Ex Parte Alroy

Board of Patent Appeals and Interferences

Sep 1, 2009

09871560 (B.P.A.I. Sep. 1, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DANIEL ALROY
__________

Appeal 2009-001920
Application 09/871,560
Technology Center 1600
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Decided: September 1, 2009
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Before DONALD E. ADAMS, DEMETRA J. MILLS, 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 identifying brain loci of neural correlates of a particular elementary
mental state. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

Appeal 2009-001920
Application 09/871,560

Statement of the Case
The Claim
Claim 6 is on appeal. Claim 6 reads as follows:
6. A method for identifying brain loci of neural
correlates of a particular elementary mental state, such as
any innate submodality element of sensation, comprising the
steps of:
(1) establishing correspondence between said
submodality element of sensation and the external stimulus
that normally elicits it, and then with a voluntary behavioral
response, thus establish correspondence between said
stimulus and said response, so that said behavioral response
following said stimulus signifies the presence of the said
element of sensation, and the absence of said behavioral
response signifies the absence of said element of sensation;
(2) detecting, immediately following said external
stimulus and said corresponding behavioral response, brain
loci that manifest transient increased activation;
(3) identifying, among the said brain loci that
manifested increased activation, activation in response to
said stimulus, those whose inactivation selectively
eliminates said behavioral response to said external
stimulus, without eliminating behavioral responses to
external stimuli that induce other elements of sensation
within the same submodality.

The prior art
The Examiner does not rely upon any evidence.
The issues
A. The Examiner rejected claim 6 under 35 U.S.C. § 112, first paragraph
as failing to comply with the written description requirement (Ans. 3-7).
B. The Examiner rejected claim 6 under U.S.C. § 112, first paragraph as
lacking enablement (Ans. 7-10).
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A. 35 U.S.C. § 112, first paragraph - written description requirement
The Examiner finds that steps 1, 2, and 3 lack descriptive support in
the Specification (see Ans. 4-6). For step 1, the Examiner finds that “the
cited pages in the [S]pecification do not disclose a step of establishing
correspondence in the context of the claimed method” (Ans. 4). For step 2,
the Examiner finds that “[n]one of these citations describe an immediate
detection of brain loci after performing step 1” (Ans. 5). For step 3, the
Examiner finds that “the cited pages in the [S]pecification do not disclose
identifying brain loci that activated in response to an external stimulus
whose inactivation would eliminate a behavior response to the external
stimulus” (Ans. 5-6).
Appellant contends that
Regarding New Matter Rejection. The discussion below of
the enablement requirement and the Trivedi patent indicates
that the Examiner misconstrued the present Specification in
several crucial respects. Such misconstruction severed the
connection between the Specification and the claim,
contributing to an appearance that the claim is new matter.
In addition, Applicant now understands that alternative
wording, or lack of strict synonymy, can be grounds for new
matter rejection. Such formulation flaws can generally be
amended. Applicant would have amended the non-compliant
language of the claim had the Examiner pointed out the non-
compliant claim elements

(App. Br. 9).
In view of these conflicting positions, we frame the written
description issue before us as follows:
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Did the Examiner err in finding that the disclosure of the Specification
failed to demonstrate possession and descriptive support for steps 1-3 of
claim 6?
Findings of Fact (FF)
1. Claim 6 is drawn to a “method for identifying brain loci of
neural correlates of a particular elementary mental state” (Claim 6).
2. The Specification teaches that “[i]n identifying the correlates of
innate fear, for example, conditioned fear cues should be minimized, and the
stimulus employed should evoke an innate response, such as abrupt loud
noise or smell of cats” (Spec. 29).
3. The Specification teaches that “[e]lementary mental states are
innate, evoked in the brain, and other than intensity and duration, have no
internal constituents. The taste sensations of sweet, salty, sour, and bitter are
innate” (Spec. 8).
4. Claim 6 requires a first step of “establishing correspondence
between said submodality element of sensation and the external stimulus
that normally elicits it, and then with a voluntary behavioral response”
(Claim 6).
5. The Specification teaches that “experimental animals are
trained to exhibit stimulus-recognition behavioral response. Correct
recognition is reinforced by reward” (Spec. 29).
6. The Specification teaches “[t]raining animals to manifest
behavioral response to external stimulus. . . . Group A is trained to exhibit
behavioral response Rj to stimulus Sj; and Group B is trained to exhibit
response Rk to stimulus Sk” (Spec. 31).
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7. Claim 6 requires a second step of “detecting, immediately
following said external stimulus and said corresponding behavioral response,
brain loci that manifest transient increased activation” (Claim 6).
8. The Specification teaches that “[b]rain loci manifesting
increased metabolic activity in response to the stimuli are identified by
means of radioactively labeled glucose analog . . . . Prior to exposing the
animals to these stimuli, radioactive 2-DG is injected into the afferent
neurons . . . . The animals are sacrificed and their brains are subjected to
autoradiography” (Spec. 30).
9. The Specification teaches an alternative detection method in
which “[v]oltage sensitive dyes show activation gradients in the brain”
(Spec. 30).
10. Claim 6 requires a third step of “identifying, among the said
brain loci that manifested increased activation . . . those whose inactivation
selectively eliminates said behavioral response to said external stimulus,
without eliminating behavioral responses to external stimuli that induce
other elements of sensation within the same submodality” (Claim 6).
11. The Specification teaches that a “brain locus identified as
activated in response to the particular external stimulus is then deactivated.
The inactivation technique may consist of local surgical lesion, local
application of neurotoxin (in non-human primates reverse deactivation
would be used, such as local application of lidocaine)” (Spec. 31).
12. The Specification teaches a post deactivation test in which
“[g]roup A mice, with brain loci deactivation . . . are then presented with
external stimulus Sj, that normally is followed in them by behavioral
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response Rj. Lj is the brain locus whose inactivation selectively abolishes
behavioral response Rj” (Spec. 31).
Principles of Law
It is the Examiner's “initial burden [to] present [ ] evidence or reasons
why persons skilled in the art would not recognize in the disclosure a
description of the invention defined by the claims.” In re Wertheim, 541
F.2d 257, 263 (CCPA 1976).
To satisfy the written description requirement, the inventor must
“convey with reasonable clarity to those skilled in the art that, as of the filing
date sought, he or she was in possession of the invention.” Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). “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).
“Although [the inventor] does not have to describe exactly the subject
matter claimed … the description must clearly allow persons of ordinary
skill in the art to recognize that [the inventor] invented what is claimed.” In
re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989).
Analysis
While the Examiner is correct that the specific language of the claims
was not disclosed ipsis verbis in the Specification (Ans. 4-5), ipsis verbis
support is not required. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed.
Cir. 1996).

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The Examiner finds that “the cited pages in the [S]pecification do not
disclose a step of establishing correspondence in the context of the claimed
method. Rather, the cited pages appear to be discussing the state of the prior
art” (Ans. 4). However, the discussion of the prior art is part of the
Specification, and can be relied upon for descriptive support. More
importantly, the process of claim 6 is discussed in detail at pages 29-31 of
the Specification, which detail each of the steps of claim 6 as performed in
mice and other experimental animals (FF 1-12).
We are not persuaded by the Examiner’s argument that the example at
page 29 does not “describe an immediate detection of brain loci after
performing step 1” (Ans. 5). The reasonable understanding of methods with
steps numbered P1, P2, P3, etc., is sequential performance of the steps (see
Spec. 29-30). Further, the discussion at page 30 of the Specification in
which animals are pretreated with a radioactive metabolite, then subjected to
a stimulus, and then sacrificed to identify the brain loci is reasonably
understood as occurring after establishing the correspondence found in step
1 (FF 1-3, 8). We note that Appellant’s Specification also provides non-
destructive methods to detect specific regions of interest (See, e.g., Spec. 30,
step P4).
We also are not persuaded by the Examiner’s argument that “[n]one
of these citations disclose step 3 of the instant claim” (Ans. 6). The
Specification reasonably details, prospectively, the method of inactivation
(FF 10-12). While the Examiner is correct that there is not a working
example in which the Appellant actually identifies a brain loci which
functions to selectively eliminate a behavioral response, the Specification
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teaches the step of identification of Lj, where “Lj is the brain locus whose
inactivation selectively abolishes behavioral response Rj” (Spec. 31; FF 12).
We also do not find persuasive the Examiner’s argument that “the
[S]pecification does not disclose the recited method in context with the other
method steps” (Ans. 6). The Specification at pages 29-31 details the method
in specific order, with the order of steps matching those of claim 6 (FF 1-
12).
Conclusion of Law
The Examiner erred in finding that the disclosure of the Specification
failed to demonstrate possession and descriptive support for steps 1-3 of
claim 6.

B. 35 U.S.C. § 112, first paragraph - enablement requirement
The Examiner finds that
undue experimentation would be required because the brain
is a complex organ where different species have different
types of responses to external stimulus. Thus, it would
require undue experimentation to determine the actual steps
for identifying brain loci and deactivating brain loci to
eliminate a particular behavior without eliminating other
behavior responses to external stimuli.

(Ans. 8).
Appellant “respectfully submits that claim 6 is fully enabled by the
present [S]pecification and respectfully requests that the rejection under 35
USC 112 be withdrawn” (App. Br. 12).
In view of these conflicting positions, we frame the enablement issue
before us as follows:
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Did the Examiner err in finding that it would have required undue
experimentation to perform the method of claim 6?
Findings of Fact
Breadth of the Claims
13. The Examiner finds that “the instant claim is not limited to
mice. The brain is a complex organ where different species have different
types of responses to external stimulus. . . . The specification does not teach
how the tests for mice . . . are to be modified to apply those tests to other
species” (Ans. 10).
Presence of Working Examples
14. The Examiner finds that “the [S]pecification does disclose work
done on mice. However, as explained above, this example does not describe
the method steps as claimed or in context with each other” (Ans. 8).
Amount of Direction or Guidance Presented
15. The Specification teaches “[m]ethods of identifying brain loci
L in experimental animal” (Spec. 29).
16. The Specification teaches guidelines for selecting the animals to
be used for the specific neural correlates, specifically teaching that
In identifying the correlates of innate fear, for example,
conditioned fear cues should be minimized, and the stimulus
employed should evoke an innate response, such as abrupt
loud noise or smell of cats. If the goal is to identify the
correlates of basic taste, then exposure of newborn mice
should be limited to one basic taste, and information about
other tastes blocked.

(Spec. 29.)
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17. After selection of the animals, the Specification teaches that
“[a]n identical strain of mice is partitioned into two groups: Group A and
Group B (depending on available facilities, a larger number of groups may
be used). Each group is then subjected to different external stimuli. The
different stimuli are within the same sensory submodality” (Spec. 29).
18. The Specification teaches several modes of “[i]dentifing
activated brain loci” which were activated by the external stimulus (Spec.
30), including “[b]rain loci manifesting increased metabolic activity in
response to the stimuli are identified by means of radioactively labeled
glucose analog” (Spec. 30).
19. The Specification teaches another mode where “[v]oltage
sensitive dyes show activation gradients in the brain. This technique would
be used in experimental animals such as the monkey for identification of K1
proteins for functions not found in the mouse, such as color vision” (Spec.
30).
20. The Specification then teaches “[i]dentifying brain locus whose
inactivation selectively abolishes response R” where a “brain locus
identified as activated in response to the particular external stimulus is then
deactivated. The inactivation technique may consist of local surgical lesion,
local application of neurotoxin . . . [or] reversible deactivation would be
used, such as local application of lidocaine” (Spec. 31).
21. The Specification teaches testing for deactivation where
Group A mice, with brain loci deactivation in stage 05.2, are
then presented with the external stimulus Sj, that normally is
followed in them by behavioral response Rj. Lj is that brain
locus whose inactivation selectively abolishes behavioral
response Rj. Animals in Group B are then subjected to
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external stimulus Sk. Rk is that brain locus whose
deactivation selectively abolishes behavioral response Rk.

(Spec. 31.)
State of the Art and Unpredictability of the Art
22. The Examiner finds that “[b]ecause the brain is a complex
organ that is not fully understood, determining loci of the brain with
particular characteristics is unpredictable” (Ans. 9).
23. No evidence is cited by the Examiner in the rejection to support
the conclusion of unpredictability.
Principles of Law
“In order to satisfy the enablement requirement of section 112, an
applicant must describe the manner of making and using the invention ‘in
such full, clear, concise, and exact terms as to enable any person skilled in
the art … to make and use the same …. ’35 U.S.C. § 112, para. 1.”
Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1323 (Fed. Cir.
2005).
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).
The Examiner has the initial burden to establish a reasonable basis to
question the enablement provided for the claimed invention. See In re
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Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993) (Examiner must provide a
reasonable explanation as to why the scope of protection provided by a
claim is not adequately enabled by the disclosure).
Analysis
The Examiner admits that “it is well known in the art to identify if a
subject is experiencing a sensation in response to a external stimulus as in
step 1 (e.g., asking a subject what he is tasting after giving him food) and
detecting brain loci that manifest transient increased activation as in step 2
(e.g., taking brain images)” (Ans. 9). However, the Examiner contends that
the skilled artisan “would not know how to identifying [sic] brain loci that
manifest increased activation in response to the stimulus and whose
inactivation eliminates the behaviour response to the external stimulus
without eliminating the behaviour response to the to external stimuli that
induce other elements of sensation within the same submodality” (Ans. 9).
We decide this case primarily based upon who has the burden of
proof. The Examiner has the burden to provide reasonable basis for
doubting enablement. See In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir.
1993).
Based upon balancing the factors in the Wands analysis, we do not
find the Examiner has established a prima facie case showing that undue
experimentation would have been required to use the claimed invention. In
particular, the Specification provides detailed prospective procedures on
how to perform the claimed method (FF 15-21).
The Examiner has provided no evidence of unpredictability in
identifying neural correlates, no evidence of unpredictability in identifying
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brain loci with transiently increased activation and no evidence of
unpredictability in correlating inactivation data with specific brain loci (FF
22-23).
While we appreciate the Examiner’s concerns regarding the scope of
the claim (FF 13), which is broadly applicable to any organism with a brain,
with the prospective example limited to mice (FF 15-21), the rejection lacks
evidence or specific scientific reasoning as to why the differences between
the brains of mice and humans, primates, worms or other organisms would
require different tests or unpredictable experimentation. The procedure of
the Specification, in which control and test groups of animals are tested to
identify the brain locus transiently activated by the external stimulus,
followed by testing the effect of deactivation of the brain locus on different
control and test groups (FF 15-21) is reasonably applicable to all organisms
and specifically references monkeys (Spec. 30). The modes of deactivation,
whether surgical or application of neurotoxin or lidocaine, are also
reasonably applicable to all organisms (FF 20). Further, the Examiner's
apparent position that the Specification cannot teach how to use the claimed
method unless it teaches solutions to all possible species is contrary to
controlling case law. See, e.g., In re Brana, 51 F.3d 1560, 1568 (Fed. Cir.
1995).
Conclusion of Law
The Examiner erred in finding that it would have required undue
experimentation to perform the method of claim 6.
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SUMMARY
In summary, we reverse the rejection of claim 6 under 35 U.S.C. §
112, first paragraph, written description.
We reverse the rejection of claim 6 under 35 U.S.C. § 112, first
paragraph, enablement.
REVERSED

Ssc:

DANEIL ALROY
19 STANTON STREET
NEW YORK, NY 10002
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