Ex Parte Walsh et al

Patent Trials and Appeals Board

Jun 5, 2019

14790404 - (D) (P.T.A.B. Jun. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/790,404 07/02/2015
34395 7590 06/07/2019
OLYMPIC PA TENT WORKS PLLC
P.O. BOX 4277
SEATTLE, WA 98104
FIRST NAMED INVENTOR
Joseph F. Walsh
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
35107.00lCl 6156
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
06/07/2019 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):
joanne@olympicpatentworks.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH F. WALSH and SHARON KAY LASKA 1
Appeal2019-000792
Application 14/790,404
Technology Center 1600
Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving a claim to
preparations that ameliorate and/or reverse human baldness. The Examiner
rejected the claims as obvious over the prior art. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Specification states that FDA-approved treatments for baldness
"provide only a very modest, relatively short-term improvement for most
1 Appellants identify themselves as the real party in interest. Appeal Br. 1.
Herein we reference the Specification filed July 2, 2015 ("Spec."); Final
Office Action dated June 14, 2017 ("Final Act."); Appellants' Appeal Brief
filed Feb. 23, 2018 ("Appeal Br."); Examiner's Answer dated Sept. 20, 2018
("Ans."); and Appellants' Reply Brief filed Nov. 7, 2018 ("Reply Br.").
Appeal2019-000792
Application 14/790,404
users." Spec. 2:3-5. The invention is directed to preparations that treat
human hair loss by "render[ing] hair follicles accessible to treatment agents
that remove blocking oil and cell remnants to allow additional treatment
agents to enter the pilosebaceous units to kill or control microbes that disrupt
hair growth by changing, inhibiting, or interrupting one or more biological
functions of the pilosebaceous units." Id. at 2:11-15.
Claim 2, the only claim on appeal, reads as follows:
2. A preparation that ameliorates and/or reverses human
baldness, the preparation comprising:
water;
3% or less ofbenzoyl peroxide;
salicylic acid; and
one or more additional substances selected from among
D-limonene,
minoxidil,
thymol,
carvacrol,
pyrithione zinc, and
selenium sulfate.
Appeal Br. 23 (Claims Appendix).
Claim 2 stands rejected under 35 U.S.C. § 103(a) as obvious over
Niemiec2 and Martin. 3 Final Act. 3.
2 Niemiec et al., US 2002/0048558 Al, published Apr. 25, 2002
("Niemiec").
3 Martin et al., FR 2,685,638 Al, published July 2, 1993 ("Martin").
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Application 14/790,404
ANALYSIS
The Examiner rejected claim 2 as obvious over Niemiec and Martin.
Final Act. 3. The Examiner found that the preamble claim term "ameliorates
and/or reverses human baldness" "is an intended use that does not provide
patentable weight to the claimed preparation product," and stated that "if the
prior art teaches or renders obvious the structural limitations of the
composition, then the claimed invention is met." Id. at 3-4. The Examiner
found that Niemiec teaches topical anti-acne formulations, which include the
"benefit agents" salicylic acid (Ex. 1) and 2% benzoyl peroxide (Ex. 2, Ex.
3), among others. Id. at 5 ( citing Niemiec Table 6); Ans. 8-9. The
Examiner stated:
While Niemiec does not expressly teach 3 % or less of
benzoyl peroxide together with salicylic acid, Niemiec further
teaches that both salicylic acid and benzoyl peroxide are
suitable anti-acne agents for the invention. Thus, one of
ordinary skill in the art would have found it prima facie obvious
to combine salicylic acid to either one of the anti-acne
compositions (e.g., Ex 2, Ex 3, etc.) disclosed in Table 6,
forming a composition containing benzoyl peroxide, salicylic
acid and water. The artisan would have understood that the
salicylic acid would provide anti-acne function to the anti-acne
compositions disclose[ d] by Niemiec for treating acne.
Additionally, the artisan would have found it obvious to
combine Ex 1 with Ex 2 or Ex 3 because each are [sic]
separately taught to be useful for treating acne.
Id. at 6-7. The Examiner further found that while "Niemiec does not
expressly teach zinc pyrithione," "Martin teaches the use of compositions
comprising zinc pyrithione that are useful for treating acne." Id. at 7. The
Examiner found that one of ordinary skill in the art "would have found it
obvious to combine the compositions of Martin to the compositions
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suggested by Niemiec because each are separately taught to be useful for
treating acne." Id.
We adopt the Examiner's findings of fact, reasoning made in
connection with the rejection, and responses to Appellants' arguments.4 See
id. at 3-7; Ans. 4-11. We find that the Examiner has established that the
claims would have been obvious over the prior art combination of Niemiec
and Martin. Both Niemiec and Martin teach anti-acne compositions, and, as
the Examiner indicated, the law is that "[i]t is prima facie obvious to
combine two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition which is to
be used for the very same purpose." In re Kerkhoven, 626 F.2d 846, 850
(CCPA 1980); see also Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d
4 We disagree that it was improper or "clear error" for the Examiner to cite
the MPEP. Appeal Br. 11, 14. The Examiner, while referencing the MPEP,
is relying on the case law cited and discussed in the specified MPEP section
to support the rejection. See e.g., Final Act. 4. We also find Appellants'
argument that it "cannot" respond to the Examiner's position on the
preamble recitations of Appellants' claim unpersuasive. Reply Br. 2.
Whether or not the Examiner cited case law regarding claim interpretation,
the Examiner clearly set forth his position that the preamble is given no
patentable weight because it merely identifies an intended use of the
otherwise fully-claimed composition, which is complete without reference to
that intended use. Final Act. 3-4; Ans. 6. Consequently, Appellants were
adequately put on notice of the Examiner's claim interpretation and the basis
of the rejection under 35 U.S.C. § 103, as required by 35 U.S.C. § 132, such
that they could rebut the Examiner's position. In re Jung, 637 F.3d 1356,
1363 (Fed. Cir. 2011) ("[A]ll that is required of the office to meet its prima
facie burden of production is to set forth the statutory basis of the rejection
and the reference or references relied upon in a sufficiently articulate and
informative manner as to meet the notice requirement of§ 132.").
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804, 808 (Fed. Cir. 1989) ("Given the prior art teaching that both amiloride
and hydrochlorothiazide are natriuretic, it is to be expected that their co-
administration would induce more sodium excretion than would either
diuretic alone"); In re Gee, 614 F. App'x 495,498 (Fed. Cir. 2015) (non-
precedential) ("It would thus have been obvious to combine coffee grounds
and honey, each of which is taught by the prior art to be useful for treating
viral infections, to create a third composition which is also useful for treating
viral infections."). Appellants' arguments have not persuaded us that the
Examiner's determination of obviousness is incorrect. We address those
arguments below.
Many of Appellants' arguments flow from the premise that their claim
requires a preparation for treating baldness, whereas the prior art
compositions cited by the Examiner are directed to treating acne. See, e.g.,
Appeal Br. 8, 15-21; Reply Br. 2, 4-5. Thus, we begin, as the Examiner
did, by addressing whether the claim term "ameliorates and/or reverses
human baldness" is entitled to patentable weight. As noted above, the
Examiner found that this claim term is not entitled to patentable weight.
Final Act. 3. We agree.
As our reviewing court has stated, "as a general rule preamble
language is not treated as limiting." Arctic Cat Inc. v. GEP Power Prods.,
Inc., 919 F.3d 1320, 1327 (Fed. Cir. 2019) (citations omitted). Exceptions
arise where, for example, the preamble recites "essential structure." Id. But
"a preamble is not limiting 'where a patentee defines a structurally complete
invention in the claim body and uses the preamble only to state a purpose or
intended use for the invention."' Id. at 13 2 8 ( quoting Catalina Mktg. Int 'l,
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Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). "[T]he
rule against giving invention-defining effect to intended-use preamble
language reflects a longstanding substantive aspect of the patent statute-
specifically, the 'well settled' fundamental principle 'that the recitation of a
new intended use for an old product does not make a claim to that old
product patentable."' Arctic Cat, 919 F.3d at 1328 (quoting In re Schreiber,
128 F.3d 1473, 1477 (Fed. Cir. 1997)).
Claim 2 is directed to certain preparations, i.e., compositions. It is not
directed to a method of using those preparations in any fashion. The body of
claim 2 recites the components required to be present in the claimed
preparations, and we do not perceive, nor have Appellants explained, how
stating that such a preparation "ameliorates or reverses human baldness"
further limits the compositional elements required. See, e.g., Arctic Cat, 919
F.3d at 1328 (finding preamble language reciting "personal recreational
vehicle" not limiting where it merely identified an intended use for the
claimed power distribution module, and did not impose any structural
requirement on the claimed module); cf In re Lemin, 326 F.2d 437,440
(CCP A 1964) (suggesting that an amount limitation could render an obvious
composition patentable, if it differed from the amount used for the prior art
purpose). As in Catalina, "deletion of the disputed phrase from the
preamble ... [ would] not affect the structural definition ... of the
[invention] itself." Catalina, 289 F.3d at 810. Thus, we conclude that the
preamble does not further limit the scope of protection of the claimed
preparations, and like the Examiner, do not give it patentable weight. For
this reason, we are not persuaded by Appellants' arguments that rely on the
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purported lack of motivation or reasonable expectation of success in using
the proposed prior art compositions or ingredients therein ( e.g. benzoyl
peroxide) to treat hair loss. See, e.g., Appeal Br. 4-5, 8, 15-21; Reply Br. 2,
4-5.
We next tum to Appellants' arguments that the prior art fails to
adequately teach that benzoyl peroxide and salicylic acid, either by
themselves or in combination together (without the other ingredients taught
in Niemiec Table 6), are effective to treat acne. See, e.g., Appeal Br. 8-11,
14, 15-16, 18-19, 21; Reply Br. 3, 6. We are not persuaded by these
arguments, because Niemiec identifies each of benzoyl peroxide and
salicylic acid as "benefit agents" for the treatment of acne, and teaches that
they can be used in combination. See, e.g., Niemiec ,-J 153 ("Examples of
suitable anti-acne agents include ... salicylic acid; benzoyl peroxide ... and
mixtures thereof."); claim 22. Additionally, we agree with the Examiner
that a person of ordinary skill in the art would have found it obvious to
combine salicylic acid or the formulation of Niemiec Example 1 with the
formulation of Example 2 or 3 in Table 6. Final Act. 6-7; Ans. 5. In such a
combination the resulting formulation would include not only salicylic acid
and benzoyl peroxide, but the other ingredients in Table 6 as well. Claim 2
employs the transition term "comprising." "'Comprising' is a term of art
used in claim language which means that the named elements are essential,
but other elements may be added and still form a construct within the scope
of the claim." Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir.
1997). Thus the presence of the additional ingredients in Table 6 in
combining formulations would be within the scope of claim 2.
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To the extent Appellants are arguing that Niemie does not enable a
composition of salicylic acid and benzoyl peroxide alone being effective to
treat acne (Appeal Br. 9), "a prior art printed publication cited by an
examiner is presumptively enabling barring any showing to the contrary by a
patent applicant or patentee." In re Antor Media Corp., 689 F.3d 1282, 1288
(Fed. Cir. 2012). While Niemiec suggests that the remainder of the
formulation is useful for "enhancing the transmembrane penetration of
benefit agents" (Niemiec at Abstract, emphasis added), it does not indicate
that the benefit agents fail to work without the other ingredients.
Appellants similarly argue that the prior art fails to adequately teach
that zinc pyrithione, without piroctone olamine, is effective to treat acne.
See, e.g., Appeal Br. 14; Reply Br. 3, 6, 8. We are also not persuaded by
this argument because the Examiner's rationale for obviousness does not
require that zinc pyrithione, without piroctone olamine, be effective against
acne. Rather, the Examiner explained that a person of ordinary skill in the
art would have found it obvious to combine Martin's entire formulation with
the formulation of Example 2 or 3 in Niemiec's Table 6, such that the
resulting formulation would include both zinc pyrithione and piroctone
olamine. See, e.g., Final Act. 7; Ans. 5, 7.
Appellants also argue that Martin teaches away from combining its
formulations with those of Niemiec. Specifically, Appellants note that
Martin's preferred embodiment includes an antioxidant, which they argue
would neutralize free radicals, such as those generated the benzoyl peroxide
in Niemiec's formulations. Appeal Br. 14-15; Reply Br. 8. We agree with
the Examiner that this argument is not persuasive, because Martin teaches
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that the antioxidant is optional. Ans. 11; Martin at Abstract. Thus, to the
extent a person of ordinary skill in the art would have expected that an
antioxidant would render benzoyl peroxide ineffective (see Reply Br. 8), it
would have been within the skill in the art to simply exclude the optional
antioxidant from Martin's formulation.
We next tum to Appellants' arguments directed to distinguishing In re
Kerkhoven. Appellants argue that this case is distinguishable because it
"involved claims to a process rather than claims to formulations." Appeal
Br. 11. Appellants, however, do not explain how the difference between the
type of claims (process versus composition claims) demands a different
outcome here, particularly in view of the court's clear holding that "[i]t is
prima facie obvious to combine two compositions each of which is taught by
the prior art to be useful for the same purpose, in order to form a third
composition which is to be used for the very same purpose." In re
Kerkhoven, 626 F.2d at 850 (emphasis added).
Appellants also assert that In re Kerkhoven is distinguishable because
the "simple detergents" at issue "lack any of the many complex types of
interactions with biological molecules and physiological contexts,
synergisms, antagonisms, bioavailability problems, including those
discussed specifically by Niemiec, and other complexities that always
accompany pharmaceutical preparations." Appeal Br. 12; see also Reply Br.
2-4. We address this argument together with Appellants' arguments based
on the chemical differences between salicylic acid, benzoyl peroxide, and
zinc pyrithione, and its arguments regarding whether the Examiner's
proposed combination would be safe and effective to treat acne. Appeal Br.
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12-14; Reply Br. 3-4, 6-7. For example, Appellants argue that "[n]o one
familiar with biochemistry or physiological chemistry would ever conclude
that it would be obvious to mix compounds from entirely different chemical
families together in order to derive a useful therapeutic composition unless
the compounds were known to be effective and lacking in deleterious side
effects when combined." Appeal Br. 12. Appellants additionally argue that
"[t]he Examiner's assertions that the proposed combinations would have
anti-acne properties are entirely conclusory and unsupported by any
evidence that they would have any desirable biological effects." Reply Br.
4.
We are not persuaded by these arguments. We agree with the
Examiner that it would have been obvious to combine the anti-acne
formulations taught by each of Niemiec and Martin, with a reasonable
expectation that such a combination would also be an effective anti-acne
formulation. Such a combination would be no more than "the predictable
use of prior art elements according to their established functions." KSR Int 'l
Co. v. Teleflex Inc., 550 U.S. 398,417 (2007); see also id. at 417 (quoting
Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)) ("[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."). On this record, aside
from the argument regarding the antioxidant, which we addressed above,
Appellants have not pointed to persuasive evidence suggesting that the
Niemiec or Martin formulations, either individually or in combination,
would not treat acne, or that the chemical differences between salicylic acid,
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benzoyl peroxide, and zinc pyrithione would undercut the expected effects
of the formulations as taught by those references. Attorney argument is "no
substitute for evidence." See, e.g., Johnston v. IVAC Corp., 885 F.2d 1574,
1581 (Fed. Cir. 1989).
Finally, Appellants assert that there is a "long-felt but unresolved need
for effective treatments for baldness as well as a rather spectacular number
of failures of others." Appeal Br. 3, 20; see also Reply Br. 8-9. Even
assuming that Appellants are correct about a long-felt need and failure of
others, we determine that such factors do not overcome the prima facie case
of obviousness here. It is not enough to merely point out a long-felt need or
failure of others; Appellants must also demonstrate that their claimed
invention satisfies the long-felt need and overcomes the failure of others.
See, e.g., In re Cavanagh, 436 F.2d 491,496 (CCPA 1971) (noting that it is
"incumbent upon appellant ... to bring forward evidence of his satisfaction
of the need"). Appellants have not done so. For example, Appellants
acknowledge that there are at least two known compounds that have
"modest" efficacy in treating baldness. Appeal Br. 20; Spec. 2:3-5; see also
Reply Br. 9. The record, however, contains no information as to whether the
claimed preparations have better efficacy for baldness compared to the
existing treatments so as to meet the long-felt, unmet need. Accordingly, on
this record, Appellants' arguments on these secondary considerations of
nonobviousness are insufficient to overcome the prima facie case of
obviousness.
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SUMMARY
We affirm the rejection of claim 2 under 35 U.S.C. § 103(a) as
obvious over Niemiec and Martin.
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. § l .136(a)(l )(iv).
AFFIRMED
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