Ex Parte Chen et al

Patent Trial and Appeal Board

Nov 30, 2017

14214377 (P.T.A.B. Nov. 30, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/214,377 03/14/2014 Guohua Chen 091500-0501/8131.US00 5336
108547 7590 12/04/2017
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
EXAMINER
BOWMAN, ANDREW J
ART UNIT PAPER NUMBER
1717
NOTIFICATION DATE DELIVERY MODE
12/04/2017 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):
mweipdocket @ mwe. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte Ex parte GUOHUA CHEN,
ZHONGLI DING, ESI GHARTEY-TAGOE,
ASHUTOSH SHASTRY, ROBERT WADE WORSHAM,
and PARMINDER SINGH
Appeal 2017-004741
Application 14/214,377
Technology Center 1700
Before MICHAEL P. COLAIANNI, GEORGE C. BEST, and
N. WHITNEY WILSON, Administrative Patent Judges.
WILSON, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision finally rejecting claims 1—11 and 13—26. We have jurisdiction over
the appeal under 35 U.S.C. § 6(b).
We reverse.
1 The real party in interest is said to be Corium International, Inc. (Appeal
Br. 1).
Appeal 2017-004741
Application 14/214,377
BACKGROUND
The ’377 Application is directed to a method of making an array of
microstructures (Spec. 111). According to the Specification, such
microstructures may be used as a delivery system for transdermally
administering a therapeutic agent, drug, or vaccine {id. at 12). Independent
claim 1 is representative of the claims on appeal, and is reproduced below
from the Claims Appendix to the Appeal Brief:
1. A method of making an array of microstructures
comprising:
(a) dissolving or suspending at least one therapeutic
agent and at least one polymer in one or more solvents to form
a polymer matrix solution or suspension;
[(]b) dispensing the polymer matrix solution or
suspension on a mold having an array of microstructure
cavities;
(c) filling the micro structure cavities in the mold with
the polymer matrix solution or suspension;
(d) removing excess polymer matrix solution or
suspension on the mold surface;
(e) a first drying step comprising drying the polymer
matrix solution or suspension at a temperature of about 5—50° C
in a chamber having a partial pressure of water of about 0.01
mTorr to about 203 Torr or a relative humidity of about 50-
95% for about 5—30 minutes;
(f) a second drying step comprising drying the
polymer matrix solution or suspension at about 5—50° C for
about 30 minutes in an oven without controlled partial pressure
of water or relative humidity to form an array of
microstructures; and
(g) drying the microstructures under vacuum at about
5-50° C.
Appeal Br. 11 (Claims App.)).
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Application 14/214,377
REJECTIONS
(1) Claims 1—11 and 13—26 under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement.
(2) Claims 1—7, 10, 11, 13, and 15—26 under 35 U.S.C. § 103(a) as
unpatentable over Singh.2
(3) Claims 8 and 9 under 35 U.S.C. § 103(a) as unpatentable over
Singh in view of Sagi.3
(4) Claim 14 under 35 U.S.C. § 103(a) as unpatentable over Singh
in view of Young.4
DISCUSSION
Rejection (1)
The Examiner finds that the Specification as filed does not describe,
within in the meaning of § 112, the limitation of claim 1 requiring that the
second drying step to take place “in an oven without controlled partial
pressure of water or relative humidity” (Final Act. 2).
To satisfy the written description requirement of § 112, the
Specification must allow a person of ordinary skill in the art to recognize
that the inventor invented what is claimed. In re Gosteli, 872 F.2d 1008,
1012 (Fed. Cir. 1989). The Specification must reasonably convey to a
person of ordinary skill in the art that the inventor had possession of the
2 Singh et al., U.S. Patent Pub. No. 2011/0276028 Al, published November
10, 2011.
3 Sagi et al., U.S. Patent Pub. No. 2011/0006458 Al, published January 13,
2011.
4 Young, U.S. Patent Pub. No. 2006/0108914 Al, published May 25, 2006.
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Application 14/214,377
claimed subject matter as of the filing date. Ralston Purina Co. v. Far-Mar -
Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985); see also Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The Specification,
however, need not describe the claimed subject matter word-for-word. In re
Wertheim, 541 F.2d257, 262 (CCPA 1976).
The Examiner acknowledges that although the Specification “does
have circumstances wherein there is no humidity control. . . , this is not the
same as particularly excluding the use of humidity control in the second
drying step” (Final Act. 2). However, as noted above, the Specification need
not describe the claimed subject matter word for word in order to comply
with the written description requirement.
We agree with Appellants that, even in the absence of an express
statement expressly excluding control of the relative humidity, one of skill in
the art would reasonably infer from the Specification that the second drying
step does not necessarily include such control. As noted by Appellants, the
Specification discloses and exemplifies a first drying step chamber with
controlled partial pressure of water or relative humidity (Appeal Br. 3, citing
Spec. 175; see also Reply Br. 3—4, citing Spec. 1102). We note that the
Specification discloses that “controlling humidity at least during the primary
drying step results in microstructures that dissolve evenly” (Spec. 177,
emphasis added). The Specification further discloses that the mold is then
removed from the first drying step chamber and placed in an oven for the
second drying step (id. at || 75, 91, 102). Based on this disclosure, we find
that the Specification describes, within the meaning of § 112, a second
drying step oven without control of humidity or partial pressure.
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Application 14/214,377
Accordingly, we reverse the rejection of claims 1—11 and 13—26 under
35 U.S.C. § 112(a).
Rejections (2TT4)
The Examiner finds that Singh discloses drying a mold in an incubator
at 32° C for 30 minutes (Final Act. 4, citing Singh Example 3). The
Examiner further finds that Singh discloses each of the limitations of claim 1
except that Singh does not teach drying by “both controlled step (e) and
uncontrolled step (f) wherein the two steps have a combined run time of
about 35 minutes to an hour” (Final Act. 5). However, the Examiner
determines that a person of skill in the art “would have realized that the
length of a drying operation directly affects the overall dryness and therefore
the material properties and release rate of a coating produced” (id.). Thus,
according to the Examiner, the ordinary skilled artisan would have
optimized Singh’s drying time in order to control such material properties
and release rate (id.).
The Examiner further finds that “the only distinction between the two
steps is the control of the partial pressure in the first and a lack thereof in the
second” (Ans. 4). Thus, according to the Examiner, Singh’s single drying
step “can reasonably read on either or both steps . . .” (id.).
Appellants argue, inter alia, the Examiner’s mere assertion
that the single drying step as taught by Singh approaches a drying
time similar to that in claimed steps (e) and (f) disregards the fact
that the claim requires two distinct drying steps with different
drying conditions, and nowhere does Singh show or suggest a
method having two separate drying steps having separate
conditions (controlled and then uncontrolled).
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(Appeal Br. 6—7). Specifically, Appellants assert that the Examiner’s
finding that Singh’s oven inherently possesses the requisite control over
partial pressure is based “on unfounded assumptions about the prior art (e.g.,
that volume is not relevant. . .)” (id. at 6, citing Final Act. 5; Adv. Act. 2).
Appellants further argue that the Examiner has not established that “ovens
necessarily control humidity as would be required to establish a prima facie
case of obviousness based on inherency” (Appeal Br. 7). Furthermore,
Appellants contend that the Examiner reversibly erred in concluding that
“Singh inherently discloses ... a second drying step with no control over
these parameters based on the technically simplistic calculations proffered
that fail to consider all variables in a system” (id.).
Appellants’ arguments are persuasive.
It is well understood that to reject a claim in a patent application as
obvious under 35 U.S.C. § 103(a), the Examiner must establish a prima facie
case of obviousness, which includes a showing that each of the claimed
limitations are either shown or suggested by the prior art. “In the absence of
a proper prima facie case of obviousness, an applicant who complies with
the other statutory requirements is entitled to a patent.” In re Rouffet, 149
F.3d 1350, 1355 (Fed. Cir. 1998). In this instance, the Examiner’s statement
that the control of partial pressure in the first drying step and lack thereof in
the second step is “the only distinction between the two steps” is incorrect
(Ans. 4). There is another distinction—claim 1 requires a first drying step in
a chamber having control over partial pressure or relative humidity and a
second drying step in an oven without controlled partial pressure or relative
humidity. Moreover, the record evidence is silent as to any finding that the
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applied prior art teaches or suggests sequential drying steps of controlled
relative humidity and then uncontrolled relative humidity.
Therefore, we agree with Appellants that the Examiner has not
persuasively shown that Singh’s single drying step discloses, teaches, or
suggests a method having two separate drying steps: (i) the first having
controlled partial pressure of water or relative humidity and (ii) the second
without such control. Accordingly, we reverse the obviousness rejection
over Singh (Rejection (2)).
With respect to Rejections (3) and (4), which recite the combination
of Singh with various secondary references, the Examiner does not rely on
any of the secondary references to address a method having two separate
drying steps, one having controlled conditions and the other having
uncontrolled conditions, discussed above. Accordingly, we also reverse
these rejections.
CONCLUSION
We REVERSE the rejection of claims 1—11 and 13—26 under 35
U.S.C. § 112(a), as failing to comply with the written description
requirement.
We REVERSE the rejection of claims 1—7, 10, 11, 13, and 15—26 under
35 U.S.C. § 103(a) as unpatentable over Singh.
We REVERSE the rejection of claims 8 and 9 under 35 U.S.C.
§ 103(a) as unpatentable over Singh in view of Sagi.
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We REVERSE the rejection of claim 14 under 35 U.S.C. § 103(a) as
unpatentable over Singh in view of Young.
REVERSED
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