Ex Parte 8129422 et al

Patent Trial and Appeal Board

May 13, 2016

95002048 (P.T.A.B. May. 13, 2016)

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.
95/002,048 07/24/2012 8129422 70901-07500 1077
127044 7590 05/13/2016
Porzio, Bromberg & Newman P.C.
1200 New Hampshire Ave., NW
Suite 710
Washington, DC 20036
EXAMINER
KUNZ, GARY L
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
05/13/2016 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 2016-000745
Reexamination Control 95/002,048
Patent 8,129,422 B2
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 12–19,1 22–34, 36–39, and 42–44 in the
above-identified inter partes reexamination of United States Patent

1 In the Appeal Brief, Patent Owner canceled claim 18 by amendment
pursuant 37 CFR 41.33(b)(1) and 1.116(b)(1). Appeal Br. 1. However, we
could not find a paper in the records where the Examiner entered the
amendment.
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8,129,422. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§
6(b), 134, and 315 (pre–AIA). We affirm, but designate the affirmances
new grounds of rejection.
BACKGROUND
The patent in dispute is this appeal is U.S. Patent 8,129,422 B2 (“the
’422 patent”) which issued March 6, 2012, based on Application No.
12/806,356, filed Aug. 10, 2010. There are two named inventors, Roger
Harris and Mark Dunnett. The patent is subject to a terminal disclaimer to
the term of U.S. 7,825,084. The real party in interest and owner of the ’422
patent is Natural Alternatives International, Inc. (“Patent Owner”).
Reel/Frame 24935/0010.
A request for inter partes reexamination of the ’422 patent was filed
July 19, 2012 on behalf of Woodbolt Distributors, LLC (“Requester”) under
35 U.S.C. §§ 311–18 and 37 C.F.R. §§ 1.902–1.997. Woodbolt is also the
Respondent in this proceeding. An oral hearing was held March 16, 2016.
A transcript of the hearing will be entered into the record in due course
(“Hearing Tr.”).
This inter partes reexamination is related to the inter partes
examination of U.S. Patent No. 8,067,381 B1, Reexamination Control
95/002,001 (“’001 Reexamination”). The final rejection by the Examiner in
the latter reexamination was appealed to the Patent Trial and Appeal Board
(“PTAB”) and assigned appeal number 2015-000225. A decision (“’001
Decision”) was mailed in this related reexamination on July 17, 2015 in
which the Examiner was affirmed. ’001 Decision. The claims in the ’001
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Reexamination are directed to a dietary supplement comprising beta-alanine,
the same dietary supplement which is claimed in this present reexamination.
The ’422 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.” ’422 patent,
col. 1, ll. 50–56. The claimed subject matter of the ’422 patent is directed to
compositions that comprise beta-alanine or a derivative of it. Id. at col. 8, ll.
27–34. Beta-alanine is an amino acid. According to the ’422 patent,
administering beta-alanine increases beta-alanylhistidine dipeptide in muscle
tissue which favorably affects muscle performance. Id. at col. 8, l. 34 to col.
9, l. 4. The dipeptide increases the buffering capacity of muscles and
decreases muscle fatigue. Id. at col. 1, ll. 38–40; col. 14, ll. 25–28.
Claims 12–19, 22–34, 36–39, and 42–44 stand rejected by the
Examiner as unpatentable under 35 U.S.C. §§ 102 and 103. Claim 12 is
representative of the rejected claims and is reproduced below:
12. A method to avoid or delay the onset of muscular fatigue
in a subject, comprising:
a) providing to the subject an amount of an amino acid to
blood or blood plasma effective to increase beta-alanylhistidine
dipeptide synthesis in muscle tissue, wherein said amino acid is
at least one of:
i) beta-alanine that is not part of a dipeptide,
polypeptide or oligopeptide;
ii) an ester of beta-alanine that is not part of a
dipeptide, polypeptide or oligopeptide; or
iii) an amide of beta-alanine that is not part of a
dipeptide, polypeptide or oligopeptide; and
b) exposing the muscle tissue to the blood or blood
plasma, whereby the concentration of beta-alanylhistidine is
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increased in the muscle tissue, thereby avoiding or delaying the
onset of muscular fatigue,
wherein the amino acid is provided as a dietary
supplement, and
wherein the subject is not a horse.

PRIORITY
One of the threshold issues in the present inter partes reexamination is
whether the claims are entitled to the priority of U.S. Application
08/909,513, filed August 12, 1997 (“the ’513 application”) claiming priority
to UK applications filed in 1996. Appeal Br. 3. This issue was decided
against Patent Owner in the related ’001 Reexamination and the claims were
denied benefit of the ’513 priority application. ’001 Decision 15. The
earliest filing date of the claims was determined to be April 10, 2003. Id.
As a result of this determination, the patent based on the ’513 application —
U.S. Patent 5,965,596 (“Harris ’596”) — was determined to be prior art and
anticipatory to all claims in the ’001 Reexamination. Id. at 26.
The priority issue in this present reexamination is the same as in the
’001 Reexamination. Both sets of claims involve dietary supplements
comprising beta-alanine. The application from which the ’422 patent arose
claims benefit of the same chain of priority applications as does the patent in
the ’001 Reexamination. The Patent Owner is the same in both
reexaminations and has made the same priority arguments in this case as in
the ’001 Reexamination. For consistency and efficiency, we incorporate the
priority discussion and determination in the ’001 Decision into this decision.
We deny the ’422 patent benefit of the ’513 priority application for the same
reasons as in the ’001 Decision. The ’001 Reexamination Decision is
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attached. The earliest filing date of the ’422 patent is April 10, 2003.
Consequently, Harris ’596 is prior art to the ’422 patent.
REJECTIONS
The claims stand rejected by the Examiner as follows:
1. Claims 12–19, 22–34, and 38–44 under 35 U.S.C. § 102(b) as
anticipated by Harris ’596.2
2. Claims 12, 17, 19, 25–27, 31, 38, and 39 under 35 U.S.C. § 102(b)
as anticipated by Gardner.3
3. Claims 12, 13, 17, 19, 25–27, 31, 38, 39, and 44 under 35 U.S.C. §
102(b) as anticipated by Asatoor.4
4. Claims 12, 17, 19, and 22 under 35 U.S.C. § 102(b) as anticipated
by EP593.5
5. Claims 12, 17, and 19 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Wu6 as evidenced by Li.7

2 Roger Harris, et al., US 5,965,596 (iss. Oct. 12, 1999) (“Harris ’596”).
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 411–22 (1991) (“Gardner”).
4 A.M. Asatoor et al., Intestinal Absorption of Carnosine and its Constituent
Amino Acids in Man, 11 Gut, 250–54 (1970) (“Asatoor”).
5 Andre Rougereau, EP 0 280 593 B1 (pub. June 12, 1991) (French
language) (“EP593”) (all references to EP593 are to the English translation
of it.
6 Hui-Chun Wu & Chyuan-Yuan Shiau, Proximate Composition, Free
Amino Acids and Peptides Contents in Commercial Chicken and Other Meat
Essences, 10 J. Food and Drug Analysis 170–77 (2002) (“Wu”).
7 Y.F. Li et al. Bioactivities of Chicken Essence, 77 J. of Food Science,
R105–10 (2012) (“Li”).
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6. Claims 12–19 under 35 U.S.C. § 103(a) as obvious in view of
Setra8 and Bakardjiev9 or Bauer.10
7. Claims 12–19, 22–39, and 42–44 under 35 U.S.C. § 103(a) as
obvious in view of Setra and Asatoor.
8. Claims 12–19, 22–39, and 42–44 under 35 U.S.C. § 103(a) as
obvious in view of Setra and Gardner.
9. Claims 23, 24, and 28 under 35 U.S.C. § 112, first paragraph, as
lacking a written description in the ’422 patent for the claims added during
reexamination.
CLAIM INTERPRETATION
We begin with claim interpretation because before a claim can be
compared to the prior art, it must by properly interpreted. During
reexamination of an unexpired patent, the PTO must give claims their
broadest reasonable construction consistent with the specification. In re Am.
Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Suitco
Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir. 2010); In re Abbott Diabetes
Care Inc., 696 F.3d 1142, 1146 (Fed. Cir. 2012).

8 Glan Paolo Negrisoli, EP 0 449 787 A2 (pub. Oct. 2, 1991) (“Setra”).
9 Anastasia Bakardjiev & Karl Bauer, Transport of ẞ-alanine and
biosynthesis of carnosine by skeletal n1usde cells in primary culture, 225
Eur. J. Biochem., 617–23 (1994) (“Bakardjiev”).
10 Karl Bauer & Michael Schulz, Biosynthesis of carnosine and related
peptides by skeletal muscle cells in primary culture 219 Eur. J. Biochem.,
43–47 (1994) (“Bauer”).
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“avoiding or delaying the onset of muscular fatigue”
Claim 12 is directed to a “method to avoid or delay the onset of
muscular fatigue in a subject.” The method comprises “providing to the
subject an amount of an amino acid to blood or blood plasma effective to
increase beta-alanylhistidine dipeptide synthesis in muscle tissue.” The
amino acid is beta-alanine or an ester derivative of it. The muscle is exposed
to the blood or blood plasma comprising the beta-alanine “thereby avoiding
or delaying the onset of muscular fatigue.”
The Examiner did not give the functional limitation “avoiding or
delaying the onset of muscular fatigue” patentable weight and interpreted the
claim to read on administration of “any amount of beta-alanine.” Right of
Appeal Notice (mailed Aug. 8, 2014) (hereinafter “RAN”) 7. The
Examiner’s rationale for this interpretation is that Example 4 of the patent
showed no change in muscle carnosine (a “beta-alanylhistidine dipeptide”)
after two weeks of administration of three daily doses of 40 mg/kg beta-
alanine. Id. at 6. The Examiner found this to be a “contradiction” because
the claims require both an increase in carnosine concentration in the muscle
and a delay in muscle fatigue onset. Id. The Examiner also found that the
dosages in the patent are lower than those described as effective in Patent
Owner’s evidence of relevant dosages, namely that provided in Tallon and
Balcombe (3.2 grams per day), providing an additional contradiction to the
teachings in the patent. Id. at 6–7.
Upon consideration of this issue, we conclude that the Examiner
improperly ignored the functional limitation recited both in the preamble and
body of the claim. The ’422 patent describes using beta-alanine and its
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derivatives to increases the anaerobic capacity of muscle and delay muscle
fatigue. ’422 patent, col. 8, ll. 27–39. The patent explains that the beta-
alanine increases the synthesis of beta-alanylhistidine dipeptides, such as
carnosine, which buffer hydronium ions in the muscle and improves muscle
performance. Id. at col. 8, ll. 36–67. The purpose of administering the beta-
alanine is therefore to enhance muscle function, such as avoiding or delaying
muscle fatigue. Id. at col. 7, ll. 3–7; col. 8, ll. 66–67. In this context, it is
improper to ignore the explicit statements both in the preambles and the
bodies of claims 12, 25, and 44 that the method is for “avoiding or delaying
the onset of muscular fatigue” and that the “beta-alanylhistidine dipeptide”
produced from beta-alanine administration accomplishes the stated purpose
of the claim and the invention described in the ’422 patent.
Example 4 investigated the effect of administration of 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 on the
carnosine content of muscle and isometric endurance at 66% of maximal
voluntary contraction force (MVC). ’422 patent, col. 17, ll. 19–24. The
results showed an increase in endurance time for 5 of the 6 subjects tested,
and in one subject taking a higher dose of beta-alanine. Id. at col. 18, ll. 33–
40. The Examiner criticized this study because the inventors reported that
there was no apparent change in the muscle carnosine content in the muscle
of the six subjects biopsied. Id. at col. 18, ll. 29–30.
In our opinion, the fact that Example 4 did not show an increase in
muscle carnosine is not a basis to ignore the functional limitations of claim
12. Claim 12 requires administration of beta-alanine or a derivative of it to
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accomplish the purpose of the claim to avoid or delay muscle fatigue. This
method is described in the ’422 patent and performed in Example 4.
Example 4 did not validate the mechanism by which the beta-alanine
improved the muscle performance (i.e., by increasing carnosine content in
the muscle). However, a rise in blood levels of beta-alanine was reported
with three smaller doses per day of 10 mg/kg of body weight each (id. at col.
16–17 (Example 3)) and the stated purpose of the method for treating muscle
fatigue (id. at col. 18, ll. 33–40) was demonstrated. Co-inventor Roger C.
Harris, Ph.D., provided a declaration (dated October 28, 2013) in which he
attached the results of experiments, including the results of the experiments
in Example 4 of the ’422 patent, which “show that the muscle carnosine
content increased for three of the six subjects, but the muscle content for all
six subjects tested averaged out to no increase. (Exhibit 1 at page 11).” 2013
Harris Decl. ¶ 4. Dr. Harris explained that the differences could be due to
variation in responses observed in populations and inaccurate test methods.
Id. at ¶¶ 3, 6. In view of this evidence, and the fact that the Example 4
shows that administration of beta-alanine achieved the purpose of the
claimed method, we conclude that the Examiner’s reason to ignore the
functional limitations based on a “contradiction” in Example 4 is not
supported by the weight of evidence.
The Examiner also found that the wide dosage range, including low
dosages and single-administrations to be inconsistent with teachings in the
’422 patent that sustained treatment with beta-alanine is necessary to delay
onset of muscle fatigue. RAN 6–7. We do not agree. As argued by Patent
Owner, the claims are not limited to humans or large animals, but cover
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small animals where lower dosages would be appropriate. Consequently,
the disclosure of various dosages is not inconsistent and does not defy logic
as asserted by the Examiner. Moreover, as discussed below, the claims
cover administration of multiple daily doses, where individual doses could
be more or less depending upon the time period over which they are
administered.

Single dosage
Patent Owner contends that the claim requires more than one “single
dose” of beta-alanine. Appeal Br. 10. Patent Owner argues that
neither Examiner nor Requester has produced any scientific data
or facts to demonstrate that the delay of muscular fatigue
achieved by the claimed method, as evidenced in Example 4, was
not from the “amount. . . effective” required in the method of
Claim 12 or that short term exposure of a single dose has an
effect.
Id. Patent Owner asserts that as “evidenced by declarations from those of
skill in the art (Ex. 7 ¶¶13, 20-22; Ex. 8 ¶8) and the scientific publications
(Ex. 9 at 5; Ex. 10 at 18), it is known that an effective amount is not a single
dose and certainly not de minimis amounts.” Appeal Br. 11.
First, we look to the ’422 patent written description because claims
must be interpreted in light of it. The ’422 patent describes administering a
composition comprising beta-alanine in multiple doses over periods of two
or three days or more (col. 4, ll. 10–26; col. 3, ll. 65–67; col. 10, ll. 24–28).
However, while administration might be preferably administered more than
two or three days, we have not been guided to adequate disclosure in the
’422 patent or to language in the claims which would exclude administration
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of one dosage only from being effective to achieve the claimed result of
delaying muscle fatigue. Figure 9 of the ’422 patent shows an increase in
plasma beta-alanine after a single administration (col. 17, ll. 1–15) and such
an increase in plasma levels of beta-alanine is described in the ’422 patent as
leading to the increase in the beta-alanylhistidine dipeptide. Id. at col. 9, ll.
5–13. Thus, it is not inconsistent with the patent that a single dose of beta-
alanine could have a transient increase in the beta-alanylhistidine dipeptide
and produce a corresponding short-lived delay in muscle fatigue.
Patent Owner directs us to disclosure in the ’422 patent that long term
administration of beta-alanine led to increase in beta-alanylhistidine
dipeptide (Appeal Br. 9), but such result does not provide evidence that
shorter term administration would not result in a detectable amount so of
delay in onset of muscle fatigue. Dr. Harris, in the context of discussing the
anticipation rejections, stated that a “single dose of beta-alanine would be
unlikely to have any measurable effect on fatigue,” stating that it could be
stored at another “location in the body, such as the liver” (2012 Harris Decl.
¶ 13), but Dr. Harris did not provide objective evidence to support this
statement. For example, Dr. Harris did not explain why a single-dose might
be directed to the liver, but, other regimens covered by the claim, such as
one-dose daily for three days, would not be directed to the liver.
We decline to import limitations from the ’422 patent into the claims.
“For example, a particular embodiment appearing in the written description
may not be read into a claim when the claim language is broader than the
embodiment.” SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870,
875 (Fed. Cir. 2004). Claims 12 and 25 recite “providing to the subject an
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amount of an amino acid to blood or blood plasma effective to increase beta-
alanylhistidine dipeptide synthesis in muscle tissue.” The claim does not
specify a time period over which the “amount . . . effective” to increase the
dipeptide is provided. The discussion at column 8 under the “Detailed
Description” teaches that increasing the amount of beta-alanylhistidine
dipeptides within muscle favorably affects muscle performance. ’422
patent, col. 8, ll. 66–67. The dipeptide is synthesized within the body from
beta-alanine and L-histidine. Id. at col. 8, ll. 49–50. We have not been
directed to a teaching in the patent that a single-dose would not increase
levels of the beta-alanine in the blood and result in an increase in synthesis
of the dipeptide.
In addition to this reasoning, we also note that dependent claims
specifically require that the supplement “is provided on consecutive days”
(claim 22) and “provided for at least 14 days” (claims 23, 24, 28 (although
differently worded).
Under the doctrine of claim differentiation:
[“D]ifferent words or phrases used in separate claims are
presumed to indicate that the claims have different meanings and
scope.” Karlin Tech. Inc. v. Surgical Dynamics, Inc., 177 F.3d
968, 971–72 (Fed. Cir. 1999). Although the doctrine is at its
strongest “where the limitation sought to be ‘read into’ an
independent claim already appears in a dependent claim,”
Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910
(Fed.Cir.2004), there is still a presumption that two independent
claims have different scope when different words or phrases are
used in those claims, Kraft Foods, Inc. v. Int'l Trading Co., 203
F.3d 1362, 1365–69 (Fed. Cir. 2000)[.]
Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1368–69 (Fed. Cir.
2005).
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Claim 12 recites that an amount of beta-alanine is provided to the
subject. Dependent claims specifically require that the supplement “is
provided on consecutive days” (claim 22) and “provided for at least 14
days” (claims 23, 24, 28). Independent claim 44 recites “the use of the
dietary supplement for administration over a continuous period of time.”
Each of these claims are presumptively narrower than claim 12 in requiring
consecutive or continuous administration of the beta-alanine supplement.
Thus, reading these limitations into claim 12, and requiring claim 12 to read
on repeated administration of beta-alanine would be improper based on the
doctrine of claim differentiation.
In reaching this conclusion, we have not ignored the report by Mark
Tallon, Ph.D., that “research . . . on β-alanine in humans demonstrated that
by consuming 800 mg four times a day for five weeks, a significant load or
increase in muscle carnosine levels was achieved[]” and that “3.2 grams of β-
alanine supplementation daily, can likely impart the desired benefits.” Ex. 3,
pp. 5, 6. However, Patent Owner has not identified language in the claim
that requires a specific degree of increase in carnosine in the muscle nor a
specific degree of delay in muscle fatigue. For this reason, we conclude that
the claims cover any detectable amount of improvement in muscle fatigue
even if such amount is not long-term or optimal.
“amount . . . effective”
The claims comprise providing an amount of an amino acid to blood
or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis
in muscle tissue, which avoids or delays the onset of muscular fatigue. We
interpret the effective amount to encompass 1) a single dosage (see above) or
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2) multiple dosages administered over one or more days, where the total
amount of the dosages is effective to increase the dipeptide and delay muscle
fatigue.
The interpretation that “amount . . . effective” also covers the quantity
of beta-alanine over a time period when 2) multiple dosages are
administered is the interpretation espoused by Patent Owner (Appeal Br. 14)
and consistent with the ’422 patent. For example, the ’422 patent describes
administering small amounts of beta-alanine, e.g., 80 mg, to large amounts,
e.g., 16 gm, in a per day amount, with little guidance on which amounts at a
single-dosage increase the dipeptide synthesis and delay muscle fatigue.

“dietary supplement”
The claim requires the beta-alanine to be administered as a “dietary
supplement.” Patent Owner contends that “dietary supplement” is a
structural limitation to the claim. Appeal Br. 13. Patent Owner argues that
an Amendment filed October 11, 2011, during the prosecution of the
application which led to the ’422 patent, disavowed pharmaceuticals and
foods as dietary supplements (id. at 16, 22). Patent Owner also asserts that
the ’422 patent clearly delineates dietary supplements from pharmaceuticals
and foods (id. at 16).
The ’422 patent teaches that “the composition is a pharmaceutical
composition, a dietary supplement or a sports drink.” ’422 patent, col. 3, ll.
18–19. The patent also teaches that compositions of the invention can be
used for the “preparation of a dietary supplement (including, e.g., drinks,
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gels, foods) or pharmaceutical composition for humans or animals.” Id. at
col. 5, ll. 11–14.
Patent Owner asserts that dietary supplement is a structural limitation,
but did not provide evidence of its structure, other than to assert it is
different from a food or pharmaceutical. Appeal Br. 17. We take note of the
fact that pharmaceuticals may require approval by the FDA to be marketed
for treatment of a disease while supplements are subject to a different
standard of review. However, Patent Owner did not elucidate a structural
difference between dietary supplements and pharmaceutical agents. In the
Remarks filed October 11, 2011 in the application that led to the ’422 patent
(“Remarks”), it was stated that “By dietary supplements the Applicant
means an addition to the diet in a pill, capsule, tablet, powder, or liquid
form, which is not a natural or conventional food, and which effectively
increases the function of tissues when consumed.” Remarks 6.
Pharmaceuticals are typically administered as pills and capsules. Patent
Owner contends they disavowed “pharmaceuticals” in the Remarks, but we
have not been directed to a clear statement where such disavowal was made.
While we agree that that the ’422 patent uses the terms “dietary
supplements” and “pharmaceuticals,” it appears that “pharmaceuticals” are
being used in its normal conventional way to mean a regulated drug. For
example, the ’422 patent describes administering insulin and insulin-action
modifiers, such as sulphonylurea, a thiazolidinedione or a biguanide, which
are traditional drugs to treat diabetes (’422 patent, col. 2, ll. 48–60; col. 3, ll.
16–17), and therefore would be recognized by one of ordinary skill in the
art as “pharmaceuticals.” Thus, the evidence indicates that the term
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“pharmaceuticals” is used in the ’422 patent to mean regulated drugs, but not
for beta-alanine and the other disclosed amino acids and dipeptides.
Nonetheless, Patent Owner has not provided a definition that would exclude
the pharmaceuticals disclosed in the ’422 patent from being considered
dietary supplements, and thus being a narrower class within a broader class.
Accordingly, we decline to give “dietary supplements” the narrow reading
advocated by Patent Owner.
Patent Owner also states that foods were disavowed during the
prosecution of the ’422 patent. Appeal Br. 22. Patent Owner cites the
Remarks which, we agree contain the following statement: “To be clear, the
term ‘dietary supplement’, as claimed, does not encompass, and does not
mean, a natural or conventional food, such as chicken or chicken broth, for
example.” Remarks 6. Based on this statement and in the content of the
’422 patent which is supplementing foods and diets with beta-alanine (e.g.,
at col. 1, ll. 38–45; col. 2, ll. 45–60), we will not construe “dietary
supplement” to read on a conventional food, absent processing, derivation,
or, e.g., the addition of beta-alanine to it.

1. ANTICIPATION BY HARRIS ’596
Patent Owner contends that Harris ’596 is a direct parent to the ’422
patent and is not anticipatory prior art. Appeal Br. 19. Because we have
determined that the ’422 patent’s earliest filing date is April 10, 2003, Harris
’596, which issued October 12, 1999, is prior art under 35 U.S.C. § 102(b)
(pre-AIA). Thus, we affirm the Examiner’s decision that Harris ’596
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anticipates claims 12–19, 22–34, and 38–44 for the reason given by the
Examiner and as set forth in the Request.

2. ANTICIPATION BASED ON GARDNER
Gardner describes experiments on the intestinal absorption of
carnosine. Gardner 411 (“Summary”). As part of the experiments, Gardner
described ingestion of “an approximately isotonic test meal containing 2 g β-
alanine plus 2 g histidine” by one subject. Id. at 413:10–11. The Examiner
found that Garner’s description of ingesting 2 g of beta-alanine meets the
claimed dietary supplement. RAN 23.
Patent Owner contends that Gardner does not anticipate the claimed
method because the claims do not cover a single-dosage, but rather
“administering the dietary supplement of free amino acid beta-alanine given
over a period of at least multiple days.” Appeal Br. 20.
As discussed above, we will not import limitations from the ’422
patent into the claims. Even if multiple doses are preferred and most
effective, the claim language does not exclude a single dose from achieving
the claimed result. The 2 gm amount of beta-alanine disclosed by Gardner
falls within the range described in the ’422 patent. ’422 patent, col. 9, ll.
35–38 (“In one aspect, the total amount of beta-alanine (or other
composition of the invention) administered can be at least 200mg, from 200
mg to 5 g, or from 5 g or more per day for a human”). In example 5 of the
’422 patent, beta-alanine was administered at 1.6 gm a day. Id. at col. 19, ll.
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29–33). Based on this evidence, there is reasonable basis to believe that all
the functional limitations of the claims are met.11
Patent Owner contends that Gardner does not describe the dosage
between 0.4 g and 16 g recited in claim 25. Appeal Br. 21. This argument is
not correct, because Gardner expressly describes administering 2g beta-
alanine as discussed above.
For the foregoing reasons, we affirm the rejection of claims 12, 17,
19, 25–27, 31, 38, and 39 as anticipated by Gardner.

3. ANTICIPATION BY ASATOOR
Asatoor describes a single administration of beta-alanine and L-
histidine to human subjects. Asatoor 250 (“Methods”). Asatoor teaches
that histidine and beta-alanine “were taken together in an amount which
would be produced after hydrolysis of the above dose of carnosine.” Id. at
251. The Examiner found the amounts were equivalent to 1.8 g of beta-
alanine. RAN 18. The Examiner found that Asatoor’s description of
ingesting 1.8 g of beta-alanine meets the claimed dietary supplement. RAN
18. The tests “were carried out at intervals of at least two weeks.” Asatoor
250–251.

11 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’s arguments with respect to Asatoor are substantially
identical to those discussed above for Gardner as being unpersuasive. PO
App. Br. 19-22.
We affirm the rejection of claims 12, 13, 17, 19, 25–27, 31, 38, and 39
as anticipated by Asatoor for the same reasons as for Gardner.
We reverse the rejection of claim 44 because the Examiner did not
establish that Asatoor’s disclosure of “intervals of at least two weeks”
constitutes a description of “administration [of beta-alanine] over a
continuous period of time.”

4. ANTICIPATION BY EP593
EP59312 describes a composition containing beta-alanine in
combination with various vitamins for the treatment of cancer. EP593 ¶ 11.
EP593 teaches that “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.” Id. ¶ 18. The Examiner found that such
amounts fall within the range of dosages cited in the ’422 patent and thus
would have been reasonably expected to delay onset of muscle fatigue as
required by the claims. RAN 21. Patent Owner contends that EP593
describes pharmaceuticals for treatment of cancer, which was disavowed
during the prosecution of the ’422 patent. Appeal Br. 22–23. Patent Owner
states (citing In re Halleck, 422 F.2d 911 (CCPA 1970)), “a therapeutic use
does not inherently anticipate or render obvious a use in another non-

12 References to EP593 are to the English translation. However, the
referenced amounts only appear in the original.
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therapeutic method.” Id. at 23. Patent Owner also argues that the dosages
administered in EP593 are lethal. Id. at 24.
Patent Owner contends that EP593’s beta-alanine composition is a
“pharmaceutical” which is excluded from the claim, but Patent Owner has
not identified a characteristic of it that makes it different from the beta-
alanine composition of the claim. EP593 is administering beta-alanine, not a
regulated drug. See “CLAIM INTERPRETATION.” Patent Owner has not
explained why their own beta-alanine is not a pharmaceutical, while the
beta-alanine of EP593 is a pharmaceutical.
Patent Owner cited Halleck for holding that a composition for
therapeutic use could not inherently anticipate a non-therapeutic use. There
is no such per se rule. In Halleck, the claims were drawn to compositions
comprising a substance for stimulating animal growth. Halleck, 422 F.2d at
912. The PTO had cited Merck’s description of a pharmaceutical
comprising the same substance used to stimulate animal growth, but for a
therapeutic indication. Halleck, 422 F.2d at 913. The court found that it
was not “clear that therapeutic administration of the materials according to
the teaching of Merck would inherently result in a feed composition
containing an amount of substance effective for growth stimulation or that
the animal would be administered such an amount.” Id. This case is
distinguishable from Halleck because the Examiner found that EP593
describes amounts of beta-alanine which would reasonably be expected to
delay muscle fatigue, thus providing factual basis to assert the claim
limitations would inherently be met by EP593.
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Patent Owner also asserts the dosages described in EP593 would be
lethal. Appeal Br. 24. This argument is based on Material Safety Data
Sheet for Beta-Alanine (Ex. 16). The data sheet has the following
information under “Toxicological Information”:
Routes of Entry: Ingestion.
Toxicity to Animals: Acute oral toxicity (L050): 1000 mg/kg
[Rat].
Chronic Effects on Humans: Not available.
Other Toxic Effects on Humans:
Very hazardous in case of ingestion. Slightly hazardous in case
of skin contact (irritant).
Special Remarks on Toxicity to Animals: Not available.
Special Remarks on Chronic Effects on Humans: Not available.
Special Remarks on other Toxic Effects on Humans: Not
available.
The evidence of lethality is for a rat. We understand that such
information could not be obtained for a human, but Patent Owner did not
provide arguments as to why this value is pertinent to a human.
Nonetheless, based on the Examiner’s findings, Patent Owner
contends that EP593 describes “initial set of dosages of 360g and later
maintenance doses of 120g and 80g providing the individual is still alive
(initial ingestion of 3.6g/kg of body weight for a 100kg human). Given the
LD50 dose for a 100kg subject is 100g, this is nearly four times the amount
expected to kill.” Appeal Br. 24.
The Examiner erred in finding that EP593 discloses “a total
consumption of 360 g, 120 g, and 80 g.” RAN 21.
Example 1 of EP593 is a composition comprising 90 gm beta-alanine.
Paragraph 27 states that the dose is “administered 24 hours to an etching
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treatment” and the “administration is made orally in four equal parts, every
six hours.”
Example 2 of EP593 is a composition containing 30 gm beta-alanine.
Paragraph 29 teaches that the composition is administered for maintenance
therapy in four parts over 24 hours.
Example 3 is a composition containing 20 gm beta-alanine.
Paragraph 32 also indicates that the composition is administered over a 24
hour period.
Thus, the Examiner incorrectly found that 90 gm of beta-alanine is
administered four times a day. Rather, the translation teaches that the dose
of 90 gm is administered over a 24 hour period in four equal parts of 22.5 g
each. The LD50 for a rat is 1000 mg/kg or 1 gm/kg. Patent Owner
identified a body weight of 100 kg for a human, which would be 100 gm for
the LD50 based on the rat. Appeal Br. 24. Thus, at the highest daily dosage
of Example 1, the amount of beta-alanine is 90 gm, administer in 4 doses of
22.5 g each, which is less than then LD50 of a rat, and the other dosages
disclosed in EP593 are even less. Consequently, the evidence does not
support a finding that EP593 describes administering lethal amounts of beta-
alanine.
For the foregoing reasons, we affirm the rejection of claims 12, 17,
19, and 22 as anticipated by EP593.

5. ANTICIPATION BASED ON WU
Wu teaches that “essences” of chicken, beef, clam, and eel have been
available in Taiwan markets as nutritional supplements. Wu 170 (col. 2).
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Wu teaches the free amino acid and peptide content of these essences. Id.
Table 2 shows the free amino acid content of six essences of chicken, where
the highest level of beta-alanine content is 9.5 mg/100 g (D). Table 3 shows
the free amino acid content of beef, hard clam, freshwater clam, and eel
essences, where the highest level of beta-alanine content is 13.4 mg/100 g in
eel essence. The Examiner found that Wu’s description of a meat essence
with free beta-alanine meets the claimed dietary supplement. RAN 25.
Patent Owner contends that the Amendment filed in the application
which led to the ’422 patent specifically disavowed “natural or conventional
food” such as that of “beef, pork, chicken, meat extract supplements and
predigested meat/protein supplements” and does not encompass “naturally
occurring compositions.” Appeal Br. 25; Ex. 2 at 6, 7.
Patent Owner also argues:
Wu teaches an average of 7.6 mg (a de minimis amount) of free
beta-alanine per 100 g of beef essence (not beef). This would
require a total daily intake of 165.69 kg of beef essence (or
365.28 pounds) for a 105kg person.
Response to ACP (Aug. 23, 2013) 31. Patent Owner states: “Requiring a
person to eat almost twice their weight daily in beef essence is not possible
because it contains high amounts of MSG and NaCl.” Appeal Br. 25; 2012
Harris Decl. ¶ 34.
The calculation made by Patent Owner is based on Example 4’s
supplementation with 40 mg beta-alanine per kilogram. 2012 Harris Decl. ¶
34. The claims, however, do not require this amount of beta-alanine. The
’422 patent teaches that daily dosages as low as 80 mg of beta-alanine can
be administered. (“In an 80 kilogram person, suitable dosages per day can
be between 0.08 grams to 16.0 grams of beta-alanine.” Col. 9, ll. 50-52.)
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Such amount would require less two pounds of the chicken essence (9.5 mg
beta-alanine /100 g essence) or eel essence (13.4 mg beta-alanine /100 g
essence), a much lower amount than the amounts proposed by Patent Owner.
Nonetheless, there is insufficient evidence in the record to determine how
much of the essence is generally ingested by a human per day. Thus, the
Examiner did not meet the burden of showing that Wu describes a method of
providing an amount of beta-alanine effective to “to increase beta-
alanylhistidine dipeptide synthesis in muscle tissue” and “avoid or delay the
onset of muscular fatigue in a subject.” In addition, there is insufficient
evidence to determine whether the “essence” is natural food, or a derivative
of a food that would constitute a “food supplement.” The rejection of claims
12, 17, and 19 as anticipated by Wu is reversed.

6. OBVIOUSNESS BASED ON SETRA AND BAUER OR BAKRDJIEV
Setra describes the use of carnosine “for the treatment of muscular
fatigue and improving athletic performances in persons subjected to
prolonged physical efforts.” Setra 2:3–5. Setra explains that carnosine, and
other dipeptides comprising the histidine imidazole ring, serve as
intracellular buffering agents which treated the uncontrolled release of
protons during increased muscle activity which is one of the main causes of
muscle fatigue. Id. at 2:9–25. Setra does not describe utilizing beta-alanine
to increase the carnosine levels. However, the Examiner cited Bakardjiev or
Bauer for teaching that uptake of beta-alanine by embryonic chick pectoral
muscle cell cultures results in the biosynthesis of carnosine. RAN 38 (citing
Bakardjiev, Abstract and Bauer, Abstract). The rate of uptake and
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biosynthesis increased under differentiation conditions. See Bakardjiev 620
(emphasis in original) (“Uptake of ẞ-alanine as a function of muscle cell
differentiation.”) The Examiner determined it would have been obvious to
the person of ordinary skill in the art to modify the carnosine treatment of
Setra by administering free beta-alanine and using the biosynthesis reaction
described in Bakardjiev (and Bauer) in order provide a method for delaying
the onset of muscular fatigue in a subject. RAN 38. The Examiner stated:
[T]here is a reasonable likelihood that upon the ingestion of beta-
alanine, this amino acid level is increased in muscle tissue and
then incorporated into beta-alanylhistidine (carnosine), at least in
chickens, and likely humans as well. Consequently, the
motivation to combine Setra with Bauer and Barkardjiev [sic,
Bakardjiev] is that the administration of beta-alanine is expected
to increase the concentration in muscle tissue and thereafter to be
incorporated into beta-alanylhistidine.
RAN 63.
Patent Owner argues that “Bauer and Bakardjiev use isolated systems
of immature myoblasts from embryonic chick pectoral muscle. These
primitive immature muscle cell systems are not representative of processes
of in vivo systems.” Appeal Br. 28 (footnote omitted). Dr. Harris testified
that “Neither reference demonstrates an ability to increase carnosine levels
in mature muscle cells in vivo beyond the normal levels and processes, nor
that these immature cells would increase carnosine above steady state
levels.” Id. (citing 2012 Harris Decl. ¶ 48). Dr. Harris also distinguished
immature muscle cell culture systems from processes that occur in the body,
including describing the different possible fates of beta-alanine in the body,
such as being directed to tissues other than muscle, and undergoing
metabolism, oxidation, excretion, and uptake by tissues in the body other
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than muscle. Id. ¶¶ 50–52. Based on these differences, Dr. Harris
concluded that one of ordinary skill in the art would “not be able to see any
link between this isolated system and that of an in vivo system that works to
destroy greater than 90% of consumed beta-alanine.” Id. ¶ 52.
Patent Owner’s argument is persuasive. The Examiner did not
provide evidence that the chick muscle cell culture system described
Bakardjiev would reasonably predict the fate of beta-alanine in the body of a
subject. As pointed out by Dr. Harris, there are significant differences
between an isolated cell culture system and a body with multiple organs,
tissues, and numerous pathways which are absent from an isolated cell.
Obviousness requires a reasonable likelihood of success. In re Merck & Co.,
Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (Fed. Cir. 1986). In this case,
while Bakardjiev may have demonstrated that carnosine is synthesized from
beta-alanine in differentiating chick muscle cells in cell culture, a
preponderance of the evidence does not support the Examiner’s conclusion
that it would be reasonably likely that administration of beta-alanine and
L-histidine to a subject would result in the production carnosine in such
amounts to delay or avoid the onset of muscle fatigue. The same argument
holds true for Bauer which contains the same teachings as in Bakardjiev.
The Examiner also did not provide sufficient reason to have replaced
carnosine with the precursor beta-alanine; the Examiner stated it was likely
to work, but did not provide an adequate reason to have made the
substitution. Accordingly, the obviousness rejection of claim 12–19 as
obvious in view of Setra and Bakardjiev or Bauer is reversed.

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7, 8. OBVIOUSNESS BASED ON SETRA AND ASATOOR OR
GARDNER
The teachings in Setra, Asatoor, and Gardner have been explained
above. The Examiner found it would have been obvious to have
administered beta-alanine in Setra’s method for treating muscle fatigue, as
taught by Asatoor and Gardner, “for the purpose of reducing muscle fatigue
by reducing the hydronium ion concentration in the muscles as taught by
Setra.” RAN 27, 32.
The preponderance of the evidence does not support the Examiner’s
rejection. The Examiner has not provided evidence, or a rationale, as to why
providing beta-alanine to a subject would be reasonably expected to reduce
muscle fatigue. Setra teaches that carnosine, and other dipeptides
comprising the histidine imidazole ring, serve as intracellular buffering
agents which treated the uncontrolled release of protons during increased
muscle activity which is one of the main causes of muscle fatigue. Setra
2:9–25. The Examiner states:
[I]t 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 composition of Setra because
Asatoor teaches the rapid uptake of free amino acid beta-alanine
and Gardner also teaches the uptake of beta-alanine from the
intestine into the blood while carnosine is degraded quickly in
the bloodstream. The purpose for combining Setra with either
Asatoor and/or Gardner is to support the amount of carnosine in
the muscle tissue by including beta-alanine that can combine
with histidine to from carnosine in the muscle tissue.
RAN 61.
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However, the Examiner did not establish that administering histidine
and beta-alanine would have resulted in increased levels of carnosine in the
muscle. Asatoor and Gardner provided beta-alanine and L-histidine, but the
Examiner did not direct our attention to disclosure in these publications that
carnosine levels were increased. Consequently, there is inadequate evidence
that ingesting both amino acids would have resulted in carnosine levels in
such amounts that would delay or avoid the onset of muscle fatigue as taught
by Setra. Accordingly, the obviousness rejection of claims 12–19, 22–39,
and 42–44 as obvious in view of Setra and Asatoor or Gardner is reversed.

9. WRITTEN DESCRIPTION REJECTION
The written description rejection of claims 23, 24, and 28 (RAN 9)
reciting providing the dietary supplement for at least 14 days is reversed
because the ’422 patent clearly describes a fourteen day period (“two
weeks”) or more. ’422 patent, Fig. 17, col. 4, ll. 22–26, col. 10, ll. 24–28;
Examples 4–5.
CONCLUSION
All the claims are anticipated by Harris ’596 (rejection 1).
We affirm anticipation rejections 2–4. Since our claim interpretation
is different from the Examiner’s and our rationale for affirming the
rejections is different from the Examiner’s, we designate the affirmances 2–
4 as new grounds of rejections.
Rejections 5–7 are reversed.

TIME PERIOD
This decision contains a new ground of rejection under 37 C.F.R.
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§ 41.77(b). Section 41.77(b) provides that “[a] new ground of rejection . . .
shall not be considered final for judicial review.” That section also provides
that Patent Owner, WITHIN ONE MONTH FROM THE DATE OF THE
DECISION, must exercise one of the following two options with respect to
the new grounds of rejection to avoid termination of the appeal proceeding
as to the rejected claims:
(1) Reopen prosecution. The owner may file a response requesting
reopening of prosecution before the examiner. Such a response
must be either an amendment of the claims so rejected or new
evidence relating to the claims so rejected, or both.

(2) Request rehearing. The owner may request that the proceeding
be reheard under § 41.79 by the Board upon the same record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing is
sought.

In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the
appeal may file a request for rehearing of the decision within one month of
the date of: . . . [t]he original decision of the Board under § 41.77(a).” A
equest for rehearing must be in compliance with 37 C.F.R. § 41.79(b).
Comments in opposition to the request and additional requests for rehearing
must be in accordance with 37 C.F.R. § 41.79(c)–(d), respectively. Under
37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a)
of this section, for requesting further rehearing under paragraph (c) of this
section, and for submitting comments under paragraph (b) of this section
may not be extended.

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An appeal to the United States Court of Appeals for the Federal
Circuit under 35 U.S.C. §§ 141–144 and 315 and 37 C.F.R. § 1.983 for an
inter partes reexamination proceeding “commenced” on or after November
2, 2002 may not be taken “until all parties’ rights to request rehearing have
been exhausted, at which time the decision of the Board is final and
appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See
also MPEP § 2682 (8th ed., Rev. 8, July 2010).
Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79.
In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this decision becomes final and
appealable under 37 C.F.R. § 41.81, a party seeking judicial review must
timely serve notice on the Director of the United States Patent and
Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983.

AFFIRMED; 37 C.F.R. § 41.77(b)

hh
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For PATENT OWNER:

PORZIO, BROMBERG & NEWMAN P.C.
1200 New Hampshire Ave., NW
Suite 710
Washington, DC 20036

For THIRD PARTY REQUESTOR

Barry Evans
LUCAS & MERCANTI, LLP
30 Broad Street
21st Floor
New York, NY 10004