Ex Parte Buehler

Patent Trial and Appeal Board

Oct 26, 2016

12782269 (P.T.A.B. Oct. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121782,269 05/18/2010
27777 7590 10/28/2016
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.
MCP5048USCNT1 4305
EXAMINER
BERRIOS, JENNIFER A
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
10/28/2016 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GAIL K. BUEHLER 1
Appeal2015-000755
Application 12/782,269
Technology Center 1600
Before DONALD E. ADAMS, LORA M. GREEN, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a dye-free pharmaceutical suspension. Claims 1, 4, 6, 7,
9, 12, 14--18, 24, 26, 29, 36, and 37 are on appeal as rejected under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 We understand the Real Party in Interest to be McNeil-PPC, Inc., a wholly
owned subsidiary of Johnson & Johnson. Br. 1.
Appeal2015-000755
Application 12/782,269
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 1, 18, and 3 6 are the independent claims. Claim 1 is
representative, and reads as follows:
1. A dye-free pharmaceutical suspension, comprising:
(a) a therapeutically effective amount of a first active agent
consisting essentially of a first substantially water insoluble
active agent having an average particle size of between about 10
and about 100 microns,
(b) an effective amount of a non-reducing sweetener comprising
sorbitol;
( c) an effective amount of water; and
( d) an effective amount of a suspending system;
wherein the dye-free pharmaceutical suspension has a pH of
from about 5 to about 6 and is substantially free of a reducing
sugar.
Br. 10 (Claims App'x).
The following rejections are on appeal:
Claims 1, 4, 6, 7, 9, 12, 14--18, 24, 26, and 29 stand rejected under 35
U.S.C. § 103(a) over Blase2 and Kumar. 3 Final Action 3.
2 U.S. Patent No. 5,409,907 (issued to Blase on Apr. 25, 1995) (hereinafter
"Blase").
3 Ashir Kumar, MD, et al., The Mystery Ingredients: Sweeteners,
Flavorings, Dyes, and Preservatives in Analgesic/ Antipyretic,
Antihistamine/Decongestant, Cough and Cold, Antidiarrheal, and Liquid
Theophylline Preparations, 91 PEDIATRICS 927-33 (1993) (hereinafter
"Kumar").
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Application 12/782,269
Claims 1, 4, 6, 7, 9, 12, 14--18, 24, 26, 29, and 36 stand rejected under
35 U.S.C. § 103(a) over Blase, Kumar, Munshi,4 and Singh.5 Final Action 6.
Claims 1, 4, 6, 7, 9, 12, 14--18, 24, 26, 29, 36, and 37 stand rejected
under 35 U.S.C. § 103(a) over Blase, Kumar, Munshi, Singh, and
Sorrentino. 6 Final Action 8.
Except where otherwise indicated, we adopt the Examiner's findings
of fact, reasoning on scope and content of the prior art, and conclusions set
out in the Final Action and Answer. Any findings of fact set forth below are
provided to highlight certain determinations by the Examiner or identify
facts established by Appellant.
FINDINGS OF FACT
FF 1. Blase disclosed:
The present invention provides a pharmaceutical suspension
comprising a therapeutic amount of a drug; a suspending system
consisting essentially of an effective amount of xanthan gum and
microcrystalline cellulose to form a stable suspension system in
an aqueous solution; water; and optionally an effective amount
of sweetening agents and flavoring agents to provide a palatable
taste to said pharmaceutical suspension.
Blase col. 2: 12-19 (makes no mention of requiring any or a specific
sweetener, i.e., "optionally," and makes no mention of including a dye);
see also Final Action 3---6 (discussing Blase).
4 U.S. Patent No. 4,427,681 (issued to Munshi on Jan. 24, 1984) (hereinafter
"Munshi").
5 U.S. Patent No. 5,759,579 (issued to Singh et al. on June 2, 1998)
(hereinafter "Singh").
6 U.S. Patent No. 4,892,877 (issued to Sorrentino on Jan. 9, 1990)
(hereinafter "Sorrentino").
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Application 12/782,269
FF2. Blase also disclosed, "[ c ]oloring agents also may be
incorporated in the suspension to provide an appealing color to the
suspension." Blase 6: 5---6; see also Final Action 3---6 (discussing Blase).
FF3. Blase disclosed, "[t]he flavoring and coloring
ingredients added to the mixture should be of the type and amount
desired for the particular suspension to meet the preferences dictated by
the intended consumer of such suspension e.g. pediatric or adult."
Blase 8:9-13; see also Final Action 3---6 (discussing Blase).
FF4. Blase disclosed, "[u]p to about 20 grams
pharmaceutical active per 100 mL may be readily taste masked with the
addition of sweeteners and flavoring agents. However, this may vary
depending on the palatability of the pharmaceutical active." Blase
4:27-31; see also Final Action 3---6 (discussing Blase).
FF5. Blase disclosed, "[m]asking the flavor of bitter
pharmaceuticals may be accomplished by using flavoring agents and
sweeteners to overpower the bitter flavor of the pharmaceutical. The
bitter flavor also can be minimized by limiting the amount of water
present in the suspension." Blase 4:34--38; see also Final Action 3---6
( discussing Blase).
FF6. Blase disclosed a substantial selection of sweeteners,
including sorbitol and artificial sweeteners, as follows:
Suitable sweetening agents include but are not limited to sugars
such as monosaccharides, disaccharides and polysaccharides.
Examples of suitable sugars include but are not limited to xylose,
ribose, glucose, mannose, galactose, fructose, dextrose, sucrose,
maltose, partially hydrolyzed starch or com syrup, and sugar
alcohols such as sorbitol, xylitol, mannitol, glycerin and
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Application 12/782,269
combination thereof. Presently preferred as a sugar sweetener is
high fructose com syrup provided as an aqueous solution ....
Water soluble artificial sweeteners also may be employed in
place of or in addition to sugar sweeteners. Examples of suitable
artificial sweeteners include but are not limited to aspartame,
sucrose, cyclamates, saccharin and mixtures thereof.
Blase 4:38---60; see also Final Action 3---6 (discussing Blase).
FF7. Blase disclosed, "[t]he preferred sweeteners for
acetaminophen suspension are high fructose com syrup, sorbitol and
glycerin." Blase 6: 62---63; see also Final Action 3---6 (discussing Blase).
FF8. Blase disclosed how and in what amount to include
fructose, sorbitol, or glycerin as the sweetener:
The high fructose com syrup should be provided as an aqueous
solution containing 77% by weight solid. The fructose content
of the high fructose com syrup should be about 55%. The
amount of aqueous high fructose com syrup percent in the
acetaminophen suspension should be in the range of from about
20 to about 80 grams per 100 ml of suspension. The sorbitol also
should be present as an aqueous solution containing 70% sorbitol
by weight. The amount of aqueous sorbitol present in the
acetaminophen suspension should be in the range of from about
1 to about 30 grams of sorbitol per 100 mL of the suspension.
The amount of glycerin in the acetaminophen suspension should
be in the range of from about 1 to about 20 grams of glycerin per
100 mL of the suspension.
Blase 6:64--7:10; see also Final Action 3---6 (discussing Blase).
FF9. Blase claimed its pharmaceutical suspension includes a
sweetening agent, as follows:
selected from the group consisting of xylose, ribose, glucose,
mannose, galactose, fructose, dextrose, sucrose, maltose,
partially hydrolyzed starch solids, partially hydrolyzed com
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syrup solids, sorbitol, xylitol, mannitol, glycerin, aspartame,
sucralose, cyclamates, saccharin and mixtures thereof.
Blase claim 2; see also Final Action 3---6 (discussing Blase).
FFlO. Kumar disclosed, "[a]dverse effects reported with
sweeteners are summarized in Table 10. . .. [S]ome of these adverse
effects (eg, cariogenicity, osmotic diarrhea) are dose related .... "
Kumar 928 (right col.); see also Br. 7 (contending Kumar teaches away
from sorbitol as excipient); cf Ans. 10-11 (contending Kumar explains
any adverse effects of sorbitol are dose dependent and arguing a lack of
evidence on dose and other prior art).
FFl 1. Kumar disclosed sorbitol can cause the following
adverse effects: "[ o ]smotic diarrhea, poor absorption of active drug,
flatulence, [and] abdominal pain." Kumar 932 (table 10); see also Br. 7
(contending Kumar teaches away from sorbitol as an excipient).
FF12. ~v1unshi disclosed, "[ c ]ompositions employing titanium
dioxide as an opacifying agent and which are thixotropic gels easily
convertible to pourable liquids with moderate shaking" and "the
product is converted to a pourable liquid having a viscosity of from
about 300 to about 800 cps." Munshi Abstract and col. 2: 1--4; cf Br.
7-8 (contending Munshi's disclosed gels are not liquid suspensions);
see also Spec. 2: 14--18 (distinguishing suspensions from emulsions).
FF13. Munshi disclosed, "the compositions of this invention
can contain any suitable optional ingredients such as buffers,
flavorants, colorants, sweeteners, preservatives, solubilizing agents and
the like in amounts generally known for these agents." Munshi 3:26-
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30; see also Final Action 7 and Ans. 11 (identifying that colorants are
optional in Munshi).
DISCUSSION
We discuss all obviousness rejections together because they were
argued together by Appellant. We conclude the Examiner has established a
prima facie case that the claims would have been obvious over the cited
prior art combinations. We address Appellant's arguments below.
Appellant argues, "Blase [] does not disclose or suggest a dye-free
suspension composition that is substantially free of a reducing sugar. In
fact, Blase [] does not even mention or discuss reducing sugars," and "[i]t is
clear that Blase [] did not contemplate formulating a dye free suspension,
nor did Blase [] understand the detrimental effects that reducing sugars have
on the stability of dye free suspensions." Br. 6. Regarding the "dye-free"
claim element, Appellant contends the Examiner's determination that
colorant/dye is merely optional in the Blase and Munshi formulations is
incorrect because each example in the references includes colorant. Br. 8.
Regarding the "substantially free of a reducing sugar" claim element,
Appellant contends the Blase formulations require high fructose com syrup,
which is a reducing sugar (see Spec. 7:17-8:2), and argue that one of
ordinary skill in the art would not substitute sorbitol or glycerin for such
fructose because the solution could never be sweet enough using reasonable
amounts of the alternative sweeteners. Br. 7. We are not persuaded by these
arguments.
The cited prior art teaches and suggests a dye-free pharmaceutical
formulation. Blase, in describing its most basic invention, disclosed a
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pharmaceutical suspension with several components, none of which was a
dye or coloring. FF 1. It is apparent from the remainder of the Blase
disclosure that including dye is an option, but it is equally apparent from the
full Blase disclosure that it is not required. See FF2 and FF3. Whether each
example provided by Blase includes dye or coloring is not determinative,
because the test of obviousness is "whether the teachings of the prior art,
taken as a whole, would have made obvious the claimed invention." In re
Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991).
Similarly, while each Blase example includes fructose as a sweetener
and Blase identifies fructose as its preferred sweetener, the reference's
disclosure is not so limited. Blase discloses many alternatives to fructose,
including sorbitol and several artificial sweeteners, and it is unquestionable
that the Blase compositions can be free of fructose and free of a reducing
sugar. See FF6-FF9. Appellant's arguments regarding the sweetness of
fructose and that of other Blase-disclosed sweeteners, and the amounts of
each required to provide equivalent sweetness are not persuasive. See Br. 6.
The appealed claims do not recite any specific, required sweetness factor
and Blase expressly discloses suitable amounts of sorbitol or glycerin to be
provided in its pharmaceutical solutions. See FF8.
Appellant contends Kumar teaches away from using the recited
sorbitol because the reference discloses it can cause diarrhea, poor drug
absorption, flatulence, and abdominal pain, in a rationale largely paralleling
that of the Examiner for omitting dye from the pharmaceutical of Blase and
Munshi. Br. 7; see also FFlO and FFl 1 (relevant portions of Kumar). An
important difference between the two positions exists, however, in that Blase
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suggests either including or not including dye, which makes each alternative
obvious, and suggests including sorbitol, which makes using this sweetener
obvious. Therefore, although it might be obvious not to include sorbitol
because it could present adverse effects, it is also obvious to include it
because the Blase reference expressly suggests doing so. The fact that the
use of sorbitol might have some drawbacks is not determinative of
obviousness, as "a given course of action often has simultaneous advantages
and disadvantages, and this does not necessarily obviate motivation to
combine" or to modify or select certain embodiments from the prior art.
Medichem, S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
Finally, Appellant argues Munshi is not relevant because its disclosure
is directed to thixotropic gels rather than liquid suspensions. Br. 7-8. This
is not persuasive.
While Munshi does disclose that its pharmaceutical compositions are
initially thixotropic gels, which may or may not be significantly different
from liquid suspensions (this is not entirely clear because the Specification
only explicitly distinguishes liquid suspensions from emulsions-see Spec.
2: 14--18), the reference also discloses that these gels are "easily convertible
to pourable liquids," which may or may not include suitable optional
ingredients, such as colorants and sweeteners. FF12 and FF13. Appellant
does not address this aspect of Munshi' s disclosure, which refutes her
arguments thereover.
For the above reasons, we find the preponderance of evidence
supports the Examiner's determination of obviousness. We affirm the
rejections.
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SUMMARY
The rejection under 35 U.S.C. § 103(a) over Blase and Kumar is
affirmed.
The rejection under 35 U.S.C. § 103(a) over Blase, Kumar, Munshi,
and Singh is affirmed.
The rejection under 35 U.S.C. § 103(a) over Blase, Kumar, Munshi,
Singh, and Sorrentino is affirmed.
All claims fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
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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