Edward Sinofsky et al.

Patent Trials and Appeals Board

Dec 31, 2019

11397123 - (D) (P.T.A.B. Dec. 31, 2019)

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.
11/397,123 04/03/2006 Edward Sinofsky 10124/05601 5713
30636 7590 12/31/2019
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
EXAMINER
EISEMAN, LYNSEY C
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
12/31/2019 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):
mmarcin@fkmiplaw.com
okaplun@fkmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte EDWARD SINOFSKY and
JON T. MCINTYRE
__________________

Appeal 2019-003111
Application 11/397,123
Technology Center 3700
____________________

Before JAMES P. CALVE, BRANDON J. WARNER, and
FREDERICK C. LANEY, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the decision
of the Examiner to reject claims 1–8 and 28. Appeal Br. 2. Claims 9–27 are
cancelled. Id. at 17 (Claims App.). We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies Boston Scientific Scimed, Inc. as the real party in interest. Appeal
Br. 2.
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CLAIMED SUBJECT MATTER
The claimed device detects changes in properties of a target tissue
mass that is treated with heat to shrink or necrose the tissue. Spec. ¶¶ 1, 3.
An illumination element provides light to a target area and a sensing element
receives light from the illumination element after the light is reflected from a
target portion of the tissue. Id. ¶ 3. Reflectance changes at one or more
wavelengths are monitored during treatment to determine when a desired
level of treatment is completed. Id. ¶ 8. Claim 1, the sole independent
claim, is reproduced below with disputed terms emphasized in italics.
1. A device, comprising:
a tissue ablation device;
a probe coupled to the tissue ablation device, the probe
configured to detect changes in tissue properties comprising:
an illumination element configured to deliver light
to an external surface of a target tissue, and
a sensing element configured to receive light from
the illumination element after reflection from the external
surface of the target tissue; and
a controller configured to detect changes in spectral
reflectance of the light received by the sensing element and
configured to determine a change in a depth of ablation below
the external surface of the target tissue, the controller
configured to control energy delivery from the tissue ablation
device to the target tissue based on the depth of ablation
dete1mined by the controller.

REJECTIONS
Claims 1–4, 7, 8, and 28 are rejected under 35 U.S.C. § 102(b) as
anticipated by Balbierz (US 2002/0026127 A1, pub. Feb. 28, 2002).
Claims 5 and 6 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Balbierz and Benaron (US 6,594,518 B1, iss. July 15, 2003).
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ANALYSIS
Claims 1–4, 7, 8, and 28
Rejected as Anticipated by Balbierz
Appellant argues that Balbierz does not disclose all of the claimed
illumination and sensing elements. See Appeal Br. 3–13. In particular,
Appellant . . . submits that Balbierz does not teach or suggest an
illumination element and a sensing element in the same probe,
with the illumination element ‘configured to deliver light to an
external surface of a target tissue,’ and the sensing element
‘configured to receive light from the illumination element after
reflection from the external surface of the target tissue,’ as
recited in claim 1.
Reply Br. 4–5, see id. at 7–8 (same); Appeal Br. 9–10.
Appellant argues that Balbierz fails to satisfy these claim limitations
in two ways. First, because Balbierz emits incident light 22ib from emitter
22me within the volume 5sv of a target tissue site 5’ and returning light
22rb is reflected back/returns from tumor mass 5” as a composite of
interactions of the light within volume 5sv of target tissue site 5’ to detector
22md, the illumination element is not configured to deliver light to an
external surface of a target tissue and the sensing element is not configured
to receive this light after reflection from the external surface of the target
tissue for spectral analysis as claimed. Reply Br. 6–8. Second, Balbierz
teaches at least two resilient members 18, one having emitter 22me and the
other having detector 22md, positioned at separate locations to create an
optical path through a sample of tissue rather than capturing any light that is
reflected from an external surface of the tissue as claimed or providing the
illumination and sensing elements as part of the same probe as claimed.
Appeal Br. 9–10; Reply Br. 8. We address each argument in turn.

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We first interpret “target tissue” in claim 1. The target tissue has an
external surface that reflects light delivered from an illumination element.
Appeal Br. 16 (Claims App.). Target tissue is treated by an ablation device
and includes connective tissues, tumors, and fibroids. Spec. ¶ 1. “The
treatment device delivers energy to the tissue mass targeted for treatment.”
Id. ¶ 6. Target tissue mass 16 may be located in an organ. Id. ¶ 10. A probe
with an illumination element “provid[es] light to a target area” and a sensing
element receives light from the illumination element “after reflection from a
target portion of tissue.” Id. ¶ 3. The probe 20 is “positioned adjacent to an
external surface of the target tissue mass 16.” Id. ¶ 10.
We thus interpret “target tissue” as tissue to which light is delivered
and reflected therefrom. We agree with the Examiner that Balbierz teaches
a target tissue as tumor mass 5” in Figures 2 and 5, as reproduced below.

Figure 2 above illustrates member 18’ with light emitting member 22me
emitting incident beam 22ib that reflects as returning beam 22rb from tumor
mass 5” to light detecting member 22md. Balbierz ¶¶ 48, 50; see Ans. 7.
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Figure 5 above illustrates a similar single resilient member 18 with
light emitter 22me delivering light as incident probe beam 22ib to exterior
surface of target tumor mass 5” and light detector 22md receiving light that
is reflected from the exterior surface as returning light 22rb. Balbierz ¶ 50.
Appellant’s Specification describes the claimed device being used to
detect changes in tissue properties of ablated target tissue such as cancerous
tumors. Spec. ¶¶ 12, 18. Appellant discloses that other tissue surrounding
a target tissue mass (e.g., a tumor) can be ablated and checked for spectral
reflectance monitoring with the illuminating and sensing element. Id. ¶ 12.
Therefore, the Specification discloses that a target tissue may be
contained within other tissue. Even if Balbierz illuminates healthy tissue
around a target tissue mass 16, Balbierz also detects changes in tumor mass
5” by illuminating an external surface of the target tissue (tumor mass 5”)
and sensing light reflected to a sensing element from the external surface of
tumor mass 5” as claimed. Balbierz ¶¶ 45, 48, 50, 59, 64, 65, 74, Figs. 2, 5.
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Although Balbierz may illuminate other tissue in sample volume 5sv
that surrounds tumor mass 5”, Balbierz delivers light to an external surface
of “a target tissue” (tumor mass 5”) and receives light after it is reflected
from the external surface of tumor mass 5” as claimed. Id. The fact that
Balbierz illuminates other tissue in sample volume 5sv in addition to
illuminating a target tissue (tumor mass 5”) is not precluded by claim 1.
Claim 1 recites “[a] device, comprising” and “a probe . . . comprising
an illumination element . . . and a sensing element.” Appeal Br. 16 (Claims
App.). The use of the open-ended transition “comprising” for the claimed
device and probe means that claim 1 reads on Balbierz so long as Balbierz
discloses all of the limitations as recited in the body of claim 1, even though
Balbierz may include additional features that perform other functions as
well. See In re Skvorecz, 5 F.3d 1262, 1267 (Fed. Cir. 2009) (holding that
the use of the transitional phrase “comprising” “means that the device may
contain elements in addition to those explicitly mentioned in the claim.”);
CIAS, Inc. v. All. Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (“In
the patent claim context[,] the term ‘comprising’ is well understood to mean
‘including but not limited to.’” (citation omitted)).
Balbierz’s illuminating element is configured to deliver light to an
external surface of “a target tissue” such as tumor mass 5” as illustrated in
Figures 2 and 5 above. Appellant does not dispute that Balbierz delivers
light to an exterior surface of tumor mass 5”. Rather, Appellant argues that
this exterior surface of tumor mass 5” does not correspond to the claimed
“exterior surface” of “a target tissue” because tumor mass 5” is included
within a larger tissue volume 5sv. Reply Br. 6–8.
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This argument is not persuasive because it is not commensurate with
the scope of claim 1, which broadly recites “a target tissue.” We agree with
the Examiner that tumor mass 5” of Balbierz is “a target tissue” as claimed.
Appellant’s Specification informs us that a target tissue broadly includes
tumor masses such as Balbierz’s tumor mass 5”. Claim 1 only requires a
device and probe with an illuminating element that can deliver light to an
exterior surface of a target tissue and a sensing element that can receive that
light as reflected from the external surface of the target tissue. Claim 1
does not recite a method of illuminating different types of tissues.
Balbierz’s light emitting member 22me and light detecting member
22md can be optic fibers. Balbierz ¶¶ 50, 51. Light emitting member 22me
can be coupled optically to a light emitting diode or diode laser 17 operable
at a range of wavelengths to include 300 to 850 nm. Id. ¶ 58; Ans. 8.
Appellant discloses similar illumination and sensing element optic
fibers. Spec. ¶ 15. Illumination element 23 produces laser light of 635 nm,
which is in the range of Balbierz’s light emitting member. Id. Appellant’s
arguments about the Figure 8 embodiment of Balbierz, which is not relied
on by the Examiner, does not explain why elements cited by the Examiner
are not configured as illumination and sensing elements, or why they don’t
deliver or receive light reflected from tumor mass 5”. Appeal Br. 8–13.
In addition to illustrating emitter 22me delivering light to an exterior
surface of tumor mass 5” and detector 22me receiving light reflected from
tumor mass 5” in Figures 2 and 5, Balbierz discloses that the probe detects
and records spectral information about a tissue spectra/profile from such
optically induced tissue reflectance of incident light 22i in sample volume
5sv which includes tumor mass 5”. See Balbierz ¶¶ 50, 59, 64, 65; Ans. 11.
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Appellant’s argument that Balbierz uses such reflectance to obtain a
spectral profile 19s that serves as a fingerprint of the tissue type to provide
a composite of light interactions within the entire sample volume 5sv is not
persuasive for several reasons. First, claim 1 does not preclude the claimed
device from delivering and receiving other light besides the light reflected
from the external surface of a target tissue as Balbierz does. Claim 1 only
requires the light reflected from an external surface of a target tissue to be
received so a controller can detect changes in the spectral reflectance of the
light received by the sensing element. Balbierz’s device performs this
function, as the Examiner correctly finds, as well as other functions.
Balbierz ¶¶ 45, 48, 50, 59, 64, 65, 74, Figs. 2, 5.
Balbierz discloses that the device detects optical tissue interaction of
metabolic chromophores 33 of cancerous tissue (not the surrounding tissue
in the sample volume 5sv) and analyzes the spectral profile 19s of the tissue
to predict the tissue type and/or tissue condition such as necrosis or thermal
injury from ablation and heat treatment. Id. ¶ 65. The tissue types can have
a signature profile 19s that is matched to a database of tissue profiles. Id.
Balbierz analyzes individual spectral profiles 19s for particular properties of
chromophores and tissue types. Id. ¶¶ 60, 65. Balbierz uses a controller to
determine the depth of ablation of a target tissue from spectral profiles and
reflected light as claimed. Id. ¶¶ 8, 45, 48, 53, 60, 64, 74–78.
Thus, Balbierz analyzes light reflected from an external surface of a
target tissue (tumor mass 5”) to determine a spectral profile used to identify
the tissue and assess the degree of necrosis and ablation of tumor mass 5”,
e.g., by comparing ablated tissue to unablated tissue using emitters 22me
and detectors 22md as claimed. Id. ¶¶ 8, 45, 48, 53, 60, 64, 65, 74–78.
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Based on the foregoing analysis, Appellant’s second argument that
Balbierz measures optical properties of tissue between an emitter and
detector rather than as light reflected from an external surface of a target
tissue as claimed also is not persuasive. The fact that Balbierz’s device can
sense tissue optical properties by transmitting light from an emitter on one
flexible element to a detector on another flexible element is not precluded
by claim 1, which plainly recites a probe “comprising” an illumination
element and a sensing element. As long as Balbierz’s device includes an
illumination and sensing element that are configured to perform the
functions recited in claim 1, as discussed above, the device may include
other elements that perform other functions, and the device will fall within
the scope of claim 1. In re Crish, 393 F.3d 1253, 17 (Fed. Cir. 2004); see
Reply Br. 8; Appeal Br. 9–10. The Examiner is not relying on Figures 8a–
8d of Balbierz to anticipate claim 1. See Ans. 7, 10–11.
Appellant’s conclusory argument that Balbierz does not receive and
analyze light reflected from an external surface of target tissue or have a
controller that detects changes in spectral reflectance of the light as claimed
(Appeal Br. 13) is not persuasive of error in the Examiner’s findings that
Balbierz discloses these features and a controller as claimed. Ans. 10–13;
see 37 C.F.R. § 41.37(c)(1)(iv) (“[A]rguments [in Appeal Brief] shall
explain why the examiner erred as to each ground of rejection contested by
appellant.”); In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (noting the
Board’s long-standing practice under its rules to require an applicant to
identify the alleged error in an examiner’s rejections and holding “even
assuming that the examiner had failed to make a prima facie case, the Board
would not have erred in framing the issue as one of ‘reversible error.’”).
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Moreover, to the extent Appellant argues patentability of the device
of claim 1 over Balbierz based on alleged differences in a target tissue that
is illuminated and detected by Balbierz’s device rather than on the features
and configuration of Balbierz’s device that performs the claimed functions
with a probe illuminating element and sensing element as claimed, any such
differences in the material worked upon is not material to the patentability
of claim 1 over Balbierz’s device when Balbierz discloses all limitations of
the device recited in claim 1 as discussed above. See In re Casey, 370 F.2d
576, 580 (CCPA 1967) (“It will be seen that the Lampert case pertains to
the impropriety of relying on a method concept to distinguish a structural
claim over the prior art and Rishoi and the others indicate that inclusion of
the material or article worked upon by a structure being claimed does not
impart patentability to the claims.”); see also In Re Rishoi, 197 F.2d 342,
345 (CCPA 1974) (“In our opinion there is no patentable combination
between a device and the material upon which it works.”).
Thus, we sustain the rejection of claim 1, and claims 2–4, 7, 8, and
28, which are not argued separately by Appellant. See Appeal Br. 3–13.
Claims 5 and 6
Rejected over Balbierz and Benaron
Appellant argues that the Examiner’s reliance on Benaron to teach
features recited in claims 5 and 6 does not cure the deficiency of Balbierz as
to claim 1, from which claims 5 and 6 depend. Appeal Br. 14–15.
Because we sustain the rejection of claim 1 as anticipated by Balbierz,
there are no deficiencies for Benaron to cure in this regard. Thus, we also
sustain the rejection of claims 5 and 6.

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CONCLUSION
Claims
Rejected
35 U.S.C. § Reference/Basis Affirmed Reversed
1–4, 7, 8, 28 102(b) Balbierz 1–4, 7, 8,
28

5, 6 103(a) Balbierz,
Benaron
5, 6
Overall
Outcome
1–8, 28
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED