Ex Parte Lerner et al

Board of Patent Appeals and Interferences

Jan 26, 2012

11543512 (B.P.A.I. Jan. 26, 2012)

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.
11/543,512 10/05/2006 Laran J. Lerner LERN 0101 PUSP1 6515
22045 7590 01/27/2012
BROOKS KUSHMAN P.C.
1000 TOWN CENTER
TWENTY-SECOND FLOOR
SOUTHFIELD, MI 48075
EXAMINER
CHONG, YONG SOO
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
01/27/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LARAN J. LERNER, KEVIN S. LERNER,
JASON SEAN LERNER, and TREVOR MATTHEW LERNER
__________

Appeal 2011-011893
Application 11/543,512
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method of treating herpes infections. The Examiner has rejected claims as
obvious under 35 U.S.C. §103(a). We have jurisdiction under 35 U.S.C.
§ 6(b) (2011). We affirm.

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STATEMENT OF THE CASE
The invention relates to a method of treating herpes viral infections
comprising applying to skin a treatment composition including a
halogenated hydrocarbon, such as a methyl halide or ethyl halide, which is
delivered via a fine point spray, a mist spray or a pressurized intradermal
pump.
Claims 1, 9, 10, 12, and 15-17 are on appeal. Appellants have argued
claims 16 and 17 separately in their Appeal Brief. (App. Br. 7). 37 C.F.R.
§ 41.37(c)(1)(vii). Independent claim 1 is representative and reads as
follows:
1. A method of treating herpes viral infections (HVI), the method
comprising the steps of:
(1) diagnosing whether a patient's condition is associated with a
herpes viral infection;
(2) selecting a treatment composition from a group consisting
of: a) a halogenated hydrocarbon, b) a halogenated hydrocarbon plus
an antiviral agent, c) a halogenated hydrocarbon plus an anti-pruritic
and an analgesic, d) a halogenated hydrocarbon plus an antiviral agent
plus an anti-pruritic and an analgesic, and (e) mixtures of
compositions (a-d).
(3) choosing a way for delivery of the treatment composition,
the way for delivery being selected from the group consisting of a fine
point spray generated from a pressured container, a mist spray
generated from a pressurized container, a pressurized intradermal
pump, and combinations thereof;
(4) applying the treatment composition to an area of skin to be
treated through the chosen way for delivery;
(5) evaluating effectiveness of the treatment composition
applied through the chosen way for delivery; and
(6) reapplying the treatment composition as needed.
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Dependent claim 16 recites that the treatment composition includes methyl
halide or ethyl halide. Dependent claim 17 recites that the treatment
composition is in a gaseous form.
THE REJECTION ON APPEAL
Claims 1, 9, 10, 12, and 15-17 stand rejected over Johnson (U.S. Publ.
Appl. No. 2002/0188028 A1) in view of Thorpe et al. (U.S. Publ. Appl. No.
2004/0131622 A1) (Ans. 4).
OBVIOUSNESS
Examiner’s Findings
The Examiner finds that Johnson teaches a “method of treating
complications from herpes in patient [sic] by topically administering an anti-
infective and/or antimicrobial active agent,” such as an organic compound
having at least one carbon-halogen bond, in a carrier in an applicator (Ans.
4). In addition, the Examiner finds that Johnson teaches “organohalides of a
broad formula CnH2n+1, with n being anything from 1 to 50 (paragraph
0062)” (id. at 4-5). The Examiner states that this reference also teaches
diagnosis of a patient, and further “notes that steps 2-6 are inherent since
they are commonly practiced by all physicians treating a patient with herpes
infection and skin lesions” (id. at 5). The Examiner further finds that
“[c]onventional application methods include spraying …” and “notes that
‘methyl or ethyl halides’ are obvious to one of ordinary skill in the art
because they are the simplest forms of the organohalides of a broad formula
CnH2n+1, where n is 1 or 2, as taught by Johnson et al.” (id.).
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Regarding Thorpe, the Examiner states that this reference teaches a
method of treating viral infections, such as herpes, as well as “conventional
administration for the composition to include topical, intradermal,
intramuscular, intravenous, subcutaneous, which involve the use of syringes
(paragraphs 0670-0671), pumps (paragraph 1156), implants (paragraphs
0203, 0310, 0636), and transdermal patches (paragraph 0652)” (Ans. 5).
According to the Examiner, it would have been prima facie obvious to
combine the well-established and commonly used topical and intradermal
administration methods taught by Thorpe with the methods and
compositions for treating herpes taught by Johnson (id. at 6-7).
Appellants’ Contentions
Appellants contend that “halogenated hydrocarbon …, when
presented in a fine point spray or mist spray generated from a pressurized
container, or when presented intradermally via a pressurized pump, induces
a physical freezing of the virus’ genetic materials and causes a temporary
‘frostnip’ … [which] … can speed up the healing process and reduce
recurrence of herpes related skin lesions.” (App. Br. 4) (citations omitted.)
Appellants argue that neither Johnson nor Thorpe alone or in combination
disclose or suggest this “claimed” feature (id. at 5). Appellants contend that
the disclosure of spraying in Johnson relates to prior art methods that
“cannot be effectively used in Johnson’s method or to achieve Johnson’s
intended purpose” (id. (emphasis in original); see also Reply Br. 2). Along
these lines, Appellants assert that “Johnson’s composition must be delivered
by applicators with skin-rubbing” (id. at 6).
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According to Appellants, because the methods disclosed in Thorpe
“could/would not be introduced to replace the skin-rubbing method of
delivering mandated by Johnson,” a skilled artisan would not combine the
teachings of the two cited references to arrive at Appellants’ claimed
invention. (App. Br. at 6.)
Regarding claim 16, Appellants contend that the broad formula
disclosed in Johnson (paragraph 0062) of CnH2n+1, with n being anything
from 1 to 50, fails to render obvious methyl halide or ethyl halide.
According to Appellants, Johnson focuses on the use of benzalkonium
chloride, a bulky molecule, which is not a methyl or ethyl halide (id. at 7).
Regarding claim 17, Appellants argue that the instant Specification teaches
an aerosol mist or spray directed to skin lesions (id.). Appellants cite to
Exhibits I and II showing dictionary definitions of “aerosol” and “mist” in
an effort to contrast these features from a composition in a liquid, as
disclosed in Johnson (id.).
Issues on Appeal
Based on the above, the issues on appeal are (i) whether the combined
disclosures of Johnson and Thorpe teach elements recited in pending claims,
and (ii) whether it would have been obvious to combine the prior art
administration methods taught in Johnson and Thorpe with the treatment
compositions and methods disclosed in Johnson to arrive at the claimed
invention.
FINDINGS OF FACT
1. The instant Specification discloses that cold therapy treatments, such
as halogenated hydrocarbon treatments, including ethyl chloride
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(chloroethane) and fluori-methane, in the form of sprays, were known
in the prior art. (Spec. last ¶ on p. 4, and ¶ spanning pp. 4-5, see also
¶ spanning pp. 9-10 (discussing, for example, commercially sold
chloroethane sprays).)
2. The Specification defines “alkyl” in relation to “halogenated
hydrocarbon (alkyl halide)” to mean a “hydrocarbon having from 1 to
12 carbon atoms unless otherwise specified.” (Spec. 6.)
3. Johnson describes the treatment of disordered epithelial tissues, such
as cold sores, resulting from disorders such as herpes. (Johnson, ¶
[0003].)
4. Johnson describes examples of conventional application methods and
compositions as provided in WO 98/42188 and in WO 98/11778,
which teach applying treatment compositions by “spraying, dabbing,
dusting, swabbing, sponging, brushing, pouring, dispensing, covering
or heavily coating” (Johnson, ¶ [0012], emphasis added).
5. With regard to treatment compositions, Johnson teaches biologically
active agents such as organohalides having “an alkyl group attached
thereto such as a simple CnH2n+1, chain, where n is in a range from 1 to
about 50.” (Johnson, ¶ [0062].)
6. Johnson discloses applicators for use in treatment. Such applicators
may be “configured to enable the treatment composition to be either
delivered with vigorous agitation or to be merely delivered onto the
disordered tissue.” (Johnson, ¶¶ [0110], see also [0132].) Johnson
further teaches that “[s]uch flexibility is useful since tissue disorders
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such as cold sores typically progresses in stages that have varying
pain thresholds.” (Johnson, ¶ [0110].)
7. Thorpe also teaches compositions to treat viral infections. (Thorpe,
Abstract, ¶¶ [0635] – [0636], [0651] - [0655].) Thorpe refers to many
types of dosage forms, including sprays and aerosols (id. at ¶¶ [0635],
[0655]), and perfusion pumps (id. at ¶ [1156]).
PRINCIPLES OF LAW
An obviousness analysis compares the claimed invention and the prior
art to determine whether “the subject matter as a whole would have been
obvious at the time the invention was made” to a person having ordinary
skill in the art. Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed.
Cir. 2006). The ultimate question of obviousness is one of law, based upon
factual inquiries set forth in the Graham case: (1) the scope and content of
the prior art; (2) the differences between the prior art and the claims at issue;
(3) the level of ordinary skill in the pertinent art; and (4) objective evidence
of non-obviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17
(1966).
Obviousness requires the showing that a person of ordinary skill at the
time of the invention would have selected and combined those prior art
elements in the normal course of research and development to yield the
claimed invention. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
In addition, there must be “an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id. at 418. Such a
reason might be found in “interrelated teachings of multiple patents; the
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effects of [design or marketplace] demands . . . and the background
knowledge possessed by a person having ordinary skill in the art.” Id.
ANALYSIS
Independent claim 1 recites the following basic concepts: (1)
diagnosing a patient’s condition, (2) selecting a treatment composition, (3)
choosing and then (4) applying a delivery method to administer the
treatment composition, (5) evaluating the effectiveness of the treatment
composition via the delivery method, and then (6) reapplying the treatment
composition as needed. As noted by the Examiner, and understood by those
skilled in the art, the basic concepts of (1) – (6) in treatment methods were
obvious, and in fact, followed generally by medical practitioners when
treating any disease. (Ans. 5.) Appellants have not suggested otherwise.
Thus, the issue boils down to whether the art relied upon by the
Examiner would have suggested a method of treating herpes viral infections
by delivering to the skin a halogenated hydrocarbon via a fine point or mist
spray generated from a pressurized container, or via a pressurized
intradermal pump.
As mentioned above, and pointed out by the Examiner, Johnson
expressly teaches a method of treating disordered tissue, such as a cold sore
caused by herpes, using halogenated hydrocarbons, including organohalides
having “an alkyl group attached thereto such as a simple CnH2n+1, chain,
where n is in a range from 1 to about 50.” (Johnson, ¶ [0062]; FF5; Ans. 4-
5.) The instant Specification indicates that the term “halogenated
hydrocarbon” encompasses at least n = 1-12. (Spec. 6.) For the reasons
discussed below regarding claim 16, we agree with the Examiner that n = 1-
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12 (such as n = 1 or 2), as the simplest forms of the organohalides presented,
would have been obvious choices when considering n = 1-50, as taught in
Johnson.
Johnson also describes “[e]xamples of conventions application
methods” such as spraying. (Johnson, ¶ [0012]; Ans. 5, 6.) In the context
of treating viral infections, Thorpe likewise refers to common dosage forms,
including sprays and aerosols (Thorpe, ¶¶ [0635], [0655]), and perfusion
pumps (id. at ¶ [1156]). (Ans. 5, 7.)
In response to the cited spraying disclosure in Johnson, Appellants
argue that prior art spraying methods “cannot be effectively used in
Johnson’s method or to achieve Johnson’s intended purpose” (App. Br. 5)
(emphasis in original) (see also Reply Br. 2). Along these lines, Appellants
assert that “Johnson’s composition must be delivered by applicators with
skin-rubbing” (id. at 6) (emphasis added). In other words, according to
Appellants, a skilled artisan would not have considered using a spray to
deliver the treatment compositions disclosed in Johnson because Johnson
itself indicated that such compositions must be delivered by applicators with
skin-rubbing.
We disagree with this assessment of Johnson. As noted above,
Johnson teaches that applicators may be “configured to enable the treatment
composition to be either delivered with vigorous agitation or to be merely
delivered onto the disordered tissue.” (Johnson, ¶¶ [0110], [0132]; FF6;
(emphasis added.) Thus, treatment composition may be delivered by
applicators with skin-rubbing (i.e., vigorous agitation), but also may be
“merely delivered” onto the skin. Johnson clearly contemplated delivering
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the disclosed treatment compositions without skin rubbing, including via
“conventional applications methods” described in Johnson, such as spraying.
We note that Appellants have not argued in their briefs, nor cited
evidence indicating, that any specific type of spraying (e.g., “a fine point
spray generated from a pressured container” or “a mist spray generated from
a pressurized container”) imparts special features or is otherwise non-
obvious over “spraying” as disclosed in both Johnson and Thorpe.
Appellants argue an alleged lack of reasoning to combine Johnson and
Thorpe (App. Br. 6). We agree with the Examiner, however, that both
references taught methods for treating viral infections, and described
conventional methods for administering treatment compositions in that
context. (Ans. 7.) A skilled artisan reading Johnson would have considered
a reference such as Thorpe, which confirmed and described relevant ways to
deliver a treatment composition. In response, Appellants again assert that
“Johnson’s composition must be delivered by applicators with skin-rubbing”
(App. Br. 6) (emphasis added). As discussed above, this assertion is
incorrect. Johnson clearly contemplated delivering the disclosed treatment
compositions without skin rubbing, including via “conventional applications
methods” described in both Johnson and Thorpe, such as spraying.
Regarding claim 16, Appellants assert that the formula of
organohalides having a CnH2n+1, chain, where n is in a range from 1 to about
50, as disclosed in Johnson (¶ [0062]), is so broad that it cannot render
obvious a methyl or ethyl halide. (App. Br. 7.) In support, Appellants argue
that Johnson does not address the observation that lower carbon
organohylides “are believed to evaporate relatively rapidly, causing cooling
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and contracting of blood vessels and alleviating pain” (id.). Appellants also
contend that Johnson prefers a liquid, and the use of benzalkonium chloride,
a bulkier compound that is not a methyl or ethyl halide (id.).
We agree with the Examiner, however, that the use of a methyl or
ethyl halide would have been obvious in light of the disclosure in Johnson of
organohalides having a CnH2n+1, chain, where n is in a range from 1 to about
50. As stated by the Examiner, methyl and ethyl halides were obvious
choices because they were the simplest forms of the organohalides
encompasses by the formula. (Ans. 5.) The Examiner’s findings are further
supported by a discussion of the prior art in the instant Specification. As
noted in the Specification, cold therapy treatments, such as halogenated
hydrocarbon treatments, including ethyl chloride (chloroethane) and fluori-
methane, in the form of sprays, were known in the prior art. (Spec. last ¶ on
4, ¶ spanning 4-5, ¶ spanning 9-10; FF1.)
Because treatment compositions comprising methyl and ethyl halides,
administered in the form of sprays, were previously and commercially sold
for the relief and treatment of herpes virus skin lesions (id.), one would have
been motivated to use these two forms of organohalide CnH2n+1, chain
compositions in the form of a spray in the methods of treating herpes, as
taught in Johnson.
We are not persuaded by Appellants’ arguments that Johnson
“prefers” organohalides that are of a liquid and that the reference discloses
the use of a different molecule. Appellants provide no information as to
why one would not choose known and commercially available methyl or
ethyl halide compositions, which squarely fall within the organohalides
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formula disclosed in Johnson, as an alternative to benzalkonium chloride.
Moreover, the fact that Johnson refers to a liquid form (Johnson, ¶ [0108])
does not preclude the use of a liquid as administered as via spray, as also
taught in Johnson.
Regarding claim 17, Appellants again argue that Johnson uses a
treatment composition of organohalide in a liquid. (App. Br. 7). Appellants
cite to Exhibits I and II presenting dictionary definitions of “aerosol” (i.e., a
gaseous suspension of fine particles) and “mist” (i.e., fine droplets of liquid).
Such definitions, however, do not preclude or teach away from the use of a
liquid in the form of an aerosol or mist, which are otherwise obvious forms
of administering a liquid. This is especially true in light of both Johnson’s
and Thorpe’s teachings of sprays as “conventional application methods.”
See, e.g., Johnson, ¶ [0012]; Thorpe ¶ [0635] and [0657] (referring to sprays
and aerosols.) Thus, Appellants have not persuaded us that either claim 16
or 17 is non-obvious over cited prior art.
CONCLUSION OF LAW
Because Johnson, in view of Thorpe, teach and suggest methods for
treating disordered tissue, such as cold sores caused by herpes, using
halogenated hydrocarbons, such as methyl or ethyl halide, including as
administered by a spray or aerosol (i.e., in a “gaseous form” as defined by
Appellant regarding “aerosol”), we agree with the Examiner that claim 1, as
well as claims 16 and 17, are obvious over these two references. Because
claims 9, 10, 12, and 15 stand or fall with claim 1, we conclude that the
Examiner has set forth a prima facie case of obviousness to those claims as
well.
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SUMMARY
We affirm the rejection of claims 1, 9, 10, 12, and 15-17 under 35
U.S.C. §103(a) as unpatentable over Johnson in view of Thorpe.
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. § 1.136(a).

AFFIRMED

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