Ex Parte RUBIN

Patent Trial and Appeal Board

Jan 23, 2019

14017524 (P.T.A.B. Jan. 23, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/017,524 09/04/2013 Arkady RUBIN
122066 7590 01/25/2019
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.
ARSTPOlOO 1045
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
01/25/2019 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):
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
Appeal2018-000302
Application 14/017,524
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 from the Examiner's
rejection of claims to an intravaginal drug delivery device which have been
rejected as anticipated and as obvious. 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 Sept. 4, 2013
("Spec."); Final Office Action of June 22, 2016 ("Final Act."); Appeal Brief
of Mar. 15, 2017 ("Br."); and Examiner's Answer of July 13, 2017 ("Ans.").
Appeal2018-000302
Application 14/017,524
STATEMENT OF THE CASE
"Uterine fibroids are common. They include fibromyomas, myomas,
fibromas, leiomyomata, etc. and are classified into submucosal, intramural,
and subserosal fibroids." Spec. 1. "Uterine fibroids may be associated with
a number of symptoms, including heavy menstrual bleeding (sometimes
accompanied by anemia), menstrual pain, pelvic or abdominal pressure, pain
during intercourse and obstructive symptoms, including increased frequency
of urination (due to diminished bladder capacity) and constipation.[]
Fibroids may also cause infertility." Id. The Specification describes
a method for effectively reducing the size of uterine fibroids or
the uterus and/or improving fibroid-related symptoms without
the undesirable side effects of oral medications by providing for
intravaginal delivery of a selective progesterone receptor
modulator (SPRM), anti-progestin, or anti-progestational agent
at doses which are significantly lower than oral doses known in
the art.
Id. at 5.
Claims 15-17, 20, and 26 are on appeal. 3 Claim 1 is the sole
independent claim on appeal and reads as follows:
15. An intra vaginal drug delivery device comprising:
a drug delivery device; and
a therapeutically effective amount of an active agent,
wherein the drug delivery device is configured to deliver the
active agent directly to uterine fibroids, wherein further the
drug delivery device delivers a daily dose of the active agent
3 Claims 1-14, 18, 21, 22, 24, 25, and 27 are pending in the application but
have been withdrawn from consideration as directed to non-elected species.
Final Act. 3. Appellant elected examination of the remaining claims with
mifepristone as the active agent, a vaginal ring as the delivery device and
where the active agent is mixed throughout the vaginal ring. Id. at 2.
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Application 14/017,524
which does not exceed 500 mcg, wherein the active agent is
mifepristone.
The claims stand rejected as follows 4:
Claims 15-17 have been rejected under 35 U.S.C. § 102(b) as
anticipated by Chen. 5
Claims 15-17 and 20 have been rejected under 35 U.S.C. § 102(b) or
§ 103(a) and anticipated by or as unpatentable over Chen.
Claim 26 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Chen.
FIRST ANTICIPATION REJECTION-CLAIMS 15-17
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that claims 15-1 7 are
anticipated by Chen.
The Examiner finds that Chen, in paragraph 84, discloses a vaginal
ring which comprise Mifepristone. Final Act. 5. The Examiner finds that
the release rate for the ring as shown in Figure 3, reproduced below, is less
than 500 µg per day. Id.
4 Claim 20 was also rejected under 35 U.S.C. § 112, first paragraph for
failure to comply with the written description requirement. Final Act. 34.
This rejection was withdrawn by the Examiner. Ans. 2.
5 Chen et al., US 2005/0197 651 A 1, published Sept. 8, 2005 ("Chen").
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Appeal2018-000302
Application 14/017,524
Mifepristone & Silicon Rubber
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FIG. 3
Figure 3 of Chen shows the release rate of a prior art vaginal ring containing
Mifepristone.
The Examiner finds that the limitation "configured to deliver the
active agent directly to uterine fibroids" is a characteristic of a vaginal ring
containing Mifepristone citing In re Best, 562 F .2d 1252 (CCP A 1977),and
In re Fitzgerald, 619 F.2d 67 (CCPA 1980). Final Act. 6.
Appellant does not present any arguments on appeal with respect to this
rejection. See Br. 8; Ans. 2-3. Therefore, we affirm the rejection with
respect to claims 15-17, and 20. 37 C.F.R. § 4I.37(c)(l)(iv).
SECOND ANTICIPATION REJECTION -CLAIMS 15-17 AND 20
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that claims 15-17 and 20
are anticipated by Chen. Alternatively, the issue is whether a preponderance
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Appeal2018-000302
Application 14/017,524
of the evidence supports the Examiner's conclusion that the subject matter of
claims 15-17 and 20 would have been obvious over Chen.
The Examiner finds that Chen discloses the preparation of vaginal
rings with an active agent mixed throughout. Final Act. 18. The Examiner
finds that in the discussion of Application 3, Chen discloses a vaginal ring
containing Mifepristone. Id. The Examiner finds that Chen discloses that a
vaginal ring of Chen containing Mifepristone was used to treat a woman
with uterine myoma (fibroids). Final Act. 19. The Examiner fids that Chen
discloses that the use of the ring was clinically effective. Id. The Examiner
finds that Figure 4 of Chen, reproduced below, teaches that the ring of
Application 3 had a maximum weekly release rate of 1200 µg during the
first week, which equates to an average daily release rate of 170 µg. Id. at
19-20.
Mifepristone & Invention
1400·--------------....
a 1200"
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Week
FIG. 4
Figure 4 of Chen shows the weekly release rate of a vaginal ring
containing Milfepristone.
Alternatively, the Examiner finds that Chen discloses that based on
the disclosure in Clinical Trial I of Chen, the vaginal ring used would have a
daily release rate of 400 mcg at the end of the last week on the trial. Final
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Application 14/017,524
Act. 21. In reaching this finding the Examiner assumes that the release rate
disclosed in Figure 4 is actually a daily release rate and that the release rate
on day 1 was 1200 µg. Id.
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).
"Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference." In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
Analysis
We adopt the Examiner's findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. Final Act. 17-24; Ans. 5-14. We find the
Examiner has established that the claims 15, 16, and 20 are anticipated by
Chen and that the subject matter of claim 17 would have been obvious over
Chen. Appellant has not produced evidence showing, or persuasively
argued, that the Examiner's determinations on anticipation with respect to
claims 15, 16, and 20 and obviousness with respect to claims 17 are
incorrect. Only those arguments made by Appellant in the Brief have been
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Application 14/017,524
considered in this Decision. Arguments not presented in the Brief are
waived. See 37 C.F.R.
§ 4I.37(c)(l)(iv) (2015). We address Appellant's arguments below.
Appellant contends that Chen does not disclose a release rate of less
than 500 µg per day. Br. 8. Appellant argues that the x-axis of the graph on
Figure 4 of Chen should be read as days, not weeks. Id. Appellant argues
that the Examiner concedes that the device referenced in Figure 4 has a daily
release rate of greater than 500 µg. Id. Appellant also points to the graphs
in Figures 5 and 6 which report data based on a daily release rate as
supporting the contention that Figure 4 should be read as reporting daily
release data. Id. Appellant contends that this interpretation is consistent in
that Chen teaches that the release rate can reach as high as 1 to 10 mg per
day. Br. 10. Appellant also contends that the Examiner has improperly
extrapolated the data in Figure 4 in an effort to shown that the ring would
eventually have a release rate of less than 500 µg. Id. at 9.
We have considered Appellant's arguments and find them
unpersuasive. We do not agree with Appellant that Figure 4 would be
interpreted as reporting daily and not weekly release data. The data reported
in Figure 4 is consistent with the two Clinical Tests reported in Chen. In test
1, a vaginal ring containing Mifepristone was used by a patient from
November 13, 2000 to March 20, 2001. Chen ,r 90. Similarly, in test 2 the
patient used the vaginal ring containing Mifepristone from July 2000 to
October 2000. Id. ,r 92. Thus, both tests lasted at least 12 weeks, the same
time period reported in Figure 4.
Appellant's reliance of Figures 5 and 6 is misplaced. Those figures
report the release rated for Danazol, a different active substance. Paragraph
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Appeal2018-000302
Application 14/017,524
83, cited by Appellant at page 10 of the Appeal Brief, refers to yet another
active agent Raloxifene. Appellant has not pointed to any teaching in Chen
which would suggest that a vaginal ring with Mifeprestone would exhibit the
same release rate as the rings containing Danazol or Raloxifene.
Having concluded that Figure 4 teaches a weekly release rate rather
that a daily release rate, we agree with the Examiner that the weekly rate
correlates to a maximum average release rate of 170 µg. This rate is less
than 500 µg recited in claim 15 and within the range of 100 to 400 µg
recited in claim 20.
Appellant found that the Examiner presented an alternative argument
regarding anticipation based on the assumption that Figure 4 reported a daily
release rate as opposed to a weekly release rate. Appellant's remaining
arguments address this alternate argument. See Br. 10-11. As discussed
above, we find that Figure 4 teaches a weekly rate and not a daily rate.
Appellant's arguments regarding the Examiner's extrapolation of a daily rate
are not persuasive.
Claim 16
Claim 16 has not been separately argued and, therefore, falls with
claim 15. 37 C.F.R. § 4I.37(c)(l)(iv).
Claim 17
Appellant separately argues the patentability of claim 1 7. Claim 1 7
depends from claim 15 and adds the limitation that the active agent is mixed
throughout the vaginal ring. Br. 29 (Claims App'x).
In addition to reiterating the arguments made with respect to claim 15,
Appellant contends that the Mifepristone in the ring of Application 3 in
Chen is not mixed throughout the ring. Id. at 12-13. Appellant contends
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Application 14/017,524
that Chen discloses a structure where the Mifepristone is applied as a layer
on a ring and then covered with another layer of polymer. Br. 13 ( citing
Chen ,r,r 61-63, Fig. 2B).
In reply the Examiner argues that the term "'throughout"' is defined
to mean "'in or to every part."' Ans. 13. The Examiner contends that
application of a layer containing the active agent meets this definition in that
the layer is applied to every part. Id.
We have considered both arguments and find that Appellant has the
better position. The term at issue is not merely "throughout" but "mixed
throughout." We interpret this phrase to call for a mixture of the active
agent and polymer to be found throughout the structure, not in a discrete
layer.
This does not end out inquiry, however. The Examiner has also
rejected claim 17 as obvious over Chen. Chen teaches an embodiment
wherein the active agent is dispersed throughout vaginal ring. Chen ,r 42,
Fig. 2A. As discussed in Chen, Figure 2A discloses a vaginal ring with the
active agent dispersed within substantially all of the ring and a thin cover
over the ring. Chen ,r 39. One skilled in the art would use the design of
Figure 2A for a vaginal ring because is a simpler design as opposed to the
three layer construction used in Application 3. "It is ordinarily true that the
omission of an element and its function is uninventive. " In re Perrine, 111
F.2d 177, 178 (CCPA 1940).
While claim 17 is not anticipated by claim 1 7, we agree with the
Examiner that the subject matter of claim 17 would have been obvious over
Chen.
Claim 20
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Application 14/017,524
Claim 20 depends from claim 1 and narrow the range of active agent
released to 100 to 400 µg a day. Br. 29 (Claims App'x). Appellant contends
that Chen does not disclose a vaginal ring with a release rate within this
range. Id. at 14.
Appellant's argument is not persuasive. As discussed above, the
maximum daily release rate for the vaginal ring disclosed in Figure 4 of
Chen is 170 µg, well within the range recited in claim 20. Therefore, Chen
anticipates claim 20.
OBVIOUSNESS
The Examiner has rejected claims 15-17, 20, and 26 as obvious over
Chen.
As discussed above, we find that claims 15, 16, and 20 are anticipated
by Chen. Since Chen anticipates these claims, Chen also renders the claims
obvious. "[A] disclosure that anticipates under § 102 also renders the claim
invalid under§ 103, for 'anticipation is the epitome of obviousness."'
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Application 14/017,524
Connell v. Sears, Roebuck & Co., 722 F2d 1542, 1548 (Fed. Cir. 1983)
(quoting In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982)).
With respect to claim 17, we have addressed the issue of obviousness
in our discussion above.
We now address the issue of whether a preponderance of the evidence
supports the Examiner's conclusion that the subject matter of claim 26
would have been obvious over Chen.
Claim 26 depends from claim 20 and narrows the daily release rate to
a range of from 250 µg to 300 µg. Br. 30 (Claims App'x).
The Examiner finds
it would alternately have been obvious to one of ordinary skill
in the art at the time of the instant invention to explore the
optimal daily dosage to achieve treatment of uterine fibroids
(selection of initial daily doses, between the Figure 3 and
Figure 4 encompass a range to explore that includes the recited
ranges of claims 15, 20 and 26, including the narrower range of
claim 26, from 250-300 µg/day), while balancing minimization
of side effects and reducing cost of the drug, giving daily
dosages within the ranges of claims 15, 20 and 26, giving the
instant elected mifepristone vaginal rings. Chen teaches the
same therapeutic purpose as the instant application, treatment of
uterine fibroids; therefore routine optimization for the same
purpose would have arrived at the same daily dosing as a result
of this optimization process.
Final Act. 23.
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.
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Application 14/017,524
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.
Oetiker, 977 F.2d at 1445.
"[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 (CCPA 1955).
"To be particularly probative, evidence of unexpected results must
establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
one of ordinary skill in the art at the time of the invention." Bristol-Myers
Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
"Consistent with the rule that all evidence of nonobviousness must be
considered when assessing patentability, the PTO must consider comparative
data in the specification in determining whether the claimed invention
provides unexpected results." In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995);
see also In re Margolis, 785 F.2d 1029, 1031 (Fed. Cir. 1986). However,
"[i]t is well settled that unexpected results must be established by factual
evidence. Mere argument or conclusory statements in the specification does
not suffice." In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984); see also
In re Wood, 582 F.2d 638, 642 (CCPA 1978) ("Mere lawyer's arguments
and conclusory statements in the specification, unsupported by objective
evidence, are insufficient to establish unexpected results."); Soni, 54 F.3d at
750.
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Application 14/017,524
Analysis
We find the Examiner has established that the subject matter of claim
26 would have been obvious to one of ordinary skill in the art at the time the
invention was made over Chen. 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
Brief are waived. See 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv) (2015). We address
Appellant's arguments below.
Appellant's arguments are primarily based on the assumption that
Figure 4 of Chen discloses a daily release rate of 1200 µg and not a weekly
rate. See Br. 15-26. As discussed above, we have concluded that Figure 4
of Chen discloses a weekly release rate of 1200µg which equates to a daily
release rate of 170µg.
Appellant contends that Chen teaches a release rate for Mifepristone
significantly greater than 500 µg and that one skilled in the art would not be
motivated to use a lower dose ofMifepristone. Br. 16-18. We are
unpersuaded by this argument.
Chen teaches a daily release rate of 170 µg of Mifepristone. Chen,
Fig. 4; Final Act. 20. Chen also teaches that the prior art taught a ring that
had a maximum release rate of30 µg/day. Chen, Fig. 3. Chen goes on to
teach that it is an object of Chen to produce a vaginal ring that has a large
enough quantity of an active agent to be medically effective over time while
reducing the side effects associated with the active agent. Id. ,r,r 8, 14. We
agree with the Examiner that one skilled in the art would be motivated to
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Application 14/017,524
optimize the amount of Mifepristone to achieve maximum effectiveness with
a minimum degree of side effects. Final Act. 23.
Appellant argues that the claimed invention produces surprising and
unexpected results. Br. 17. Appellant contends that the present invention
permits the use of lower doses of active agent that traditional oral
administration. Id. Appellant also argues that the doses and treatment
periods recited in the Specification are unexpected shorter than that recited
in Chen. Id.
We have considered Appellant's arguments and are unpersuaded.
Other than the statement in the Brief, Appellant has offered no evidence that
the results achieved by the claimed invention are unexpected. In addition,
Appellant has not presented any evidence showing a comparison of the
claimed invention against the closet art, namely Chen. Absent actual
evidence, statements in the brief and attorney arguments are insufficient to
overcome a finding of obviousness.
Appellant's remaining arguments address the extrapolation by the
Examiner showing that even if Figure 4 recited daily release rates, the
vaginal rings would, at some point in time exhibit a release rate of less than
500µg. Br. 19-20. We find these arguments unpersuasive for the reasons
stated above.
Appellant also argues that Chen teaches away from the claimed
invention. Id. at 21. Appellant's argument is based on the assumption that
Chen teaches a daily release rate of 1200µg of Milfepristone in Figure 4 and
that Chen teaches maximizing the dosage of active agent. Id.
Again we find this argument unpersuasive as Chen does not criticize,
discredit, or otherwise discourage the use of the claimed dosage range. In re
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Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). In fact, as discussed above,
Chen does the opposite. Figure 4 of Chen does not teach a daily release rate
of greater than 500 µg but in fact teaches a lower daily amount, 170µg.
Final Act. 20. This lower amount, coupled with the teaching in Chen to
maximize the amount while reducing side effects would lead one skilled in
the art to optimize the amount of Mifepristone to arrive at the range of
Mifepristone recited in claim 26.
Conclusion
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of the claims would have been
obvious over Chen.
DECISION
We affirm the first rejection of claims 15-17 and 20 under 35 U.S.C.
§ 102(b).
We affirm the second rejection of claims 15, 16, and 20 under
35 U.S.C. § 102(b).
We reverse the second rejection of claim 17 under 35 U.S.C. § 102(b).
We affirm the rejection of claims 15-17, 20, and 26 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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