Ex Parte Kawazoe et al

Patent Trial and Appeal Board

Mar 1, 2017

10528150 (P.T.A.B. Mar. 1, 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.
10/528,150 03/17/2005 Takeshi Kawazoe 2005 0459A 2807
513 7590 03/03/2017
WENDEROTH, LIND & PONACK, L.L.P.
1030 15th Street, N.W.,
Suite 400 East
Washington, DC 20005-1503
EXAMINER
JAVANMARD, SAHAR
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/03/2017 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):
ddalecki@wenderoth.com
eoa@ wenderoth. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TAKESHI KAWAZOE, SHIGEHIKO SUZUKI,
YUKIKO INAMOTO, and MITSUHIRO KAWADA1
Appeal 2016-001664
Application 10/528,150
Technology Center 1600
Before RYAN H. FLAX, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for reduction of scar contracture. Claims 8—11
are on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm, and we enter a new ground of rejection of claims 9 and 10
under 35 U.S.C. § 112, second paragraph, for indefiniteness.
1 We understand the Real Party in Interest to be TEIKOKU SEIYAKU CO.,
LTD. Br. 2.
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Application 10/528,150
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 8—11 read as follows:
8. A method for reduction of scar contracture in a course of
therapy of wound or dermal injury which comprises
administering a medicament containing acetylsalicylic acid in an
effective amount to a wound lesion of a patient who would
develop a keloid or a hypertrophic scar, wherein the wound is an
all layer-incised wound.
9. A method for reduction of scar contracture in a course of
therapy of wound or dermal injury which comprises
administering a medicament containing acetylsalicylic acid in an
effective amount of 0.005 to 1000 gg/g per tissue weight to a
wound lesion of a patient who would develop a keloid or a
hypertrophic scar, wherein the wound is an all layer-incised
wound.
10. A method for reduction of scar contracture in a course of
therapy of wound or dermal injury which comprises
administering a medicament containing acetylsalicylic acid in an
effective amount of 0.01 to 800 pg/g per tissue weight to a wound
lesion of a patient who would develop a keloid or a hypertrophic
scar, wherein the wound is an all layer-incised wound.
11. A method for reduction of scar contracture in a course of
therapy of wound or dermal injury which comprises
administering a medicament containing acetylsalicylic acid in an
effective amount of 20 to 80% by weight per total weight of the
medicament to a wound lesion of a patient who would develop a
keloid or a hypertrophic scar, wherein the wound is an all layer-
incised wound.
Br. 14 (Claims App’x).
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The following rejection is on appeal:
Claims 8—11 stand rejected under 35 U.S.C. § 103(a) over Konishi2
andCapelli.3 Final Action 3.
The following new ground of rejection is designated:
Claims 9 and 10 are rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
OBVIOUSNESS
Findings of Fact
Except as otherwise indicated herein, 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. The facts set out below
highlight certain evidence.
FF1. Capelli teaches a method for reduction of scar contracture in
a course of therapy of wound or dermal injury, which comprises
administering a medicament containing acetylsalicylic acid in an
effective amount to a wound lesion of a patient who would develop a
keloid or a hypertrophic scar, in that it disclosed “methods and kits for
improving the size and appearance of a healed wound or scar. The
composition includes a therapeutically effective amount of at least one
cyclooxygenase inhibitor,” and that the cyclooxygenase inhibitor is
“acetylsalicylic acid,” and that the scar is “a hypertrophic scar [or] a
2 U.S. Patent 5,916,918, issued June 29, 1999 to Ryoji Konishi et al.
(hereinafter “Konishi”).
3 International Patent Application Pub. No. WO 01/70210 A2, published
Sept. 27, 2001 (hereinafter “Capelli”).
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keloid.” Capelli Abstract, 2:20—22, 3:25—26, 4:13, claims 57 and 60;
see also Final Action 6—7, and Ans. 6—9 (discussing Capelli).
FF2. Capelli disclosed not only treating an existing scar to
improve its size or appearance, but also applying “an effective amount
of a cyclooxygenase inhibitor,” such as acetylsalicylic acid, to a
“healed wound,” “ for preventing ... the appearance of a hypertrophic
or keloid scar.” Capelli 5:7—10 (emphasis added); see also Final
Action 6—7, and Ans. 6—9 (discussing Capelli).
FF3. Capelli defined a “healed wound” as “a closed wound or a
wound surface that is closed by regrowth of an epithelial barrier. A
wound is ‘closed’ after an open wound has been re-epithelialized.
Closed wounds can result in the formation of a scar.” Capelli 6:16—
19; see also Final Action 6—7, and Ans. 6—9 (discussing Capelli).
FF4. Capelli disclosed “a composition comprising up to about 35
percent of. . . acetylsalicylic acid,” a “composition compris[ing] . . .
about 2 percent to about 5 percent of acetylsalicylic acid,” a dosage
“comprising from about 1 microgram to about 3000 micrograms . . .
per square centimeter of treated tissue,” and “a composition
comprising from about 0.01 percent to about 80 percent... of said
[acetylsalicylic acid] composition in admixture with a
pharmaceutically acceptable carrier.” Capelli 3:25—26, 4:3—5, 24:5—
11, 25:6—10, claim 60; see also Final Action 6—7, and Ans. 6—9
(discussing Capelli).
FF5. Capelli disclosed that wounds that are treated by
acetylsalicylic acid “may result from any of a number of types of skin
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traumas such as laceration, avulsion, bum, surgery, infection, acne,
chemical facial peel, and accident.” Capelli 6:27—28; see also Final
Action 6—7, and Ans. 6—9 (discussing Capelli).
FF6. Konishi is directed to and disclosed a topical preparation
containing acetylsalicylic acid for treating “every skin injuries [sic]”
to “promote the formation of epidermal tissue” and to “inhibit[] the
formation of cmst even in a deep skin injury as reached to [sic] the
muscular level [and] promote[] the formation of granulation tissue and
epidermal tissue,” thereby teaching such a treatment to a wound that is
an all layer-incised wound. Konishi Abstract, 1:12—15, 1:26:27, 1:55—
63, 2:7—8; see also Final Action 4—7, and Ans. 6—9 (discussing
Konishi).
FF7. Konishi teaches an all layer-incised wound as it disclosed
experimental examples where, prior to treatment by topical
acetylsalicylic acid, test animals were subjected to biopsy-like
incision “by a round punch (inner diameter, 12 mm) to induce
injuries” and “by a round punch (inner diameter 10 mm) to induce
injuries.” Konishi 8:35—41 (Experiment 2), 10:7—14 (Experiment 6);
see also Final Action 4—7, and Ans. 6—9 (discussing Konishi).
Discussion
We find the Examiner has established that claims 8 and 11 would
have been obvious over Konishi and Capelli. Appellants have not produced
evidence showing, or persuasively argued, that the Examiner’s
determination of obviousness, as to these claims, is incorrect. Only those
arguments made by Appellants in the Briefs have been considered in this
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Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015). We address Appellants’ arguments below.
As an initial matter, we find that a person of ordinary skill in the art
having Capelli’s disclosure before them would understand that wounds that
would develop a keloid or hypertrophic scar can be treated with topical
compositions of up to 80% acetylsalicylic acid to prevent or mitigate the
occurrence or appearance of such scars. FF1—FF5. Capelli is directed to
treating wounds and nothing in Appellants’ claims limits the invention to a
specific state of healing for a wound so as to render Capelli’s disclosure
concerning epithelialized wounds inapplicable. Further, a skilled artisan
would be motivated to look to other references, such as Konishi, that are also
directed to treating wounds with acetylsalicylic acid (i.e., aspirin) for other
insights and advantages for such treatments. FF6—FF7. Upon combining
Capelli with Konishi, which are each directed to the same field of topically
treating wounds with aspirin, the skilled artisan would predictably apply
such an acetylsalicylic acid treatment early in the wound-healing cycle
where the wound is not yet healed at all, as in the “hardly curable” bedsores
of Konishi, and continue to treat the wound, including after wound closure
and later, to reduce scarring, as taught in Capelli. As each of Capelli and
Konishi indicate that such acetylsalicylic acid treatments were effective in
treating wounds, the skilled artisan would likewise reasonably expect
success in slightly modifying the techniques of Capelli as taught by Konishi
to treat wounds and mitigate scars.
Appellants argue the prior art combination does not address the claim
elements “reduction of scar contracture” and “to a wound lesion of a patient
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who would develop a keloid or a hypertrophic scar.” Br. 5. This argument
is not persuasive.
We find that, in view of Capelli’s disclosure of treating a healed
wound to prevent scarring, either on its own or paired with Konishi’s
disclosure of treating open wounds to improve healing, the prior art
combination teaches reducing scar contracture because preventing the
appearance of a scar is reducing its contracture. See FF2, FF6. Furthermore,
Capelli is focused on treating patients that have or would develop a keloid or
hypertrophic scar using, inter alia, acetylsalicylic acid. FF1, FF2.
Appellants argue the prior art combination does not teach an “all
layer-incised wound.” Br. 6. Appellants contend the Examiner gives no
rationale for this feature being suggested by the references. Id. These
arguments are not persuasive.
We understand that the way Konishi, in its examples, discloses
injuring research-animal-subjects with a round punch, which is a biopsy
tool, teaches an all-layer (all skin layers, i.e., epidermis, dermis, and
subcutaneous tissue) incised wound. FF7. Further, bedsores, which is a
focus of Konishi, are well known as potentially being very deep in the tissue,
even exposing bone in the case of a stage IV bedsore. Moreover, Capelli
disclosed that its acetylsalicylic acid treatment can be used on wounds
resulting from a variety of causes, including lacerations and surgery, which
would include all-layer incised wounds. FF5. All this, combined, suggests
an all layer-incised wound would be treated in the manner disclosed by the
references.
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Appellants argue there is no “patient who would develop a keloid or
hypertrophic scar” in the prior art references. Br. 7. Appellants assert that
they have provided evidence demonstrating that not all patients with a
wound lesion will develop a keloid or hypertrophic scar. Br. 7 (citing
“Attachments” 2—7, indicated by Appellants as submitted Apr. 28, 2011).4
These arguments are not persuasive.
Capelli is expressly directed to patients that have or will develop
keloids or hypertrophic scars and treating or preventing the appearance of
those scars. FF2. Thus, whether or not all patients with lacerations will
develop such scars is immaterial here because we have such patients
disclosed in Capelli; therefore, invoking the doctrine of inherency is not
necessary for the Examiner to establish obviousness.
Appellants argue, based on the same evidence cited in the preceding
argument, but specifically attachment 45 to the Inamoto Declaration (dated
May 15, 2014), that their invention provides unexpected results. Br. 8. This
argument is not persuasive.
“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
4 We understand Appellants to be referencing documents submitted on May
19, 2014, with the Inamoto Declaration, dated May 15, 2014, because the
prosecution record shows no such documents filed April 28, 2011, except an
excerpt from Dorland’s Illustrated Medical Dictionary, submitted with an
amendment and request for continued examination.
5 Chuma J. Chike-Obi et al., Keloids: Pathogenesis, Clinical Features, and
Management, 23 Semin Plast Surg 178-84 (2009).
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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).
Attachment 4 discloses (at 180—83) several methods used to treat
keloid scars including, surgery, corticosteroid treatment, imiquimod
treatment, interferon-a-2b treatment, 5-flurouracil treatment, mytomycin C
treatment, retinoid treatment, radiotherapy, laser therapy, cryotherapy, and
silicone therapy, and concludes that “keloids are difficult to treat” and “[n]o
optimal treatment has been identified to date.” Attachment 4 does not
mention acetylsalicylic acid treatment. Whether or not Attachment 4’s
review of less-than-effective treatments for keloid scars provides some
foundation for what a skilled artisan may have expected for such scars,
Capelli discloses that acetylsalicylic acid is an effective treatment for both
keloid and hypertrophic scars, thus making Appellants’ results expected.
Expected beneficial results are not evidence of nonobviousness. See In re
Skoner, 517 F.2d 947, 950 (CCPA 1975). Appellants’ proffered evidence
fails in this regard.
The Inamoto Declaration further cites the Specification (at 15—17)
regarding test 1, directed to treating a bum, and test 2, directed to an in vitro
experiment using a fibroblast suspension, as evidencing unexpected results;
however, neither of these tests are commensurate in scope with the claims as
neither is directed to an incision wound or preventing a keloid or
hypertrophic scar. “The evidence presented to rebut a prima facie case of
obviousness must be commensurate in scope with the claims to which it
pertains.” In re Dill, 604 F.2d 1356, 1361 (CCPA 1979). Appellants’
proffered evidence also fails in this regard.
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Appellants also challenge the Examiner’s contention that the
inhibition of crust formation is the same as inhibiting scar formation. Br. 9.
This argument is not persuasive.
While Konishi does disclose that its topical acetylsalicylic acid
treatment was effective to prevent a crust formation in deep wounds (FF6), it
is the disclosure of Capelli, that its acetylsalicylic acid treatment is effective
to prevent the appearance of keloids and hypertrophic scars (FF2), that
teaches the relevant element of the claimed invention. Konishi’s disclosure
supports Capelli’s disclosure, and the rejection is based on the combination
of the references.
Appellants argue that one of skill in the art would not have combined
Konishi and Capelli (citing Inamato Declaration) because patients
predisposed to keloid or hypertrophic scaring are different from patients not
so predisposed. Br. 10. This argument is not persuasive.
As discussed, supra, Capelli is expressly directed to treating patients
with or who will develop keloid or hypertrophic scars and it is immaterial
here that not all wounded patients are predisposed to such scaring.
Therefore, this argument is not persuasive.
Regarding claim 9, Appellants argue the Examiner has not discussed
how “an effective amount of 0.005 to 1000 pg/g per tissue weight” is shown
in the prior art. Br. 11. We agree. The Examiner has not addressed this
element of claim 9, directed to the dose of acetylsalicylic acid for treating a
wound. For this reason, we are compelled to reverse the rejection as to this
claim.
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Regarding claim 10, Appellants argue the Examiner has not discussed
how “an effective amount of 0.01 to 800 pg/g per tissue weight” is shown in
the prior art. Br. 11. We agree. The Examiner has also not addressed this
element of claim 10, likewise directed to the dose of acetylsalicylic acid for
treating a wound. For this reason, we are also compelled to reverse the
rejection as to this claim.
Regarding claim 11, Appellants argue the Examiner has not discussed
how “an effective amount of 20 to 80% by weight per total weight of the
medicament” is shown in the prior art. Br. 12. Appellants point out that
Konishi limits its amount of acetylsalicylic acid to no more than 15%. Id.
This argument is not persuasive.
Appellants overlook that Capelli teaches compositions with
acetylsalicylic acid in amounts between 0.01% and 80% and 1—3,000 gg/cm2
tissue to be treated. FF4. “A prima facie case of obviousness typically
exists when the ranges of a claimed composition overlap the ranges
disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003). Here, Capelli’s dosage range of about 0.01—80% envelops the range
of “20 to 80%” of the claim. Therefore, the dosage range recited by claim
11 is obvious in view of Capelli, regardless of Konishi’s narrower range.
For the reasons discussed above, we affirm the obviousness rejection
as to claims 8 and 11 and reverse as to claims 9 and 10.
NEW GROUND OF REJECTION: INDEFINITENESS
Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter a new
ground of rejection for claims 9 and 10 under 35U.S.C. § 112, second
paragraph (pre-AIA) (or 35 U.S.C. § 112(b)) as indefinite because they
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recite “an effective amount of 0.005 to 1000 pg/g per tissue weight” and “an
effective amount of 0.01 to 800 pg/g per tissue weight,” respectively.
Findings of Fact
FF8. Claims 9 and 10 each define a dose, i.e., “effective amount,”
of acetylsalicylic acid based upon “pg/g per tissue weight.” Br. 14.
FF9. The Specification states:
The concentration of acetylsalicylic acid in the tissue which need
the exhibition of inhibiting keloid and/ or hypertrophic scar
formation is 0.001-1500 pg/g per tissue weight, preferably
0.005-1000 pg/g per tissue weight, more preferably 0.01-800
pg/g per tissue weight.
Spec. 5:11—14. This is the only incidence of the term “tissue weight”
in the Specification and, other than its use in Appellants’ claims and
appeal briefing, its only incidence in the prosecution history.
Discussion
“[A] claim is indefinite when it contains words or phrases whose
meaning is unclear,” i.e., “ambiguous, vague, incoherent, opaque, or
otherwise unclear in describing and defining the claimed invention.” In re
Packard, 751 F.3d 1307, 1310-13 (Fed. Cir. 2014); see also MPEP
§ 2173.02(1) (Rev. 07.2015, Nov. 2015) (advising examiners that a rejection
for indefmiteness is appropriate “after applying the broadest reasonable
interpretation to the claim, if the metes and bounds of the claimed invention
are not clear”).
While we understand the plain meaning of the words “tissue weight,”
in the proverbial abstract, is definable as a measurable variable (i.e., how
much tissue weighs), the question here is whether this term, as used in the
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context of administering a dosage amount “to a wound lesion of a patient,”
defines a unit of measure that would be understood by one of ordinary skill
in the art. We conclude that the plain meaning of “tissue weight” simply
makes no sense as it is used in the claims in light of the fact that there is no
way to know the extent of the tissue referred to or how one of skill might
determine the weight of such tissue that is a part of a patient.
We do not end our analysis here, though. We also ask whether one of
ordinary skill in the art would understand what is claimed when the claim is
read in light of the Specification. Power-One, Inc. v. Artesyn Techs., Inc.,
599 F.3d 1343, 1350 (Fed. Cir. 2010); Orthokinetics, Inc. v. Safety Travel
Chairs, Inc., 806 F.2d 1565, (Fed. Cir. 1986). Looking to the Specification,
we find the only incidence of the language “tissue weight” is as follows:
The concentration of acetylsalicylic acid in the tissue which
need the exhibition of inhibiting keloid and/ or hypertrophic
scar formation is 0.001-1500 gg/g per tissue weight, preferably
0.005-1000 gg/g per tissue weight, more preferably 0.01-800
gg/g per tissue weight.
FF9 (emphasis added).
This excerpt from the Specification does not clearly define this claim
term and does not provide a means of deciphering it in the context of the
claims. For example, does “tissue weight” refer to only the tissue that can
benefit from the drug? If so, how would a skilled artisan specifically
identity that tissue and how could its weight be determined, assuming the
tissue is still a part of the patient, so as to determine a corresponding amount
of active component? Does “tissue weight” refer to the tissue that will be
exposed to the drug once it is applied to a wound? If so, we have the same
problems just discussed; how is this tissue specifically defined and how
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would one determine its weight? Understanding the “tissue” must be a part
of the wound to be treated, how far does the tissue (of which one must
determine its weight) extend from the lesion? These are but a few questions
that cannot be answered on the present record on appeal, which compels a
determination that the respective language of claims 9 and 10 does not
establish reasonably clear metes and bounds for the invention.
Looking to the evidence of record in this appeal does not add clarity
to the relevant claim language. None of the references cited in the
Examiner’s final rejection uses the language “tissue weight” for any
purpose, much less to identify a dosage. Capelli, for example, identifies a
dosage of cyclooxygenase inhibitor to be administered, e.g., acetylsalicylic
acid, based on a percentage of the composition or the area of tissue to be
treated, i.e., square centimeters, but does not mention the tissue’s weight.
FF4. Fikewise, Konishi discloses determining a dose as a percentage by
weight of a composition or as a certain amount (e.g., 0.5 mg) of
acetylsalicylic acid per injured region, but, again, does not mention the
injured tissue’s weight in determining dosage. Konishi 1:55—57, 2:50-58,
8:39-42. Additionally, none of the “attachments” to the Inamato
Declaration, cited by Appellants, mention using “tissue weight” to determine
a pharmaceutical dose.
A further search of the prosecution record also identifies no use of the
term “tissue weight” except in Appellants’ Specification, claims, and
Appellants’ briefing, as indicated, supra. FF9. Thus, we are aware of no
evidence of record that reasonably informs one of ordinary skill in the art as
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to the meaning of the language “tissue weight” in the context of claims 9 and
10.
In light of the facts and reasoning set forth above, we conclude claims
9 and 10 are indefinite and enter a new ground of rejection.
SUMMARY
The rejection under 35 U.S.C. § 103(a) over Konishi and Capelli is
affirmed as to claims 8 and 11, but is reversed as to claims 9 and 10.
We designate a new ground of rejection for claims 9 and 10 under 35
U.S.C. § 112, second paragraph, as indefinite.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides, “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
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claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
AFFIRMED, 37 C.F.R, $ 41.50(b)
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