Ex Parte Horstmann et al

Patent Trial and Appeal Board

Nov 30, 2018

12302065 (P.T.A.B. Nov. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/302,065 12/11/2008
38263 7590 11/30/2018
ProPat, LLC
1794 Deer Park Lake Road
Spruce Pine, NC 28777
FIRST NAMED INVENTOR
Michael Horstmann
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.
06/023LTS 4273
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
11/30/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL HORSTMANN, MOHAMMAD SAMET!,
and TOBIAS JUNG
Appeal2017-010600
Application 12/302,065
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Michael Horstmann, Mohammad Sameti, and Tobias Jung
("Appellants") 1 appeal under 35 U.S.C. § 134(a) from the Examiner's final
decision rejecting claims 1-6 and 9-27. We have jurisdiction under
35 U.S.C. § 6(b ).
We reverse.
1 The real party in interest is identified as LTS Lohmann Therapie-Systeme
AG. Appeal Br. 3.
Appeal2017-010600
Application 12/302,065
STATEMENT OF THE CASE
The Specification
According to Appellants, their invention
relates to a transdermal therapeutic system, preferably as
transdermal patch, which has an active ingredient-containing
matrix which consists substantially of a water-insoluble base
material such as, for example, rubber and synthetic polymers,
into which water-soluble and/or water-swellable inclusion
bodies, e.g. composed of polyvinyl alcohol or polyethylene
glycol, which comprise micronized or nanoscale active
ingredient particles are incorporated.
Spec. at [57]. A benefit or object of their invention over prior art
transdermal therapeutic systems is "increased active ingredient flux ... ,
improved stability, improved uniformity in the provision of the increased
active ingredient flux and less use of excipients." Spec. 5:20-26.
The Rejected Claims
Claims 1---6 and 9-27 stand rejected. Final Act. 1. Of those, claims 1
and 22 are independent. Appeal Br. 35, 37--40. Claim 1 is representative
and reproduced below.
1. A transdermal therapeutic system with an active
ingredient-containing matrix comprising an essentially water-
insoluble base material having inclusion bodies which are
separated from one another, said inclusion bodies formed from
water-soluble or water-swellable material containing active
ingredient particles dispersed inside or suspended inside said
water-soluble or water-swellable material, wherein said active
ingredient particles are micro- or nanoparticles, said active
ingredient, in the state prior to the application of the
transdermal therapeutic system to the skin, is neither liquid nor
dispersed or suspended in liquid, the active ingredient particles
have a size that is less than 20 % of the particle size of the
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inclusion bodies, and the active ingredient has a melting point
above 50 QC.
Appeal Br. 35.
The Appealed Rejections
The following rejections are before us for review:
1. claims 1---6, 9, 10, and 12-27 under 35 U.S.C. § 103 as
unpatentab le over Becher ,2 Asmus, 3 Watanabe, 4 Weinreich, 5 and
Horstmann6 (Final Act. 2-8); and
2. claims 11 and 24 under 35 U.S.C. § 103 as unpatentable over
the same references (id. at 8-9). 7
DISCUSSION
Rejection 1
The Examiner rejected claims 1---6, 9, 10, and 12-27 under 35 U.S.C.
§ 103 as unpatentable over Becher, Asmus, Watanabe, Weinreich, and
Horstmann. Final Act. 2-8. The Final Action discusses what these five
references allegedly teach but does not articulate how a person of ordinary
2 US 2004/0191281 Al, published Sept. 20, 2004 ("Becher").
3 US 5,270,358, issued Dec. 14, 1993 ("Asmus").
4 US 2004/0091542 Al, published May 13, 2004 ("Watanabe").
5 US 6,440,336 Bl, issued Aug. 27, 2002 ("Weinreich").
6 US 5,230,898, issued July 27, 1993 ("Horstmann").
7 The Final Action articulates the rejections differently but it is understood to
include typographical errors in that regard. For example, Rejection 1 refers
to Becher "as applied to claims 1---6, 9, 10 and 12-18, 20-22, and 25 above."
Final Act. 2. However, there is no application of Becher "above."
Additionally, Rejection 2 explicitly encompasses claims 1---6, 9-18, 20-22,
24, and 25, but then proceeds to discuss only claim 8, which is cancelled,
and claims 11 and 24. Compare id. at 8, with id. at 9.
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Application 12/302,065
skill in the art allegedly would have combined those teachings, let alone a
reason for doing so. See Final Act. 2-8; KSR Int 'l Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007) ("[R]ejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." (quoting In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006))); Belden Inc. v. Berk-TekLLC, 805 F.3d 1064, 1073 (Fed. Cir.
2015) ("[O]bviousness concerns whether a skilled artisan not only could
have made but would have been motivated to make the combinations or
modifications of prior art to arrive at the claimed invention.").
Instead, after identifying certain teachings in the five relied-upon
references, the Final Action merely states:
It would have been obvious to one of ordinary skill in the
art, at the time the invention was made, to combine the
disclosures of Becher and Watanabe to arrive at the invention of
claims 1 and 22 because nano-sized particles of active agents
exhibit improved dispersibility, good stability, and more
accurate delivery of the active agents into the targeted sites (see
above).
Final Act. 8. This is a conclusory statement, insufficient under KSR and the
like.
The statement, which mentions only two of the five relied-upon
references, fails to explain how the prior art teachings would have been
combined or a reason why a person of ordinary skill in the art allegedly
would have done so.
"An examiner bears the initial burden of presenting a prima facie case
of obviousness." In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
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2011 ). The Examiner here has failed to meet that burden. For this reason,
we reverse the rejection.
Additionally, we are persuaded by Appellants' arguments that the
Examiner has not shown how the prior art meets at least one limitation of the
independent claims, as explained next.
Claims 1 and 22: "said active ingredient, is neither liquid
nor dispersed or suspended in liquid"
Becher "relates to administration forms for transdermal, transmucosal
or epicutaneous (topic) application of active substances, such as transdermal
therapeutic systems (TTS), topic active substance plasters or transmucosal
therapeutic systems." Becher ,II. It discloses a "matrix" having "a plurality
of particles containing open-pores or capillary spaces, said particles serving
as active substance reservoir." Id. ,I8. Ultimately, "the pores or capillary
spaces are filled with active substance liquid or solution." Id. ,I32.
Independent claims 1 and 22 recite "said active ingredient, in the state
prior to the application of the transdermal therapeutic system to the skin, is
neither liquid nor dispersed or suspended in liquid." (Emphasis added).
The Examiner found that Becher meets this limitation because it
teaches that the loaded particles may be subject to a drying
process to remove any remaining residues of liquid or solvent
(see [0032]). (See also [0053] and [0055], explaining that active
substance in liquid state is preferred (i.e. not required) and
[0057], explaining that the medicament may be in the form of a
gel).
Final Act. 3 (bracketed content in original). We are not persuaded by the
Examiner's interpretation of Becher.
Becher discloses filling the capillaries or pores of the particles with
"liquid active substance." Id. ,I32 (emphasis added). Thereafter, "the loaded
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particles can be separated from the excess active substance fluid or solution"
and subjected to "a drying process to remove any remaining residues of
liquid or solvent." Id. What is dried are "residues of liquid or solvent," not
the liquid active substance that has been loaded into the capillaries or pores.
Id. Moreover, whatever is dried is removed. Id. Thus, if Becher were
teaching that all of the liquid active substance, including that in the
capillaries or pores, is dried, it would teach that the active substance would
be removed. Id.
The Examiner has not shown that Becher, or any other reference,
teaches particles containing active ingredient that is "is neither liquid nor
dispersed or suspended in liquid," as required by the independent claims.
For this additional reason, we reverse the rejection of claims 1 and 22, as
well as dependent claims 2---6, 9, 10, 12-21, and 23-27. See In re Fritch,
972 F.2d 1260, 1266 (Fed. Cir. 1992) ("[D]ependent claims are nonobvious
if the independent claims from which they depend are nonobvious.").
Rejection 2
The Examiner rejected claims 11 and 24 as unpatentable over the
same references as in Rejection 1. Final Act. 8-9. Claims 11 and 24 depend
from claim 1. Because we reverse the rejection of claim 1 over the same
prior art references, we likewise reverse the rejection of claims 11 and 24.
See In re Fritch, 972 F.2d at 1266.
CONCLUSION
For the reasons discussed, we reverse the Examiner's rejections of
claims 1---6 and 9-27.
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REVERSED
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