Ex Parte Dvoretzky et al

Board of Patent Appeals and Interferences

Aug 27, 2012

11087492 (B.P.A.I. Aug. 27, 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.
11/087,492 03/22/2005 Israel Dvoretzky 791-001.002
(302-390-7-6)
7904
4955 7590 08/27/2012
WARE FRESSOLA VAN DER SLUYS & ADOLPHSON, LLP
BRADFORD GREEN, BUILDING 5
755 MAIN STREET, P O BOX 224
MONROE, CT 06468
EXAMINER
SMITH, KAITLYN ELIZABETH
ART UNIT PAPER NUMBER
3739
MAIL DATE DELIVERY MODE
08/27/2012 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 ISRAEL DVORETZKY and JOHN E. KULEZA
__________

Appeal 2011-005538
Application 11/087,492
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for lack of written description and obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
Appeal 2011-005538
Application 11/087,492

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STATEMENT OF CASE
24. A method for effectively and efficiently treating subcutaneous
maladies in a human body comprising the steps of:
A. providing at least one systemic medication comprising one selected
from the group consisting of corticosteroids, chemotherapeutic agents,
anesthetics, antihistamines, anti-infectives, anti-bacterials, anti-parasitics,
anti-viral agents, anti-oxidants, immunomodulators, and anti-neoplastics;
B. rubbing the selected medication onto the skin surface of an
individual having a subcutaneous malady to be treated, said medication
being applied to the skin surface in an area having close proximity to the
known site of the subcutaneous malady, with said medication being devoid
of any permeation enhancing agent;
C. placing a heat delivery patch or exothermic pad on the skin surface
in overlying relationship with the applied medication for enabling the
application of heat directly to the medication, said heat delivery
patch/exothermic pad being constructed to provide a heat source for
elevating the skin temperature to between about 39° C and 44° C for a
period of time ranging between about one and ten hours in response to the
exposure thereof with oxygen;
D. obtaining a holding and supporting member comprising an
elongated, substantially continuous, enlarged sheet of material formed from
foamed thermoplastic elastomeric material which comprises a combination
of open cells and closed cells constructed to provide controlled transmission
of oxygen therethrough while also providing heat insulating; and
E. positioning the holding and supporting member in overlying,
aligned, securing and retaining relationship with the heat delivery
patch/exothermic pad and the applied medication, with said holding and
supporting member peripherally surrounding the portion of the body where
the subcutaneous malady exists, for causing the controlled transmission of
oxygen through the holding and supporting member while also insulating the
skin surface from heat loss through the holding and supporting member to
effectively enable the heat delivery patch/exothermic pad to generate the
heat source for elevating the skin temperature to between about 39° C and
44° C and maintain said elevated temperature for a period of time ranging
between about one and ten hours, thereby enabling the effective and efficient
delivery of the medication to the subcutaneous malady by providing a
continuous source of heat for achieving enhanced subcutaneous delivery of
the medication.
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Application 11/087,492

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25. The method defined in Claim 24, wherein said holding and
supporting member is further defined as being formed in a hollow,
continuous, generally cylindrical shape, and said method if further defined
as comprising the step of:
F. telescopically advancing the cylindrically shaped holding and
supporting member onto a desired portion of the human body for
peripherally surrounding the body portion and effectively securely holding
and retaining the heat delivery patch/exothermic pad in aligned relationship
with the applied medication for providing the desired heat retention and
oxygen transmission.

Cited References

Last US 4,905,998 Mar. 6, 1990
Argaud US 4,963,360 Oct. 16, 1990
Dvoretzky et al. US 5,534,021 Jul. 9, 1996
Quan et al. US 5,601,839 Feb. 11, 1997

Grounds of Rejection
Claims 2, 4-10, 14-17, 19, and 23-26 are rejected under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement.
Claim 25 is rejected under 35 U.S.C. § 112, second paragraph, as
being indefinite for failing to particularly point out and distinctly claim the
subject matter which applicant regards as the invention.
Claims 2, 4-10, 16, 17, 19, 23, 24, 26, and 27 are rejected under 35
U.S.C. § 103(a) as being unpatentable over Dvoretzky et al. in view of Quan
et al. and Argaud Claims 14, 15 and 25 are rejected under 35 U.S.C. §
103(a) as being unpatentable over Dvoretzky et al. in view of Quan et al. and
Argaud as applied to claim 24 above, and further in view of.

Appeal 2011-005538
Application 11/087,492

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FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 4-
10.

Discussion Rejection 1
Claims 2, 4-10, 14-17, 19 and 23-26 are rejected under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement. This is a new ground of rejection made in the Answer, page 3.

ISSUE
The Examiner concludes that
Claims 24 and 27 recite "rubbing" a medication into the skin
which is not described in the specification. The application has
support for "applying" the medication to the skin surface which
can be achieved, for example, by applying a medicated pad or
patch to the skin. However, there is no disclosure for the much
more specific "rubbing" of a medication into the skin surface.

(Ans. 4.)

Appellants do not respond to this rejection with a Reply Brief. The
written description rejection is summarily affirmed.

Discussion Rejection 2
Claim 25 is rejected under 35 U .S.C. § 112, second paragraph, as
being indefinite for failing to particularly point out and distinctly claim the
subject matter which applicant regards as the invention.

Appeal 2011-005538
Application 11/087,492

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ISSUE

The Examiner argues that
Claim 25 recites "telescopically advancing" the holding and
supporting member. The examiner is unclear as to what
applicant is trying to claim. Telescopically is defined as
extensible or compressible by or as if by the sliding of
overlapping sections. Therefore, the examiner does not
understand how the holding and supporting member is
telescopically advanced. The examiner has for the purpose of
applying prior art interpreted "telescopically advancing" as
meaning securing the holding and supporting member.

(Ans. 5.)

Appellants argue that
the term “telescopically advancing” is clear in view of the
specification and figures. For example, Figures 1, 2, 3 and 4
show a substantially cylindrical holding and supporting member
(21). It is understood that a substantially cylindrical member
can be telescopically positioned around a substantially
cylindrical surface by sliding the member around the surface.
Accordingly, this is what is meant by “telescopically
advancing” in claim 25, and the details shown in Figures 1-4
clarify this limitation of claim 25.

(App. Br. 6.)

The issue is: Is the term “telescopically advancing” in claim 25
indefinite?

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Application 11/087,492

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ANALYSIS
According to the Examiner,
Telescopically is defined as extensible or compressible by or as
if by the sliding of overlapping sections. Telescopically
advancing would not be understood to be sliding the member
around the surface as this is not the plain meaning of the word
telescopic. As applicant has not provided a special definition of
telescopic in the specification and applicant's use of the word
mean something entirely difference than the plain meaning of
the word.

(Ans. 10-11.)
We are persuaded by the Examiner’s argument. We carefully
reviewed Figures 1-4 and accompanying text in the Specification. However,
we find Appellants have provided not special definition in the Specification
of the phrase “telescopically advancing.” “Without evidence in the patent
specification of an express intent to impart a novel meaning to a claim term,
the term takes on its ordinary meaning.” Optical Disc Corp. v. Del Mar
Avionics, 208 F.3d 1324, 1334 (Fed. Cir. 2000). Our mandate is to give
claims their broadest reasonable interpretation. In re American Academy Of
Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004). “An essential
purpose of patent examination is to fashion claims that are precise, clear,
correct, and unambiguous. Only in this way can uncertainties of claim scope
be removed, as much as possible, during the administrative process.” In re
Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
We agree with the Examiner that the term “telescopically advancing”
would not be understood by one of ordinary skill in the art to be sliding the
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Application 11/087,492

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member around the surface as this is not the plain meaning of the word
“telescopic.”
We affirm the claim indefiniteness rejection for the reasons of record.

Discussion Rejections 3 and 4

Claims 2, 4-10, 16, 17, 19, 23, 24, 26, 27 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Dvoretzky et al. in view of Quan et al.
and Argaud.
Claims 14, 15 and 25 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dvoretzky et al. in view of Quan et al. and Argaud as
applied to claim 24 above, and further in view of Last.
ISSUE
The Examiner argues that Dvoretzky teaches each element claimed
exceptthat “Dvoretzky et al. does not disclose that the medication is a
specifically selected systemic medication (claims 24 and 27), that the
medications exhibit improved or enhanced penetration from the application
of a heat gradient thereto and devoid of any permeation enhancing agent
(claims 24 and 27).” (Ans. 7.) The Examiner relies on Quan to make up for
this deficiency of Dvoretzky, and relies on Argaud for the disclosure of an
exothermic pad. (Id. at 8.) The Examiner concludes that
It would have been obvious to one skilled in the art to add one
or more of the transdermally deliverable medications disclosed
by Quan et al. to the medicated heat pad disclosed by
Dvoretzky et al. in order to take advantage of the improved
absorption through the skin caused by heat as disclosed by
Argaud.

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Application 11/087,492

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(Id.)

Appellants contend that

Dvoretzky provides no disclosure or suggestion of applying a
medication, or rubbing a medication (which is actually the
language of claim 24), onto the skin surface of an individual
having a subcutaneous malady. Dvoretzky provides no
motivation of rubbing a medication into the skin, since
Dvoretzky only discusses keratolytic agents, which as discussed
above are only for the thinning of skin and are not medications.

(App. Br. 7.)

Appellants further argue that Quad and Argaud fail to make up for this
deficiency of Dvoretzky. (Id. at 8-9.)
The issue is: Does the cited prior art teach rubbing a medication on
the surface of the skin, as claimed?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (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 relevant art; and (4) objective
evidence of nonobviousness, if present.
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Application 11/087,492

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“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellants’ arguments as set forth in the Answer. We find
the Examiner has set forth a prima facie case of obviousness in the Answer.
We provide the following additional comment.
In response to Appellants’ argument that none of the cited art
describes rubbing a medicament onto the skin, the Examiner argues that
“Dvoretzky teaches that various keratolytic agents can be incorporated with
and/or into the exothermic pad (Col. 5, lines 5-6).” (Ans. 11.) The
Examiner further contends that
There is no implied sequence to the claimed method and no
disclosure of the importance of sequentially performing the
method. Therefore, Dvoretzky reads on the recitation of
"rubbing." The examiner takes this position as rubbing is
defined by Merriam-Webster as to move along a surface of a
body with pressure or to cause to move with pressure and
friction along a surface. Therefore, the device of Dvoretzky will
inherently provide for rubbing as this will occur at the time of
application as well as during use as the device of Dvoretzky
will move relative to the skin thus causing friction between the
pad and the skin.

(Id. at 12.)

Appellants have failed to explain, with appropriate evidence, why the
device of Dvoretzky would not inherently provide for rubbing at the time of
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application of the device as well as during use as the device of Dvoretzky as
the device will move relative to the skin and medicament, thus causing
friction between the pad and the skin.
For this reason, the obviousness rejections are affirmed for the reasons
of record.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections.
The written description and indefiniteness rejections are also affirmed.
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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