Ex Parte Murty et al

Patent Trials and Appeals Board

Jul 3, 2019

14454145 - (D) (P.T.A.B. Jul. 3, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/454,145 08/07/2014
1009 7590 07/08/2019
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 II 2335
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
07/08/2019 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
Ex parte SANTOS B. MURTY and RAM B. MURTY
Appeal 2019-000869
Application 14/454, 145
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 Dec. 13, 2017
("Final Act."), Appeal Brief filed June 13, 2018 ("App. Br."), Examiner's
Answer mailed Sept. 14, 2018 ("Ans."), and Reply Brief filed Nov. 13, 2018
("Reply").
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Application 14/454, 145
STATEMENT OF THE CASE
Claims 1-20 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) 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 and 5-20 under 35 U.S.C. § 103 as unpatentable over
Peresypkin, 2 and Whittle, 3 as evidenced by the National Nutrient
Database;4
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 Basic Report: 04518, Oil, corn, industrial and retail, all purpose salad or
cooking, USDA Research Service, National Nutrient Database for Standard
Reference, NDB Id 04518, available at http://ndb.na1.usda/gov, last accessed
June 27, 2015 ("National Nutrient Database").
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II. Claim 2 under 35 U.S.C. § 103 as unpatentable over Peresypkin and
Whittle, as evidenced by the National Nutrient Database, and further
in view of Gao; 5
III. Claims 3 and 4 under 35 U.S.C. § 103 as unpatentable over
Peresypkin and Whittle, as evidenced by the National Nutrient
Database, and further in view of Schwarz. 6
With respect to the first rejection, Appellants do not argue dependent claims
6-14, 17, and 19 separately from their respective independent claims so
those claims stand or fall with claims 1, 18, and 20. See 37 C.F.R. § 41.37
( c )( 1 )(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
FFI. 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-
5 Ping Gao et al., US 2002/0119198 Al, published Aug. 29, 2002 ("Gao").
6 Joseph Schwarz, US 2005/0037073 Al, published Feb. 17, 2005
("Schwarz").
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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.
According to Peresypkin, "[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, CI4-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.
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
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"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.
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
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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 [ ofJ 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
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 composition comprising
10.59% magnesium aluminum silicate and 17 .65% microcrystalline cellulose.
Id. ,I 58.
ANALYSIS
I. Obviousness rejection of claims 1 and 5-20 over Peresypkin,
Whittle, as evidenced by the National Nutrition Database7
Examiner finds that Peresypkin teaches a "lipophilic self-emulsifying
delivery vehicle" as recited in claim 1, but with a different hydrophobic
7 Examiner cites the National Nutrient Database only as evidence that "com
oil is a tri-glyceride" containing certain amounts of fatty acids. Final Act. 4.
Appellants do not dispute that finding, nor is it otherwise related to the
arguments raised in this appeal. Thus, we do not further address it here.
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active agent. See 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, 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. According to Examiner, one of skill
in the art 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 surfactants in lipophilic delivery vehicles. Id. at 5---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, thereby establishing a prima facie case of obviousness.
Id. at 4, 6; see also Ans. 4--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
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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 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. 8 As Examiner observed,
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. Final Act. 5; FFl.
Whittle teaches that cannabinoids face the same problem (low solubility and
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. On balance, the evidence here indicates that Examiner is merely
proposing the use of a known prior art feature (i.e., Peresypkin's vehicle) for
its known function. KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)
8 Contrary to Appellants' characterization, Examiner's rationale for this
combination has not "evolved" over the course of this appeal. Reply Br. 3.
Examiner articulated the same reasoning in the earlier office action. See
Final Act. 5-6.
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("[W]hen the question is whether a patent claiming the combination of
elements of prior art is obvious," the answer depends on "whether the
improvement is more than the predictable use of prior art elements according
to their established functions."). 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 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
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.
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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% ), 9 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
15 of the Specification does. 10 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
9 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.
10 There are two compositions described in Example 15. Spec. 45. The
Murty Declaration does not specify which one was tested.
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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. 11 See In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) (Evidence
of unexpected results must be "commensurate in scope with the degree of
protection sought by the claim" to demonstrate non-obviousness.).
11 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
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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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
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
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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.").
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."
Final Act. 18. 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. at 16. 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 routing optimization. See MPEP
2144.05(II). We therefore determine that Examiner has articulated a
sufficient rationale for this combination.
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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 and Whittle. We therefore affirm that rejection.
II. Obviousness rejection of claim 2 over Peresypkin, Whittle, as
evidenced by the National Nutrient Database, and Gao
Examiner's rejection of claim 2 is largely premised on the same
findings supporting the rejection of claims 1 and 5-20, which we affirm
above. Examiner additionally relies on Gao' s teaching of self-emulsifying
compositions comprising free fatty acids, such as oleic acid, in amounts (5-
35 wt%) that overlap with the "about 1-70 wt%" range recited in claim 2.
Final Act. 7-8. Examiner determines that it would be obvious to add oleic
acid in such amounts to Peresypkin's delivery vehicle because "Gao teaches
that incorporating free fatting acids ... improves solubility and prevents
phase separation between components of a self-emulsifying composition"
and "Peresypkin's composition already teaches the inclusion of oleic acid."
Id. at 8.
We agree that Examiner's findings concerning Gao, as well as the
rationale Examiner articulates for combining Gao with the other references,
are supported by the record. See FF7. We are 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. See FF5-FF6. And Peresypkin teaches long chain
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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 premised on the combination of these
references. See Soft Gel, 864 F.3d at 1341.
For these reasons, we are unpersuaded by Appellants' arguments
concerning the rejection of claim 2 and affirm the same.
III. Obviousness rejection of claims 3 and 4 over Peresypkin, Whittle,
as evidenced by the National Nutrient Database, and Schwarz
Examiner's rejection of claims 3 and 4 is largely premised on the
same findings supporting the rejection of claims 1 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." 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. 21. 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.
We are not persuaded by Appellants' arguments. Schwarz, like the
other cited references, is directed to self-emulsifying formulations of
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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
Peresypkin composition (i.e., the combination of Peresypkin' s digestible
oil/surfactant vehicle with Whittle's cannabinoid). Final Act. 9. Examiner's
stated combination of teachings from Peresypkin, Whittle, and Schwarz
renders obvious the composition in claims 3 and 4.
Appellants' arguments that Schwarz fails to teach various aspects of
claims 3 and 4 does not distinguish 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 claims 3 and 4 and affirm the same.
SUMMARY
We affirm the rejection of claims 1 and 5-20 under 35 U.S.C. § 103 as
unpatentable over Peresypkin and Whittle, as evidenced by the National
Nutrient Database.
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We affirm the rejection of claim 2 under 35 U.S.C. § 103 as
unpatentable over Peresypkin, Whittle, as evidenced by the National
Nutrient Database, and Gao.
We affirm the rejection of claims 3 and 4 under 35 U.S.C. § 103 as
unpatentable over Peresypkin, Whittle, as evidenced by the National
Nutrient Database, 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
17