Ex Parte Hartlep et al

Patent Trial and Appeal Board

Jan 21, 2016

11251548 (P.T.A.B. Jan. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
111251,548
108549 7590
Tucker Ellis LLP
Brainlab AG
950 Main A venue
Suite 1100
FILING DATE
10/14/2005
01/25/2016
Cleveland, OH 44113-7213
FIRST NAMED INVENTOR
Andreas Hartlep
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.
013658/000489 5420
EXAMINER
MACFARLANE, STACEY NEE
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
01125/2016 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):
patents@tuckerellis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREAS HARTLEP and CHRISTOPH PEDAIN 1
Appeal2013-000467
Application 11/251,548
Technology Center 1600
Before TONI R. SCHEINER, DEMETRA J. MILLS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for planning treatment of Amyotrophic Lateral Sclerosis (ALS). The
Examiner has rejected the claims as lacking definiteness, subject matter
eligibility, written description, and enablement. We have jurisdiction under
35 U.S.C. § 6(b). We affirm at least one rejection of each claim.
1 Appellants identify the real party in interest as Brainlab AG (App. Br. 2).
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Application 11/251,548
STATEMENT OF THE CASE
Claims 1-7, 9, 10, 12-20, 23, and 24 are on appeal (App. Br. 1). 2
Claim 1 is illustrative and reads as follows:
1. A method for planning treatment of Amyotrophic Lateral Sclerosis
(ALS), wherein the treatment utilizes an agent suitable for treating ALS via
delivery within the brain, the method comprising the steps of:
identifying a target region of the brain that is to receive the agent, said
identifying including
measuring electrical activity from cells within a region of
interest of the brain via a device inserted into the brain;
identifying different cell types based on the measured electrical
activity; and
identifying the target region to include cell types that exhibit
the same electrical activity;
developing an initial plan for delivery of the agent to the target region;
obtaining and/or calculating anatomical patient data and/or anatomical
patient parameters of the target region;
performing a computer simulation of a distribution or concentration of
the agent in the target region, said simulation based on i) the initial plan and
ii) the anatomical patient data and/or anatomical patient parameters; and
outputting the simulation for review.
Claim 18 is the only other independent claim on appeal and is set forth in the
Claims Appendix to Appellants' Appeal Brief (App. Br. 55-56).
Claims 1-7, 9, 10, 12-20, 23, and 24 stand rejected under 35 U.S.C.
§ 101 for being directed to non-statutory subject matter (Ans. 5).
Claims 1-7, 9, 10, 12-20, 23, and 24 also stand rejected under
35 U.S.C. § 112, second paragraph (id. at 18).
2 As stated in the December 19, 2011, Final Office Action (hereinafter
"Final OA"), claim 22 is also pending but has been withdrawn from
consideration (Final OA 1 ).
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In addition, claims 1-7, 9, 10, 12-20, 23, and 24 stand rejected under
35 U.S.C. § 112, first paragraph, as failing to comply with both the written
description and enablement requirements (id. at 21 & 24).
The Examiner and/or Appellants rely on the following references of
record:
Mimoun Azzouz et al., VEGF Delivery with Retrogradely
Transported Lentivector Prolongs Survival in a Mouse ALS Model, 429
NATURE 413-17 (2004) (hereinafter "Azzouz");
Ennio Esposito et al., A Review of Specific Dietary Antioxidants and
the Effects on Biochemical Mechanisms Related to Neurodegenerative
Processes, 23 NEUROBIOLOGY AGING 719-35 (2002) (hereinafter
"Esposito");
R. P. Iacono et al., Electrophysiologic Target Localization in
Posteroventral Pallidotomy, 139 ACTA NEUROCHIRURGICA 433--41 (1997)
(hereinafter "Iacono");
Andres Lozano et al., Methods for Microelectrode-Guided
Posteroventral Pallidotomy, 84 J. NEUROSURG. 194--202 (1996) (hereinafter
"Lozano");
Govind Nair et al., Diffusion Tensor Imaging Reveals Regional
Differences in the Cervical Spinal Cord in Amyotrophic Lateral Sclerosis,
53 NEUROIMAGE 576-83 (2010) (hereinafter "Nair"); and
S. Yoshida, Application of Pixe in Medical Study: Environmental
Minerals and Neurodegenerative Disorders, 9 INT'L J. PIXE 245-57 (1999)
(Abstract only) (hereinafter "Yoshida").
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INDEFINITENESS
The Examiner argues that "Claim 1 is indefinite because the term
'suitable' is a relative term" and "is not defined by the claim itself, nor does
the specification provide a standard for ascertaining the requisite degree of
suitability" (Ans. 19). In particular, the Examiner argues that because, "at
the time of filing, there was NO known drug that was suitable for delivery to
the brain for the treatment of ALS, then the metes and bounds of the
invention are ambiguous" (id. at 30). We are not persuaded.
Claim 1 recites "an agent suitable for treating ALS via delivery within
the brain" (App. Br. 53). In this context, we conclude that one of ordinary
skill in the art would understand the term "suitable" to mean that the agent is
appropriate for treating ALS via delivery within the brain. Although the
Specification may not define the requisite degree of suitability, the Examiner
does not adequately explain why the term "suitable" would not have been
understood by one of ordinary skill in the art. In addition, whether or not
such an agent was known in the art at the time of the invention, we do not
agree with the Examiner that this raises an indefiniteness issue.
The Examiner also argues:
Claims 1 and 18 are rejected ... because the claims state "the
treatment utilizes an agent" but the claim does not set forth
those method steps involved in the utilization. Thus, it is
unclear what method/process applicant is intending to
encompass. While the claims state the agent is "suitable for
treating Amyotrophic Lateral Sclerosis (ALS) via delivery
within the brain", there is no positive recitation of active
delivery of any agent to the brain. A claim is indefinite where it
merely recites a use without any active, positive steps
delimiting how this use is actually practiced.
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(Ans. 18-19.) We are not persuaded.
As noted by Appellants, claims 1 and 18 "are not directed to a method
for 'using' a specific agent,' but instead are directed to a method for
planning treatment of a disease" (App. Br. 5). In addition, these claims "set
forth a number of steps defining the method for planning treatment and ...
are [therefore] not 'use' claims" (id. at 5---6). We do not agree with the
Examiner that reciting, in the preamble, that the treatment being planned
"utilizes an agent suitable for treating ALS via delivery within the brain"
renders this indefinite.
In particular, we agree with the Examiner that "there is no positive
recitation of active delivery of any agent to the brain" (Ans. 18-19). In fact,
claim 1 does not even recite that the initial plan involves direct delivery of
the agent to the target region, nor does claim 18 recite that the planned
placement of the delivery instrument directly delivers the agent to the target
region (App. Br. 53 & 55-56). However, we do not agree with the
Examiner that this lack of specificity makes the claims unclear. Instead, the
claims are merely broad.
In addition, the Examiner argues:
Claim 1 is incomplete in that it is missing the essential method
steps required for "developing an initial plan for delivery",
"obtaining and/or calculating patient data parameters",
"computer simulation... distribution or concentration" where
none of steps are defined. Absent the positive recitation of
active steps, a skilled artisan would not be reasonably apprised
as to whether he has infringed upon the claimed method.
(Ans. 19.) The Examiner also argues:
[A] person having ordinary skill in the art would not be
reasonably apprised as to the metes and bounds of "identifying
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the target region based on the measured electrical activity"
within the brain, nor would the artisan know what "anatomical
data", "patient data" or "patient parameters" would be
characteristic of said region and useful for the method.
(Id. at 31.) We are not persuaded.
First, we agree with Appellants that the failure to recite the steps in
additional detail does not render the claim indefinite (App. Br. 8). We also
agree with Appellants that the Examiner does not adequately explain why
anatomical patient data and/ or parameters for use in performing a computer
simulation would not have been "known by the person having ordinary skill
in the art" (Reply Br. 8). In addition, as discussed in more detail in the
context of the enablement rejection, we conclude that the Examiner has not
provided sufficient basis to support the position that "a person having
ordinary skill in the art would not be reasonably apprised as to the metes and
bounds of 'identifying the target region based on the measured electrical
activity"' (Ans. 31 ).
The Examiner also argues:
Claim 2 is indefinite because it recites the method of Claim 1
further comprising an additional step but does not relate back to
the parent claim such that a skilled artisan would know when
this additional step is to take place within the plurality of steps
required by the parent claim.
(Ans. 19.) In particular, the Examiner argues:
[T]he recitation of delivering the agent "based on the plan" is
analogous to a use claim - attempting to claim a process without
setting forth any steps involved in that process. Furthermore,
the steps recited in the parent claim do not inform the steps for
delivery, they only recite planning, therefore, Claim 2 is at
least missing a critical link or relationship between the steps of
the method and the added step of actual delivery.
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(Id. at 31.) We conclude that claim 2 is indefinite.
According to Appellants: "[C]laim 2 sets forth that agent is delivered
based on the plan. In order to be delivered based on the plan, a person
having ordinary skill in the art would readily appreciate the step of claim 2 is
executed after the planning method of claim 1 has been performed." (App.
Br. 11.) Thus, we understand that Appellants are interpreting claim 2 to
refer to a step that occurs after the planning is complete, which does not
refer back to the preamble recitation of a method for planning treatment.
Alternatively, "the plan" in claim 2 could refer to the "initial plan" in
claim 1 and arguably be part of a method for planning treatment, i.e., the
agent could be delivered to the target region as part of the planning of future
treatment. Given that this alternative interpretation better conforms to the
preamble, we agree with the Examiner that claim 2 is indefinite. However,
we agree with Appellants that claim 2 is not indefinite for being analogous
to a use claim (Reply Br. 9).
In addition, the Examiner argues that "Claims 3 and 7 are indefinite
since the intended metes and bounds of the 'agent' is/are not defined"
(Ans. 19). In particular, the Examiner argues:
[T]he claim reads upon administration of "at least one of
antioxidants" (plural) or "neurotropic growth factors" (plural).
It is unclear if the claim encompasses administration of a single
antioxidant or growth factor; or if administration of any number
of antioxidants is encompassed so long as neurotropic growth
factors are not also administered, and vice versa.
(Final OA 4.) We agree.
We note that Appellants attempted to amend these claims in an
Amendment filed with the Appeal Brief on May 21, 2012, and that these
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amendments have been incorporated into the Claims Appendix to the Appeal
Brief (compare 5/21/12 Amend. with App. Br. 53 & 54). However, these
amendments have not been entered (Ans. 3). Without these amendments,
we agree with the Examiner that it is not clear to what the "at least one of'
refers and whether multiple neurotropic growth factors or antioxidants are
required.
The Examiner also argues that claim 4 is indefinite because "[ t ]here is
no antecedent basis within the parent claim(s) for the actual placement of a
delivery instrument" and "for the flow rate within the initial plan" (Ans. 20
& 32). However, claim 4 recites "adjusting a flow rate ... based on an
actual placement of the delivery instrument" (App. Br. 53-54). Thus, we
agree with Appellants that there is no antecedent basis issue (id. at 14 &
Reply Br. 12).
In addition, the Examiner argues:
Claim 5 is vague and indefinite because it recites the method
further comprising an additional step but does not relate back to
the parent claim. Thus, one of ordinary skill would not be
apprised as to when this additional step is to take place within
the plurality of steps required by the method of the parent
claim. Additionally, the step requires "refining a planned
placement of a deliver instrument" but there are no active steps
provided for "refining". Without knowing the active steps
required, one of ordinary skill would not be reasonably apprised
as to when they would be infringing the metes and bounds of
the claim.
(Ans. 20.) The Examiner also argues that "[t]here is no antecedent basis for
'the planned catheter placement"' (Final OA 4). We agree with the
Examiner that claim 5 is indefinite.
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In the May 21, 2012, Amendment discussed above, Appellants also
attempted to amend claim 5 to delete the term "catheter" and this
amendment has been incorporated into the Claims Appendix to the Appeal
Brief (compare 5/21/12 Amend. with App. Br. 54). However, this
amendment was not entered (Ans. 3). Without this amendment, we agree
with the Examiner that there is no antecedent basis for "the planned catheter
placement" (Final OA 4). However, we are not persuaded by the
Examiner's additional arguments regarding claim 5 for the reasons set forth
by Appellants (App. Br. 16).
The Examiner also argues that "Claim 6 is indefinite for recitation of
'calculating takes into consideration ... properties of the agent' because none
of the so called 'consideration' has been defined" (Ans. 20). In particular,
the Examiner argues:
[C]laim 6 is a use claim ... because it merely recites a use
\~1ithout any active, positive steps delimiting ho\~1 this use is
actually practiced. Here, the claim recites calculating includes
using a chemical, pharmaceutical or biological property of the
agent to perform the calculation but does not actually recite the
active steps delimiting how this process is practiced, or
illuminating how or what chemical, pharmaceutical or
biological properties relate to said calculation.
(Id. at 33.) We are not persuaded by these arguments for the reasons set
forth by Appellants (App. Br. 17: Reply Br. 14--15).
In addition, the Examiner argues:
Claim 9 is unclear in that it appears to be missing essential
method steps. Claim 9 is drawn to the method of claim 1
further comprising calculating a concentration or a distribution
of the agent in the target region, but Claim 1 merely recites a
simulation of a distribution. Thus, it is unclear what parameters
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are to be calculated if there hasn't been any agent delivered "in
the target region".
(Ans. 20.) In particular, the Examiner argues that "the claim recites use
without active steps to delineate that process" and that "[i]t is unclear what
process is employed for calculating the possible concentration and how the
calculated diffusion tensor is used in that process" (id. at 33). We are not
persuaded.
First, there is no per se rule that the term "using" renders a claim
unclear. In addition, the Examiner does not adequately explain why claim 9
is unclear. In particular, it is not clear to us why actual delivery, rather than
a computer simulation, as recited in the claim, is required to calculate a
concentration or distribution.
The Examiner also argues:
Claims 12, 14 and 18 are indefinite for their recitation of a
"desired" or "predetermined" agent concentration, distribution
or flow rate. There is no method step within the parent claim
that provides antecedent basis for the determination of these
required elements. Thus, the metes and bounds of a method
that requires one to achieve a desired or predetermined amount
are indefinite.
(Ans. 20.) In particular, the Examiner argues:
[T]he claim method hinges upon method steps aimed at
achieving a predetermined concentration, distribution, or flow
rate, but the specification has not defined those elements.
Therefore, "predetermined" in this case is random and limitless,
and a skilled artisan would not be reasonably apprised as to
when they had achieved the method or infringed upon the
invention.
(Id. at 34.) We are not persuaded by these arguments for the reasons stated
by Appellants (App. Br. 20-21; Reply Br. 16-17).
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In addition, the Examiner argues that "Claims 15 and 16 are
incomplete because they recite the method 'further comprising the step of
limiting the flow rate' but they fail to delineate any active, positive steps
delimiting how one of ordinary skill is to practice 'limiting flow rate"'
(Ans. 21 ). However, we agree with Appellants that the Examiner does not
adequately explain why this is indefinite (Reply Br. 18).
The Examiner also argues:
Claim 20 is vague and indefinite because it recites the method
further comprising an additional step but does not relate back to
the parent claim. Thus, one of ordinary skill would not be
apprised as to when this additional step is to take place within
the plurality of steps required by the method of the parent
claim. Additionally, the step requires "refining a planned
placement of a deliver instrument" but there are no active steps
provided for "refining". Without knowing the active steps
required, one of ordinary skill would not be reasonably apprised
as to when they would be infringing the metes and bounds of
the claim.
(Ans. 21.) We are not persuaded.
Claim 20 depends from claim 18, which recites that placement of a
delivery instrument is planned "based on at least one of the calculated
diffusion tensor, the images, the calculated agent distribution, or the
calculated agent concentration" (App. Br. 56). Claim 20 additionally recites
"refining the planned placement of the delivery instrument based on the
simulated agent distribution and/or the simulated agent concentration" (id.).
Thus, we understand that claim 20 requires an initial plan to place a delivery
instrument, followed by a refinement of that plan. We agree with Appellants
that the Examiner does not adequately explain why this is indefinite (Reply
Br. 19--20).
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Conclusion
The evidence supports the Examiner's conclusion that claims 2, 3, 5,
and 7 are indefinite. Claims 3, 4, 6, and 14--16 are also indefinite based on
their dependency, directly or indirectly, from claims 2 or 5. We therefore
affirm the indefiniteness rejection of claims 2-7 and 14--16.
However, the Examiner has not set forth a prima facie case that
claims 1, 9, 10, 12, 13, 17-20, 23, and 24 are indefinite. We therefore
reverse the indefiniteness rejection of these claims.
SUBJECT MATTER ELIGIBILITY
The Examiner rejects the claims "under 35 U.S.C. § 101 because the
claims as a whole are directed to an abstract idea and are therefore ineligible
subject matter" (Final OA 5---6). In particular, the Examiner finds that "the
present claims are directed to a general abstract concept of 'how a physician
should plan to conduct treatment"' (6/2/11 OA 12).
Principles of Law
"Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title." 35 U.S.C. § 101. Supreme Court precedents,
however, provide three specific exceptions to the broad categories of§ 101:
laws of nature, natural phenomena, and abstract ideas. Bilski v. Kappas, 561
U.S. 593, 601 (2010). "The 'abstract ideas' category embodies 'the
longstanding rule that ' [a Jn idea of itself is not patentable.'"' Alice Corp.
Pty. Ltd. v. CLS Banklnt'l, 134 S. Ct. 2347, 2355 (2014) (citing Gottschalk
v. Benson, 409 U.S. 63, 67 (1972)).
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In Alice, the Supreme Court referred to the two-step analysis set forth
in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289
(2012), as providing "a framework for distinguishing patents that claim laws
of nature, natural phenomena, and abstract ideas from those that claim
patent-eligible applications of those concepts." Alice, 134 S. Ct. at 2355
(citing Mayo, 132 S. Ct. at 1289). Under Mayo, "[w]e must first determine
whether the claims at issue are directed to a patent-ineligible concept." Id.
Next, "we consider the elements of each claim both individually and 'as an
ordered combination' to determine whether the additional elements
'transform the nature of the claim' into a patent-eligible application." Id.
(citing Mayo, 132 S. Ct. at 1297-98).
Under Mayo, to be patentable, a claim must do more than simply state
the law of nature or abstract idea and add the words "'apply it."' Mayo, 132
S. Ct. at 1294; Benson, 409 U.S. at 67. For example, "the mere recitation of
a generic computer cannot transform a patent-ineligible abstract idea into a
patent-eligible invention." Alice, 134 S. Ct. at 2358. "Thus, if a patent's
recitation of a computer amounts to a mere instruction to 'implemen[t ]' an
abstract idea 'on ... a computer,' that addition cannot impart patent
eligibility." Id. (internal citation omitted).
In addition, the "notion that [extra ]-solution activity, no matter how
conventional or obvious in itself, can transform an unpatentable principle
into a patentable process exalts form over substance." Parker v. Flook, 437
U.S. 584, 590 (1978). See also Mayo, 132 S. Ct. at 1298 ("Purely
'conventional or obvious' '[pre]-solution activity' is normally not sufficient
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to transform an unpatentable law of nature into a patent-eligible application
of such a law.").
A challenged patent claim, properly construed, must incorporate
enough meaningful limitations to ensure that it claims more than just an
abstract idea and not just a mere "drafting effort designed to monopolize the
[abstract idea]." Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1297). "Simply appending conventional steps, specified at a high level of
generality," is not "enough" for patent eligibility. Id. (quoting Mayo, 132 S.
Ct. at 1300).
Analysis
Under the Mayo analysis, our first question is whether claim 1 is
directed to a judicial exception. Similar to the claim in Alice, present
claim 1 is directed to "a method of organizing human activity." 134 S. Ct. at
2356. See also SmartGene, Inc. v. Advanced Biological Labs., SA, in which
a "method for guiding the selection of a therapeutic treatment regimen" was
considered an abstract idea. 555 F. App'x 950, 954--55 (Fed. Cir.), cert.
denied, 135 S. Ct. 58 (2014). In addition, with the exception of a single
measuring step, claim 1 recites a series of steps that can be conducted in a
person's mind or on a computer. 3 Thus, we agree with the Examiner that
present claim 1 is directed to an abstract idea.
3 We note that claim 1 recites an "obtaining and/or calculating" step (App.
Br. 53). However, given the "and/or" language, this step does not actually
require that anything be obtained.
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Our second question is whether claim 1 recites additional elements
that amount to significantly more than the judicial exception. The evidence
on this record does not indicate that it does.
We understand that claim 1 recites "performing a computer simulation
... and outputting the simulation for review" (App. Br. 25). However, the
Examiner finds that the "computer is merely an object on which the method
operates it is incidental to the execution" (Ans. 36). In addition, Appellants
have not adequately explained why performing the claimed computer
simulation and outputting the simulation for review requires more than a
general purpose computer. As noted above, "the mere recitation of a generic
computer cannot transform a patent-ineligible abstract idea into a patent-
eligible invention." Alice, 134 S. Ct. at 2358.
We also understand that claim 1 recites "measuring electrical activity
from cells within a region of interest of the brain via a device inserted into
the brain" (App. Br. 25). However, the Examiner finds that this step merely
recites "data gathering" (Ans. 35-36). Appellants have not adequately
explained why this step amounts to more than extra-solution data gathering.
See Mayo, 132 S. Ct. at 1297-98 (the claimed step of determining the level
of the relevant metabolites in the blood was considered pre-solution activity
that was insufficient to transform a patent-ineligible claim into one that was
patent eligible).
We recognize that present claim 1, unlike the claim in Mayo, specifies
that the measurement is conducted "via a device inserted into the brain"
(App. Br. 25). However, there is insufficient evidence on this record to
indicate that using a device that is inserted into the brain to make this
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measurement is not conventional in the art. Instead, the Specification briefly
discloses that "[ e ]lectrical activity can be monitored by placing measurement
electrodes on a catheter or probe and inserting the probe into or near the
target region" (Spec. 8: 19-20), without clearly indicating that this was not
known in the art. In addition, in responding to the enablement rejection
discussed below, Appellants admit that microelectrode recording and
inserting a probe into the brain were known in the art at the time of the
present invention and provide Iacono and Lozano as evidence that this is the
case (App. Br. 47-52). 4 Thus, we conclude that the evidence of record
supports the Examiner's position that this data gathering step is
"conventional and obvious extra-solution activity that cannot save the
claim[]." PerkinElmer, Inc. v. Intema Ltd., 496 F. App'x 65, 73 (Fed. Cir.
2012).
Conclusion
The evidence supports the Examiner's conclusion that claim 1 does
not recite patent eligible subject matter. We therefore affirm the § 101
rejection of claim 1. Claims 2-7, 9, 10, 12-20, 23, and 24 have not been
4 We note that Lozano teaches:
The dura was penetrated with a sharp probe and the
microelectrode guide tube . . . was stereotactically placed into
the cerebrum so that the tip was 1.5 to 2.0 cm from the intended
target location. A sterile microelectrode . . . was inserted into
the guide tube so that the tip of the microelectrode was flush
with the tip of the stereotactically placed guide tube. The
microelectrode was fastened . . . so that the tip could be
advanced up to and beyond the intended target while recording
neuronal activity.
(Lozano 195.)
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argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
ENABLEMENT
The Examiner concludes that the "instant specification is not enabling
because one cannot follow the guidance presented therein, or within the art
at the time of filing, and practice the claimed method with a reasonable
expectation of success without first making a substantial inventive
contribution" (Ans. 28).
Principles of Law
"[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without 'undue experimentation."' In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993). However, "a patent disclosure need not enable information
within the knowledge of an ordinarily skilled artisan," nor does not the law
"expect an applicant to disclose knowledge invented or developed after the
filing date." Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254 (Fed. Cir.
2004).
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by
the description of the invention provided in the specification of
the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the
scope of enablement. If the PTO meets this burden, the burden
then shifts to the applicant to provide suitable proofs indicating
that the specification is indeed enabling.
Wright, 999 F.2d at 1561-62.
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The Specification states:
Analysis
There are several approaches to treating ALS and its symptoms.
However, the only FDA approved medication is Riluzol[ e]
(Rilutek), which is administered systemic .... Other treatments
for ALS involve neurotrophic growth factors or combination
therapies with agents from different families of neurotrophic
growth factors and/or Riluzol[e] and/or anti-oxidants (e.g.,
vitamin E).
(Spec. 1: 29 to 2: 4.) The Specification discloses "a planned targeted
delivery of a therapeutic substance to the brain for the effective treatment of
ALS" and that "the effectiveness of the plan can be analyzed prior to
performing the treatment" (id. at 3: 14--16). The Specification also
discloses:
As used herein, an "agent" or "agents" to be infused includes
therapeutic substances such as, for example, neuro-protective
substances that inhibit pre-synaptic release of glutamate and/or
influence the activation of sodium channels, antioxidants, and
any other agent useful for treating ALS through targeted
infusion. Riluzol[ e] is an example of an agent that can be used
in accordance with the present invention.
(Id. at 5: 5-10.) We conclude that the Examiner has not set forth a prima
facie case that the Specification does not enable a method for planning
treatment of ALS using an agent suitable for treating ALS via delivery
within the brain.
The Examiner states that, "[a]lthough at the time of filing (2004),
dietary antioxidants were hypothesized to benefit ALS by scavenging free
radicals (for review see Esposito ... ), there was nothing within the
literature to teach or suggest the delivery of antioxidants within the brain"
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(Ans. 25). In addition, the Examiner states that, "[ e ]ven regarding Riluzole,
there is no guidance that it could be administered directly to the brain with a
reasonable expectation of success to treat ALS" (id. at 50). However, the
Specification specifically identifies Riluzole and antioxidants as examples of
agents that can be infused according to the invention (Spec. 5: 5-10). We
conclude that the Examiner has not provided sufficient basis to doubt this
assertion.
The Examiner also states:
[E]ven within the current state of the art there is no predictable
means for identifying regions within the living brain affected by
ALS's pathology. On the contrary, the consensus within the
literature is that "the spinal cord bears the brunt of the disease"
(Nair ... ). Thus, since no specific brain regions have been
identified as specifically associated with ALS pathology, there
is nothing of record to teach or suggest that target regions could
be predictably identified by electrical activity, and certainly
there was nothing of record to suggest a region could be
identified as an ALS target region by means of an EEG.
(Ans. 26.) We are not persuaded.
The Specification discloses "a planned targeted delivery of a
therapeutic substance to the brain for the effective treatment of ALS"
(Spec. 3: 14--15). In addition, the Specification identifies the hippocampus
as a target region (id. at 8: 1--4 & 9: 7). We conclude that the Examiner has
not provided sufficient evidence to doubt these assertions. We note the
Examiner's position that Yoshida does not provide "a clear specific nexus
between the hippocampus and ALS" and that "there is nothing within the art
to teach or suggest an agent delivered in the hippocampus would treat ALS
with a reasonable expectation of success" (Ans. 49). However, the
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Examiner bears the initial burden to show that one of ordinary skill in the art
would have doubted Appellants' statements that ALS could be treated by
targeted delivery of a therapeutic substance to the brain, specifically the
hippocampus. The Examiner has not met this burden.
The Specification also discloses that "[ e ]lectrical activity can be
monitored by placing measurement electrodes on a catheter or probe and
inserting the probe into or near the target region" (Spec. 8: 19--20). In
addition, the claims require "measuring electrical activity from cells within a
region of interest of the brain via a device inserted into the brain" (App.
Br. 53 & 55 (emphasis added)). Appellants argue that an "EEG involves the
recording of electrical activity along the scalp, i.e., on the outer surface of
the head," and is therefore not within the scope of the present claims (Reply
Br. 23-24). In addition, the Examiner states that an EEG "can identify
regions with the same electrical field activity by electrodes placed on the
scalp" (Ans. 26 (emphasis added)). Thus, it is not clear why the alleged
failure to suggest that an ALS target region can be identified by means of an
EEG is even relevant to the current claims.
With regard to identifying the target region by electrical activity, we
agree with Appellants that a method that more accurately identifies the
borders of a region of interest results in the identification of a region, as
required by claims 1and18 (Reply Br. 57-58). In addition, we agree with
Appellants that the Examiner has not adequately explained why Iacono and
Lozano fail to support Appellants' position that one of ordinary skill the art
would have been able to use the claimed identification sub-steps to more
accurately identify the borders of a region (App. Br. 47-52). We understand
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the Examiner's position that Iacono provides "evidence that microelectrode
recording can accurately target the globus pallidus," which "has been well-
characterized as a target of interest and treatment for Parkinson's disease"
(Ans. 50-51). However, the Examiner does not adequately explain why one
of ordinary skill in the art would have been unable to use the techniques
taught in Iacono, as well as in Lozano, to more accurately identify the
borders of a target for ALS.
In addition, the Examiner states:
[W]hile growth factor treatment of ALS was known in the art at
the time of filing, these studies were aimed at administration of
therapeutics to the muscle so that they may be retrogradely
conveyed to the spinal cord (for example, see Azzouz ... ) and
NOT for delivery within the brain as required by the instant
claims.
(Ans. 26.) We are not persuaded.
Azzouz does specifically disclose "injection of a VEGF-expressing
lentiviral vector into various muscles" (Azzouz 413). However, the
Examiner has not provided an adequate basis to doubt that this agent or other
growth factors would be "suitable for treating ALS via delivery within the
brain," as recited in claims 1 and 18.
The Examiner also states: "[T]he disclosure states the data 'can be
obtained using known techniques' ... then gives examples of MRI, CT scan,
etc. The claims, however, are not limited to these examples. Rather
'obtaining patient data' broadly encompasses obtaining, for example, the
patient's name, date of birth, or blood pressure." (Ans. 27.) However,
claim 1 clearly recites "obtaining and/or calculating anatomical patient data
and/or anatomical patient parameters of the target region" (App. Br. 53). In
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addition, claim 1 clearly recites that the target region is a "region of the
brain" (id.). Thus, we do not agree with the Examiner that obtaining patient
data, as recited in claim 1, "encompasses obtaining ... the patient's name,
date of birth, or blood pressure" (Ans. 27).
Conclusion
The Examiner has not set forth a prima facie case that the claims lack
enablement. We therefore reverse the enablement rejection.
WRITTEN DESCRIPTION
Citing to Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F.3d
1336 (Fed. Cir. 2010) (en bane), the Examiner finds that reference has been
provided "to cases where the courts have reasoned that the disclosure must
provide the public meaningful disclosure, and ... that the generic guidance
of the instant disclosure does not provide meaningful disclosure of the
invention" (Ans. 37). The Examiner also finds:
(Id.)
[E]vidence [has been provided] that the instant [disclosure]
does not establish any structure-function correlation between
the various parameters and planning treatment, and fails to
provide a representative number of species of the parameters
that are common to the members of the genus claimed.
Specifically, there is nothing within the disclosure that
establishes structure-function correlation or representative
number of species with respect to the steps of "measuring",
"developing", "obtaining", etc.
Principles of Law
"Requiring a written description of the invention limits patent
protection to those who actually perform the difficult work of 'invention'-
that is, conceive of the complete and final invention with all its claimed
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limitations-and disclose the fruits of that effort to the public." Ariad
Pharms., 598 F.3d at 1353.
Precedent illustrates that the determination of what is needed to
support generic claims to biological subject matter depends on a
variety of factors, such as the existing knowledge in the
particular field, the extent and content of the prior art, the
maturity of the science or technology, the predictability of the
aspect at issue, and other considerations appropriate to the
subject matter.
Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
(1) [E]xamples are not necessary to support the adequacy of a
written description[;] (2) the written description standard may
be met ... even where actual reduction to practice of an
invention is absent; and (3) there is no per se rule that an
adequate written description of an invention that involves a
biological macromolecule must contain a recitation of known
structure.
Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006).
The Examiner "bears the initial burden ... of presenting a prima facie
case ofunpatentability." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992).
Insofar as the written description requirement is concerned, that
burden is discharged by "presenting evidence or reasons why
persons skilled in the art would not recognize in the disclosure a
description of the invention defined by the claims." . . . If ...
the specification contains a description of the claimed
invention, albeit not in ipsis verb is (in the identical words), then
the examiner ... , in order to meet the burden of proof, must
provide reasons why one of ordinary skill in the art would not
consider the description sufficient.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) (quoting In re Wertheim,
541F.2d257, 263 (CCPA 1976)).
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Analysis
We conclude that the Examiner has not set forth a prima facie case
that the claims lack written descriptive support.
The Examiner finds that "the claim recites delivery of a suitable agent
[for treating ALS] within the brain[, but that t]he specification recites mere
examples to which the claims are not limited" (Ans. 38-39). As noted by
Appellants (App. Br. 31 ), the Specification discloses that "an 'agent' or
'agents' to be infused includes therapeutic substances such as, for example,
neuro-protective substances that inhibit pre-synaptic release of glutamate
and/or influence the activation of sodium channels, antioxidants, and any
other agent useful for treating ALS through targeted infusion" and that
"Riluzol[ e] is an example of an agent that can be used in accordance with
the present invention" (Spec. 5: 5-10). We conclude that the Examiner has
not adequately explained why this disclosure fails to support the recitation of
a "suitable" agent.
The Examiner also finds:
[I]t is not clear within the art what area of the brain is an area of
interest in ALS since the pathology of the disease originates
within the spinal cord. Certainly without adequate written
description, a skilled artisan would not be reasonably apprised
as to what electrical activity characterizes a region of interest or
target region within the brain that is relevant to ALS.
(Ans. 39.) However, as noted by Appellants (Reply Br. 35), the
Specification identifies the hippocampus as a target region (Spec. 8: 1--4 &
9: 7). As also noted by Appellants: "[T]he claims do not recite the electrical
activity itself is characteristic of ALS. [Instead], the measured electrical
activity can be used to delineate between tissue regions, thereby identifying
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the target region with greater accuracy." (Reply Br. 35-36 (citing to App.
Br. 46-52).) In view of this explanation, we conclude that the Examiner has
not adequately explained why the Specification fails to disclose the claimed
method of identifying a target region.
In addition, the Examiner finds that "the claims are drawn to a genus
of delivery mechanisms and the specification does not describe a reduction
to practice of any specific means of delivery" and that "there is substantial
variation expected among the species ... within the claimed genus and
unpredictability with respect to delivery at different sites within the brain
parenchyma" (Ans. 40). However, as noted by Appellants (App. Br. 32), the
Specification discloses that "an initial trajectory for a delivery instrument,
e.g., a catheter, is planned" (Spec. 8: 29-30). In addition, the Examiner
acknowledges that "delivery means are known in the art" (Ans. 40).
Moreover, the failure of a Specification to describe an actual reduction to
practice is insufficient to demonstrate that the written description is
inadequate. Falkner, 448 F.3d at 1366. Thus, we conclude that the
Examiner fails to adequately explain why the Specification lacks written
description of delivery mechanisms.
The Examiner also finds that the "claims are drawn to genera of
anatomical data and patient parameters and the specification does not
describe a reduction to practice of any specific data or parameters that are
useful for the method" (Ans. 41 ). However, as noted above, the failure of a
Specification to describe an actual reduction to practice is insufficient to
demonstrate that the written description is inadequate. In addition, as noted
by Appellants (App. Br. 33), the Specification discloses:
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Patient data and/or parameters relating to the brain can be
obtained using known techniques, including, for example,
magnetic resonance . . . or nuclear spin resonance methods
(MRI), computer tomography (CT), positron em1ss10n
tomography (PET), single photon emission computerized
tomography (SPECT), biopsy, x-rays and/or ultrasound .... In
addition to the above imaging techniques, patient parameters
such as, for example, tissue density, the distribution of tissue
structures, and/or the blood flow through a particular area of
tissue, also can be obtained from known data of typical
specimens and/or measured using other accepted medical
procedures.
(Spec. 5: 12-23.) Given this disclosure, the Examiner does not adequately
explain why one of ordinary skill in the art would not have been aware of the
types of anatomical patient data and/ or parameters that would be needed to
perform a computer simulation.
In addition, the Examiner finds that "the specification has not
provided adequate written description of the outputs that fulfill the
functional requirements of the claims" (Ans. 43). However, as noted by
Appellants (App. Br. 35), the Specification discloses that the "computer can
provide the results of the calculations via a computer display, for example"
(Spec. 6: 8-9). The Examiner does not adequately explain why one of
ordinary skill in the art would not have been aware of other outputs that are
provided from a computer simulation.
Conclusion
The Examiner has not set forth a prima facie case that the claims lack
written descriptive support. We therefore reverse the written description
rejection.
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SUMMARY
We affirm the rejection of claims 1-7, 9, 10, 12-20, 23, and 24 under
35 U.S.C. § 101 for being directed to non-statutory subject matter. We also
affirm the rejection of claims 2-7 and 14--16 under 35 U.S.C. § 112, second
paragraph.
However, wereversetherejectionofclaims 1, 9, 10, 12, 13, 17-20,
23, and 24 under 35 U.S.C. § 112, second paragraph. We also reverse both
of the rejections under 35 U.S.C. § 112, first paragraph.
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
cdc
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