Ex Parte Lanphere et al

Patent Trial and Appeal Board

Jun 1, 2018

13628892 (P.T.A.B. Jun. 1, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/628,892 09/27/2012
121974 7590 06/05/2018
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Janel L. Lanphere
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.
7310505002 6036
EXAMINER
EKRAMI, YASAMIN
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
06/05/2018 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JANEL L. LANPHERE, JOHN SPIRIDIGLIOZZI,
ORLA MCCULLAGH, and PAUL D. DICARL0 1
Appeal2017-006456
Application 13/628,8922
Technology Center 1600
Before TONI R. SCHEINER, DEMETRA J. MILLS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a method of forming a gel in a
subject. The Examiner rejected the claims as obvious under 35 U.S.C.
§ 103. Appellants appeal the rejections pursuant to 35 U.S.C. § 134(a). We
have jurisdiction under 35 U.S.C. § 6(b) and affirm the rejection.
STATEMENT OF THE CASE
Claims 29--35 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious in view of Lanphere '775 (US Pat. Appl. Publication 2005/0129775
Al, pub. June 16, 2005) and Campbell (US Pat. Appl. Publication
1 The Appeal Brief ("Appeal Br.") 3 lists Boston Scientific Scimed, Inc.as
the real-party-in-interest.
2 The application is referred to as "the '892 Specification."
Appeal2017-006456
Application 13/628,892
2011/0142936 Al, pub. June 16, 2011). Final Office Action ("Final Act.")
2.
Claim 29, the only independent appealed claim, is reproduced below:
29. A method, comprising: forming a gel in a tissue of a
subject; and exposing the gel to radiation to heat the tissue,
wherein the gel has an impedance of at most 60 ohms at an
applied power of two Watts.
CLAIMS
None of the rejected claims disclose the components of the claimed
gel that possesses the required property of "an impedance of at most 60
ohms at an applied power of two Watts." However, original claim 1 is
directed to a particle having "an impedance of at most 60 ohms at an applied
power of two Watts," the same functional limitation in claim 29. Original
dependent claim 6 was directed to the particle of claim 1, where "the particle
comprises alginate."
With respect to particles comprising alginate, the '892 Specification
discloses:
In certain embodiments, a particle can include one or more
gelled materials, and/or can be in a gel form. For example, a
particle may be formed of a gelling precursor (e.g., alginate)
that has been gelled by being contacted with a gelling agent
(e.g., calcium chloride).
'892 Spec. ,-r 82.
The '892 Specification also describes making gels without
ferromagnetic materials that comprise alginate and calcium chloride. Spec.
i-fi-1 182-184; Table 5 (Sample No. 44).
The Specification also describes gels made with alginate and
polyvinyl alcohol (PV A) which were gelled with calcium chloride. Spec.
i-fi-1131-135, 139 (Table 1).
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Application 13/628,892
Thus, based on the original claims and the supporting description in
the '892 Specification, we find that a gel with the properties recited in claim
29 can comprise alginate (original dependent claim 6), or alginate and PV A,
as gelling precursors and calcium chloride as a gelling agent. 3
REJECTION
The Examiner found that Lanphere '775 discloses a method of
disposing a gel in a tissue and exposing the gel to radiation to heat the tissue
as required by claim 29. Final Act. 3. The Examiner found that Lanphere
'775 discloses particles made of a gel and that such gel particles "read on"
the claimed gel having the recited impedance. Id. The Examiner
specifically pointed to claim 18 of Lanphere '77 5 which is list of polymers
that make up Lanphere '775's gel particles. Id. The list includes PVA,
which is one of the same polymers disclosed in the '892 Specification (see
above in '892 Spec. i-fi-f 131-135, 139 (Table 1 )), as suitable for the disclosed
and claimed gels. Because of the identity between the polymers described in
Lanphere '775 and those in the Specification, the Examiner had a reasonable
basis to conclude that Lanphere '775's gel particles possessed the claimed
impedance properties.
3 In making this determination, we note that we did not find disclosure in the
'892 Specification expressly teaching the composition of a gel having "an
impedance of at most 60 ohms at an applied power of two Watts."
However, the "Summary" states the invention is directed to particles having
this property. '892 Spec. i-fi-14, 5. For this reason, we have reasonably
presumed that all the gels described in the Specification meet the recited
limitation.
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Appeal2017-006456
Application 13/628,892
The Examiner found that Lanphere '775 "is silent about specifically
teaching forming the gel inside the body" as recited in claim 29. Final Act.
4. However, the Examiner found that Campbell describes a gel that "can be
formed in-situ that supports tissue around a lumpectomy site to stabilize the
tissue at the margins of the lumpectomy so the margins can be precisely
targeted by subsequent treatments." Id. The Examiner determined it would
have been obvious to form a gel inside a tissue because "Campbell teaches
an in situ formed hydrogel can seal tissue margins to reduce seroma
formation." Id.
Claim 29
Appellants contend, citing paragraph 138 of Lanphere '775, that the
reaction conditions described by Lanphere '775 for forming a gel include
high temperatures and highly acidic conditions which are "inappropriate for
in vivo gel formation." Appeal Br. 7. Appellants referred to US Pat App,
2004/0096662 Al, cited in Lanphere '775 for the reaction conditions. Id.
This argument is not persuasive.
The example in lJS Pat App, 2004/0096662 Al that Appellants refer
to in which high temperatures and acidic conditions are used is for PV A:
Reactor vessel 330 contains an agent that chemically reacts
with the base polymer to cause cross-linking between polyrner
chains and/or within a polymer chain. The agent diffuses into
the solid drops from the surface of the particle in a gradient
which, it is believed, provides more cross-linking near the
surface of the solid drop than in the body and center of the
drop. Reaction is greatest at the surface of a solid drop,
providing a stif±~ abrasion-resistant exterior. For polvvinvl
alcohol) for example, vessel 330 includes one or more
aldehydes, such as formaldehyde) glyoxal, benzaldehyde,
aterephthalaldehyde, succinaldehyde and glutaraldehyde for the
acetalization of polyvinyl alcohol. Vessel 330 also includes an
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Appeal2017-006456
Application 13/628,892
acid, for example, strong acids such as sulfuric acid,
hydrochloric add, nitric add and weak acids such as acetic
acid, formic acid and phosphoric acid. In embodiments, the
reaction is primarily a L3-aceta1ization.
l.JS Pat App. 2004/0096662 Al ii 85 (underlining added),
However, Lanphere also discloses alginate and PVA/alginate gels
(Lanphere ~775 ~if 39, 136, 138), which are the same gel materials disclosed
in the Specification (Spec.~!-~! 182-----184, 131----135, 139} Paragraph 138 of
Lanphere '77 5, cited by Appellants in the A.ppeal Brief (p. 7) and Reply
Brief (p. 7), specifically discloses a method of making an alginate gel using
calcium chloride. There is no mention in this method of the high
temperatures and acidic conditions that Appellants argued make Lanphere
'775 untenable for "forming a gel in a tissue of a subject" as required by
claim 29. Appeal Br. 7. Consequently, Appellants have not provided
persuasive evidence that Lanphere '775's gels could not be formed in vivo as
claimed.
Appellants also contend that "neither Lanphere ['775] nor Campbell
describes a gel that has an impedance of at most 60 ohms at an applied
power of two Watts." Appeal Br. 7.
As already discussed, Lanphere '775 discloses the same materials for
a gel as those disclosed in the '892 Specification, namely, alginate and
PV A/alginate. The Examiner referred to these material in setting forth the
rejection (Final Act. 5, 6).
As held in In re Best, 562 F.2d 1252, 1255 (CCPA 1977)
(citations and footnote omitted):
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
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Application 13/628,892
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.
Once "the PTO shows sound basis for believing that the products of
the applicant and the prior art are the same, the applicant has the burden of
showing that they are not." In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
In this case, the identity between the materials used to make the
particles in Lanphere '775 and in the '892 Specification provided a
reasonable basis to believe that the particles in Lanphere '775 would also
possess the claimed impedance values. Appellants have not provided
persuasive evidence to the contrary. We note that Campbell also teaches
alginate in its gels (i-f 30).
Claim 31
Claim 31 depends from claim 29, and further recites "wherein the gel
does not comprise a ferromagnetic material." Appellants state that Lanphere
'775 "is directed to ferromagnetic particles and methods (see Title and
Abstract), which obviously contain a ferromagnetic material." Appeal Br. 9.
Appellants argue "that one of ordinary skill in the art would not, upon
reading Lanphere ['775], have excluded ferromagnetic materials from a
composition formed in accordance with the teachings of Lanphere ['775]"
because
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Application 13/628,892
Lanphere ['775] postulates that "the presence of the
ferromagnetic material(s) in the particles may enhance the
burning of the tissue (which results in damage or destruction of
the tissue) during heating" (see paragraph [O 150]). Such an
effect could obviously not be achieved without a ferromagnetic
material
Appeal Br. 9-10.
This argument does not persuade us that the Examiner erred.
Lanphere '775 does not state that ferromagnetic material is required to
heat the tissue as claimed, but rather states that it "may enhance the burning
of the tissue ... during heating." Lanphere '775 150 (emphasis added).
Thus, while Lanphere '775 teaches its presence in their particles,
ferromagnetic material does not appear to be a necessary component.
In addition to this, the claim does not expressly require that the gel per
se heats the tissue. The '892 Specification states that the particles "can be
used to control the transmission of RF radiation through tissue, and/or to
help transmit RF radiation to a specific location in a target site." '892 Spec.
i-f 27. The Specification also states that "particles having a relatively low
impedance can enhance a tissue heating and/or ablation procedure by
transmitting RF radiation from an RF electrode through the tissue." Id. at
i-f 55. Campbell also teaches that the "the hydrogel tended to increase
normal tissue radiation doses." Campbell at i-f 144. Thus, the evidence does
not support Appellants' contention that the ferromagnetic material is
necessary to achieve the claimed result of heating the tissue.
While Lanphere' 77 5 is largely directed to gels with ferromagnetic
material, paragraph 138, identified by Appellants in their briefs, describes
particles lacking this material. Thus, there is explicit disclosure in
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Application 13/628,892
Lanphere' 77 5 of a particle lacking ferromagnetic material as required by
claim 31.
Claim 34
Claim 34 has all the limitations of claims 29 and 33, with the
additional limitation that disposing the one or more liquid components in the
tissue of a subject to form a gel includes mixing the one or more liquid
components.
While Appellants attempt to distinguish the claimed subject matter
based on the Examiner's oblique reference to Lanphere '775's formed gels,
we note that Campbell was also cited by the Examiner for its teaching of
forming a gel in a subject. Final Act. 4. If "flowable precursors" are used to
make the hydro gel as described in paragraph 5 of Campbell cited by the
Examiner, "mixing" would be a conventional step to facilitate interspersing
of the precursor components. It does not seem to us that a conventional step
of "mixing" liquid components is adequate to establish patentability of an
otherwise obvious claim.
Summary
For the foregoing reasons, we affirm the rejection of claims 29, 31,
and 34 as obvious in view of Lanphere '775 and Campbell. Claims 30, 32,
33, and 35 fall with these claims because separate arguments for their
patentability were not provided. 37 C.F.R. § 37.41(c)(l)(iv),
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Application 13/628,892
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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