Ex Parte Patel

Patent Trial and Appeal Board

May 7, 2018

12956659 (P.T.A.B. May. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/956,659 11/30/2010
34282 7590 05/09/2018
QUARLES & BRADY LLP (TUC)
Attn: IP Docket
ONE SOUTH CHURCH A VENUE, SUITE 1700
TUCSON, AZ 85701-1621
Bhiku Patel
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.
146133.00016 9754
EXAMINER
MORNHINWEG, JEFFREY P
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
05/09/2018 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BHIKU PATEL 1
Appeal2017-004994
Application 12/956,659
Technology Center 1700
Before FRANCISCO C. PRATS, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
composition for increasing the bioavailability of oils which have been
rejected as anticipated and as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
"Omega fatty acids are essential fatty acids ('EPA') as they are
required for good nutritional balance but they are not produced by the body;
1 Appellant identifies the Real Party in Interest PruGen IP Holdings, Inc.
Appeal Br. 1.
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Application 12/956,659
they must be obtained from other sources." Spec. 1. Dietary supplements
are often used to increase dietary intake of omega-3 fatty acids. Spec. 3--4.
One problem with the dietary supplements is that consumers find them too
large and uncomfortable to take. Spec. 4. The Specification describes
compositions that enhance the bioavailability of consumed oil.
Claims 1, 2, 39, and 40 are on appeal. Claim 1 is representative and
reads as follows:
1. A composition for increasing the bioavailability of oils
in humans and animal consisting of polyoxyethylene sorbitan
monooleate and tocopheryl polyethylene glycol succinate in a
ratio ranging from about 1: 1 to about 4: 1.
The claims have been rejected2 as follows:
Claims 1 and 2 have been rejected under 35 U.S.C. § 102(b) as
anticipated by Ke. 3
Claims 39 and 404 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Ke in view of Mishra. 5
2 Claim 1 was rejected for obviousness-type double patenting over claim 1
of co-pending application USSN 12/906,419. Final Act. 6. The Examiner
withdrew this rejection after Appellant filed a terminal disclaimer. Ans. 6.
3 Ke et al., Physical characterizations of microemulsion systems using
tocopheryl polyethylene glycol 1000 succinate (TPGS) as a surfactant for
the oral delivery of protein drugs, 102 J. Controlled Release 489 (2005)
("Ke").
4 Claims 1 and 2 were also rejected under 35 U.S.C. § 103(a). Final Act. 3.
That rejection was withdrawn by the Examiner. Ans. 6.
5 Mishra et al., US 6,284,268 Bl, issued Sept. 4, 2001 ("Mishra").
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Issue
ANTICIPATION
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's finding that claims 1 and 2 are
anticipated by Ke.
The Examiner finds that Ke discloses forming microemulsions from a
premix of tocopheryl polyethylene glycol succinate ("TPGS") and Tween 80
which fixed weight ratios of 4:1, 2:1, 1:1, 1:2, and 4:1. Final Act. 2. The
Examiner finds that Ke teaches that Tween 80 is polyoxyethylene sorbitan
monooleate. Id. The Examiner finds that the premixes of Ke do not contain
any additional components, thus, they consist of the recited components.
Final Act. 3. With respect to the use of the composition to increase
bioavailability of oils recited in the preamble of claim 1, the Examiner finds
that it should not be given any patentable weight as it merely recites the
intended use of the claimed composition. Id.
Appellant contends that Ke does not anticipate the claimed
composition and that the compositions of Ke comprise additional
components, namely, water and Captex 300. Appeal Br. 7. In support of
this contention, Appellant points to the phase diagrams shown in Figure 5 of
Ke, which show compositions using various ratios of Tween 80 and TPGS
in combination with water and Captex 300.
Appellant also argues that Tween 80 does not consist of
polyoxyethylene sorbitan monooleate but comprises additional components.
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Appeal Br. 13-22. In support of this argument, Appellant cites to Kerwin, 6
Sigma Aldrich, NOF,7 and Christiansen8 to support the argument that Tween
80 does not consist of polyoxyethylene sorbitan monooleate. Appeal Br.
13-20. Appellant also argues that the declarations 9 of Dr. Patel show that
the polyoxyethylene sorbitan monooleate used in the invention is not the
same as Tween 80. Appeal Br. 20-23.
Findings of Fact.
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
FF 1. Ke teaches the preparation of premixes of TPGS with various
Tweens at fixed weight ratios of 4/1, 2/1, 1/1, 1/2, and 1/4. Ke 491.
FF2. One of the Tweens used in Ke was Tween 80. Id.
FF3. Ke teaches that Tween 80 is polyoxyethylene 20 sorbitan
monooleate, which has a molecular weight of 1310 and a hydrophile-
lipophile balance ("HLB") of 15. Ke 505, Table 1.
FF4. The Specification discloses that "[p ]olyoxyethylene sorbitan
monooleate has been used for many years in the food and pharmaceutical
6 Kerwin, Polysorbates 20 and 80 used in the formulation of protein
biotherapeutics: structure and degradation pathways, 97 J. Pharm. Sci.
2924 (2008) ("Kerwin").
7 NOP America Corp., Ultra-Purity Polysorbate 80 & 20,
http://www.nofamerica.com/store/index.php?/dispatch=catgories.view&cate
gory_id=3 (2016) ("NOP").
8 Christiansen et al., Stability of the non-ionic surfactant polysorbate 80
investigated by HPLC-MS and charged aerosol detector, 66 Pharmazie 666
(2011) ("Christiansen").
9 Declaration Under 37 C.F.R. § 1.132, filed Aug. 20, 2012 ("Patel I") and
Declaration Under 37 C.F.R. § 1.132, filed May 19, 2015 ("Patel II").
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Application 12/956,659
industries. It is most commonly sold under the trade name polysorbate 80
and is widely available." Spec. 8.
FF5. In his first declaration Dr. Patel states that "[i]n the claims as
presently amended, my first surfactant is polyoxyethylene sorbitan
monooleate I," which has an average molecular weight of 1310 and a HLB
of 15. Patel I i-fi-f 12 and 13.
Analysis
We find the Examiner has established that the claims are anticipated
by Ke. Appellant has not produced evidence showing, or persuasively
argued, that the Examiner's determinations on anticipation are incorrect.
Only those arguments made by Appellant in the Briefs have been considered
in this Decision. Arguments not presented in the Briefs are waived. See
37 C.F.R. § 41.37(c)(l)(iv) (2015). We have identified claim 1 as
representative; therefore, claim 2 falls with claim 1. We address Appellant's
arguments below.
Appellant contends that Ke does not teach a composition consisting of
only TPGS and polyoxyethylene sorbitan monooleate but rather teaches
those compounds mixed with water and Captex 300. Appeal Br. 7.
Appellant cites to the teaching of Ke that the purpose of the study was to
characterize the behaviors of various pseudo-ternary systems containing
Captex 300, water, and surfactants. Id. Appellant also contends that the
phase diagrams in Figure 5 all disclose compositions that either do not
contain TPGS or relate to a composition containing all four compounds.
Appeal Br. 7-13.
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Application 12/956,659
We have considered Appellant's argument and find it unpersuasive.
While Ke discloses the preparation of compositions comprising Captex 300
and water combined with various surfactant compositions, Ke also clearly
teaches that the surfactants, including Tween 80 and TPGS, are premixed.
FFl and 2. Even though the premix was subsequently used to create a final
composition containing other compounds, the premix still anticipates the
present claims. In re Mullin, 481 F.2d. 1333, 1335-36 (CCPA 1973) ("It
matters not one whit that it was intended to be and appreciated as being an
intermediate structure rather than an end use item.").
Appellant next argues that Tween 80 comprises compounds in
addition to polyoxyethylene sorbitan monooleate and thus the premix of Ke
does not consist of YPGS and polyoxyethylene sorbitan monooleate.
Appeal Br. 13-20. Appellant points to various articles that show that Tween
80 or its equivalent polysorbate 80 can contain additional fatty acid moieties.
Id. Appellant also cites to the Patel Declarations as evidence that Tween 80
is not pure polyoxyethylene sorbitan monooleate. Appeal Br. 21-23. We
remain unpersuaded.
Appellant's argument is inconsistent with the Specification, which
clearly teaches that polysorbate 80 is the same as polyoxyethylene sorbitan
monooleate. FF4. Polysorbate 80 is the same as Tween 80. Kerwin
Abstract. Moreover, Dr. Patel states that the polyoxyethylene sorbitan
monooleate described in the claims has a molecular weight and HLB that are
the same as those of Tween 80. FF3 and 5.
With respect to the articles and product specification cited by the
Appellant, the additional compounds recited in those references appear to be
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Application 12/956,659
impurities normally associated with polyoxyethylene sorbitan monooleate.
They are not excluded from the composition by the use of the term
"consisting of." Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); MPEP
§ 2111.03 II.
Conclusion
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that claims 1 and 2 are anticipated by Ke.
OBVIOUSNESS
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
claims 39 and 40 would have been obvious over Mishra combined with Ke.
The Examiner finds that Mishra teaches forming a microemulsion of
an oil component with a surfactant system where the oil component
comprises omega-3 fatty acids and the surfactant system may comprise one
or more surfactants. Final Act. 4. The Examiner finds that the omega-3
fatty acids used in Mishra comprise eicosapentaenoic acid ("EPA") and
docosahexaenoic acid ("DHA"). Id. The Examiner finds that the surfactants
used in Mishra include Tween 80 and TPGS. Id.
The Examiner finds that Ke discloses microemulsion systems formed
from a premix of Tween 80 and TPGS at weight ratios of 4:1, 2:1, 1:1, 1:2,
and 4: 1. Id. The Examiner concludes:
[I]t would have been obvious to one of ordinary skill in the art
for the surfactant system for the microemulsion of Mishra to
comprise TPGS, as Mishra teaches that TPGS and mixtures of
other surfactants may be used and as Ke teaches that it is a
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distinctive compound used in microemulsions as a solubilizer,
emulsifier, absorption enhancer, plasticizer, and as a water-
soluble source of vitamin E. It would have been further
obvious to combine the TPGS with Tween 80, as Mishra
teaches that Tween 80 and mixtures of other surfactants may be
used and as Ke teaches that (i) TPGS is not sufficient on its
own; (ii) that Tweens are the most widely used, commercially
inexpensive, and readily available; and (iii) that Tween 80 is
more effective than Tween 60 in forming a microemulsion.
The surfactant system of Mishra in view of Ke would thus
specifically include Tween 80 and TPGS wherein it would have
been obvious to use known and workable ratios of about 1: 1 to
4: 1 as shown by Ke. As the premix compositions of Mishra
and Ke do not include additional ingredient components, the
teachings of Mishra and Ke encompass or at least make obvious
premix compositions consisting of the claimed ingredients.
Final Act. 5.
Appellant contends that Mishra does not cure the deficiencies of Ke in
that Mishra does not teach a composition consisting of polyoxyethylene
sorbitan monooleate and TPGS in a ratio of from 1: 1 to 4: 1. Appeal Br. 23.
Appellant contends that none of the examples of Mishra use the claimed
combination of surfactants. Appeal Br. 24. Appellant argues that Mishra
does not provide any guidance that would lead one skilled in the art to select
TPGS and Tween 80 as the surfactants. Appeal Br. 24--25. Appellant also
contends that neither reference discloses the use of EPA or DHA. Appeal
Br. 25.
Findings of Fact
FF6. Mishra discloses microemulsion systems comprising an omega-
3 fatty acid oil and a surfactant system. Mishra col. 4, 1. 60-col. 5, 1. 10.
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FF7. Omega-3 fatty acid oils used in the microemulsions of Mishra
include EPA and DHA. Mishra col. 5, 11. 34--39; col. 6, 11. 28-36.
FF8. Surfactants used to create the microemulsions of Mishra include
Tween 80 and Vitamin E-TPGS. Mishra col. 8, 11. 16-31.
FF9. Mishra teaches that the surfactant system is prepared by mixing
separately the chosen surfactants in their determined ratios. Mishra col. 10,
11. 13-15.
Analysis
We find the Examiner has established that the subject matter of the
claims would have been obvious to one of ordinary skill in the art at the time
the invention was made over Mishra combined with Ke. Appellant has not
produced evidence showing, or persuasively argued, that the Examiner's
determinations on obviousness are incorrect. Only those arguments made by
Appellant in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv)
(2015). Claim 39 is representative; therefore, claim 40 falls with claim 39.
We address Appellant's arguments below.
Appellant begins by arguing that Mishra does not remedy the
deficiencies of Ke in that Mishra does not teach a surfactant system
consisting of polyoxyethylene sorbitan monooleate in a ration of from 1: 1 to
4: 1. Appeal Br. 23. We are not persuaded. As discussed above, Ke teaches
a surfactant system comprising the recited components in the recited ratios.
Appellant argues that none of the examples of Mishra use the claimed
surfactant system. Appeal Br. 24. While we agree with Appellant that the
examples of Mishra use different surfactants, Mishra does teach the use of
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Tween 80 and TPGS. FF8. Moreover, Ke teaches the use of Tween 80 and
TPGS as a surfactant system in the recited ratios. FF 1. Thus, the combined
teachings of the references would lead one skilled in the art to use the
claimed surfactant system. "[W]hen a patent claims a structure already
known in the prior art that is altered by the mere substitution of one element
for another known in the field, the combination must do more than yield a
predictable result." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
(citing United States v. Adams, 383 U.S. 39, 50-51 (1966)).
Appellant next argues that the teachings of Mishra would lead one
skilled in the art to test thousands of possible combinations as Mishra
provides no guidance as to which component to use. Appeal Br. 24. We
remain unpersuaded.
We agree with the Examiner that the number of surfactants does not
render the selection of any of them non-obvious. Ans. 13. Picking one of a
finite number of known solutions to a known problem is obvious. KSR, 550
U.S. at 421. Moreover, as discussed above, Ke specifically teaches a
surfactant system consisting of polyoxyethylene sorbitan monooleate and
TPGS. We agree with the Examiner that the combined teachings of the
references would have led one killed in the art to develop the claimed
composition.
Finally, Appellant contends that neither reference teaches the use of
eicosapentaenoic acid and docosahexaenoic acid. We are not persuaded.
Mishra specifically teaches the use of EPA and DHA. FF7.
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Conclusion
We conclude that a preponderance of the evidence supports the
Examiner's finding that the subject matter of claims 39 and 40 would have
been obvious over Mishra combined with Ke.
SUMMARY
We affirm the rejection under 35 U.S.C. § 102(b ).
We affirm the rejection under 35 U.S.C. § 103(a).
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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