Ex Parte RUBIN

Patent Trial and Appeal Board

Oct 12, 2018

13973394 (P.T.A.B. Oct. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/973,394 08/22/2013 Arkady RUBIN
122066 7590 10/16/2018
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ATTORNEY DOCKET NO. CONFIRMATION NO.
ARSTP0098 1968
EXAMINER
PROSSER, ALISSA J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
10/16/2018 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):
pair@mb-ip.com
eofficeaction@appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ARKADY RUBIN 1
Appeal2017-008646
Application 13/973,394
Technology Center 1600
Before FRANCISCO C. PRATS, JAMES A WORTH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for reducing excessive menstrual blood loss, which have been rejected as
obvious and for non-statutory obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
"Heavy menstrual bleeding affects the lives of millions of women and
often requires medical attention and initiation of appropriate therapy." Spec.
1 Appellant identifies the Real Party in Interest as ARSTAT, Inc. Br. 3.
Appeal2017-008646
Application 13/973,394
1. Treatments for heavy menstrual blood loss include use of hormonal
contraceptives, nonsteroidal anti-inflammatory drugs, and even surgery.
Spec. 1-2. The Specification describes a method for locally administering
tranexamic acid to reduce menstrual blood flow. Spec. 5.
Claims 1, 3, 6, 7, 10, 11, 15, and 16 are on appeal. 2 Claim 1 is
illustrative and reads as follows:
1. A method for reducing excessive menstrual blood loss in a
female comprising:
administering intravaginally to the female a
therapeutically effective amount of an active agent on an
intravaginal delivery device directly into the uterine cavity
during a menstrual period, wherein the intravaginal delivery
device is a vaginal ring, wherein the active agent is
incorporated into the vaginal ring as a pharmaceutically
acceptable combination, wherein the active agent consists of
tranexamic acid delivered at a daily agent dose that does not
exceed 500 mg.
The claims stand rejected as follows:
Claims 1, 3, 6, 7, 10, 11, 15, and 16 have been rejected under 35
U.S.C. § 103(a) as unpatentable over Moodley3 in view of Harrison. 4
2 Claims 8, 9, and 1 7-26 are pending in the application but have been
withdrawn from examination as directed to non-elected inventions. Final
Act. 2.
3 Moodley et al., Vaginal absorption of low-dose tranexamic acid from
impregnated tampons, 81 S. African Med. J. 150 (1992) ("Moodley").
4 Harrison et al., US 6,086,909, issued July 11, 2000 ("Harrison").
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Application 13/973,394
Claims 1, 3, 6, 7, 10, 11, 15, and 16 have been provisionally rejected
for non-statutory obviousness-type double patenting over co-pending
application 13/973,337 in view of Harrison.
OBVIOUSNESS-TYPE DOUBLE PAETENTING
Appellant has not substantively responded to this rejection but has
argued that the rejection is premature in that "patentable subject matter has
not been identified" in either application. Br. 20.
Since Appellant has not responded to the rejection, we summarily
affirm the rejection. 37 C.F.R. § 4I.37(c)(iv).
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
the rejected claims would have been obvious over Moodley combined with
Harrison.
The Examiner finds that Moodley teaches administration of
tranexamic acid vaginally using tampons impregnated with between 300 and
350 mg of tranexamic acid. Final Act. 4. The Examiner finds that patients
using the tampons reported reduction in the amount of menstrual flow. Id.
The Examiner finds that Harrison teaches the use of a vaginal ring to
administer drugs transvaginally. Final Act. 6. The Examiner concludes
It would have been obvious to one of ordinary skill in the
art at the time the invention was made to modify the
intra vaginal tranexamic acid delivery system of Moodley
comprising an impregnated tampon in favor of an intravaginal
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Application 13/973,394
Id.
delivery system comprising a vaginal ring with the drug
incorporated throughout as taught by Harrison because simple
substitution of functionally equivalents elements yields
predictable results, absent evidence to the contrary.
Appellant contends that the combination of Moodley and Harrison is
improper. Br. 7. Appellant argues that modifying the tampon of Moodley
with the teaching of Harrison would make the tampon unusable for its
intended purpose - absorption of menstrual flow. Id. Appellant also
contends that there is no motivation to combine the references. Id.
Appellant argues that neither Moodley nor Harrison teach or suggest
all of the limitation of the claims. Br. 8. Appellant contends that neither
reference teaches a daily maximum dose limit of 500 mg. Br. 9-14.
Appellant argues that one skilled in the art would not have combined
the references as the references are directed to treating different medical
conditions. Br. 15-18. Appellant also contends that the claimed invention
produced surprising and unexpected results. Br. 18-19.
Findings of Fact
We adopt the Examiner's findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. Final Act. 3-7. The following findings are included for emphasis and
reference purposes.
FPL Moodley discloses a study to determine the effectiveness of
vaginal delivery of tranexamic acid compared to oral administration of
tranexamic acid. Moodley 150.
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Application 13/973,394
FF2. One group of patients studied by Moodley inserted a single
tampon impregnated with tranexamic acid for six hours while a second
group inserted an impregnated tampon every 2 hours for a total of 6 hours.
Id.
FF3. The amount of tranexamic acid impregnated in the tampons
used in the study by Moodley ranged from 30 to 350 mg. Id.
FF4. Both groups in the study reported a subjective reduction in the
amount of menstrual flow over the period of tampon application. Id. at 151.
Id.
FF5. Moodley concludes
It would seem that the medicated tampon may have a
practical application for situations where reduction in the
amount of menstrual flow is required. Vaginal application of
[tranexamic acid] has several advantages: gastrointestinal side
effects are avoided; the drug was easily administered on a
vehicle that in any case absorbed the menstrual loss: the method
was well tolerated; and infrequent applications were as effective
as more frequent applications resulting in reduction of the cost
by application of low doses.
FF6. Harrison teaches the use of intra vaginal drug delivery system to
treat dysmenorrhea. Harrison col. 1. 11. 13-16.
FF7. Harrison teaches that the intravaginal drug delivery system
allows for delivery of the drug in lower concentrations than required for
systemic treatments and produces. Id. col 1, 11. 17-21.
FF8. The intra vaginal drug delivery device of Harrison may comprise
a tampon-like device or a vaginal ring. Id. col. 9, 11. 6-7.
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Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prim a f acie
case ofunpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"[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).
"[I]nterrelated teachings of multiple patents; the effects of demands
known to the design community or present in the marketplace; and the
background knowledge possessed by a person having ordinary skill in the
art, all [ can provide] an apparent reason to combine the known elements in
the fashion claimed." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418
(2007).
The fact that two prior art devices could not physically be combined
does not mean that those skilled in the art would have found that combining
features of the two devices would be nonobvious. Orthopedic Equip. Co. v.
United States, 702 F.2d 1005, 1013, 217 USPQ 193, 199-200 (Fed. Cir.
1983).
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Application 13/973,394
"[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation." In re Aller, 220 F.2d 454, 456 (CCP A 1955).
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 Moodley combined with Harrison. Both
Moodley and Harrison discloses methods for intravaginal delivery of drugs.
FFl and FF6. Moodley teaches the intravaginal delivery of tranexamic acid
to reduce menstrual flow using a tampon. FF 1-5. Harrison teaches that a
vaginal ring can be used to administer drugs vaginally. FF6-8. We agree
with the Examiner that it would have been obvious to substitute the vaginal
ring of Harrison for the tampon of Moodley as the art teaches that they are
equivalent devices for delivering drugs vaginally. Final Act. 6, FF8. We
also agree with the Examiner that one skilled in the art would have been
motivated to use less than 500 mg of tranexamic acid by the teachings of
Moodley that infrequent administration of tranexamic acid delivered the
same result as more frequent administration thereby reducing costs. Final
Act. 4--5, FF5. Harrison also teaches that intravaginal drug delivery can
reduce costs. Harrison col. 6, 11. 19-29.
Appellant has not produced evidence showing, or persuasively argued,
that the Examiner's determinations as to obviousness are incorrect. Only
those arguments made by the Appellant in the Briefs have been considered
in this Decision. Arguments not presented in the Briefs are waived. See 37
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C.F.R. § 4I.37(c)(l)(iv) (2015). We have identified claim 1 as
representative; therefore, all claims fall with claim 1. We address
Appellant's arguments below.
Appellant contends that the references cannot be properly combined.
Br. 7. Appellant contends that Moodley only teaches the use of a tampon to
administer tranexamic acid and that the tampon was specifically selected so
as to absorb menstrual flow. Id. Appellant argues that since a vaginal ring
cannot absorb menstrual flow, it would render the device in Moodley
unsatisfactory for tis intended purpose. Br. 7-8.
We have considered Appellant's arguments and find them
unpersuasive. Moodley teaches that a tampon can be used as a device to
intra vaginally administer tranexamic acid. FF 1-6. Harrison teaches that
both tampons and vaginal rings can be used to administer drugs
intravaginally. FF6-8. It would have been obvious to substitute one
equivalent drug delivery system for another.
Appellant next argues that the references do not teach or suggest the
specific amount of tranexamic acid required by the claims - namely less
than 500 mg daily. Br. 8. Appellant argues that while Moodley teaches
using tampons containing from 300 to 350 mg of tranexamic acid, during
regular use, the tampons would be replaced several times a day resulting in a
daily dose oftranexamic acid of from 1200 to 3400 mg. Br. 9-10.
Appellant argues that Moodley would not lead one skilled in the art to use
less than 500 mg a day. Br. 10. Appellant also argues that Harrison does not
cure the deficiency of Moodley. Id.
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Again we are unpersauded by Appellant's arguments. As the
Examiner points out, Moodley teaches a single administration of 300 to 350
mg of tranexamic acid. Ans. 6, Moodley 150. (patients in group A had 1
medicated tampon inserted and removed after 6 hours.). The Examiner goes
on to point out that Moodley provides motivation to optimize the dosage of
tranexamic acid in that it teaches that infrequent administration was as
effective as frequent administration which could lead to lower costs. Ans.
6-7, FF5.
Appellant argues that the teachings of Moodley and Harrison cannot
be properly be combined in that the references treat separate and distinct
disorders. Br. 14--17. Appellant contend that the teachings of Moodley are
limited to treating menorrhagia whereas Harrison treats dysmenorrhea. Id.
Appellant argues that one skilled in the art would not look to methods for
treating one to treat the other. Id.
Appellant's arguments are still unpersuasive. While the references are
directed to treating different disorders, both are directed to method and
devices for intravaginal drug delivery. FFl-8. Given the teachings of the
reference, especially the teachings in Harrison that tampon-like devices and
vaginal rings both can be used for intravaginal delivery, FF8, we agree with
the Examiner that one skilled in the art would have been motivated to use a
vaginal ring in place of the tampon used in Moodley.
Appellant concludes by arguing that the claimed method provides
unexpected and surprising results which satisfy a long felt need. Br. 18-19.
This argument is unpersuasive.
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As the Examiner points out, there is no evidence in the record to
support Appellant's contention that the claimed invention produces
surprising results or that there is a long felt need. "Attorneys' argument is
no substitute for evidence." Johnston v. IVAC Corp., 885 F.2d 1574, 1581
(Fed. Cir. 1989).
In addition, Moodley teaches that intravaginal delivery of tranexamic
acid at doses lower than by oral administration were effective in reducing
menstrual flow. Moodley 151. That the present invention achieves the same
result cannot be said to be surprising or unexpected.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 1 would have been
obvious over Moodley combined with Harrison.
Claims 3, 6, 7, 10, 11, 15, and 16 have not been argued separately
and therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection for non-statutory obviousness-type double
patenting.
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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