Ex Parte Perovitch et al

Patent Trial and Appeal Board

Oct 15, 2018

13140745 (P.T.A.B. Oct. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/140,745 06/17/2011
23373 7590 10/17/2018
SUGHRUE MION, PLLC
2100 PENNSYLVANIA A VENUE, N.W.
SUITE 800
WASHINGTON, DC 20037
FIRST NAMED INVENTOR
Philippe Perovitch
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.
Ql24406 9481
EXAMINER
MCMILLIAN, KARA RENITA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
10/17/2018 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):
PPROCESSING@SUGHRUE.COM
sughrue@sughrue.com
USPTO@sughrue.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIPPE PEROVITCH and MARC MAURY
Appeal2017-003642
Application 13/140,745
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREYN. FREDMAN, and
DEBORAH KATZ, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2,3 under 35 U.S.C. § 134 involving claims to a
liquid formulation for the buccal transmucosal administration of an anti-
nausea, anti-emetic active ingredient from the setron family. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the joint inventors, Philippe Perovitch and Marc
Maury, as the real party in interest (see App. Br. 2).
2 We have considered and herein refer to the Specification of June 17, 2011
("Spec."); Final Office Action of Feb. 5, 2014 ("Final Act."); Appeal Brief
of Apr. 22, 2016 ("App. Br."); Examiner's Answer of Nov. 3, 2016
("Ans."); and Reply Brief of Jan. 3, 2017 ("Reply Br.").
3 An oral hearing was held on October 9, 2018 but Appellants waived
transcription due to the unavailability of a court reporter.
Appeal2017-003642
Application 13/140,745
Statement of the Case
Background
"Setrons are pharmaceutical active ingredients used mainly for the
prevention or treatment of nausea and vomiting syndromes linked to cancer
therapies. These are powerful lipophilic anti-emetic molecules of low
molecular weight, which operate at central nervous system level as receptor
antagonists" (Spec. 1: 12-17). The "quickest and most effective way to
administer setrons is by intravenous transfusion" but to "protect the veins of
patients, to facilitate taking the medication, and to reduce costs, it is ...
preferable to avoid the intravenous route" (Spec. 1 :34 to 2:7).
"The present invention relates to a formulation for instantaneous
buccal transmucosal systemic administration of at least one active ingredient
belonging to the setron family" (Spec. 1:3---6).
The Claims
Claims 1, 3, 6, 9, and 19 are on appeal. Claim 1 is representative and
reads as follows:
1. A liquid formulation for the buccal transmucosal
administration of an anti-nausea, anti-emetic active ingredient
from the setron family, wherein the formulation is a solution
having a pH in the range 5.0 to 9.0 and combining:
· an active ingredient from the setron family in base
and/ or salt form; and
· a hydroalcoholic solution consisting of water and
ethanol, titrating from 40° to 70° alcohol, in which said active
ingredient is present in a stable and completely dissolved state,
wherein said formulation contains 2 mg to 8 mg of active
ingredient in 0.5 to 2 mL of hydroalcoholic solution,
2
Appeal2017-003642
Application 13/140,745
wherein all of the active ingredient passes passively
through the buccal mucosa within 6 seconds of administration,
and
wherein said hydroalcoholic solution is the only solvent
of said formulation.
The Issues
A. The Examiner rejected claims 1, 6, and 9 under 35 U.S.C. § I02(a) as
anticipated by Krishnaiah4 (Ans. 2-7).
B. The Examiner rejected claims 1, 3, 6, 9, and 19 under 35 U.S.C.
§ I03(a) as obvious over Heit5 (Ans. 7-11).
A. 35 U.S.C. § 102(a) over Krishnaiah
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Krishnaiah anticipates claim
1?
Findings of Fact
1. Krishnaiah teaches "a menthol-based transdermal therapeutic
system for ondansetron hydrochloride" (Krishnaiah 228, col. 1 ).
2. Krishnaiah teaches: "Ondansetron hydrochloride is a novel and
specific antagonist of 5-HT 3 receptor indicated for the treatment of
chemotherapy induced nausea and vomiting in patients with cancer"
(Krishnaiah 228, col. 1 ).
4 Krishnaiah et al., Penetration-Enhancing Effect of Ethanolic Solution of
Menthol on Transdermal Permeation of Ondansetron Hydrochloride Across
Rat Epidermis, 15 DRUG DELIVERY 227-34 (2008).
5 Heit et al., US 2006/0239928 Al, published Oct. 26, 2006.
3
Appeal2017-003642
Application 13/140,745
3. Krishnaiah teaches the "recommended oral dosing regimen of
ondansetron hydrochloride for emeogenic neoplastic agents is 8 mg"
(Krishnaiah 228, col. 1 ).
4. Table I of Krishnaiah is reproduced below:
TABLE.!
Coinpositinn of HPC gid drug reservoir containing ondansetron
hydrochlorhk and selected concentrnlions of mt::r1thol
Ingredients
Ondan;,,etron hydrochloride
I'vlen!hol
HPC
Eihanol fo{F.{vlv} q.s.
Quantity present in the
HPC drug reservoir
fornmbtion { q .. ,v/v,,,.•)
1 n
15 LS
0 2
100 100
HI
l.5
4
2
100
J\/
L5
i.'
')
lOO
HPC = hydroxypropyl cellulose.
V
L5
10
100
Table I of Krishnaiah teaches a composition, identified as "I", that comprises
1.5 % w/w of the ondansetron hydrochloride salt in a hydroalcoholic
solution that is 60% v/v ethanol that contains 2 % w/w HPC (Krishnaiah
228, col. 2).
5. Krishnaiah teaches for preparation of the drug reservoir:
Ethanol and water were mixed in different ratios so as to obtain
binary solvent systems of 20:80 v/v, 40:60 v/v or 60:40 v/v of
ethanol in water. The composition of the drug reservoir (2%
w/w HPC gel) containing selected concentrations of menthol
was given in Table 1. The HPC powder was added to 60% v/v
ethanol-water solvent system while being stirred by means of a
stirrer (Mis Remi Motors, India) at 2,500 rpm and the resulting
mixture was mixed continuously at 37QC until the gel was
formed (1 h). Ondansetron hydrochloride and menthol, in the
required quantity, were added to HPC gel and mixed well for
4
Appeal2017-003642
Application 13/140,745
complete dissolution. The drug reservoir formulations were left
overnight at room temperature (28 to 30QC).
(Krishnaiah 228, col. 2).
6. Krishnaiah teaches for permeation studies that: "Two grams of
the drug reservoir formulation or 2 ml of drug solution containing 30 mg of
ondansetron hydrochloride, was placed in the donor cell" (Krishnaiah 229,
col. 1 ).
7. The Examiner finds Krishnaiah's composition I inherently
comprises "a pH in the range of 5.0 to 9.0" (Ans. 4).
Principles of Law
The Examiner bears the initial burden of establishing a prima facie
case of anticipation. In re King, 801 F.2d 1324, 1326-27 (Fed. Cir. 1986).
Anticipation under 35 U.S.C. § 102 requires that "'each and every element
as set forth in the claim is found, either expressly or inherently described, in
a single prior art reference."' In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
1999).
Analysis
Appellants contend Krishnaiah "require[ s] hydroxypropyl cellulose
(HPC) for their transdermal administration of ondansetron"; teaches "a
transdermal formulation with a maximum transdermal flux of 77 .85
µg/cm2/hour ... This would require more than 20 hours to administer a
dosage of 2 mg"; and "teach a gel for their transdermal formulation" (App.
Br. 11, 14, 1 7; emphasis omitted).
The Examiner finds Krishnaiah "demonstrates the solubility of
ondansetron hydrochloride in various ethanol-water cosolvent systems and
ethanol or water alone as shown in Table 2 (see page 230). There is
5
Appeal2017-003642
Application 13/140,745
absolutely no teaching therein which suggests that HPC is included in these
formulation[s]" (Ans. 13). The Examiner further contends Krishnaiah
"discloses a composition comprising the same ingredients as claimed in the
instant application ... and as such any composition disclosed in the prior art
comprising the same ingredients as claimed will meet the limitations of the
claims even if the intended use is not specifically disclosed in the prior art"
(id.).
We agree with Appellants. Krishnaiah does not teach a composition
that lacks HPC, but rather teaches regarding Table 1 that HPC was added to
the ethanol-water solvent system "until a gel was formed" and only then was
the ondansetron "added to the HPC gel" (FF 5).
Krishnaiah also teaches that the permeation studies shown in Figure 1
used "[t]wo grams of the drug reservoir formulation or 2 ml of drug solution
containing 30 mg of ondansetron hydrochloride" (FF 6). As already noted,
the reservoir solution contains HPC (FF 5) and there is no indication that the
drug solution was a different composition than the drug reservoir
formulation.
Even if we agreed with the Examiner that the composition used in
Figure 1 lacked HPC and was in liquid form, Figure 1 shows a drug flux that
required hours for delivery of the ondansetron, a time frame excluded by the
limitation in claim 1 requiring that "wherein all of the active ingredient
passes passively through the buccal mucosa within 6 seconds of
administration."
We are not persuaded by the Examiner's inherency argument because
"[i]nherency ... may not be established by probabilities or possibilities. The
mere fact that a certain thing may result from a given set of circumstances is
6
Appeal2017-003642
Application 13/140,745
not sufficient." MEHL/Biophile Int'!. Corp. v. Milgraum, 192 F.3d 1362,
1365 (Fed. Cir. 1999). In this case, the Examiner has not established that a
solution identical to that recited by claim 1 was created by Krishnaiah which
had the same amount of active setron agent in the hydroalcoholic solution,
the same pH, in liquid form.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Krishnaiah anticipates claim 1.
B. 35 U.S.C. § 103(a) over Heit
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Heit renders claim 1 obvious?
Findings of Fact
8. Heit teaches "transmucosally administering a prophylactically
or therapeutically effective amount of one or more active agents to an animal
in need thereof. Preferred administering means include, but are not limited
to, sprays or mists of the one or more active agents into the oral cavity of the
animal" (Heit ,r 2).
9. Heit teaches a spray composition "(i.e., propellant free
composition), for transmucosal administration of a pharmacologically active
agent soluble in a pharmacologically acceptable polar solvent comprises in
weight % of total composition: aqueous polar solvent from about 30 to about
99.69%, active agent from about 0.001 to about 60%" (Heit ,r 186).
10. Heit teaches a "preferred polar solvent is aqueous ethanol"
(Heit ,I 128).
7
Appeal2017-003642
Application 13/140,745
11. Heit teaches: "Non-limiting examples of suitable anti-emetic
agents include ... 5HT -3 receptor antagonists such as ondansetron,
granisetron, tropisetron, dolasetron, hydrodolasetron, azasetron, ramosetron,
lerisetron, indisetron and palonosetron" (Heit ,r 141 ).
12. Heit teaches
assays may optionally be employed to help identify optimal
dosage ranges. The precise dose to be employed in the
compositions may also depend on the route of administration
and the seriousness of the disease, disorder, or condition and on
the animal being treated, and should be decided according to
the judgment of the practitioner and each animal's particular
circumstances.
(Heit ,I 169).
13. Heit teaches: "Suitable dosage ranges for transmucosal
administration to the oral mucosa are generally from about 0.001 milligram
to about 200 milligrams of a non-steroidal anti-inflammatory agent of the
invention per kilogram body weight" (Heit ,r 191 ).
14. Heit teaches: "To administer a transmucosal oral mist, the
commissure of the animal's ... lips will be grasped ... opening the
buccal space. The mist is typically directed caudally and towards the
gingival and/or buccal mucosal surfaces" (Heit ,r 174).
15. Heit teaches that: "If the dose is greater than about 3 00 to about
500 micro liters, the dose may be split between both sides of the mouth"
(Heit,I 174).
16. Heit teaches the "compositions, if desired, can also contain
minor amounts of ... pH buffering agents" (Heit ,r 127).
17. Heit teaches the transmucosal methods provide a "shorter time
frame needed to achieve maximum plasma concentration and greater
8
Appeal2017-003642
Application 13/140,745
bioavailability may be provided by the compositions and methods of the
invention" (Heit ,r 63).
18. Heit teaches: "Transmucosal administration of the active agent
compositions of the invention preferably exhibits increased bioavailability,
requires smaller doses, and exhibits shorter time to reach maximum plasma
concentration after administration" (Heit ,r 153; emphasis added).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 7-11; FF 8-18) and agree that the
claims are obvious over Heit. We address Appellants arguments below.
Appellants contend "Heit et al. contains extremely generic paragraphs
filled with laundry lists of possible components. Further, Heit et al. provide
no particular guidance for how to prepare a suitable transmucosal
formulation for any of the disparate active ingredients, except for the few
examples set forth in the reference" (App. Br. 22). Appellants contend
(Id.).
Heit et al. do not even disclose any examples that employed an
active ingredient from the setron family. Heit et al. 's failure to
provide specific guidance regarding the preparation of a
formulation for setrons is particularly significant given that
using this route for delivering an active ingredient in the setron
family was not obvious.
We do not find the "laundry list" argument persuasive. Simply
because Heit "discloses a multitude of effective combinations does not
9
Appeal2017-003642
Application 13/140,745
render any particular formulation less obvious." Merck & Co. v. Biocraft
Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). In Corkill, an obviousness
rejection was affirmed in light of prior art teachings that "hydrated zeolites
will work" in detergent formulations, even though "the inventors selected
the zeolites of the claims from among 'thousands' of compounds." In re
Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Here, Heit teaches buccal transmucosal administration of drugs (FF 8,
9, 14) including a variety of setron family drugs (FF 11) in a hydroalcoholic
solution with ethanol as the preferred solvent (FF 9, 10) in overlapping
dosages of drug (FF 13), overlapping volumes of administration to the
buccal mucosa (FF 15) in a pH buffered solution (FF 16). Such "picking
and choosing may be entirely proper in the making of a 103, obviousness
rejection." In re Arkley, 455 F.2d 586, 587 (CCPA 1972). We also agree
with the Examiner that an ordinary "artisan would be able to clearly
envisage Applicant's claimed compound from the list of preferred active
agents since the genus is limited, thus very few combinations can be
obtained (see abstract and claim 6)" (Ans. 17).
Appellants contend "there are no examples in Heit et al. that
employed a setron. Further, there is no disclosure in Heit et al. that provides
some form of teaching regarding a suitable composition for delivering a
setron via transmucosal administration" (App. Br. 23). Appellants also
contend "none of the examples of Heit et al. employed a hydroalcoholic
solution consisting of water and ethanol, titrating from 40° to 70° alcohol,
wherein the hydroalcoholic solution was the only solvent in the formulation"
(App. Br. 24).
10
Appeal2017-003642
Application 13/140,745
We find this argument unpersuasive because "a reference is not
limited to the disclosure of specific working examples." In re Mills, 470
F .2d 649, 651 (CCP A 1972). Heit teaches and claims ondansetron
compositions for buccal administration (FF 8, 11; see Heit 29, claims 1, 4,
6). Heit further teaches overlapping ranges of alcohol concentrations (FF 9).
In cases involving overlapping ranges, we and our predecessor
court have consistently held that even a slight overlap in range
establishes a prima facie case of obviousness ... The normal
desire of scientists or artisans to improve upon what is already
generally known provides the motivation to determine where in
a disclosed set of percentage ranges is the optimum
combination of percentages.
In re Peterson, 315 F.3d 1325, 1329, 1330 (Fed. Cir. 2003). Heit provides a
reason to optimize the composition and expressly teaches to "identify
optimal dosage ranges" (FF 12). Heit provides reasons to optimize for rapid
delivery, teaching that a "shorter time frame needed to achieve maximum
plasma concentration and greater bioavailability may be provided by the
compositions and methods of the invention" (FF 17, cf FF 18).
Appellants contend
claim 1 further requires that all of the 2 to 8 mg of the setron
must pass through the buccal mucosa within 6 seconds. Heit al.
cannot inherently disclose this element of the claims for a
number of reasons. For example, Heit et al. do not specifically
address this type of rapid delivery of the active ingredient.
Instead, Heit et al. repeatedly refers to "minutes," and never
refers to administration within seconds. This is most likely,
among other reasons, because Heit et al. are directed to
formulations to be delivered by spraying. Appellants addressed
the drawbacks with this type of approach.
(App. Br. 25).
11
Appeal2017-003642
Application 13/140,745
We find this argument unpersuasive for two reasons. First, we agree
with the Examiner that Heit "teaches the same transmucosal administration
of active ingredients including ondansetron, and thus an ordinary skilled
artisan would necessarily arrive at the exact amounts of ondansetron and
aqueous ethanol as claimed in the instant application since the intended
purpose of providing a composition by transmucosal administration is the
same" (Ans. 20). That is, the optimized liquid ondasetron formulation in a
hydroalcoholic solution for buccal administration rendered obvious by Heit
(FF 9-17) would have reasonably shared the inherent property of passive
administration within six seconds as required by claim 1. As noted in Best,
Where, as here, the claimed and prior art products are identical
or substantially identical ... the PTO can require an applicant
to prove that the prior art products do not necessarily or
inherently possess the characteristics of his claimed product. ..
. Whether the rejection is based on 'inherency' under 35 U.S.C.
§ 102, on 'prima facie obviousness' under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO' s inability to manufacture
products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Appellants provide no
evidence that any of the liquid formulations of Heit, administered by the
buccal transmucosal route directly as preferred by the Specification
(compare Spec. 4:20-15 to 5:9-14), rather than as a spray or oral mist as
taught by Heit (see Heit ,r,r 266, 270, 278, etc.), would not satisfy the 6
second functional requirement of claim 1.
Second, while we agree that the recitation "wherein all of the active
ingredient passes passively through the buccal mucosa within 6 seconds of
administration" limits claim 1, the limitation relies upon a particular
intended administration mode. That is, claim 1 is a product claim and the 6
12
Appeal2017-003642
Application 13/140,745
second limitation represents an intended delivery mode for the liquid
formulation. The 6 second limitation does not impose any particular
structural limitation on the liquid formulation itself. A "mere statement of a
new use for an otherwise old or obvious composition cannot render a claim
to the composition patentable." In re Zierden, 411 F.2d 1325, 1328 (CCPA
1969).
Appellants rely upon the Maury Declaration, 6 which states "the
claimed formulation is not a simple matter of optimization" (Maury Deel.
,r 17). Appellants contend the Maury "Declaration explained that the
claimed rapid absorption-within 6 seconds-of all of the active
ingredient is only possible with the specific claimed formulation"
(App. Br. 26).
Appellants contend
the claimed formulation is not a simple matter of optimization,
but instead provides a very specific combination of features to
obtain a huge benefit to the patient. Furthermore, Heit et al. do
not provide a person of ordinary skill in the art with any
information to obtain or arrive at the claimed formulation
having the claimed rate of administration.
(App. Br. 27).
We find these arguments and Declaration unconvincing because there
is no persuasive evidence rebutting the express statement of Heit that
dosages may be optimized (FF 12) and teachings of overlapping ranges of
the components (FF 9-16). Claim 1 broadly encompasses a wide range of
6 Declaration of Dr. Marc Maury, dated June 27, 2014.
13
Appeal2017-003642
Application 13/140,745
hydroalcoholic solutions from 40Q to 70Q alcohol7 that significantly overlaps
the 30 to about 99.69% range for alcohols disclosed by Heit (FF 9). "In fact,
when, as here, the claimed ranges are completely encompassed by the prior
art, the conclusion is even more compelling than in cases of mere overlap."
Peterson, 315 F.3d at 1330. We have considered Dr. Maury's statements
along with the express teachings of Heit, but find them unpersuasive because
no criticality or unexpected results are demonstrated for the somewhat
smaller range of ethanol concentrations. See In re American Academy of
Science Tech Center, 367 F.3d 1359, 1370 (Fed. Cir. 2004) ("[T]he Board is
entitled to give such weight to declarations as it deems appropriate.")
Indeed, when Appellants contend that the examples of Heit were
"either below or above the claimed range of 40° to 70°", Appellants fail to
take the next step and provide experimental evidence showing that these
compositions would not have inherently resulted in rapid absorption within 6
seconds when administered as directed by the Specification. While Heit's
use of different administration modes, either oral or spray, fail to achieve
this absorption, claim 1 is a product claim, not a method claim. To the
extent that the 6 second limitation imposes a particular administration mode,
Appellants provide no evidence that Heit's compositions, when so
administered, would not satisfy the rapid absorption requirement.
Appellants contend that "absent any guidance in Heit et al., it would
have required lengthy and costly experimentation to obtain efficient
formulations. This is clearly undue and unreasonable experimentation,
7 The Reply Brief notes that "40° ethanol is equal to 33.4% ethanol and that
titrating 70° ethanol is equal to 62.5% ethanol" (Reply Br. 6-7).
14
Appeal2017-003642
Application 13/140,745
which demonstrates that Heit et al. do not suggest or enable the claimed
formulation" (App. Br. 29; cf App. Br. 28).
We are not persuaded because attorney argument is not evidence,
even calculations that "formulation experiments for all said 46 active
ingredients would require 7 x 46 = 322 months-27 years" (App. Br. 28).
Moreover, Appellants do not establish, with evidence, any of the underlying
presumptions of this calculation (see App. Br. 28). See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take
the place of evidence."). See also In re De Blauwe, 736 F.2d 699, 705 (Fed.
Cir. 1984) (Arguments and conclusions unsupported by factual evidence
carry no evidentiary weight.)
Nor do Appellants provide evidence to establish that the ordinary
artisan, using Heit's guidance as a roadmap, would have required undue
experimentation based on the Wands factors. See In re Wands, 858 F.2d
731, 737 (Fed. Cir. 1988). There is no evidence of unpredictability in this
highly skilled art with detailed guidance provided by Heit (FF 9-17). See
Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1386 (Fed. Cir.
2013) ("a considerable amount of experimentation is permissible," as long as
it is "merely routine" or the disclosure "'provides a reasonable amount of
guidance' regarding the direction of experimentation" (quoting Johns
Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360-61 (Fed. Cir. 1998)).
Here, Heit provides guidance regarding selection of the amount and type of
active agent, the amount and type of solvent, and specifically teaches liquid
formulations for buccal transmucosal administration that may include
setrons in ethanol based hydroalcoholic solutions (FF 9-17).
15
Appeal2017-003642
Application 13/140,745
Appellants also contend a "person of ordinary skill in the art would
appreciate that a sprayable formulation, as is disclosed by Heit et al., will be
mainly swallowed. This makes it impossible to have all of the active
ingredient pass through the mucosa. Accordingly, no evidence is needed to
confirm Appellants' assertion" (Reply Br. 7-8).
We find this argument unpersuasive for two reasons. First, mere
assertions are not evidence. De Blauwe, 736 F.2d at 705. Second, this
argument imposes a requirement not present in claim 1, the mode of
administration of the formulation, because claim 1 is limited to the product,
not the method of administration. The issue is not whether Heit, when
administered as a spray, satisfies the requirements of the claim, but rather
whether the composition of Heit when administered as a liquid to the buccal
mucosal surfaces, necessarily has complete passage of active agent "through
the buccal mucosa within 6 seconds" as required by claim 1. The Examiner
has reasonably shifted the burden, under Best, to Appellants to demonstrate
that Heit would not inherently satisfy this requirement when administered in
the same way as Appellants, and Appellants have provide no such evidence.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that Heit
renders claim 1 obvious.
SUMMARY
In summary, we reverse the rejection of claims 1, 6, and 9 under
35 U.S.C. § 102(a) as anticipated by Krishnaiah.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Heit. Claims 3, 6, 9, and 19 fall with claim 1.
16
Appeal2017-003642
Application 13/140,745
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
17