Ex Parte Buehler et al

Patent Trial and Appeal Board

Oct 4, 2016

11457316 (P.T.A.B. Oct. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111457,316 07/13/2006
27777 7590 10/06/2016
JOSEPH F SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
Gail K. Buehler
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
MCP5135USNP 6982
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
10/06/2016 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):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
pairjnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GAIL K. BUEHLER, EDWARD A. KOCH, and
DANA J. RECHEN 1
Appeal2015-002662
Application 11/457,316
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
decongestant suspension, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
"A common problem associated with liquid dosage forms is the often
disagreeable taste of the active agents." (Spec. i-f 4.) According to
Appellants' Specification, "suspensions typically offer superior taste
1 Appellants identify the Real Party in Interest as McNeil-PPC, Inc. (Br. 2.)
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Application 11/457,316
masking to other liquid forms." (Spec. i-f 4.)2 Appellants' "invention is
directed to discovery of a stable aqueous APAP [("acetaminophen")]
suspension with dissolved phenylephrine product that [is] palatable." (Spec.
i-f 10; see id. i-f 8.)
Claims 17-23 and 29-36 are on appeal. 3 Claim 17 is representative
and reads as follows:
17. A decongestant suspension, comprising:
(a) a therapeutically effective amount of AP AP,
(b) a therapeutically effective amount phenylephrine,
(b) an effective amount of a non-reducing sweetener;
( c) an effective amount of water; and
( d) an effective amount of a suspending system;
wherein the pharmaceutical suspension has a pH of from about
4 to about 6 and is substantially free of a reducing sugar.
(Br. 10.)
The following ground of rejection by the Examiner is before us on
review:
Claims 17-23 and 29-36 under 35 U.S.C. § 103(a) as unpatentable
over Ratnaraj,4 Santos,5 and Munayyer.6
2 The Specification defines a suspension as "a two-phase system having
solid substantially water insoluble active agent particles dispersed
throughout a liquid medium." (Spec. i-f 5.)
3 Claims 1-16 and 24--28 are also pending, but stand withdrawn from
consideration. (Br. 2.)
4 Ratnaraj et al., EP 0620001 Al, published Oct. 19, 1994.
5 Santos et al., US 2003/0118654 Al, published June 26, 2003.
6 Munayyer et al., US 6,132,758, issued Oct. 17, 2000.
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DISCUSSION
The Examiner finds that Ratnaraj teaches a pharmaceutical suspension
having a pH between about 3 and about 7 that includes acetaminophen;
pseudoephedrine; chloropheniramine maleate; sweeteners, such as sucrose
and sorbitol; water; and, a suspending system. (Ans. 3.) The Examiner
recognizes that Ratnaraj does not teach using the decongestant
phenylephrine or that the suspension is "free of a reducing sugar." (Ans. 3.)
The Examiner finds that Santos teaches decongestants used in liquid
pharmaceutical compositions "include phenylpropanolamine,
pseudoephedrine, and phenylephrine." (Ans. 3.) The Examiner further finds
that Munayyer teaches antihistamine syrup compositions frequently contain
decongestants such as pseudoephedrine and phenylpropanolamine, along
with acetaminophen and guaifenesin. (Ans. 4.) The Examiner notes that
Munayyer teaches that traditionally antihistamine syrup formulations contain
sucrose, but "artificial sweeteners, such as sorbitol, can be used to avoid
dental and medical problems which may be aggravated by higher caloric
sweeteners," and indicates that Munayyer exemplifies an antihistamine
formulation using only sorbitol as the sweetener. (Ans. 4 (citing Munayyer
Ex. 4 and 1:15-21).)
In light of the foregoing disclosures, the Examiner concludes that it
would have been obvious to substitute phenylephrine in place of
pseudoephedrine in the Ratnaraj formulation with a reasonable expectation
of success "because [Santos teaches] these two drugs are functional
equivalent drugs for decongestants." (Ans. 4.) The Examiner further
concludes that it would have been obvious to one of ordinary skill in the art
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to use only sorbitol in the Ratnaraj formulation "because MUNA YY[]ER
disclosed artificial sweeteners, such as sorbitol, can be used to avoid dental
and medical problems which may be aggravated by higher caloric
sweeteners." (Id.) The Examiner also notes that one of ordinary skill in the
art would have a reasonable expectation of success since Munayyer
discloses a composition in which only sorbitol is used. (Ans. 4 (citing
Munayyer Ex. 4).)
We agree with the Examiner's factual findings and conclusion that it
would have been obvious with a reasonable expectation of success to use
only sorbitol, rather than both sucrose and sorbitol, in the Ratnaraj
suspension, as well as substitute phenylephrine for pseudoephedrine.
Appellants argue that the rejection is improper because (a) "even if
the suspension composition in Example 2 [of Ratnaraj] is in a syrup, it does
not necessarily follow that every syrup includes a suspension," (b)
Munayyer is non-analogous art because it is "a ~not a suspension,"
( c) Santos does not exemplify a formula that includes phenylpropanolamine,
pseudoephedrine, and phenylephrine, "which would be included in different
amounts, which would require reformulating and adjusting other ingredients
in the composition," and ( d) "it cannot be assumed that substituting one
component for another will not affect the pH of the composition" and that
"substituting sorbitol solution for high fructose com syrup[] would likely
result in changes to the percentages of other ingredients in the formulation
which would also likely affect the pH." (Br. 5-6.) We do not find the
foregoing arguments convincing.
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Appellants acknowledge that Ratnaraj discloses a suspension that
"contains suspended acetaminophen and at least one additional
pharmaceutical active." (Br. 5.) Indeed, as the Examiner noted (Ans. 3, 5),
Ratnaraj Example 2 teaches a pharmaceutical suspension including xantham
gum and microcrystalline cellulose/sodium carboxymethylcellulose, which
are disclosed in the Specification as suitable ingredients to form a
suspension. (Spec. i-fi-154--57.) Furthermore, Ratnaraj teaches that "the
suspending system" "is suitable for suspending acetaminophen powder in an
aqueous solution." (Ratnaraj 3:56-57.) In light of this teaching, it is beside
the point that not "every syrup includes a suspension" (Br. 5).
As to Appellants' argument that Munayyer is non-analogous art, we
note that "[i]n order to rely on a reference as a basis for rejection of the
applicant's invention, the reference must either be in the field of the
applicant's endeavor or, if not, then be reasonably pertinent to the particular
problem with which the inventor was concerned." In re Oetiker, 977 F.2d
1443, 1447 (Fed. Cir. 1992). We agree with the Examiner that because both
Munayyer and Ratnaraj teach sweetened pharmaceutical compositions, i.e.
"syrups," where a sweetener is used to assist in masking the bitter taste of
the actives in the composition (Ratnaraj 4:28--44; Munayyer 1 :6-28), and
both are concerned with "common liquid over-the-counter [pharmaceutical
compositions] for cold and flu symptoms," they are analogous references.
(Ans. 5---6.)
As to Santos, as the Examiner noted (Ans. 6), the teachings of that
reference are not limited to the disclosed examples. Rather, a reference is
available for all that it teaches to a person of ordinary skill in the art. In re
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Inland Steel Co., 265 F.3d 1354, 1356 (Fed. Cir. 2001); Merck & Co., Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("'[T]he fact that a
specific [embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered.' In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)."). Claim 19
of Santos specifically provides for a liquid pharmaceutical composition that
includes a "decongestant selected from phenylpropanolamine,
pseudoephedrine, phenylephrine, and combinations thereof." (Santos 11
(claim 19).) Thus, Santos teaches aqueous liquid pharmaceutical
compositions in which the decongestants phenylephrine and
pseudoephedrine are equivalent alternatives imparting decongestant activity
to the formulation, and the Examiner properly relied upon Santos' disclosure
in claim 19.
Regarding Appellants' pH argument, the Examiner noted that
"Appellants have previously acknowledged that Ratnaraj et al. does disclose
a pH of 4.5." (Ans. 6.) Appellants do not contradict the foregoing.
Moreover, we confirm that Ratnaraj discloses that the composition of
Example 2, which contains the buffering agent citric acid in an amount of
0.075 g/100 mL that was added to the composition after the active
ingredients, suspending system, and sweetener were added to the solution,
has a pH of 4.45. (Ratnaraj 9-10.) A pH of 4.45 is about pH 4.5.
Furthermore, as the Examiner noted (Ans. 7), Ratnaraj teaches to adjust the
composition to obtain the desired pH of about 3-7. (Ratnaraj 4--5.) Thus,
we agree with the Examiner that one of ordinary skill in the art would have
found it obvious to adjust the pH after adding sorbitol in place of sucrose to
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obtain a pH in the claimed range of about 4---6. "[W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation." In re
Aller, 220 F.2d 454, 456 (CCPA 1955).
For the foregoing reasons, Appellants do no persuade us that the
Examiner erred in rejecting claim 17 for obviousness over Ratnaraj, Santos,
and Munayyer.
Claims 18-23 and 29-36 have not been argued separately and
therefore fall with claim 17. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 17-23 and 29-36 under 35 U.S.C.
§ 103(a) as unpatentable over Ratnaraj, Santos, and Munayyer.
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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