Ex Parte Tran et al

Patent Trial and Appeal Board

Feb 14, 2019

12726326 (P.T.A.B. Feb. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/726,326 03/17/2010
43734 7590 02/14/2019
RONALDJ. MEETIN, ATTORNEY AT LAW
210 CENTRAL A VENUE
MOUNTAIN VIEW, CA 94043-4869
FIRST NAMED INVENTOR
David Van Tran
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.
R-0017 US 1003
EXAMINER
BRANSON, DANIELL
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
02/14/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID VAN TRAN and DAVID NGUYEN TRAN
Appeal 2018-001039 1,
Application 12/726,326
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for treating allergic rhinitis, hemorrhoids, toothache, dandruff, male itching,
and bromhidrosis using a salt of peroxymonosulfuric acid. 2 The Examiner
rejected the claims as containing new matter, as failing to comply with the
enablement requirement, as indefinite, and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm-in-part.
1 Appellants identify the Real Party in Interest as LuTran Industries, Inc.
(see App. Br. 1 ).
2 We have considered and herein refer to the Specification of Mar. 1 7, 2010
("Spec."); Non-Final Office Action of Nov. 30, 2016 ("Non-Final Act.");
Appeal Brief of April 15, 2017 ("App. Br."); Examiner's Answer of Sept.
11, 2017 ("Ans."); and Reply Brief of Nov. 8, 2017 ("Reply Br.").
Appeal2018-001039
Application 12/726,326
Statement of the Case
Background
"Peroxymonosulfates are generally strong oxidizing agents, i.e., they
readily provide ( or release) oxygen under certain conditions at standard
temperature (20-25°C) and standard pressure (760 torr)" (Spec. ,r 171).
"The oxidizing capability of the peroxymonosulfate used in forming the
medicinal drug of type I is believed to be a factor in the drug's effectiveness
in combating bacterial, eukaryotic, prion, and viral pathogens that attack
humans and in causing non-pathogenic-caused inflammation to be reduced
in humans" (id. ,r 172).
The Claims
Claims 1-5, 8-12, 14--24, 26-30, and 61-94 are on appeal. 3
Independent claims 1 and 18 are representative below and read as follows:
1. A method comprising administering a medicinal drug to
a person sufficiently to treat a medical condition of the person
or/and to prevent the person from contracting the medical
condition, the medicinal drug formed at least partially with salt
of peroxymonosulfuric acid, the medical condition comprising
at least one of allergic rhinitis, hemorrhoids, toothache,
dandruff, male itching, and bromhidrosis.
18. A method comprising administering a medicinal drug non-
topically to a person sufficiently to treat a virus-caused medical
condition of the person or/and to prevent the person from
contracting the medical condition, the medicinal drug formed at
least partially with potassium hydrogen peroxymonosulfate.
3 The Examiner repeatedly recites "claims which depend therefrom" but
fails to specifically list these claims in the statement of rejection (see, e.g.,
Non-Final Act. 4, 9). MPEP § 2103(I)(C) states "Examiners should begin
claim analysis by identifying and evaluating each claim limitation."
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Application 12/726,326
The Issues
A. The Examiner rejected claims 1, 8, 22, 73, 79, and 85 under 35 U.S.C.
§ 112, first paragraph, new matter (Non-Final Act. 3--4).
B. The Examiner rejected claims 1-5, 8-12, 14--24, and 26-30 under 35
U.S.C. § 112, first paragraph, scope of enablement (Non-Final Act. 4--8).
C. The Examiner rejected claims 1-5, 8-12, 14--24, 26, and 61-94 under
35 U.S.C. § 112, second paragraph (Non-Final Act. 9-10).
D. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 72, 73, 78,
79, 84, and 85 under 35 U.S.C. § I03(a) as obvious over Bologna, 4
VirkonS, 5 VirkonS MSDS, 6 Martin, 7
Burkhart,8 Banerjee,9 and Weinstein 10 (Non-Final Act. 11-15).
E. The Examiner rejected claims 61---68 under 35 U.S.C. § I03(a) as
obvious over Weinfield 11 and Martin (Non-Final Act. 15-17).
F. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 72, 73, 78-
80, and 84--86 under 35 U.S.C. § I03(a) as obvious over Bologna, VirkonS,
Martin, Burkhart, and Coleman 12 (Non-Final Act. 17-18).
4 Bologna et al., US 2003/0091644 Al, published May 15, 2003.
5 Virkon@S, The Ultimate Broad Spectrum Virucidal Disinfectant.
6 VirkonS, Virkon-S EPA Reg #62432-1, Material Safety Data Sheet
Pharmacal Research Laboratories, Inc., www.pharmacal.com, revised Mar.
12, 2012, last visited Jan. 2019 ("VirkonS MSDS").
7 Martin, US 2005/0062017 Al, published Mar. 24, 2005.
8 Burkhart et al., US 2007/0244195 Al, published Oct. 18, 2007.
9 Banerjee et al., Combined inhalational and oral supplementation of
ascorbic acid may prevent influenza pandemic emergency: A hypothesis, 26
Nutrition 128-32 (2010).
10 Weinstein et al., Topical Treatment of Common Supeifzcial Tinea
Infections, 65 Am. Family Physician 2095-102 (2002).
11 Weinfield, US 2010/0021530 Al, published Jan. 28, 2010.
12 Coleman, III, US 2003/0113349 Al, published June 19, 2003.
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G. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 69, 71-73,
75, 77-79, 81, 83-85 and 87-94 under 35 U.S.C. § 103(a) as obvious over
Bologna, VirkonS, Martin, Burkhart, and Ohmori 13 (Non-Final Act. 19-20).
H. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 70, 72, 73,
76, 78, 79, 82, 84, and 85 under 35 U.S.C. § 103(a) as obvious over
Bologna, VirkonS, Martin, Burkhart, and Gallina14 (Non-Final Act. 20-22).
A. 35 US.C. § 112,first paragraph, new matter
The Examiner finds that claims "were amended or newly added to
recite 'male itching[,]' but the [S]pecification does not provide support for
differentiating between itching in one gender or the other" (Non-Final Act.
4). The Examiner finds that "in examples 41--43 where itching is treated, the
itching is either located on the neck and back or involves itching over the
whole body, itching which could affect males as well as females" (id.)
Appellants contend:
Using salt of peroxymonosulfuric acid to treat male itching is
clearly disclosed in [S]pecification examples 41 - 43. Since the
[S]pecification supports male itching, there is no need for the
[S]pecification to differentiate between male itching and female
itching. Whether salt of peroxymonosulfuric acid can be used
to treat female itching is immaterial to the claims now limited
to using salt of peroxymonosulfuric acid to treat male itching.
(App. Br. 7).
The issue with respect to this rejection is: Does a preponderance of the
evidence of record support the Examiner's finding that the Specification
13 Ohmori et al., US 5,135,952, issued Aug. 4, 1992.
14 Gallina, US 5,234,914, issued Aug. 10, 1993.
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fails to provide descriptive support for treatment of male itching using a salt
of peroxymonosulfuric acid?
Findings of Fact ("FF'')
1. Examples 41--43 of the Specification are reproduced below:
Example 41 - itching: An adult male had extreme
itching for 5 years. The male reported that he had tried many
treatments for the itching without success. The Medicine was
provided to the male as a 1 % solution for topical administration
via complete-body immersion for 20 minutes 2 times a day for
2 weeks. The male reported that the itching had diminished by
at least 50% on day 3 and that the itching was substantially
gone at the end of the 2 weeks. The male reports that he now
uses the Medicine twice a week as an itch preventative.
Example 42 - itching: An adult male had itching
throughout his body. The male stated that the itching was less
at night than in the daytime. The male reported that he had
tried many treatments, such as hydrocortisone, anti-histamines,
and herbs, for the itching but without success. The Medicine
was provided to the male as a 1 % topical administration via
complete-body immersion for 10 minutes a day for 2 weeks.
The male reported that he used the Medicine 3 times a week for
2 weeks and that the itching was substantially gone at the end
of the 2 weeks. The male reports that he now uses the
Medicine at an onset of the itching.
Example 43 - itching: An adult male reported that he
had red patches on his neck and back at birth, that the red
patches began to itch as he reached middle age, and that he
rubbed the red patches but did not scratch them for fear of
tearing his skin. The male further reported that he had tried
hydrocortisone and antihistamines to treat the itching but had
little success. The Medicine was provided to the male as a 1 %
solution for topical administration 3 times a day at 4-hour
intervals for 2 weeks. The male reported that the itching was
greatly reduced on day 5 and gone on day 10. The male reports
that he now uses the Medicine once or twice a day for 2 days at
an onset of the itching and that the itching then goes away.
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(Spec. ,r,r 289--291).
Analysis
In this case, the Specification provides express support for treatment
of itching in males using a salt of peroxymonosulfuric acid (FF 1 ). We
therefore agree with Appellants that the Specification provides support for
treatment of "male itching." That this further limits the claim from itching
in general is not an issue, because Appellants clearly have possession of a
treatment of itching in males (FF 1 ).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner's finding that the Specification fails to provide descriptive support
for treatment of male itching using a salt of peroxymonosulfuric acid.
B. 35 US.C. § 112,first paragraph, scope of enablement
The Examiner finds
the [S]pecification, while being enabling for a method of
treatment of allergic rhinitis, hemorrhoids, urticaria, toothache,
tinea pedis, non-topical treatment of acute viral
nasopharyngitis, dandruff, and bromhidrosis, it does not
reasonably provide enablement for a method of prevention of
hemorrhoids, all toothaches, allergic rhinitis and every virus-
caused medical condition unlimited to any timeframe or
treatment of every medical condition caused by a virus.
(Non-Final Act. 4).
Appellants contend there is
sufficient information in the [S]pecification for medical doctors
to develop medical prevention plans for administering
medicinal drugs fanned respectively at least partially with salt
of peroxymonosulfuric acid, potassium hydrogen
peroxymonosulfate, and potassium monopersulfate triple salt
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composition to treat or/and prevent hemorrhoids, toothache, and
allergic rhinitis of specific patients as well as virus-caused
medical conditions of specific patients using topical
administration.
(App. Br. 12).
The issue with respect to this rejection is: Does a preponderance of the
evidence of record support the Examiner's conclusion that the Specification does not
enable the full scope of the claimed invention?
Findings of Fact
Breadth of Claims
2. Claims 14, 18, and 27 broadly encompass treatment or
prevention of any "virus-caused medical condition" using potassium
hydrogen peroxymonosulfate.
3. Claims 1, 8, and 22 broadly encompass treatment or prevention
of, among other listed diseases, any allergic rhinitis, any hemorrhoids, any
toothaches and any itching in men using any salt of peroxymonosulfuric
acid.
Presence of Working Examples
4. The Specification provides evidence in the form of short term
treatment of patients with viral medical conditions including five patients
with viral nasopharyngitis (Spec. ,r,r 276-280, (Examples 28-32)) and four
patients with herpes simplex virus (Spec. ,r,r 281-284 (Examples 33-36)).
5. The Specification provides evidence in the form of short term
treatment of five patients with allergic rhinitis (Spec. ,r,r 249-253 (Examples
1-5) ), four patients with hemorrhoids (Spec. ,r,r 263-266 (Examples 15-
18) ), three patients with toothaches (Spec. ,r,r 271-273 (Examples 22-24)),
three patients with male itching (Spec. ,r,r 289-291 (Examples 41--43)).
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Amount of Direction or Guidance Presented
6. The Specification asserts:
In accordance with the invention, people afflicted with diseases
and other debilitating medical conditions caused by bacterial,
eukaryotic, prion, and viral pathogens, again including fungal,
spore-caused, and parasitic infections, and by nonpathogenic-
caused inflammation are treated with a medicinal drug formed
at least partially with water-soluble inorganic halide and an
oxidizing agent reactable in water, typically aqueous solution,
with the halide to generate hypohalite ions.
(Spec. ,r 199).
7. The Specification teaches that "topical technique is often used
to administer the medicinal drug of type I or II" and that "[ n ]on-topical
techniques for administering the drug of type I or II include oral
administration, intranasal administration, intraoptical administration, vaginal
administration, rectal administration, urethral administration, and injection
alternately referred to as infusion or parenteral administration" (Spec.
,r,r 233-234).
8. The Specification states the "dosages of the medicinal drug of
type I or II varies depending upon the selected route of administration, the
recipient's characteristics, including age, body weight, general state of
health, desired therapeutic effect, the duration of the treatment, and the
disease or other debilitating medical condition being treated" (Spec. ,r 242).
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Relative skill in the art
9. The Examiner finds the "relative skill of those in the pharmaceutical
development and medical treatment arts is high, requiring advanced education and
training" (Non-Final Act. 5).
State of the Prior Art and Unpredictability of the Art
10. The Specification teaches that: "[m]edications to treat
aspergilloma have not been shown to eradicate the fungi" (Spec. ,r 17); that
"[ r ]esearch is ongoing to find safe and effective treatments for debilitating
conditions produced by spore pathogens" (Spec. ,r 20); that "viruses are
difficult to eliminate without killing the host cells" (Spec. ,r 29); that
"vaccines do not guarantee complete protection from many diseases,
particularly viral diseases" (Spec. ,r 34); and that "[t]here is currently no cure
or treatment to eradicate herpes simplex 1 or 2 from the body at activations
of HSV-1 or HSV-2" (Spec. i146).
11. The Specification teaches that "[ u ]rticaria, or hives, is a skin
condition characterized by raised red skin welts," "is generally caused by
direct contact with an allergenic substance or an immune response to food or
some other allergen but can appear for other reasons," and "can be very
difficult to treat" (Spec. ,r,r 66-67). The Specification teaches that "[i]tching
can be related to anything from dry skin to cancer" (Spec. ,r 80).
12. Okeson teaches that toothache pain "may not be of dental
origin" and that "[ n ]on-odontogenic toothaches are often difficult to identify
and can challenge the diagnostic ability of the clinician" (Okeson,
Abstract). 15
15 Okeson et al, Non-odontogenic toothache, 79 Northwest Dent. 37--44
(2000) Abstract only.
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13. Misra teaches "[ d]rugs can reduce oedema, relieve pain and
help in thrombosis, but cannot definitively cure haemorrhoids" (Misra 1490,
col. 1 ). 16
Quantity of Experimentation
14. The Examiner finds that it would require a "novel and extensive
research program to show that the instant claimed compositions treat and
eliminate the risk of developing every type of medical condition caused by a
virus, allergic rhinitis, hemorrhoids and toothache, regardless of etiology"
(Non-Final Act. 7-8).
15. The Specification teaches the "efforts of researchers in
developing treatments for viral infections have been repeatedly frustrated by
both the morphology and the metabolic nature of viruses. In brief, no
efficient way for treating many viral diseases is currently available" (Spec.
if 50).
Principles of Law
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by
the description of the invention provided in the [S]pecification
of the application.
In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993).
Factors to be considered in determining whether a disclosure
would require undue experimentation ... include (1) the
quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
16 Misra et al., Drug Treatment of Haemorrhoids, 65 Drugs 1481-91
(2005).
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of the prior art, ( 6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth
of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Analysis
In addressing the Wands factors, the Examiner has provided
substantial evidence of unpredictability that relates to several different
dimensions of claim scope. The scope of independent claims 14, 18, and 2 7
encompasses treatment of any virus whatsoever, but the evidence of record
is drawn solely to nine patients, five with viral nasopharyngitis and four
patients with herpes simplex virus (FF 4). The Specification itself
recognizes that "viruses are difficult to eliminate without killing the host
cells" (Spec. ,r 29); that "vaccines do not guarantee complete protection from
many diseases, particularly viral diseases" (Spec. ,r 34 ); and that "[ t ]here is
currently no cure or treatment to eradicate herpes simplex 1 or 2 from the
body at activations ofHSV-1 or HSV-2" (Spec. ,r 46) (FF 10). The
Specification further notes there is "no efficient way for treating many viral
diseases is currently available" (FF 14 ).
Other than generic treatment recitations (FF 8), the Specification does
not provide evidence or reasoning that would predictably demonstrate that
the claimed treatment would be expected to treat any viral infection in a
patient, ranging from the flu virus and rhinovirus causing the common cold,
to measles virus, HIV, and ebola viruses. Viruses differ in their surface
proteins, in the presence or absence of a lipid bilayer, in whether their
genome is DNA or RNA, whether their genome is double or single stranded,
the cell tropism of infection, and many other parameters.
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Therefore, in light of the limited working examples and disclosure in
the Specification, the large and unpredictable amount of experimentation
necessary, and the very large breadth of claims 14, 18, and 27, we agree with
the Examiner that the Specification does not enable the broad scope of
claims 14, 18, and 27.
Similarly, the scope of independent claims 1, 8, and 22 encompasses
treatment of any type of itching in men in any location due to any cause
ranging from infections such as impetigo or folliculitis to allergic reactions
such as some types of dermatitis, agents such as poison ivy, and medication
induced itching. These claims also encompass any type of toothache pain,
whether caused by an abscess or infection, inflammation, tooth decay or a
cracked tooth (see, e.g., Spec. ,r 70).
There are working examples of only three patients with toothache and
three with male itching (FF 5). All three of these toothache patients were
individuals whose pain was due to tooth extraction and not due to abscess,
infection, inflammation, tooth decay, cracked teeth, or other causes of
toothache (see Spec. ,r,r 270-272). Thus, these working examples do not
provide evidence commensurate with the scope of the claim. Similarly, the
male itching patients are limited to three examples and are not
commensurate with the scope of the claim (see Spec. i-fi-f 289--291).
The Specification provides little guidance on specific clinical
treatments that would address the full scope of these claims (FF 7, 8). The
Specification itself demonstrates that treatment of conditions including
itching is unpredictable (FF 11 ). Moreover, the Examiner cites Okeson to
establish that toothache treatment can be difficult due to diagnostic concerns
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(FF 12) and cites Misra to establish some degree of unpredictability in
hemorrhoid treatment (FF 13).
Therefore, in light of the limited working examples and disclosure in
the Specification, the large and unpredictable amount of experimentation
necessary, and the large breadth of claims 1, 8, and 22, we agree with the
Examiner that the Specification does not enable the broad scope of claims 1,
8, and 22. See In re Fisher, 427 F.2d 833, 839 (CCPA 1970) ("[T]he scope
of the claims must bear a reasonable correlation to the scope of enablement
provided by the [S]pecification to persons of ordinary skill in the art.").
Appellants contend the disclosed
information is sufficient for medical doctors to develop medical
plans for administering medicinal drugs formed respectively at
least partially with salt of peroxymonosulfuric acid, potassium
hydrogen peroxymonosulfate, and potassium monopersulfate
triple salt composition to prevent hemorrhoids, toothache, and
allergic rhinitis of specific patients as well as virus-caused
medical conditions of specific patients using topical
administration.
(App. Br. 13).
We are not persuaded. Decisions by the Federal Circuit support the
conclusion of undue experimentation. In Alza, the specific compound,
methylphenidate, used for treating ADHD was known and the "enablement
issue reduce[ d] to factual considerations with regard to whether undue
experimentation is required to make oral dosage forms other than osmotic
dosage forms that meet the limitations of the claims." Alza Corp. v. Andrx
Pharm., LLC, 603 F.3d 935, 938 (Fed. Cir. 2010). In that much simpler
situation, where the compound was known to be effective and alternative
dosage forms were known to exist, Alza found that the "Wands factors weigh
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in favor of finding that the experimentation required to practice part of the
claimed invention was not routine." Id. at 943-944. Here, where there are a
variety of different medical conditions being treated and substantial evidence
of unpredictability, the Wands factors also weigh in favor of a finding that
the experimentation necessary to enable the rejected claims was not routine.
Appellants also contend that
It is certainly possible, perhaps even probable, that the methods
recited in claims 1, 8, and 22 will not prevent hemorrhoids,
toothache, and allergic rhinitis in all instances and that the
topical-drug-administration methods recited in claims 14, 22,
and 27 will not prevent virus-caused in all instances. However,
this in itself is insufficient to find claims 1, 8, 14, 18, 22, and 27
and their dependent claims to lack enablement by the
[S]pecification in light of all the dosage concentrations, drug
administration intervals, drug administration procedures, and so
on regarding medical treatment recited in the specification for
treating and preventing hemorrhoids, toothache or allergic
rhinitis.
(Reply Br. 5).
We find this argument unpersuasive because
Enablement serves the dual function in the patent system of
ensuring adequate disclosure of the claimed invention and of
preventing claims broader than the disclosed invention .... This
important doctrine prevents both inadequate disclosure of an
invention and overbroad claiming that might otherwise attempt
to cover more than was actually invented. Thus, a patentee
chooses broad claim language at the peril of losing any claim
that cannot be enabled across its full scope of coverage.
MagSil Corp. v. Hitachi Global Storage Technologies, Inc., 687 F.3d 1377,
1380-1381 (Fed. Cir. 2012). Appellants did not identify credible evidence
rebutting the evidence advanced by the Examiner that the claimed methods
would not reliably or predictably treat the full scope of viral infections,
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toothaches, and itches encompassed by the claims. Accordingly, the
Examiner had reasonable scientific basis to find the claims to be overbroad
and not enabled for their full scope of coverage.
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that the Specification does not enable the full scope of the
claimed invention.
C. 35 US.C. § 112, second paragraph
The Examiner finds that claims "recite 'male itching' yet no definition
of this phrase is given in the specification. Itching has many different
etiologies, most of which affect both females as well as males" (Non-Final
Act. 9). The Examiner finds that "it is unclear if the claim is limited to only
those causes of itching that can only affect males, such as fungal infection of
male genitalia ('jock itch'), or if this recitation in the claim reads on other
causes of itching which affect males, but can affect females as well" (id.).
The Examiner also finds the phrase "medicinal drug formed at least
partially with salt of peroxymonosulfuric acid" indefinite because "it would
have been unclear what the metes and the bounds of the claims were and
whether a peroxymonosulfate was actually required by the claim" (Non-
Final Act. 9--10).
Appellants contend "whether salt of peroxymonosulfuric acid can be
used to treat female itching is immaterial to the claims now limited to using
salt of peroxymonosulfuric acid to treat male itching" (App. Br. 14).
Appellants also contend "there is no ambiguity as to what constitutes salt of
peroxymonosulfuric acid" and a "claim recitation that a medicinal drug is
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'formed at least partially with salt of peroxymonosulfuric acid' necessarily
requires that the medicinal drug be formed at least partially with the
chemical composition known as salt of peroxymonosulfuric acid" (App. Br.
16).
We agree with Appellants. The term "male itching" is not indefinite,
but rather broad. That is, any itching experienced by a person identifying as
male would constitute "male itching." While we agree with the Examiner
that the breadth of the claim raises a scope of enablement issue as affirmed
above, this unsupported breadth does not mean it is indefinite. In re
Johnson, 558 F.2d 1008, 1016 n. 17 (CCPA 1977). Even "undue breadth is
not indefiniteness." Id.
As to the phrase "medicinal drug formed at least partially with salt of
peroxymonosulfuric acid," we agree with Appellants that claim 1 necessarily
includes some amount of a salt of peroxymonosulfuric acid as expressly
recited. Again, the claim broadly encompasses situations where the drug is
entirely composed of the salt of peroxymonosulfuric acid and situations
where the drug has this salt as a relatively minor constituent, so long as the
amount of peroxymonosulfuric acid functions to "treat a medical condition"
and/or "to prevent the person from contracting the medical condition" as
also required by claim 1.
We therefore reverse the rejections of claims under 35 U.S.C. § 112,
second paragraph as indefinite.
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D. 35 US.C. § 103(a) over Bologna, VirkonS, VirkonS MSDS, Martin,
Burkhart, Bane,jee, and Weinstein
The Examiner finds Bologna teaches the "use of unexpectedly low
concentrations of peroxide over an extended period of time to treat or
prevent infections without irritation" where the "peroxide source may be
benzoyl peroxide or a salt of peroxomonosulfuric acid" (Non-Final Act. 11-
12). The Examiner acknowledges that Bologna does not "specifically teach
the medical condition treated is one listed in either of claims 1 or 8 or is a
viral infection" (id.).
The Examiner finds that
Virkon comprises potassium peroxymonosulfate and the Virkon
S reference demonstrates that Virkon has been proven to have
virucidal, bactericidal, sporicidal and fungicidal efficacy,
including efficacy against the herpes simplex virus,
corona virus, which Banerjee et al. evidences is one of the most
likely causes of acute viral nasopharyngitis ... and the fungus
trichophyton rubrum, which Weinstein evidences is the cause of
most tineas, including tinea pedis as well as tinea cruris (IE
jock itch).
(Non-Final Act. 12). The Examiner finds Martin teaches a composition with
minimal amounts of a "byproduct that is usually found in potassium
monopersulfate salt compositions [and] is extremely irritating when it comes
in contact with its users" (id. at 13). The Examiner finds Burkhart teaches a
"composition comprising benzoyl peroxide to treat dandruff and jock itch"
(id.).
The Examiner finds it obvious to use a "salt of peroxymonosulfuric
acid of Bologna et al. in a method of treating or preventing herpes simplex
infection, acute viral nasopharyngitis, dandruff and male itching (IE jock
itch) as Virkon teach that potassium peroxymonosulfuric acid is effective at
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killing the virus and fungus responsible for these conditions" (Non-Final
Act. 13).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that the prior art
renders the claims obvious?
Findings of Fact
16. Bologna teaches "the use of unexpectedly low concentrations of
peroxide over an extended period of time to provide a beneficial effect by
treating or preventing vaginal infections without ... causing significant
irritation of the sensitive tissues of the vagina" (Bologna ,r 19).
17. Bologna teaches the "peroxide source may be selected from a
variety of sources, both organic and inorganic. Typical forms of peroxide
sources are those used for treating mucosa and related epithelial tissue ....
Preferably the peroxide source is one of the following forms ... benzoyl
peroxide [or] peroxomonosulfuric acid and its salts)" (Bologna ,r 30).
18. VirkonS teaches a broad spectrum virucidal disinfectant that
was safe "in the drinking water of broiler chicks" as well as safe for
"spraying and fogging over broiler chicks" (VirkonS, 1 ). VirkonS teaches
"[ c ]omplete control - aerial, surface, and water system disinfectant"
(VirkonS, 2).
19. Virkon MSDS teaches that VirkonS is composed of 1 %
potassium peroxymonosulfate and 99% water (see Virkon MSDS 1 ).
20. Banerjee teaches "acute viral nasopharyngitis, is a mild, self-
limiting infectious disease that can be caused by more than 100 different
viruses. Of these, rhinovirus and corona virus are responsible for
approximately 50-70% of all common colds" (Banerjee 128, col. 1 ).
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21. Weinstein teaches "[ t ]richophyton rubrmn is the most common
pathogen causing dermatomycoses, including tinea pedis, tinea corporis, and
tinea cruris" (Weinstein 2096, col. 1; emphasis omitted).
22. Burkhardt teaches "[a]pplying the benzoyl peroxide in a gel (or
cream) form in an alcohol base on top of the two sprays directly onto the
skin surface .... We are finding this combination helpful in treating fungal
infections (jock itch, athlete's foot, nail fungus)" (Burkhardt ,r,r 112-113).
Principles of Law
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup International 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 International Co. v. Teleflex
Inc., 550 U.S. 398,418 (2007).
Analysis
Claims 1, 8, and 22
We focus our analysis on "male itching" because each of these claims
recites different types of medical conditions including "male itching". We
interpret 'jock itch" and "athlete's foot" as types of "male itching"
consistent with the Specification's teaching that "[a]n itch is a sensation felt
on an area of skin which causes a person to scratch the area. Itching can be
related to anything from dry skin to cancer" (Spec. ,r 80).
We note the Board may rely on less than all of the references applied
by the Examiner in an obviousness rationale without designating it as a new
ground of rejection. In re Bush, 296 F.2d 491,496 (CCPA 1961). We also
note that "where a rejection is predicated on two references each containing
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pertinent disclosure ... we deem it to be of no significance, but merely a
matter of exposition, that the rejection is stated to be on A in view of B
instead of on B in view of A, or to term one reference primary and the other
secondary." Id.
Burkhardt teaches administering benzoyl peroxide to a person for
treatment of conditions including jock itch and athletes foot (FF 22).
Burkhardt does not suggest the use of a salt of peroxymonosulfuric acid.
Bologna teaches treatment of infections, including yeast infections,
using peroxides (FF 16) and teaches "the peroxide source is one of the
following forms ... benzoyl peroxide [or] peroxomonosulfuric acid and its
salts)" (FF 17).
The Examiner reasons that
as Bologna et al. demonstrate that benzoyl peroxide and
salts of peroxomonosulfuric acids are known equivalents in the
art and as Burkhart et al. teach that the use of a composition
comprising benzoyl peroxide to treat jock itch (IE male itching)
... it would have been obvious to one of ordinary skill in the
art to utilize salts of peroxomonosulfuric acids to attempt to
treat ... male itching.
(Non-Final Act. 14).
We agree with the Examiner that selecting such known equivalents
would have been obvious. See KSR, 550 U.S. at 417 ("If a person of
ordinary skill can implement a predictable variation, [section] 103 likely
bars its patentability.") This result is also consistent with Wrigley, which
found a "strong case of obviousness based on the prior art references of
record. [The claim] recites a combination of elements that were all known
in the prior art, and all that was required to obtain that combination was to
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substitute one well-known ... agent for another." Wm. Wrigley Jr. Co. v.
Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012).
Here, where the substitution is selection of a different peroxide for
treatment of jock itch where both peroxides were disclosed in a single
reference as useful in the treatment of infections, including yeast (i.e. fungal)
infections, we agree with the Examiner that the ordinary artisan would have
had reason to substitute one well-known peroxide for another.
Appellants respond that "[ n ]othing has been presented during the
examination of this application to show that benzoyl peroxide is generally
interchangeable with peroxymonosulfuric acid or its salts" (App. Br. 25).
We find this argument unpersuasive because Bologna teaches
treatment of fungal infections with peroxide sources (FF 16) and teaches the
interchangeability of benzoyl peroxide and peroxymonosulfuric acid
expressly, teaching "[p ]referably the peroxide source is one of the following
forms ... benzoyl peroxide [or] peroxomonosulfuric acid and its salts)" (FF
17).
Appellants contend "benzoyl peroxide ... is chemically structured
very differently from both peroxymonosulfuric acid" and that "[ w ]hile
benzoyl peroxide and (certain) salts of peroxomonosulfuric acid may serve
as peroxide sources peroxide, this does not mean that benzoyl peroxide and
(certain) salts ofperoxomonosulfuric acid are equivalents in the art" (App.
Br. 25-26).
We find this argument unpersuasive. At a minimum, Bologna
suggests these two compounds are equivalent in function (FF 17). In any
case of substituting equivalents, the structure will necessarily differ, or there
would be no substitution, so this argument from structure is not persuasive.
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Moreover, to the question of whether benzoyl peroxide and salts of
peroxomonosulfuric acid are equivalent in function, Appellants only provide
attorney argument rather than evidence. However, "[a]ttorney's argument in
a brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974).
Appellants contend that there would not have been a reasonable
expectation of success because regarding treatment using substituted
compounds, "[ s ]uch results are just too difficult to predict, especially here
where benzoyl peroxide is chemically structured very differently from both
peroxymonosulfuric acid and potassium hydrogen peroxymonosulfate"
(App. Br. 26).
We find this argument unpersuasive for several reasons. First, the
efficacy of both of the compounds against fungi in Bologna along with the
efficacy of benzoyl peroxide against jock itch in Burkhardt (FF 1 7, 22)
supports a finding of a reasonable expectation of success in using a known
effective fungal treatment agent against a known disease. "[O]bviousness
does not require absolute predictability of success ... all that is required is a
reasonable expectation of success." In re Kubin, 561 F.3d 1351, 1360 (Fed.
Cir. 2009) ( emphasis omitted).
Second, Appellants provide no rebuttal evidence, only attorney
argument. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)
(Arguments and conclusions unsupported by factual evidence carry no
evidentiary weight.) Third, as noted above, the structural differences
between the compounds provides no support for Appellants' argument
regarding efficacy because both compounds are peroxides and function due
to the peroxide source (FF 17).
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Appellants point to a related case in which unpredictability was
asserted by the Examiner (see App. Br. 27-28). We find this argument
unpersuasive because "[ e Jach case must be decided on its own merits." In re
Gyurik, 596 F.2d 1012, 1016 (CCPA 1979).
Claims 14, 18, and 27
We note that these claims broadly recite treatment of viruses "non-
topically" with the peroxymonosulfuric acid salt.
Appellants contend "nothing in the Virkon S webpages or in the
Virkon S MSDS indicates that any of the Virkon S testing on human-
infecting pathogens was done in vivas, i.e., on living humans" (App. Br. 22).
Appellants contend the "fact that a disinfectant successfully kills or
otherwise neutralizes a pathogen in an in vitro environment does not mean
that that the disinfectant will successfully kill or otherwise neutralize the
pathogen when it is carried by a living human without causing significant
injury to the human" (App. Br. 23).
The Examiner responds
one of ordinary skill in the art would have had a reasonable
expectation of successfully treating the claimed conditions
because the Virkon S reference demonstrates that this
compound successfully combats the pathogens responsible for
these conditions and because in vivo tests were conducted in
Virkon S demonstrating that Virkon S is both safe and effective
at treating conditions in vivo.
(Ans. 9 (emphasis omitted)).
We agree with Appellants because VirkonS is focused on a virucide
that functions as an "aerial, surface, and water system disinfectant" (FF 18).
The Examiner does not provide an adequate reason why a disinfectant would
be used "non-topically" (i.e., internally) to treat viral infections of a patient
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as required by claims 14, 18, and 27. Just because VirkonS may
demonstrate that the compound is safe if present in drinking water of broiler
chicks in order to disinfect their water, does not suggest that the disinfectant
was intended or would function to treat or prevent a viral infections
occurring inside the chickens.
Indeed, as our affirmance of the scope of enablement rejection above
demonstrates, there is substantial unpredictability as to whether a salt of
peroxymonosulfuric acid would function to treat viruses at all. The
Examiner provides no evidence using this compound to treat or prevent virus
infections with a non-topical mode of administration, nor does the Examiner
provide a reasonable expectation of success for using a non-topical peroxide
in treatment or prevention of viruses.
Conclusion of Law
A preponderance of the evidence of record support the Examiner's
conclusion that the prior art renders claims 1, 8, and 22 obvious.
A preponderance of the evidence of record does not support the
Examiner's conclusion that the prior art renders claims 14, 18, and 27
obvious.
E. 35 US.C. § 103(a) over Weinfield and Martin
The Examiner finds that W einfield teaches topical application of "an
anti-infective agent, such as potassium peroxymonosulfate" "to treat a
fungal infection, such as onychomycosis" (Non-Final Act. 15). The
Examiner finds that W einfield teaches "organisms which produce nail
infections also produce a chronic type of tinea pedis" (id.). The Examiner
finds the treatment agent would have "successfully treated the infection in
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skin of the foot (tinea pedis) as the infection is caused by the same fungus"
(id.).
The Examiner acknowledges that Weinfield doesn't teach "the
specific salts that are used to treat or prevent the medical condition and that
the disease treated is athlete's foot" (Non-Final Act. 16).
The Examiner finds Martin teaches "a potassium monopersulfate
triple salt composition" that lacks a byproduct that "is extremely irritating
when it comes in contact with its users" (Non-Final Act. 16). The Examiner
finds it obvious to "utilize the potassium monopersulfate triple salt of Martin
in the method of W einfield because Martin teaches his salt is substantially
free of the extremely irritating byproduct" (id.).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that the prior art
renders claims 61---68 obvious?
Findings of Fact
23. Weinfield teaches "a system and method for delivering an anti-
infective agent through the nail of a subject having a nail infection such as,
for example, onychomycosis" (Weinfield ,r 11 ).
24. Weinfield teaches "the anti-infective agent can comprise a
multifunctional component that functions as an antifungal, antibacterial,
surfactant, keratolytic, and drying agent. ... [T]he anti-infective agent
comprises a component selected from the group consisting of ...
potassium peroxymonosulfate" (Weinfield ,r 16).
25. Weinfield teaches a "subject having an onychomycosis
diagnostic of a Trichophyton genus was treated .... The presence of fungal
hyphae in the subject was consistent with Trichophyton Rubrum or
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Trichophyton Mentagrophytes. Nails infected with these organisms also
produce a chronic type of tinea pedis" (Weinfield ,r 78).
26. Martin teaches a method of "production [ of] potassium
monopersulfate having low oxodisulfate byproduct" (Martin ,r 2). Martin
teaches the triple salt form "makes a good ... component in ... cleansing
agents" but "is limited in its utility because of the presence of an irritating
byproduct" that "can cause undesirable effects on humans" (Martin ,r,r 3--4).
27. Martin teaches production of a triple salt of potassium
monopersulfate that "has an active oxygen content higher than 4.3 and has
substantially no irritant" (Martin ,r 98).
Analysis
We agree with and adopt the Examiner's position with regard to this
rejection (Non-Final Act. 15-17, FF 23-27). We address Appellants
arguments below.
Appellants contend "[n]owhere, as far as Applicants' Attorney can
determine, does W einfield mention tinea pedis by that name or by either of
its other common names athlete's foot and ringworm of the foot" (App. Br.
30).
We note that this is incorrect because W einfield specifically teaches
that tinea pedis is found in infected nails (FF 25), Weinfield teaches
treatment of such nails with an anti-infective agent (FF 23), and Weinfield
teaches that one such agent is potassium peroxymonosulfate (FF 24).
Appellants contend that "Martin does not disclose that a medicinal
drug formed at least partially with salt of peroxymonosulfuric acid is used to
treat any debilitating human medical condition or to prevent a person from
contracting any debilitating human medical condition" (App. Br. 30).
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We note that Weinfield teaches potassium peroxymonosulfate, a
potassium salt, as well as the use of this compound for treatment of
infections including tinea pedis and therefore renders claim 61 obvious
alone (FF 23-25). The Examiner cited Martin to address the triple salt
composition of claims 66-68. Martin teaches synthesis of a triple potassium
salt as required by claims 66-68 (FF 26-27). We agree with the Examiner
that the ordinary artisan, interested in using a salt form of
peroxymonosulfuric acid, would have looked to Martin's formulation
because Martin teaches that this formulation lacks an irritating byproduct
"that can cause undesirable effects on humans" (FF 26). Thus, an ordinary
artisan would have had reason to select Martin's formulation of the
potassium peroxymonosulfate as that used in Weinfield's method of treating
infective diseases such as tinea pedis in order to minimize irritation in the
patients (FF 23-27).
Appellants point to a related case in which unpredictability was
asserted by the Examiner (see App. Br. 30-32). We find this argument
unpersuasive because "[ e Jach case must be decided on its own merits."
Gyurik, 596 F.2d at 1016.
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that the prior art renders claims 61---68 obvious.
F.-H 35 US.C. § 103(a) rejections
Appellants contend "[rr]othing in Coleman indicates that botulinum
toxin reacts similarly to peroxymonosulfuric acid, potassium hydrogen
peroxymonosulfate, or potassium monopersulfate triple salt composition.
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As far as Applicants' Attorney can determine, Coleman is totally irrelevant"
(App. Br. 33-34). Appellants similarly contend that Ohmori "is totally
irrelevant" and that "Gallina is totally irrelevant" (App. Br. 36-39).
The Examiner responds that
One of ordinary skill in the art would have found it obvious to
utilize salts of peroxymonosulfuric acid as a preservative in the
compositions taught by Coleman, Ohmori and Gallina for use
in treating the selected medical conditions because each of
these references teaches including a preservative and Virkon S
demonstrates that salts of peroxymonosulfuric acid demonstrate
excellent broad spectrum of antimicrobial properties
characteristic of a preservative.
(Ans. 14--15 (emphasis omitted)).
We agree with Appellants. The Examiner does not provide any
persuasive reason to select the components of Coleman, Ohmori, or Gallina
for use with the peroxymonosulfuric acid and salts in Bologna or VirkonS.
The use of a preservative in these references does not persuade us that the
Examiner has established a prima facie case of obviousness. We therefore
reverse these rejections.
SUMMARY17
In summary, we reverse the rejection of claims 1, 8, 22, 73, 79, and 85
under 35 U.S.C. § 112, first paragraph, new matter.
We affirm the rejection of claims 1-5, 8-12, 14--24, and 26-30 under
35 U.S.C. § 112, first paragraph, scope of enablement.
We reverse the rejection of claims 1-5, 8-12, 14--24, 26, and 61-94
17 We note that claims 69-71, 74--77, 80-83, and 86-94 are not subject to
any pending affirmed rejections.
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under 35 U.S.C. § 112, second paragraph.
We affirm the rejection of claims 1, 8, and 22 under 35 U.S.C.
§ 103(a) as obvious over Bologna, VirkonS, VirkonS MSDS, Martin,
Burkhart, Banerjee, and Weinstein. Claims 2-5, 9-12, 23, 24, 26, 72, 73,
78, 79, 84, and 85 fall with claims 1, 8, and 22.
We reverse the rejection of claims 14, 18, and 27 under 35 U.S.C.
§ 103(a) as obvious over Bologna, VirkonS, VirkonS MSDS, Martin,
Burkhart, Banerjee, and Weinstein. We also reverse the rejection of
dependent claims 15-17, 19-21, and 28-30.
We affirm the rejection of claims 61---68 under 35 U.S.C. § 103(a) as
obvious over Weinfield and Martin.
We reverse the rejection of claims 1-5, 8-12, 14--24, 26-30, 72, 73,
78-80, and 84--86 under 35 U.S.C. § 103(a) as obvious over Bologna,
VirkonS, Martin, Burkhart, and Coleman.
We reverse the rejection of claims 1-5, 8-12, 14--24, 26-30, 69, 71-
73, 75, 77-79, 81, 83-85 and 87-94 under 35 U.S.C. § 103(a) as obvious
over Bologna, VirkonS, Martin, Burkhart, and Ohmori.
We reverse the rejection of claims 1-5, 8-12, 14--24, 26-30, 70, 72,
73, 76, 78, 79, 82, 84, and 85 under 35 U.S.C. § 103(a) as obvious over
Bologna, VirkonS, Martin, Burkhart, and Gallina.
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-IN-PART
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