Ex Parte Eckhouse et al

Patent Trial and Appeal Board

Feb 12, 2019

14717061 (P.T.A.B. Feb. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/717,061 05/20/2015
67801 7590 02/14/2019
MARTIN D. MOYNIHAN d/b/a PRTSI, INC.
P.O. BOX 16446
ARLINGTON, VA 22215
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Shimon Eckhouse
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.
62727 2384
EXAMINER
CHICKOS, SARAH J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
02/14/2019 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):
usptomail@ipatent.co.il
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHIMON ECKHOUSE, TAMAR LOTAN, and ARI A YALON
Appeal2018-003743
Application 14/717 ,061
Technology Center 1600
Before FRANCISCO C. PRATS, ROBERT A. POLLOCK, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal the Examiner's final rejection of claims 1 and 3-5
under 35 U.S.C. § 134(a). The appealed claims are directed to methods of
treating motion sickness via the topical application of scopolamine and
stinging cells or stinging capsules. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 According to Appellants, the real party-in-interest is "NanoCyte (Israel)
Ltd., also known as Starlet Derma Ltd., also known as Monterey Bay Labs
Ltd.". App. Br. 2.
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Application 14/717 ,061
STATEMENT OF THE CASE
According to the Specification, "members of the phylum Cnidaria
possess a sophisticated injection system folded within cnidocysts. Upon
cnidocyst activation high internal pressure develops which triggers the
ultrafast discharge of a long thin tubule that penetrates the prey and injects
the cnidocyst content." Spec. 6:6-9.
As used herein the phrase "stinging capsules" refers to
the capsules ( cnidocysts ), which are contained in stinging cells.
The phrase "stinging cells" refers to the specialized cells ( e.g.
cnidocytes or nematocytes) present in, for example, all
members of the phylum Cnidaria, Myxozoa, and
Dinoflagellata. The stinging capsules house the delivery
tubule. The stinging capsules act as microscopic syringes and
serve as a prey or defense mechanism. The stinging capsule is
a hardened dense capsule filled with liquid, containing a highly
folded inverted tubule which sometimes features specialized
structures such as shafts, barbs, spines, and/or stylets.
Id. at 9:4--10:5.
"The present inventors have now shown, the feasibility of using a
topically applied gel containing isolated cnidocysts for immediate systemic
delivery of hydrophilic drugs such as the muscarinic antagonist, tropane
alkaloid, scopolamine and atropine." Id. at 6:10-15. "The stinging capsule
according to the teachings of the present invention can be an isolated
stinging capsule or alternatively it can form a part of a stinging cell." Id. at
10:6-7.2 In one embodiment, "the stinging cell/capsule is derived from a sea
anemone," such asNematostella vectensis. Id. at 10:16-18.
2 Although the Specification makes clear that stinging capsules are
components of stinging cells, these terms are functionally interchangeable
for the purpose of our analysis.
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Application 14/717 ,061
Claim 1, the sole independent claim before us, recites:
1. A method of treating motion sickness in a subject in need
thereof, the method comprising applying to a skin surface of the
subject scopolamine and stinging cells or stinging capsules, said
stinging cells or capsules being, upon discharge, capable of
delivering said scopolamine into the subject in a systemic
manner, so as to treat said motion sickness in the subject and
wherein said scopolamine and stinging cells or stinging
capsules are in different formulations.
The Examiner rejects claims 1, 4, and 5 under pre-AIA
35 U.S.C § I03(a) as unpatentable over Crooks (US 2006/0193784 Al,
published Aug. 31, 2006), Lotan (US 7,338,665 B2, issued Mar. 4, 2008),
Apuya (US 2007/0199090 Al, published Aug. 23, 2007), and Eckhouse3
(US 2007/0160546 Al, published July 12, 2007). Fin. Act. 4.
The Examiner rejects claim 3 under pre-AIA 35 U.S.C § I03(a) as
unpatentable over Crooks, Lotan, Apuya, and Eckhouse as applied to claims
1, 4, and 5, and further in view of Lotan '272 (US 2006/0099272 Al,
published May 11, 2006). Id. at 8.
In this Appeal, Appellants focus on claim 1 and do not argue the
dependent claims separately. See Appeal Br. 11; Reply 1. Accordingly, we
focus on the independent claim and the rejection over Crooks, Lotan, Apuya,
and Eckhouse.
FINDINGS OF FACT
FF 1. Crooks teaches that scopolamine, in the form of oral tablets and
topical skin patches, is commonly used for the prevention of motion
3 Although this reference names Tamar Lotan and Shimon Eckhouse as co-
inventors, we follow the Examiner's convention in referring to it as
"Eckhouse."
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Application 14/717 ,061
sickness. Crooks ,r,r 3 5, 3 6. Crooks states that "[ w ]hile oral or
transdermal systems may be readily provided to deliver scopolamine to a
person experiencing or seeking to prevent nausea and other symptoms,
there is a delay of onset of action before the effective entry of the
scopolamine into the patient circulation," "plasma concentrations of the
drug indicate major interindividual variations," and "these options often
have poor bioavailability and unpleasant side effects." Id. ,r,r 4, 37-38.
Seeking to address these problems, Crooks discloses a method for
treating motion sickness by administering scopolamine as a sublingual
spray. See id. ,r,r 3 8--40, 51, 59, Abstract.
FF2. Lotan teaches that"[ o ]rally administered drugs must be resistant to
the low pH conditions and digestive enzymes present in the
gastrointestinal (GI) tract." Lotan, 1 :33-35. And although "[i]n
transdermal delivery, the active ingredient penetrates the skin and enters
the capillary blood or the lymph circulation system, which carries the
drug to the target organ or to the tissue or has a local effect" (id. at 2: 16-
19), "[b ]iological, biochemical and/or physical barriers often limit
delivery of therapeutic agents to target tissue. For example, skin and/or
various organ membranes are physical barriers, which must be traversed
by a topically administered drug targeted at internal tissues." Id. at 1 :28-
33. Thus,
[a]lthough transdermal delivery offers an alternative to
some invasive delivery methods, the efficiency thereof is
affected by the physical and chemical properties of a drug and
physiological or pathological parameters such as the skin
hydration, temperature, location, injury, and the body
metabolism.
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Application 14/717 ,061
To overcome the limitations of invasive and non-invasive
delivery devices, the present inventors propose the use of
"stinging cells" ( e.g. cnidocytes, nematocytes and the like) or
"stinging capsules" (e.g., cnidocysts, nematocysts and polar
capsules) isolated therefrom for tissue delivery of a therapeutic
or cosmetic agents.
Id. at 2:27-38.
FF3. In particular, Lotan discloses the use of stinging cells or capsules as a
transdermal drug delivery device, wherein the drug or other compound
may be "disposed in a liquid surrounding, or stored within, the ...
stinging capsule." See, e.g., Lotan at 1:18-24; 3:18-5:18; 6:11-21.
According to Lotan, "[b ]y utilizing isolated stinging cells or capsules for
delivery of an agent of choice, the present invention enables easy,
efficient and painless delivery of a therapeutic or a cosmetic agents into,
for example, mammalian tissues such as for example dermal tissues." Id.
at 6:44--48. Lotan further teaches that use of stinging cells or capsules
"enables efficient delivery of the compounds," prevents gastrointestinal
complications, and "provides other benefits such as less frequent dosing;
better controlled drug release, and a greater ability to target delivery to
specific tissue sites." Id. at 2:57----67, 13:36-42. As stated by Lotan, "the
present invention ... efficiently deliver[ s] agents into a tissue while
being devoid of the limitations inherent in prior art invasive or non-
invasive delivery devices and compositions." Id. at 3:9-14; see id. at
5:12-18.
FF4. Lotan teaches that, in some embodiments, delivery via the disclosed
stinging cell or stinging capsule systems can be used to deliver topical
anesthetic drugs such as cocaine. Id. at 13:43-51; see also 15:36-16:23
( targeted delivery of psoralen, sildenafil citrate, and diphenhydramine
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hydrochloride). However, the systems "can also be utilized to deliver
drugs into blood circulation .... In such cases, the present invention can
be utilized to deliver drugs such as hormones ( e.g., insulin), antibiotics,
cardiac drugs and the like." Id. at 14:6-12.
FF5. Apuya teaches that "[a]lkaloid compounds can be grouped into classes
based on chemical and structural features." Apuya ,r 151. Cocaine and
scopolamine are included in the tropane alkaloid class. Id. ,r,r 151, 155.
FF6. Eckhouse discloses that it is known to use stinging cells to administer
active agents into living skin but "for local treatment it is preferred not to
treat the skin as the active agents may enter the systemic circulation."
Eckhouse ,r 17. Accordingly, Eckhouse teaches methods of use of
stinging cells or capsules for delivering beneficial agents to non-skin
keratinous substances such as hair and nails. See e.g., id. at Abstract,
,r,r 18-20, 50. Such beneficial agents include antifungals, antibacterials,
antivirals, insecticides, hair and nail cosmetic agents, sunscreens, dyes,
fragrances, peptides, and hormones. Id. ,r,r 34--36, 68-72. One such
embodiment
compris[ es] applying a composition including, at least one
active agent onto an outer surface of a non-skin keratinous
substance, applying at least one stinging capsule to the outer
surface of the non-skin keratinous substance and triggering a
discharge of the at least one stinging capsule to thereby deliver
the active agent into the keratinous substance.
Id. ,r 20; see ,r 84, claim 10.
ANALYSIS
The Examiner finds that,
it would have been obvious for one of ordinary skill in the art
following the method of Crooks to use stinging cells or stinging
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capsules taught by Lotan to deliver scopolamine to treat motion
sickness in order to increase the effectiveness or bioavailability
of the active ingredient when the stinging capsule device is
used to deliver the active ingredient based on Lotan's teaching
that cocaine is a suitable active ingredient to deliver via stinging
cells or capsules and Apuya's teaching that cocaine and
scopolamine are structurally and functionally similar.
Ans. 5-8; see Fin. Act. 4--8.
Appellants respond that (1) Lotan is directed to targeted delivery of
locally acting drugs and does not teach the use of stinging cells to increase
the bioavailability of systemically-active drugs (App. Br. 6; Reply Br. 1-3);
(2) the Examiner has not established a reason to combine Crooks and Lotan
with Apuya because Apuya does not teach any functional similarity between
cocaine and scopolamine (Fin. Act. 7-9; Ans. 3--4); and (3) Eckhouse
teaches away from the claimed invention because it does not teach systemic
administration of an active agent but is exclusively directed to the local
delivery of compounds to non-skin keratinous targets (Fin. Act. 9-10; Ans.
4--5). We address Appellants' arguments below.
We disagree with Appellants' interpretation of Lotan as failing to
teach the use of stinging cells to increase the bioavailability of systemically
active drugs. First, Lotan discloses the use of stinging cells or capsules as a
transdermal drug delivery device. FF3. Although in some embodiments
Lotan discloses that the stinging cells or capsules may be used to deliver
topical anesthetic drugs such as cocaine, Lotan expressly states that they
may also be used to deliver a wide variety of drugs into systemic circulation.
FF4. Second, Lotan discloses that problems with oral and topical delivery
are overcome by the use of stinging cells or capsules. FF2-3. As we
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understand the teachings of Lotan, such benefits include the efficient
delivery of drugs into systemic circulation. See FF3.
With respect to reason to combine, Crooks discloses that oral tablets
and topical patches for the delivery of scopolamine are known to have
problems, including with bioavailability. FF 1. And, as just discussed, Lotan
discloses that problems with oral and topical delivery are overcome by the
use of stinging cells or capsules, including providing the benefit of efficient
delivery of drugs into systemic circulation. See FF3. Accordingly, we find
no error in the Examiner's determination that one of ordinary skill in the art
would understand Lotan to teach the use of stinging cells or capsules to
increase the effectiveness or bioavailability of the active ingredient. See
Ans. 5. Moreover, irrespective of whether Lotan expressly teaches an
increase in bioavailability, the reference's disclosure that "the present
invention ... efficiently deliver[ s] agents into a tissue while being devoid of
the limitations inherent to prior art invasive or non-invasive delivery devices
and compositions," provides substantial support for the combination set
forth by the Examiner. See Lotan, 3:9--14, 5:12-18; FF2-3.
And although Appellants argue that Apuya does not teach any
functional similarity between cocaine and scopolamine, we find that issue to
be beside the point: there is no dispute as to whether the two drugs behave
differently in the body. Rather, the pertinent issue is whether one of
ordinary skill in the art would understand that scopolamine is amenable to
administration using the stinging cell system disclosed in Lotan. In this
respect, Appellants advance no reason why one of ordinary skill in the art
would believe that scopolamine-taught by Crooks as appropriate for
systemic transdermal delivery via topical skin patches (FF 1 }-would be
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incompatible with Lotan's transdermal stinging cell or stinging capsule
system. To the contrary, Lotan teaches that the stinging cell system may be
used for the systemic delivery of a diverse variety of drugs including
"hormones (e.g., insulin), antibiotics, cardiac drugs and the like." See FF4.
Moreover, as recognized by the Examiner, one of ordinary skill in the art
would also understand from Apuya that as members of the tropane class of
alkaloids, cocaine and scopolamine share chemical and structural features
and, thus, both would reasonably be expected to be deliverable in the Lotan
stinging cell system. See FF 1; Fin. Act. 5---6. Further supporting the idea
that one of ordinary skill in the art would expect that scopolamine could be
delivered using Lotan's system, we further note that Eckhouse, like Lotan,
teaches that a wide variety of compounds may be delivered via stinging
cells. See FF6.
Third, we do not agree with Appellants' argument that Eckhouse
teaches away from the claimed invention because it is exclusively directed to
the local delivery of compounds to non-skin keratinous targets and does not
teach systemic administration of an active agent. As an initial matter,
Appellants' argument is unpersuasive because the Examiner does not rely on
Eckhouse for systemic delivery or delivery to the skin, but merely its
teaching that stinging cells or capsules can be applied separately from the
active agent as required by claim 1. See Fin. Act. 7-8; Ans. 7-8 ("Eckhouse
is being cited for its teaching that the active agent and stinging cells or
capsules are in different formulations.").
Appellants also misconstrue the nature of teaching away, which
requires a reference to actually criticize, discredit, or otherwise discourage
the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
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Application 14/717 ,061
2004 ). Even if Appellants were correct that Eckhouse teaches nothing more
than the local delivery of compounds to non-skin keratinous targets, which it
does not, such a disclosure does not constitute a teaching away "because
such disclosure does not criticize, discredit, or otherwise discourage the
solution claimed." Id. It simply provides an alternative use of stinging cells
for drug delivery to the skin.
Appellants, moreover, are not correct regarding the scope of
Eckhouse' s teachings. Although Eckhouse is generally directed to the use of
stinging cells or capsules for delivering compounds to non-skin keratinous
targets, it expressly acknowledges that it is known to use stinging cells to
administer active agents into the skin, and that such agents may enter
systemic circulation. FF6. Thus, rather than teaching away from the
claimed invention, Eckhouse supports the Examiner's rejection.
In sum, we find no error in the Examiner's conclusion that one of
ordinary skill in the art would have been motivated to transdermally
administer scopolamine using the stinging cell or stinging capsule systems
of Lotan and Eckhouse for the treatment of motion sickness as taught by
Crooks, where Lotan teaches the benefits of using stinging cells or stinging
capsules for the systemic administration of a wide variety of drugs including
cocaine, and Apuya teaches that cocaine and scopolamine share chemical
and structural features.
SUMMARY
For the reasons above, we affirm the Examiner's decision rejecting
claim 1. Appellants do not argue claims 3-5 separately and they fall with
claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
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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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