Ex Parte Vitaris et al

Patent Trial and Appeal Board

Feb 13, 2017

12550045 (P.T.A.B. Feb. 13, 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.
12/550,045 08/28/2009 Ronald F. Vitaris HKN-00427 1147
(1)/1215-010US1
127558 7590 02/15/2017
Covidien LP/Shumaker & Sieffert P.A.
Attn: IP Legal Department
15 Hampshire Street
Mansfield, MA 02048
EXAMINER
ORWIG, KEVIN S
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
02/15/2017 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):
iplegalus@covidien.com
pairdocketing @ ssiplaw.com
medtronic_mitg-pmr_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RONALD F. VITARIS, HARISH A. PATEL, E. DAVID FINK,
SHARON A. MULLIGAN, BRIAN DOWD, SCOTT ORR,
and CHIRAG B. SHAH1
Appeal 2016-001007
Application 12/550,045
Technology Center 1600
Before ERIC B. GRIMES, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a wound
dressing. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Medtronic pic of
Dublin, Ireland. (Appeal Br. 3.)
Appeal 2016-001007
Application 12/550,045
STATEMENT OF THE CASE
Claims on Appeal
Claims 21 and 23—31 are on appeal.2 (Claims Appendix, Appeal Br.
15—17.) Claims 21 and 27 are illustrative and read as follows:
Claim 21: An article comprising:
a film layer;
a tissue-contacting biodegradable hydrogel layer comprising
polyhexamethylene biguanide (PHMB); and
a collagen layer disposed between the film layer and the tissue­
contacting biodegradable hydrogel layer.
Claim 27: A wound dressing, comprising:
a film layer;
a tissue-contacting biodegradable layer comprising a hydrogel and
polyhexamethylene biguanide (PHMB);
a collagen layer disposed between the film layer and the tissue­
contacting biodegradable layer; and
an adhesive layer between the film layer and the collagen layer
Examiner’s Rejections3
1. Claims 27—31 stand rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (new matter).
(Ans. 2—5.)
2. Claims 21 and 23—31 stand rejected under 35 U.S.C. § 103(a) as
2 Claims 1—20 and 22 are cancelled, and claims 32—36 are withdrawn. (Final
Act. dated Dec. 11, 2014, at 2.)
3 Claims 21 and 23—31 stand provisionally rejected for obviousness-type
double patenting over claims 1, 2, 5, 29, and 30 of copending Application
No. 12/548,532 in view of Carpenter. (Ans. 10-11.) However, Patent and
Trademark Office records indicate that U.S. Application No. 12/548,532 was
abandoned on Oct. 21, 2016. Thus, this rejection is moot.
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Application 12/550,045
unpatentable over Carpenter,4 Hiltner,5 and Quarfoot.6 (Id. at 5—10.)
FINDINGS OF FACT
We adopt as our own the Examiner’s findings regarding the scope and
content of the prior art, and reasons to combine the cited references. The
following findings are included for emphasis and reference convenience.
FF 1. The Examiner finds that Carpenter teaches multilayer wound
dressings that can be formulated to release a wound healing agent at a
controlled rate, comprising a biodegradable hydrogel layer and a supporting
polymer layer, that the hydrogel matrices may be loaded with a
medicament/bioactive agent that is released directly at the treatment site as
the matrix degrades, and that any antibiotics/antimicrobials known in the art
can be used throughout the polymer and hydrogel layer. (Ans. 6, citing
Carpenter || 6, 32, 40-41, 46, 56, 69—71, 134, and 264; claims 37, 39, 45,
47, and 48.)
FF 2. The Examiner finds that Carpenter teaches the use of an
occlusive backing layer (i.e., a film layer) to prevent liquid or gas
penetration through the wound dressing. (Ans. 17, citing Carpenter 1257,
claim 12.)
FF 3. The Examiner finds that Hiltner teaches “bioabsorbable
collagen-based wound dressings containing a linear polymer biguanide such
as PHMB.” (Ans. 7, citing Hiltner Title; Abstract; || 17—18.)
4 Carpenter et al., US 2006/0188486 Al, published Aug. 24, 2006
(“Carpenter”).
5 Hiltner et al., US 2005/0260251 Al, published Nov. 24, 2005 (“Hiltner”).
6 Quarfoot, US 4,759,354, issued July 26, 1988 (“Quarfoot”).
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Application 12/550,045
FF 4. The Examiner finds that Hiltner teaches “that collagen is
advantageous in wound dressings as it is an endogenous material, can be
easily absorbed by the body, has hemostatic and wound healing activities,
and is outstandingly well tolerated by the body........ [, and] is superior to
exogenous, synthetic materials.” (Ans. 7, citing Hiltner || 4, 5, and 9.)
FF 5. The Examiner finds that Hiltner teaches “that linear polymer
biguanides are well tolerated antimicrobials known for their good
microbicidal action and effectiveness over a wide pH range, and
compatibility with a host of other pharmaceutical agents.” (Ans. 7, citing
Hiltner || 16, 29, and 30.)
FF 6. The Examiner finds reasons to combine the teachings of
Carpenter and Hiltner; namely, “to use collagen as the support polymer
overlying the wound-contacting hydrogel layer in Carpenter’s dressings” in
order to achieve the benefits of collagen as taught by Hiltner, and “to include
an advantageous wound healing agent like PHMB in both the support and
hydrogel layers, or at least in the wound-contacting hydrogel layer” of
Carpenter in order to achieve the benefits of PHMB as taught by Hiltner.
(Ans. 16-17.)
FF 7. The Examiner finds that Quarfoot teaches collagen-containing
wound dressings, that the dressing may incorporate a backing (i.e., a film
layer), and that Quarfoot teaches an adhesive layer between the collagen
layer and the backing (film) layer. (Ans. 8—9, citing Quarfoot col. 7,11. 52—
55; Abstract; Fig. 1.)
DISCUSSION
We adopt and agree with the Examiner’s findings, analysis, and
conclusions regarding the obviousness rejection, as set forth in the Final
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Application 12/550,045
Action (Final Act. 2—10) and Examiner’s Answer (Ans. 5—10 and 15—24),
and that rejection is affirmed. However, we disagree with the Examiner
regarding the rejection based on35U.S.C. § 112, first paragraph, and that
rejection is reversed.
We begin with a brief discussion of the scope of claims 21 and 27.
See In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[Djuring
examination proceedings, claims are given their broadest reasonable
interpretation consistent with the [Specification.”). We find that neither
claim 21 nor claim 27 limits whether or not the claimed collagen layer may
contact a wound or tissue when in use. The patentability of claims 21 and
27 “depends on the claimed structure, not on the use or purpose of that
structure.” Catalina Mktg. Inti, Inc. v. Coolsavings.com, Inc., 289 F.3d
801, 809 (Fed. Cir. 2002); see also Hewlett-Packard Co. v. Bausch &Lomb
Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (“apparatus claims cover what a
device is, not what a device does”). Moreover, claims 21 and 27 do not
recite that any layer is coextensive with another layer or otherwise limit
whether one or more layers may be in contact with a wound or tissue at any
given time.
Rejection No. 1 — Written Description
Issue
Whether the Specification’s description shows that Appellants were in
possession of the wound dressing recited in claim 27.
Analysis
The Examiner finds that Appellants’ response filed Nov. 21, 2014,
introduced new matter into the claims. (Ans. 3.) The Examiner finds that
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Application 12/550,045
Amended claim 27 recites “an adhesive layer between the film
layer and the collagen layer”, and now requires a specific four
layer arrangement of 1) a film layer, 2) an adhesive, 3) a collagen
layer, and 4) a biodegradable hydrogel comprising PHMB, in
that order. Clear written description support is not present for this
specific arrangement in the instant application. ... the support
cited by [Appellants] is improperly selected from multiple
distinct embodiments described separately in the application.
Appellants are picking and choosing specific elements from the
distinct embodiments originally disclosed to now arrive at a
different arrangement than what was clearly disclosed in the
original application.
(Id.)
Appellants argue that the Specification, including Figure 1, describes
an embodiment in which the laminate/dressing 10 may be provided with an
adhesive 13 between a film layer 12 and an antimicrobial-containing patch
or strip 14. (Appeal Br. 12.) Appellants also point to the Specification’s
statement that “the laminate/dressing 10 may contain biodegradable collagen
and PHMB.” (Id.) Appellants also argue that the Specification, including
Figure 9, describes a laminate/dressing 10' comprising a collagen layer 24
sandwiched between a biodegradable hydrogel containing PHMB 26 and an
outer film layer 28. (Id. at 12—13.) Figures 1 and 9, showing embodiments
of Appellants’ wound dressing, are illustrated below:
FIGURE 1 FIGURES
EXHIBIT 1: FIG. 1 of Appellant’s disclosure EXHIBIT 2: FIG. 9 of Appellant’s disclosure
(Id. at 12.)
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Appellants argue further that the Specification “clearly connects the
laminate/dressing 10' of Figure 9 with the laminate/dressing 10 of Figure 1,
at least in paragraph [0059].” (Id. at 13.)
We find that Appellants have the better position. The written
description requirement does not require Appellants “to describe exactly the
subject matter claimed, [instead] the description must clearly allow persons
of ordinary skill in the art to recognize that [he or she] invented what is
claimed.” Union Oil Co. v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed.
Cir. 2000) (quoting In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)).
Thus, while the “specific four layer arrangement” of claim 27 may not be
described in ipsis verbis, such a description is not required to satisfy the
written description requirement. See In re Wertheim, 541 F.2d 257, 265
(CCPA 1976).
Here, Appellants provide a persuasive explanation from the
Specification that the features of the alternate embodiments shown in
Figures 1 and 9 are not mutually exclusive, or “distinct” as characterized by
the Examiner. (Ans. 11—13.) Rather, the embodiments reflect possible
arrangements of the respective layers of the wound dressing. This is also
reflected in the Specification’s description of (1) an article comprising a film
layer, an adhesive layer, a patch or strip comprising an antimicrobial agent
disposed on the same side of the film layer as the adhesive layer, and a sheet
attached to the side of the film layer opposite the patch or strip (Spec. 119),
and (2) an article comprising a film layer, a collagen layer, and a
biodegradable hydrogel layer (comprising PHMB) disposed between the
film layer and the collagen layer (id. at 120), followed by the statement that
“the present invention provides wound dressings formed from any of the
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Application 12/550,045
above-mentioned articles” (id. at 121.). Accordingly, we find that a person
of ordinary skill in the art would understand that Appellants have described
a multilayer wound dressing in which the various layers may be configured
relative to each other in accordance with the intended use or application of
the wound dressing.
Conclusion
A preponderance of evidence of record establishes that Appellants
were in possession of the wound dressing recited in claim 27. Accordingly,
the rejection of claim 27 under 35U.S.C. § 112, first paragraph, and claims
28—31 dependent thereon, is reversed.
Rejection No. 2 — Obviousness
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under 35 U.S.C. § 103(a).
Analysis
Claim 21
Appellants argue that the Examiner “failed to set forth a prima facie
case of obviousness, at least because the cited references fail to disclose all
claimed features,” the references teach away from the proposed modification
and claimed subject matter, and because the proposed modification
“improperly relies on hindsight.” (Appeal Br. 4—5.)
Claimed Features
Appellants do not persuasively describe the particular claimed
features that they contend are not disclosed by the cited references, and
otherwise fail to persuade us of any error by the Examiner in combining the
teachings of the cited references to arrive at claims 21 and 27. Moreover,
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Application 12/550,045
we find that the Examiner has established a prima facie case of obviousness.
(See FF 1-7.)
As the Supreme Court explained in KSR, “when a patent claims a
structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result.” KSR Int’l v. Teleflex Inc., 550
U.S. 398, 416 (2007); see also id. at 417 (“[W]hen a patent ‘simply arranges
old elements with each performing the same function it had been known to
perform’ and yields no more than one would expect from such an
arrangement, the combination is obvious.”) (quoting Sakraida v. Ag Pro,
Inc., 425 U.S. 273, 282 (1976)).
In this case, we agree with the Examiner that it would have been
obvious to substitute the collagen of Hiltner in place of the polymer support
of Carpenter. (Ans. 16—17.) The polymers of Carpenter include poly(amino
acids) that “biodegrade over time,” thereby “releasing the bioactive agent
into the wound bed while the polymer is absorbed therein.” (Carpenter
1140, 83, and 264; FF 6.) Similarly, the collagen taught by Hiltner is a
protein that is dissolved or absorbed in the body over time to promote
healing of wounds. (Hiltner 112, 9, 11, and 13.) Thus, we discern no error
in the Examiner’s finding “that collagen and the polymer of Carpenter are
functional equivalents.”7 (Ans. 19.) We also agree with the Examiner that it
would have been obvious to use the PHMB of Hiltner as the bioactive agent
7 This finding is also consistent with Appellants’ argument that one having
ordinary skill in the art would not have substituted collagen for the polymer
of Carpenter because they “would have understood Carpenter as already
describing a polymer layer that has these properties” of collagen. (Appeal
Br. 8; Reply Br. 6.) See KSR, 550 U.S. at 416-17.
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Application 12/550,045
in Carpenter’s wound dressings given the desirable properties of PHMB as
taught by Hiltner. (Id. at 17; FF 5, 6.)
Teaching Away
Appellants argue that “Quarfoot and Hiltner teach away from a tissue­
contacting biodegradable hydrogel layer and a collagen layer disposed
between the film layer and the tissue-contacting biodegradable hydrogel
layer by describing that collagen should be in contact with the wound bed.”
(Ans. 7; see also Reply Br. 4—6.)
We are not persuaded. Appellants acknowledge Carpenter’s teaching
that “either a polymer layer or a hydrogel layer may be in contact with the
wound bed.” (Appeal Br. 7; FF 1.) Moreover, the scope of claim 21
(discussed above) includes use of the collagen in contact with the wound
bed, in addition to the hydrogel layer. Accordingly, neither Quarfoot nor
Hiltner teach away from Carpenter or claim 21 because they do not criticize,
discredit, or otherwise discourage the claimed invention. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004).
Hindsight
Appellants take issue with the Examiner’s supplemental rationale for
combining the references by arguing that “[t]he proposed construction for
‘initial delivery’ by the hydrogel layer and ‘further healing’ by the collagen
layer ‘after the hydrogel has been degraded’ amounts to speculation, relies
on hindsight in view of [Appellants’] disclosure, and is not supported by
evidence of record.” (Appeal Br. 9; see also Reply Br. 6—8.) Appellants
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Application 12/550,045
support that argument by reference to a patent to Won8 that they contend
“describes hydrogels lasting for at least 58 days.” (Appeal Br. 9—10.)
We are not persuaded. As the Examiner points out, “the supplemental
reasoning to which [Appellants] refer [] was only provided to address
[Appellants’] prior arguments, and it is not required for the finding of
obviousness.” (Ans. 20.) Moreover, as the Examiner further explains, the
reasoning “is supported by the teachings of the prior art, and is neither
speculation, nor improper hindsight.” (Id.) The Examiner explains in detail
how both Carpenter and Hiltner teach “a hydrogel having a more rapid (i.e.
different) degradation rate/drug delivery rate than the long residence time
polymer/collagen,” and why Appellants’ reliance on Won is unpersuasive.
(See Ans. 20-23.) In addition, because the Examiner’s reasoning is
supported by reference to specific disclosures in the prior art, we are
unpersuaded by Appellants’ hindsight argument. See Otsuka Pharm. Co.,
Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012).
We discern no error in the Examiner’s rejection of claim 21 as
obvious.9
8 Won et al., US 6,388,047, issued May 14, 2002 (“Won”).
9 We also acknowledge, but are unpersuaded by, Appellants’ apparent
argument in the Reply Brief that the Examiner’s alternate reliance on only
Carpenter and Hiltner to reject claim 21 (Ans. 17) constitutes a new ground
of rejection. (Reply Br. 8.) The Examiner’s statement that “Quarfoot is not
even necessary to render [the film layer] limitation obvious, as Carpenter
already does so” (Ans. 17) is not a new ground of rejection, at least because
Appellants had the opportunity to respond to the basic thrust of the rejection.
See In re Kronig, 539 F.2d 1300, 1302-03 (CCPA 1976).
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Claim 27
Appellants repeat essentially the same arguments advanced in
connection with claim 21, and they are unpersuasive for the reasons set forth
above. Accordingly, we discern no error in the Examiner’s rejection of
claim 27 as obvious.
Conclusion of Law
A preponderance of evidence of record supports the Examiner’s
rejection of claims 21 and 27 under 35 U.S.C. § 103(a). Claims 23—26 and
claims 28—31 were not argued separately and fall with claims 21 and 27,
respectively.
SUMMARY
We reverse the rejection of claims 27—31 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
We affirm the rejection of claims 21 and 23—31 as obvious under 35
U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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
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