Ex Parte Thompson et al

Patent Trial and Appeal Board

May 3, 2018

15047960 (P.T.A.B. May. 3, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
15/047,960 02/19/2016
26868 7590
Hasse & Nesbitt LLC
8837 Chapel Square Drive
Suite C
CINCINNATI, OH 45249
05/07/2018
FIRST NAMED INVENTOR
RONALD J. THOMPSON
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.
RJT-002M 1012
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
05/07/2018 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):
uspatent@hn-iplaw.com
patent@hn-iplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RONALD J. THOMPSON and JAMES M. THOMPSON 1
Appeal2018-004071
Application 15/047,960
Technology Center 1600
Before RICHARD J. SMITH, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition comprising tadalafil, menthol, and I-arginine for treatment of
the orgasmic component of female sexual dysfunction.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real parties in interest are the named
inventors, Ronald J. Thompson and James M. Thompson. (Br. 3.)
Appeal2018-004071
Application 15/047,960
STATEMENT OF THE CASE
Claims on Appeal
Claims 1-14 are on appeal. 2 (Br. 17-18 (Claims Appendix).) Claim
1 is illustrative and reads as follows:
1. A composition comprising tadalafil, menthol, and 1-
arginine for treatment of the orgasmic component of female
sexual dysfunction, wherein the composition is topically applied
to the clitoris and genital tissues of the subject, and wherein the
composition compensates for low testosterone levels in the
subject by inducing and prolonging sustained clitoral
vasodilation and erection.
Examiner's Rejection
Claims 1-14 stand rejected under 35 U.S.C. § 103 as unpatentable
over Thompson-I, 3 Held, 4 and Thompson-2. 5 (Final Act. 4---6.)
FINDINGS OF FACT
The following findings are provided for emphasis and reference
purposes. Additional findings may be found in this Decision, the Final
Action, and the Examiner's Answer.
FF 1. Thompson-I teaches "a topical clitoral sensitizing compound
combination consisting essentially of L-arginine and a cooling agent
comprised of Menthol and a 5-phosphodiaesterase inhibitor, wherein the
2 Claims 15-18 are withdrawn from consideration. (Final Action dated
April 28, 201 7 ("Final Act."), 1.)
3 Thompson et al., US 2004/0258774 Al, pub. Dec. 23, 2004 ("Thompson-
1").
4 Held, US 8,440,671 B2, issued May 14, 2013.
5 Thompson et al., US 2005/0245494 Al, pub. Nov. 3, 2005 ("Thompson-
2").
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Application I5/047,960
combination is applicable manually to the clitoris." (Thompson-I, Abstract
and claim I; Final Act. 4.)
FF 2. Thompson-I teaches that the clitoral compound combination
may include "any 5-phosphodiaesterase inhibitor." (Thompson-I, i-f 7; Ans.
4.)
FF 3. Thompson- I teaches that the compound sildenafil is a 5-
phosphodiaesterase inhibitor, that "the size of the sildenafil molecule
requires the aid of a vehicle, or absorbing agent, to allow absorption of the
sildenafil into the corpus cavemosa of the clitoris," and that the menthol
component of the combination facilitates the transport of the sildenafil
across the mucous membrane. (Thompson-I, i-f 4; Final Act. 4.)
FF 4. Held teaches that tadalafil (Cialis®), vardenafil (Levitra®), and
sildenafil (Viagra®) are phosphodiesterase-5 inhibitors, that they may be
used in a sustained release dosage form, and that administration may be
transmucosal, such as vaginal. (Held col. I2, 11. 39-56; col. 9, 1. 60-col. I 0,
1. 2; col. I9, 1. 65---col. 20, 1. 52; col. 2I, 11. 55-65; Final Act. 4.)
FF 5. Thompson-2 teaches a combination of menthol/1-arginine and
the 5-PDE (5-phosphodiesterase) inhibitor vardenafil. (Thompson-2,
Abstract; Final Act. 5.)
DISCUSSION
We adopt the Examiner's findings and conclusions as our own,
including with regard to the scope and content of, and motivation to
combine, the prior art, as set forth in the Final Action (Final Act. 4--6) and
Answer (Ans. 3-5). We discern no error in the rejections of claims I-I4 as
obvious.
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Application I5/047,960
Issue
Whether a preponderance of evidence of record supports the
Examiner's rejection under 35 U.S.C. § I03.
Analysis
We limit our consideration to claim I because the claims were not
argued separately.
Based on the Examiner's findings (see, e.g., FF I-5), the Examiner
concludes that:
It would have been obvious to one of ordinary skill in the art to
employ tadalafil as a 5-phosphodiesterase inhibitor in
Thompsons- I's topical clitoral sensitizing compound
combination consisting essentially of L-arginine and menthol
because Thompson-I teaches that any 5-PDE inhibitor can be
employed and mentions [sildenafil], and that instantly claimed
tadalafil is disclosed by Held as [a] 5-PDE inhibitor that [] is
interchangeable with 5-PDE inhibitors [sildenafil] and
vardenafil. It would have been obvious to one of ordinary skill
in the art to interchange one 5-PDE for another when specific 5-
PDEs are taught as equivalents and the 5-PDE inhibiting activity
is retained. Accordingly, the instant claim is obvious therefrom.
(Final Act. 5.)
Appellants argue that tadalafil is not interchangeable with other PDE-
5 inhibitors, especially for treatment of female sexual dysfunction. (Br. I 0-
I 5.) In support of that argument, Appellants assert that the terms tadalafil or
Cialis® are never mentioned in Thompson- I, that "while Held defines what
PDE-5 inhibitors are," it does not specifically teach or suggest that all PDE-
5 inhibitors are interchangeable, and that Thompson-2 only mentions
vardenafil as a PDE-5 inhibitor "with no mention of PDE-5 inhibitors being
interchangeable." (Id. at I2.) Appellants also refer to the Specification and
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Application I5/047,960
Thompson Declaration6 as support for the contention that "tadalafil has a
much longer duration of action than other PDE-5 inhibitors," and that the
lower molecular weight of tadalafil "allows it to diffuse across the clitoral
mucous membrane barrier and into the clitoral corpus cavemosa more easily
than other PDE-5 enzyme inhibitors, prolonging the vasodilation initially
induced by the I-arginine." (Id. at I2-I3, citing Spec. i-f 33 and Deel. i-fi-127-
30.) Appellants further assert that the Examiner has improperly taken
Official Notice that all PDE-5 inhibitors are interchangeable without citing a
prior art reference or documentary evidence to support that factual
determination. (Id. at I3-I4.)
We are not persuaded. The test for obviousness is "what the
combined teachings of the references would have suggested to those of
ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I)
(citing cases). Here, Thompson- I expressly teaches that any PDE-5
inhibitor may be used in its clitoral compound combination. (FF I, 2; Ans.
4.) While Thompson-I teaches sildenafil as the PDE-5 inhibitor,
Thompson-2 teaches vardenafil as the PDE-5 inhibitor, consistent with the
teaching in Thompson-I that any PDE-5 inhibitor may be used. (FF 2, 5.)
Held identifies PDE-5 inhibitors as including tadalafil, vardenafil, and
sildenafil. (FF 4.)
Here, the prior art clearly teaches that any PDE-5 inhibitor may be
used in the compound combination of Thompson- I, including tadalafil, such
that claim I constitutes the mere substitution of one PDE-5 inhibitor
(tadalafil) for another PDE-5 inhibitor (sildenafil) known in the field,
6 Declaration Under 37 CPR§ 1.I32 of Ronald J. Thompson, MD, dated
March I4, 20I 7 ("Deel." or "Thompson Declaration").
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Application I5/047,960
yielding predictable results. 7 See KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398, 4I6 (2007); see also Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
683 F.3d I356, I364 (Fed. Cir. 20I2) ("This case presents a strong case of
obviousness ... [because the claim] recites a combination of elements that
were all known in the prior art, and all that was required to obtain that
combination was to substitute one well-known cooling agent for another.")
Appellants' arguments that tadalafil has a much longer duration of
action than other PDE-5 inhibitors, and that tadalafil's lower molecular
weight allows it to diffuse across the clitoral mucous membrane more easily,
are similarly unpersuasive with respect to the interchangeability of PDE-5
inhibitors. Appellants present no evidence of unexpected results that
includes a comparison to the closest prior art. See Final Act. 3; Ans. 5.
Moreover, the issue is whether the art suggested the use of tadalafil in the
compound combination of Thompson-I. Keller, 642 F.2d at 425. Here, we
find that the art suggests the use of tadalafil in the compound combination of
Thompson- I (i.e., the substitution of sildenafil with tadalafil). See In re
Omeprazole Patent Litigation, 483 F.3d I364, I374 (Fed. Cir. 2007)
("[T]his court finds no ... error in [the] conclusion that it would have been
obvious to one skilled in the art to substitute one ARC [alkaline reacting
compound] for another.").
We note Appellants' reference to "studies finding that tadalafil, but
not sildenafil or vardenafil, potently inhibits the phosphodiesterase PDE- I I,
which is present in female clitoral tissues but not in male penile erectile
tissues." (Br. I3.) Although Appellants rely on those studies to support the
7 Thompson-I also suggests that the use of a PDE-5 inhibitor smaller than
sildenafil would be desirable. (FF 3.)
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contention that PDE-5 inhibitors are not interchangeable, those studies (as
described by Appellants) also appear to suggest that a person of ordinary
skill in the art would have been motivated to use tadalafil rather than
sildenafil or vardenafil. 8 Moreover, Appellants' argument highlights a need
to clarify an apparent misconception by Appellants; namely, a finding that
PDE-5 inhibitors are interchangeable does not mean that all PDE-5
inhibitors are identical or have identical properties. See, e.g., Omeprazole
Patent Litigation, 483 F.3d at 1374 (obvious to replace I-arginine with an
alkaline salt of phosphoric acid, carbonic acid, or silicic acid). Thus, the fact
that PDE-5 inhibitors may not exhibit identical inhibition of PDE-11 does
not mean that PDE-5 inhibitors are not interchangeable for purposes of the
present obviousness analysis. See Keller, 642 F.2d at 425.
Appellants' argument regarding Official Notice is also unpersuasive.
Here, the Examiner points to prior art that establishes that PDE-5 inhibitors
are interchangeable (i.e. "any 5-phosphdiaesterase inhibitor") in a
composition as claimed. (FF 1, 2.)
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claim 1 under 35 U.S.C. § 103. Claims 2-14 were not
argued separately and fall with claim 1.
Conclusion of Law
A preponderance of evidence of record supports the Examiner's
rejection of claims 1-14 under 35 U.S.C. § 103.
8 The page cited by Appellants (at Br. 13) specifically refers to two articles,
one dated 2005 and the other dated 2011, both published prior to Appellants'
filing date. See Response After Final dated May 17, 2017, at 7.
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Application 15/047,960
SUMMARY
We affirm the rejection of all claims on appeal.
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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