Medtronic, Inc.

Patent Trials and Appeals Board

Feb 9, 2021

2020003960 (P.T.A.B. Feb. 9, 2021)

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.
14/627,843 02/20/2015 Jamu K. Alford 1123-191US01/
C00005761.US
6280
71996 7590 02/09/2021
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
02/09/2021 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMU K. ALFORD and STEVEN M. GOETZ
Appeal 2020-003960
Application 14/627,843
Technology Center 3700
Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK,
Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–25. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real parties in interest as Medtronic, Inc. and
Medtronic plc. Appeal Br. 3.
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Application 14/627,843

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THE CLAIMED SUBJECT MATTER
Appellant’s invention relates to systems and methods for preventing
neural degeneration using ultrasound. Claims 1, 12, and 20 are independent.
Claim 1, reproduced below, is illustrative of the claimed subject matter:
1. A method for reducing or preventing neural degeneration
within a brain of a patient, the method comprising:
selecting a set of ultrasound parameter values to define
ultrasound energy deliverable via one or more ultrasound
transducers; and
delivering, via the one or more ultrasound transducers,
ultrasound energy focused to a targeted region of the brain of the
patient according to the set of ultrasound parameter values,
wherein the set of ultrasound parameter values are selected to
define ultrasound energy delivered via the one or more
ultrasound transducers that reduces or prevents neural
degeneration within at least a portion of the brain instead of
reducing at least one of symptom frequency or symptom severity
caused by the neural degeneration.
REJECTIONS2
1. Claims 1–25 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement.

2 The rejections of claims 1–25 under 35 U.S.C. § 103 based on Mishelevich
(US 2013/0281890 A1), published Oct. 24, 2013, Khanna
(US 2012/0265123 A1), published Oct. 18, 2012, and Fowler
(US 2009/0099622 A1), published Apr. 16, 2009, are withdrawn in the
Answer. Ans. 3. Although the Examiner states, “The Office withdraws the
103 rejection,” because none of the rejections set forth on pages 5–9 of the
Final Action are repeated in the Examiner’s Answer, and because there is no
response to Appellant’s arguments regarding these rejections, we consider
each of the rejections under 35 U.S.C. § 103, including the rejection of
claims 1–5, 7, 8, 10, 12–17, and 19–25 under 35 U.S.C. § 102(a)(1) or, in
the alternative, under 35 U.S.C. 103, as being withdrawn. See generally
Ans.
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Application 14/627,843

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2. Claims 1–25 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the enablement requirement.
OPINION
Rejection 1; Written Description
The Examiner finds that the Specification does not reasonably convey
to one skilled in the relevant art that the inventor had possession of the
claimed invention, at the time the application was filed. Final Act. 2.
According to the Examiner, the Specification does not describe adequately
how to achieve the claimed result of reducing or preventing neural
degeneration. Id. In particular, the Examiner asserts that the Specification
fails to disclose specific steps or treatment parameters that reduce or prevent
neural degeneration. Id. at 2–3.
Although Appellant groups each independent claim under separate
headings, Appellant does not present arguments for independent claims 12
and 20 other than those for claim 1. Appeal Br. 17–22. We select claim 1 as
representative and claims 2–25 stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
Appellant argues that the written description requirement is satisfied
because the Specification provides examples of delivering ultrasound energy
to reduce or prevent neural degeneration, which include ultrasound
parameter values and brain target locations. Appeal Br. 17; see also Reply
Br. 8–9. In particular, Appellant asserts that ranges for waveforms that
target “the subthalamic nucleus” to reduce neuron degeneration for
Parkinson’s disease, as well as specific target regions for Alzheimer’s
disease are disclosed. Id. (citing Spec. ¶¶ 30, 78). According to Appellant,
because one skilled in the art would have been aware of various publications
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in the area of brain stimulation, Appellant need not explicitly recite every
specific detail related to ultrasound delivery to evidence that the inventors
were in possession of the claimed subject matter. Id. at 18. Specifically,
Appellant asserts that disclosure of all treatment parameters is not required
in order to show possession, and that Appellant’s disclosure of “certain
frequency ranges and target locations for ultrasound delivery in order to
reduce or prevent neural degeneration . . . would have been sufficient to
show possession of the claimed subject matter.” Id. at 19.
The Examiner responds that Appellant’s Specification recognizes that
treatment parameters include more than just ultrasound frequency, and
include at least intensity, treatment time, amplitude, and duty cycle. Ans. 10
(citing Spec. ¶ 44). According to the Examiner, possession is not shown by
just disclosing one of numerous ultrasound treatment parameters. Id. The
Examiner asserts that just because ultrasound therapy was known in the art
does not evidence possession of the claimed subject matter because none of
the references relied on by Appellant reduce or prevent neurodegeneration.
Ans. 10–11. For the following reasons, we sustain the Examiner’s written
description rejection.
To satisfy the written description requirement of the first paragraph of
35 U.S.C. § 112, a specification must describe the claimed invention in
sufficient detail that one skilled in the art can reasonably conclude that the
inventor had possession of the claimed invention. Vas-Cath, Inc. v.
Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991). Specifically, the
specification must describe the claimed invention in a manner
understandable to a person of ordinary skill in the art and show that the
inventor actually invented the claimed invention. Id.; Ariad Pharms., Inc. v.
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Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In addition,
the specification must “demonstrate that the patentee possessed the full
scope of the invention recited in [the] claim.” LizardTech, Inc. v. Earth
Resource Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005). “The
primary consideration is factual and depends on the nature of the invention
and the amount of knowledge imparted to those skilled in the art by the
disclosure.” In re Wertheim, 541 F.2d 257, 262 (CCPA 1976).
Appellant’s Specification describes various frequency ranges for
neuroprotective ultrasound waveforms. For example, the Specification
describes “a frequency ranging between approximately 0.1 MHz and 20
MHz.” Spec. ¶ 30. However, as the Examiner correctly notes, the
Specification does not explicitly describe what intensity, treatment time,
amplitude, or duty cycle would be used with those frequency ranges to
reduce or prevent neurodegeneration. See Ans. 10–11. Thus, resolution of
the present appeal depends on whether one of ordinary skill in the art would
discern from the Specification and the knowledge possessed by one of
ordinary skill in the art that Appellants possessed the full scope of the
invention recited in claim 1.
Although Appellant asserts that the Spieles-Engemann3 article and the
Bystritsky4 article evidence that low energy ultrasound provides
neuroprotective benefits and that ultrasound therapy was known in the art,
these references do not support Appellant’s contention that “the frequency

3 Spieles-Engemann et al., Stimulation of the Rat Subthalamic Nucleus is
Neuroprotective Following Significant Nigral Dopamine Neuron Loss,
National Institutes of Health, Neurobiol. Dis. 2010 July; 39(1):105–115
4 Bystritsky et al., A review of low-intensity focused ultrasound pulsation,
Brain Stimulation (2011) 4, 125–36
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and location to deliver ultrasound would have been sufficient to show
possession of the claimed subject matter.” Appeal Br. 19. Spieles-
Engemann discloses stimulation at a “frequency of 130 Hz, 60 μs pulse
width, and an intensity of 30–50 μA” (Spieles-Engemann, 5) for a duration
of 2 weeks (“it appears that 2 weeks of stimulation of the STN can halt the
nigral THir neuron degeneration” (Spieles-Engemann, 9). Similarly,
Bystritsky discloses various frequency ranges as well as the duration of the
pulse and the pulse energy. For example, Bystritsky discloses “Frequency:
0.661 and 0.1986 MHz[.] Duration: continuous for 30 s, or pulsed at 1 ms or
10 ms at 10 or 20 Hz[.] Energy: 100–875 W/cm2;” and “Frequency: 0.48
MHz[.] Duration: 1 ms or 100–1600 Hz for 20 ms. Energy: 0.01-2.5
W/cm2.” Bystritsky, 130–132. Thus, both Spieles-Engemann and
Bystritsky disclose more than frequency to achieve their results. Indeed,
Bystritsky queries “what parameters (ie, intensity, frequency, and duration
of US bursts and the length of interpulse interval) should be used for either
stimulation or inhibition of neuronal tissue?” Bystritsky, 127.
Moreover, Appellant’s Specification discloses that “[c]ontroller
device 28 controls the transducers of array 23 to generate waveforms
corresponding to a set of ultrasound parameters.” Spec. ¶ 24 (emphasis
added). The Specification discloses that “ultrasound parameters may
include, but are not limited to, identification of active ultrasound
transducers, waveform shape, waveform amplitude, waveform frequency,
duty cycle, the waveform phase, the number of waveforms within each burst
of waveforms, and the frequency of bursts of waveforms.” Id. Neither the
Specification nor the articles cited by Appellant provide support for
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Appellant’s assertion that controlling waveform frequency by itself is
sufficient to provide written description support for the claimed invention.
Our reviewing court states “it is ‘not a question of whether one skilled
in the art might be able to construct the patentee’s device from the teachings
of the disclosure . . . [r]ather, it is a question whether the application
necessarily discloses that particular device.’” Lockwood v. American
Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (quoting Jepson v.
Coleman, 314 F.2d 533, 536 (CCPA 1963)). See also Ariad
Pharmaceuticals, 598 F.3d at 1352. (“[W]e have repeatedly stated that
actual “possession’ or reduction to practice outside of the specification is not
enough. Rather . . . it is the specification itself that must demonstrate
possession.”). This reasoning is applicable here. Appellant’s contentions
would substitute speculation by a skilled artisan regarding what treatment
parameters from a “set of ultrasound parameter values” might be used with
the disclosed frequency to prevent neural degeneration for the required
disclosure in the Specification demonstrating possession of the claimed
invention.
Appellant’s contention that the claims are supported by the written
description because the prior art provides a “foundation of information and
the additional information provided by Appellant’s specification (e.g.,
example frequencies, target locations, and low energy ultrasound) . . .
provide[s] sufficient detail showing that the inventors had possession of the
claimed subject matter,” is not supported by evidence. Reply Br. 9–10. For
example, Spieles-Engemann and Bystritsky are directed to work on small
mammals (rats), and Bystritsky discloses that “it is still unclear that low-
intensity US pulsations would be able to penetrate into deep areas of the
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brain and be precisely navigated through an intact human skull,” and that “a
more systematic, and broader, evaluation is needed of the duration of
optimal treatment in different neuronal circuits, and structures, as well as
how many treatments are needed to modify the circuits for a prolonged
period.” Bystritsky 133–134.
We have considered all of Appellant’s arguments, the Specification in
its entirety, and the evidence presented by Appellant concerning the
purported knowledge possessed by one of ordinary skill in the art at the time
of Appellant’s invention. For the foregoing reasons, we agree with the
Examiner that the Specification does not provide written description support
for the claimed invention in accordance with 35 U.S.C. § 112, first
paragraph, because one of ordinary skill in the art would not reasonably
understand that, at the time the application was filed, Appellant possessed
the full scope of the invention recited in claim 1, i.e., a set of ultrasound
parameter values that reduce or prevent neural degeneration. Therefore, we
sustain the rejection of claim 1. Claims 2–25 fall with claim 1.

Rejection 2; Enablement
Based on an analysis of the Wands factors, the Examiner finds that the
Specification does not enable one skilled in the art to make and/or use the
claimed invention. Final Act. 3; In re Wands, 858 F.2d 731 (Fed. Cir.
1988). In particular, the Examiner determines that, “the ordinary person in
the art would need [to perform an] undue amount of experimentation” to use
the invention. Id. at 5.
Appellant argues that the “[S]pecification provides example
ultrasound parameter values and target locations of the brain that define
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delivery of the claimed ultrasound energy such that a skilled person would
be able to make and use the subject matter of the claimed without undue
experimentation.” Appeal Br. 8. In particular, Appellant asserts that each of
the Wands factors support Appellant’s position that “one skilled in the art
would have been able to make or use the claimed subject matter without
undue experimentation.” Id. at 9–14. According to Appellant, the
Examiner’s position that “one skilled in the art of ultrasound delivery for
therapy would need undue experimentation to identify a few parameters
such as duration or intensity of ultrasound delivery,” is not supported. Id. at
14–15. For the following reasons, we sustain the Examiner’s enablement
rejection.
We note that the Wands court elected to consider “all of the factors.”
Wands, 858 F.2d at 740. However, it is not necessary to review all the
Wands factors to find an enabling disclosure. Rather, the Wands factors “are
illustrative, not mandatory” and what is relevant to an enablement
determination depends upon the facts of the particular case. See Amgen, Inc.
v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991); see also Enzo
Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999);
Warner-Lambert Co. v. Teva Pharms. USA, Inc., 418 F.3d 1326, 1337 (Fed.
Cir. 2005).
Bearing this in mind, although the Examiner’s omission of the “level
of one of ordinary skill” detracts from the Examiner’s Wands analysis, we
do not agree with Appellant that it is fatal to the Examiner’s enablement
analysis. See Appeal Br. 11. The enablement provision in the first
paragraph of 35 U.S.C. § 112 requires that “there must be sufficient
disclosure, either through illustrative examples or terminology, to teach
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those of ordinary skill [in the art] how to make and how to use the invention
as broadly as it is claimed.” In re Vaeck, 947 F.2d 488, 496 (Fed. Cir.
1991).
We agree with the Examiner that although the Specification discloses
a frequency of the waveform (see Ans. 4), claim 1 recites a “set of
ultrasound parameter values are selected to define ultrasound energy
delivered via the one or more ultrasound transducers that reduces or prevents
neural degeneration.” The Specification does not disclose what values of
ultrasound parameters other than frequency are required. That is, whereas
“[c]ontroller device 28 may control array 23” for neuroprotective waveform
emissions, the Specification does not disclose which “different ultrasound
parameter sets are used to define the neuroprotective waveforms.” Spec.
¶ 29.
The Specification enumerates several ultrasound parameters (“The
ultrasound parameters may include, but are not limited to, identification of
active ultrasound transducers, waveform shape, waveform amplitude,
waveform frequency, duty cycle, the waveform phase, the number of
waveforms within each burst of waveforms, and the frequency of bursts of
waveforms.”) (Spec. ¶ 24) that may be iteratively adjusted (Spec. ¶ 44). The
Specification, however, provides no working examples of a particular
combination of ultrasound parameters, or the requisite threshold values
thereof, if any, that denote a reduction in or prevention of neural
degeneration within a brain. Further, the Specification is silent as to how, if
at all, the value of one ultrasound parameter might impact the significance of
another ultrasound parameter in indicating whether there is a reduction in or
prevention of neural degeneration.
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Additionally, the claims are broad in scope, in that they seek to cover
any and all ultrasound parameters that will reduce or prevent neural
degeneration without disclosing sufficient ultrasound parameter values to
accomplish that function. Appellant’s assertion that “the art supplements
and supports the specification’s teaching” is not persuasive. The Federal
Circuit explains that:
[Although] a specification need not disclose what is well known
in the art . . ., that general, oft-repeated statement is merely a rule
of supplementation, not a substitute for a basic enabling
disclosure. . . . [W]hen there is no disclosure of any specific
starting material or of any of the conditions under which a
process can be carried out, undue experimentation is required;
there is a failure to meet the enablement requirement that cannot
be rectified by asserting that all the disclosure related to the
process is within the skill of the art. It is the specification, not
the knowledge of one skilled in the art, that must supply the novel
aspects of an invention in order to constitute adequate
enablement.
Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir.
1997).
Indeed, Spieles-Engemann’s disclosure of a frequency of 130 Hz (see
Spieles-Engemann 4–5) is outside Appellant’s disclosed range of 0.1 MHz
to 20 MHz, and as noted above Spieles-Engemann also discloses duration,
pulse width, and intensity for stimulation and, thus, neither supplements nor
supports the specification’s teachings of which set of ultrasound parameter
values will reduce or prevent neural degeneration. Similarly, Bystritsky’s
disclosure of various frequencies, including some frequencies outside
Appellant’s disclosed range, coupled with Bystritsky’s disclosure of duration
and intensity and that adjusting these parameters affect bioelectric activity
neither supplements nor supports the Specification’s teachings of which set
of ultrasound parameter values will reduce or prevent neural degeneration.
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We have considered all of Appellant’s arguments, the Specification in
its entirety, and the evidence presented by Appellant concerning the
purported knowledge possessed by one of ordinary skill in the art at the time
of Appellant’s invention. For the above reasons, the subject matter of claims
1–25 is not disclosed in the present application so as to enable one skilled in
the art to make and/or use the claimed invention. Accordingly, claims 1–25
fail to satisfy the enablement requirement of 35 U.S.C. § 112(a).
CONCLUSION
The Examiner’s rejection is affirmed.
More specifically,
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–25 112(a) Written Description 1–25
1–25 112(a) Enablement 1–25
Overall
Outcome:
1–25

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED