Denis Markov et al.

Patent Trials and Appeals Board

Aug 30, 2019

12935018 - (D) (P.T.A.B. Aug. 30, 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.
12/935,018 09/28/2010 Denis Markov 2008P00291WOUS 1220
24737 7590 08/30/2019
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
JONES, DAMERON LEVEST
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/30/2019 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):
katelyn.mulroy@philips.com
marianne.fox@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
__________

Appeal 2018-008846
Application 12/935,0181
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”), which have
been rejected as anticipated and/or obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
This Application returns to us after Appellants elected continued
examination following our Decision affirming the Examiner’s anticipation

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

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and obviousness rejection made in the Final Action dated November 15,
2013. During the continued examination, Appellants amended the method
claim to more specifically recite the components of the biocompatible
product and the manner of visually monitoring that product, presumably to
address our conclusion in the prior decision that the prior art relied upon by
the Examiner met the Specification’s definitional requirement of a
“biocompatible product” under the broadest reasonable construction, and
taught imaging the biocompatible product. Ex Parte Markov, Appeal 2015-
000546, slip op. 6–9 (PTAB Aug. 30, 2016) (“Prior Decision”).
Claims 2–9, 12, 13, 17, and 18 are on appeal. Claim 12 is
representative and reads as follows:
12. A method for visually monitoring a biocompatible
product, comprising:
introducing a biocompatible product comprising at least
one magnetic particle imaging (MPI) tracer agent into a body of
a subject, the biocompatible product further comprising at least
one of an artificial tissue construct, a microcarrier, a
microcontainer and an implant; and
visually monitoring the biocompatible product by
detecting signals arising from the at least one MPI tracer agent
by magnetic particle imaging over a period of time sufficient
for tissue development, tissue remodelling and/or degradation
of the biocompatible product to occur in the body of the
subject.
(Appeal Br. 15.)

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The following grounds of rejection by the Examiner are before us on
review:
Claims 3, 5, 7, 9, 12, 13, and 17 under 35 U.S.C. § 102(b) as
anticipated by Feldmann.2
Claims 2–9, 12, 13, 17, and 18 under 35 U.S.C. § 103(a) as obvious
over Rosengart.3
DISCUSSION
Claim Construction
Appellants’ disagreement with the Examiner’s prior art rejection rests
in large part on the construction of the term “microcarrier” in claim 12
(Appeal Br. 7–8; Reply Br. 2–3) and “monitoring . . . by magnetic particle
imaging over a period of time sufficient for” (Appeal Br. 8–9; Reply Br. 3–
4).
The Examiner contends that the term “microcarrier” encompasses a
coating surrounding a magnetic particle tracer agent. (Final Action 3.)
Appellants contend that such a “shell” cannot be a microcarrier because
claim 7 requires that “the at least one MPI tracer agent is surrounded by a
pharmaceutically acceptable shell” and thus the shell of that claim “must be
differentiable from the artificial tissue construct, the microcarrier, the
microcontainer and the implant defined in independent claim 12.” (Appeal
Br. 7; Reply Br. 3.)
The Examiner contends that imaging the coated magnetic particle
tracer agent to detect the signal of that particle, which can only take place so

2 Feldmann et al., WO 2005/046733A1, published May 26, 2005.
3 Rosengart et al., US 2006/0025713 A1, published Feb. 2, 2006.
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long as the particle remains in the body, meets the visually monitoring step,
which does not require a series of images be generated. (Ans. 11; Final
Action 3.) Appellants contend that monitoring over a period of time
sufficient for some action to occur requires “making multiple visual
observations during the specified period” which requires that a series of
images be checked to determine any changes over time. (Reply Br. 3–4.)
Microcarrier
We first construe microcarrier as used in claim 12.
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). Appellants define the terms
“microcarrier” and “pharmaceutically acceptable shell” in the Specification
as follows:
As used herein, the term “microcarrier” refers to a rigid or
semi-rigid optionally porous particulate material used to
support cell culture or as drug delivery system.
. . .
A “pharmaceutically acceptable shell” within the context of the
present invention is a layer of a substance or a substance
mixture which covers the core of the MPI tracer agent in such a
way that, when administered to a patient, life-threatening side
effects do not arise.
(Spec. 4.) While separate definitions are provided for these terms, we
conclude that the terms are not mutually exclusive. That is a material which
is pharmaceutically acceptable and covers a magnetic particle as well as
preventing life-threatening side effects from arising may also be capable of
acting in the capacity as a drug delivery system. When the shell acts in such
a manner, it would be considered a microcarrier as well.
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Claim 8, which depends from claim 7, requires the shell to have a
particular component, i.e., “at least one ligand immobilized on the surface.”
This, again does not render the shell to be mutually exclusive from a
microcarrier. Rather, this simply specifies an element of the shell which
may serve to enhance drug delivery.
“Under the doctrine of claim differentiation, it is presumed that
different words used in different claims result in a difference in meaning and
scope for each of the claims.” Clearstream Wastewater Sys., Inc. v. Hydro-
Action, Inc., 206 F.3d 1440, 1446 (Fed. Cir. 2000). We do not find this
doctrine vitiated by the foregoing interpretation. It is certainly true that
claims 7 and 8 can be understood to define a structure that is different from
the microcarrier, but as just discussed, under the broadest reasonable
interpretation, they can also be understood to further refine the structure of
the microcarrier, thereby providing a different meaning from claim 12. In
summary, we determine that the term “microcarrier” as used in claim 12
encompasses a layer of material forming a shell that surrounds the magnetic
particle imaging tracer agent.
Visually monitoring
Next we construe the “visually monitoring” phrase. The plain
language of the limitation requires monitoring occur over a period of time,
which includes a time period sufficient such that degradation of the
biocompatible product would occur in the body of the subject. Moreover,
the visual form of the monitoring for this period requires detecting signals
arising from the at least one MPI tracer agent by magnetic particle imaging.
While we agree with the Examiner that the claim does not require a series of
images be taken, it nevertheless requires a method by which the signals can
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be detected visually during a certain period of time, e.g. live feed video
surveillance.
Anticipation
The Examiner finds Feldmann discloses methods that use magnetic
particles that are visually monitored in cells and tissues. (Final Action 3.)
The Examiner notes that the particles comprise a magnetic core and a shell
and are administered in an amount effective to generate an image of the cell
or tissue and the distribution of the particles are imaged with an imaging
device. (Id.) The Examiner finds that, while Feldmann does not specifically
state that degradation of the particles occur in the body, such would
“inherently occur as the subject (e.g., target area) may only be imaged [for]
only as long as the biocompatible product remains in the body.” (Id. at 3–4.)
We disagree with the Examiner’s conclusion that Feldmann
anticipates the method set forth in claim 12. The Examiner contends that the
visually monitoring limitation is met because the biocompatible product may
only be imaged with an imaging device as long as it remains in the body,
i.e., before it is excreted. (Final Action 3–4.) However, that imaging may
only occur prior to excretion of the MPI does not establish that Feldmann
teaches imaging for a period of time sufficient for degradation of the
biocompatible product to occur. With respect to duration, Feldmann simply
indicates that the pharmaceutical formulation is administered “in an amount
sufficient to generate the cell, tissue, or body image” and imaging is of “the
distribution of the pharmaceutical formulation.” (Feldmann 12:20–22).
Therefore, we agree with Appellants that Feldmann does not expressly or
impliedly teach the visually monitoring step as claimed.
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Consequently, we do not sustain the Examiner’s rejection of claims 3,
5, 7, 9, 12, 13, and 17 as being anticipated by Feldmann.

Obviousness
The Examiner finds that Rosengart teaches a magnetic particle based
therapy and diagnostic method that uses a magnetic particle that may be
coated with a biocompatible polymer such as polylactic co-glycolic acid or
polylactic acid. (Final Action 8.) The Examiner finds that the “composition
may be used to treat or diagnose a disease, disorder, or condition in a
subject, or to remove, inhibit, or inactivate a deleterious substance.” (Id.)
The Examiner finds that the method includes “simultaneously
monitoring and treating a stent surrounding tissue or organ system by
combining magnetic spheres suitable for both diagnosis and treatment.”
(Id.) The Examiner also finds that Rosengart discloses that “the method may
be use[d] with ultrasound to release encapsulated active compound from the
magnetic particles due to degradation which facilitates visualization of the
target cell, [or] tissue.” (Id. at 10 (citing Rosengart ¶ 161).) Thus, the
Examiner concludes that Rosengart detects “signals from the magnetic
agent(s) at the target site or during degradation.” (Id.) The Examiner
concludes that the inventions of Rosengart disclose overlapping subject
matter with the claimed invention. (Id.)
We disagree with the Examiner’s conclusion that Rosengart renders
the method of claim 12 obvious. We disagree with the Examiner that
Rosengart monitors the magnetic particle over a period of time sufficient for
tissue development or tissue remodeling or degradation of the biocompatible
product to occur. We agree with Appellants that Rosengart is directed to a
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method for drug delivery that assists in removing deleterious material from a
biological system. (Appeal Br. 11; Rosengart ¶¶ 21, 22.) It is also true that
Rosengart describes using magnetic particles introduced to a patient as
diagnostic agents. (Rosengart ¶¶ 27, 42.) But, Rosengart does not provide
for a specific time period for imaging the particle when used as a diagnostic
agent.
Paragraph 161 of Rosengart, to which the Examiner refers as teaching
the use of ultrasound which facilitates imaging, does not teach a time period
for which imaging must take place. (Rosengart 161.) The ultrasound energy
is used to trigger the release of encapsulated active agent that results in
treating a blood clot. It is true that Rosengart notes that the ultrasound
energy may cause release of the encapsulated plasminogen activator such
that the particle is degraded “sufficient to release encapsulated compounds.”
(Id.) However, there is no mention of imaging until the biocompatible
product is degraded.
While it may be the case that the ultrasound is also used to image the
clot tissue to which the active agent is administered, there is no mention of
imaging until the biocompatible product is degraded. And, the Examiner
does not provide persuasive reasoning or evidence to establish why one of
ordinary skill in the art would have found it obvious to modify Rosengart to
image over a period of time “until the biocompatible product is degraded.”
Consequently, we do not sustain the Examiner’s rejection of claims 2–
9, 12, 13, 17, and 18 under 35 U.S.C. § 103(a) as being obvious over
Rosengart.
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SUMMARY
We reverse the rejection of claims 3, 5, 7, 9, 12, 13, and 17 under 35
U.S.C. § 102(b) as anticipated by Feldmann.
We reverse the rejection of claims 2–9, 12, 13, 17, and 18 under 35
U.S.C. § 103(a) as obvious over Rosengart.

REVERSED