Ex Parte Locke et al

Patent Trial and Appeal Board

Sep 6, 2017

13588747 (P.T.A.B. Sep. 6, 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.
13/588,747 08/17/2012 Christopher Brian Locke VAC.1023US 2862
60402 7590 09/08/2017
KINETIC CONCEPTS, INC.
c/o Harness Dickey & Pierce
5445 Corporate Drive
Suite 200
Troy, MI 48098
EXAMINER
MENSH, ANDREW J
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
09/08/2017 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):
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 CHRISTOPHER BRIAN LOCKE,
TIMOTHY MARK ROBINSON, and AMY K. MCNULTY
Appeal 2016-007233
Application 13/588,7471
Technology Center 3700
Before HUBERT C. LORIN, NINA L. MEDLOCK, and
BRUCE T. WIEDER, Administrative Patent Judges.
WIEDER, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1, 3—8, 10, 12, 23, 24, 27, 29, 30, 33,
and 35—43. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, “[t]he real party in interest is KCI Licensing,
Inc., assignee of record, which is a subsidiary of Kinetic Concepts,
Incorporated.” (Appeal Br. 3.)
Appeal 2016-007233
Application 13/588,747
CLAIMED SUBJECT MATTER
Appellants’ claimed invention “relates generally to medical treatment
systems and, more particularly ... to reduced-pressure treatment and
debridement systems and methods.” (Spec. 12).
Claims 1, 23, and 33 are the independent claims on appeal. Claim 1 is
illustrative. It recites (emphasis added):
1. A reduced-pressure treatment system for debriding a
treatment area of a tissue site, the system comprising:
a hydrogel adapted to cover the treatment area, wherein
the hydrogel comprises a blocked acid debriding agent;
a manifold adapted to cover the hydrogel and distribute
reduced pressure to the tissue site; and
a sealing drape for placing over the tissue site and
manifold, the sealing drape adapted to form a fluid seal over the
tissue site and manifold;
a reduced-pressure interface for delivering reduced
pressure to the manifold; and
a reduced-pressure subsystem for providing reduced
pressure.
REJECTIONS
Claims 1, 3—8, 10, 12, 23, 24, 27, 29, 33, and 35—432 are rejected
under 35 U.S.C. § 103(a) as being unpatentable over Haggstrom
(US 7,569,742 B2, iss. Aug. 4, 2009) and Dickson, Jr. et al.
(US 2006/0052416 Al, pub. Mar. 9, 2006) (hereinafter “Dickson”).
2 In view of the reference to “an intermediate foam layer” in paragraph 11
on page 9 of the Final Action, we treat the reference in that paragraph to
“claims 10 and 43” as a typographical error and that the reference should
have read “claims 12 and 35.” (See Final Action 5, 9.)
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Application 13/588,747
Claim 30 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Haggstrom, Dickson, and Ji (US 2008/0226724 Al, pub.
Sept. 18,2008).
ANALYSIS
The Examiner finds that Haggstrom discloses all of the limitations of
claim 1 except that “Haggstrom is silent in regard to the debriding agent
being a blocked acid debriding agent.” (Final Action 5—6). The Examiner
finds that Dickson discloses this limitation and determines that
it would have been obvious to one having ordinary skill in the art
at the time the invention was made to modify the debriding
hydrogel disclosed by Haggstrom to comprise a
pharmaceutically acceptable salt, such as glycolic or lactic acid,
and formulation materials, such as arginine, similar to that
disclosed by Dickson, in order to provide a composition which
includes pharmaceutically acceptable salts, but is able to
maintain/preserve its pH level through the addition of arginine,
as suggested by Dickson in paragraph [0226].
(Id. at 6.)
Appellants disagree and argue that the Examiner has used the
Appellants’ disclosure “to piece together parts of’ Dickson. (Appeal Br. 6.)
Specifically, Appellants argue that “[t]here is no reason to select glycolic
acid from one list and arginine from the other, unless the selector is being
guided by Applicants’ own description of the invention.” (Id. at 9.)
Moreover, Appellants argue, “every Dickson disclosure of a
‘pharmaceutically acceptable salt’ is restricted to disclosing a salt of one of
the active compounds I—V.” (Id. at 7.) “Dickson does not suggest using a
pharmaceutically acceptable salt of a formulation material such as arginine
or any of the other formulation materials of paragraph [0226].” (Id.)
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Application 13/588,747
In relevant part, with regard to pharmaceutically acceptable salts,
Dickson discloses:
“Pharmaceutically acceptable salt” refers to a salt of a compound
that is pharmaceutically acceptable and that possesses the desired
pharmacological activity of the parent compound. Such salts
include: (1) acid addition salts, formed with inorganic acids such
as hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid,
phosphoric acid, and the like; or formed with organic acids such
as acetic acid, propionic acid, hexanoic acid,
cyclopentanepropionic acid, glycolic acid, pyruvic acid, lactic
acid, malonic acid, succinic acid, malic acid, maleic acid,
fumaric acid, tartaric acid, citric acid, benzoic acid, 3-(4-
hydroxybenzoyl)benzoic acid, cinnamic acid, mandelic acid,
methanesulfonic acid, ethanesulfonic acid, 1,2-ethane-disulfonic
acid, 2-hydroxyethanesulfonic acid, benzenesulfonic acid, 4-
chlorobenzenesulfonic acid, 2- naphthalenesulfonic acid, 4-
toluenesulfonic acid, camphorsulfonic acid, 4-methylbicyclo
[2.2.2]-oct-2-ene-l-carboxylic acid, glucoheptonic acid, 3-
phenylpropionic acid, trimethylacetic acid, tertiary butylacetic
acid, lauryl sulfuric acid, gluconic acid, glutamic acid,
hydroxynaphthoic acid, salicylic acid, stearic acid, muconic acid,
and the like; or (2) salts formed when an acidic proton present in
the parent compound either is replaced by a metal ion, e.g., an
alkali metal ion, an alkaline earth ion, or an aluminum ion; or
coordinates with an organic base such as ethanolamine,
diethanolamine, triethanolamine, N-methylglucamine,
dicyclohexylamine, and the like.
(Dickson | 85, emphasis added.)
Dickson also discloses:
In certain embodiments, a pharmaceutical composition of the
present disclosure can contain formulation materials for
modifying, maintaining, or preserving, for example, the pH,
osmolarity, viscosity, clarity, color, isotonicity, odor, sterility,
stability, rate of dissolution or release, adsorption or penetration
of the composition. In certain embodiments, suitable
formulation materials include, but are not limited to, amino acids
such as glycine, glutamine, asparagine, arginine or lysine;
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Application 13/588,747
antimicrobials; antioxidants such as ascorbic acid, sodium
sulfite, or sodium hydrogensulfite; buffers such as borate,
bicarbonate, Tris-HCl, citrates, phosphates or other organic
acids; bulking agents such as mannitol or glycine; chelating
agents such as ethylenediamine tetraacetic acid (EDTA);
complexing agents such as caffeine, polyvinylpyrrolidone, beta-
cyclodextrin, hydroxypropyl-beta-cyclodextrin, or sulfobutyl
ether P-cyclodextrin; fillers; monosaccharides; disaccharides;
and other carbohydrates such as glucose, mannose, or dextrins;
proteins such as serum albumin, gelatin or immunoglobulins;
coloring, flavoring and diluting agents; emulsifying agents;
hydrophilic polymers such as polyvinylpyrrolidone; low
molecular weight polypeptides; salt-forming counterions such as
sodium; preservatives such as benzalkonium chloride, benzoic
acid, salicylic acid, thimerosal, phenethyl alcohol,
methylparaben, propylparaben, chlorhexidine, sorbic acid or
hydrogen peroxide; solvents such as glycerin, propylene glycol
or polyethylene glycol; sugar alcohols such as mannitol or
sorbitol; suspending agents; surfactants or wetting agents such as
pluronics, PEG, sorbitan esters, polysorbates such as polysorbate
20, polysorbate 80, triton, tromethamine, lecithin, cholesterol,
tyloxapal; stability enhancing agents such as sucrose or sorbitol;
tonicity enhancing agents such as alkali metal halides, such as
sodium or potassium chloride, mannitol, sorbitol; delivery
vehicles; diluents; excipients and/or pharmaceutical adjuvants
(Remington's Pharmaceutical Sciences, 18th Edition, A.R.
Gennaro, ed., Mack Publishing Company (1990)).
(Id. 1226, emphasis added.)
Dickson discloses a similarly lengthy list of conditions that may be
treated by its disclosed chemical entities. (See Dickson || 183, 187).
“[Wjound healing” is listed among the conditions. (Id. 1187.)
The Examiner does not indicate that Dickson specifically discloses
selecting from its lengthy lists glycolic acid or lactic acid {see Dickson | 85)
and arginine {see id. 1226) for use in wound healing (see id. 1187). Rather,
the Examiner finds that “Dickson does not disclose the use of arginine and
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Application 13/588,747
glycolic/lactic specifically in combination” (Answer 6), but that combining
arginine with glycolic or lactic acid would have been “obvious to try” {id.
at 7).
[T]he Supreme Court stated that an invention may be found
obvious if it would have been obvious to a person having
ordinary skill to try a course of conduct:
When there is a design need or market pressure to solve
a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it
is likely the product not of innovation but of ordinary
skill and common sense. In that instance the fact that a
combination was obvious to try might show that it was
obvious under § 103.
Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed.
Cir. 2009) (quoting KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007))
(emphasis added).
When “what would have been ‘obvious to try’ would have been
to vary all parameters or try each of numerous possible choices
until one possibly arrived at a successful result, 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” an invention would not have been obvious.
Id. See also Ortho—McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d
1358, 1364 (Fed. Cir. 2008) fKSR posits a situation with a finite, and in the
context of the art, [a] small or easily traversed[] number of options.”).
In this case, the Examiner has not established that, at the time of
Appellants’ invention, there was a recognized problem relating to wound
healing for which a combination of glycolic or lactic acid and arginine was
one of a finite number of identified, predictable solutions. Therefore, we do
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Application 13/588,747
not agree that it would have been obvious to try the combination of glycolic
or lactic acid and arginine for wound healing.
Additionally, and as noted above, the Examiner finds that one would
have been motivated to make the composition of glycolic or lactic acid and
arginine “in order to provide a composition which includes pharmaceutically
acceptable salts, but is able to maintain/preserve its pH level through the
addition of arginine, as suggested by Dickson in paragraph [0226].” (Final
Action 6.) We disagree. The Examiner does not indicate where in Dickson
or elsewhere the prior art discloses that maintaining a constant pH level is a
desirable characteristic of a debriding hydrogel. Nor is it clear why one
would want to maintain a constant pH level. Indeed, rather than maintaining
a constant pH level, the Specification discloses moderating the rate of
change of the pH level. (See Spec. 140-41.) In particular, the Specification
discloses that “[t]he blocked acid debriding agent has the effect of
moderating the rate of decrease of the pH of the treatment area” and that
“[t]he slower pH change helps to avoid a stinging sensation for the patient.”
(Id. 140.) In view of the above, we do not agree that one of skill in the art
would have been motivated make the composition.
We are persuaded that the Examiner erred in rejecting claim 1 under
§ 103 in view of Haggstrom and Dickson. Independent claims 23 and 33
each contains a similar limitation and, for the same reasons, we are
persuaded that the Examiner erred in rejecting independent claims 23 and 33
and dependent claims 3—8, 10, 12, 24, 27, 29, 30, and 35—43.3
3 The rejection of dependent claim 30 based on Ji, in combination with
Haggstrom and Dickson, does not cure the deficiency in the Examiner’s
rejection of independent claim 23, from which claim 30 depends.
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Application 13/588,747
DECISION
The Examiner’s rejections of claims 1, 3—8, 10, 12, 23, 24, 27, 29, 30,
33, and 35—43 under 35 U.S.C. § 103(a) are reversed.
REVERSED
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