Ex Parte Svetlik

Patent Trial and Appeal Board

Nov 25, 2013

11368127 (P.T.A.B. Nov. 25, 2013)

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.
11/368,127 03/03/2006 Harvey E. Svetlik 21844.001-AP 6951
42922 7590 11/25/2013
WHITAKER CHALK SWINDLE & SCHWARTZ PLLC
301 COMMERCE STREET
Suite 3500
FORT WORTH, TX 76102-4186
EXAMINER
BIANCO, PATRICIA
ART UNIT PAPER NUMBER
3772
MAIL DATE DELIVERY MODE
11/25/2013 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 HARVEY E. SVETLIK
____________________

Appeal 2011-001974
Application 11/368,127
Technology Center 3700
____________________

Before: EDWARD A. BROWN, LYNNE H. BROWNE, and
CARL M. DeFRANCO, Administrative Patent Judges.

BROWNE, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2011-001974
Application 11/368,127
2
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of claims
10, 12, 14, and 17. Claims 1-9 are withdrawn from consideration. Claims
11, 13, 15, 16 and 18-20 are canceled. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.

CLAIMED SUBJECT MATTER
The claims are directed to a method of manufacturing a wound
treatment-dressing. Independent claim 10 is reproduced below:
10. A method of manufacturing a wound treatment-
dressing for placing over a wound treatment area to fight
microbial organisms in the wound, the method comprising the
steps of:
providing a dressing body having at least a wound
contacting surface layer which is formed from a medically inert,
hydrophilic, moisture permeable, inherently flexible, urethane
open-cell foam which provides conformational area contact
over the wound treatment area without local non-contact;
wherein the foam which makes up at least the wound
contacting surface of the dressing body exists as a foam matrix
comprised of interconnected foam cells with cell walls which
has incorporated therein a combination of inorganic
antimicrobials as active agents, the active agents being
incorporated into the foam matrix both topically on a foam cell
surface and integrally within the foam cell wall, whereby the
foam functions as a liquid absorber with liquid exudate being
absorbed from the wound treatment area into the foam matrix
where it is retained against free flow out of the wound
treatment-dressing and is kept away from the wound to
facilitate healing, whereby microbial organisms are removed
from the wound and killed in an external killing zone;
wherein the open-cell foam is made by the steps of:
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Application 11/368,127
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physically mixing a given weight percentage of
each antimicrobial agent, in the form of particles, into
the polymer foam ingredients prior to foaming; and
producing a finished manufactured foam wound
treatment-dressing from the polymer foam ingredients,
including the antimicrobial agents, in a foaming step such
that the antimicrobials are mechanically included in the
foam cell wall upon foaming, whereby some quantity of
antimicrobial particles will be totally encapsulated into
the wall’s polymer structure with the remaining
quantity protruding through the polymer wall boundary
to be physically exposed into the void space of the open-
foam cell, the incorporation of the antimicrobial particles
during the foaming step resulting in the antimicrobial
particles being physically captured and no longer mobile,
thus providing for the sterile rinsing and potential re-use
of the wound treatment-dressing;
wherein the particles which are encapsulated into
the foam's cell structure and wall comprise the
combination of gentian-violet, methylene-blue and
colloidal or ionic silver, wherein the gentian-violet and
methylene-blue components are present in the foam
matrix as nano-sized particles which range in spherical
diameter from about 19 microns to 8000 microns, and
wherein the finished manufactured foam wound
treatment-dressing has an antimicrobial concentration of
each of the gentian-violet, methylene-blue and colloidal
or ionic silver components in the range from 0.0001 % to
9% (gr/gr) by weight of each component; and
wherein the foam body which makes up the
finished manufactured foam wound treatment-dressing
has a thickness in the range from about 2 to 10 mm.

PRIOR ART
Kelly
Park
Shanbrom
US 4,985,467
US 5,858,313
US 6,361,786 B1
Jan. 15, 1991
Jan. 12, 1999
Mar. 26, 2002
Nielsen US 2004/0086549 A1 May 6, 2004
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Application 11/368,127
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GROUND OF REJECTION
Claims 10, 12, 14, and 17 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Nielsen, Shanbrom, Kelly, and Park.

OPINION
Obviousness
Appellant argues claims 10, 12, 14, and 17 as a group. See App. Br.
20. We select independent claim 10 as the representative claim and claims
12, 14, and 17 stand or fall with claim 10. See 37 C.F.R. § 41.37(c)(1)(vii)
(2011).
The Examiner determines that the combined teachings of Nielsen,
Shanbrom, Kelly, and Park render claim 10 obvious. In particular, the
Examiner finds that “Nielsen fails to disclose a method [in which] the active
agents comprise the combination of gentian-violet, methylene-blue and
colloidal or ionic silver.” Ans. 6. The Examiner further finds that:
Shanbrom teaches a method of treating polymeric material
including polyurethane (col. 3, lines 9 -20) for use in medical
grade products. The polymers are selected based on their ability
to preferentially absorb various microbicides or disinfectant
dyes in which methylene blue and gentian violet (col. 2, lines
40-41) are disclosed as especially preferred, in order to provide
polymeric surfaces which resist microbial growth and adhesion
(col. 2, lines 24-32). The methylene blue and gentian violet is
introduced to the polymer during manufacture of the polymer
rather than treating the formed polymer with a microbicide
solution (col.7, lines 54-60).
Id.
Appellant states that “[t]he Nielsen reference operates in a totally
different fashion from Applicant's claimed wound treatment-dressing due to
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Application 11/368,127
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differences in manufacture . . . [because Nielsen] describes the released
silver ions as being ‘transported into the wound bed to exercise antimicrobial
activity.’” Br. 13. While these statements appear to be true, they are not
indicative of error because claim 10 does not preclude wound treatment
dressings that release silver ions from being manufactured in accordance
with the method set forth therein. In other words, the Examiner correctly
finds that Nielsen’s wound dressing, as modified, is manufactured in
accordance with the method set forth in claim 10. See Ans. 4-20.
Furthermore, the Examiner correctly finds that Nielsen’s wound dressing,
resulting from modifying Nielsen’s method, performs the functions set forth
in claim 10. Id. The fact that Nielsen’s wound dressing performs additional
functions beyond those claimed does not negate these findings. Thus,
Appellant’s statements are not indicative of error.
Appellant argues that Nielsen “does not suggest the desirability of
adding gentian violet and methylene blue, or the synergistic effect to be
obtained thereby.” Br. 14. Appellant’s argument is not responsive to the
rejection as articulated by the Examiner, which does not rely upon Nielsen to
suggest the desirability of adding gentian violet and methylene blue. Rather,
the rejection relies upon Shanbrom for these features. Further, Appellant has
not identified any evidence showing a synergistic effect being obtained by
adding gentian violet and methylene blue to the particles disclosed by
Nielsen.1 Accordingly, Appellant’s argument is unpersuasive.
Appellant states that “[t]he teaching of the Shanbrom reference differs
from Applicant’s invention primarily in that Shanbrom is describing a solid
polymer preferred product, i.e., solid medical devices such as catheters,

1 We note that Appellant’s unsupported claim of a synergistic effect in the
Specification is ineffective without evidentiary support. See Spec. 16.
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gloves, contact lenses; not wound dressings.” Br. 14. While true, this
statement is similarly not indicative of error. Nonobviousness cannot be
established by attacking the references individually when the rejection is
predicated upon a combination of prior art disclosures. See In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Appellant argues that “Park
nowhere suggests the efficacy of Applicant’s manufacturing technique of
processing the dry particles into the pre-polymer mixture as uniformly and
easily as possible.” Br. 15. Appellant’s argument is not convincing as
Appellant’s “manufacturing technique of processing the dry particles” is not
claimed. It is well-established that unclaimed features cannot be relied upon
for patentability. In re Self, 671 F.2d 1344, 1348 (CCPA 1982).
Appellant argues that Nielsen “fails to recognize any stated
criticality of the nature of the substrate being used.” Br. 16. We are
unaware of any requirement that a reference recognize the criticality of a
particular claimed feature. Appellant does not dispute the Examiner’s
finding that Nielsen discloses “a method of manufacturing a wound
treatment-dressing, comprising the steps of: providing a dressing body
[0002] having at least a wound contacting surface layer [0030] which is
formed from a medically inert, hydrophilic, moisture permeable,
urethane open-cell foam [0030].” Ans. 4. Accordingly, Appellant has not
apprised us of error.
Appellant argues that Nielsen “does not teach or suggest the
combination of Applicant’s specific ‘trilogy’ of elements.” Br. 17. We
agree; however, this is not indicative of error. One cannot show
nonobviousness by attacking references individually where the rejections are
based on combinations of references. In re Merck & Co., 800 F.2d at 1097.
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In this case, the rejection relies upon the combined teachings of Nielsen and
Shanbrom for Appellant’s specific “trilogy” of elements.
Appellant argues that “[t]here is no teaching in Nielsen of bound
versus free antimicrobial agents in the polymer matrix or of the use of
uniform sized particles of a specified size range.” Br. 17. The Examiner
correctly finds that the “antimicrobials are physically incorporated into the
foam . . . whereby some quantity of antimicrobial particles will be totally
encapsulated into the wall’s polymer structure” (i.e., that they are bound).
Ans. 4-5; see Nielsen, paras. [0009], [0030]. Thus, Appellant’s argument
that Nielsen does not teach bound antimicrobial agents is unpersuasive.
Furthermore, the Examiner does not rely on Nielsen to teach particles of the
specified size range. Rather, the rejection relies upon the combined
teachings of Nielsen, Shanbrom, Kelly, and Park for this feature. Ans. 7-8.
As discussed supra, one cannot show nonobviousness by attacking the
references separately when the rejection is based on a combination of
references. Accordingly, Appellant’s argument is not persuasive.
Appellant argues that “there is set forth no objective basis for
combining the teachings of the references in the manner used by this
rejection, and selecting the helpful portions from each reference while
ignoring the unhelpful portions.” Br. 17. We disagree. For each of the
proposed modifications, the Examiner articulated reasons for the
modification. Ans. 4-10. Further, the Supreme Court, in KSR Int’l Co. v.
Teleflex, Inc., 550 U.S. 398 (2007), has provided guidance when addressing
a concern about picking and choosing among the teachings of the references.
For over a half century, the Court has held that a “patent for a
combination which only unites old elements with no change in
their respective functions . . . obviously withdraws what already
is known into the field of its monopoly and diminishes the
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Application 11/368,127
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resources available to skillful men.” Great Atlantic & Pacific
Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152–
153, 71 S.Ct. 127, 95 L.Ed. 162 (1950). This is a principal
reason for declining to allow patents for what is obvious. The
combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield
predictable results.
KSR, 550 U.S. at 415-16.
Appellant further argues that the Examiner has not addressed the
requirement for “an expectation of success.” See Br. 18. To the extent that
such a requirement exists after KSR, it is encompassed by the requirement
that the results be predictable. Where, as in this case, the Examiner has set
forth findings that show that the invention is a combination which only
unites old elements with no change in their respective functions, the burden
shifts to Appellant to show that the results would not be predictable.
Appellant has not provided evidence or persuasive argument that this is the
case. Accordingly, Appellant’s argument is unconvincing.
Appellant further argues that the references do not teach all of the
claim limitations because the rejection relies upon the discovery of optimum
values. See Ans. 18-19. However, Appellant has not explained why the
discovery of the optimum values would be beyond the skill of one of
ordinary skill in the art. Accordingly, Appellant’s argument is not
persuasive.
For these reasons, we find the subject matter of claim 10, and claims
12, 14, and 17 which fall therewith, to be prima facie obvious.
Secondary Considerations
As noted above, we have found the subject matter of the claims on
appeal to be prima facie obvious. Whenever obviousness is found with
respect to the subject matter on appeal, and Appellant furnishes evidence of
Appeal 2011-001974
Application 11/368,127
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secondary considerations, it is our duty to reconsider the issue of
obviousness anew, carefully weighing the evidence for obviousness with
respect to the evidence against obviousness. See, e.g., In re Eli Lily & Co.,
902 F.2d 943, 945 (Fed. Cir. 1990). We are also mindful that the objective
evidence of nonobviousness in any given case may be entitled to more or
less weight depending on its nature and its relationship with the merits of the
invention. See Stratoflex Inc. v. Aeroquip, 713 F.2d 1530, 1538 (Fed. Cir.
1983). To be given substantial weight in the determination of obviousness
or nonobviousness, evidence of secondary considerations must be relevant to
the subject matter as claimed, and therefore we must determine whether
there is a nexus between the merits of the claimed invention and the
evidence of secondary considerations. Ashland Oil, Inc. v. Delta Resins &
Refractories, Inc., 776 F.2d 281, 305 n.42 (Fed. Cir. 1985), cert. denied, 475
U.S. 1017 (1986).
Objective evidence which must be factually supported by an
appropriate affidavit or declaration to be of probative value includes
evidence of unexpected results, commercial success, solution of a long-felt
need, inoperability of the prior art, invention before the date of the reference,
and allegations that the author(s) of the prior art derived the disclosed
subject matter from the applicant. See, e.g., In re De Blauwe, 736 F.2d 699,
705 (Fed. Cir. 1984) (“It is well settled that unexpected results must be
established by factual evidence.” “[A]ppellants have not presented any
experimental data showing that prior heat-shrinkable articles split. Due to
the absence of tests comparing appellant’s heat shrinkable articles with those
of the closest prior art, we conclude that appellant’s assertions of
unexpected results constitute mere argument.”) (emphasis added). See also
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In re Lindner, 457 F.2d 506, 508 (CCPA 1972); Ex parte George, 21
USPQ2d 1058 (Bd. Pat. App. & Inter. 1991).
Appellant submits the declaration of Dr. Stephen Warren as evidence
of non-obviousness. Appellant contends that “Dr. Warren's Declaration
shows successful treatment of serious wounds or sores which were
practically intractable in the past. Certainly, the nature of the result achieved
is a direct consequence of the manufacturing technique employed to produce
the subject wound dressing.” Br. 20. We understand Appellant’s contention
is that the declaration provides evidence of unexpected results for a wound-
treatment dressing manufactured by the claimed method, when the dressing
is used to treat “serious wounds or sores.” However, the Examiner
determines that Dr. Warren’s declaration does not address
the novel or unobvious nature of the method of manufacturing
the wound treatment-dressing. Therefor as noted above the
scope of the declaration is not commensurate with the scope of
the claims. For one to attest to the novel and/or unobvious
nature of the claimed invention, the declaration would have to
address the method of manufacture rather than the alleged
attributes and benefits the final end product device achieves in
the field of wound healing.
Ans. 16. The Examiner further finds that “Dr. Warren’s position is
unsupported by any comparative studies providing detailed analysis of the
RTD dressing compared to other common prior art dressings.” Id. We
understand the Examiner’s position to be that the declaration evidence has
no nexus to the claimed invention and that the declaration is unsupported by
any comparative studies at all, let alone studies comparing the claimed
method to the closest prior art. We agree. Dr. Warren’s declaration is
opinion testimony directed to the ultimate legal conclusion. When
considered in light of all of the evidence of record it is given little weight.
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See In re Brandstadter, 484 F.2d 1395 (CCPA 1973). Accordingly, we find
that the evidence of non-obviousness does not outweigh the evidence of
obviousness.
For these reasons, we sustain the Examiner’s rejection of claim 10,
and claims 12, 14, and 17 which fall therewith.

DECISION
The Examiner’s rejection of claims 10, 12, 14 and 17 is AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2009).

AFFIRMED

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