Ex Parte Libinaki

Patent Trial and Appeal Board

Feb 2, 2018

13577124 (P.T.A.B. Feb. 2, 2018)

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.
13/577,124 08/03/2012 Roksan Libinaki 024944-9033-US00 3898
23409 7590 02/06/2018
MICHAEL BEST & FRIEDRICH LLP (Mke)
100 E WISCONSIN AVENUE
Suite 3300
MILWAUKEE, WI 53202
EXAMINER
FAN, LYNN Y
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
02/06/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mkeipdocket@michaelbest.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROKSAN LIBINAKI
Appeal 2018-001743
Application 13/577,1241
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a carrier for
delivering a nutraceutical or cosmeceutical active ingredient. The Examiner
rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 20, 22—24, 26—28, 30-33, 35—38, and 40-42 under 35 U.S.C.
1 Appellant states that the “real party in interest is Phosphagenics Limited,
the assignee of record for this application.” Appeal Br. 3.
Appeal 2018-001743
Application 13/577,124
§ 103(a) as being unpatentable over Gavin,2 Ogru,3 and Reference.com4
(Ans. 3—6).
Claim 20 is the sole independent claim on appeal and reads as
follows:
20. A carrier for the delivery of a nutraceutical or
cosmeceutical active comprising non-neutralised tocopheryl
phosphate and a hydrophobic vehicle, wherein the non-
neutralised tocopheryl phosphate comprises a mixture of mono-
(tocopheryl) phosphate and di-(tocopheryl) phosphate, and
wherein the pH of the non-neutralised tocopheryl phosphate is
in a range of about 2 to about 4, and wherein the carrier
comprises the hydrophobic vehicle in an amount of at least
about 80.0%w/w of the total concentration of the carrier.
Appeal Br. 14.
DISCUSSION
The Examiner’s Prima Facie Case
The Examiner found that Gavin described a carrier having almost all
of the features required by the rejected claims, and cited Ogru as evidence
that it would have been obvious to include, in Gavin’s carrier, a hydrophobic
vehicle at the claimed concentrations. Ans. 3—5.
The Examiner found that Gavin’s carrier also differed from the
claimed carriers in that “Gavin does not teach the claimed pH of the non-
neutralized tocopheryl phosphate, as recited in claims 20 and 22.” Id. at 4.
The Examiner found, however, that Gavin “does teach the formulation
comprising a mixture of mono-(tocopheryl) phosphate and di-(tocopheryl)
2 US 2009/0036354 A1 (published Feb. 5, 2009).
3 US 2009/0005348 A1 (published Jan. 1, 2009).
4 https://www.reference.com/science/normal-ph-levels-human-stomach-
52a8cl518ee846ba (accessed Nov. 8, 2016).
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Appeal 2018-001743
Application 13/577,124
phosphate and a biologically active compound for enteral or oral
administration” and noted that, “[a]t the time of the claimed invention, it was
well known in the art that the standard pH level of a human stomach is 1 -5
(p 1 of Reference[.com]).” Id.
The Examiner concluded, therefore, that an ordinary artisan would
have considered it obvious “to incorporate tocopheryl phosphate having a
more acidic pH in a carrier to protect a formulation at acidic pH
corresponding to the transit in the stomach and to release biologically active
compounds rapidly once the formulation arrives in small intestine.” Id. at 4—
5.
The Examiner reasoned, in particular, that “at the time of the claimed
invention, one of ordinary skill in the art would have been motivated by the
cited reference to incorporate tocopheryl phosphate having a more acidic pH
with a reasonable expectation for successfully obtaining a carrier.” Id. at 5.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, but also reaffirmed the importance of determining
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” Id. at 418 (emphasis added).
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Application 13/577,124
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
We agree with Appellant that a preponderance of the evidence does
not support the Examiner’s contention that the cited references would have
suggested modifying Gavin’s carrier to have a pH within the range of about
2 to about 4, as recited in claim 20.
In particular, we agree with Appellant’s contention that “the
Examiner’s assertion that formulating tocopheryl phosphate at a pH of about
2 to about 4 would ‘protect a formulation’ through transit in the stomach or
‘release the biological compounds rapidly’ upon arrival in the small intestine
is entirely unsupported in the record.” Appeal Br. 8.
In response to Appellant’s argument in that regard, the Examiner
advances a somewhat distinct rationale, finding that “in acidic medium,
acidic drug is present more in unionized form, which increases its
absorption.” Ans. 8.
The Examiner notes in particular that the rejected claims “require the
carrier being formulated for oral administration. Gavin does disclose that
the carrier is formulated for oral administration (para 0064, 0072), and
Reference [.com] (the evidentiary reference used in the rejections set forth in
the Office action dated 11/15/2016) does disclose that stomach is an acidic
medium.” Id.
Therefore, the Examiner reasons, an ordinary artisan “would have
been motivated by the reference to incorporate a [tocopheryl phosphate/
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Application 13/577,124
tocopheryl diphosphate] mixture having a more acidic pH to achieve better
drug absorption via oral administration.” Id.
Additionally, the Examiner contends, “for pure argument-sake (and
not to introduce new grounds of rejection), PharmaTutor (2010)[5] teaches
that weak acid is absorbed at a faster rate from stomach (pH 1.4-2) (p.2 para
6).” Id.
We agree with Appellant that the Examiner has not explained
adequately, under either of the rationales advanced, why the cited references
would have suggested modifying Gavin’s carrier to have a pH within the
range of about 2 to about 4, as recited in claim 20.
We acknowledge that Gavin discloses using its carrier in oral
formulations. Gavin | 64. We are not persuaded, however, that the
Examiner has explained adequately how or why formulating Gavin’s carrier
to have the same pH as the stomach would somehow protect a drug
contained within the carrier from the stomach’s acidity.
We acknowledge also the disclosure in PharmaTutor that “weak acid
is absorbed at a faster rate from stomach (pH 1.4- 2).” PharmaTutor 2. We
are not persuaded, however, that the Examiner has explained adequately
why an ordinary artisan would have modified Gavin’s drug carrier to have
the same pH as the stomach, based on the fact that a weakly acidic drug
might be absorbed faster in the stomach. We are not persuaded, therefore,
that the Examiner has advanced sufficient evidence to support a finding that
modifying Gavin’s carrier to have a pH within the range of about 2 to about
5 https://web.archive.Org/web/20100424055334/http://www.pharmatutor.org/
pharmacology/general-pharmacology/physical-properties-drugs.html (2010).
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Application 13/577,124
4, as recited in claim 20, would enhance the absorption of a drug being
delivered by the carrier.
In sum, Appellant persuades us, for the reasons discussed, that the
Examiner has not shown by a preponderance of the evidence that the cited
references would have rendered the composition of claim 20 obvious to an
ordinary artisan. We, therefore, reverse the Examiner’s rejection under
§ 103(a) of claim 20, as well as its dependent claims.
REVERSED
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