Ex Parte Wynn et al

Patent Trial and Appeal Board

Nov 3, 2017

10697546 (P.T.A.B. Nov. 3, 2017)

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.
10/697,546 10/30/2003 David W. Wynn MCP-5015 7575
27777 7590 11/07/2017
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
11/07/2017 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):
j nju spatent @ corn s .j nj. com
lhowd@its.jnj.com
pair_jnj @ firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID W. WYNN,
GERARD McNALLY, and NICK PARIKH1
Appeal 2015-007447
Application 10/697,546
Technology Center 1600
Before ERIC B. GRIMES, LORA M. GREEN, and ERICA A. FRANKLIN,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a liquid
dosage form and a method of administering a dosage form, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as McNeil-PPC, Inc. (Br. 2.
The pages of the Appeal Brief are not numbered but we refer to the page
with the heading “APPEAL BRIEF” as page 1 and number the other pages
consecutively.)
Appeal 2015-007447
Application 10/697,546
STATEMENT OF THE CASE
Claims 13—16, 18—22, 26, 27, 29-31, 36-42, and 47—52 are on appeal.
Claim 26 is illustrative and reads as follows:
26. A liquid suspension dosage form comprising:
a) a first portion of particles containing an NS AID, said NS AID
being released from the dosage form in a substantially immediate manner
upon contact of the dosage form with a dissolution medium;
b) a second portion of particles containing said NS AID, said
NS AID being released from the particles in a controlled manner upon
contact of the dosage form with the dissolution medium;
c) water, or mixtures of water and a pharmaceutically acceptable
water-miscible co-solvent selected from the group consisting of glycols,
alcohols, and glycerol, and
d) a buffering agent,
wherein said particles in said second portion are comprised of a core
that is substantially covered by a coating thereon, and said coating is
comprised of a controlled release composition comprising one or more
enteric polymers and one or more insoluble film forming polymers wherein
the weight ratio of the insoluble film forming polymer(s) and the enteric
polymer(s) is from about 80:20 to about 99:1, said first portion of particles
and said second portion of particles are suspended in component c), wherein
the pKa of said NS AID is greater than the pH of the liquid suspension
pharmaceutical dosage form, and wherein the dosage form has a duration of
therapeutic effect for at least about 12 hours after administration.
DISCUSSION
This application was the subject of an earlier appeal to this Board
(Appeal 2010-011409, decided March 16, 2011). The rejection of record
was reversed in that appeal, the application was returned to the examining
corps, and Appellants filed a Request for Continued Examination. During
the continued prosecution, claim 26 was amended to add a requirement for a
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Application 10/697,546
buffering agent, the Examiner rejected the claims over a different
combination of references, and this appeal followed.
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as obvious based on Shah,2 Sakamoto,3 and Santus.4 (Ans. 2.5)
The Examiner finds that Shah discloses a dosage form comprising
immediate release (uncoated) drug particles and extended release (coated)
drug particles. (Id.) The Examiner finds that the extended release particles
are coated with a combination of polymers comprising water insoluble
polymers such as cellulose acetate and ethylcellulose. (Id. at 2—3.) The
Examiner also finds that the active agent in Shah’s particles can be an
NS AID such as ibuprofen or naproxen, and that Shah suggests that its
composition can be dispersed in water to provide a suspension. (Id. at 3.)
The Examiner finds that Shah does not teach the ratios of insoluble
polymer-to-enteric polymer recited in claim 26, but concludes that reaching
a value within the claimed range would have been “well within the level of
skill in the art as seen in [Sakamoto].” (Id.) The Examiner finds that
Sakamoto discloses a controlled release coating comprising water-insoluble
2 Shah, US 6,126,969, Oct. 3, 2000.
3 Sakamoto, US 4,828,840, May 9, 1989.
4 Santus, US 5,670,171, Sept. 23, 1997.
5 The statement of the rejection states that it is also based on “evidence[]
[provided] by Acetaminophen fact sheet.” (Ans. 2.) The “Acetaminophen
fact sheet” refers to a document cited in the Information Disclosure
Statement filed May 19, 2011; that document, however, is not referred to in
any way by the Examiner in the explanation of the rejection or in responding
to Appellants’ arguments in either the Office Action mailed July 25, 2014 or
in the Answer. We therefore consider its inclusion in the statement of the
rejection to be a typographical error.
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Application 10/697,546
polymers, such as cellulose acetate and ethylcellulose, and enteric polymers.
{Id. at 3 4.) The Examiner finds that “[t]he water-insoluble polymers are
combined with the enteric polymers to form an extended release coating
where the insoluble polymer is present in a ratio to the enteric polymer of
8.7:1 (example 13) within the limits of the instant claims.” {Id. at 4.)
With regard to the limitation of claim 26 that “the pKa of said NSAID
is greater than the pH of the liquid suspension pharmaceutical dosage form,”
the Examiner finds that Santus
disclose[s] a liquid suspension comprising citric acid at a
concentration of 0.75% (Example 24). Naproxen has a pKa of
4.15 (4.2). While the reference is silent to the pH of the overall
of the formulation, so are the instant claims. The citric acid is
present in an amount at least (five) 5 times as much as the closest
example of the instant specification.
(Id. at 5.) The Examiner concludes that “[bjuffering agents would be an
obvious addition to reduce pH of the entire formulation,” because they are
well-known for use in analgesic suspensions and “in order to adjust the
flavor and overall compliance of the formulation.” {Id.)
We agree with the Examiner that the claimed dosage form, and
method of administering it, would have been obvious to a person of ordinary
skill in the art based on the cited references. Shah discloses “a mixture of
polymeric coated, sustained release acetaminophen particles and uncoated,
quick release acetaminophen particles pressed together in a tablet.” (Shah
2:43—46.) Shah states that, alternatively, the “particles can be packaged into
a pouch with other active or inactive ingredients. It can be dispersed into
water in form of suspension.” {Id. at 4:14—17.) Shah also states that its
dosage form can comprise NSAIDs such as naproxen or ibuprofen. (Id. at
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Application 10/697,546
6:14.) Thus, Shah suggests a liquid dosage form comprising water and a
combination of immediate release (uncoated) particles and sustained release
(coated) particles containing an NSAID.
Shah states that its sustained release particles “are provided with a
sustained-release coating formulation comprising a water-insoluble, water-
permeable and slightly water-swellable polymer coating.” (Id. at 3:1—5.)
“Particular examples of suitable polymers for use in the sustained-release
coating of the combined immediate-release/sustained-release acetaminophen
formulations includes: methyl cellulose, ethyl cellulose,. . . cellulose
acetate,” etc. (Id. at 4:59-64.) Thus, Shah suggests coating the sustained
release particles of its dosage form with a water-insoluble polymer such as
ethyl cellulose or cellulose acetate.
Sakamoto discloses sustained release formulations comprising an
active ingredient, a coating layer of “practically water-repellent material,”
and a coating layer of “practically pH-independent and water-insoluble film­
coating material.” (Sakamoto 1:43—54.) Sakamoto discloses that the water-
insoluble coating material can be, among other things, ethylcellulose or
cellulose acetate. (Id. at 4:1—6.) Sakamoto also states that the film-coating
materials can be employed together with additives such as enteric coating
materials such as hydroxypropylmethylcellulose phthalate (HPMCP). (Id. at
4:16—21.) Sakamoto discloses a specific example of granules coated with a
dispersion comprising 174 grams of ethylcellulose and 20 grams of HPMCP.
(Id. at 7:64 to 8:10.) A ratio of 174:20 is equivalent to a ratio of 8.7:1,
which is within the range of ratios recited in claim 26.
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Application 10/697,546
Santus discloses “a controlled-release pharmaceutical dosage form in
liquid suspension delivering therapeutic levels of naproxen . . . with a single
daily administration.” (Santus 3:21—24.) Santus discloses that its dosage
form comprises coated granulates and a vehicle containing “buffering agents
such as citric acid and sodium nitrate [sic, citrate].” {Id. at 6: 27—38.) One
exemplary composition disclosed by Santus comprised 0.75 weight % citric
acid. {Id. at 13:5—18.)
The Examiner finds that the pKa of naproxen is 4.15. (Ans. 5.)
Appellants do not dispute this finding. {See Br. 4—6.) The Specification’s
only example of a suspension base for immediate release and controlled
release granules includes 0.18 percent w/v citric acid. (Spec. 16:8—14.)
Santus’ composition thus contains over four times as much citric acid, on a
percentage basis, and therefore would have a lower pH than the suspension
base exemplified in the Specification.
We agree with the Examiner that Santus’ composition would
reasonably be expected to have a lower pH than the Specification’s
exemplary composition, which presumably meets the limitations of claim
26, and therefore Santus’ composition reasonably appears to meet the
limitations of claim 26. We also agree with the Examiner that it would have
been obvious to combine the elements of the prior art controlled-release
dosage forms in the manner recited in claim 26 because doing so simply
requires combining known elements for their known functions to yield a
predictable result. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007).
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Application 10/697,546
Appellants argue:
While [Santus] does disclose the use of a buffering agent, e.g.,
citric acid, in analgesic suspensions, it does not disclose or
suggest that the pKa of the NS AID is greater than the pH of the
liquid suspension pharmaceutical dosage form, which is a
required feature of independent Claims 26 and 31. Notably,
Example 24 of [Santus] does not even provide a pH value. Thus,
Applicants maintain that the combination of [Shah], [Sakamoto],
and [Santus] would not lead to the claimed liquid suspension
recited in Claims 26 and 31.
(Br. 5-6.)
This argument is not persuasive. As discussed above, the
Specification’s sole example of the inventive dosage form includes a
suspension base containing 0.18 % w/v of citric acid, while Santus’ Example
24 formulation 0.75 weight % citric acid. Citric acid, being an acid, lowers
the pH of a composition. A greater percentage of citric acid therefore results
in a lower pH, and Santus’ composition would therefore have a lower pH
than the composition exemplified in the Specification.
Neither the Specification nor Santus discloses the pH of the
exemplified compositions. However, the composition exemplified in the
Specification presumably meets the claim limitation that “the pKa of said
NS AID is greater than the pH of the liquid suspension pharmaceutical
dosage form.” Since Santus’ exemplified composition has a lower pH than
the Specification’s exemplified composition, it is reasonable to conclude that
Santus’ composition, and therefore the composition made obvious by the
cited references, meets that limitation as well. Appellants have presented no
evidence to support a contrary conclusion. See In re Best, 562 F.2d 1252,
1254—55 (CCPA 1977):
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Application 10/697,546
“[Wjhere the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent characteristic
of the prior art, it possesses the authority to require the applicant
to prove that the subject matter shown to be in the prior art does
not possess the characteristic relied on.”
(quoting In re Swinehart, 439 F.2d 210, 212—13 (CCPA 1971)).
Claims 13—16, 18—22, 27, 29—31, 36-42, and 47—52 have not been
argued separately and therefore fall with claim 26. 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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