Ex Parte Murty et al

Patent Trials and Appeals Board

Jun 25, 2019

14821039 - (D) (P.T.A.B. Jun. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/821,039 08/07/2015
1009 7590 06/27/2019
KING & SCHICKLI, PLLC
800 CORPORATE DRIVE, SUITE 200
LEXINGTON, KY 40503
FIRST NAMED INVENTOR
Santos B. Murty
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.
1907-002 CIP III 1716
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
06/27/2019 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):
uspto@iplawl.net
laura@iplawl.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte SANTOS B. MURTY and RAM B. MURTY
Appeal2019-000845
Application 14/821,039
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
VALEK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants submit this appeal 1 under 35 U.S.C. § 134 involving
claims to a composition administered to the gastrointestinal system as a
dosage form of cannabinoids and/or standardized marijuana extracts in a
self-emulsifying vehicle, 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 Murty Pharmaceuticals, Inc.
Appeal Br. 3. Herein we refer to the Office Action mailed Nov. 3, 2017
("Non-Final Act."), Appeal Brief filed May 31, 2018 ("App. Br."),
Examiner's Answer mailed Sept. 14, 2018 ("Ans."), and Reply Brief filed
Nov. 13, 2018 ("Reply").
Appeal2019-000845
Application 14/821,039
STATEMENT OF THE CASE
Claims 1 and 3-20 are on appeal. Claims 1, 18, and 20 are
independent claims. Claim 1 is representative and reads as follows:
1. A composition administered to the gastrointestinal system as
a dosage form of cannabinoids and/or standardized marijuana
extracts in a self-emulsifying system operable to avoid hepatic
first pass metabolism via targeted chylomicron/lipoprotein
delivery, thereby promoting lymphatic transport, comprising:
(a) about 1 to 60 wt% of a pharmacologically active form
of cannabinoids and/or standardized marijuana extracts;
(b) an oily medium consisting of: (i) about 15 to 35 wt%
of one or more triglycerides formed from long chain fatty
having from C13 to C24 carbon atoms; and (ii) about 15 to 35
wt% of one or more mixed glycerides formed from long chain
fatty having from C13 to C24 carbon atoms; and (iii) one or more
free fatty acids formed from unesterified long chain fatty acids
having from C13 to C24 carbon atoms; and
( c) about 10 to 60 wt% of a surfactant which promotes
self-emulsification.
App. Br. 22.
Appellants seek review of the following rejections:
I. Claims 1, 3, and 5-20 under 35 U.S.C. § 103 as unpatentable over
Peresypkin, 2 Whittle, 3 and Gao4; and
II. Claim 4 under 35 U.S.C. § 103 as unpatentable over Peresypkin,
Whittle, and Gao, and Schwarz. 5
2 Andrey V. Peresypkin et al., US 2007/0298099 Al, published Dec. 27,
2007 ("Peresypkin").
3 Brian A. Whittle et al., US 6,730,330 B2, issued May 4, 2004 ("Whittle").
4 Ping Gao et al., US 2002/0119198 Al, published Aug. 29, 2002 ("Gao").
5 Joseph Schwarz, US 2005/0037073 Al, published Feb. 17, 2005
("Schwarz").
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Application 14/821,039
Appellants do not argue dependent claims 3, 5-14, 17, and 19 separately
from their respective independent claims so those claims stand or fall with
claims 1, 18, and 20. 37 C.F.R. § 41.37 (c)(l)(iv). Appellants present an
additional argument pertaining to the "viscosity modifying agents"
limitation of claims 15 and 16, which we address separately below.
The issue for each rejection is: Does the preponderance of evidence
of record support Examiner's conclusion that the cited prior art renders
obvious the claimed compositions?
Findings of Fact
FF 1. Peresypkin teaches a "self-emulsifying or self-microemulsifying
composition comprising 1) Compound I; 2) a surfactant having an HLB of 1
to 8; and 3) a surfactant having an HLB of over 8 to 20; and optionally, 4) a
digestible oil and/or cosolvent and/or antioxidant or preservative."
Peresypkin Abst. Compound I is "N-[1 S,2S]-3-( 4-chlorophenyl)-2-(3-
cyanophenyl)-1-methylpropyl]-2-methyl-2-{[5-trifluoromethyl]pyridine-2-
yl}oxy}propanamid," which Peresypkin describes as an "inverse agonist of
the Cannabinoid-1 (CBI) receptor." Id. Abst., ,r 7. Peresypkin teaches that
Compound I has "low aqueous solubility (<0.4 µg/ml)" and "[w]hen dosed as
a crystalline solid ... was found to be very poorly orally bioavailable ...
even when surfactant was included in the formulation to increase in vivo
solubility." Id. ,r,r 6, 10, 79. According to Peresypkin, "oral bioavailability
[ of Compound I] is surprisingly increased dramatically by using a liquid-
filled capsule dosage form" taught therein. Id. ,r 6.
FF2. Peresypkin teaches that the digestible oil in its compositions "acts as a
solvent for Compound I" and "disperses to form the ( emulsifiable) oil droplet
phase once the pre-concentrate has been added to water." Peresypkin ,r 31.
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Peresypkin teaches that "[ s ]uitable digestible oils or fats (liquid or semi-solid
vehicles), which can be used alone as the vehicle or in a vehicle which
includes a digestible oil as part of a mixture, include ... long chain
triglycerides (LCT, C 14-C20), and mixtures of mono-, di-, and triglycerides,
or lipophilic derivatives of fatty acids such as esters with alkyl alcohols." Id.
,r 37. Peresypkin teaches that the delivery vehicle may additionally contain a
lipophilic solvent such as "polyol esters of fatty acids" or "oleic acid." Id. ,r
38.
FF3. Peresypkin teaches that the surfactant in its composition promotes
self-emulsification. See Peresypkin ,r 32. In particular, Peresypkin teaches
that "[t]he presence of one or more surfactants can, upon contacting the
pharmaceutical composition with water, yield an emulsion that ... is
generated in vivo by contacting the aqueous fluids of the gastrointestinal
tract." Id. ,r 28. Peresypkin further teaches that the combination of a low
HLB surfactant and a high HLB surfactant in such formulations provides
"superior emulsification." Id. ,r 34. According to Peresypkin, the formation
of such emulsions "can improve bioavailability and may reduce the food
effect in man (i.e., the effect of food upon absorption and/or bioavailability of
a drug)." Id. ,r 28.
FF4. Peresypkin teaches that "[t]he ratio of Compound I, surfactants,
digestible oils, and/or cosolvents depends upon the efficiency of
emulsification and the solubility, and the solubility depends on the dose per
capsule that is desired." Peresypkin ,r 46. Peresypkin teaches that one "class"
of formulations having "advantageous bioavailability are those wherein the
ratio of components are: 0.01-25% Compound I; 0-70% digestible oil; 0-
50% high HLB surfactant; 0-70% low HLB surfactant." Id.
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FF5. Whittle teaches that cannabinoids, such as tetrahydrocannabinol, are
lipophilic and "have very low solubility in aqueous excipients." Whittle col.
2, 11. 20-21, col. 3, 11, 29-32. According to Whittle, the "highly non-polar
solvents" in which cannabinoids are soluble may not be "pharmaceutically
acceptable" and "impose[] a ceiling on the dose which can be given using
conventional pharmaceutical methods of formulation." Id. at col. 3, 11. 16-
25. To address these issues, Whittle teaches "formulation of a cannabinoid in
a matrix which contains at least one self-emulsifying surfactant" that "results
in the generation of an oil in water (o/w) emulsion." Id. at col. 3, 11. 33-37.
Whittle teaches that the "matrix may further comprise one or more
viscolising agents (agents which increase viscosity)." Id. at col. 2, 11. 8-10.
FF6. In addition to examples intended for sublingual and buccal
administration, Whittle, in Example 8, teaches "a soft gelatin capsule which
can be crushed to release the medicament to give an emulsion." Whittle col.
7, 11. 60-62. According to Whittle, this "capsule provides an emulsified form
of medicament which can be absorbed from any part of the GI tract." Id. at
col. 7, 11. 64---66.
FF7. Gao also describes a "self-emulsifying formulation" that "is useful for
administering extremely water-insoluble active agents." Gao ,r 14. Gao
teaches "[t ]he addition of a fatty acid" to improve "solubility" and "prevent[]
or eliminate[] phase separation [ of] the components" in such formulations.
Id. ,r,r 27, 29. Gao teaches that "fatty acids, preferably containing about 6 to
22 carbon atoms, are suitable" and that the "amount of fatty acid preferably
comprises about 5 wt.% to about 35 wt.% of the formulation." Id. ,r,r 27, 30.
FF8. Schwarz discloses a "solid self-emulsifying dosage form for improved
delivery of poorly soluble hydrophobic compounds." Schwarz title. Schwarz
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teaches that the combination of microcrystalline cellulose and a silicate-type
sorbent in such compositions "resulted in a preparation with good
flowability, without water granulation, avoid[ ed] oil leakage during tableting,
and yielded tablets with high hardness and excellent friability." Id. ,r 46. In
Example 2, Schwarz describes a self-emulsifying compositions comprising
10.59% magnesium aluminum silicate and 17.65% microcrystalline cellulose.
Id. ,I 58.
ANALYSIS
I. Obviousness rejection of claims 1, 3, and 5-20 over Peresypkin,
Whittle, and Gao
Examiner finds that Peresypkin teaches a "lipophilic self-emulsifying
delivery vehicle" as recited in claim 1, but with a different hydrophobic
active agent. See Non-Final Act. 4--5. Examiner determines it would be
prima facie obvious to use Peresypkin's vehicle to deliver "other
hydrophobic active agents such as cannabidiol and THC, particularly to
improve drug solubility and bioavailability, particularly as Whittle teaches
that cannabidiol (a hydrophobic active agent) can be incorporated with self-
emulsifying lipophilic delivery vehicles." Id. at 5-6. According to
Examiner, one of skill would reasonably expect this combination to be
successful because Peresypkin teaches that its vehicle "improve[ s] solubility
and bioavailability" of a hydrophobic drug and "Whittle teaches
hydrophobic poorly soluble drugs such as cannabidiol" can be effectively
"delivered with self-emulsifying vehicles." Id. at 6. With regard to the
weight percentage ranges in claims 1, 18, and 20, Examiner finds that "the
modified Peresypkin [i.e., Whittle' s cannabidiol in place of the active agent
in Peresypkin' s self-emulsifying vehicle] teaches overlapping ranges,"
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thereby establishing a prima facie case of obviousness. Id. at 8; see also
Ans. 5.
Appellants argue that Peresypkin does not "either alone or in
combination with any of the cited reference, even remotely contemplate the
optimal ranges" in the independent claims. App. Br. 12. Appellants further
contend that Peresypkin does not teach a cannabidiol, but rather "teaches
only multiple compositions" comprising Compound I ( which Appellants
refers to as the "Propanamide Compound") as the active ingredient. Id. at
14. As for Whittle, Appellants argue that "[t]he only example ... that even
remotely contemplates gastro-intestinal administration of a medicament for
cannabinoids via an emulsifier is Example 8" and that the Declaration of
Santos B. Murty dated July 12, 2012 ("Murty Declaration") demonstrates
that Whittle Example 8 "does not self-emulsify whatsoever." Id. at 12, 17.
Finally, Appellants urge in the Reply Brief that "Examiner's reasoning for
combining the Peresypkin and Whittle references" is "unsupported and
vague" and "does not qualify as an articulated reason for combining the
references." Reply Br. at 3--4 ( emphasis in original).
We are not persuaded by Appellants' arguments and agree with
Examiner's statement of the rejection and responses to Appellants'
arguments in the Answer and Non-Final Action, which we adopt and
incorporate by reference. We further address Appellants' arguments below.
At the outset, we agree that Examiner has articulated a sufficient
rationale for the stated combination of Peresypkin' s self-emulsifying vehicle
with Whittle's cannabinoid active agent. 6 As Examiner observed,
6 Contrary to Appellant's characterization, Examiner's rationale for this
combination has not "evolved" during the course of this appeal. Reply Br.
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Peresypkin teaches a "lipophilic self-emulsifying delivery vehicle" for the
delivery of a hydrophobic compound (Compound I) that is described as
having poor oral bioavailability in non-emulsified forms. Non-Final Act. 5;
FF 1. Whittle teaches that cannabinoids face the same problem (low
solubility/bioavailability) as the drug in Peresypkin and proposes the same
general approach to address that problem (administration in an oil-in-water
emulsion) that Peresypkin teaches is accomplished by its delivery vehicle.
See FF5. Thus, the record supports Examiner's determination that the use
Peresypkin's self-emulsifying delivery vehicle to deliver a cannabinoid to
the gastrointestinal system would be obvious to a skilled artisan.
We are not persuaded by Appellants' argument that Examiner's
rationale is too "vague" or "generic" to support the rejection. See Reply Br.
3--4. Contrary to Appellants' characterization, Examiner's rejection is not
based solely on a generic finding that Whittle and Peresypkin both teach
hydrophobic, water insoluble drugs. Id. In addition to the fact that the
references' active agents share similar physical properties, the rejection is
premised on Whittle' s teaching that it is beneficial to administer the claimed
active agent (i.e., a cannabinoid) in an oil-in-water emulsion combined with
Peresypkin's teaching that its delivery vehicle is effective to form such
emulsions in the gastrointestinal tract. See Non-Final Act. 5---6. Thus, there
is evidence specific to cannabinoids in the record demonstrating a rationale
to administer such to the gastrointestinal tract in a self-emulsifying vehicle.
We are not persuaded by Appellants' argument that Whittle is
primarily directed to cannabinoid emulsions in sublingual and buccal
3. Examiner articulated the same reasoning in the earlier office action. See
Non-Final Act. 5---6.
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delivery systems. See App. Br. 12. As Appellants concede, Whittle also
teaches a capsule embodiment that is administered orally to "provide an
emulsified form of medicament" for absorption in the gastrointestinal tract
in Example 8. See FF6. Thus, Whittle specifically teaches that the benefits
of delivering cannabinoids in an emulsion extends to oral delivery systems.
We further determine that Examiner has demonstrated a prima facie
case of obviousness for the weight percentage ranges in claims 1, 18 and 20.
Peresypkin teaches weight percentage ranges for its active agent (0.01-25%),
digestible oil (0-70% ), and surfactants (0-50% high HLB, 0-70% low HLB)
that substantially overlap with ranges for the cannabinoid ( 1-60% ), oils (3 0-
70% 7), and surfactant (10-60%) in claims 1, 18 and 20. See FF4. Our
reviewing court has "consistently held that even a slight overlap in range
establishes a prima facie case" and that a prima face case also "exists when
the claimed range and the prior at range do not overlap but are close enough
such that one skilled in the art would have expected them to have the same
properties." In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). We
agree with Examiner that the overlapping ranges in Peresypkin are sufficient
to establish a prima facie case of obviousness for the claimed ranges.
To the extent Appellants contend that the Murty Declaration
demonstrates the criticality of the claimed ranges or otherwise rebuts
Examiner's prima facie obviousness case, we disagree. The Murty
Declaration purports to show that the capsule composition in Whittle
Example 8 does not form an emulsion, whereas the composition in Example
7 This range is the sum of the "about 15 to 35 wt% of one or more
triglycerides" and "about 15 to 35% wt% of one or more mixed glycerides"
recited in claims 1, 18, and 20.
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15 of the Specification does. 8 See generally Murty Deel. at 6-8. Even if
this is true, Appellants' evidence is not sufficient to overcome Examiner's
prima facie showing for two reasons. First, the Murty Declaration does not
compare the claimed compositions to the closest prior art, i.e., Peresypkin's
self-emulsifying delivery vehicle. See In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence
of nonobviousness, the results must be shown to be unexpected compared
with the closest prior art."). Thus, it does not evidence that the claimed
ranges provide optimal or unexpected results as compared to the ranges
taught in Peresypkin. Second, the Murty Declaration only provides evidence
regarding a single example with particular ingredients in particular amounts
selected from the much broader range of ingredients and amounts recited in
claims 1, 18, and 20. As such, the evidence provided by the Murty
Declaration is not reasonably commensurate with the breadth of Appellants'
claims. 9 See In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) (Evidence
8 There are two compositions described in Example 15. Spec. 45. The
Murty Declaration does not specify which one was tested.
9 Appellants also refer to statements in the notice of allowance and an
interview summary from the prosecution of "the parent application, U.S.
Patent Application Ser. No. 12/876,292 (now issued U.S. Patent No.
9,265,724)," arguing that Examiner allowed claims with "similar
percentages" to issue in the '724 patent based at least in part on the Murty
Declaration and Specification Examples 15 and 16. App. Br. 11. Examiner
explains that the decision to allow the '724 patent claims is consistent with
the present rejections because "the instant claims are much broader in scope
to what was issued for U.S. Patent 9,265,724 and [are] not commensurate in
scope" with the evidence Appellant has presented. Ans. 4. In any event, we
are not concerned with the previously allowed claims because our review is
focused on the rejections of the claims presented in this appeal. See Appl 'n
of Hutchison, 154 F.2d 135, 137 (C.C.P.A. 1946) ("We are not concerned, of
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of unexpected results must be "commensurate in scope with the degree of
protection sought by the claim" to demonstrate non-obviousness.).
We are likewise unpersuaded by the testimony in the Murty
Declaration regarding Whittle Example 8. As Examiner explains, "Whittle
is not relied upon for the functional language or delivery system." Ans. 6.
Thus, Dr. Murty's testimony that the delivery vehicle in Whittle Example 8
did "not result in self-emulsification of a pharmaceutically active substance"
does not address the stated rejection, which is premised on the use of
Peresypkin's delivery vehicle. See Murty Deel. 6. Appellants cannot
overcome Examiner's rejection "by attacking [Whittle] individually"
because "the rejection is based upon the teachings of a combination of
references." See Soft Gel Techs., Inc. v. Jarrow Formulas, Inc., 864 F.3d
1334, 1341 (Fed. Cir. 2017) (quoting In re Merck & Co., 800 F.2d 1091,
1097 (Fed. Cir. 1986)).
For the same reasons, we are not persuaded by Appellants' arguments
that Peresypkin only teaches Compound I as the active agent in its
compositions. See App. Br. 12-16. Those arguments attack Peresypkin
individually, whereas Examiner's rejection is premised on the combination
of the cannabinoid active agent taught in Whittle with Peresypkin's self-
emulsifying delivery vehicle. Appellants argue that Compound I is
insufficiently soluble in "pure long chain triglyceride and fatty acid
solvents" to achieve a dosage form that avoids "hepatic first pass
course, with the allowed claims in either the patent or in this application.
The sole question for our determination is whether the ... claims on appeal
were properly rejected, and this we pass upon without further reference to,
and without comparing them with, the claims [that have been allowed].").
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metabolism via targeted chylomicron/lipoprotein delivery," as claimed. Id.
at 15-16. But even if that were true, the rejection is premised on Whittle' s
cannabinoid-not Compound I-as the active agent. The stated combination
of Peresypkin's delivery vehicle with Whittle's active agent provides a
structurally similar dosage form to that recited in claims 1, 18, and 20. Such
similarity demonstrates a prima facie case of obviousness for the functional
limitation "operable to avoid hepatic first pass metabolism via targeted
chylomicron/lipoprotein delivery, thereby promoting lymphatic transport" of
claims 1, 18, and 20. See In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990)
( en bane) ("[S]tructural similarity between claimed and prior art subject
matter, proved by combining references or otherwise, where the prior art
give reason or motivation to make the claimed compositions, creates a prima
facie case of obviousness, and ... the burden (and opportunity) then falls on
an applicant to rebut that primafacie case.").
We are likewise unpersuaded by Appellants' arguments that Gao
discloses different active agents and "fails the [sic] disclose the appropriate
amount and percentage of Long Chain Triglyceride required for targeting
lymphatic transport after swallowing a capsule through the gastrointestinal
tract" because those limitations are taught by other references in the stated
combination. App. Br. 19. As explained above, Whittle teaches a
cannabinoid as the active agent in a self-emulsifying composition. FF5-
FF6. Peresypkin teaches long chain triglycerides in the digestible oil
component of its self-emulsifying delivery vehicle in amounts that overlap
with the claimed range. See FF2, FF4. Appellants cannot overcome
Examiner's rejection by attacking Gao individually because the rejection is
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premised on the combination of these references. See Soft Gel, 864 F .3d at
1341. 10
Finally, we are not persuaded by Appellants' additional argument
concerning the "viscosity modifying agent" of claims 15 and 16. Appellants
urge that Examiner has failed to articulate a sufficient rationale to combine
Whittle' s viscosity modifying agent with Peresypkin' s delivery vehicle.
App. Br. 20. We disagree. Examiner determines "it would have been
readily apparent to a person of ordinary skill in the art to add the viscosity
modifying agents as disclosed in Whittle to a self-emulsifying system with
the result effective parameter of adjusting viscosity of the composition."
Non-Final Act. 15. In particular, Examiner finds that "[a]djusting viscosity
of compositions is well established in the pharmaceutical arts and it is
routine and common in pharmaceutical science to achieve the desired
consistency of the composition." Id. Appellants do not dispute Examiner's
finding that viscosity is a result effective variable or that adding an agent to
modify the viscosity would be a matter of routine optimization. See MPEP
2144.05(II). We therefore determine that Examiner has articulated a
sufficient rationale for this combination.
10 Examiner relies on Gao for its teaching of "self-emulsifying compositions
which comprise [free] fatty acids to improve solubility of the composition."
Non-Final Act. 7-8. Appellants in their briefs do not clearly present any
argument disputing Examiner's findings regarding Gao. Even if such an
argument had been raised, we determine that Examiner's findings
concerning Gao, and the rationale for combining such with the other
references, are supported by the record. See FF7.
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For all these reasons, Appellants' arguments fail to persuade us that
Examiner erred in rejecting claims 1, 3, and 5-20 as obvious over
Peresypkin, Whittle, and Gao. We therefore affirm that rejection.
II. Obviousness rejection of claim 4 over Peresypkin, Whittle, Gao,
and Schwarz
Examiner's rejection of claim 4 is largely premised on the same
findings supporting the rejection of claims 1, 3, and 5-20, which we affirm
above. In addition, Examiner determines that Schwarz teaches the semi-
solid inducer limitation of claim 4 and that it would be obvious to add such
to the modified Peresypkin composition "to provide a composition having
good flowability, and good control of oil leakage for tableted compositions."
Non-Final Act 9.
Appellants contend that Schwarz is inapplicable because "it is
directed to a solid composition" that "by pharmaceutical definition are solid
compressible powder blends ( e.g., compressed tablets), not semi-solid
formulations as in the present application. App. Br. 20. Moreover,
Appellants urge that Schwarz teaches different "biologically active
hydrophobic compounds" and "fails [to] disclose the appropriate amount and
percentage of Long Chain Triglyceride required for targeting lymphatic
transport after swallowing a capsule through the gastrointestinal tract." Id.
at 21.
We are not persuaded by Appellants' arguments. Schwarz, like the
other cited references, is directed to self-emulsifying formulations of
hydrophobic active agents. FF8. Examiner has articulated a sufficient
rationale for why a skilled artisan would find it obvious to add the
microcrystalline cellulose and a silicate taught in Schwarz to the modified
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Peresypkin composition (i.e., the combination of Peresypkin's digestible
oil/surfactant vehicle with Whittle's cannabinoid). Non-Final Act. 9.
Examiner's stated combination of teachings from Peresypkin, Whittle, and
Schwarz renders obvious the composition in claim 4.
Appellants' arguments that Schwarz fails to teach various aspects of
claim 4 does not address the stated combination of references. "[N]on-
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references." Soft Gel, 864 F.3d at 1341 (quoting In re Merck & Co., 800
F .2d at 1097). Examiner's rejection relies on the combination of
Peresypkin's delivery vehicle with Whittle's cannabinoid at the overlapping
percentages taught in Peresypkin. Appellants' arguments that Schwarz does
not independently disclose the same limitations merely attacks Schwarz
"individually"-not the "combination of references" on which Examiner's
rejection is based. See id.
For these reasons, we are unpersuaded by Appellants' arguments
concerning the rejection of claim 4 11 and affirm the same.
11 Claims 3 and 5 also require a "semi-solid inducer." Appellants do not
separately argue the "semi-solid inducer" limitation of those claims. Thus,
our decision to affirm the rejection of claim 1 also applies to claims 3 and 5.
See 37 C.F.R. § 41.37 (c)(l)(iv). We further note that, just as it does for
claim 4, Schwarz teaches the "semi-solid inducer" limitations of claims 3
and 5 and that the weight percentages taught in Schwarz overlap with the
range recited in claim 5. FF8.
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SUMMARY
We affirm the rejection of claims 1, 3, and 5-20 under 35 U.S.C.
§ 103 as unpatentable over Peresypkin, Whittle, and Gao.
We affirm the rejection of claim 4 under 35 U.S.C. § 103 as
unpatentable over Peresypkin, Whittle, Gao, and Schwarz.
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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