Ex Parte 7034083 et al

Board of Patent Appeals and Interferences

Feb 22, 2011

90008491 (B.P.A.I. Feb. 22, 2011)

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.
90/008,491 03/22/2007 7034083 KUZ-0019 6986
50571 7590 02/22/2011
THE HARRIS FIRM
922 N STREET , NW STE . 101
WASHINGTON, DC 20001
EXAMINER
DIAMOND, ALAN D
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
02/22/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte TAKASHI YASUKOCHI, TOSHIRO
YAMAGUCHI, TETSURO TATEISHI,
and NARUHITO HIGO
____________________

Appeal 2011-000986
Reexamination Control No. 90/008,491
Patent 7,034,083
Technology Center 3900
____________________

Before: RICHARD E. SCHAFER, ROMULO H. DELMENDO, and
MICHAEL P. TIERNEY, Administrative Patent Judges.
SCHAFER, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2011-000986
Control 90/008,491

2
Hisamatsu Pharmaceutical Co., Inc. (Appellant) appeals the final
rejection of Claims 1 and 3-10. 35 U.S.C. §§ 134(b) and 306. We have
jurisdiction. 35 U.S.C § 6(b).
We affirm.
Background
A decision on the merits affirming all grounds of rejections during the
reexamination of Appellant’s patent was previously entered in this appeal.
One of the issues Appellant raised related to the permissible scope of
reexamination during the course of the proceeding following an
unchallenged initial order for reexamination:
The rejection of claims 1, 3, 4, 6 and 8-10 over Tsubota
alone, does not support a substantial new question of
patentability ("SNQ"), which is required for each rejection
during Reexamination under 35 U.S .C. § 303(a) . . . .
Br. 18. The Examiner held that the question was petitionable, i.e.,
procedural, and not reviewable by the Board. Ans. 23. Our earlier opinion
agreed with the Examiner. We held that the issue was not related to the
threshold condition of initiating a reexamination - a substantial new
question of patentability. Rather Appellant was actually challenging the
propriety of entry of a particular rejection made during the course of a
properly initiated reexamination. We stated:
We are unaware of any statutory or delegated authority
that would allow us to review the decision to enter a
particular rejection in a properly initiated reexamination.
Challenges to the Director's statutory authority to conduct
the reexamination and enter a particular rejection must be
made to the Director or the Director's designee, not to this
board.
BPAI Decision, Appeal 2009-015332, mailed June 15, 2010 p. 10.
Appeal 2011-000986
Control 90/008,491

3
Shortly after our decision was entered the Director delegated certain
matters related to ex parte reexamination and the existence of substantial
new question of patentability to the Chief Administrative Patent Judge.
Notice, Clarification on the Procedure for Seeking Review of a Finding of a
Substantial New Question of Patentability in Ex Parte Reexamination
Procedures, 75 Fed. Reg. 36,357 (June 25, 2010). In light of the notice we
withdrew our opinion in order to consider the effect of the notice on our
decision. Subsequently we issued an order under 37 CFR § 41.50(d)
requiring further briefing. Order issued September 9, 2010. Both Appellant
and the Examiner filed supplemental briefs.
Decisions
For the reasons detailed below enter the following decisions:
1. We remain of the view that the question --whether a particular
rejection made during the course of a properly initiated reexamination should
not be entered because that rejection is outside the scope permitted by the
reexamination statute-- is procedural and petitionable and therefore not
before us;
2. The Director’s Notice did not delegate authority to the Board to
review the examiner’s decision to enter a particular rejection of the type
made here because it is outside the scope permitted for ex parte
reexamination;
3. We affirm the rejections of Claim 1 and 3-10 under 35 U.S.C. §
103(a).
Statement of the Case
An examiner finally rejected the claims under 35 U.S.C. § 103(a)
relying on the teachings of the following prior art:
Appeal 2011-000986
Control 90/008,491

4
5,049,417 Tsubota
5,344,655 Sakai
3,221,745 Coover
4,190,492 Eckert
4,544,699 Biale
Ans. 4.
The examiner entered four rejections relying on (1) Tsubota alone2
and Tsubota combined with (2) Sakai and Coover,3 (3) Eckert and Biale,4
and (4) Sakai, Coover, Eckert, and Biale.5 Ans. 6-14.
The Claimed Subject Matter
The claimed subject matter relates to adhesive compositions. The
adhesives are a type that may incorporate drugs for epidermal
administration, for example, as part of a drug-delivery patch. In relevant
part, Claim 1, the sole independent claim, is directed to:
An adhesive . . . said adhesive comprising a polymer
consisting of [two classes of specified monomers] . . . the
polymer is crosslinked by boric acid or a boric acid
derivative, and substantially no water is used in
production of the adhesive.
Br. 29. Claim 1 is reproduced in its entirety in the margin with indenting
added. 6 The specific monomers recited in Claim 1 that make-up the
polymer and the relative amounts of each are not at issue in this appeal.7

2 Claims 1, 3, 4, 6, and 8-10. Ans. 6-9.
3 Claims 5 and 7. Ans. 9-10.
4 Claims 1, 3, 4, 6, and 8-10. Ans. 10-14.
5 Claims 5 and 7. Ans. 14.
6 Claim 1.
An adhesive
to be affixed to a skin surface,
said adhesive comprising
a polymer consisting of
Appeal 2011-000986
Control 90/008,491

5
According to the Appellant’s written description, the adhesive is made
by dissolving or emulsifying the polymer in an appropriate solvent. Written

one or more kinds of acrylic or methacrylic monomer
unit,
at least one of the kinds of acrylic or methacrylic
monomer unit having a hydroxy group, and
one or more kinds of other monomer unit selected from
the group consisting of
vinyl acetate,
N-vinyl-2-pyrrolidone,
itaconic acid,
maleic acid,
allylamine,
vinyl propionate,
methylvinylpyrrolidone,
vinylpyridine,
vinylpiperidone,
vinylpiperazine,
vinylpyrazine,
vinylpyrrole,
vinylimidazole,
vinylcaprolactam,
vinyloxazole,
vinylmorpholine, and
vinylpyrrolidone,
wherein the acrylic or methacrylic monomer unit
contained in the polymer is 50% to 90% by weight,
the polymer
is crosslinked by boric acid or a boric acid derivative, and
substantially no water is used in production of the
adhesive.

7 The examiner made detailed findings and explained why the specific
monomer and the relative amounts would have been obvious. Final Office
Action filed January 14, 2008, pp. 6-14; Ans. 6-14. Appellants have not
challenged those findings and conclusions. Rather, they rely on the process
recitation in the claims.
Appeal 2011-000986
Control 90/008,491

6
Description8, p. 8, ll. 1-4. The solvent may be aqueous or organic (non-
aqueous). Written Description, p. 8, ll. 1-4. The solvent is removed by
heating. Written Description, p. 8, ll. 1-5. The aqueous solvent is “water or
a mixed solvent containing water as a main component.” Written
Description, p. 3, ll. 22-23. The non-aqueous solvent is “an organic solvent
or a mixed solvent containing an organic solvent as a main component.”
Written Description, p. 3, ll. 19-21. The polymer must also be cross-linked
using boric acid or a boric acid derivative. Written Description, p. 8, ll. 10-
23. According to Appellant, the resulting adhesive composition, whether
using an aqueous or non-aqueous solvent, “contains substantially no water.”
Written Description, p. 4, ll. 18-19. Appellant defines “containing
substantially no water” as meaning (1) that no water is used in making the
adhesive or (2) that the adhesive produced contains no water:
“containing substantially no water” means that no water
is used in the production of the adhesive or the patch, or
that the adhesive or the patch that is produced contains
no water.
Written Description, p. 5, ll. 3-6.
Appellant’s written description identifies a broad assortment of
materials that may be part of the adhesive. These include liquids compatible
with the polymer; such as absorption promoting agents, solubilizing agents
and plasticizers (written description, p. 9, ll. 4-9), a wide variety of drugs
(written description, p. 10, l. 3 – p. 14, l. 8), and antioxidants, preservatives,
ultraviolet-absorbing agents, and anti-crystallizing agents (written
description, p. 15, l. 26 – p. 16, l. 19).

8 All references to the “written description” are to the written description
that was a part of the original specification filed July 23, 2004.
Appeal 2011-000986
Control 90/008,491

7

The Prior Art
Appellant’s brief only addresses the Tsubota reference in detail, and
does not address the specific teachings of the other references. Appellant
refers to these references, only in passing, as not remedying the alleged
deficiencies in Tsubota’s teachings. Br. 24, 25, and 28. Accordingly, we
only need address the teachings of the Tsubota patent to decide this appeal.
Tsubota
Tsubota describes an air-permeable medical adhesive tape for
application to skin. Tsubota 1:7-14. The tape includes a layer of an
adhesive composition. In order to obtain the desired air permeability,
Tsubota teaches forming pores or voids in the layer. Air permeability is said
to allow dissipation of moisture from the skin. Moisture trapped under the
skin may lead to inflammation. Tsubota 1:14-17.
Tsubota describes the technique for making the tape. A layer of a
solution of an adhesive polymer in a hydrophobic organic solvent is applied
to a substrate. Tsubota 2:36-38. The solvent is evaporated leaving behind a
layer of adhesive. Tsubota 4:33-35. The pores are formed in the layer by
applying water drops to the adhesive solution layer prior to evaporation of
the solvent. Tsubota 2:33-50. Evaporation of the solvent leaves an adhesive
layer with entrapped water drops. Tsubota 2:44-47. The water may include
a crosslinking agent such as boric acid. Tsubota 11:21-32. The boric acid
causes the polymer contiguous to the water drops to crosslink, preserving the
shape of the water drops as adhesive-free pores when the water is
subsequently removed. Tsubota 2:33-50; 6:36-38. The water is removed by
evaporation. Tsubota 4:33-55. Based upon this description, we infer that no
Appeal 2011-000986
Control 90/008,491

8
water is left behind after the drying step and Tsubota’s adhesive composition
contains no water. Tsubota’s adhesive appears to have both crosslinked and
uncrosslinked polymer. Tsubota notes that the crosslinking agent is not
included in the adhesive solution in order to avoid loss of adhesiveness that
could occur due to the crosslinking. Tsubota, 6:45-51.
Issues
1.
Appellant contends that the rejection of Claims 1, 3, 4, 6, and 8-10 on
Tsubota alone should be withdrawn because the Office is estopped from
rejecting the claims on this ground. Br. 18-24. According to Appellant, that
rejection would not qualify as a substantial new question of patentability and
therefore may not be used to reject the claims:
The rejection of claims 1, 3, 4, 6 and 8-10 over Tsubota
alone, does not support a substantial new question of
patentability ("SNQ"), which is required for each
rejection during Reexamination under 35 U.S .C.
§ 303(a), because Tsubota: (1) is the identical art as was
used before (2) was previously used to show the same
limitations already found patentable, (3) and is used now
in the same way as it was used to for these same
limitations that were previously examined, without being
viewed in any discernable new light.
Br. 18.
The examiner contends that the issue is petitionable and not subject to
appeal. Ans. 23.
Thus, an issue before us is whether the examiner erred in holding that
the issue is petitionable.
Appeal 2011-000986
Control 90/008,491

9
2.
Appellant contends that the examiner’s rejections should be reversed.
According to Appellant, the product-by-process recitation of Claim 1 that
“substantially no water is used in production of the adhesive” patentably
distinguishes the claimed composition from the prior art:
Structural characteristics of the product produced by the
methodology of Tsubota are distinct from the structural
characteristics of the present invention.
Br. 13. Specifically, Appellant contends that Tsubota’s adhesive is porous
while the claimed adhesive is not and that Tsubota’s adhesive is not entirely
crosslinked while Appellant’s adhesive is entirely crosslinked:
The adhesive of the present invention produced with
substantially no water does not contain these
communicating pores. Further, unlike Tsubota, there is
crosslinking through the adhesive layer of the instant
invention.
Br. 13 (emphasis added).
The examiner contends that the product-by-process recitation is
insufficient to patentably distinguish the claimed adhesives from those
suggested by the prior art. Specifically, the examiner construes the claims as
not excluding the presence of pores or uncrosslinked polymer. Ans. 19-20.
The dispositive patentability issue in this appeal is whether the
examiner correctly construed the Claim 1 subject matter as not excluding
pores or uncrosslinked polymer?
Discussion
Estoppel
Appellant argues that the rejection of Claims 1, 3, 4, 6, and 8-10 over
Tsubota should be withdrawn because the rejection does not rise to a
Appeal 2011-000986
Control 90/008,491

10
substantial new question of patentability. Br. 18-24. The examiner held that
this issue is a petitionable matter that is not reviewable by appeal to the
board and declined to address the issue. Ans. 23.
A review of the prosecution history shows that Appellant requested
reexamination of Claims 1, 3, and 6 of its patent stating that U.S. Patent
5,866,632 (Hashimoto) and a publication titled “Medical Adhesive” (Jiang)
were pertinent to the patentability of those claims. Request for Ex parte
Reexamination, filed March 22, 2007, pp. 2-6.
An examiner determined that a substantial new question was raised by
the request as to Claims 1, 3, and 6. Order Granting Request for Ex Parte
Reexamination dated April 11, 2007, pp. 3-5. The examiner ordered that
Claims 1, 3, and 6 be reexamined. The examiner also ordered that Claims 2,
4, and 5 would be reexamined along with the other claims. Id. at 5. Claims
2-6 depend from Claim 1.
Appellant did not object to the reexamination of Claims 2, 4, and 5.
Appellant responded by filing an amendment to Claim 1 and cancelling
Claim 2. Amendment filed May 10, 2007.
The examiner entered rejections of Claims 1 and 3-6. Paper entered
October 3, 2007. The claims were rejected relying on U.S. Patents
5,344,655 (Sakai); 5,866,632 (Hashimoto); 3,042,723 (Jenkner); and
3,221,745 (Coover).
Appellant answered with a second amendment to Claim 1 and added
new Claims 7-10. Claims 7-10 also depend from Claim 1. Paper filed
December 26, 2007, pp. 3-5. Appellant also argued that the rejections had
been overcome. Paper filed November 30, 2007, pp. 6-12.
Appeal 2011-000986
Control 90/008,491

11
The examiner held that the amendments overcame the rejections.
Paper entered January 14, 2008, pp. 2-3. The examiner also entered the four
grounds of rejection now under appeal. These rejections relied on Tsubota
alone or combined with various combinations of Sakai, Coover, Biale, and
Eckert. Id. at 5-14.
The rejection of Claims 1, 3, 4, 6, and 8-10 over Tsubota alone is said
to be impermissible since that rejection does not constitute a substantial new
question of patentability. Br. 18-24.
The existence of a substantial new question of patentability is a
prerequisite to the initiation of a reexamination proceeding by the Director.
35 U.S.C. § 303. Appellant, while casting its argument in terms of a
substantial new question patentability, does not assert that a substantial new
question sufficient to initiate this proceeding did not exist. Indeed, it was
Appellant who requested reexamination of its patent and, after
reexamination was ordered, took advantage of the reexamination provisions
to twice amend its claims. Rather than challenge the propriety of initiating
reexamination, Appellant seeks to estop the Director from entering a
rejection that, in Appellant’s view, was effectively overcome during the
original prosecution. Thus, Appellant challenges the scope of the Director’s
authority under 35 U.S.C. § 305, delegated to the examiner, to conduct the
reexamination and enter the rejection. Specifically, Appellant challenges the
Director’s authority to enter a rejection relying on Tsubota alone in a
properly initiated reexamination. This is an issue totally separate from the
issue of the patentability of claims over Tsubota. Not all decisions rendered
by examiner’s are subject to review by the Board.
Appeal 2011-000986
Control 90/008,491

12
Whether a disputed issue is reviewed by petition or by appeal
generally depends on whether the issue relates to the process or procedures
of examination or to the substantive merits of patentability. Issues relating
to process or procedure are reviewed by petition, while issues relating to the
substantive merits of patentability are reviewed by appeal to the Board.
Section 1.181 of 37 CFR reflects this distinction in defining petitionable
issues as those that are (1) not appealable to the Board, (2) by statute or rule
to be decided or reviewed by the Director, and (3) to invoke the supervisory
authority of the Director.9 In an ex parte reexamination, patent owners may
only appeal “any decision adverse to the patentability of any original or
proposed amended or new claim of the patent” and “the final rejection of
any claim” (emphasis added). 35 U.S.C. §§ 306 and 134(b). In this appeal,
in addition to seeking review of the examiner’s determination on the

9 37 CFR 1.181. Petition to the Director.

(a) Petition may be taken to the Director:
(1) From any action or requirement of any
examiner in the ex parte prosecution of an application, or
in ex parte or inter partes prosecution of a reexamination
proceeding which is not subject to appeal to the Board of
Patent Appeals and Interferences or to the court;
(2) In cases in which a statute or the rules specify
that the matter is to be determined directly by or reviewed
by the Director; and
(3) To invoke the supervisory authority of the
Director in appropriate circumstances. For petitions
involving action of the Board of Patent Appeals and
Interferences, see § 41.3 of this title.

Appeal 2011-000986
Control 90/008,491

13
patentability of the subject matter claimed, Appellant seeks review of the
examiner’s decision to enter the rejection.
Appellant’s challenge to the Office’s authority to enter any rejection
based on Tsubota because that reference fails to raise a substantial new
question of patentability is not a challenge to the examiner’s unpatentablity
decision. Appellant’s estoppel argument does not challenge the merits of
patentability (35 USC §§ 101, 102, and 103) or sufficiency of the
specification (35 U.S.C. § 112), the substantive merits matters typically
reviewed by the Board on appeal. Rather it challenges the correctness of the
reexamination process. Appellant asks us, in effect, to order that the
examiner withdraw the rejections. In other words, Appellant asks the Board
to exercise supervisory authority over the examiner. The exercise of
supervisory authority over the examination is clearly the prerogative of the
Director and, in our view, must be raised by petition. 37 CFR § 1.181(a)(3).
We agree with the examiner that the decision to enter the rejections over
Tsubota is petitionable. We are unaware of and Appellant has not directed
us to a jurisdictional basis for us to exercise such authority.
We withdrew our earlier opinion to consider the effect of the Notice
on our decision. We hold that the Notice does not delegate authority to the
Board to decide whether a particular rejection made during the course of
prosecution following a properly initiated reexamination is outside the scope
permitted in an ex parte reexamination. The notice addresses those
situations where a patent owner challenges an examiner’s threshold
determination that a substantial new question has been presented. The
Notice delegates the authority “to review issues related to the examiner’s
determination that a reference raises a SNQ” to the Chief APJ. Notice, 75
Appeal 2011-000986
Control 90/008,491

14
Fed. Reg. 36,357. The examiner’s determination is not challenged in this
appeal. Appellant requested that its patent be reexamined. Request for Ex
parte Reexamination, filed March 22, 2007, pp. 1-6. The examiner held that
a substantial new question had been raised by that request. Order Granting
Request for Ex Parte Reexamination dated April 11, 2007, pp. 3-5. The
examiner’s determination that the cited references raise a SNQ is
unchallenged.
Patentability
Appellant’s allegations of error are principally limited to the subject
matter of Claim 1. The additional recitations of dependent Claims 3-5 and 7-
10 are not asserted as a basis of patentability separate from Claim 1.
Appellant’s brief also specifically references dependent Claim 6. We
therefore limit our comments to Claims 1 and 6. 37 C.F.R. §
41.37(c)(1)(vii).
Product-by-Process
Appellant relies on a “product by process” recitation to distinguish the
claimed subject matter from the prior art. Br. 13.
A claim to a product may include the process by which it is made.
However, the patentability of a product ordinarily does not depend on the
method of making it. In re Pilkington, 411 F.2d 1345, 1348 (CCPA 1969).
If the product in a product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though the prior
product was made by a different process. In re Marosi, 710 F.2d 799, 803
(Fed. Cir. 1983); Johnson & Johnson v. W.L. Gore, 436 F.Supp. 704, 726
(D. Del. 1977); see also In re Fessmann, 489 F.2d 742, 744-45 (CCPA
1974). However, where the process recitation is shown to impart unobvious
Appeal 2011-000986
Control 90/008,491

15
characteristics or properties to the product that are not possessed by the prior
art product, the product may be patentable. Marosi, 710 F.2d at 803.
(Where a product-by-process claim is rejected over a prior art product that
appears to be identical, although produced by a different process, the burden
is upon the applicants to come forward with evidence establishing an
unobvious difference between the claimed product and the prior art product.)
In other words, regardless of the process recitation, the product itself must
have characteristics that patentably distinguish it from the products of the
prior art. Thus, Appellant’s arguments that the references relied upon by the
examiner do not teach the process limitation, are unavailing. It is the
properties and characteristics of the adhesive compositions that must be
compared.
Appellant asserts two differences to patentably distinguish its
composition from Tsubota’s: (1) Tsubota’s “adhesive” contains pores, while
Appellant’s “adhesive” is non-porous and (2) that appellant’s adhesive is
completely crosslinked while Tsubota’s is not. Br. 13.
The Presence of Pores in the Adhesive Layer
In our view, the pores described by Tsubota do not patentably
distinguish Appellant’s composition. The pores are adhesive-free voids that
are surrounded by crosslinked adhesive. Notwithstanding Appellant’s
argument to the contrary, the pores are not part of Tsubota’s adhesive
composition. The pores are part of the structure of Tsubota’s air permeable
“adhesive layer.” Claim 1 is directed to an adhesive composition, not to an
adhesive layer. An adhesive applied to a substrate, such as a patch, in a
checkerboard pattern of alternating regions of adhesive and no-adhesive
would similarly describe the structure of the adhesive layer, but would not
Appeal 2011-000986
Control 90/008,491

16
describe a property of the applied adhesive itself. As noted by the Examiner
(Ans. 18), Claim 1 is directed to the adhesive itself, not to an adhesive layer
or a medical tape having an adhesive layer.
For this reason, Appellant’s declaration evidence, showing the
formation of a pore-free “adhesive layer” is insufficient to demonstrate that
the claimed adhesive composition is patentably distinguishable from the
prior art adhesive composition.
The Presence of Uncrosslinked Polymer
Appellant’s second distinction, the presence of both crosslinked and
uncrosslinked polymer in Tsubota’s adhesive, is more to the point. The
presence of uncrosslinked polymer is a characteristic or property of the
adhesive itself. Tsubota’s adhesive includes crosslinked polymer in the
regions of the adhesive contiguous with the pores. The remaining polymer
is arguably uncrosslinked.
In the examiner’s view, the claims do not require that the polymer in
the composition be completely crosslinked. Ans. 19 and 20. We agree.
Claim 1 is directed to an:
adhesive to be affixed to a skin surface, . . . comprising a
polymer . . . the polymer is crosslinked by boric acid or a
boric acid derivative and substantially no water is used in
production of the adhesive.
Br. 29 (emphasis added). The transitional word “comprising” is a term of art
in claim drafting indicating that the claim is open ended. Comprising means
that the named elements are essential, but other elements may be added.
Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). A
claim drafter uses the term “comprising” to mean “I claim at least what
follows and potentially more.” Vehicular Techs. Corp. v. Titan Wheel Intl.
Appeal 2011-000986
Control 90/008,491

17
Inc., 212 F.3d 1377, 1383 (Fed. Cir. 2000). Regardless of the transitional
phrase used, claims must be read in light of specification and teachings in
the underlying patent. In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed.
Cir. 2010). Additionally, “the prosecution history can often inform the
meaning of the claim language by demonstrating how the inventor
understood the invention and whether the inventor limited the invention in
the course of prosecution, making the claim scope narrower than it would
otherwise be.” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005)
(en banc).
Review of the record does not reveal a clear indication that the
applicant departed from the generally understood meaning of “comprising.”
Nothing in the claim language, specification, or prosecution history compels
an exceptional reading of “comprising” to require the presence of only
crosslinked polymer.
There are two recitations in Claim 1 of interest on this point: (1) the
functional recitation that the adhesive is “to be affixed to a skin surface,”
and (2) the product-by-process recitation stating that “substantially no water
is used in production of the adhesive.”
The functional recitation would certainly exclude any polymers or
other additions that would preclude affixing the adhesive to the skin.
However, the presence of uncrosslinked polymer would not have this result.
Tsubota’s adhesive, which includes both crosslinked and uncrosslinked
polymer, is said to be for use in adhering the tape to skin. E.g., Tsubota
1:12-21 and 2:33-36.
The product-by-process recitation also does not preclude the presence
of uncrosslinked polymer in the claimed composition. The patentability of
Appeal 2011-000986
Control 90/008,491

18
the adhesive is determined by a comparison of the claimed composition with
the prior art adhesive. On this record there is no basis to conclude that the
crosslinked polymer formed according to Tsubota’s technique is patentably
different than the crosslinked polymer formed without using an aqueous
solvent. The fact that water is excluded as a solvent simply does not compel
a conclusion that uncrosslinked polymer is excluded from the scope of
Appellant’s Claim 1. While Tsubota describes using water to create voids in
the adhesive layer, Tsubota removes the water (Tsubota 2:48-49) leaving an
adhesive containing “substantially no water” as defined by Appellant.
Written Description, p. 5, ll. 3-6.
Looking to the specification, Appellant identifies a variety of
additional materials that may be added to the adhesive. These include
liquids compatible with the polymer; such as absorption promoting agents,
solubilizing agents, and plasticizers. Written Description, p. 9, ll. 4-9. A
wide variety of drugs may also be incorporated. Written Description, p. 10,
l. 3 – p. 14, l. 8. Additionally, antioxidants, preservatives, ultraviolet-
absorbing agents, and anti crystallizing agents can be incorporated. Written
Description, p. 15, l. 26 – p. 16, l. 19. Thus, Appellant contemplates that
Claim 1 encompasses numerous additional components not specifically
recited in that claim.
While Appellant’s Examples 1 and 2 appear to describe completely
crosslinked adhesives, claims are not ordinarily construed to be limited to
the disclosed preferred embodiments. Laitram Corp. v. Cambridge Wire
Cloth Co., 863 F.2d 855, 865 (Fed. Cir. 1988) (“References to a preferred
embodiment, such as those often present in a specification, are not claim
Appeal 2011-000986
Control 90/008,491

19
limitations.”) And Appellant has specifically stated that the claims are not
limited to the examples:
[T]he present invention is not limited to these Examples
and can be modified in a variety of ways without
departing from the scope and spirit of the present
invention.
Written Description, p. 17, ll. 22-24.
Looking to the prosecution history, we do not see a clear disavowal by
Appellant that the scope of Claim 1 excludes adhesives that include
uncrosslinked as well as crosslinked polymer. An argument made to the
Office constitutes a disclaimer only if it is “clear and unmistakable.”
Schindler Elevator Corp. v. Otis Elevator Co., 593 F.3d 1275, 1285 (Fed.
Cir. 2010); Purdue Pharma L.P. v. Endo Pharms., Inc., 438 F.3d 1123, 1136
(Fed. Cir. 2006). An “ambiguous disavowal” will not suffice. Computer
Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1375 (Fed. Cir. 2008).
While Appellant has consistently argued that certain language of Claim 1
would not have been obvious, Appellant has not directly answered the
Examiner’s claim scope issue. We fail to see any clear indication that an
adhesive composition including both crosslinked and uncrosslinked polymer
is outside the scope of Claim 1. The issue is whether Claim 1 excludes the
presence of uncrosslinked polymer, not whether a totally crosslinked
polymer would have been obvious.
Based upon the record argued before us, we conclude that the broadest
reasonable construction of the claims does not exclude adhesives comprising
both crosslinked and uncrosslinked polymer.10 Considering the claim

10 In this regard, we note that Appellant, as the author of its claims, has
the responsibility to present claims that clearly and unambiguously
Appeal 2011-000986
Control 90/008,491

20
language, the written description and the prosecution history, the relevant
question is: Does Tsubota describe an adhesive “comprising a polymer . . .
the polymer crosslinked by boric acid?” In light of the presence of boric
acid-crosslinked polymer in the adhesive composition described by Tsubota,
we think the answer is yes. Appellant’s claim 1 encompasses subject matter
that is not patentably distinct from the prior art. Claim 1 is, therefore,
unpatentable. A claim that encompasses unpatentable subject matter is
unpatentable notwithstanding that the claim may also encompass patentable
subject matter. In re Muchmore, 433 F.2d 824, 826, (CCPA 1970) (noting
that the appellant’s claims were too broad in the sense of section 103, since
they read on both obvious and unobvious subject matter).
Appellant’s argument that Tsubota teaches away from a completely
crosslinked adhesive is not persuasive in light of our conclusion that Claim 1
does not preclude uncrosslinked adhesive.
We affirm the examiner’s rejections of Claim 1. Since the subject
matter of dependent Claims 3-5 and 7-10 have not been asserted to be
patentable for reasons different than Claim 1, we affirm the rejections of
those claims also. 37 C.F.R. § 41.37(c)(1)(vii).

distinguish its subject matter from the prior art. During the reexamination
before the examiner, Appellant had ample opportunity to amend the claims.
It would have been a relatively simple matter for Appellant to have modified
their claims to exclude the presence of uncrosslinked polymer. Indeed, we
think that under circumstances such as those here, where the claims could
have been simply amended to clearly exclude uncrosslinked polymer, it
would be inappropriate for the Office to accept a disavowal of scope, no
matter how clearly stated, in lieu of an amendment to the claims. It should
not require litigation to determine to the scope of the subject matter the
inventors claim as their property.
Appeal 2011-000986
Control 90/008,491

21
Claim 6
Appellant makes separate reference to Claim 6. This claim adds the
recitation that “the boron-containing compound is dissolved in a hydrophilic
organic solvent.” Appellant notes the pores present in Tsubota’s adhesive
layer and again argues that “Claim 6 produced with boric acid or boric acid
derivative dissolved in hydrophilic organic solvent does not contain these
communicating pores.” E.g., Br. 24.
The additional language of Claim 6 is a statement of how the adhesive
is produced. This process step alone can not patentably distinguish the
adhesive composition absent some unobvious characteristic or property not
shared with the prior art adhesive. Marosi, 710 F.2d at 803. Appellant
argues that the pores are the distinguishing characteristic. E.g., Br. 24. For
the reasons stated above, we disagree that the pores are a required part of
Tsubota’s adhesive composition. The presence of pores in Tsubota’s
adhesive layer does not patentably distinguish Tsubota’s disclosed
composition from Appellant’s.
We affirm the examiner’s rejections of Claim 6.
Final Decision
We affirm the Examiner’s rejections of Claims 1 and 3-10 under 35
U.S.C. § 103(a).
AFFIRMED

KMF

THE HARRIS FIRM
922 N Street, N.W., SUITE 101
Washington, D.C. 20001