Ex Parte RUBIN

Patent Trial and Appeal Board

Dec 6, 2018

13973337 (P.T.A.B. Dec. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/973,337 08/22/2013 Arkady RUBIN
122066 7590 12/10/2018
M&B IP Analysts, LLC
500 Headquarters Plaza
Morristown, NJ 07960-7070
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.
ARSTP0099 9818
EXAMINER
HAGOPIAN, CASEY SHEA
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
12/10/2018 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
Appeal2017-010273
Application 13/973,337
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 appeal2 under 35 U.S.C. § 134 of the Examiner's rejection
of claims to a product and method 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.
1 Appellant identifies the Real Party in Interest as ARSTAT, Inc. Br. 3.
2 We have considered and herein refer to the Specification of Aug. 22, 2013
("Spec."); Non-Final Office Action of Apr. 4, 2016 ("Non-Final Act.");
Appeal Brief of Dec. 29, 2016 ("Br."); and Examiner's Answer of May 10,
2017 ("Ans.").
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Application 13/973,337
STATEMENT OF THE CASE
The Specification provides background information as follows:
There are tens of millions of menstruating women in the
United States. A woman's menstrual bleeding pattern plays a
significant role in her life, influencing her work productivity,
her social and leisure activities, as well as her physical and
psychological state of well-being.
If a woman's periods are so heavy or so long that she
finds them distressing she is experiencing heavy menstrual
bleeding. A volume of menstrual blood loss (MBL) exceeding
80 ml per menstrual cycle is defined as menorrhagia. One-third
of all women experience heavy menstrual bleeding at some
point in their lives, and in W estem countries about 5% of
reproductive-aged women seek treatment for it annually.
Spec. 1.
"Among non-hormonal medications, oral tranexamic acid is
considered as a firstline treatment option for the treatment of menorrhagia."
Spec. 2. Tranexamic acid is typically administered orally, however the
typical dosage regimen carries a risk of severe adverse reactions including
the risk of blood clots and stroke. Spec. 2-3.
The Specification describes a method and product which effectively
reduces menstrual blood loss without the undesirable side effects of oral
treatments. Spec. 4.
Claims 1-3, 10-15, 22-25, and 30-35 are on appeal. Claims 1, 11,
and 22 are the independent claims and read as follows:
1. A method for reducing excessive menstrual blood loss in
a female, comprising:
delivering a low dose of an active agent by administering
intravaginally to the female the active agent on an absorbent
feminine sanitary product during menstrual bleeding, wherein
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the low dose of the active agent is delivered to the uterine
cavity to have a therapeutic effect on the female's endometrial
tissue, wherein the feminine sanitary product is routinely
utilized to absorb the menstrual flow and is replaced during
days of excessive menstrual bleeding, wherein the active agent
is incorporated in the feminine sanitary product as a
pharmaceutically acceptable composition, wherein the active
agent is tranexamic acid, and wherein the amount of the
tranexamic acid in the feminine sanitary product ranges from
100 mg to 200 mg.
11. A medicated feminine sanitary product, comprising:
a therapeutic low dose of an active agent, suitable for
local delivery to the uterine cavity, wherein the active agent
reduces excessive menstrual blood loss, wherein the medicated
feminine sanitary product is highly absorbent to absorb heavy
menstrual flow, wherein the active agent is incorporated in the
medicated feminine sanitary product as a pharmaceutically
acceptable composition, wherein the active agent is tranexamic
acid, and wherein the amount of the tranexamic acid in the
feminine sanitary product ranges from 100 mg to 200 mg.
22. A pharmaceutical composition for intravaginal
administration, comprising:
a therapeutically effective amount for local intravaginal
delivery of an active agent that reduces menstrual blood loss,
wherein the active agent is tranexamic acid, wherein the
composition is being delivered on a feminine sanitary product,
and wherein the amount of the tranexamic acid in the feminine
sanitary product ranges from 100 mg to 200 mg.
3
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Application 13/973,337
The claims stand rejected3 as follows:
Claims 1-3, 10-13, 15, 22, 23, 25 and 30-35 have been rejected under
35 U.S.C. § I03(a) as unpatentable over Knox. 4
Claims 11, 12, 14, 15, 22, 23, 25-29, 31, 32, 34 and 35 have been
rejected under 35 U.S.C. § I03(a) as unpatentable over Rourke. 5
Claims 22, 24, 32, and 35 have been rejected under 35 U.S.C.
§ I03(a) as unpatentable over Tsubakino. 6
Claims 1-3, 10-15, 22-25, and 30-35 have been rejection for non-
statutory obviousness-type double patenting over claims 1, 3, 6, 7-11, and
14--26 of copending application USSN 13/973,394 in view ofHarrison. 7
Issue
OBVIOUSNESS
Knox
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 1-3, 10-13, 15, 22, 23, 25 and 30-35 would have been obvious over
Knox.
3 Claims 1-3, 10-15, 22-25, and 30-35 were rejected on the grounds ofnon-
statutory obviousness-type double patenting over USSN 14/041,501 in view
of Harrison. Non-Final Act. 18. USSN 14/041,501 has been abandoned
rendering the rejection moot. Notice of Abandonment mailed May 12, 2017.
4 Knox, US 6,758,840 B2, issued July 6, 2004 ("Knox").
5 Rourke et al. US 2009/0131890 Al, published May 21, 2009 ("Rourke").
6 Tsubakino et al. JP 2005 029529 A, published Mar. 2, 2005 ("Tsubakino").
Citations are to the English translation of record.
7 Harrison et al. US 6,086,909, issued July 11, 2000 ("Harrison").
4
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The Examiner finds the Knox teaches treatment of female specific
disorders such as heavy menstrual bleeding using an intravaginal device.
Non-Final Act. 5. The Examiner finds that the intravaginal device of Knox
may comprise a tampon loaded with 100 micrograms to 1 gram of a
pharmaceutical agent such a tranexamic acid. Id. The Examiner finds that
Knox teaches that the intravaginal device should be replaced every 4 to 8
hours. Id. The Examiner finds that while Knox does not specifically teach a
loading of between 10 and 200 mg,
it would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to optimize the
concentration/amount of tranexamic acid by way of routine
experimentation with a reasonable expectation of success
because Knox teaches the general conditions of the claim and it
is not inventive to discover the optimum ranges of said
tranexamic acid within an already disclosed general range.
Id. at 6.
The Examiner concludes that "the teachings of Knox render the
instant claims primafacie obvious." Id.
Appellant contends that Knox fails to provide any specific guidance or
teaching that would have led one skilled in the art to develop the claimed
invention. Br. 8. Appellant notes that Knox discloses a wide range of
conditions that can be treated as well as a wide range of drugs that can be
incorporated into the device. Id. Appellant argues that the broad range of
dosages recited in Knox would not have lead one skilled in the art to use the
specific narrow range recited in the claims. Id. at 9.
Appellant argues that Knox does not teach or suggest a structure that
is capable of Appellant's intended use, namely a feminine sanitary product
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which can be used to reduce menstrual blood flow. Id. Appellant argues
that Knox does not provide any guidance as to the dosing regimen to be
used. Id. at 10. Appellant contends that Knox discourages the use of an
active agent in liquid form and does not teach or suggest the use the
advantages of using low levels of tranexamic acid. Id. at 11.
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. The following findings are included for emphasis and reference
purposes.
FF 1. Knox teaches:
The invention relates to drug delivery devices for
insertion into the vagina, rectum or nasal cavity comprising a
body, a layer of fluid-impermeable material on at least part of
said body and one or more pharmaceutical agents disposed on
the surface of the material remote from said body, wherein said
body comprises absorbent material. The devices exploit the
highly vascularized nature of the vaginal, nasal and rectal
mucosal tissue to deliver pharmaceutical agents to localized
areas and/or into underlying tissues.
Knox Abstract.
FF2. Knox teaches:
For the intra-vaginal device, the presence of absorbent
material allows the device to fulfil the function of a
conventional tampon in addition to its role in delivering
pharmaceutical agents. Accordingly, it may be used during
menstruation in place of a conventional absorbent article. Such
a device may comprise essentially a normal tampon modified to
include the fluid-impermeable material and the pharmaceutical
agent.
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Knox col. 5, 11. 1-7. (emphasis added)
FF3. The Specification teaches that a feminine sanitary product can
be a tampon. Spec. 5.
FF4. Knox teaches:
During menstruation, such a device may thus be used to
deliver the pharmaceutical agent and to function simultaneously
as a conventional absorbent article. Where the device is
intended for use on days on which there is menstruation, or
where the onset of menstruation is anticipated, a pharmaceutical
agent formulated for more immediate release and uptake
through the vaginal mucosa, for example in the form of a dry
powder, may be used. Fast delivery of the complete dosage of
pharmaceutical agent is preferable in order that the device may
be replaced after the recommended period for replacement of
such articles, which is generally between 4 and 8 hours.
Knox col. 5, 11. 19-29
FF5. The amount of active agent used in the devices of Knox range
from 100 µ g to 1 g. Knox col. 6, 11. 51---60.
FF6. The intravaginal device of Knox may be used for the
management of female-specific disorders such as heavy menstrual bleeding.
Knox col. 7, 11. 20-24.
FF7. Knox teaches that the pharmaceutical agent used for the
intravaginal device is one which modulates thrombotic and fibrinolytic
cascades and thus controls abnormal bleeding that may occur during
menstruation. Knox col. 7, 11. 41--44.
FF8. One of the anti-fibrinolytic agents which can be used with the
intravaginal device of Knox is tranexamic acid. Knox col. 7, 11. 62-63,
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FF9. Knox teaches "the device of the present invention enables the
pharmaceutical agent to be administered close to the treatment site, thus
lowering the systemic concentration and reducing the occurrence of
unwanted side-effects." Knox col. 7, 11. 57-61.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
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).
[A] prior art reference that discloses a range
encompassing a somewhat narrower claimed range is sufficient
to establish a prima facie case of obviousness. That is not to
say that the claimed composition having a narrower range is
unpatentable. Rather, the existence of overlapping or
encompassing ranges shifts the burden to the applicant to show
that his invention would not have been obvious.
In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003).
To show criticality of a claimed range, "'it is not inventive to discover
the optimum or workable ranges by routine experimentation.' In re Aller,
220 F.2d 454, 456 (CCPA 1955). Only if the 'results of optimizing a
variable' are 'unexpectedly good' can a patent be obtained for the claimed
critical range in such cases. In re Antonie, 559 F .2d 618, 620 (CCP A
1977)." In re Geisler, 116 F.3d 1465, 1470(Fed. Cir. 1997)
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"[T]he patentability of apparatus or composition claims depends on
the claimed structure, not on the use or purpose of that structure." Catalina
Mktg. Int'!, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir.
2002).
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 Knox. 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
Brief have been considered in this Decision. Arguments not presented in the
Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015). Claim 1 is
representative; therefore, all claims fall with claim 1. We address
Appellant's arguments below.
Appellant contends that the disclosure of Knox is so broad that it
would not lead one skilled in the art to treating any specific disease or
disorder with any specific method of treatment or device. Br. 8-9.
Appellant argue that the broad dosage range of Knox is too broad for one
skilled in the art to discover the optimum range by routine experimentation.
Id. We are not persuaded.
While Knox discusses treating several different disorders, Knox
specifically teaches using a feminine hygiene product loaded with
tranexamic acid to treat or reduce menstrual bleeding. FFl, 2, and 4--8.
With respect to the dosage range, the range recited in the claims falls
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squarely within the range taught by Knox and is therefore prima facie
obvious. In re Peterson, 315 F.3d at 1330.
We also agree with the Examiner that it would be well within the skill
in the art to find the desired range, especially since Knox teaches that the
advantage of the invention is the use of doses lower of anti-fibrinolytic
agents than administer orally. Knox col. 7, 11. 41-61. In addition, Knox
teaches "undesirably high dosages may be avoid using the device of the
invention as the concentration in the vicinity of the tissue wall is maintained
at a high level due to the structure of the device." Knox col. 6, 11. 57-59.
Appellant argues that "the cited art does not disclose a structure
capable of, much less suitable for Appellant's intended use" which is
intra vaginal delivery of tranexamic acid. Br. 9. Again, we are not
persuaded.
Knox clearly teaches the use of a tampon to deliver drugs
intravaginally to reduce menstrual blood flow. FFl, 2, & 4. A tampon is a
feminine hygiene product. FF3. Tranexamic acid is one of the drugs that
can be used to reduce menstrual blood flow. FF7 & 8. The device disclosed
in Knox is capable of and is suitable for the same use as the devices recited
in the instant claims.
Appellant argues that Knox does not teach or suggest any specific
details relating to the doses of tranexamic acid to use, the frequency of use
of medicated tampons and the amount of drug to apply to each tampon. Br.
10-11.
We have considered Appellant's argument and find it unpersuasive.
With respect to the dosage of tranexamic acid, while Knox does not teach
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the specific range recited in the claims, as noted above, Knox teaches a
range encompassing the claimed range. FF5. Moreover, Knox teaches that
the amount used on the tampons is less than the amount administered orally.
See, Knox col. 7, 11. 41---61. Knox gives one skilled in the art sufficient
guidance to optimize the amount of tranexamic acid and create a device
having tranexamic acid present in the recited range.
Appellant argues that the preferred dosage levels of Knox are well
below the claimed dosage range and would not have lead one skilled in the
art to the claimed range. Br. 10. While the preferred range recite in Knox is
below that recited in the claims, as discussed above, the broader range taught
by Knox encompasses the claimed range rendering the claims prima facie
obvious.
Appellant argues that Knox criticized the use of medicaments in liquid
form. Br. 11. Appellant's argument is unpersuasive in that claim 1 does not
require that the tranexamic acid be in liquid form.
Secondary Indicia of Non-Obviousness
Appellant contends that there is sufficient evidence of secondary
indicia to establish that the subject matter of the claims would not have been
obvious. Br. 19. Appellant contends that it is "surprising and unexpected
the reduction in menstrual blood loss may occur in the absence of detectable
plasma concentrations or in the presence of circulating levels of the drug that
are much lower than reported upon administration of oral tablets" and that
this can be achieved through the use of feminine hygiene products. Id. This
argument is unpersuasive.
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"[B]y definition, any superior property must be unexpected to be
considered evidence of non-obviousness. Thus, in order to properly evaluate
whether a superior property was unexpected, the [fact-finder] should have
considered what properties were expected. " Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1371 (Fed. Cir. 2007).
Knox clearly teaches that the use of tampons impregnated with anti-
fibrinolytic agents such as tranexamic acid is effective in reducing menstrual
flow and results in lower systemic concentration of the drugs and reduced
occurrence of unwanted side-effects. FF6-9. Therefore, the results
achieved by Appellant's invention are not 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 Knox.
Claims 2, 3, 10-13, 15, 22, 23, 25 and 30-35 have not been argued
separately and therefore fall with claim 1. 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv).
Rourke
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 11, 12, 14, 15, 22, 23, 25-29, 31, 32, 34 and 35 would have been
obvious over Rourke.
The Examiner finds that Rourke teaches incorporating protease
inhibitors, such as tranexamic acid, into absorbent articles such as a sanitary
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napkin or menstrual pad. Non-Final Act. 9. The Examiner finds that
Rourke teaches
percentages of the protease inhibitor in terms of the weight of
the article (e.g., 0.0001 % to 30%, 0.0001 % to 10%, 0.001 %
to 5%, 0.001 % to 1 %; see paragraph [0100]), in terms of the
composition (e.g., 0.01 % to about 50%, about 0.5% to about
25%, about 1 % to about 10%; see paragraph [O 11 OJ) as well as
concentrations per surface area ( e.g., about 0.05 mg/in2 to about
80 mg/in2, about 1 mg/in2 to about 40 mg/in2 , 4 mg/in2 to about
26 mg/in2 ; see paragraph [0113]).
Id. The Examiner concludes that while Rourke does not specifically teach
an embodiment comprising 100 mg to 200 mg,
it would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to optimize the amount of
tranexamic acid by way of routine experimentation with a
reasonable expectation of success because Rourke teaches the
general conditions of the claim and it is not inventive to
discover the optimum ranges of said tranexamic acid within an
already disclosed general range. It is also within the knowledge
of a skilled artisan to convert percentages to concentrations and
vice versa.
Id. at 10.
Appellant contends that one skilled in the art reading Rourke would
not be motivated to use tranexamic acid as Rourke teaches that tranexamic
acid does not meet the IC50 criteria for protease inhibitory activity. Br. 12.
Appellant argues that one skilled in the art would not arrive at the recited
amount of tranexamic acid by routine optimization. Id. at 12-13. Appellant
argues that the product disclosed in Rourke is not capable of functioning for
the intended use of the claimed product. Id. at 13. Appellant contends that
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Rourke is silent about reduction of menstrual bleeding but is instead focused
on reducing undesirable skin reactions, particularly diaper rash. Id. at 14.
With respect to claim 22, Appellant argues that claim 22 is directed to
a pharmaceutical composition for local intravaginal administration of
tranexamic acid. Id. at 15. Appellant contends that Rourke does not teach
or suggest such a composition. Id.
Findings of Fact
FF 10. Rourke teaches an absorbent article where at least a portion of
the article has a protease inhibitor incorporated therein to prevent or reduce
skin irritation or dermatitis. Rourke Abstract.
FF 11. Rourke teaches that the absorbent article can be feminine
hygiene garments such as sanitary napkins. Rourke ,r 35.
FF 12. Rourke teaches that the protease inhibitors that can be used in
the practice of the invention include tranexamic acid. Rourke ,r 90.
FF 13. The term feminine hygiene product as used in the instant
Specification includes sanitary napkins. Spec. 5.
FF14. Rourke teaches that the amount of protease on the absorbent
product can range from "0.0001 % to 30%, more preferably from 0.0001 %
to 10%, still more preferably from 0.001 % to 5%, and especially 0.001 % to
1 % by weight of the article." Rourke ,r 100.
FF15. Rourke also teaches:
In order to deliver an effective concentration of the protease
inhibitor to the skin via an absorbent article over time, an
effective amount of the skin care composition containing the
inhibitor that is applied to or migrated to one or more of the
wearer-contacting surfaces of the article depends, to a large
extent on the particular skin care composition used. The
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quantity of the composition on at least a portion of the wearer-
contacting surface of the absorbent article preferably ranges
from about 0.05 mg/in2 (0.0078 mg/cm2) to about 80 mg/in2 (12
mg/cm) more preferably from about 1 mg/in2 (0.16 mg/cm2) to
about 40 mg/in2 (6 mg/cm2), still more preferably from about 4
mg/in2 (0.6 mg/cm2) to about 26 mg/in2 ( 4 mg/cm2). However,
these ranges are by way of illustration only and the skilled
artisan will recognize that the nature of the composition will
dictate the level that must be applied to deliver an effective
amount of the protease inhibitor and that the desirable level is
ascertainable by routine experimentation in light of the present
disclosure.
Rourke ,r 113.
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 Rourke. 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
Brief have been considered in this Decision. Arguments not presented in the
Briefs are waived. See 37 C.F.R. § 4I.37(c) (1) (IV) (2015). We have
identified claim 1 as representative; therefore, with the exception of claim
22, which was argued separately, the remaining claims fall with claim 1.
We address Appellant's arguments below.
Appellant contends that Rourke does not teach or suggest the present
invention in that Rourke teaches that tranexamic acid does not have the
protease inhibitory activity required by Rourke nor does Rourke provide any
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guidance as to how to optimize the products disclosed in Rourke to achieve
the application discovered by Appellant. Br. 12.
Appellant's argument is unpersuasive. The claims at issue in this
rejection are directed to feminine hygiene products having tranexamic acid
incorporated therein. See, Br. 24 (Claims App'x). Rourke discloses sanitary
napkins having tranexamic acid incorporated therein. FFl0-12. Thus
Rourke discloses the same products as the present invention which can be
used for the same purpose as the present invention.
With respect to the amounts of tranexamic acid, while Rourke does
not specifically teach the claimed range, As the Examiner has demonstrated,
using the ranges of amounts of protease inhibitor per area of the device
disclosed in Rourke, the amount of tranexamic acid disclosed in Rourke
overlaps with the ranges recited in the claims. Ans. 16-17. In addition,
Rourke teaches that "the skilled artisan will recognize that the nature of the
composition will dictate the level that must be applied to deliver an effective
amount of the protease inhibitor and that the desirable level is ascertainable
by routine experimentation in light of the present disclosure." FF15. We
agree with the Examiner that
it would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to optimize the amount of
tranexamic acid by way of routine experimentation with a
reasonable expectation of success because Rourke teaches the
general conditions of the claim and it is not inventive to
discover the optimum ranges of said tranexamic acid within an
already disclosed general range.
Ans. 17.
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Appellant contends that the devices in Rourke are directed to treating
completely different disorders and diseases than the claimed invention. Br.
19. Appellant contends that Rourke is directed to treating skin disorders
whereas the present invention is directed to reducing menstrual blood flow.
Id.
We have considered Appellant's argument and find it unpersuasive.
As the Examiner points out, Appellant's argument is directed to the intended
use of the claimed product. Ans. 19. Since the claims at issue in this
rejection are composition claims not method claims, the intended use does
not impart patentability especially since, as demonstrated above, Rourke
teaches almost exactly the same structure as recited in the claims.
With respect to claim 22, Appellant argues that Rourke does not teach
or suggest a pharmaceutical composition for intravaginal administration
comprising tranexamic acid to reduce menstrual blood loss as recited in
claim 22. Br. 15. This argument is unpersuasive.
Here again, Appellant's arguments focus on the intended use or mode
of delivery of a particular product and not on the composition or structure of
the product itself. Again, these do not render the subject matter of the
claims, a pharmaceutical composition patentable. Catalina Mktg. Int 'l, Inc.,
289 F.3d at 809.
Claim 22 is directed to a pharmaceutical composition. Br. 25. The
Specification does not define the term. A common dictionary definition of
the term pharmaceutical composition is "as a medicinal drug."8 A medicinal
8 Webster's Online, htt12s://www.meniam-
webster.com/dictionary/pharmaceutical.
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drug is defined as "something that treats or prevents or alleviates the
symptoms of a disease. " 9 Rourke teaches that protease inhibitors such as
tranexamic acid can be used to treat skin conditions such as dermatitis.
FFlO. We therefore find that Rourke discloses a pharmaceutical
composition.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claims 11 and 22 would
have been obvious over Rourke.
Claims 12, 14, 15, 23, 25-29, 31, 32, 34 and 35 have not been argued
separately and therefore fall with claims 11 and 22. 37 C.F.R.
§ 4I.37(c)(l)(iv).
Tsubakino
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 22, 24, 32, and 35 would have been obvious over Tsubakino.
The Examiner finds that Tsubakino teaches suppositories containing
20 to 250 mg of tranexamic acid. Non-Final Act, 13. The Examiner finds
that the terms "for intra vaginal administration", "for local intra vaginal
9 medicinal drug. (n.d.) WordNet 3.0, Farlex clipart collection. (2003-
2008). Retrieved November 30 2018 from
https://www.thefreedictionary.com/medicinal+drug
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delivery" and "is being delivered on a feminine sanitary product" relate to
the intended use of the claimed pharmaceutical composition and to not show
a patentable distinction. Id. The Examiner finds that while Tsubakino does
not the specific dosage range recited in the claims, the ranges overlap and
that it would have been within ability of one skilled in the art to optimize the
amount of tranexamic acid. Id. at 14.
Appellant contends that the claims at issue require the presence of a
feminine sanitary product and that Tsubakino does not teach or suggest this
claim limitation. Br. 16. Appellant argues that Tsubakino is directed to the
treatment of hemorrhoids which is a different disorder than that treated by
the claimed composition. Id at 17. Appellant argues that Tsubakino is not
analogous art and cannot be properly cited against the claims. Br. 18.
Findings of Fact
FF 16. Tsubakino teaches the preparation of suppositories containing
20 to 250 mg pf tranexamic acid to treat hemorrhoids. Tsubakino ,r 12.
FF 17. Claim 24 of the instant application reads "The composition of
claim 22, wherein the composition is formulated as a tablet or suppository."
FF 18. Tsubakino teaches that tranexamic acid has an "anti bleeding
operation by antiplasmin operation, an antiallergic action, and an anti-
inflammatory activity." Tsubakino ,r 7.
FF19. The claimed invention is directed "[a] pharmaceutical
composition" for controlling bleeding using tranexamic acid. Br. 25 ( claim
22).
Principles of Law
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"It is axiomatic that, in proceedings before the PTO, claims in an
application are to be given their broadest reasonable interpretation consistent
with the specification and that claim language should be read in light of the
specification as it would be interpreted by one of ordinary skill in the art."
In re Sneed, 710 F.2d 1544, 1548, 218 USPQ 385, 388 (Fed. Cir. 1983)
( citation omitted).
"Two criteria have evolved for determining whether prior art is
analogous: (1) whether the art is from the same field of endeavor, regardless
of the problem addressed, and (2) if the reference is not within the field of
the inventor's endeavor, whether the reference still is reasonably pertinent to
the particular problem with which the inventor is involved." In re Clay, 966
F.2d 656, 658-59, 23 USPQ2d 1058, 1060 (Fed. Cir. 1992).
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 Tsubakino. 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 Brief have been considered in this Decision. Arguments not
presented in the Brief are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015).
We have identified claim 22 as representative; therefore, all claims fall with
claim 22. We address Appellants' arguments below.
Appellant contends that claim 22 requires the presence of a feminine
sanitary product and that Tsubakino does not teach or suggest the presence
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of a feminine sanitary product. Br. 16-1 7. We do not interpret claim 22 as
requiring the presence of a feminine sanitary product.
Claims 22 calls for a pharmaceutical composition that is "delivered on
a feminine sanitary product." Br. 25 (Claims App'x). We agree with the
Examiner that under the broadest reasonable interpretation, this limitation
should be read as an intended use and not as a structural limitation. Ans. 21.
This interpretation is consistent with the wording of the claim itself which is
directed to "[a] pharmaceutical composition." Br. 25. This interpretation is
also consistent with claim 24 which depends from claim 22 and adds the
limitation that the pharmaceutical composition is formulated as a "tablet or
suppository." Br. 25. The limitation referring to delivery using a feminine
sanitary product is directed to how the pharmaceutical composition can be
delivered and not the structure or components of the composition. Thus it is
directed to an intended use and does not impart a patentable distinction over
the prior art.
Appellant argues that the terms "intravaginal administration" and
"local intravaginal delivery" distinguish the present invention described in
Tsubakino. Br. 17. Appellant contends that Tsubakino is directed to
treatment of hemorrhoids, which is completely different than vaginal
administration to control menstrual blood flow. Id.
We have considered Appellant's argument and find it unpersuasive.
As with the limitation regarding use of a feminine sanitary product for
delivery of the composition, the terms intra vaginal delivery and intravaginal
administration are statements of intended use and do not impart any
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structural limitation on the claimed composition that distinguishes over
Tsubakino's composition. Ans. 22.
Appellant contends that Tsubakino does not teach the specific dosage
range recited in the claims, 100 to 200 mg. While this is true, Tsubakino
does teach that the active agent, tranexamic acid is present in an amount
ranging from 20 to 250 mg, overlapping with the range recited above. FF16.
[A] prior art reference that discloses a range encompassing a somewhat
narrower claimed range is sufficient to establish a prima facie case of
obviousness. In re Peterson, 315 F.3d at 1330.
Appellant contends that Tsubakino is non-analogous art in that
Tsubakino is directed to a completely different problem that that addressed
by the present invention. Again, we find this argument unpersuasive.
We agree with the Examiner that "both the reference and the instant
invention are concerned with delivering the composition ( e.g., in the form of
a suppository) internally to a mucosal surface to impart an anti-bleeding
effect. Therefore, the reference is considered to be 'reasonably pertinent' to
the claimed invention. Contrary to Appellant's assertion, Tsubakino is
analogous art." Ans. 23.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 22 would have been
obvious over Tsubakino.
Claims 24, 32, and 35 have not been argued separately and therefore
fall with claim 22. 37 C.F.R. § 4I.37(c)(l)(iv).
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DOUBLE PATENTING
Appellant has not substantively responded to the rejection but has
argued that the rejection is premature in that "patentable subject matter has
not been identified." Br. 20.
Since Appellant has not responded to the rejection, we summarily
affirm the rejection. 37 C.F.R. § 4I.37(c)(iv).
SUMMARY
We affirm the rejections under 35 U.S.C. § I03(a).
We affirm the rejection for non-statutory obviousness-type double
patenting.
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.I36(a).
AFFIRMED
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