Ex Parte Buehler

Patent Trial and Appeal Board

Dec 19, 2016

10978035 (P.T.A.B. Dec. 19, 2016)

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.
10/978,035 10/29/2004 Gail K. Buehler MCP5046USNP 1836
27777 7590 12/21/2016
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
MAEWALL, SNIGDHA
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/21/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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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. BUEHLER1
Appeal 2015-006492
Application 10/978,035
Technology Center 1600
Before RICHARD M. LEBOVITZ, TAWEN CHANG, 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 APAP suspension. Claims 17—30 and 32—35
are on appeal as rejected under 35 U.S.C. § 103(a) and on the ground of
obviousness-type double patenting. 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. 2 (Appellant did not supply
pagination for her brief; for the purposes of this Decision we apply page
numbers therefor based on counting).
Appeal 2015-006492
Application 10/978,035
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 17, 34, and 35 are the independent claims. Claim 17
is representative and reads as follows:
17. A dye-free APAP suspension, consisting essentially of:
(a) a therapeutically effective amount of APAP;
(b) an effective amount of non-reducing sweetener;
(c) from about 25 to about 60 grams per 100 mL of suspension
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 comprises less than about 4 grams
per 100 mL of suspension of a reducing sugar.
Br. 11 (Claims App’x).
The following rejections are on appeal:
Claims 17—22, 26, 27, 29, 30, 32, and 33 stand rejected under 35 U.S.C.
§ 103(a) over Ratnaraj2 and Munayyer.3 Final Action 2.
2 European Patent Application Pub. No. EP 0 620 001 A1 (published Oct.
19, 1994) (hereinafter “Ratnaraj”).
3 U.S. Patent No. 6,132,758 (issued Oct. 17, 2000, to Farah J. Munayyer et
al.) (hereinafter “Munayyer”).
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Claims 17—30 and 32—35 stand rejected under 35 U.S.C. § 103(a) over
Munshi,4 Kumar,5 and Blase.6 Final Action 5.
Claims 34 and 35 stand rejected under 35 U.S.C. § 103(a) over
Munshi, Kumar, Blase, and Singh.7 Final Action 8.
Claims 17—30 and 32—35 stand provisionally rejected on the ground of
nonstatutory obviousness-type double patenting over claims 1—35 of
copending Application No. 11/457,316.8 Final Action 8.
Claims 17—30 and 32—35 stand provisionally rejected on the ground of
nonstatutory obviousness-type double patenting over claims 1—4, 6—9, 11,
12, 14—19, 24—26, 28, 29, 36, and 37 of copending Application No.
12/782,269.9 Final Action 8.
DISCUSSION
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
4 U.S. Patent No. 4,427,681 (issued Jan. 24, 1984) (hereinafter “Munshi”).
5 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”).
6 U.S. Patent No. 5,409,907 (issued Apr. 25, 1995, to Cynthia M. Blase et
al.) (hereinafter “Blase”).
7 U.S. Patent No. 5,759,579 (issued June 2, 1998) (hereinafter “Singh”).
8 The Final Rejection of all claims of U.S. Patent Application No.
11/457,316 was affirmed by the Board on Oct. 6, 2016. The application was
abandoned on December 7, 2016.
9 The Final Rejection of all claims of U.S. Patent Application No.
12/782,269 was affirmed by the Board on Oct. 28, 2016.
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Application 10/978,035
Answer. The findings of fact set forth below are provided only to highlight
certain evidence of record.
Rejections under 35 U.S.C. § 103(a)
We discuss all obviousness rejections together because they were
argued together by Appellant. We find the Examiner has established a prima
facie case that the claims would have been obvious over the cited prior art
combinations. Appellant has not presented persuasive arguments or
evidence that the Examiner’s determination was incorrect. We address
Appellant’s arguments below.
Appellant argues claim 17 recites “less than about 4 grams per
100 mL of suspension of a reducing sugar,” and that Ratnaraj’s disclosure
indicates its sweetening systems are predominantly comprised of the
reducing sugar high fructose com symp (HFCS), noting Example 1 includes
73% thereof, and urges that “[t]his is contrary to the claimed suspension” as
claimed. Br. 6. This is not persuasive.
Ratnaraj may indicate that HFCS is its preferred sweetener, but it also
discloses many alternatives thereto, including the teaching to replace HFCS
with artificial sweeteners, which are not reducing sugars and, therefore, meet
the disputed claim limitation. Ratnaraj 4:33 44. Even when HFCS is
included in the Ratnaraj suspension, the reference indicates that it may be
present “in the range of from 0 to about 110 grams per 100 mL of the
suspension,” which includes the claimed range of “less than about 4 grams
per 100 mL.” Id. at 4:39. It is well established that, when there is a range
disclosed in the prior art, and the claimed invention overlaps or falls within
that range, there is a presumption of obviousness. In re Peterson, 315 F.3d
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Application 10/978,035
1325, 1329 (Fed. Cir. 2003); Iron Grip Barbell Co. v. USA Sports, Inc., 392
F.3d 1317, 1322 (Fed. Cir. 2004).
Appellant argues Munayyer is not directed to suspensions, but syrups,
and so the reference is not analogous art. Br. 6. This is not persuasive.
The Examiner notes, while Munayyer may be directed to a syrup
rather than a suspension, it is not cited for the form of composition, but for
its disclosure that non-reducing artificial sweeteners, such as sorbitol and
others, can be used in liquid pharmaceutical (oral) formulations in place of
higher caloric sweeteners (e.g., HFCS) for avoidance of dental and medical
problems that can be aggravated by such sweeteners. Ans. 9.
As to Appellant’s argument that Munayyer is not analogous art, “[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). “[I]t is necessary to consider ‘the reality of the
circumstances,’ ... — in other words, common sense—in deciding in which
fields a person of ordinary skill would reasonably be expected to look for a
solution to the problem facing the inventor.” Id. (quoting In re Wood, 599
F.2d 1032, 1036 (CCPA 1979)). Munayyer is directed to (oral) liquid
pharmaceutical formulations while the appealed claims are also (oral)
pharmaceutical formulations. The field of the invention is pharmaceutical
formulations. We have not been directed to persuasive evidence that one of
skill in the art would have been deterred from looking at pharmaceutical
formulations simply because they are not in the form of a suspension as
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required by the claims. The reality of the circumstances and common sense
dictate that Munayyer is analogous art to be considered in analyzing the
obviousness of the claimed subject matter.
Appellant argues if one were to combine Ratnaraj with Munayyer by
substituting the artificial sweetener, e.g., sorbitol solution, of Munayyer for
the HFCS of Ratnaraj, “the resulting composition would likely have a pH
outside the range of about 5 to about 6.” Br. 6—7. Appellant also argues that
such a change “would likely also result in changes to the percentages of
other ingredients in the formulation which would also likely affect the pH.”
Id. at 7.
In response to this argument, the Examiner again (this was also
pointed out in the Final Action at 5) notes Appellant provides no evidence to
support these allegations. Ans. 10. It is well settled that arguments of
counsel cannot take the place of factually supported objective evidence. See,
e.g., In re Huang, 100 F.3d 135, 139-40 (Fed. Cir. 1996); In re De Blauwe,
736 F.2d 699, 705 (Fed. Cir. 1984). In any event, as also noted by the
Examiner, Ratnaraj teaches that the pH of its suspension should be in the 3—
7 range, which tightly bookends the 4—6 pH range recited by claim 17, and
“adjusting pH is a simple and common practice in the pharmaceutical field.”
Ans. 10. See In re Peterson, 315 F.3d at 1329; Iron Grip, 392 F.3d at 1322
for the obviousness of overlapping or encompassed ranges.
Appellant argues Munshi is directed to thixotropic gels, which are
different from liquid suspensions (as claimed). Br. 7. Appellant challenges
the Examiner to provide a basis for the assertion that Munshi’s thixotropic
gels are suspensions. Id. These arguments are not persuasive.
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We note that, while Munshi does disclose its pharmaceutical
compositions are initially thixotropic gels (employing Avicel® as a
suspending agent for the composition), 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.” Munshi abstract, 1:6—7,
1:39-40, 1:49—50, 1:60-61, 1:65—2:3; see also Ans. 11 (discussing same).
Appellant does not address this aspect of Munshi’s disclosure, which refutes
her arguments thereover.
Appellant also argues Munshi’s examples include a colorant, which is
not permissible under claim 17. This is not persuasive.
While Appellant is correct that Munshi’s examples include colorant,
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—30 (emphasis added). This
teaches that each of these ingredients are optional and not mandatory. “But
in a section 103 inquiry, ‘the 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.’” Merck & Co. v. Biocraft
Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In reLamberti, 545
F.2d 747, 750 (CCPA 1976)). Thus, the disclosure of Munshi’s preferred
embodiments as containing dye is not determinative.
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Appellant argues Blase does not disclose dye-free suspensions
substantially free of a reducing sugar; Blase’s preferred sweetener is HFCS,
making it clear the reference does “not contemplate formulating a dye free
suspension” or “the detrimental effects that reducing sugars have on the
stability of dye free suspensions.” Br. 8.
The cited prior art teaches and suggests a dye-free pharmaceutical
formulation. Blase, in describing its most basic invention, disclosed a
pharmaceutical suspension with several components, none of which was a
dye or coloring. 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). 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 Blase 6:5—6, 8:9—13. 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 HFCS as a sweetener
and Blase identifies HFCS as its preferred sweetener, the reference’s
disclosure is not so limited. Blase discloses alternatives to HFCS, including
sorbitol and several non-reducing artificial sweeteners, establishing that the
Blase compositions can be free of fructose and free of a reducing sugar. See
Blase 4:38—60, 6:62—7:10, claim 2. Appellant’s argument that Blase fails to
recognize the significance of how a reducing sugar can affect a dye-free
suspension is not determinative because Blase suggests including as little as
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Application 10/978,035
0 grams of sugar while using suitable artificial sweeteners (Blase 4:50—53,
4:56—63), and the Kumar reference provides explicit reasons to omit dye
from an acetaminophen suspension (Kumar 932 (Table 11)). “In
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee
controls. . . . [A]ny need or problem known in the field of endeavor at the
time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 419-20 (2007).
Appellant argues the Examiner used impermissible hindsight in
formulating the rejections by taking “[bjits and pieces from various
references [] carefully selected to recreate Applicant’s invention.” Br. 8.
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here, the Examiner
has not reached beyond the explicit disclosures of the prior art and, so, no
hindsight was necessary in making the rejections. “[Fjamiliar items may
have obvious uses beyond their primary purposes, and in many cases a
person of ordinary skill will be able to fit the teachings of multiple patents
together like pieces of a puzzle.” KSR, 550 U.S. at 420.
Appellant argues if one were to combine the teachings of Munshi,
Kumar, Blase, and Singh, the resulting composition would be a thixotropic
gel composition that includes reducing sugars and non-reducing sugars, and,
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accordingly, claim 17 is patentable over the proposed combination. This is
not persuasive.
Appellant herself is unreasonably picking and choosing bits and
pieces of the prior art most unlike the appealed claims in making this
argument, while ignoring other portions of the prior art that teach or suggest
the claim elements. The Examiner has explained how the skilled artisan
would reasonably combine the disclosures of these references, incorporating
the suspension taught by Blase to have acetaminophen, xanthan gum, and
microcrystalline cellulose, at a pH of 4—10, while omitting a reducing sugar
in favor of the artificial sweetener of Munshi and omitting the optional dye
because of Kumar’s warning, and also incorporating propylene glycol taught
by Munshi and Singh. Final Action 8—12; Ans. 16.
For the reasons above, we find Appellant’s arguments unpersuasive
and affirm the Examiner’s obviousness rejections.
Obviousness-Type Double Patenting Rejections
As to the rejection over U.S. Patent Application No. 11/457,316,
which was abandoned December 7, 2016, we dismiss the obviousness-type
double patenting rejection as moot. As to the rejection over U.S. Patent
Application No. 12/782,269, which was not argued by Appellant, we
summarily affirm the rejection.
SUMMARY
The rejection of claims 17—22, 26, 27, 29, 30, 32, and 33 under 35 U.S.C.
§ 103(a) over Ratnaraj and Munayyer is affirmed.
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The rejection of claims 17—30 and 32—35 under 35 U.S.C. § 103(a)
over Munshi, Kumar, and Blase is affirmed.
The rejection of claims 34 and 35 under 35 U.S.C. § 103(a) over
Munshi, Kumar, Blase, and Singh is affirmed.
The rejection of claims 17—30 and 32—35 on the ground of
nonstatutory obviousness-type double patenting over claims 1—35 of
Application No. 11/457,316 is dismissed.
Claims 17—30 and 32—35 on the ground of nonstatutory obviousness-
type double patenting over claims 1—4, 6—9, 11, 12, 14—19, 24—26, 28, 29,
36, and 37 of Application No. 12/782,269 is affirmed.
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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