Ex Parte Scarantino et al

Patent Trial and Appeal Board

Oct 21, 2016

12823598 (P.T.A.B. Oct. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/823,598 06/25/2010
20792 7590
MYERS BIGEL, P.A.
PO BOX 37428
RALEIGH, NC 27627
10/21/2016
FIRST NAMED INVENTOR
Charles W. Scarantino
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.
505 l -2222CT6 8195
EXAMINER
BRUTUS, JOEL F
ART UNIT PAPER NUMBER
3777
MAILDATE DELIVERY MODE
10/21/2016 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 PATENT TRIAL AND APPEAL BOARD
Ex parte CHARLES W. SCARANTINO, H. TROY NAGLE,
LESTER C. HALL, JEFFREY MUELLER, and
BAHRAM G. KERMAN!
Appeal2014-009269
Application 12/823,598
Technology Center 3700
Before: ANNETTE R. REIMERS, BEYERL Y M. BUNTING, and
BRENT M. DOUGAL, Administrative Patent Judges.
DOUGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a Final Rejection of
claims 1-31. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
Appeal2014-009269
Application 12/823,598
CLAIMED SUBJECT MATTER
The claims are directed to methods and systems for monitoring
patients undergoing treatment for cancer. Claims 1 and 11 are independent.
Claims 2-10 and 21-26 depend directly or indirectly from claim 1, while
claims 12-20 and 27-31 depend directly from claim 11. Claim 1,
reproduced below, is illustrative of the claimed systems and claim 11, also
reproduced below is illustrative of the claimed methods:
1. An oncology monitoring system, comprising:
a first plurality of radiation sensors configured to reside
proximate a target tumor treatment site of a patient, wherein the
radiation sensors are configured to provide radiation data of solid
tissue associated with an internally administered radioactive
substance at the target tumor treatment site while the radiation
sensors are held in position proximate the target tumor treatment
site of the patient; and
a first portable receiver in communication with the
plurality of radiation sensors, the first portable receiver
configured to obtain radiation data from the radiation sensors at
a plurality of different times, wherein the first portable receiver
is in communication with at least one computer that tracks
variation in the radiation data to allow the at least one computer
to determine at least one of the following:
(a) cell proliferation data at the tumor treatment site;
(b) a response to a therapeutic treatment at the tumor
treatment site; and
( c) a favorable or unfavorable treatment period for
a future therapeutic treatment at the tumor treatment site;
wherein the at least one computer is (i) a local computer
or a remote computer or (ii) a local computer and a remote
computer.
11. A method of evaluating an oncology patient, comprising:
electronically obtaining in vivo radiation data associated
with a tumor treatment site of a patient at a plurality of different
times during at least one time period using a portable receiver
while a patient is away from a clinical site, wherein the radiation
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data is associated with a radiolabeled substance administered to
the patient;
electronically monitoring variation in the obtained
radiation data over the at least one time period; and
evaluating at least one of a treatment strategy and the
tumor treatment site based on the monitored radiation data.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Dunphy us 3,958,558 May 25, 1976
Lemelson us 4,764,359 Aug. 16, 1988
Huffman us 4,976,266 Dec. 11, 1990
Haskin us 5,005, 126 Apr. 2, 1991
Gastouniotis us 5,438,329 Aug. 1, 1995
Markowitz us 5,626,630 May 6, 1997
Feierbach us 5,935,078 Aug. 10, 1999
Kamb us 5,998, 136 Dec. 7, 1999
Fruehauf us 6,008,007 Dec. 28, 1999
Gonzalez-Lepera us 6,149,593 Nov. 21, 2000
Nerone US 6,800,957 B2 Oct. 5, 2004
Besson US 2004/0015058 Al Jan. 22, 2004
REJECTIONS 1
I. Claims 1, 3, 10-12, 14, and 15 are rejected under 35 U.S.C. §
103(a) as being unpatentable over Lemelson, Markowitz, and Besson.
II. Claim 2 is rejected under 35 U.S.C. §103(a) as being unpatentable
over Lemelson, Markowitz, Besson, and Gonzalez-Lepera.
III. Claims 4, 9, and 16 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Lemelson, Markowitz, Besson, and Haskin.
1 Claims 1-20 are also rejected for nonstatutory obvious-type double
patenting, which rejections are not appealed. Final Act. 3-6; Appeal Br. 22.
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IV. Claim 5 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Lemelson, Markowitz, Besson, Haskin, and Gastouniotis.
V. Claim 6 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Lemelson, Markowitz, Besson, Haskin, and F eierbach.
VI. Claim 7 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Lemelson, Markowitz, and Besson.
VII. Claims 8, 17, and 18 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Lemelson, Markowitz, Besson, and Dunphy.
VIII. Claims 13, 19, 20, 22, and 27 are rejected under 35 U.S.C.
§ 103 (a) as being unpatentable over Lemelson, Markowitz, Besson, and
Huffman.
IX. Claims 21, 23, and 28 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Lemelson, Markowitz, Besson, and Kamb.
X. Claims 21, 24--26, and 29-31 are rejected under 35 U.S.C. §103(a)
as being unpatentable over Lemelson, Markowitz, Besson, and Fruehauf.
OPINION
REJECTION I
Claim 1
The Examiner finds that Lemelson teaches the majority of features of
claim 1. Final Act. 6-7. The Examiner relies on the teachings of Besson for
a first portable receiver in communication with the plurality of sensors and
on Markowitz for sensors that are held "in a position proximate the
treatment site." Id. at 7-8. The Examiner further finds that it would be
obvious to combine these teachings to allow "for monitoring while taking a
walk or during automobile drives." Id. at 8.
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Appellants argue that Lemelson does not teach or suggest in claim 1 :
a first plurality of radiation sensors configured to reside
proximate a target tumor treatment site of a patient, wherein the
radiation sensors are configured to provide radiation data of solid
tissue associated with an internally administered radioactive
substance at the target tumor treatment site while the radiation
sensors are held in position proximate the target tumor treatment
site of the patient.
Appeal Br. 7. Appellants further argue that Lemelson provides only a
limited description of the "detectors" relied on for teaching "radiation
sensors." Id. Specifically, Appellants argue that "[t]here is clearly no
enablement for radiation sensors that relay radiation data from tumor site
tissue in the patient." Id. (emphasis omitted). This argument is not
persuasive because "a reference must be considered not only for what it
expressly teaches, but also for what it fairly suggests." In re Bell, 991 F. 2d
781, 785(Fed. Cir. 1993) quoting In re Burckel, 592 F.2d 1175, 1179 (CCPA
1979).
Further, prior art references are presumed enabled. In re Antor Media
Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012). In order for us to find that the
prior-art reference is not enabled, Appellants need to show that no
embodiment of the claim of the prior-art reference is enabled. See Schering
Corp. v. Geneva Pharm., 339 F.3d 1373, 1381 (Fed. Cir. 2003). Appellants'
statements concerning the amount of description of the radiation sensors do
not provide us with any evidence that the claim of Lemelson is not enabled.
Concerning Lemelson's teachings related to "radiation sensors," as
noted by both the Examiner (Final Act. 7) and Appellants (Appeal Br. 7.),
Lemelson at column 3, lines 2-8 states:
In a preferred form, a computer or computers may be employed
to analyze signals generated by sensing means, such as a detector
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or detectors of body fluid or blood components, radiation passing
through the tumor site or emitted therefrom and other variables
indicative of the type and extent of the cancer.
Appellants argue that the cited passage only teaches sensors "using
body fluid" and not "radiation sensors that transmit radiation data from
tumor sites in the body." Appeal Br. 7. The Examiner found that
"Lemelson discloses ... detectors (relied on as the plurality of radiation
sensors) of radiation passing through the tumor site or emitted therefrom."
Final Act. 7. Appellants' arguments do not demonstrate convincingly that
the Examiner's understanding is incorrect. Specifically, Appellants'
arguments do not show why or how a radiation detector that uses body fluid
is outside of the bounds of the claim where the radiation data is "radiation
passing through the tumor site or emitted therefrom," i.e., "radiation data of
solid tissue" as required by claim 1.
Appellants then argue that "tracer elements" discussed in Lemelson
must also be the detectors relied on for teaching "radiation sensors" by the
Examiner. Appeal Br. 8. Appellants argue that such an interpretation would
be inappropriate as the "tracer elements" are part of the "drug unit or
microcapsule, which the Examiner identifies as the internally administered
radioactive substance of Claim 1." Id.
Though it is possible that the tracer elements are one form of the
detectors, there is no indication in Lemelson that the discussion on detectors
is limited to this embodiment. Further, the sections of Lemelson cited by
Appellants for the tracer elements (Lemelson col. 4:40-47, col 10:57---62)
appear to be separate embodiments from the detector embodiments (id. col.
3: 1-11) relied on by the Examiner.
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Appellants then move on to Besson and Markowitz and argue that
these references do not teach or suggest the claimed radiation sensors.
Appeal Br. 9, 10. Appellants also argue that Besson's portable device is
only used to obtain information about bodily functions and not radiation data
and that Markowitz does not have a portable receiver that detects radiation
data. Id.
Appellants' arguments are not consistent with how the Examiner
relies on Besson and Markowitz in the rejection. Neither Besson nor
Markowitz is relied on for radiation sensors or detecting radiation data. As
noted by the Examiner, "Besson et al is used to teach a portable receiver in
communication with a plurality of sensors" and "the sensors of Markowitz et
al are used for the location of the sensors proximate (meaning implanted) a
treatment/tumor site." Answer 22-23.
Appellants' arguments are also unconvincing as they focus on the
references individually and do not explain why the combination of
references and teachings would not suggest the claimed invention. One
cannot show nonobviousness by attacking references individually where the
rejections are based on combinations of references. See In re Merck & Co.,
800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants also argue that the Examiner's reason to combine the
references is conclusory. Appeal Br. 10. In support, Appellants argue that
"Lemelson does not provide any teaching, motivation or suggestion to
employ remote monitoring" and Besson is specific to monitoring "bodily
functions" and has nothing to do with radiation sensors." Id. at 10-11.
"Contemplation" by a specific reference, such as Lemelson, is not
required to support a finding of obviousness. Appellants' argument is
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foreclosed by KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007), in which
the Court rejected the rigid requirement of a teaching or suggestion or
motivation to combine known elements in order to show obviousness. KSR,
550 U.S. at 415. The Court noted that an obviousness analysis "need not
seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ." Id. at 418.
Concerning Besson the Examiner explains:
remote monitoring is extremely well-known in many fields
where data needs to be accessed for convenience. Furthermore,
Besson taught explicitly a skilled artisan would have been
motivated to employ remote monitoring for the purpose of
monitoring while taking a walk or during automobile drives [see
0119, Besson et al] - i.e., convenience while doing everyday
activities.
Answer 23. Thus, Appellants' arguments are not consistent with how
Besson in used in the rejection and do not inform us of error in the rejection.
In the Reply Brief, Appellants argue for the first time that the
Examiner has not provided a reason to combine the teachings of Markowitz
with Besson and Lemelson. Reply Br. 3--4. Though the Examiner includes
Markowitz when discussing the reasons to combine (see Final Act 8,
Answer 8-9), Appellants do not explain why the Examiner's stated reason to
combine (i.e. to allow for remote monitoring) does not apply to Markowitz.
Further, Appellants did not set forth this argument in a timely manner prior
to filing of the Reply Brief to permit the Examiner an opportunity to fully
respond. See 37 C.F.R. § 41.41(b)(2) (2014) ("Any argument raised in the
reply brief which was not raised in the appeal brief, or is not responsive to
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an argument raised in the examiner's answer ... will not be considered by
the Board for purposes of the present appeal, unless good cause is shown).
For all of the above reasons, we are not informed of error in the
rejection of claim 1.
Claim 3
Claim 3 depends from claim 1 and adds "the first portable receiver is
configured to be worn by the patient." The Examiner finds that Markowitz
"disclose[s] repeater 14 (relied on as the receiver) [that] is worn externally
by the patient 13 in a manner similar to a beeper or pager" and that such a
system would be obvious "in order to provide monitoring while the patient is
away from the medical setting." Final Act. 12.
Appellants state, without explanation, "that one skilled in the art
would not modify such device [of Besson] to be worn by the patient."
Appeal Br. 12. Also stating that the device of Besson "is configured to
remotely receive RF signals," Appellants do not provide any further
discussion or explanation. Further, no discussion of the teachings of
Markowitz is provided. Id.
Merely reciting the language of a claim and asserting that the cited
prior art references do not disclose that limitation is insufficient. See In re
Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) ("[W]e hold that the Board
reasonably interpreted Rule 41.37 to require more substantive arguments in
an appeal brief than a mere recitation of the claim elements and a naked
assertion that the corresponding elements were not found in the prior art.").
For these reasons, we are not apprised of error in the Examiner's
rejection of claim 3.
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Claim 10
Claim 10 depends from claim 1 and adds "a second plurality of
radiation sensors positioned on a second patient and a second portable
receiver in communication with the second plurality of radiation sensors,
wherein the first and second receivers are configured to transmit respective
radiation data to the at least one computer."
The Examiner relies on Besson for "disclos[ing] several receiving
units for simultaneously monitor[ing sensors on] a number of patients."
Final Act. 9.
Similar to claim 1 above, Appellants focus on the lack of claimed
radiation sensors in Besson. Appeal Br. 12. But, as noted above, the
Examiner found that Lemelson teaches the radiation sensors. Appellants'
arguments are unconvincing as they do not discuss the teachings for which
Besson is relied on (i.e. several receiving units that monitor sensors on
different patients).
For these reasons, we are not apprised of error in the Examiner's
rejection of claim 10.
Claim 11
The Examiner finds that Lemelson teaches all of the features of claim
11 with the exception of "using a portable receiver while the patient is away
from a clinical site and monitoring variation in the obtained radiation data
over at least one time period." Final Act. 9-10 (emphasis added). The
Examiner relies on the teachings of Markowitz for a portable receiver worn
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by a patient and on Besson for monitoring while the patient is taking a walk
or drive. Id.
The Examiner does not identify specifically that any reference teaches
"monitoring variation in the obtained radiation data over the at least one
time period" as required by claim 11. In the Answer, the Examiner
acknowledges that Appellants have identified this error (Appeal Br. 14), but
other than disagreeing, the Examiner does not identify where or explain how
this feature is taught by the cited references. Answer 24--25.
For this reason, we do not sustain the rejection of claim 11.
Claims 12, 14and15
Claims 12, 14, and 15 depend from claim 11. We do not sustain the
rejection of claims 12, 14, and 15 for the same reason as claim 11.
REJECTION II
Claim 2
Claim 2 depends from claim 1 and adds "wherein the radiation
sensors are configured to obtain radiation data associated with beta radiation
from the administered radioactive substance." The Examiner relies on the
teachings of Gonzalez-Lepera for these features. Final Act. 12.
Appellants admit that Gonzalez-Lepera teaches a "beta particle
detector" but argue that it "does not teach or suggest a plurality of radiation
sensors" or "tracking dynamic variation in radiation at a tumor site during
treatment." Appeal Br. 16. As Gonzalez-Lepera is not relied on for "a
plurality of radiation sensors" or "tracking dynamic variation" we are not
convinced of error in the Examiner's rejection.
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Appellants' arguments are also unconvincing as they focus on the
references individually and do not explain why the combination of
references and teachings would not suggest the claimed invention. See In re
Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986).
Appellants also argue that Gonzalez-Lepera is addressed to a different
problem than Appellants' invention. Appeal Br. 16. But one problem claim
2 of the present Application is clearly directed to is "obtain[ing] radiation
data associated with beta radiation" which is the admitted function of
Gonzalez-Lepera's "beta particle detector." Id. ("Gonzalez-Lepera does
describe technical issues associated with detecting beta radiation in vivo.").
Further, this argument is not convincing because "[a] reference is reasonably
pertinent if, even though it may be in a different field from that of the
inventor's endeavor, it is one which, because of the matter with which it
deals, logically would have commended itself to an inventor's attention in
considering his problem." In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992).
"In other words, 'familiar items may have obvious uses beyond their
primary purposes."' In re ICON Health and Fitness, Inc., 496 F.3d 1374,
1380 (Fed. Cir. 2007) (quotingKSRint'l Co. v. Teleflex, Inc., 550 U.S. 398,
420 (2007)).
For these reasons, we are not informed of error in the rejection of
claim 2.
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REJECTION Ill
Claims 4, 9, and 16
Claims 4 and 9 depend from claim 1, and 16 depends from claim 11.
The Examiner finds that Haskin teaches the additional features of these
claims. Final Act. 13.
Appellants state that Haskin does not disclosure the features of claims
4, 9, and 16. Appeal Br. 17. This is not enough. Merely reciting the
language of a claim and asserting that the cited prior art references do not
disclose that limitation is insufficient. See In re Lovin, 652 F.3d at 1357.
Appellants also assert that Haskin "does not have a portable receiver."
Haskin is not relied on for a portable receiver. Thus, we are not informed of
error in the rejection of claims 4 and 9. Because claim 16 depends from
claim 11, for which we do not sustain the Examiner's rejection for reasons
described above, we also do not sustain the Examiner's decision rejecting
claim 16.
REJECITON IV
Claim 5
Claim 5 depends from claim 4 and adds "wherein the first portable
receiver is self-powered." The Examiner relies on Gastouniotis for the self-
powered receiver. Final Act. 14.
Appellants argue "[ w ]hile Gastouniotis generally describes data
transfer between remote locations, Gastouniotis does not teach or suggest
collecting/storing/transmitting radiation data of a tumor site of a patient
using a portable receiver." Appeal Br. 18.
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As Gastouniotis is not relied on for "collecting/storing/transmitting
radiation data" we are not convinced of error in the Examiner's rejection.
Appellants' arguments are also unconvincing as they focus on the references
individually and do not explain why the combination of references and
teachings would not suggest the claimed invention.
REJECTIONV
Claim 6
Claim 6 depends from claim 4 and adds "wherein the first portable
receiver has a rechargeable power source." The Examiner relies on
Feierbach for the rechargeable power source. Final Act. 15.
Appellants argue "[ w ]hile Feierbach generally describes a portable
device capable of data transfer associated with certain physiological
attributes, [Feierbach] does not teach or suggest a portable device that is
capable of collecting/storing/transmitting radiation data of a tumor site of a
patient." Appeal Br. 18-19.
As Feierbach is not relied on for "collecting/storing/transmitting
radiation data" we are not convinced of error in the Examiner's rejection.
Appellants' arguments are also unconvincing as they focus on the references
individually and do not explain why the combination of references and
teachings would not suggest the claimed invention.
REJECTION VI
Claim 7
Claim 7 depends from claim 4 and adds "the first portable receiver is
configured to engage a vehicle electrical power connection." The rejection
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of claim 7 from the Final Action was withdrawn in the Examiner's Answer
and a new rejection was entered. Answer 20-21.
The Examiner finds that in view of the teachings of Besson, that
monitoring can occur while driving, it would be obvious to "hav[ e] the
receiver configured to engage a vehicle electrical power connection for the
purpose of charging the receiver during automobile drives." Id. at 20.
Appellants argue that the Examiner provides no evidence for this
conclusion. Reply Br. 2-3. But this is not enough to convince us or error in
the Examiner's reasoning. Instead, the relevant inquiry is whether the
Examiner has set forth "some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness." See In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) cited with approval in KSR, 550
U.S. at 418. Appellants do not argue or provide evidence that it would not
be obvious to connect an electric monitoring device to "a vehicle electrical
power connection for the purpose of charging the receiver during automobile
drives" as articulated by the Examiner.
Appellants also argue that the rejection is in error because claim 7
depends from claim 4 and the rejection does not include Haskin which is
used to reject claim 4. Id. We consider this error to be a typographical error
and not reason to reverse the rejection.
For these reasons we sustain the rejection of claim 7.
REJECTION VII
Claims 8, 17 and 18
Claim 8 depends from Claim 1 and adds "the radiation sensors are
wireless sensors that communicate with the first portable receiver." The
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Examiner finds that Dumphy teaches an "implantable wireless transducer"
and "means for wireless transmission." Final Act. 16.
Similar to claim 1 above, Appellants focus on the lack of claimed
radiation sensors in Dumphy. Appeal Br. 19-20. But, as noted above, the
Examiner found that Lemelson teaches the radiation sensors. Appellants'
arguments are unconvincing as they do not discuss the teachings for which
Dumphy is relied on (i.e., wireless transducer and transmission).
For these reasons, we sustain the Examiner's decision rejecting claim
8. Because claims 17 and 18 depend from claim 11, for which we do not
sustain the Examiner's rejection for reasons described supra, we also do not
sustain the Examiner's decision rejecting claims 17 and 18.
REJECTIONS VIII & IX
Claims 13, 19, 20--23, 27, and 28
Appellants provide no arguments with respect to the rejections of
claims 13, 19, 20-23, 27, and 28. Because claims 13, 19, 20, 27, and 28
depend from claim 11, for which we do not sustain the Examiner's rejection
for reasons described above, we also do not sustain the Examiner's decision
rejecting claims 13, 19, 20, 27, and 28. Because claims 21-23 depend from
claim 1, for which we sustain the Examiner's rejection for the reasons
described above, we also sustain the Examiner's decision rejecting claims
21-23.
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REJECTION X
Claims 21, 24-26, and 29-31
Appellants state that Fruehauf does not disclosure underlined portions
of claims 21, 24--26, and 29-31 and that these features would not be
obvious. Appeal Br. 21-22. This is not enough. Merely reciting the
language of a claim and asserting that the cited prior art references do not
disclose that limitation is insufficient. See In re Lovin, 652 F.3d at 1357.
For this reason we sustain the rejection of claims 21, and 24--26.
Because claims 29-31 depend from claim 11, for which we do not sustain
the Examiner's rejection for reasons described above, we also do not sustain
the Examiner's decision rejecting claims 29-31.
DECISION
The Examiner's rejection of claims 1-10, and 21-26 is affirmed.
The Examiner's rejection of claims 11-20, and 27-31 is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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