Ex Parte Markov et al

Patent Trial and Appeal Board

Aug 26, 2016

12935018 (P.T.A.B. Aug. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/935,018 09/28/2010 Denis Markov
24737 7590 08/30/2016
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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.
2008P0029 l WOUS 1220
EXAMINER
JONES, DAMERON LEVEST
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/30/2016 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):
marianne.fox@philips.com
debbie.henn@philips.com
patti. demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DENIS MARKOV and HANS MARC BERT BOEVE 1
Appeal 2015-000546
Application 12/935,018
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of using a magnetic particle imaging tracer agent to visually monitor a
biocompatible product via magnetic particle imaging ("MPI"), and a
computer-readable medium embodying instructions to configure a process to
carry out the method, which have been rejected as anticipated and obvious.
The computer-readable medium claim has also been rejected for containing
new matter not described in the originally-filed application. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as KONINKLIJKE PHILIPS
ELECTRONICS N.V. (Appeal Br. 3.)
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Application 12/935,018
STATEMENT OF THE CASE
"The present invention relates to ... [a] method[] for non-invasive
imaging of biocompatible products." (Spec. 1:7-8.) Claims 2-15 are on
appeal. Claims 12 and 15 are representative and read as follows:
12. A method comprising a step of using a magnetic particle
imaging (MPI) tracer agent to visually monitor a biocompatible
product using magnetic particle imaging, the biocompatible
product comprising at least one MPI tracer agent.
15. A non-transitory computer readable medium embodying
computer instructions which, when executed by a processor,
configure the processor to visually monitor a biocompatible
product using the method of claim 12.
(Appeal Br. 14.)
The following grounds of rejection by the Examiner are before us on
review:
Claim 15 under 35 U.S.C. § 112, first paragraph, as failing to comply
with the written description requirement for reciting a limitation which was
not clearly disclosed in the specification as-filed.
Claims 5, 7, 9, 10, and 12-14 under 35 U.S.C. § 102(b) as anticipated
over Feldmann. 2
Claims 2-15 under 35 U.S.C. § 103(a) as obvious over Feldmann,
Hamm, 3 and Gleich. 4
2 Feldmann et al., WO 2005/046733Al, published May 26, 2005.
3 Hamm et al., US 2004/0030379 Al, published Feb. 12, 2004.
4 Gleich, WO 2004/091397 A2, published Oct. 28, 2004.
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Claim 15: New Matter
DISCUSSION
The Examiner finds that the "non-transitory computer readable
medium embodying computer instruction" recited in claim 15 does not have
adequate written description support in the Specification as originally filed.
(Final Action 3; Non-Final 3--45; Ans. 2.) In particular, the Examiner
contends that because "a non-transitory computer readable medium
embodying computer instructions, e.g., floppy disk, disk, or computer disk
readable-only memory (CD-ROM), is neither recited in the claim nor
disclosed in the instant specification," the limitation "a non-transitory
computer readable medium embodying computer instructions" is "new
matter." (Final Action 4.) The Examiner acknowledges Appellants' position
that "magnetic fields are imperceptible to human beings without some sort
of hardware assistance" and that "magnetic particle imaging, as discussed
throughout the present Specification, must inherently involve a processor
interacting with a non-transitory computer readable medium." (Non-Final
10.) However, the Examiner notes that "[t]he instant invention disclosed
modes of imaging, not specific equipment/devices/apparatus used for the
various imaging modalities." (Ans. 4.) And "if Appellants['] intended to
claim specific components utilized in the various imaging modalities, then
the specification should have included such disclosure" in "full, clear,
concise, and exact" terms in the written description in order to avoid a new
matter rejection. (Ans. 3--4.)
5 Non-Final Office Action dated Apr. 24, 2013.
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We disagree with the Examiner's conclusion that the claimed "non-
transitory computer readable medium" is "new matter" to the application as
originally filed. "The presence or absence of literal support in the
specification for the claim language" is not determinative of whether the
application as originally filed supports the later claimed subject matter. In re
Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983). "The test for determining
compliance with the written description requirement is whether the
disclosure of the application as originally filed reasonably conveys to the
artisan that the inventor had possession at that time of the later claimed
subject matter." Id.; Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (en bane). "[T]he test requires an objective inquiry
into the four comers of the specification from the perspective of a person of
ordinary skill in the art ... [to determine whether] the specification ...
describe[ s] an invention understandable to that skilled artisan and show[ s]
that the inventor actually invented the invention claimed." Ariad, 598 F.3d
1351.
Appellants contend that the Specification adequately describes the
claimed computer readable medium at least because the Specification refers
to detecting signals by magnetic particle imaging, which involves magnetic
field measurements. (Appeal Br. 5---6.) Appellants explain that one of
ordinary skill in the art would understand that because magnetic fields are
not "naturally perceptible to human beings," MPI described in the
Specification for "direct 3D imaging of magnetic particles, i.e., MPI tracer
agents" necessarily requires "a processor interacting with a non-transitory
computer readable medium." (Appeal Br. 5---6.) In light of the foregoing,
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we agree with Appellants that the Specification as filed would reasonably
convey to one of ordinary skill in the art that the inventors had possession of
the claimed non-transitory computer readable medium, i.e., one that
embodies "instructions which, when executed by a processor, configure the
processor to visually monitor a biocompatible product using [a magnetic
particle imaging tracer agent to visually monitor a biocompatible product
using magnetic particle imaging]." (Claim 15.)
For the foregoing reasons, the Examiner's new matter rejection of
claim 15 under 35 U.S.C. § 112, first paragraph is reversed.
Claim 12: Anticipation
The Examiner finds that Feldmann teaches the method of claim 12.
(Final Action 3; Non-Final 5; Ans. 6.) In particular, the Examiner finds that
the contrast medium that includes iron oxide particles, such as yFe20 3 in the
core, meets the magnetic particle imaging tracer agent requirement, as well
as the biocompatible product requirement-the yFe20 3 being the MPI tracer
agent. (Non-Final 5; Ans. 6.) Regarding the method, the Examiner
contends that Feldmann teaches administering the contrast agent to a living
organism and imaging, by MPI, the distribution of the contrast agent. (Non-
Final 5---6; Ans. 6-7 (noting that the imaging modalities disclosed, including
MPI, are a "visual representation (monitoring) of the location at which the
particles are found" over time as they are "localizing at the target area").)
According to the Examiner, because an MPI tracer agent is used to image,
Feldmann inherently discloses the required use of an MPI tracer agent to
"visually monitor a biocompatible product." (Final Action 3; see also
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Ans. 7 ("if one is administering the particles to a subject for medical
imaging purposes, then not only are those particles localizing at the target
area, but the imaging modalities are the visual representation (monitoring) of
the location at which the particles are found").) The Examiner also notes, in
regard to monitoring, that the claims "do not require that one visually review
the contrast agent for extended periods of time." (Ans. 7.)
We agree with the Examiner's factual finding and conclusion that
Feldmann anticipates the method set forth in claim 12.
We disagree with Appellants (Reply Br. 7) that the Examiner has
"fail[ ed] to consider the scope of the method of claim 12 in view of the
definition for 'biocompatible product' provided in the specification." To the
contrary, the Examiner has properly given claim 12 the "broadest reasonable
interpretation consistent with the specification." In re Hyatt, 211F.3d1367,
1372 (Fed. Cir. 2000). We agree with the Examiner that Feldmann's
contrast agent, whose core includes yFe20 3, meets the definitional
requirement provided in the Specification of a "biocompatible product."
(Non-Final 5; Advisory Action6 2.) As the Appellants recognize (Appeal
Br. 8), the biocompatible product as defined in the Specification simply has
to be an "artificial product that does not cause toxic or injurious effects on
biological systems." (Spec. 3:31--4:1.) The contrast agent used in Feldmann
is such a product. Indeed, Appellants do not argue to the contrary, just that
Feldmann does not teach "a method of using contrast agents in order to
image an artificial biocompatible product such as an implant or scaffold."
6 Advisory Action dated Mar. 6, 2014.
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(Appeal Br. 9 (emphasis added).) However, while implants and scaffolds
are described in Appellants' Specification as examples of biocompatible
products (Spec. 6:15-21, 9:5-15), they are not the only examples in the
Specification, and we find no suggestion in the intrinsic record that
Appellants intended claim 12, which simply requires "a biocompatible
product," to have so limited a scope. Indeed, other examples of
biocompatible products described in the Specification include
"microspheres, liposomes, and nanoparticles." (Spec. 7: 12-16.)
Moreover, as the Examiner noted (Non-Final 5), the contrast agent
comprises at least one MPI tracer agent-y F e20 3. This meets claim 12 's
requirement of "the biocompatible product comprising at least one MPI
tracer agent."
Furthermore, we also disagree with Appellants that "Feldmann also
fails to teach 'visual monitoring' as recited in the method of claim 12"
(Reply Br. 8). Regardless of whether the contrast agent "is introduced
intravenously or by like means to a target site of a living organism to
increase the image sensitivity of certain organs or tissues at the target site
(Feldmann, p. 13, line 5)," (Appeal Br. 9), as the Examiner explained,
Feldmann teaches visually monitoring the biocompatible product. (Advisory
Action 2; Ans. 6-7.) That is so because, in the MPI technique disclosed in
Feldmann, the contrast agent that is administered in a pharmaceutical
formulation for medical imaging purposes is detected by an imaging
technique that "image[s] the distribution of the pharmaceutical formulation."
(See, e.g., Feldmann 12:6-23, 17:16-20:30 (Examples 7-11 describing
contrast agents that can be used for magnetic particle imaging).)
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Appellants contend that "[t]he step of 'visual monitoring' requires that
a series of imaging be conducted over a period of time" and that Feldmann
does not teach this. (Reply Br. 8.) We disagree with Appellants' claim
interpretation. Claim 12 does not recite obtaining a "series of imaging" in
order to "visually monitor," nor does the Specification define "visually
monitor" in such a fashion. Indeed, no special definition is provided in the
Specification for the term "visually monitor." Thus, we agree with the
Examiner that, under the broadest reasonable construction of the phrase in
claim 12, the imaging modalities taught by Feldmann for which the contrast
agent can be used to image inherently provide a visual representation of the
contrast agent location, i.e., visual monitoring of the "biocompatible
product." (Ans. 7.)
We also agree with the Examiner that Feldman teaches monitoring
using MPI. (Non-Final 7-8.) Feldmann indicates that the detection of the
contrast agent can be accomplished using "a magnetic resonance
tomography (MRI) device, a magnetic particle imaging device, a positron
emission tomography (PET) device, a single photon emission computed
tomography (SPECT) device, a computed (CT) tomography device, or an
ultrasound (US) device, or equivalent." (Feldmann 12: 6-25). There is no
question that Feldmann would anticipate if it contained a working example
of administering the contrast agent and MPI was used to measure the
distribution of the contrast agent. In re Slayter, 2 7 6 F .2d 408, 411 ( CCP A
1960) ("It is well settled that a generic claim cannot be allowed to an
applicant if the prior art discloses a species falling within the
claimed genus."). However, working examples are not the sole manner by
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which a reference can be found to anticipate. The disclosure of a small
genus may anticipate a species. Bristol-Myers Squibb Co. v. Ben Venue
Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001). For that to be the case,
the genus must be limited to the extent that a person of ordinary skill in the
art can "at once envisage each member of [the] limited class [of elements
embraced by the genus]." Eli Lilly & Co. v. Zenith GoldlinePharms., Inc.,
471 F.3d 1369, 1376 (Fed. Cir. 2006). Feldmann specifies six imaging
methods that can be used, and notes that the contrast agent of the invention
is administered in an amount that would enhance any one of those imaging
methods. (Feldmann 12: 6-25). While Feldmann does not provide a
working example of using magnetic particle tracer agents to visually monitor
the contrast agent using magnetic particle imaging, the small genus of
imaging techniques disclosed in Feldmann along with Feldmann's disclosure
that the contrast agent "fulfil[l]s the special requirements of the medical
imaging technique of medical particle imaging" (Spec. 6:23-32), would
allow a person of ordinary skill in the art to "at once envisage" using
magnetic particle imaging to visually monitor the contrast agent. Id. Thus,
we agree with the Examiner's implicit conclusion that Feldmann's
disclosure of the small genus of methods for monitoring the contrast agent
that includes MPI anticipates claim 12.
For the foregoing reasons, we affirm the Examiner's anticipation
rejection of claim 12 over Feldmann.
Claims 5, 7, 9, 10, 13, and 14 have not been argued separately, and
therefore, fall with claim 12. 37 C.F.R. § 41.37(c)(l)(iv).
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Claim 12: Obviousness
The Examiner finds that Feldmann does not teach biocompatible
products such as an implant with an MPI tracer agent adhered to the surface
of it and then evaluating MPI data obtained. (Final 4; Non-Final 8.) The
Examiner finds, however, that Hamm and Gleich teach the foregoing. (Non-
Final 8-9.) In particular, the Examiner notes that Hamm teaches "coating
magnetic particles ... such as iron oxide particles ... which read on [the
claimed] MPI tracer agent," on an implantable medical device, such as
sutures. (Non-Final 8.) The Examiner further finds that the magnetic
coating on the implantable medical device is further coated with a
biologically active material that is released from the implanted medical
device on application of an external energy source, "such as MRI ... which
can also locate [the] implanted medical device." (Non-Final 8-9.)
The Examiner finds that Gleich teaches a magnetic particle imaging
method involving evaluating the signal from the MPI tracer agent, such as
yFe203, to obtain information about the change in the spatial distribution of
the magnetic particles in order to determine substance concentrations. (Non-
Final 9-10.)
The Examiner concludes that it would have been obvious to
incorporate the coated implants of Hamm, e.g., sutures with the coated MPI
tracer agent and biologically active material, into the method of Feldmann so
that a person of ordinary skill in the art can not only locate the
biocompatible product, "but also permit on-demand delivery of drug from
the implanted medical device. (Non-Final 10.) The Examiner contends that
one of ordinary skill in the art would have had a reasonable expectation of
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success in this modification because both Feldmann and Hamm "are in the
same field of endeavors such as using iron oxide particles for imaging."
(Non-Final 10-11.) The Examiner further concludes that it would have been
obvious to one of ordinary skill in the art to use MPI and evaluate the
obtained data in the Feldmann method in order to "obtain information about
the change in the spatial distribution of the magnetic particles to determine
substance concentration" regarding the implanted medical device. (Non-
Final 11.)
We agree with the Examiner's factual findings and conclusion that the
method of claim 12 would have been obvious over Feldmann, Hamm, and
Gleich.
Appellants argue that the Examiner's rejection is in error because
Hamm is directed to MRI not MPI and Gleich does not "teach or suggest at
least, 'using a magnetic particle imaging (MPI) tracer agent to visually
monitor a biocompatible product using magnetic particle imaging, the
biocompatible product comprising at least one MPI tracer agent,' as in claim
12." (Appeal Br. 10-11.) We do not find these arguments persuasive. In
particular, with respect to Appellants' argument that Gleich does not teach
or suggest the entirety of claim 12, we note the rejection is for obviousness
based on a combination of references, not Gleich alone. As discussed above,
Feldmann by itself meets the limitations of claim 12. However, the
Examiner further rejected the claims as obvious to address additional
biocompatible products within the scope of Appellants' invention. In that
regard, we find the Examiner provided sufficient reason explaining why it
would have been obvious to substitute the biocompatible product with an
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MPI tracer agent as taught in Hamm into the method of Feldmann. (Final
Action 10-11; Ans. 10-11.)
In particular, as Feldmann explains, "[t]he basic principle [of MPI] is
based on conventional magnetic resonance imaging (MRI)." (Feldmann 1:
20-22.) Moreover, Hamm teaches the use of magnetic particles that meet
the size of the magnetic particles taught for use in Feldmann (which is
within claimed range). (Compare Hamm i-f45 (noting "[t]he average size of
the particles is within the range from about 0.01 µm to about 10 µm") with
Feldmann 18: 5-18 (Example 8), 9:18-21, and Appeal Br. 13 (claim 9
(reciting that the "at least one MPI tracer agent has a particle size between 5
and 5000 nm").) As the Examiner noted, the person of ordinary skill in the
art would have been motivated to use Hamm's coated implants in the
Feldmann method because, by doing so, "the person of ordinary skill in the
art can "use magnetic particle (see [0025] and Figure 4A of HAMM) as a
carrier molecule (see [0030] of HAMM) to release a biologically active
material such as nitric oxide adduct (see [0030] and [0072] of HAMM)" and
thus "not only locate the biocompatible product such as an implanted
medical device (see [0085] of Hamm et al) but also permit on-demand
delivery of drug from the implanted medical device (see [0004] and [0049]
of Hamm et al), and reasonably expect success since both Feldman et al and
Hamm et al are in the same field of endeavors (the documents both involve
using iron oxide particles for imaging purposes)" (Id.)
Moreover, we agree with the Examiner that
It would have been obvious to the person of ordinary skill in the
art at the time the invention was made to incorporate evaluating
the obtained MPI data into FELDMANN's method. The person
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of ordinary skill in the art would have been motivated to make
those modifications because, by doing so, the person of
ordinary skill in the art can obtain information about the change
in the spatial distribution of the magnetic particles to determine
substance concentration (see Abstract of GLEICH) in the
biocompatible product such as implanted medical device (see
[0085] of HAMM), and reasonably would have expected
success because FELDMANN, GLEICH, and HAMM are in
the same field of endeavors such as using iron oxide particles
for imaging.
(Final Action 11; Ans. 11-12.)
Claims 2-11 and 14 have not been argued separately, and therefore,
fall with claim 12. 37 C.F.R. § 41.37(c)(l)(iv).
While Appellants purportedly argue claim 15 separately, Appellants
do not advance any specific argument regarding the rejection of claim 15
other than referring to their arguments made in connection with the rejection
of claim 12. (Appeal Br. 5.) For the reasons discussed with respect to claim
12, we affirm the Examiner's rejection of claim 15 as being obvious over
Feldmann, Hamm, and Gleich.
SUMMARY
We reverse the rejection of claim 15 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement for
reciting a limitation which was not clearly disclosed in the specification as-
filed.
We affirm the rejection of claims 5, 7, 9, 10, and 12-14 under 35
U.S.C. § 102(b) as anticipated over Feldmann.
We affirm the rejection of claims 2-15 under 35 U.S.C. § 103(a) as
obvious over Feldmann, Hamm, and Gleich.
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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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