Ex Parte Stukanov

Board of Patent Appeals and Interferences

Mar 15, 2012

11789108 (B.P.A.I. Mar. 15, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte IGOR IGOREVICH STUKANOV
__________

Appeal 2011-008932
Application 11/789,108
Technology Center 1600
__________

Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of reducing neurotoxicity. The Examiner rejected the claims as containing
new matter, as failing to comply with the written description requirement, as
indefinite, and as non-enabled. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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Statement of the Case
Background
The Specification teaches “a method for oral delivery of new drugs,
molecules, proteins, and other healing substances to the targeted place in the
body via digestive tract, using the autonomous mobile self-controlled
capsules directed by control systems on the internal chip inside the capsule”
(Spec. 2).
The Claims
Claims 1-6 are on appeal. Claims 1-6 are reproduced below:
1. An autonomous method for delivery of a healing substance
to a target place in gastrointestinal tract or blood system,
comprising the following steps:
a) a healing substance is placed into a mobile autonomous
self-controlled capsule with a healing substance delivery
mechanism, sensors and internal chip (or chips) with a control
system installed on it;
b) a digital image of a targeted region is loaded into
memory of said chip;
c) the capsule enters into the gastrointestinal tract via
mouth of a patient and moves toward said targeted place;
d) the capsule is directed to said targeted place via control
signals sent from said control system ;
e) signals from said sensors are sent to said control system
on said internal chip inside the capsule;
f) the control system compares digital images received
from said sensors with the digital image of said targeted place
stored on said chip to determine if said targeted place is reached;
g) when the capsule reaches said targeted place, said
control unit sends a signal to release said healing substance and
this healing substance is released from the capsule and directed to
said targeted place by said healing substance delivery
mechanism.

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2. The method as in claim 1, where said healing substance is
a composition of chemical elements in solid or fluid or gas form.

3. The method as in claim 1, where said healing substance is
a set of electromagnetic waves from a source of electromagnetic
waves.

4. The method as in claim 1, where said healing substance is
a set of mechanical waves from a source of mechanical waves.

5. The method as in claim 1, where said healing substance is
a set of sound or ultrasound waves from a source of sound or
ultrasound waves.

6. The method as in claim 1, where said healing substance is
a flow of physical particles from a source of physical particles.

The issues
1

A. The Examiner rejected claims 1-6 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement by
containing new matter (Ans. 7-9).

1
Appellant should be aware of the mandates of 37 C.F.R. § 1.3,
which reads “[a]pplicants and their attorneys or agents are required
to conduct their business with the United States Patent and
Trademark Office with decorum and courtesy ….” We recognize
that Appellant is pro se, but Appellant makes a number of
statements which are not in compliance with the rule (see, e.g.,
“even a person with English as a second language” (App. Br. 4),
“Knowledge of how to place something into a container is
available even to a chimpanzee” (App. Br. 7)). Based on these
unfortunate remarks and others, the entirety of the Brief was
susceptible to non-entry. It should be evident that disparaging
remarks by Appellant do nothing to advance his cause.
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B. The Examiner rejected claims 1 and 3-6 under 35 U.S.C. § 112,
second paragraph as indefinite (Ans. 9, 39-41).
C. The Examiner rejected claims 1-6 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement
(Ans. 11-23).
D. The Examiner rejected claims 1-6 under 35 U.S.C. § 112, first
paragraph because the specification does not reasonably provide enablement
for the claimed invention (Ans. 24-38).
A. 35 U.S.C. § 112, first paragraph, new matter
The Examiner finds that
Claims 1 - 6 introduce new matter as the claims recite the
limitations: “an autonomous method for delivery ... e) ... to
determine if said targeted place is reached ...” (claim 1);
“from a source of electromagnetic waves” (claim 3); “from a
source of mechanical waves” (claim 4); from a source of
sound or ultrasonic waves” (claim 5), “from a source of
physical particles” (claim 6).

(Ans. 7.)
Appellant contends that the “Examiners [sic] interpreted the claims
without any regard not only to the current status of the art, but also to simple
human logic, which resulted in violation of USPTO rules” (App. Br. 4-5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s finding that the claims incorporate new matter?
Findings of Fact
1. The Specification teaches that the
internal control system on the chip compare images
receiving from imaging sensors with the image of a target
region, which is stored on the current or a separate chip. If
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the current image is similar to the pre-stored on the chip
image of the target region then the control system activates
the healing substance delivery mechanism for delivery of
healing substance. This mechanism directs the healing
substance to the targeted place.

(Spec. 3-4.)
2. The Specification teaches, in original claim 3, the “method as in
claim 1, where the healing substance is a set of electromagnetic waves”
(Spec. 6).
3. The Specification teaches, in original claim 4, the “method as in
claim 1, where the healing substance is a set of mechanical waves” (Spec.
6).
4. The Specification teaches, in original claim 5, the “method as in
claim 1, where the healing substance is a set of sound or ultrasound waves”
(Spec. 7).
5. The Specification teaches, in original claim 6, the “method as in
claim 1, where the healing substance is a flow of physical particles” (Spec.
7).
Principles of Law
“[T]he written description requirement does not demand either
examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the
written description requirement.” Ariad Pharmaceuticals, Inc. v. Eli Lilly
and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010).

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Analysis
The Specification has ipsis verbis support for a device with an internal
control system which includes a delivery mechanism which directs the
healing substance to a targeted location (FF 1). This provides literal support
for limitation in claim 1 for “[a]n autonomous method of delivery . . . to
determine if said targeted place is reached.”
In addition, while the Specification does not expressly recite a
“source” for the electromagnetic waves, mechanical waves, ultrasound
waves, or physical particles, the original claims 3-6 which teach either a set
of waves or flow of physical particles are reasonably interpreted as
demonstrating possession of the concept of a source component which
generates the waves or flow of particles.
Conclusion of Law
The evidence of record does not support the Examiner‟s finding that
the claims incorporate new matter.
B. 35 U.S.C. § 112, second paragraph
The Examiner finds it indefinite, regarding claim 1, “whether „it‟
refers to the mobile autonomous self-controlled capsule, the healing
substance delivery mechanism, or the internal chip” (Ans. 9). The Examiner
finds it indefinite “how one would obtain a „set‟ of electromagnetic waves, a
„set‟ of mechanical waves, a „set‟ of sound or ultrasonic waves, or a „flow‟
of physical particles. Moreover, it is not clear to the Examiner how one
would place such a „set‟ or „flow‟ into the capsule” (Ans. 40) (emphasis
removed).
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Appellant contends that an ordinary artisan would reasonably interpret
the claim so “that „it‟ relates to the „chip‟, because the chip is the last
element in the list of elements mentioned in the claim” (App. Br. 4).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that the claims are indefinite?
Principles of Law
“The test for definiteness is whether one skilled in the art would
understand the bounds of the claim when read in light of the specification.”
Miles Laboratories, Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir.
1993).
However, the fact that a claim is broad does not mean that it is
indefinite, and even undue breadth is not indefiniteness. In re Johnson, 558
F.2d 1008, 1016 n.17 (CCPA 1977).
Analysis
We find that the ordinary artisan would have recognized that in the
clause of Claim 1 which states “mobile autonomous self-controlled capsule
with a healing substance delivery mechanism, sensors and internal chip (or
chips) with a control system installed on it,” the word “it” is reasonably
understood as referring to the chip. While we appreciate the Examiner‟s
concern, the reasonable interpretation of the word “it” in claim 1 is that it
refers to the internal chip.
The Examiner also finds that the “set” of electromagnetic waves,
mechanical waves, ultrasonic waves and flow of particles recited in claims
3-6 are indefinite. With regard to claims 3, 5, and 6, which are drawn to a
“set” of electromagnetic waves, ultrasonic waves and flow of particles,
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respectively, we are not persuaded by the Examiner‟s rejection. The
ordinary artisan would recognize that a “set” of electromagnetic waves
broadly reads on any electromagnetic treatment, whether using a laser beam
or photoactivation with non-collimated light. Similarly, a “set” of
ultrasound waves or “flow” of physical particles broadly read on sound
waves or radionuclides, respectively. Each of these were well known
treatment modalities in the prior art, and the claims simply broadly claim the
treatments without limitation.
We find that claim 4 stands on a different ground. Claim 4 is drawn
to a “set of mechanical waves.” Appellant‟s Specification does not explain
what is meant by “mechanical waves,” nor does the Specification teach how
such “mechanical waves” would effect or cause any treatment of any
disease. Consequently, we conclude that this phrase is indefinite since the
skilled artisan would have no idea what is intended by the phrase
“mechanical waves.”
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that claim
4 is indefinite.
The evidence of record does not support the Examiner‟s conclusion
that claims 1-3, 5, and 6 are indefinite.
C. 35 U.S.C. § 112, first paragraph, description
The Examiner finds that “Applicant has not provided sufficient detail
to demonstrate possession of . . . what kind of „image of a targeted region is
loaded into memory of the chip,‟ . . . how does „[t]he control system
compare [] images received from the sensors with the image of the target
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place stored on the chip,‟ how does the capsule know when it has „reach[ed]
the targeted place‟” (Ans. 15-16).
Appellant contends that “[h]ow to make an autonomous self-
controlled (which does not require attention of a human operator)
device from a non-autonomous device is a 50 year old field with practical
applications used by NASA, military and robotic industry. If something is
practicing for over 50 years it means it is reduced to practice” (App. Br. 5).
Appellant contends that:
The application describes that a digital image of the target
place is loaded onto chip. When the capsule moves, an
image of the current position from the sensors is compared
with the image of the targeted place. A [sic] one of the
simplest methods is to check if the difference is not
significant (in limits of error) then the system considers that
the target place was reached. These are basic principles,
which are well known in the art and described in textbooks.
The targeted place is identified by a doctor, during
examination procedures. This is a standard practice and is
well known.

(Id. at 6.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s finding that the claims lack written descriptive
support?
Findings of Fact
6. The Examiner finds that “[n]o evidence of actual reduction to
practice was found in the specification” (Ans. 14).
7. The Examiner finds that “[n]o drawings, diagrams, or flow
charts were found in the specification” (id.).
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8. The Examiner finds that “[n]o method of identifying a target
place, obtaining an image of it, loading that image on a chip, or comparing
that image with data from sensors is disclosed” (id. at 17).
Principles of Law
“[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, … or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement.” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d at 1352.
“One shows that one is „in possession‟ of the invention by describing
the invention, with all its claimed limitations.” Lockwood v. American
Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
Analysis
Appellant expressly relies upon the prior art to satisfy the description
requirement, contending that he does “not need describe in details
components of the capsule (which are well known in the art)” (App. Br. 5).
Appellant “assumes that a person skilled in the art knows scientific and
engineering principles as well as able to find the relevant information
available in the public domain” (id.).
The Examiner has provided prior art, particularly Madar,
2
who teaches
an autonomous capsule (Madar, col. 2, l. 39). Madar teaches that the
capsule

2
Madar et al., US 7,515,953 B2, issued Apr. 7, 2009.
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is introduced into the lumen of the intestine. Cells in the
intestinal wall are illuminated from a light source mounted
to the solid support with a wavelength that excites a
particular fluorescent signal emitted by the fluorescent label
on the exogenous probe. A detector mounted to the solid
support detects whether illuminated cells emit the particular
fluorescent signal. If the particular fluorescent signal is
detected, then drug is released that kills the abnormal
intestinal cells.

(Madar, col. 3, ll. 33-41.)
Thus, relative to Madar and the other prior art cited by the Examiner,
the apparently novel aspect of Appellant‟s invention is the targeting system
where the
internal control system on the chip compare images
receiving from imaging sensors with the image of a target
region, which is stored on the current or a separate chip. If
the current image is similar to the pre-stored on the chip
image of the target region then the control system activates
the healing substance delivery mechanism for delivery of
healing substance. This mechanism directs the healing
substance to the targeted place.

(Spec. 3-4; FF 1.)
However, as explained by the Examiner, the Specification is silent
regarding how the system performs this comparison, nor is there any
disclosure of the mechanism, software, flow diagram or other logic by which
the chip is able to perform the complicated comparison required to
determine that a particular region of the intestinal tract is the targeted region
(FF 6-8). Indeed, there is no disclosure in the Specification of how an image
of the targeted region is initially obtained for comparison and used for
targeting.
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In addition, Appellant has not identified any prior art reference which
teaches prior identification of an intestinal region or other body lumen
followed by detection and comparison using an automated system, where the
automated system was sufficiently reliable to permit automated treatment
without review by a human. Thus, Appellant‟s reliance on the prior art for
descriptive support is misplaced.
The written description requirement “serves a teaching function, as a
„quid pro quo‟ in which the public is given „meaningful disclosure in
exchange for being excluded from practicing the invention for a limited
period of time.‟” Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922
(Fed. Cir. 2004). In this case, the Specification does not provide a
meaningful disclosure of the invention to the public in return for the grant of
a patent, failing to satisfy the basic quid pro quo underlying the patent
system.
Conclusion of Law
The evidence of record supports the Examiner‟s finding that the
claims lack written descriptive support.
D. 35 U.S.C. § 112, first paragraph, enablement
The Examiner finds that “one skilled in the art could not practice the
invention without undue experimentation” (Ans. 25).
Appellant contends that “the Examiners had requested more details in
descriptions of steps of the method and components of the capsule (such as
sensors, how images are loaded on chips, etc.) all of which are old
technologies well known in the art” (Reply Br. 3).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that undue experimentation would have
been required to perform the claimed method?
Findings of Fact (FF)
Breadth of Claims
9. Claim 1 is drawn to the use of any “healing substance” in the
gastrointestinal system or blood system where the capsule is delivered “via
mouth of a patient” and where a “control system compares digital images . . .
with the digital image of said targeted place stored on said chip to determine
if said targeted place is reached.”
Presence of Working Examples
10. The Examiner finds that no “specific structures are disclosed”
(Ans. 35).
Amount of Direction or Guidance Presented
11. The Examiner finds that “[n]o instruction is given on . . . how
to program the device to compare the images and to identify the target
location, . . . how to program the capsule to direct it to the target location”
(id. at 36).
State of the Prior Art and Unpredictability of the Art
12. Madar teaches an autonomous capsule (Madar, col. 2, l. 39).
13. Madar teaches that the capsule
is introduced into the lumen of the intestine. Cells in the
intestinal wall are illuminated from a light source mounted
to the solid support with a wavelength that excites a
particular fluorescent signal emitted by the fluorescent label
on the exogenous probe. A detector mounted to the solid
support detects whether illuminated cells emit the particular
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fluorescent signal. If the particular fluorescent signal is
detected, then drug is released that kills the abnormal
intestinal cells.

(Madar, col. 3, ll. 33-41.)
14. Frisch
3
teaches that a “method for detection of neoplasms . . .
includes the step of administering to a person a radioactively labeled
marking agent and . . . inserting into a body lumen an autonomous, typically
wireless device capable of detecting ionizing radiation” (Frisch, col. 3, ll. 1-
7).
Principles of Law
“[T]he question of undue experimentation is a matter of degree. The
fact that some experimentation is necessary does not preclude enablement;
what is required is that the amount of experimentation „must not be unduly
extensive.”‟ PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564
(Fed. Cir. 1996).
Factors to be considered in determining whether a
disclosure would require undue experimentation … include
(1) the quantity of experimentation necessary, (2) the
amount of direction or guidance presented, (3) the presence
or absence of working examples, (4) the nature of the
invention, (5) the state of the prior art, (6) the relative skill
of those in the art, (7) the predictability or unpredictability
of the art, and (8) the breadth of the claims.

In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

3
Frisch et al., US 7,787,928 B2, issued Aug. 31, 2010.
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Analysis
We agree with the Examiner that undue experimentation would have
been required to enable the full scope of the claim. As an introductory point,
claim 1 encompasses delivery to both the gastrointestinal tract and blood
system, but the capsule “enters into the gastrointestinal tract via mouth of a
patient” (Claim 1). There is no guidance on how the capsule moves from the
mouth and gastrointestinal tract into the blood system.
Equally substantively, Appellant has provided no guidance on how to
program or otherwise design the autonomous capsule to compare a stored
digital image with the digital images obtained by the capsule to identify the
targeted location in the stored digital image in the context of the
environment of the gastrointestinal tract. Not only are there no working
examples, but there is no teaching whatsoever in the Specification on how to
perform this necessary comparison to reach a targeted location (FF 10-11).
Appellant has not identified a prior art reference which has already solved
this problem, so on the evidence of record, the prior art alone cannot enable
this element. While Madar and Frisch both teach modes of targeting, their
modes involve the use of either fluorescently or radioactively labeled probes
which first bind to a target, which bound target is then identified by the
presence of the labeled probes, not based upon a digital image of the target
itself (FF 12-14).
Thus, as we balance the Wands factors, we conclude that undue
experimentation would have been required to enable the claimed method.
See Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir.
1997) (“Patent protection is granted in return for an enabling disclosure of
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an invention, not for vague intimations of general ideas that may or may not
be workable.)
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that undue
experimentation would have been required to perform the claimed method.
SUMMARY
In summary, we reverse the rejection of claims 1-6 under 35 U.S.C. §
112, first paragraph as failing to comply with the written description
requirement by containing new matter.
We reverse the rejection of claims 1, 3, 5, and 6 under 35 U.S.C. §
112, second paragraph as indefinite.
We affirm the rejection of claim 4 under 35 U.S.C. § 112, second
paragraph as indefinite.
We affirm the rejection of claims 1-6 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement.
We affirm the rejection of claims 1-6 under 35 U.S.C. § 112, first
paragraph because the specification does not reasonably provide enablement
for the claimed invention.

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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