Ex Parte Wenzel et al

Patent Trial and Appeal Board

Apr 21, 2017

11957169 (P.T.A.B. Apr. 21, 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.
11/957,169 12/14/2007 Scott W. Wenzel 64047835US01 8805
(27839-1695)
45736 7590 04/25/2017
Christopher M. Goff (27839)
ARMSTRONG TEASDALE LLP
7700 Forsyth Boulevard
Suite 1800
St. Louis, MO 63105
EXAMINER
BREDEFELD, RACHAEL EVA
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
04/25/2017 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):
uspatents @ armstrongteasdale.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SCOTT W. WENZEL, DAVID WILLIAM KOENIG,
DOUGLAS R. HOFFMAN, CANDACE DYAN KRAUTKRAMER,
BRIAN THOMAS, CHERYL MOCADLO, and CHELSEA MAGIN
Appeal 2016-0076021
Application 11/957,169
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
RYAN H. FLAX, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a formulation for promoting
skin cleanliness and health. The Examiner rejected the claims under 35
U.S.C. § 103 as obvious. We have jurisdiction under 35 U.S.C. § 6(b). The
rejections are affirmed.
STATEMENT OF THE CASE
Appellants appeal from the Examiner’s rejections of claims 1, 10—16,
and 20—39 under pre-AIA 35 U.S.C. § 103(a) as obvious. The Examiner set
1 The Appeal Brief page 1 (“Appeal Br.”) (dated Jan. 13, 2016) lists
Kimberly-Clark Worldwide, Inc., as the real-party-in-interest.
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Application 11/957,169
forth six grounds of obviousness rejections over the claims. Final Action
pages 4, 8, 9, 11, 16, 17 (“Final Act.”) (dated Aug. 14, 2015). Each
rejection is over the same two publications, Minerath et al. (WO
2004/022117 Al, publ. Mar. 18, 2004) (“Minerath”) and SaNogueira et al.
(US Patent No. 6,830,746 B2, pat. Dec. 14, 2004) (“SaNogueira”), with
additionally cited publications to reach further limitations in the claims. All
the rejections turn on the issue of whether it was obvious at the time of the
invention to combine Minerath and SaNogueira.
There are two independent claims, claims 1 and 28. Claim 28 is
representative and reproduced below:
28. A formulation for promoting skin cleanliness and health,
the formulation comprising from about 1% to about 5% by total
weight of the formulation of dimethicone; from about 3% by total
weight of the formulation to about 9% by total weight of the
formulation of glycerin; from about 0.5% by total weight of the
formulation to about 3% by total weight of the formulation of
Vitamin E acetate; from about 1% by total weight of the
formulation to about 5% by total weight of the formulation of
Nylon-12; a pharmaceutically acceptable carrier; and from about
0.5% by total weight of the formulation to about 15% by total
weight of the formulation of at least one viscoelastic agent
selected from the group consisting of polyethylene glycol 400
monolaurate, polyethylene glycol 600 monolaurate,
polyethylene glycol 1000 monolaurate, polyethylene glycol 4000
monolaurate, polyethylene glycol 600 dilaurate, polyethylene
glycol 600 lauryl ether, and combinations thereof.
REJECTIONS
Claim 28 is directed to a formulation for promoting “skin cleanliness
and health.” The formulation comprises: (1) dimethicone; (2) glycerin; (3)
vitamin E; (4) Nylon-12; (5) a viscoelastic agent selected from a specifically
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recited list of agents; and (6) a pharmaceutically acceptable carrier. The
claim recites a weight percent range of the total weight of the formulation
for each of components (1) to (5).
Claim 1 has the same six components as claim 28, but further requires
(7) a first temperature modulator which is an insulating agent, and (8) a
second temperature modulator which is a warming agent.
The Examiner found Minerath describes a moisturizing and
lubricating composition for use on the bodyfacing surface of an absorbent
product, such as an on inter-labial pad. Final Act. 4. The Examiner found
that Minerath teaches a composition with (1) dimethicone; (2) glycerin; (3)
vitamin E; (5) a viscoelastic agent of the claimed list; and (6) a
pharmaceutically acceptable carrier, where each component is disclosed in
amounts which are encompassed by or overlapping with the claimed
amounts. Id. at 6, 7.
The Examiner acknowledged that Minerath does not disclose the
presence of (4) nylon-12 in its composition, but found that SaNogueira
describes a sunscreen lotion that contains nylon-12 to “provide an enhanced,
silky, and smooth feeling to the skin.” Id. at 6. The Examiner determined it
would have been obvious to one of ordinary skill in the art to use nylon-12
in Minerath’s composition to soften skin and prevent it “from drying out in
the absence of an undesirable greasy feeling,” as taught by SaNogueira. Id.
at 7.
For claim 1, the Examiner found that Minerath describes (7) a first
temperature modulator, but not (8) a second temperature modulator selected
from the claimed list of modulators. Id. at 12. However, the Examiner
found that Kupper (WO 97/02273, publ. Jan. 23, 1997) describes a topical
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composition with the same temperature modulator as in claim 1, and
determined it would have been obvious to one of ordinary skill in the art to
include it in Minerath’s composition for its known and expected benefit. Id.
at 13.
Temperature properties; claimed amounts
Appellants contend that the combination of Minerath and SaNogueira
“neither discloses nor suggests combining the claimed elements let alone in
the claimed concentration ranges — in order to achieve” the beneficial results
described in the Specification. Appeal Br. 9. Appellants also contend that
Minerath’s composition is hydrophilic and solid at room temperature in
contrast to the claimed formulation, which is not hydrophilic and not solid at
room temperature. Id. at 10. Thus, Appellants argue that Minerath “is not a
proper piece of art to start from for an obviousness rejection.” Id.
Appellants also argue that the skilled worker would not have combined
Minerath with SaNogueira because SaNogueira “teaches a lotion that has
characteristics (e.g., solid at room temperature, etc.) that conflict with the
teachings of Minerath.” Id.
The claims do not limit the recited formulation to one that is not
hydrophilic or solid at room temperature. Thus, Appellants’ argument is not
persuasive because the claims are not limited to a formulation with these
properties. Appellants did not establish that the amounts of each component
recited in the claims would necessarily result in a formulation which is not
hydrophilic and not solid at room temperature. To the contrary, the
Examiner found that Minerath describes a composition with the same
components as in claim 1, and in amounts that encompass or overlap with
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the claimed amounts, providing a reasonable basis to believe that the prior
art formulation would have the same properties as claimed. Final Act. 6, 7.
Appellants disputed that the recited amounts are described in Minerath
(Appeal Br. 8), but did not identify an error in the Examiner’s factual
findings, which are supported by a preponderance of the evidence (Final
Act. 5-7).
With respect to Appellants’ contention that the teachings in Minerath
and SaNogueira “conflict,” the only conflicting property Appellants point to
is “solid at room temperature” and Appellants inconsistently asserted that
both publications teach their respective composition is solid at room
temperature. Appeal Br. 10; Reply Br. 2. Appellants did not identify a
disclosure in SaNogueira where such temperature/physical state properties
could be found.
Nylon-12
All the claims require nylon-12. Appellants contend there “is nothing
in Minerath that would suggest to one having ordinary skill in the art”
choosing nylon-12 from SaNogueira to achieve the benefits of the claimed
formulation. Appeal Br. 10.
The Examiner found that it would have been obvious to have utilized
nylon-12 as taught by SaNogueira to impart a silky and smooth feeling with
a reasonable expectation of success. Final Act. 7. The Examiner’s findings
are supported by a preponderance of the evidence. Because both
publications describe topical formulations, we agree with the Examiner that
it would have been reasonable to expect that nylon-12 would be effective in
Minerath’s composition.
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Appellants have not identified a defect in the Examiner’s fact-finding
or conclusions, but rather stated that Minerath did not provide a reason to
use nylon-12 from SaNogueira. However, as indicated above, the reason
that would have prompted the addition of nylon-12 into Minerath’s
composition is provided by SaNogueira: to impart a silky and smooth
feeling. Final Act. 7. Consequently, absent evidence to the contrary,
Appellants’ arguments are unavailing.
Claim 1
Appellants also contend that it would not have been obvious to have
added the temperature modulator from Kupper to Minerath’s composition
because there is no “disclosure in Minerath that temperature modulation can
be achieved with Appellants’ claimed elements and/or that Appellants’
claimed elements should or could be used [] in the compositions of
Minerath.” Appeal Br. 19.
Appellants’ arguments are not persuasive. The Examiner found
reason to add a temperature modulator, which had the claimed property of
being a warming agent, to Minerath because “Kupper teaches that such
warming agents improve the perceived efficacy of compositions and deliver
pleasing aesthetics that result in consumer satisfaction.” Final Act. 13.
Appellants did not identify a flaw in the Examiner’s findings or reasoning.
As both Minerath and Kupper describe topical compositions {id.), it would
have been reasonable to expect that Kupper’s warming agent would be
effective in Minerath’s composition. Appellants did not provide evidence to
the contrary or reason to have doubted such efficacy.
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Do the results in Specification establish non-obviousness?
Appellants cited evidence in the Specification that “when the
specifically claimed components are combined in the specifically claimed
concentration ranges, the formulations result in a variety of critical,
beneficial results, such as, for example, reduction of frictional force,
increased conductance, decreased roughness and increased elasticity.”
Appeal Br. 9. Based on this evidence, Appellants contend they have
“successfully proved the criticality of the claimed formulation components
and concentration ranges, and, thus, have successfully rebutted any basis for
an obviousness rejection based upon overlapping ranges of the prior art’s
components.” Id. Specifically, Appellants state:
the formulations detailed in Table 2 of the specification as
originally filed, when tested, resulted in reduction of frictional
force and showed improved maximum force values (see, e.g.,
Table 3). Details of the other benefits and critical results of the
aforementioned results (e.g., increased conductance, decreased
roughness and increased elasticity) are described in detail in
Examples 3 and 4.
Id.
Table 2 of the Specification lists 16 different lotions (lotions 1—16),
each comprising glycerin, dimethicone, nylon-12, and vitamin E acetate,
which correspond to four of the components of the formulation of claims 1
and 28. Spec. 1194. Each component is represented by two different
amounts (“wt.%”), which fall within the scope of the claim. Id. The
Specification discloses that “Application of every lotion formulation to the
Vitro Skin® substrate reduced the frictional force value between the treated
Vitro Skin® substrate and the silk and the nonwoven spunbond test
substrates.” Id. at 1203. The Specification also discloses that “Application
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of most lotion formulations to the Vitro Skin® substrate also reduced the
frictional force between the treated Vitro Skin® substrate and the
VitroSkin® test substrate.” Id. The results are summarized in Table 3 of the
Specification. Id. at 1204.
Table 3 compares the mean force values for lotions 1—16 to an
untreated control. Id. The data does not persuade us of the non-obviousness
of the claimed subject matter. To demonstrate that the claimed invention
exhibits some superior property or advantage, it must be compared to the
closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir.
1991); In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995); Iron Grip Barbell Co.,
Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004).
In this case, Appellants do not provide evidence of a comparison to
the closest prior art. All sixteen lotions, and the amounts of components in
each one, are said by Appellants to fall within the scope of the claim.
Appeal Br. 4—5. The comparison is with an “untreated” control, not with a
composition described by Minerath which the Examiner characterized as the
closest prior art. Ans. 7—8. Thus, while Appellants contend that the
showing demonstrates the “criticality” of the claimed amounts to the
properties of the formulation {id.), there is no comparison to show that the
amounts in the claim are any better as compared to amounts outside the
claimed range which are described in Minerath.
Moreover, Appellants must show criticality of a claimed range. “‘[It]
is not inventive to discover the optimum or workable ranges by routine
experimentation.’ In re Aller, 220 F.2d 454, 456 (CCPA 1955). Only if the
‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be
obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620
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(CCPA 1977).” In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997).
Criticality of the claimed range has not been demonstrated since there is no
comparison to concentrations outside the claimed ranges.
Appellants contend that it is not necessary to make such a comparison
because “the closest prior art does not provide any comparative examples for
Appellants to test, as the closest prior art fails to disclose or suggest all of
Appellants' claimed components and ranges.” Reply Br. 4. As discussed by
the Examiner (Ans. 4), Appellants have not identified which of the four
tested components is responsible for the properties Appellants argue confer
beneficial results. Appellants cannot establish the claimed amounts in their
formulations are critical to achieve the asserted beneficial properties without
a comparison to a formulation comprising even one component in amounts
that are outside of the claimed range. Without such comparative data, it
cannot be discerned whether formulations outside the claimed range would
also possess the asserted properties. Consequently, we agree with the
Examiner that the data is insufficient to establish the non-obviousness of
claimed subject matter.
The same deficiencies are found in Examples 4 and 5 of the
Specification. As discussed by the Examiner, no comparisons were
performed to formulations having concentrations outside the claimed ranges.
Moreover, the Examiner provided evidence that the results obtained with
glycerin, nylon-12, and vitamin E would have been expected based on the
teachings in the prior art. Ans. 6—7. Appellants did not identify a flaw in the
Examiner’s finding, but merely asserted the amounts demonstrated
criticality. Reply Br. 5.
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Appellants also state the combination of the cited references “merely
lists broad ranges of some of the claimed components (e.g., 5-90% of a
humectant) and does not list the claimed components ever in combination, in
the specifically claimed ranges, let alone disclosing the benefits that can be
achieved therefrom.” Reply Br. 5. However, it is well-established that,
when there is a range disclosed in the prior art, and the claimed invention
overlaps or falls within that range, there is a presumption of obviousness. In
re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); Iron Grip Barbell Co. v.
USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). While Appellants
contend that the criticality of the claimed ranges have been established, no
comparison has been made to formulations containing components in
amounts outside the claimed ranges to determine whether such benefits are
characteristic of the claimed range or would be possessed by formulations
outside it.
In addition, the Specification indicates that not all formulations
showed the beneficial properties, i.e., “most lotion formulations [but not all]
to the Vitro Skin® substrate also reduced the frictional force between the
treated Vitro Skin® substrate and the VitroSkin® test substrate.” Spec.
1203 (emphasis and brackets added). Thus, even were beneficial results
described, it does not appear that all formulations within the scope of the
claim possess such properties. The results must also be “commensurate in
scope with the degree of protection sought by the claimed subject matter.”
In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005). Here, the results are not
commensurate with the scope of the claims because Appellants seek
protection for a genus of formulations, but it does not appear that all
formulations within the genus possess the asserted properties.
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For the foregoing reasons, we affirm the obviousness rejections of
claims 1 and 28. Claims 10-16 and 29—39 fall with claims 1 and 28 because
separate reasons for their patentability were not provided. 37 C.F.R.
§ 41.37(c)(l)(iv).
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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