Ex Parte Jaffer

Patent Trial and Appeal Board

Jun 10, 2016

12249715 (P.T.A.B. Jun. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/249,715 10/10/2008
26710 7590 06/14/2016
QUARLES & BRADYLLP
Attn: IP Docket
411 E. WISCONSIN A VENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
FIRST NAMED INVENTOR
Farouc A. Jaffer
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.
190267.US.-32865-215617 2295
EXAMINER
DONOHUE, SEAN R
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
06/14/2016 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte FAROUC A. JAFFER1
Appeal2014-002090
Application 12/249, 715
Technology Center 1600
Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and JOHN G.
NEW, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
imaging method and apparatus. The Examiner has rejected the claims for
obviousness and indefiniteness. We have jurisdiction under 35 U.S.C.
§ 6(b ). We affirm at least one rejection of each claim.
STATEMENT OF THE CASE
Claims 1-28 are pending and on appeal (App. Br. 2-3). Claim 18 is
representative and reads as follows:
1 Appellant identifies the real party in interest as The General Hospital
Corporation, Boston, Massachusetts (App. Br. 2).
Appeal2014-002090
Application 12/249, 715
An apparatus for obtaining information regarding at least one portion
of a biological structure, comprising:
at least one first hardware arrangement configured to generate a first
electro-magnetic radiation to be forwarded to the at least one portion of a
biological structure and receive, from the at least one portion of a biological
structure, a second radiation associated with the first electro-magnetic
radiation, wherein the second radiation is associated with an indocyanine
green (ICG) agent administered in the at least one portion of a biological
structure; and
at least one second arrangement which includes a computer
processing arrangement, and which is configured to obtain information
associated with the second radiation, and generate at least one image of the
at least one portion of a biological structure as a function of the second
radiation,
wherein the at least one second arrangement is configured to
determine, in vivo, whether at least one plaque structure associated with the
at least one portion of a biological structure includes at least one of an
angiogenesis or an inflammation, wherein the in vivo determination is based
on an interaction between the ICG agent and the at least one portion of a
biological structure, and wherein the determination identifies the presence of
at least one of a lipid accumulation, a macrophage, or an inflammatory cell.
Claims 1-28 stand rejected under 35 U.S.C. § 103(a) as obvious over
Alam et al. (US 2004/0156782 Al, Aug. 12, 2004) (hereinafter "Alam") in
view of Docherty et al. (US 6,915,154 Bl, July 2, 2005) (hereinafter
"Docherty") and Frangioni (US 6,869,593 B2, Mar. 22, 2005) (Ans. 3).
Claims 18-20 and 26-28 stand rejected under 35 U.S.C. § l 12(b) or
35 U.S.C. § 112, second paragraph (id. at 6).
INDEFINITENESS
The Examiner finds that "it is unclear whether the determination is
based on human reasoning or if the computer processing arrangement
performs the determination" (Ans. 6). In addition, the Examiner finds that
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Application 12/249, 715
"the claims ... do not expressly limit that the determination is done by the
second arrangement" (Final Act. 4).
Appellant argues that "it would certainly be clear to one of ordinary
skill in the art ... that the recited apparatus includes a physical arrangement
(not 'mental steps') configured in a manner to perform the stipulated
analysis and calculations" and that "a physical apparatus does not include a
representation of 'mental' steps or 'reasoning[']" (Reply Br. 2-3; see also
App. Br. 18). With regard to claims 18-20, we agree with Appellant that
"[i]t would be ... unambiguous to one having ordinary skill in the art that
the claimed arrangement is ... directed to an apparatus configured to
execute and perform a determination without a dependence on 'mental steps'
during its operation" (Reply Br. 3).
However, as noted by the Examiner, "claims 26-28 are method claims
dependent to apparatus claims 18-20" (Ans. 13). Thus, in the context of
claims 26-28, we agree with the Examiner that "the subject matter that the
Appellant intends to claim is unclear" (id.).
Conclusion
We conclude that the Examiner has not set forth a prima facie case
that claims 18-20 are indefinite. However, we conclude that the evidence
supports the Examiner's conclusion that claims 26-28 are indefinite.
Therefore, we affirm the indefiniteness rejection of claims 26-28, but
reverse the indefiniteness rejection of claims 18-20.
OBVIOUSNESS
The Examiner relies on Alam for disclosing:
a method for imaging at least one portion of an anatomical
structure ... , comprising:
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Application 12/249, 715
(i) providing an indocyanine green agent to at least one
portion of an anatomical structure; and
(ii) determining in vivo whether at least one "lesion"
(reads on plaque) is associated with at least one portion of an
anatomical structure at least includes one of an angiogenesis or
an inflammation, wherein the in vivo determination is based on
the interaction between ICG agent and the at least one portion of
the anatomical structure, and wherein the determination
facilitates a detection of at least one lesion.
( 4/17/2012 Act. 6; see also Ans. 3 ("Alam et al. teach as discussed ... in
Office action filed 17 Apr. 2012").) The Examiner finds, however, that
Alam does "not expressly teach [a] method wherein the computer processing
arrangement makes the determination and [the] determination is based on at
least one image of the interaction between the ICG agent and the at least one
portion of the biological structure" (Ans. 4).
The Examiner relies on Docherty for teaching a "method for assessing
the patency of a patient's blood vessel comprising administering a
fluorescent dye to the patient; obtaining at least one angiographic image of
the vessel portion; and ... evaluating at least one angiographic image to
assess the patency of the vessel portion" (id.). In particular, the Examiner
finds that Docherty teaches an apparatus comprising:
a device that emits radiation capable of causing fluorescent dye
to fluoresce; a camera capable of capturing the radiation emitted
by the fluorescent dye within the blood vessel as angiographic
image comprised of a plurality of pixels; and a computer
comprising a software program that calculates the diameter of the
blood vessel by comparing the number of pixels that correspond
to the blood vessel diameter with the number of pixels associated
with a preselected unit of measurement (reads on method
wherein the computer processing arrangement makes a
determination ... based on at least one image of the interaction
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Application 12/249, 715
between the [dye] and the at least one portion of the anatomical
structure ... ).
(Id.) In addition, the Examiner finds that Docherty teaches "that the
angiographic images obtain[ed] ... depict the lumen (space) inside the
arteries and veins" and that a "line of substantially uniform thickness
[indicates] a vessel that is free of atherosclerotic plaques" (id. at 5). The
Examiner also finds that Docherty teaches that, "while any fluorescent dye
may be used that provides an image, ICG is preferred because it is readily
available, and has long been approved for administration to humans" (id.).
The Examiner concludes:
It would have been obvious to one of ordinary skill in the art at
the time of invention to modify the method taught by Alam ...
by simply administering ICG to determine the presence of an
atherosclerotic plaque or lesion wherein the determination is
based on the presence of at least one lipid accumulation,
macrophage or inflammatory cell as taught by Docherty because
it would advantageously enable diagnosis of atherosclerosis
and/or therapeutic intervention and/or determining progress of
therapy.
(Id. at 12.) In addition, the Examiner concludes:
It would have been obvious to one of ordinary skill in the art at
the time of invention to modify the method taught by Alam ...
by simply determining using a computer processing arrangement
wherein the computer processing arrangement performs the
determination and wherein the determination is based on at least
one image as taught by Docherty et al. because it would provide
the advantage of a systematic, non-biased, and standardized
determination of atherosclerotic plaques in individuals suspected
of having atherosclerosis.
(Id. at 5.)
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Analysis
We will start by interpreting representative claim 18. Claim 18 recites
that "the at least one second arrangement is configured to determine, in vivo,
whether at least one plaque structure ... includes at least one of an
angiogenesis or an inflammation, ... wherein the determination identifies
the presence of at least one of a lipid accumulation, a macrophage, or an
inflammatory cell" (App. Br. A-5). It is not immediately clear how the
determination that a plaque structure includes, in particular, angiogenesis
would identify the presence of a lipid accumulation, a macrophage, and/or
an inflammatory cell or vice versa. Therefore, we look to the Specification
for guidance as to how the claim language should be interpreted.
Appellant identifies paragraphs 28, 29, 31, and 49 [sic, 42] of the
Specification as providing support for this language (App. Br. 8). We
recognize that these portions of the Specification provide support for the
terms "angiogenesis," "inflammation," "lipid," and "macrophage" (Spec.
i-fi-128, 29, 31, & 42). However, they do not clearly define the relationship
between determining that a plaque structure includes, in particular,
angiogenesis and identifying the presence of a lipid accumulation, a
macrophage, and/ or an inflammatory cell. Therefore, we look to other
portions of the Specification.
The Specification "relates generally to imaging of anatomical
structures and, more particularly, to apparatus and process for the detection
of atherosclerosis or atherosclerotic plaques" (Spec. i-f l ). In addition, in
describing the background, the Specification states that "the ability of ICG
to specifically enhance atherosclerotic plaques with high-risk features
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(including but not limited to neovessels, inflammation, and lipid) remains
unknown" (id. i-f 9). Thus, the Specification discloses an imaging method for
"determining whether at least one plaque structure associated with ... at
least one portion [of an anatomical structure] includes at least one of an
angiogenesis or an inflammation based on the interaction between the ICG
agent and the at least one portion" (id. i-f 11 ).
In addition, Appellant identifies "lipid accumulation, a macrophage,
or an inflammatory cell" as the "cardinal features of atherosclerosis and
other vessel wall diseases" (Reply Br. 5). We therefore interpret the
recitation that "the determination identifies the presence of at least one of a
lipid accumulation, a macrophage, or an inflammatory cell" to mean that the
claimed "plaque structure" has at least one of these cardinal features of
vessel wall disease, rather than that the apparatus specifically identifies at
least one of these features. We note that this interpretation appears to be
consistent with how the Examiner is interpreting this phrase (Ans. 10-11 ),
which appears reasonable given the lack of clarity provided by Appellant. In
view of this interpretation of claim 18, we conclude that the Examiner has
set forth a prima facie case that the apparatus of claim 18 would have been
obvious.
Appellant argues: "Alam, however, does not describe using targeted
ICG to image the vessel wall. In particular, Alam fails to describe
determining, in vivo, the presence of plaque, inflammation, or an
angiogenesis." (App. Br. 21.) We are not persuaded.
Instead, we conclude that the Examiner has set forth a prima facie
case that Alam discloses "determin[ing], in vivo, whether at least one plaque
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structure associated with the at least one portion of the anatomical structure
includes ... an angiogenesis," as recited in claim 18 (Ans. 9-10). In
particular, it is not clear to us how claim 18 requires using targeted ICG to
image the vessel wall.
Appellant also argues that Alam "does not describe the identification
or distinguishing of the presence of vessel wall 'lipid accumulation, a
macrophage, or an inflammatory cell' within any particular detected
'abnormality"' (App. Br. 22). In response, the Examiner finds that
"Docherty makes obvious identifying the presence of at least one of a lipid
accumulation, a macrophage, or an inflammatory cell[]" (Ans. 11 ). In
particular, the Examiner notes that atherosclerosis, as described in Docherty,
"is the narrowing, enlarging, or blockage of arteries by lipid accumulation,
macrophages and/or inflammatory cells" (id.). Appellant has not adequately
explained why it would not have been obvious to use Alam's device to
identify an atherosclerosis plaque, as described in Docherty.
In this regard, we note that the claim merely recites that "the
determination identifies the presence of at least one of a lipid accumulation,
a macrophage, or an inflammatory cell" (App. Br. A-5), which, as
acknowledged by Appellant, are the "cardinal features of atherosclerosis"
(Reply Br. 5). As discussed further above, the claim does not clearly recite
that the determination is able to distinguish these features "from other
'abnormal' tissue types or conditions" (id.). Moreover, it is not clear to us
how this recitation changes the structure of the apparatus rather than merely
reciting its intended use.
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Application 12/249, 715
In the Reply Brief, for the first time on appeal, Appellant purports to
separately argue the features of claims 17, 19, and 20 (id. at 8-9). According
to 37 C.F.R. § 41.37(c)(l)(iv), in the Appeal Brief:
For each ground of rejection applying to two or more claims, the
claims may be argued separately (claims are considered by
appellant as separately patentable), as a group (all claims subject
to the ground of rejection stand or fall together), or as a subgroup
(a subset of the claims subject to the ground of rejection stand or
fall together). When multiple claims subject to the same ground
of rejection are argued as a group or subgroup by appellant, the
Board may select a single claim from the group or subgroup and
may decide the appeal as to the ground of rejection with respect
to the group or subgroup on the basis of the selected claim alone.
Notwithstanding any other provision of this paragraph, the
failure of appellant to separately argue claims which appellant
has grouped together shall constitute a waiver of any argument
that the Board must consider the patentability of any grouped
claim separately.
In the Appeal Brief, Appellant argued the claims as a group and did not
present any separate arguments as to individual claims. Thus, Appellant's
arguments in the Reply Brief with respect to the separate patentability of
claims are untimely and will not be considered on appeal.
Conclusion
The evidence supports the Examiner's conclusion that Alam,
Docherty, and Frangioni suggest the apparatus of claim 18. We therefore
affirm the obviousness rejection of claim 18. Claims 1-17 and 19-28 have
not been (timely) argued separately and therefore fall with claim 18. 37
C.F.R. § 41.37(c)(l)(iv).
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Application 12/249, 715
SUMMARY
We reverse the indefiniteness rejection of claims 18-20. However,
we affirm the indefiniteness rejection of claims 26-28 and the obviousness
rejection of claims 1-28.
TIME PERIOD FOR RESPONSE
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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