Ex Parte Jaenichen et al

Patent Trial and Appeal Board

Dec 7, 2016

11326479 (P.T.A.B. Dec. 7, 2016)

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.
11/326,479 01/06/2006 Jan Jaenichen 3321-P28874 9574
13897 7590
Abel Law Group, LLP
8911 N. Capital of Texas Hwy
Bldg 4, Suite 4200
Austin, TX 78759
12/09/2016 EXAMINER
LAZARO, DOMINIC
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
12/09/2016 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):
mail @ Abel-IP.com
hmuensterer @ abel-ip. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAN JAENICHEN, GUENTHER SACHAU,
CARSTEN HARTKOPF, and THORSTEN BERG
Appeal 2015-005528
Application 11/326,479
Technology Center 1600
Before DEMETRA J. MILLS, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134. The Examiner has rejected
the claims for indefiniteness and obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE-IN-PART.
Appeal 2015-005528
Application 11/326,479
STATEMENT OF CASE
According to the Specification, “The present invention relates to a skin
or wound contact material or pad with wound healing promoter substances
and/or skin care substances which are present in encapsulated form in the
material and which controllably deliver the substance only with contact with
the wound secretion or moisture.” Spec. 1.
The Specification discloses:
The direct introduction of numerous wound healing promoter
substances and/or skincare substances into the matrix, in particular into
the polymer matrix, is not possible prior to the crosslinking reaction
thereof, since these substances possess active hydrogen atoms
(hydroxyl, amino or acid groups) which would co-react in the
crosslinking reaction, during polyurethane formation for example. The
consequences would be an under-crosslinked matrix and covalently
bonded actives no longer available for wound healing or skin care.
This problem can be remedied in accordance with the invention
by introducing the wound healing promoter or skin care actives into
the reaction mixture in encapsulated form at the same time removing
them from the crosslinking reaction.
Spec. 25. In a preferred embodiment, the polycondensate matrix is a
polyurethane (Spec. 4) and water-absorbing polymer A is a cross-linked
polyacrylic acid (Spec. 9—10).
The following claims are representative.
45. A skin or wound contact material, wherein the
material comprises a polycondensate matrix and a water­
absorbing polymer A incorporated therein, the polymer A being
doped with at least one of a wound healing promoter substance
B and a skin care substance C and the polycondensate matrix
being not doped with the at least one of substance B and
substance C.
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47. The skin or wound contact material of claim 45,
wherein the polymer A has been doped at least by incorporation
of the at least one of substance B and substance C into the
polymer A at least one of before a beginning of a
polymerization of the polymer A and before an end of a
formation of the polymer A.
48. The skin or wound contact material of claim 47,
wherein the polymer A has been doped at least by incorporation
of the at least one of substance B and substance C into the
polymer A at least before a beginning of a polymerization of
the polymer A.
56. The skin or wound contact material of claim 45,
wherein the at least one of substance B and substance C is
homogeneously distributed within the polymer A.
60. The skin or wound contact material of claim 45,
wherein the polycondensate matrix is transparent.
69. The skin or wound contact material of claim 45,
wherein the polymer A exhibits one or more of
Al) a particle size distribution wherein at least 80% by
weight of particles have a size of from 10 pm to 900 pm,
determined according to ERT 420.1-99;
A2) a centrifuge retention capacity (CRC) of at least 10
g/g, determined according to ERT 441.1-99;
A3) an absorption against pressure (AAP) at 0.7 psi of at
least 4g/g, determined according to ERT 442.1-99;
A4) a water-soluble polymer content after a 16 hour
extraction of less than 25% by weight, based on a total weight
of the water-absorbing polymer, determined according ERT
470.1-99;
A5) a residual moisture content of not more than 15% by
weight, based on a total weight of the water-absorbing polymer,
determined according ERT 430.1-99.
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78. The skin or wound contact material of claim 45,
wherein the at least one of substance B and substance C
comprises coenzyme Q10.
79. A skin or wound contact material, wherein the
material comprises a self-adhesive, air and water vapor
permeable polyurethane matrix and a water-absorbing polymer
A incorporated therein, the polymer A comprising at least 50%
by weight of one or more carboxylate group containing
monomers and being doped with at least one of a wound
healing promoter substance B and a skin care substance C and
the polyurethane matrix being not doped with the at least one of
substance B and substance C.
80. The skin or wound contact material of claim 79,
wherein at least a part of the polymer A is covalently bonded to
the polyurethane matrix.
Grounds of Rejection
1. Claim 69 is rejected under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112
(pre-AIA), second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter which the
inventor or a joint inventor, or, for pre-AIA, that applicant regards as
the invention.
2. Claims 45—54, 58, 59, 61—70, 74, 76—82, and 86—89 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Mertens in view of
S chink.
3. Claims 56, 57, 71—73, 75, and 83—85 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Mertens in view of Schink and
Ueda.
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4. Claim 60 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Mertens in view of Schink and Ahrens.
Cited References
Ahrens et al. US 2002/0156411 Al Oct. 24, 2002
(“Ahrens”)
Ueda et al. US 2003/0004479 Al Jan. 2, 2003
(“Ueda”)
Schink et al. US 2004/0161454 Al Aug. 19, 2004
(“Schink”)
Mertens et al. US 2008/0021131 Al Jan. 24, 2008
(“Mertens”)
Mertens DE 100 43 710 Al Mar. 21,2002
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 2—23.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
1 “Since DE 10043710 A to Mertens et al. and WO 02/102358 A1 to Schink
et al. are in German, US 2008/0021131 Al and US 2004/0161454 Al are
respectively relied upon as an English language equivalents to which
paragraph numbers refer.” Ans. 4.
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“[OJviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Rejection 1 - indefiniteness
We agree with the Examiner’s fact finding (and adopt the same),
statement of the rejection and responses to Appellants’ arguments as set
forth in the Answer. We find that the Examiner has provided evidence to
support a prima facie case of indefmiteness. We provide the following
additional comment to the Examiner’s argument set forth in the Final
Rejection and Answer.
The Examiner finds that:
Claim 69 recites properties of the wound contact material
that must be determined by specific tests, such as ERT 420.1-
99, ERT 441.1-99, etc. The abbreviation ERT is defined in
paragraph [0191] of the published application (US
2006/0182787 Al), but the steps involved in the test
procedure(s) required to determine the various claimed
parameters are not described in the specification. As the
methods by which these properties are determined are essential
for determining whether or not a composition falls within the
scope of the current claims, patentability of the full scope of
these claims cannot be properly determined. For example, it is
unclear whether the particle size determined by ERT 420.1-99
is a number, size, weight or average diameter and what is
specifically determined in this test.
Ans. 2.
Appellants contend that:
Appellants point out that the test methods recited in claim
69 are not methods which have been designed by Appellants
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but were published in the form of a standard (and are thus,
necessarily in the public domain). It is noted that the Examiner
takes the position that “the burden is on Applicants, not the
USPTO, to provide evidence showing that the ERT 420.1-99
and ERT 441.1-99, and other ERT parameters recited would
surely be understood by the skilled artisan.” In response it is
submitted that the Office has yet to establish facts which would
make it prima facie reasonable to assume that the skilled artisan
is unable to find out and understand what the test methods set
forth in these standards are.
App. Br. 6.
ANALYSIS
We are not persuaded by Appellants’ arguments. “It is the applicants’
burden to precisely define the invention, not the PTO’s. See 35 U.S.C.
§ 112,12. . . . [T]his section puts the burden of precise claim drafting
squarely on the applicant.” In re Morris, 127 F.3d 1048, 1056, 44 USPQ2d
1023, 1029 (Fed. Cir. 1997). But, we recognize that, “[i]n the prosecution of
a patent, the initial burden falls on the PTO to set forth the basis of any
rejection, i.e., a prima facie case” Hyatt v. Dudas, 492 F.3d 1365, 1369
(Fed. Cir. 2007).
We agree with the Examiner that, once a prima facie case for
indefmiteness is established, as it has been,
the burden is on appellants, not the USPTO, to provide
evidence showing (that the ERT 420.1-99 and ERT 441.1-99,
and other ERT parameters recited would surely be understood
by the skilled artisan), in the form of a citation with a
publication (or availability) date, in order to establish that there
are no other versions, updates, etc. that have ever been made to
the recited ERT methods (i.e., does ERT 420.1-99 only refer to
one set of parameters, or could it refer to different versions of
these parameters?). To date, appellants have provided no such
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evidence. It is again noted that appellants’ 12/08/2009
Remarks (at p. 15, par.l) noted
http:// www.edana.org/Content/Default. asp?PagelD= 12,
as an example of the recited ERT methods. However, the
referenced internet content is not currently available, nor is the
referenced content available at the internet archive. In this
respect, appellants’ continued failure to provide appropriate
evidentiary references weighs in favor of the indefiniteness of
the claims. If appellants themselves cannot readily locate the
allegedly publicly available method information, then it is
unclear as to how others could be expected to do so.
Ans. 16—17. The Examiner determined that the claim was indefinite and
attempted to locate the ERT methods recited in the claim, but was unable to
do so and reasonably assumed that they were not readily available to a
person of ordinary skill in the art. When the Examiner was also seemingly
unable to locate the method standard, the burden of proof shifted to
Appellants to provide the evidence for the record. “[W]hen a prima facie
case is made, the burden shifts to the applicant to come forward with
evidence and/or argument supporting patentability.” In re Glaug, 283 F.3d
1335, 1338 (Fed. Cir. 2002). This the Appellants did not do. As one of skill
in the art must understand the ERT standard in order to comprehend the
metes and bounds of claim 69, but this information is shown by the
Examiner to not be readily available based on the record before us, we
affirm the Examiner’s indefmiteness rejection.
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Rejection 2
Claims 45—54, 58, 59, 61—70, 74, 76—82, and 86—89 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Mertens in view of Schink.
Schink discloses:
a self-adhesive, surface-doped active ingredient-containing matrix
patch for controlled delivery of active ingredients to the skin having an
absorbent, self-adhesive matrix, where the active ingredient is applied in
dissolved or liquid form to the side of the matrix intended for skin or wound
contact.
Schink Abstract. According to Schink, backing layers are absorbent, self-
adhesive polymers which are preferably polyurethanes, which may be in
foam for and which may also include fillers or fibers such as absorbent
materials. Id. H 30, 139. Superabsorbents may be added to the matrix. Id.
98, 139, 143. The resulting polyurethane backings comprising the
superabsorbents are covered with active ingredient solutions and doping of
the matrix. Id. H 26—28, 163.
Mertens discloses superabsorbent polymers with improved properties.
Mertens 121. Mertens discloses that a superabsorbent soak up ply of an
absorbent hygiene product contains superabsorbent materials and fibrous
materials including polyurethanes, and may also contain a polyurethane
cover. Id. H 59, 61—62. The superabsorbents of Mertens may be carriers of
active substances having a delayed release. Id. 1 84.
The Examiner concludes that:
it would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to take Martens’ [sic]
absorbent polymer in a polyurethane matrix and incorporate
active substances such as coenzyme Q10 and dexpanthenol, as
taught by per Schink. One would have been motivated to do so
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with a high expectation of success since both Martens [sic] and
Schink are concerned with similar problems in the art, namely
the incorporation of absorbents (Mertens, par. [0024]-[0029],
[0042]; Schink. par. [0132] and [0098]) and active substances
(Mertens, par. [0083]; Schink, abstract) into materials such as
polyurethane (Mertens, par. [0061]-[0062]; Schink. par. [0104]-
[0110], [0122]-[0134]) for articles including wound coverings
(Martens, par. [0057]; Schink, abstract). Also, Schink notes the
desirability of incorporating active ingredients which react with
reactive polymer systems such as polyurethane (Schink. par.
[0029] and [0097]) by coating processes such as Accu gravure
or flexographic printing (Schink. par. [0026]-[0027]), whereas
Martens discloses the incorporation of active substances into
absorbent polymers (Mertens, par. [0083]). In this respect, it is
well within the skill of the ordinary artisan to select appropriate
active substances for the incorporation into a wound contact
material and to take appropriate precautions for active
ingredients that may react with one or more of the forming
substances, e.g., the polycondensate matrix. Doing so amounts
to no more than combining prior art elements according to
known methods to yield predictable results, namely the
incorporation of active substances into absorbent particulates
for further incorporation into a polyurethane matrix, thus
obtaining the advantage of incorporating active ingredients so
that they are protected from reacting with the polyurethane
system (Schink. par. [0029]), e.g., dexpanthenol (Schink, par.
[0097]).
Final Act. 9—10.
Appellants contend that:
SCHINK, while mentioning both superabsorbents and active
ingredients, neither teaches nor suggests doping the superabsorbents
with the active ingredients (on the contrary, SCHINK expressly
teaches the optional presence of superabsorbents inside the matrix and
the presence of active ingredients on the outside of the matrix).
Reply Br. 19.
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ANALYSIS
We find that the Examiner has not set forth a prima facie case of
obviousness over Mertens in view of Schink. We are persuaded by
Appellants’ arguments that the Examiner has not shown that the
polycondensate is not doped, as claimed.
Claim 45 includes the limitation that, “the polycondensate matrix
being not doped with the at least one of substance B and substance C.”
What is missing from the Examiner’s analysis is a citation to disclosure in
the cited prior art of, or motivation for, doping only the superabsorbent
water-absorbing polymer A, while also not doping the polycondensate
matrix. Schink discloses polyurethane backings covered with active
ingredient solutions. Schink 1163. Schink further discloses that application
of the active ingredient may be by a coating or printing process, or by a
process where the active ingredient is put onto the surface of an adhesive
layer and penetrates in to the polymer matrix. Id. 26—27. The Examiner
fails to point to a disclosure in either Schink or Mertens where only the
water-soluble polymer A is coated with the active ingredient and not the
polycondensate, or indicate why one of ordinary skill in the art would have a
reason not to coat (dope) the polycondensate with active ingredient.
Rejection 2 is reversed. Rejections 3 and 4 are reversed for the same
reasons as rejection 2.
CONCLUSION OF LAW
The Examiner’s indefiniteness rejection is affirmed. Obviousness
rejections 2-4 are reversed.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
RE VERSED-IN-PART
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