Ex Parte Levine et al

Patent Trial and Appeal Board

Sep 22, 2016

13263038 (P.T.A.B. Sep. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/263,038 12/22/2011
50811 7590 09/26/2016
O""Shea Getz P.C.
10 Waterside Drive, Suite 205
Farmington, CT 06032
FIRST NAMED INVENTOR
Joshua D. Levine
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.
1024-0006-lWOUS 2346
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
09/26/2016 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):
uspto@osheagetz.com
shenry@osheagetz.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSHUA D. LEVINE and ROBERT A. LEVINE
Appeal2015-003896
Application 13/263,038 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and DAVID
COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating neuro-olfactory triggered illnesses and aggravated conditions.
The Examiner rejected the claims on appeal as obvious under 35 U.S.C.
§ 103(a).
We affirm-in-part
1 According to Appellants, the real parties in interest are Joshua D. Levine
and Robert A. Levine. Br. 3.
Appeal2015-003896
Application 13/263,038
STATEivIENT OF THE CASE
Claims 1, 2, 5-7, 10, 13, 15-17, and 19 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A method for treating at least one of neuro-olfactory triggered
illnesses and aggravated conditions within a subject, comprising
the steps of:
providing a composition that includes one or more agents
adapted to induce a level of anosmia/hyposmia in the subject,
which level of anosmia/hyposmia is sufficient to substantially
decrease olfactory sensory stimulation within the subject and a
neurologic response to the stimulation that is one or both of
triggering and aggravating the illness or condition; and
applying the composition to a nasopharynx region of the
subject.
The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 10, 15, 16, and 19 under 35 U.S.C. § 102 (b) as anticipated
by, or in the alternative under 35 U.S.C. § 103(a) as obvious over Zellner2 as
evidenced by Ringer's Lactate Definition. 3
2 Zellner, U.S. Patent No. 6,528,081 Bl, issued Mar. 4, 2003 ("Zellner").
3 http://medical-dictionary.thefreedictionary.com/Ringer's+ lactate+solution,
accessed on June 4, 2013 ("Ringers Lactate Definition")( cited on PT0-892,
mailed June 10, 2013).
2
Appeal2015-003896
Application 13/263,038
Claims 1, 2, 7, 10, 13, 17 and 19 under 35 U.S.C. § 102(b) as
anticipated by, or in the alternative under 35 U.S.C. § 103(a) as obvious over
Fraser4 as evidenced by GRAS List, 5 Clouse, 6 and Remington. 7
Claims 1, 2, 5-7, 10, 13, 17 and 19 under 35 U .S.C § 103(a) as
obvious over the combination of Fraser and SEHSC8 as evidenced by GRAS
List, Clouse, Remington, and Spray Definition.9
FINDINGS OF FACT
1. The Specification states:
Many physical conditions are known to be triggered or caused in
whole, or in part, or aggravated by a neuro-olfactory response to
an odorant or irritant chemical (hereinafter referred to as an
odorant or an odor), or chemicals sensed by the olfactory
receptors of a subject. Such conditions (sometimes referred to as
"disorders") can include one or more of multiple chemical
sensitivity, somatoform disorder, chronic fatigue syndrome,
fibromyalgia, panic disorder, autism, epilepsy, asthma and
posttraumatic stress disorder in which afflicted individuals have
may [sic] hypersensitivity to chemical odorants.
Specification ,-i 2.
4 Fraser et al., U.S. Patent Publication No. 2006/0264509 Al, published
Nov. 23, 2006 ("Fraser").
5 http://www. fda. gov IF ood/IngredientsPackagingLabeling/GRAS/SCOGS/
ucm084 l 04.htm, last accessed on Jun. 2, 2013 ("GRAS List") (cited on
PT0-892, mailed June 10, 2013).
6 Clouse et. al., Functional Abdominal Pain Syndrome, 130
GASTROENTEROLOGY 1492-1497 (2006) ("Clouse").
7 Remington, The Science and Practice of Pharmacy 21st Edition,
Lippincott Williams & Wilkins, 2006 ("Remington").
8 Silicones Environmental Health and Safety Counsel, Guidance for Aerosol
Applications of Silicone-Based Materials, published Sep. 2001 ("SEHSC").
9 http://en.wiktionary.org/wiki/spray, last accessed Jun. 5, 2013 ("Spray
Definition")( cited on PT0-892, mailed June 10, 2013).
3
Appeal2015-003896
Application 13/263,038
2. The Specification states:
In some embodiments, the present method utilizes an agent that
is operable to physically coat the surface of the mucous layer
coating the olfactory receptors. An example of such an agent is
a vegetable, mineral, or synthetic oil that would act as physical
barrier for the odorant or irritant chemical by naturally forming
a surface coating on the mucous layer and preventing the water
soluble odorants from entering the aqueous content of the
mucous layer. The oil coating of the olfactory receptors in the
nose will also decrease the amount of odorants reaching the
olfactory receptors by preventing odorants that are oil soluble
from leaving the coating layer. The oil layer could therefore
work as both a barrier to water soluble odorants as well as
affinity capture of the oil soluble odorants. The oil may
therefore be described as substantially inhibiting entry of an
odorant into the mucous layer overlying nasal olfactory sensors
within the subject.
Specification iJ 26.
3. Zellner discloses that its nasal spray may contain "essential oils"
and that "[l]emon oil, eucalyptus oil, balm oil, mint oil, camphor, aniseed oil,
rosemary oil and sage oil are preferably used as essential oils." Zellner col.
2, 11. 4-37.
4. Zellener discloses:
When nasal breathing is hindered or temporarily blocked, for
example, due to an increase in air-polluting concentrations
within the scope of summer smog in large cities, for example
the so-called sick-building syndrome, the MCS (multiple
chemical sensitivity) syndrome or to crust formation caused by
drying, particularly in the winter months, an increased dosage
of, for example, three to four spray applications per nostril per
day may also be necessary.
Id. at col. 2, 1. 67 - col. 3, 1. 8.
4
Appeal2015-003896
Application 13/263,038
5. Fraser discloses:
The active agents may also be administered intranasally or by
inhalation. Compositions for intranasal administration are
generally liquid formulations for administration as a spray or in
the form of drops, although powder formulations for intranasal
administration, e.g., insufflations, are also known, as are nasal
gels, creams, pastes or ointments. For liquid formulations, the
active agent can be formulated into a solution, e.g., water or
isotonic saline, buffered or unbuffered, or as a suspension.
Preferably, such solutions or suspensions are isotonic relative to
nasal secretions and of about the same pH, ranging e.g., from
about pH 4.0 to about pH 7.4 or, from about pH 6.0 to about pH
7.0. Buffers should be physiologically compatible and include,
simply by way of example, phosphate buffers. Furthermore,
various devices are available in the art for the generation of
drops, droplets and sprays, including droppers, squeeze bottles,
and manually and electrically powered intranasal pump
dispensers. Active agent containing intranasal carriers may also
include nasal gels, creams, pastes or ointments with a viscosity
of, e.g., from about 10 to about 6500 cps, or greater, depending
on the desired sustained contact with the nasal mucosal
surfaces. Such carrier viscous formulations may be based upon,
simply by way of example, alkylcelluloses and/or other
biocompatible carriers of high viscosity well known to the art
(see e.g., Remington: The Science and Practice of Pharmacy,
supra). Other ingredients, such as art known preservatives,
colorants, lubricating or viscous mineral or vegetable oils,
perfumes, natural or synthetic plant extracts such as aromatic
oils, and humectants and viscosity enhancers such as, e.g.,
glycerol, can also be included to provide additional viscosity,
moisture retention and a pleasant texture and odor for the
formulation. Formulations for inhalation may be prepared as an
aerosol, either a solution aerosol in which the active agent is
solubilized in a carrier (e.g., propellant) or a dispersion aerosol
in which the active agent is suspended or dispersed throughout
a carrier and an optional solvent. Non-aerosol formulations for
inhalation may take the form of a liquid, typically an aqueous
suspension, although aqueous solutions may be used as well. In
5
Appeal2015-003896
Application 13/263,038
such a case, the carrier is typically a sodium chloride solution
having a concentration such that the formulation is isotonic
relative to normal body fluid. In addition to the carrier, the
liquid formulations may contain water and/or excipients
including an antimicrobial preservative (e.g., benzalkonium
chloride, benzethonium chloride, chlorobutanol, phenylethyl
alcohol, thimerosal and combinations thereof), a buffering
agent (e.g., citric acid, potassium metaphosphate, potassium
phosphate, sodium acetate, sodium citrate, and combinations
thereof), a surfactant (e.g., polysorbate 80, sodium lauryl
sulfate, sorbitan monopalmitate and combinations thereof),
and/or a suspending agent (e.g., agar, bentonite,
microcrystalline cellulose, sodium carboxymethylcellulose,
hydroxypropyl methylcellulose, tragacanth, veegum and
combinations thereof). Non-aerosol formulations for inhalation
may also comprise dry powder formulations, particularly
insufllations in which the powder has an average particle size of
from about 0.1 µm to about 50 µm, preferably from about 1 µm
to about 25 µm.
Fraser iJ 288 (emphasis added).
REJECTION OF CLAIMS 1 10 15 16 AND 19 AS ANTICIPATED BY
' ' ' '
OR, IN THE ALTERNATIVE, OBVIOUS OVER ZELLNER
The Examiner found that the nasal spray of Zellner was "adapted to
induce a level of ansomia/hypoasmia" because, based on the teachings of the
Specification, the composition of Zellner would "inherently 'decrease
olfactory sensory stimulation within the subject and a neurological response
to the stimulation."' Ans. 10. Appellants argue that there is no disclosure in
Zellner "that the oils or any other constituent are operable to, or used in a
form capable of, inducing a 'level of ansomia/hyposmia [that] is sufficient to
substantially decrease olfactory sensory stimulation within the subject. .. "
App. Br. 8. On the record before us, we find that a preponderance of the
evidence supports the Examiner's rejection.
6
Appeal2015-003896
Application 13/263,038
The Specification teaches that vegetable, mineral and synthetic oils
act as a "physical barrier" when applied to the mucous layer, "substantially
inhibiting entry of an odorant." FF2. Zellner discloses a nasal spray
containing "essential oils" including"[l]emon oil, eucalyptus oil, balm oil,
mint oil, camphor, aniseed oil, rosemary oil and sage oil." FF3. Appellants
do not provide an adequate explanation as to why the oils identified in
Zellner are different from the "vegetable, mineral and synthetic oils" that the
Specification teaches act as a physical barrier to inhibit odors from entering
the mucous layer. Absent evidence to the contrary, it is reasonable to
presume that the oils disclosed in Zellner would act as a physical barrier and
thus inhibit odors because it appears that the same oils disclosed in the
Specification as useful to treat neuro-olfactory illness are applied to by
Zellner to the nasopharynx region. The burden is on the Appellants to
demonstrate that Zellner' s oils do not function in the same way as the oils
disclosed in the Specification. See In re Best, 562 F.2d 1252, 1255 (CCPA
1977) ("Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially identical
processes, the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product. ... Whether the rejection is based on 'inherency' under 35
U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is evidenced
by the PTO's inability to manufacture products or to obtain and compare
prior art products.").
Appellants cite to Zellner' s disclosure that its nasal spray is used for
"improving the 'cleaning' and moisturizing of the nasal mucous membrane"
7
Appeal2015-003896
Application 13/263,038
and argue that this shows that the nasal spray of Zellner is "not adapted to
induce a level of ansomia/hyposmia in the subject" App. Br. 8. While
Zellner' s nasal spray is said to be used to improve the cleaning and
moisturizing of the mucous membrane, this teaching does not preclude it
from also being "adapted to induce a level of ansomia/hyposmia." The
Specification makes clear that one of the ways a nasal treatment can be
adapted to induce ansomia/hyposmia is by using an oil. Specification ,-i 18
(identifying an oil-based treatment as a preferred embodiment). Indeed,
Appellants concede as much. App. Br. 7 (noting that the "present
application describes that the claimed agents may be adapted to induce the
ansomia/hyposmia in several different ways" including by using oil to
"diminish access by diffusion of odorants through the mucous layer to the
nasal sensors.").
Appellants argue that Zellner' s spray "teaches away" from the
claimed composition because it dissolves mucous. Id. But teaching away
has no application to anticipation. Celeritas Techs., Ltd. V. Rockwell Int 'l
Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998) ('\vhether a reference 'teaches
away' from the invention is inapplicable to an anticipation analysis.").
Appellants contend that Zellner' s nasal spray is an irrigant that dissolves
mucous from the nose and therefore would not induce anosmia/hyposmia in
the subject. App. Br. 8. However, at the same time, an oil is applied to the
nose by Zellner. Appellants did not provide an adequate fact-based
explanation as to why irrigation of the nose to remove mucous would result
in the oil being ineffective to induce anosmia/hyposmia. An argument made
by counsel in a brief does not substitute for evidence lacking in the record.
Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997).
8
Appeal2015-003896
Application 13/263,038
Absent evidence to the contrary, it is reasonable to assume that an oil-based
nasal spray would impede water soluble odorants even if the mucous layer
were dissolved. See In re Best, 562 F.2d 1252.
Accordingly, we affirm the Examiner's rejection of claims 1 and 19 as
anticipated by Zellner, claims 10, 15, and 16 were not separately argued and
fall with claim 1.
REJECTION OF CLAIMS 1, 2, 7, 10, 13, 17 AND 19 AS ANTICIPATED
BY OR, IN THE ALTERNATIVE, OBVIOUS OVER FRASER
The Examiner found that Fraser disclosed a "nasal drop formulation
comprising compounds that thicken the mucus membrane" and that, based
on the teachings of the Specification, these compounds would inherently
"result in a reduction of olfactory sensation, as the irritants would be unable
to reach the sensory receptors." Ans. 12; see also, id. at 6 ("the
compositions of FR_ASER would inherently meet the functional limitation of
'adapted to induce a level of ansomia/hyposamia ... because same
compositions must have same properties"). Appellants argue that Fraser
"merely discloses that the active agents for the pain composition can be
introduced intranasally." App. Br. 9. On the record before us, we find that
the Appellants have identified error in the Examiner's rejection.
Frasier is directed to a method for treating pain "using a28 subunit
calcium channel modulators or other compounds that interact with the a28
calcium channel subunit in combination with one or more compounds with
smooth muscle modulatory effects." Fraser Abstract. Frasier teaches that
the active ingredient can be delivered in multiple ways, including
"intranasally or by inhalation." FF5. Included within Frasier's disclosure
9
Appeal2015-003896
Application 13/263,038
regarding intranasal administration is the teaching that an intranasal carrier
may contain microcrystalline cellulose or sodium carboxymethylcellulose.
Id. (see emphasized text). The Examiner relies on this teaching, and the
teaching of the Specification that microcrystalline cellulose and sodium
carboxymethylcellulose operate to increase the viscosity and thickness of the
mucous layer, to support the finding that Fraser discloses a composition
adapted to induce a level of ansomia/hyposmia. Final Act. 5-6 (citing
Specification iJ 31 ).
In order for a reference to anticipate a claim, it must:
clearly and unequivocally disclose the claimed [product] or
direct those skilled in the art to the [product] without any need
for picking, choosing, and combining various disclosures not
directly related to each other by the teachings of the cited
reference. Such picking and choosing may be entirely proper in
the making of a 103, obviousness rejection, where the applicant
must be afforded an opportunity to rebut with objective
evidence any inference of obviousness which may arise from
the similarity of the subject matter which he claims to the prior
art, but it has no place in the making of a 102, anticipation
rejection.
In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972). Here, the Examiner
does not explain how or why microcrystalline cellulose and sodium
carboxymethylcellulose were selected from among the long list of potential
components of intranasal delivery vehicles provided in Fraser in such
amounts that they would achieve the stated purpose of the rejected claims.
See FF5 (listing potential components). Nor does the Examiner explain why
one would select intranasal administration over the multiple other means of
administration identified in Fraser. See, Frasier iii! 265-304 (discussing
compositions and dosage forms). On this record, the general teaching of
10
Appeal2015-003896
Application 13/263,038
Frasier that microcrystalline cellulose and sodium carboxymethylcellulose
may be included as excipients with the active pharmaceutical ingredient
when delivered intranasally does not "unequivocally disclose" the claimed
composition without the need for "picking and choosing."
Absent a specific disclosure of a nasal composition having the
claimed properties, we reverse the Examiner's finding that Fraser inherently
anticipates claims 1, 2, 7, 10, 13, 17, and 19. Similarly, because the record
does not include any explanation as to why it would have been obvious to
select microcrystalline cellulose and sodium carboxymethylcellulose in such
amounts that would achieve the stated purpose of the rejected claims, we
reverse the Examiner's finding that Fraser renders claims 1, 2, 7, 10, 13, 17
and 19 obvious.
REJECTION OF CLAIMS 1, 2, 5-7, 10, 13, 17, AND 19 AS OBVIOUS
OVER THE COMBINATION OF FRASER AND SEHSC
The Examiner's obviousness rejection of claims 1, 2, 5-7, 10, 13, 17,
and 19 over the combination of Fraser and SEHSC also relied upon the
finding that the disclosure of microcrystalline cellulose and sodium
carboxymethylcellulose in Fraser anticipates and/or renders obvious the
composition recited in the claims. Accordingly, we reverse the Examiner's
rejection of claims 1, 2, 5-7, 10, 13, 1 7, and 19 over the combination of
Fraser and SEHSC for the reasons discussed with respect to the Examiner's
rejection of claims 1, 2, 7, 10, 13, 17, and 19 over Fraser.
SUMMARY
For these reasons and those set forth in the Examiner's Answer and the
Examiner's final decision mailed April 2, 2014, we affirm the Examiner's
11
Appeal2015-003896
Application 13/263,038
rejection of claims 1, 10, 15-16 and 19 as anticipated by and/or obvious over
Zellner.
For the reasons set forth herein, we reverse the rejections based on
Fraser.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 ).
AFFIRMED-IN-PART
12