Ex Parte Kamalakaran et al

Patent Trial and Appeal Board

Feb 15, 2018

14112664 (P.T.A.B. Feb. 15, 2018)

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.
14/112,664 10/18/2013 Sitharthan Kamalakaran 2011P00455WOUS 2263
24737 7590 02/20/2018
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue LUONG, PETER
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
02/20/2018 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):
patti. demichele @ Philips, com
marianne. fox @ philips, com
katelyn.mulroy @philips .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SITHARTHAN KAMALAKARAN and BALASUNDAR RAJU
Appeal 2017-000530
Application 14/112,664
Technology Center 3700
Before DEBORAH KATZ, TAWEN CHANG, and
TIMOTHY G. MAJORS Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal under 35 U.S.C. § 134 involving
claims to a device and system for providing device visibility in medical
images, and claims to related methods. The Examiner rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter a New Ground of Rejection.
1 Appellants identify the Real Party in Interest as KONINKLIJKE PHILIPS
N.V. App. Br. 4.
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Application 14/112,664
STATEMENT OF THE CASE
Appellants’ invention “relates to medical image visibility and more
particularly to systems and methods for increasing device visibility in
medical images.” Spec. 1:4—5.
The Specification explains that “[visualization of a catheter or needle
is important in many medical intervention procedures,” but that current
techniques for visualization have drawbacks (e.g., use of toxic dyes, and lack
of clear contrast and accuracy). Id. at 1:6—14. The invention seeks to
overcome these drawbacks with “a medical device having nanoparticles
incorporated therein, the nanoparticles being configured to be responsive to
at least one excitation signal.” Id. at 1:21—23. Upon excitation by the
signal, nanoparticles on the device generate response emissions, which are
captured by a sensor and, using the response emissions, a rendering of the
device in a medical image is created. Id. at 1:23—2:1.
An embodiment of Appellants’ invention is shown below.
Spec., Fig. 1. Figure 1 shows a cross-sectional view of a portion of medical
device (100), such as a catheter, needle, probe, or balloon. Id.; see also id. at
5:13—17. As depicted, device (100) includes a surface (102) that may form a
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Application 14/112,664
cavity (104). Id. at 5:17—18. A material layer/volume (106) is formed on
the device surface (102), and layer (106) includes a composition —
nanomaterials in or on the layer — to aid in visualization of the device in
medical images. Id. at 5:18—22.
Claims 1, 4—7, 10, 15, 16, 19, 22, 23, 26, 29, 30, and 32 are on appeal.
Claims 1 and 26 are illustrative and reproduced below:
1. A medical device configured for internal use within a
subject, comprising:
a structure having a length dimension and a surface;
a volume associated with the surface and extending along
at least a portion of the length dimension; and
nanomaterials incorporated in the volume and configured
to be responsive to at least one excitation signal such that the
excitation signal generates a response from the nanomaterials to
enable location of the structure within an interior of the subject.
26. A method for generating an image of a medical device
configured for internal use within a subject, comprising:
exciting nanomaterials included in a medical device using
a first electromagnetic frequency of excitation for the
nanomaterials to obtain a first imageable response, the first
imageable response being detectable over surrounding materials;
exciting the nanomaterials included in the medical device
using a second electromagnetic frequency of excitation for the
nanomaterials to obtain a second imageable response which
includes a realizable difference from the first imageable
response, the second imageable response being detectable over
the surrounding materials;
subtracting the first imageable response from the second
imageable response to provide an image of the medical device
relative to a subject.
App. Br. 22, 26 (Claims App.).
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Application 14/112,664
The claims stand rejected by the Examiner as follows:
I. Claims 1, 4—7, 10, 15, 16, 19, 22, and 23 under 35 U.S.C.
§ 102(b) as anticipated by Lewkowicz,2 as further evidenced by
Bromberg3 (“Rejection I”).
II. Claims 26 and 32 under 35 U.S.C. § 103(a) as obvious over
Toms4 and Alfano5 (“Rejection II”).
III. Claims 29 and 30 under 35 U.S.C. § 103(a) as obvious over
Toms, Alfano, and Lewkowicz (“Rejection III).
I
Issue
Has the Examiner established by a preponderance of the evidence that
Lewkowicz, as evidenced by Bromberg, describes the subject matter of
claims 1, 4—7, 10, 15, 16, 19, 22, and 23?
Findings of Fact (FF)
The Examiner’s findings of fact and explanation of the rejection are
provided at page 2 of the Final Rejection (Aug. 13, 2015) (“Final Act.”).
See also Adv. Act. (Oct. 29, 2015) 2; Ans. 2—3, 4—6. The following findings
are provided for emphasis and convenient reference.
FF 1. Lewkowicz discloses an in vivo examining and testing device
for observing lumens in a patient’s body. Lewkowicz 19.
2 Lewkowicz et al., US 2003/0040685 Al, published Feb. 27, 2003.
3 Bromberg et al., US 2006/0040388 Al, published Feb. 23, 2006.
4 Toms et al., US 2006/0173362 Al, published Aug. 3, 2006.
5 Alfano et al., US 6,280,386 Bl, issued Aug. 28, 2001.
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FF. 2. An embodiment of Lewkowicz’s device is shown below.
-400
Id. Fig. 3C. Figure 3C shows testing device (400), having an outer coating
(404) and an internal filling (402). Id. ]f 76. The internal filling (402)
comprises a marker (403), such as a radio opaque material “or other
detectable material [e.g., dyes, radioactive markers, etc.] . . . [that] can be
viewed by x-ray or other detection methods.” Id. Lewkowicz discloses that,
in embodiments, “the marker is magnetite (Fe304), for example, powdered
magnetite in poly(methyl methacrylate).” Id.
FF 3. Lewkowicz discloses “device 400 is inserted into a patient’s
300 GI tract and can be monitored by a suitable detector 301, for example,
an x-ray machine, a gamma camera or a magnetometer.” Id. 177; see also
id. Figs. 3C and 3D. Lewkowicz discloses “detector 301 is typically moved
along the patient’s 300 body and utilizing a plurality of detectors or
receivers . . . and a processing unit 302, can detect and calculate, by known
methods, the location of the marker 403.” Id. 177; see id. 114.
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FF 4. Lewkowicz discloses:
The internal filling, which in one embodiment can be one or more
layers or a suspension or liquid or gas, typically constitutes small
particles or molecules and can produce pressure within the
device by, for example, serving as an ion source or sink. The
filling may also contain adhesives and fillers to, for example,
further provide mechanical stability to the device.
Id. 151.
FF 5. Bromberg relates to magnetic nanoparticles, and compositions
containing such particles, and discloses:
The coatings on the surface of nanostructured powders are of
great interest, because the coatings alter the charge, functionality,
and reactivity of the surface, and enhance the stability and
dispersibility of the nanoparticles in water-prepared monolayer
and bilayer surfactant coatings on magnetite (FdO4)
nanoparticles using the self-assembly method.
Bromberg | 5 (emphases added).
Analysis
Claim 1
The Examiner finds that Lewkowicz describes the subject matter in
claim 1. According to the Examiner:
Lewkowicz et al. discloses a medical device (400; Fig. 3C)
comprising a structure having a length dimension and a surface
(404; Fig. 3C); a volume associated with the surface and
extending along at least a portion of the length dimension (Fig.
3C); and nanomaterials incorporated in the volume and
configured to be responsive to at least one excitation signal such
that the excitation signal generates a response from the
nanomaterials to enable location of the structure within a subject
(403; Fig. 3C).
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Final Act. 2. The Examiner finds “magnetite powder (Fe304) [a detectable
marker (403) in Lewkowicz] ... is a nano-particle as evidenced by
Bromberg.” Adv. Act. 2. The Examiner finds that “applicant has failed to
provide a special definition or meaning to nanomaterials,”6 and the
Examiner states that “nano-particles are interpreted to be nanomaterials” as
claimed. Id. Thus, the Examiner finds Lewkowicz anticipates claim 1.
Appellants argue “Lewkowicz fails to teach or suggest at least that the
magnetite is a nanomaterial as recited in the medical device of claim 1.”
App. Br. 11. According to Appellants, “[a] ‘nanomaterial’ is a well known
term in the art that has a special meaning. Nanomaterials are known to
include nanotubes, nanorods, nanospheres, nanocages or quantum dots (See,
e.g., Original Specification, p. 6, lines 2-4).” Id. As to Bromberg,
Appellants contend “Bromberg does not evidence that the magnetite taught
by Lewkowicz must be a nanomaterial.” Id. at 12. Appellants also allege
that Lewkowicz uses the term “nano-particles” in relation to a different
embodiment and that, because this other embodiment discloses the potential
addition of markers (e.g., barium), “this embodiment teaches away from the
nanomaterials of the device of claim 1.” Id.
The preponderance of the evidence supports the Examiner’s finding
that Lewkowicz anticipates claim 1. Appellants’ Specification uses the
terms “nanomaterial” and “nanoparticle” interchangeably,7 and we are
6 Appellants agree no express definition is provided: “Applicants and the
Examiner agree that no special definition or meaning was given to the term
‘nanomaterials’ by Applicants in the Original Specification.” Reply Br. 6.
7 See, e.g., Spec. 5:25, 6:22—23 (“metallic nanoparticles”), 8:22—23 (“gold
nanorods (i.e., cylindrical gold nanoparticles)”).
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persuaded on this record that the skilled person would interpret powdered
magnetite (Fe3C>4), as taught in Lewkowicz, as a nanoparticle. FF 2, 5. The
Examiner has made a prima facie showing on this point, citing Bromberg in
support, and Appellants adduce no persuasive evidence showing that
powdered magnetite is not a nanoparticle. Appellants contend a
“nanomaterial. . . has a specific meaning,” yet Appellants do not state, or
provide evidence showing, what that “specific meaning” is. Appellants cite
a portion of the Specification but this disclosure simply lists potential
nanomaterials (carbon nanotubes, quantum dots, etc.). Spec. 6:2-4. This list
is not limiting. Indeed, other portions of the Specification confirm that
nanotubes, nanorods, etc. are just examples of nanomaterials. Spec. 3:17—18
(“nanomaterials that may be employed include, e.g., carbon nanotubes,
nanorods or nanospheres.”).8
The fact that Lewkowicz describes a use of “nano-particles”
elsewhere related to a different embodiment than the one shown in Figure
3C is also not dispositive. Lewkowicz 1 86. Those “nano-particles” are
described as having specific characteristics for a specific purpose — a solid
8 Even if Appellants were correct, and a nanomaterial was limited to, for
instance, nanotubes or quantum dots, we observe that Toms clearly teaches
the use of quantum dots/nanoparticles as imaging agents, and discloses that
such optical nanoparticles can be coated on indwelling medical devices.
Toms H 80-81. Indeed, Toms teaches quantum dots have several
advantages over conventional optical labels (e.g., dyes), including low
toxicity, high fluorescing efficiency, and resistance to photo-bleaching. See,
e.g., id. 113—4, 51. The Examiner, however, relies on Toms only for
purposes of the obviousness rejection of claims 26, 29, 30, and 32, and also
does not identify these particular teachings in the reference. So, we do not
rely on Toms or these teachings here.
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hydrophobic inner core and a cationic exterior to help facilitate
disintegration of a plug. Id. Those particular particles are not used as the
“markers” (like magnetite) in this other embodiment. But Lewkowicz does
not disclose that magnetite powder is not a nanoparticle, and Appellants cite
no disclosure that nanoparticles/nanomaterials cannot or should not be used
as imaging agents. As to this latter point, in any event, an alleged “teaching
away” is not germane to a rejection for anticipation. In re Malagari, 499
F.2d 1297, 1302 (CCPA 1974) (emphasis added) (“If the rejection under §
102 is proper, . . . appellant cannot overcome it by showing . . . teaching
away in the art, which [is] relevant only to an obviousness rejection.”).
For these reasons, we affirm the Examiner’s rejection of claim 1 as
anticipated by Lewkowicz, as evidenced by Bromberg. Claims 4, 7, 10, and
19 were not separately argued and, therefore, fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
Claims 5, 15, and 22
Claim 5 depends from claim 1, and adds “wherein the volume
includes a tube forming an annular cavity relative to the surface, the annular
cavity including the nanomaterials in suspension.’ ’ App. Br. 22 (emphasis
added). Appellants dispute whether this limitation is taught in Lewkowicz.
Id. at 13—14. Claims 15 and 22 depend from independent claims 10 and 19
respectively, and have similar limitations to the one disputed in claim 5.
The Examiner cites to Figure 3C and structure 402 in Lewkowicz as
disclosing “nanomaterials in suspension.” (Final Act. 2). Appellants argue
in response that, although
Figs. 2A and 2B have an internal filling which may be in a
suspension ...[,] Lewkowicz fails to disclose or suggest that
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the cited embodiments recited in Figs. 3C and 3D . . . having a
magnetized magnetite may be placed in a suspension within the
cavity of the device.
App. Br. 13.
On this record, the Examiner has not shown that Lewkowicz
anticipates the invention in claim 5 (or claims 15 and 22). The Examiner has
not persuasively established the magnetite marker in Figure 3C is in
suspension. The Examiner invokes Lewkowicz’s teaching in paragraph 51
(see Ans. 5; FF 4), which expressly discloses an internal filling can be a
suspension or liquid or gas, but that teaching relates to another embodiment
— the testing device shown in Figures 2A and 2B. Lewkowicz 151.
Picking and choosing from distinct embodiments in the art, while
permissible in an obviousness inquiry, is generally inappropriate to show
anticipation. In re Arkley, 455 F.2d 586, 587 (CCPA 1972) (explaining that
anticipation requires the art “clearly and unequivocally disclose the claimed
[invention] or direct those skilled in the art to the [invention] without any
need for picking, choosing, and combining various disclosures not directly
related to each other by the teachings of the cited reference.”). For this
reason, we reverse the Examiner’s rejection of claims 5, 15, and 22 as
anticipated by Lewkowicz.
Notwithstanding the above, we conclude that claim 5 (and claims 15
and 22) would have been obvious over Lewkowicz. Picking and choosing is
permissible when obviousness is the issue. And here, the skilled person
need only choose to combine features of two embodiments of a single
reference — the use of a magnetite marker (as in Fig. 3C) with the internal
filling that is a suspension (as described in relation to Figs. 2A and 2B).
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Lewkowicz H 51, 76. The reason for doing so comes expressly from
Lewkowicz, which teaches (in relation to the Fig. 3C embodiment) that
“internal filling 402 can be fabricated as described above.” Id. 176.
Reasonably understood, this disclosure points to the preceding embodiments
(i.e., Figs. 2A and 2B), which as noted teach the internal filling may be
formed as a suspension, liquid, or gas. Id. 1 51. At most, this is just a
substitution of known alternative formulations for the internal filling and is
within the capabilities of the skilled artisan. We, therefore, enter new
grounds of rejection of claims 5, 15, and 22 under 35 U.S.C. § 103(a) over
Lewkowicz. 37 C.F.R. § 41.50(b).
Claims 6, 16, and 23
Claim 6 depends from claims 1 and 5, and adds “an agitation
mechanism in communication with the suspension to prevent the
nanomaterials from settling.” App. Br. 23 (emphasis added). Appellants
dispute whether this limitation is taught in Lewkowicz. Id. at 14—15.
Claims 16 and 23 depend from independent claims 10 and 19 respectively,
and have similar limitations to the one disputed in claim 6.
The Examiner contends the disputed limitation is taught at paragraph
51 of Lewkowicz. Final Act. 2; Ans. 6. More specifically, according to the
Examiner, “Lewkowicz discloses the internal filling is a suspension or liquid
comprising small particles or molecules and can produce pressure within the
device and further contain fillers to provide mechanical stability.” Ans. 6.
The Examiner also asserts that “[i]f the prior art structure is capable of
performing the intended use, then it meets the claim.” Id.
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We are not persuaded the Examiner met the burden to show that
claims 6, 16, and 23 are anticipated by Lewkowicz. Here too, the Examiner
is improperly picking and choosing between embodiments for a rejection
under § 102. Moreover, the Examiner fails to explain how the cited
language in paragraph 51 of Lewkowicz satisfies the claimed “agitation
mechanism.” This is a structural element, not just an “intended use” as the
Examiner asserts. Id. And the Examiner does not clearly identify a structure
in the cited portions of Lewkowicz that is even capable of agitating (i.e.,
pumping, mixing, or vibrating) the nanomaterials to keep them from settling.
See, e.g., Spec. 10:19-20. For these reasons, we reverse the rejection of
claims 6, 16, and 23.
Conclusion
The preponderance of the evidence supports the Examiner’s finding
that claims 1, 4, 7, 10, and 19 are anticipated by Lewkowicz.
The preponderance of the evidence does not support the Examiner’s
finding that Lewkowicz anticipates claims 5, 15, and 22, or claims 6, 16, and
23. Those rejections are reversed but, for reasons explained, we enter a new
ground of rejection for claims 5, 15, and 22 under § 103.
II & III
The Examiner rejected claims 26 and 32 as obvious over Toms and
Alfano (Rejection II), and rejected claims 29 and 30 over Toms, Alfano, and
Lewkowicz (Rejection III). Final Act. 3^4.
The Examiner, citing only paragraph 78, finds Toms discloses the
method of claim 26 except for “subtracting the first imageable response from
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the second imageable response to provide an image of the medical device
relative to the subject.” Id. at 3^4; see Toms 178. The Examiner turns to
Alfano as teaching the “subtracting” step. Id. at 4. The Examiner relies on
Lewkowicz as teaching certain elements in dependent claims 29 and 30. Id.
There is one issue here that is dispositive on Rejections II and III:
whether the portion of Toms cited by the Examiner teaches “exciting
nanomaterials included in a medical device” as recited in claim 26, from
which each of claims 29, 30, and 32 depend. App. Br. 18. Appellants argue
the Examiner misinterprets claim 26 (and Toms) by contending the
nanomaterials and the medical device are one and the same. According to
Appellants, “[ujnder the Examiner’s interpretation, the nanomaterials would
be the recited medical device.” Id. The Examiner does not dispute this
characterization. Indeed, the Examiner’s Answer offers no response to
Appellants’ arguments on the obviousness rejections. And, in the Advisory
Action, the Examiner states “applicant has failed to provide a special
definition or meaning for the term medical device,” so “the nanomaterials
can be interpreted to the medical device.” Adv. Act. 2.
Appellants have the better position on this record. The relevant
phrase in claim 26 is “exciting nanomaterials included in a medical device.”
App. Br. 26. This indicates the nanomaterials and the medical device
(whatever it may be) are not the same thing. The Examiner’s reading
renders claim language superfluous, and results in the illogical conclusion
that nanomaterials are included in themselves. Stumbo v. Eastman
Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (rejecting construction
that makes claim terms superfluous). Even the broadest reasonable
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interpretation does not justify such a result. The Examiner has not shown
that the cited teachings in Alfano or Lewkowicz make up for this deficiency.
SUMMARY
We affirm the rejection of claims 1, 4, 7, 10, and 19 as anticipated by
Lewkowicz.
We reverse the rejection of claims 5, 15, and 22 as anticipated by
Lewkowicz, but enter a new ground of rejection of claims 5, 15, and 22 as
obvious over Lewkowicz.
We reverse the rejection of claims 6, 16, and 23 as anticipated by
Lewkowicz.
We reverse the rejection of claims 26 and 32 as obvious over Toms
and Alfano, and also reverse the rejection of claims 29 and 30 as obvious
over Toms, Alfano, and Lewkowicz.
This decision contains a new ground of rejection pursuant to 37
C.L.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
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binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01 (9th
Ed, Rev. 07.2015, Nov. 2015).
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-IN-PART; 37 C.F.R, § 41.50(b)
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