Ex Parte 8129422 et al

Patent Trial and Appeal Board

Feb 27, 2017

95002048 (P.T.A.B. Feb. 27, 2017)

UNITED STATES PATENT AND TRADEMARKOFFICE
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 02/27/2017
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
02/27/2017 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 REQUEST FOR REHEARING
This is a decision on the Request for Rehearing by Patent Owner
(“Req. Reh’g” dated June 13, 2016) of the Decision on Appeal of May 13,
2016 (“DOA”).
Patent Owner filed a Request for Rehearing on June 13, 2016. A
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.” 37 C.F.R.
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§ 41.77(b)(2). In this case, new grounds of rejection were set forth because
the Decision determined that “the Examiner improperly ignored the
functional limitation recited both in the preamble and body of the claim” of
“avoiding or delaying the onset of muscular fatigue.” DOA 7, 28. However,
in the Request for Rehearing, Patent Owner did not address this limitation as
it related to the affirmance of Rejections 1–4 (DOA 5). Rather, Patent
Owner simply repeated arguments already made during the Reexamination
proceeding, and particularly failed, in the 25-page Request for Rehearing, to
direct our attention to specific errors or misapprehensions in the Decision.
Specifically, Patent Owner: (1) repeated its arguments that the
Application was improperly denied the benefit of its priority applications
(Req. Reh’g 2–3); (2) argued that the Board had misconstrued the dosage
requirements of the claims (id., 4–16) while admitting that such arguments
had been made “repeatedly . . . throughout this reexamination” (id., 6); and
(3) argued that the Board has improperly given “dietary supplement” its
narrow meaning advocated by Patent Owner, while admitting that such
arguments have been “repeated” by Patent Owner throughout the
reexamination. Id., 17 (“Appellant has repeatedly explained that the
Amendment disavowed ‘pharmaceuticals’ of beta-alanine, such as in EP
’593 cited by the Panel in Rejection 4. The October 11, 2011 Amendment
clearly and unambiguously stated the invention required a ‘dietary
supplement’ – not a pharmaceutical.”).

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Priority
Patent Owner contends “there is no reasoned legal analysis by the
Panel regarding why the asserted break in priority--occurring after filing--
should treat an application any differently than an issued patent.” Req.
Reh’g 3.
In the Decision, we referred to the discussion of priority in the related
’001 Reexamination (DOA 2). In the Decision in the ’001 Reexamination,
this panel stated:
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.
’001 Reexamination Decision 10.
The panel also stated:
Contrary to Patent Owner’s 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 (8th
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
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claimed benefit of an earlier filed application because it was not
described or enabled in the application.
Id., 11.
Thus, while it is evident that Patent Owner disagrees with the priority
determination made in this Reexamination proceeding, it is not true that
“[t]here is no reasoned legal analysis by the Panel.” Req. Reh’g 3.
The above-reproduced passages illustrate the Panel’s reasoned analysis.
In the Request for Rehearing, Patent Owner further stated:
This complication is unnecessary if the Panel instead follows
the determination of Judge Lourie and the Federal Circuit that
the priority is determined on the day of filing and amendments
to different families do not, nunc pro tunc, affect the filing date
of already filed applications. Loughlin v. Ling, 684 F.3d 1289,
1293-94 (Fed. Cir. 2012).
Req. Reh’g 3.
In Loughlin, the issue was whether the Board correctly interpreted
§ 135(b)(2) in view of the plain language of the statute and the benefit
provision of § 120. Loughlin, 684 F.3d. at 1293. The court stated: “The first
sentence of § 120 permits an application to claim the benefit of an earlier
filing date, such that the application is treated as having been effectively
filed on the earlier date.” Id. The court determined that the Board correctly
construed “an application filed” in § 135(b)(2) as including an application
filed earlier and benefiting from the provisions of § 120. Id. Patent Owner
did not direct our attention to where in the decision “amendments to
different families” were at issue in Loughlin, and we have found no mention
of amendments. Req. Reh’g 3. Consequently, Patent Owner’s reliance on
this case to support their argument is unavailing.

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Dosage
Claim 12 is drawn to a “method to avoid or delay the onset of
muscular fatigue in a subject, comprising: a) providing to the subject an
amount of” beta-alanine or an ester or amide of it. We interpreted the claim
to include a single one-time dosage of beta-alanine. DOA 10. We found
that the Examiner had reasonable basis to believe that the single dosages
administered in Gardner and Asatoor met the claim requirement of
“avoiding or delaying the onset of muscular fatigue” because the
administered amounts fell within the amounts disclosed in the ’422 patent to
be effective for this purpose. DOA 17–18, 19.
We discern no points misapprehended or overlooked in our
determination that the claims are reasonably interpreted to include a single
one-time dosage of beta-alanine which is effective to avoid or delay the
onset of muscular fatigue. The ’422 patent describe specific examples in
which multiple dosages over two or more days are administered. ’422
patent, col. 4, ll. 24–26. However, the ’422 patent also generally refers to
dosages over a 24-hour period without requiring multiple dosages during
that period or without requiring periods of more than a day. Id., col. 3, ll.
57–61 (“In one aspect, the total dosage of the beta-alanine for a 24-hour
period is at least about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2,
1.3, 1.4, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5 or
more grams.”). The claims do not contain express language of “multiple”
dosages or “multiple” days over which dosages must be administered.
Absent such express language that easily could have been introduced into
the claim, Patent Owner contends that the requirement of increasing
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“alanylhistidine dipeptide synthesis in muscle tissue,” “thereby avoiding or
delaying the onset of muscular fatigue,” and dietary supplementation
dictates such multi-dose/multi-day dosage regimen. However, Patent Owner
has not directed us to disclosure in the ’422 patent that requires such a claim
interpretation. Instead, the patent describes a broad range of dosages for
beta-alanine (e.g., from 100 mg to 6.5 grams (id., col. 3, ll. 23–30)) without
a clear explication that certain dosages must be administered over a period
of days to achieve the claimed functional requirements.
Patent Owner cites to speculation by Dr. Harris about the fate of a
single-dosage of beta-alanine, but we found such opinion testimony to be
unpersuasive because it lacked objective scientific evidence to support it and
because it did not distinguish a similar fate occurring with dosages of beta-
alanine administered multiple times. DOA 11. Also, we do not find
sufficient evidence that “dietary supplementation” means administration
“over time” as alleged by Patent Owner. Req. Reh’g 22. For example, we
have reviewed paragraphs 13–17 of the Harris Declaration dated December
13, 2012 cited by Patent Owner and do not find well-reasoned support for
this interpretation.
In addition, Patent Owner cited publications by Mr. Bacombe and Dr.
Tallon as supporting “Appellant's position that a ‘one-time’ single dose is
not contemplated by the claims.” Req. Reh’g 8. We addressed these reports
in the Decision. See, e.g., DOA 13. During reexamination of an unexpired
patent, the PTO must give claims their broadest reasonable construction
consistent with the specification as they would be understood by one of
ordinary skill in the art. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359,
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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, 1148 (Fed. Cir.
2012). Patent Owner did not explain how the Bacombe and Tallon reports
bear upon the interpretation of the ’422 patent claims. For example, while
preferred embodiments may require beta-alanine to be administered over
days or weeks as described by Mr. Bacombe and Dr. Tallon, such
preferences does not negate the broader disclosure in the ’422 patent
covering a single effective dosage of beta-alanine.
We also have not been pointed to discernible points misapprehended
or overlooked in our conclusion that Patent Owner did not meet the burden
of demonstrating that the Examiner’s determination was incorrect that the
single-dosage of beta-alanine administered in Gardener and Asatoor avoided
or delayed the onset of muscular fatigue. The dosages described in the
publications fall within the range disclosed in the ’422 patent. DOA 17. We
simply have not been provided with evidence that the 2 and 1.8 gram
dosages administered in Gardner and Asatoor, respectively, would not have
avoided or delayed the onset of muscular fatigue in such a susceptible
subject. See Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1379 (Fed.
Cir. 2005). Absent such evidence, and because the dosages are the same as
those described in the ’422 patent, we conclude that the Examiner did not err
in determining that the publications were anticipatory to the claimed subject
matter.
Patent Owner also states that the panel ignored the limitation of
“dietary supplementation.” Req. Reh’g 17. This is not correct. The
Decision contained a section titled “dietary supplement” in which we
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concluded that “Patent Owner did not elucidate a structural difference
between dietary supplements and pharmaceutical agents.” DOA 15. Patent
Owner takes the position that the administration of beta-alanine in EP ’593
is administration of a pharmaceutical drug, while administration of beta-
alanine in their own patent is of a dietary supplement not anticipated by EP
’593, despite it being the same compound in the same quantity and in a form
that Patent Owner has not distinguished other than by name. Req. Reh’g 23.
Patent Owner asserts that the amounts in EP ’593 are to treat cancer, but
admits that such amounts are overlapping: “the Panel trudges forth and
alleges anticipation based only on the fact that there is a potential overlap in
dosing ranges.” Id., 24. To the contrary, facts were established by the
Examiner and in the Decision that the amount of beta-alanine administered
in EP ’593 falls within the range described in ’422 patent. DOA 19; RAN
21. Because the amounts are the same, there is reasonable basis to believe
that muscle fatigue would be avoided or delayed as claimed.
In view of the foregoing reasons, the rehearing is denied.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

DENIED

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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