Ex Parte Smith et al

Patent Trial and Appeal Board

Dec 20, 2016

12087837 (P.T.A.B. Dec. 20, 2016)

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.
12/087,837 12/22/2009 Daniel J. Smith UOA.593.US 2987
60402 7590 12/22/2016
KINETIC CONCEPTS, INC.
c/o Harness Dickey & Pierce
5445 Corporate Drive
Suite 200
Troy, MI 48098
EXAMINER
MACAULEY, SHERIDAN R
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
12/22/2016 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):
dgodzisz @ hdp. com
troymailroom @hdp. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL J. SMITH,
PATRICK J. TROTTER, and MAHESH BHIDE
Appeal 2015-004377
Application 12/087,837
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
for facilitating the removal of necrotic skin using nitric oxide. The
Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We reverse.
Statement of the Case
Background
A “need exists for a device and/or method to facilitate the easy
removal of necrotic tissue from wounds such as diabetic ulcers. The process
of doing so is known as debridement” (Spec. 1:6—8). “Nitric oxide has been
1 Appellants identify the Real Parties in Interest as The University of Akron
and Systagenix Wound Management IP Co. (see Br. 1).
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Application 12/087,837
used in gaseous form to facilitate wound healing. For instance, devices exist
that are gas chambers designed to conform to or surround a wound and apply
gaseous nitric oxide thereto” (Spec. 2:3—5). “[T]his process is cumbersome
inasmuch as it requires connection to an external gas source and various
fluidic parts. Furthermore, the process can incapacitate the patient when the
treatment is applied to a foot, for instance” (Spec. 2:7—10).
The Claims
Claims 1, 2, 4—22, and 25 are on appeal.2 Claim 1 is representative
and reads as follows:
1. A method for facilitating the removal of necrotic skin
comprising: applying a nitric oxide-forming composition to
necrotic tissue; activating the nitric oxide-forming composition
such that it releases nitric oxide and doses the necrotic tissue
with a dose of from about 1 to about 1000 pmole/cm2 of nitric
oxide, wherein the nitric oxide loosens the necrotic tissue; and
removing the loosened necrotic tissue.
The Issues3
A. The Examiner rejected claims 1 and 4—22 under 35 U.S.C. § 103(a) as
obvious over Stenzler4 and Holland5 (Final Act. 6—7).
B. The Examiner rejected claims 1, 3—22, and 25 under 35 U.S.C.
§ 103(a) as obvious over Stenzler, Holland, and Blake6 (Final Act. 7—9).
2 Claim 3 was cancelled in the amendment filed Nov. 9, 2012 while claims
23 and 24 are identified as withdrawn (see App. Br. 10).
3 The indefiniteness rejections were withdrawn by the Examiner in
the Advisory action mailed April 2, 2014.
4 Stenzler et al., US 2005/0191372 Al, published Sept. 1, 2005 (“Stenzler”).
5 Holland et al., US 2002/0122771 Al, published Sept. 5, 2002 (“Holland”).
6 Blake et al., US 6,682,732 Bl, issued Jan. 27, 2004 (“Blake”).
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Application 12/087,837
A. 35 U.S.C. § 103(a) over Stenzler and Holland
The Examiner finds “Stenzler teaches a method for facilitating the
removal of necrotic skin tissue comprising applying a nitric oxide (NO) to
necrotic tissue” but “Stenzler does not teach that nitric oxide is applied as a
nitric oxide-forming composition that is activated such that it releases nitric
oxide” (Final Act. 6).
The Examiner finds that “Holland teaches a method of treating a
wound using a composition that may comprise a NO-forming composition”
(Id.). The Examiner finds it obvious “to use the compositions of Holland in
debridement methods, such as those taught by Stenzler, because Stenzler
teaches that it is desirable to treat necrotic tissues with NO in a method of
debridement and Holland teaches methods of NO delivery to wound tissue”
(Id. at 7).
Appellants contend “[tjhere is no reason to believe that replacing the
gas treatment of NO with a hydrogel that delivers an NO active agent (per
Holland) would be suitable for necrotic tissue removal. The fact that direct
application of NO gas is taught to work does not predict that application of a
Holland hydrogel would work” (Br. 4). Appellants also contend that:
it is completely unknown what dosage of NO is delivered to the
wound in Stenzler, because one does not know how a particular
parts per million of NO gas delivery would relate to actual
application of NO to a given surface area of the wound. The
present claims, in distinction, are directed to a micromole
dosage per square centimeter, and there is nothing in Stenzler
that teaches such dosage. Holland does not remedy this.
(Br. 4-5).
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Appeal 2015-004377
Application 12/087,837
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Stenzler and Holland render
obvious the step of “applying a nitric oxide-forming composition to necrotic
tissue . . . with a dose of from about 1 to about 1000 pmole/cm2 of nitric
oxide” as required by claim 1?
Findings of Fact
1. Stenzler teaches “there is a need for a device and method for the
treatment of surface and subsurface infections and wounds by the topical
application of NO” (Stenzler 121).
2. Stenzler teaches “after the exposure of the wound to high
concentration of nitric oxide gas for a first treatment period (e.g., 5-8 hours
per day), the necrotic tissue may be mechanically removed easily and the
concentration of nitric oxide gas can be decreased for a second treatment
period” (Stenzler 197).
3. Stenzler teaches “high concentration preferably ranges from
about 200 ppm to 400 ppm, the decreased concentration preferably ranges
from about 5-20 ppm, and the third concentration ranges from about 20 ppm
to 200 ppm” (Stenzler 133).
4. The Examiner finds that Stenzler’s
values of 5 to 20 ppm convert to 167 to 667 pM (the molar
mass of NO is about 30; ppm/molar mass= mM; mM*1000 =
pM). Although this does not fall within claimed range of 1 to
1000 pmoles per cm2 because Stenzler does not teach the values
that are administered per wound surface area, it shows that the
values administered by Stenzler are similar to the values
administered in the claimed method.
(Ans. 4).
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Application 12/087,837
5. Holland teaches that a “dressing may function as a drug
delivery matrix to deliver active agents to the wound. ... A wide variety of
bioactive agents can be incorporated into the hydrogel. . . Active agents
include . . . nitric oxide” (Holland Tflf 57—58).
6. Holland teaches “[njitric oxide can be in the form of nitric
oxide precursors bound to or otherwise incorporated into the hydrogel.
Examples include complexes of NO with nucleophiles . . . The prior art
teaches methods of attaching many of these compounds to the backbone of
the hydrogel polymers” (Holland 172).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
While Stenzler teaches the use of nitric oxide gas for removal of
necrotic tissue (FF 2) at concentrations ranging from 5 to 400 ppm (FF 3),
the Examiner acknowledges that Stenzler does not teach the specific dose
required by claim 1 (FF 4). Holland provides no information regarding the
amounts of nitric oxide gas released by any wound dressing (FF 5—6) and the
Examiner does not otherwise establish that Holland’s wound dressings
release any particular amount of nitric oxide gas. Consequently, there is no
evidence supporting the position that the wound dressing of Holland would
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Appeal 2015-004377
Application 12/087,837
function for necrotic tissue removal by releasing nitric oxide gas in amounts
required by the claims.
We therefore find Appellants have the better position. While the
Examiner’s rationale to substitute the hydrogel for gas as obvious
equivalents is reasonable, the Examiner does not provide the underlying
evidence that the ordinary artisan would have reasonably expected sufficient
nitric oxide release from the hydrogel to achieve the necessary goal of
necrotic tissue removal. The Examiner’s finding that the Specification does
not “provide any evidence that the formulation of an NO-forming
composition to deliver a specific concentration of NO to a wound would
have been difficult” (Ans. 5) misses the point, because the issue is
reasonable expectation of success, not lack of written description. See In re
Cyclobenzaprine Hydrochloride Extended—Release Capsule Patent Litig.,
676 F.3d 1063, 1070 (Fed. Cir. 2012) (“Lack of written description,
however, is a separate defense”). The Court continues that “[wjhile it may
have been obvious to experiment with the use of the same PK profile when
contemplating an extended-release formulation, there is nothing to indicate
that a skilled artisan would have had a reasonable expectation that such an
experiment would succeed in being therapeutically effective.” Id. The same
reasoning applies to the instant case, where the absence of a known
relationship between nitric oxide gas and delivery area as recited in claim 1
represents a situation where “the prior art gave either no indication of which
parameters were critical or no direction as to which of many possible
choices is likely to be successful,” and rejected “hindsight claims of
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Application 12/087,837
obviousness.” In re Kubin, 561 F.3d 1351, 1359 (Fed.Cir.2009) (quoting In
re O’Farrell, 853 F.2d 894, 903 (Fed.Cir.1988)).
We also find that even if the ordinary artisan had reason to substitute
the hydrogel delivery matrix of Holland for the gas delivery process of
Stenzler, Holland does not provide any evidence that the amount of nitric
oxide release from the hydrogels would be sufficient to fall within the range
required by claim 1 for loosening necrotic tissue for debridement.
The Examiner contends that “the concentration of NO delivered to the
wounds is not provided, providing evidence that Appellants considered it a
matter of routine experimentation to formulate a composition to deliver a
specific concentration of NO to a wound” (Ans. 5—6).
We do not find this argument persuasive. Claim 1 requires a
particular concentration of nitric oxide to be released within a particular unit
area. As stated in Antonie, while discovery of an optimum value of a
variable is normally obvious, one exception to this rule is the situation where
the parameter optimized was not recognized to be a result-effective variable.
See In re Antonie, 559 F.2d 618, 620 (CCPA 1977). In this case, the
Examiner has not established that selecting nitric oxide doses based upon the
area to be treated, rather than the gas concentration, represents a results
effective variable. We recognize that Stenzler teaches ranges for the amount
of nitric oxide gas exposed to wounds generally (FF 3), but those ranges do
not relate to any particular delivery area, and the Examiner has
acknowledged that the ranges do not overlap those of claim 1 (FF 4).
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Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Stenzler and Holland render obvious the step of “applying a nitric
oxide-forming composition to necrotic tissue . . . with a dose of from about 1
to about 1000 pmole/cm2 of nitric oxide” as required by claim 1.
B. 35 U.S.C. § 103(a) over Stenzler, Holland, and Blake
This rejection relies upon the underlying obviousness rejection over
Stenzler and Holland. Having reversed that rejection, we also necessarily
reverse the further obviousness rejection over Blake because the Examiner
does not identify teachings in Blake regarding the amounts of nitric oxide
necessary for necrotic tissue removal.
SUMMARY
In summary, we reverse the rejection of claims 1 and 4—22 under 35
U.S.C. § 103(a) as obvious over Stenzler and Holland.
We reverse the rejection of claims 1, 3—22, and 25 under 35 U.S.C.
§ 103(a) as obvious over Stenzler, Holland, and Blake.
REVERSED
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