Omoidesouzou Co., Ltd. et al.

Patent Trials and Appeals Board

May 10, 2021

2020005193 (P.T.A.B. May. 10, 2021)

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.
15/518,256 04/11/2017 Hideyasu Takata HRTA:1025US 5870
34725 7590 05/10/2021
CHALKER FLORES, LLP
14951 NORTH DALLAS PARKWAY
SUITE 400
DALLAS, TX 75254
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
05/10/2021 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 HIDEYASU TAKATA
__________

Appeal 2020-005193
Application 15/518,256
Technology Center 1600
__________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
method for treating a skin ulcer. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Parties in Interest as Hideyasu
Takata and Omoidesouzou Co., Ltd. (see Appeal Br. 2).
2 We have considered the Specification of Apr. 11, 2017 (“Spec.”); Final
Office Action of July 24, 2019 (“Final Action”); Appeal Brief of Jan. 14,
2020 (“Appeal Br.”); Examiner’s Answer of Apr. 27, 2020 (“Ans.”); and
Reply Brief of June 25, 2020 (“Reply Br.”).
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Statement of the Case
Background
“Skin ulcers are intractable diseases in which skin tissues are deficient
due to decubitus (bed sores), burns, arterial occlusive disease, diabetes, and
the like” (Spec. ¶ 2). “When the skin ulcers are prolonged, they may lead to
bacterial infection” (id.). “Sofratulle . . . is a patch containing as an active
ingredient fradiomycin sulfate having an antibacterial action, is also used in
the treatment of mild decubitus” (id. ¶ 9). “Fiblast Spray 500 . . . is a spray-
type therapeutic agent for skin ulcers containing as an active ingredient
trafermin having an angiogenic action and granulation promoting action”
(id.).
[T]he inventor has found that the intractable decubitus can be
treated or ameliorated, when several sheets of Sofratulle patch
are used not for its intended use as the patch but are formed into
a dumpling shape or folded depending on the size of the ulcer
with a pocket, sprayed with Fiblast Spray 500 until sufficiently
impregnated with a trafermin solution and are packed in the
ulcer with a pocket to effectively adhere and leach out
fradiomycin sulfate and trafermin throughout the interior
portion of the ulcers.
(id. ¶ 10).
The Claims
Claims 1, 4–7, 16, 23, 24, 27, 29, and 31 are on appeal. Claim 1 is
representative and reads as follows:
1. A method for treating a skin ulcer, comprising packing a
cotton holding an antibiotic and a cell proliferation accelerator
in the skin ulcer with a pocket and in a state in which a defect
extending to the dermis, subcutaneous tissue, muscle or bone
occurs, whereby the cotton is formed so as to contact
substantially the whole of the inner surface of the skin ulcer.

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The Rejection
The Examiner rejected claims 1, 4–7, 16, 23, 24, 27, 29, and 31 under
U.S.C. § 103(a) as obvious over Wilcher,3 Pierce,4 Ichioka,5 Nambu,6
Frank,7 and Fonder8 (Final Act. 3–6).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Wilcher,
Pierce, Ichioka, Nambu, Frank, and Fonder render the claims obvious?
Findings of Fact
1. Wilcher teaches “compositions and materials that react with the
hemostatic system to treat or prevent bleeding” (Wilcher ¶ 13).
2. Wilcher teaches:
Effective delivery of hemostatic agents to wounds is
particularly desirable in the treatment of injuries characterized
by arterial or venous bleeding, as well as in surgical procedures
where the control of bleeding can become problematic, e.g.,
large surface areas, heavy arterial or venous bleeding, oozing
wounds, and in organ laceration or resectioning.
(Wilcher ¶ 14).

3 Wilcher et al., US 2007/0154510 A1, published July 5, 2007.
4 Pierce et al., Platelet-derived Growth Factor (BB Homodimer),
Transforming Growth Factor-β1, and Basic Fibroblast Growth Factor in
Dermal Wound Healing, 140 Am. J. Pathology 1375–88 (1992).
5 Ichioka et al., The positive experience of using a growth-factor product on
deep wounds with exposed bone, 14 J. Wound Care 105–9 (2005).
6 Nambu, US 4,524,064, issued June 18, 1985.
7 Frank et al., Approach to infected skin ulcers, 51 Can. Family Physician
1352–59 (2005).
8 Fonder et al., Treating the chronic wound: A practical approach to the
care of nonhealing wounds and wound care dressings, 58 J. Am. Acad.
Dermatology 185–206 (2008).
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3. Wilcher teaches “a puff, e.g. cotton ball, fleece, or sponge form
can be preferable for controlling the active bleeding” (Wilcher ¶ 15).
Wilcher teaches “[i]n preferred embodiments, the rough surface is exposed
to the wound so as to maximize contact of the fibers with the wound,
resulting in an improved hemostatic effect and superior adherence to the
wound” (Wilcher ¶ 21).
4. Wilcher teaches “the hemostatic devices of the invention further
include a therapeutically effective amount of one or more therapeutic agents,
such as an agent which promotes wound-healing” where “[a]gents that
promote wound-healing include anti-inflammatory agents, agents which
inhibit free radical formation, and bacteriostatic or bacteriocidal agents”
(Wilcher ¶ 30).
5. Wilcher teaches “[r]epresentative bacteriostatic or bacteriocidal
agents include antibacterial substances such as β-lactam antibiotics”
(Wilcher ¶ 33).
6. Wilcher teaches the hemostatic article may comprise
“epidermal growth factor, fibroblast growth factors, transforming growth
factors” (Wilcher 6, claim 13).
7. Ichioka teaches “[t]rafermin is a human recombinant form of
basic fibroblast growth factor (bFGF). It promotes tissue regeneration, and
gained approval for use in Japan in 2001” (Ichioka 105, col. 1).
8. Ichioka teaches “our experience suggests that trafermin
accelerates the healing of deep wounds” (Ichioka 109, col. 2).
9. Nambu teaches “wound-covering materials which, by
embedding antimicrobials in the aforesaid hydrogels, have sustained-
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releasing capacity (long durable release) for the antimicrobial agent” where
the antibiotic includes fradiomycin sulfate (see Nambu 1:47–50 and 11:59).
10. Frank teaches:
The role of topical antibiotics in treatment of wounds that are
not healing or continue to have serious exudation after 2 to 4
weeks of optimal management has been studied. A 2-week trial
of topical antibiotics with Gram-negative, Gram-positive, and
anaerobic coverage should be used in these circumstances, even
with no other evidence of critical colonization or infection.
(Frank 1356, col. 1).
11. Table I of Fonder is reproduced, in part, below:

Table I discloses gauzes as useful for packing deep wounds (Fonder 192,
Table I).
12. Fonder teaches:
Many modern gauzes are impregnated with substances intended
to optimize the healing environment . . . Gauze ribbons are ideal
for treating deep wounds and sinus tracts, which must heal from
the base upwards in order to eliminate dead space and prevent
abscess formation. Loose packing with gauze ribbons
encourages healing from the base outward. Packing should
never be tight, because this may cause localized ischemia and
wound enlargement.
(Fonder 194, col. 1–2).
13. Fonder teaches “[t]opical antibiotics can be very effective when
used against sensitive organisms” (Fonder 198, col. 2).
14. Fonder teaches the growth factor “rhPDGF-BB homodimer,
becaplermin . . . clearly increases the probability that well perfused, properly
debrided diabetic forefoot ulcers will heal completely and in shorter times.
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It also appears to be beneficial for the treatment of pressure ulcers” (Fonder
200, col. 2).
Principles of Law
“[D]uring patent prosecution when claims can be amended,
ambiguities should be recognized, scope and breadth of language explored,
and clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 3–6; FF 1–14) and agree that the prior art renders claim 1
obvious. We address Appellant’s arguments below.
Claim Interpretation
We begin with claim construction because before a claim is properly
interpreted, its scope cannot be compared to the prior art. During
prosecution, we interpret terms in a claim using the broadest reasonable
interpretation in light of the Specification. In re Morris, 127 F.3d 1048,
1056 (Fed. Cir. 1997). The phrase at issue in claim 1 is the “cotton is
formed so as to contact substantially the whole of the inner surface of the
skin ulcer.”
We first turn to the Specification which is, “[i]n most cases, the best
source for discerning the proper context of claim terms.” Metabolite Labs.,
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Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004).
The Specification teaches using an amount of therapeutic material that
can contact a part of the inner surface of the skin ulcer
(preferably 50% or more of the entire inner surface) or
substantially the whole of the inner surface (preferably more
than 90%) when the fibrous material holding an antibiotic and a
cell proliferation accelerator therein is formed into an
approximately spherical shape.
(Spec. ¶ 29). The Specification explains that the product may be “packed in
the ulcer with a pocket to effectively adhere and leach out fradiomycin
sulfate and trafermin throughout the interior portion of the ulcers” (Spec.
¶ 10). The Specification teaches “by forming Sofratulle patch into a
dumpling shape, fradiomycin sulfate (antibiotic) as its active ingredient was
effectively adhered and permeated throughout the base of ulcers” (Spec.
¶ 36).
We, therefore, understand that “substantially the whole of the inner
surface” encompasses about 90% or more of the inner surface and that this
level of contact may be achieved by loosely packing the therapeutic gauze
material into the ulcer.
Obviousness
Appellant contends “the cotton of Fonder is for covering a wound
surface and is not used in a manner as claimed in the current version of
claim 1, that is, by forming the cotton so that the cotton contacts
substantially the whole of the inner surface of a skin ulcer” (Appeal Br. 11).
Appellant notes that Fonder teaches “[p]acking should never be tight,
because this may cause localized ischemia and wound enlargement” (id.;
citing Fonder 194, col. 2).
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We find this argument9 unpersuasive because the full quote from
Fonder states:
Gauze ribbons are ideal for treating deep wounds and sinus
tracts, which must heal from the base upwards in order to
eliminate dead space and prevent abscess formation. Loose
packing with gauze ribbons encourages healing from the base
outward. Packing should never be tight, because this may
cause localized ischemia and wound enlargement.
(FF 12). Thus, Fonder actually prefers “to eliminate dead space” which is
reasonably understood as contacting the entirety of the internal surface of
deep wounds to prevent abscess formation (cf. Ans. 5). While, as Appellant
correctly notes, Fonder does not prefer tight packing, Fonder encourages
“loose packing . . . from the base outward” (FF 12). Appellant provides no
reasoning or evidence that Fonder’s loose packing of gauze from the base
outward to eliminate dead space would fail to contact substantially the whole
of the inner surface of the ulcer as required by claim 1.
In contrast, Wilcher reasonably supports the Examiner’s position
because Wilcher explains “the rough surface is exposed to the wound so as
to maximize contact of the fibers with the wound, resulting in an improved
hemostatic effect and superior adherence to the wound” (FF 3). Thus, the
ordinary artisan would also have expected the ordinary artisan to apply the
loose packing of Fonder to adhere to the entire wound because Wilcher

9 We note that Appellant’s reference to “Reference Material 1” also suggests
that packing that results in pressure is undesirable but does not address the
loose packing suggested by Fonder (see Appeal Br. 11). We also note that
in the Response dated Dec. 6, 2018, only a small portion of this reference
was provided in a non-certified translation that was not submitted with an
IDS and we are therefore unable to ascertain the complete teachings of this
reference.
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teaches “to maximize contact” for “superior adherence” (FF 3). Thus, as the
Examiner notes, “[p]acking a deep wound (such as a skin ulcer) with gauze
will by definition result in substantial contact the whole of the inner surface
of a skin ulcer since ‘packing’ of a wound is understood by artisans as gauze
being pushed into the ulcer” (Ans. 5).
Appellant contends
Fonder does not teach that when a cotton holding an antibiotic
and a cell proliferation accelerator is packed in a skin ulcer with
a pocket and the cotton comes into contact with substantially
the whole of the inner surface of the skin ulcer, that the
antibiotic effectively adheres and permeates throughout the
interior of the pocket to effectively inhibit bacterial infections
in the pocket.
(Appeal Br. 12; cf. Reply Br. 6).
We find this argument unpersuasive because Appellant is arguing
Fonder alone rather than in combination with the other disclosures in the
prior art. “Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The
Examiner’s reasoning “takes into account only knowledge which was within
the level of ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant’s disclosure.” In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
The claim requires that the cotton is holding an antibiotic and a cell
proliferation accelerator. Fonder teaches loosely packing gauze into wounds
including ulcers (FF 14) with gauzes that “are impregnated with substances
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intended to optimize the healing environment” (FF 12). Fonder teaches that
these substances can include antibiotics (FF 13) and growth factors (FF 14).
We understand growth factors to be a type of cell proliferation accelerator as
required by the claim. Wilcher teaches to maximize contact (FF 3) with
cotton gauzes (FF 2) and to include antibiotics (FF 5) and growth factors (FF
6). Ichioka specifically teaches using the Trafermin growth factor because it
accelerates healing of deep wounds (FF 7–8). Nambu teaches that
antimicrobial agents including fradiomycin may be incorporated into
wound-covering materials (FF 9).
We therefore agree with the Examiner that it would have been
obvious to loosely pack skin ulcers with antibiotic and growth factor
impregnated cotton gauze and “to maximize contact of the fibers with the
wound, resulting in . . . superior adherence to the wound” because
antibiotics, growth factors and superior adherence will result in superior
wound treatment (FF 1–14; cf. Final Act. 5–6).
Appellant contends: “In Wilcher, however, the fibers are used to stop
bleeding and thus, their use is completely different from that of the wound
dressing of Fonder. Appellant therefore submits that the Examiner’s
position in view of Wilcher represents an ex post facto analysis” (Reply Br.
6).
We find this argument unpersuasive because Wilcher does teach “to
maximize contact of the fibers with the wound, resulting in . . . superior
adherence to the wound” (FF 3). This is an independent reason to
substantially contact the entire ulcer wound surface, to improve adherence.
This general reason of improved adherence is reasonably understood as
applicable not only to bleeding wounds but also to non-bleeding wounds
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such as ulcers, for the same purpose in treating it. As already noted,
Fonder’s loose packing alone (FF 3) would have reasonably been expected
to contact substantially the entire wound surface, just as a dabbed paper
towel contacts an entire bowl, Wilcher simply provides additional reasons to
contact as much of the wound surface as practicable to improve adherence
(FF 3).
Appellant contends “a superior effect is represented by the per se fact
that packing a cotton holding an antibiotic and a cell proliferation accelerator
into the pocket of a skin ulcer improved the ulcer rather than made the ulcer
worse or intractable” (Reply Br. 10).
We are not persuaded that Appellant has provided any secondary
consideration or unexpected result for the claimed method. Appellant does
not identify a teaching in the Specification that contacting the entire inner
surface results in an unexpected or superior result. Nor does Appellant point
to a Declaration or other evidence. “[A]ny superior property must be
unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). “It is well settled that
unexpected results must be established by factual evidence. Mere argument
or conclusory statements . . . [do] not suffice.” In re Soni, 54 F.3d 746, 750
(Fed. Cir. 1995). The only indication of superior results is attorney
argument in the brief. But this is simply attorney argument without evidence
regarding the rejection as presented by the Examiner. See In re De Blauwe,
736 F.2d 699, 705 (Fed. Cir. 1984). We also note that Appellant has not
demonstrated a result commensurate in scope with the claim and has not
compared the result to the closest prior art.
Conclusion of Law
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A preponderance of the evidence of record supports the Examiner’s
conclusion that Wilcher, Pierce, Ichioka, Nambu, Frank, and Fonder render
the claims obvious.

DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 4–7, 16, 23,
24, 27, 29, 31
103 Wilcher, Pierce,
Ichioka, Nambu,
Frank, Fonder
1, 4–7, 16,
23, 24, 27,
29, 31

No time period for taking any subsequent action in connection with this appeal
may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED