act as buffering agents and improve muscular functional capacity. Id. at 14–26
S3.
All dipeptides with pKa near physiological pH can act as intracellular
buffering agents; in addition to carnosine, other dipeptides containing
histidine imidazole ring can be used such as:
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homocarnosine: α-aminobutyryl-L-histidine
anserine: β-alanyl-L-1-methyl-histidine
homoanserine: α-aminobutyryl-L-1-methyl-histidine
ophidine: β-alanyl-L-3-methyl-histidine.
Id. at 16–21.
S4. Setra teaches administration of histidine. Id. at 2: 54.
Discussion
The Examiner found that Setra describes compositions comprising carnosine
to prevent a drop in cellular pH and prevent muscle fatigue and weakness. RAN
14. The Examiner acknowledged that Setra does not teach a composition
comprising beta-alanine. Id. However, the Examiner found that
Asatoor in the same field of endeavor discloses a dietary composition
(a mixture) comprising beta-alanine and L-histidine (free amino acids)
. . . Asatoor discloses that the absorption of the free amino acids (beta-
alanine or L-histidine) is significantly more rapid than the di-peptide
(carnosine) (see pages 250 and 252).
Id.
Based on this teaching the Examiner determined it would have been obvious
to a person of ordinary skill in the art at the time of the invention “to include beta-
alanine, a known non-essential amino acid and a precursor of carnosine, alone or
together with L-histidine in the compositions of Setra because Asatoor teaches the
rapid intake of free amino acid beta-alanine.” Id.
Patent Owner contends that the Examiner erred in rejecting the claims as
obvious in view of Setra and Asatoor. Patent Owner argues: "[o]ne of ordinary
skill in the art could not glean from Asatoor that the amino acid beta-alanine could
get into the muscle and increase the function of the muscle tissue." Owner Appeal
Br. 20.
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In response to Patent Owner’s arguments that the Examiner did not provide
evidence that ingesting beta-alanine would lead to an increase in carnosine in
muscles, the Examiner stated:
It was well known in the art at the time of the invention that by
providing increasing levels of histidine and beta-alanine in the diet
would increase the concentration of carnosine in the skeletal muscle
cells (for example see Dunnett Thesis (1996), and the references cited
in the “Introduction” (pages 193–194)). Further, Hama was cited to
show that beta-alanine administration results in increased
concentrations of carnosine in rats.
RAN 28.
Hama
15
was provided by Requester on November 28, 2012 in response to
the Harris declaration. Requester stated in the comments accompanying the
publication:
Harris fails to mention and his remarks completely ignore all of the
references mentioned in the Dunnett Thesis discussed above, the work
of Hama, which established that ingested beta-alanine passed through
the gut into the blood stream and thence into muscle cells where it
formed carnosine.
Requestor’s Comments 24.
Hama has the following pertinent disclosure:
The β-alanine solution was given daily for a week in a dose of 5 g per
kg of body weight as shown in Fig, 2, β-alanine accumulated in both
liver and gastrocnemius muscle. Anserine and carnosine were not
detected in the liver, while the concentration of these dipeptides
increased in the muscle after β-alanine administration.
Hama 150–151. Fig. 2 shows the accumulation in muscle of carnosine after
rats were force fed with β-alanine. Id.

15
Hama, T., et al., J. Nutr. Sci. Viraminol., 22, 147-157, 1976.
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Patent Owner contends that the amount of beta-alanine administered to the
rats is equivalent to 400 g in an 80 kg person, which is not “psychologically safe.”
Remarks made in Amendment dated Aug. 23, 2013, p. 34. Patent Owner also
argues that the amount of beta-alanine administered to the rats is “known to kill
50% of the animals (LD50), on average. (Ex. 21).” Id. Exhibit 21 contains the
following information: “Toxicity to Animals: Acute oral toxicity (LD50): 1000
mg/kg [Rat],” i.e., 1 g per kg. Thus, Patent Owner’s argument about the LD50 is
supported by the evidence because Hama teaches administration of 5 g per kg
which is more than the LD50 of 1 g per kg. Hama 150. Dr. Harris also testified
that such doses were lethal to rats. Harris Court Decl. ¶ 16. Patent Owner
concludes that “[g]iving such lethal doses does not provide any relevant
information on normal physiological functions in the human body.” Remarks
made in Amendment dated Aug. 23, 2013, p. 34. Patent Owner’s remarks are
supported by the evidence of record. Accordingly, we agree that Hama does not
provide a reasonable expectation of success that administering beta-alanine to
humans would increase its levels in muscle because the amounts administered to
rats were lethal doses.
There is additional evidence that supports Patent Owner’s position regarding
lack of a reasonable expectation of success. An excerpt from the Ph.D. thesis of
Mark Dunnett was made of record in this proceeding. Dr. Dunnett is co-inventor
of the ’381 patent. In the thesis, Dr. Dunnett wrote that Margolis (1985) showed
that “very large doses of β-alanine . . . produced a ten-fold increase in skeletal
muscle carnosine.” Dunnett Thesis 194. A declaration was provided in the related
litigation by Frank. L. Margolis, a co-author of Margolis (1985). Dr. Margolis
testified that the “doses in my 1985 research were at such high amounts, the
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rodents would not be expected to have responded in the same way they would
respond to a lower physiologically safe dose. Administering comparably high
levels in humans would be unacceptable, if not potentially lethal.” Margolis Decl.
¶ 9. Dr. Margolis testified:
researchers in the field of exercise physiology believe that it is
necessary for humans to consume physiologically safe and sufficient
amounts of beta-alanine for at least 2-4 weeks to see any measurable
effect on muscle tissue performance. My study injected rodents with
beta-alanine for 2-5 days at toxicologically high levels. This is not a
good model for extrapolation to humans because of the evolutionary
metabolic and dietary differences.
Id. at ¶ 11.
After considering Setra, the excerpts provided from the Dunnett thesis, and
Hama, we agree with Patent Owner that the preponderance of the evidence does
not support the Examiner’s rejection. Setra alone provides no expectation that
beta-alanine would increase carnosine. Setra teaches that it is the histidine portion
of the dipeptide which acts as a buffer to reduce muscle fatigue, and even
administers free histidine. S2–S4. Consequently, there is no apparent reason to
have administered beta-alanine to reduce muscle fatigue. Hama describes beta-
alanine administration to rats and an increase in carnosine in muscle, but these
doses were above the LD50 and lethal. The evidence supports Patent Owner’s
position that the results from administering lethal doses of beta-alanine to rat are
not necessarily predictive of administering physiologically safe dosages to humans.

Summary
For the foregoing reasons, we reverse the rejection of dependent claims 2–5,
7, 8, 10–14 and 32–34 as obvious in view of Setra and Asatoor. We also reverse
the rejections of claims 6 and 9 because the additionally cited publications, Biola
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and Casey, were not said by the Examiner to make up for the deficiencies in Setra
and Asatoor.
We do not reverse the rejection of claim 1 because we found it be
anticipated by Asatoor, alone. We thus affirm the rejection of claim 1 as obvious
in view of Setra and Asatoor.

OBVIOUSNESS IN VIEW OF SETRA AND GARDNER
Obviousness rejections Grounds 7, 9, and 20 rely on Gardner, rather than
Asatoor. RAN 14. Gardner does not make up for the deficiencies cited in either
Setra or Asatoor. Consequently, we reverse these rejections, as well.

§ 112 REJECTIONS
Ground 13. The Examiner rejected new claims 15–36 as lacking written
description. The Examiner only addressed claims 15 and 35. Claims 15 and 35 are
not appealed. Appealed claims 32–34 do not depend from either of these claims.
Consequently, since the Examiner has not provided a basis to reject claims 32–34
under 35 U.S.C. § 112, first paragraph, we reverse the written description rejection
of these claims.
Ground 14. The Examiner rejected claims 32–34 as indefinite under § 112,
second paragraph (pre-AIA). The Examiner stated:
Claims 32–34 . . . are dependent on composition of 1 and recite
the functional properties of the composition and states the form of the
composition supplied. The claims are indefinite, since it is not clear
whether the claims are drawn to a composition, or the function of the
composition or the physical form of the composition.
RAN 10.
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We reverse the rejection. The claims are directed to compositions so it is
clear that they are composition claims. The new limitations recited in claims 32–
34 recite properties and forms of the composition. The Examiner has not
sufficiently explained why such properties and forms make the claims indefinite.

DECISION
The Examiner’s decision adverse to the patentability of claims 1–14 and 32-
34 is affirmed.
Requests for extensions of time in this proceeding are governed by 37 C.F.R.
§§ 1.956 and 41.79(e).

AFFIRMED

ack

for PATENT OWNER:

PORZIO, BROMBERG & NEWMAN P.C.
1200 NEW HAMPSHIRE AVE., NW
WASHINGTON, DC 20036

for THIRD PARTY REQUESTOR

BARRY EVANS
LUCAS & MERCANTI, LLP
30 BROAD STREET 21ST FLOOR
NEW YORK, NY 10004