Ex Parte Warlick

Patent Trials and Appeals Board

Mar 14, 2019

14180007 - (D) (P.T.A.B. Mar. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/180,007 02/13/2014
51108 7590 03/14/2019
DAVID L. KING, SR.
5131 N.E. COUNTY ROAD 340
HIGH SPRINGS, FL 32643
FIRST NAMED INVENTOR
John Warlick
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.
DN0229 3738
EXAMINER
SMITH, RUTHS
ART UNIT PAPER NUMBER
3793
MAIL DATE DELIVERY MODE
03/14/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN WARLICK
Appeal2018-005176
Application 14/180,007
Technology Center 3700
Before JEFFREYN. FREDMAN, MICHAEL J. FITZPATRICK, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
John Warlick ("Appellant") 1 appeals under 35 U.S.C. § 134(a) from
the Examiner's final decision rejecting claims 1, 3-6, and 8-14. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellant, Mr. Warlick, identifies himself as the real party in interest.
Appeal Br. 3.
Appeal2018-005176
Application 14/180,007
STATEMENT OF THE CASE
The Specification
The disclosure "is directed to using acoustic shock waves to stimulate
an autonomic nervous system response from a patient with spinal cord nerve
damage or spinal nerve lesions resulting in a degraded nervous system."
Spec. ,II.
The Rejected Claims
Claims 1, 3-6, and 8-14 are pending and rejected. Final Act. 1.
Claim 1, the sole independent claim, is representative and reproduced below.
1. A method of treating a patient having a spinal nerve
injury resulting in complete or partial paralysis that has impaired
the autonomic nervous system or spinal cord or spinal nerve
function causing a loss of one or more visceral functions, caused
by a spinal cord injury or spinal cord lesions, or spinal cord
pathology where the patient exhibits or has a degraded
autonomic nervous system caused by the spinal nerve injury, the
method of treating comprising the steps of:
activating a response of the degraded autonomic nervous
system by treating the patient having the spinal nerve injury by
activating an acoustic shock wave generator to emit acoustic
shock waves from a shock wave head;
administering an effective exposure of acoustic shock
waves in a pulse or wave pattern having an energy density less
than 1.0 mJ/mm2 per shock wave directly onto a treatment zone
at the spinal nerve injury and below, the spinal nerve injury being
below the medulla oblongata in the lower brain stem and the
treatment zone being from a location of the spinal nerve injury
and extending to the lower end of the spinal cord; and
wherein the step of activating a response of the degraded
autonomic nervous system in either a parasympathetic nervous
system or a sympathetic nervous system or both systems of the
degraded autonomic nervous system by stimulating regeneration
or reactivation of the degraded autonomic nervous system is
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Application 14/180,007
confirmed by one or more visceral functions changing from a
nonfunctioning status to an at least partially functioning status
after the step of administering the effective exposure of acoustic
shock waves.
Appeal Br. 22.
The Appealed Rejections
The following rejections are before us for review:
1. claims 1, 3---6, and 8-14 under 35 U.S.C. § 112(b)/i-f2 (Final
Act. 2);
2.
3.
claims 3-6 and 8-14 under 35 U.S.C. § 112(d)/i-f4 (id. at 3);
claims 1, 3---6, and 9-14 under 35 U.S.C. § 103 as unpatentable
over Schaden2 (id.);
4. claims 4---6 and 14 under 35 U.S.C. § 103 as unpatentable over
Schaden and Tyler3 (id. at 4); and
5. claims 8-13 under 35 U.S.C. § 103 as unpatentable over
Schaden and Freund4 (id.).
DISCUSSION
Rejection 1
The Examiner rejected claims 1, 3---6, and 8-14 under 35 U.S.C.
§ 112(b )/i-f2. Final Act. 2.
Independent Claim 1
The Examiner determined that claim 1 was indefinite because it is
"unclear as to whether the method positively includes a step of confirming
2 US 2007/0239080 Al, published Oct. 11, 2007 ("Schaden").
3 US 2012/0289869 Al, published Nov. 15, 2012 ("Tyler").
4 US 2013/0035619 Al, published Feb. 7, 2013 ("Freund").
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Application 14/180,007
that one or more visceral functions have changed from a nonfunctioning
status to an at least partially functioning status." Id.
Claim 1 explicitly recites only two steps: (1) "activating a
response ... " and (2) "administering an effective exposure of acoustic shock
waves .... " Appeal. Br. 22. After reciting those steps, claim 1 also recites
the following:
wherein the step of activating a response of the degraded
autonomic nervous system . . . is confirmed by one or more
visceral functions changing from a nonfunctioning status to an at
least partially functioning status after the step of administering
the effective exposure of acoustic shock waves.
Id. ( emphasis added).
Appellant argues that this additional recitation constitutes "a
confirmation step." Appeal Br. 14. Appellant argues that a person of
ordinary skill in the art would understand "how to confirm the procedure
works" and that "there are details and explanations to which the method of
claim 1 are further explained in the written description." Appeal Br. 14.
However, as the Examiner points out in her Answer, "the rejection was not
based on written description but rather whether the scope of the claim
included a step of confirming that a response of the degraded nervous
system was activated." Ans. 6.
In any event, the Appeal Brief does not cite any portion of the
Specification that provides the alleged details or explanation. See Appeal
Br. 14. Likewise, in Appellant's "Summary of Claimed Subject Matter,"
Appellant does not cite any portion of the Specification in relation to the
purported confirmation step. See id. at 7-8. We have reviewed the
Specification and do not find any description of a confirming step.
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In view of the absence of any description in the Specification of the
performance of a confirming step as well as the absence of an explicit
recitation of a confirmation step in the claim itself, we agree with the
Examiner that claim 1 is indefinite. This is so because a person of ordinary
skill in the art would not know whether the claim requires any positive
action beyond performance of the two explicitly recited steps, i.e., beyond
(1) "activating a response" and (2) "administering an effective exposure of
acoustic shock waves."
The rejection of claim 1 under 35 U.S.C. § 112(b )/i-f2 is affirmed.
Dependent Claims 3---6 and 8-14
Dependent claims 3-6 and 8-14 are indefinite because they depend,
directly or indirectly, from indefinite claim 1. The Examiner also
determined that these dependent claims are indefinite for additional
reason(s).
For claims 3---6 and 9-14, the Examiner determined that they were
additionally indefinite because they "merely set forth an inherent result."
Final Act. 2. Claim 5, for example, recites that "the administered acoustic
shock waves cause a chemical release of neurotransmitters from the spinal
nerves after the patient is treated." Appeal Br. 23. Appellant argues that
"physicians know how to measure and verify this." Appeal Br. 15. But
whether physicians know how to measure the release of neurotransmitters is
not dispositive. Claim 5 does not recite a measuring step. It is unclear
whether claim 5 requires any positive action beyond performance of the two
steps explicitly recited in claim 1. The same is true for claims 3, 4, 6, and 9-
14.
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For claims 4---6 and 8, the Examiner determined that they were
additionally indefinite because each recites an incomplete "wherein" clause
that is interrupted by a subsequent "wherein" clause. Claim 4 is exemplary.
It recites:
4. The method of treating a patient having a spinal nerve
injury of claim 1 wherein the steps of activating a response of the
degraded autonomic nervous system wherein the administered
acoustic shock waves cause an increase in nitric oxide in the
treatment zone after the patient is treated.
Appeal Br. 23 ( emphasis added). The Appeal Brief does not address this
aspect of the rejection. See id. at 13-16.
For claim 8, the Examiner determined that it was additionally
indefinite because it is unclear whether the language following the word
"typically" is a limitation of the claim. Final Act. 2. Appellant explains
why its uses the term "typically" but does not dispute the Examiner's
determination that it renders the claim indefinite. See Appeal Br. 15 ("In
claim 8, the term 'typically' is argued as indefinite. This term is used
because these cases exhibit a no sweat line at least at or below the spinal
injury, but not all are below. Appellants would agree to drop that term if
required.").
For the foregoing reasons, the rejection of claims 3-6 and 8-14 under
35 U.S.C. § 112(b )/,T2 is affirmed.
Rejection 2
The Examiner rejected dependent claims 3---6 and 8-14 under 35
U.S.C. § 112( d)/,T4 for failing to further limit the subject matter being
claimed. Final Act. 3. The Examiner determined that these claims merely
recite inherent results of the method of claim 1. Id.
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Appellant does not dispute that the results recited in these claims are
inherent from the method of claim 1. See Appeal Br. 16. Instead, Appellant
argues that the claims require an action to confirm that the results have been
achieved. More specifically, Appellant argues the following:
It is hoped the physician using his ordinary skill can use these
"ques" as methodology confirmation steps. The examiner's
statement that these are merely results, ignores the training and
diagnostic expertise of physicians that routinely use test results
as diagnostic tools, whole labs are based on providing results to
physicians. It is the skilled physician that uses these results to
diagnose whether the drug or treatment prescribed is working.
Id. at 16-17.
We are not persuaded by Appellant's argument, as it is not
commensurate with the language of the claims at issue. As the Examiner
notes, "[t]he claims fail to set forth steps of determining the presence of such
results in order to determine efficacy of the treatment. The claims merely
set forth results of using the method." Ans. 6.
For the foregoing reasons, the rejection of claims 3-6 and 8-14 under
35 U.S.C. § 112(d)/,T4 is affirmed.
Rejection 3
The Examiner rejected claims 1, 3---6, and 9-14 under 35 U.S.C. § 103
as unpatentable over Schaden. Final Act. 3--4. Appellants argue these
claims together. See Appeal Br. 17-19. Accordingly, we select independent
claim 1 as representative. See 37 C.F.R. § 4I.37(c)(l)(iv).
Schaden is directed to "[a] method of enhancing the regeneration of
injured nerves [by] administering an effective exposure of pressure pulses or
acoustic shock waves in a pulse or wave pattern to the zone of injury of the
nerve during the regeneration process." Schaden, at [57]. The Examiner
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concluded that it would have been obvious to one of skill in the art to apply
the Schaden method to treat a patient having a spinal nerve injury and that
such an application of the Schaden method would inherently result in
activating visceral functions from a nonfunctioning status to an at least
partially functioning status. Final Act. 4.
Appellant attempts to distinguish Schaden on the basis that its method
results in "rejoining of cut nerve ends," whereas "[t]he present invention
does not require this and may not achieve rejoining." Appeal Br. 18. This
argument is not persuasive because it is not commensurate with the scope of
claim 1 ( or any of the pending claims). See Ans. 6 ("The Examiner notes
that while the present invention may not require rejoining of nerve ends, the
claimed invention fails to preclude such."); Georgia-Pacific Corp. v. U.S.
Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999) (The transitional term
"comprising" is "inclusive or open-ended and does not exclude additional,
unrecited elements.")
For the foregoing reasons, we affirm the rejection of claim 1 as
unpatentable over Schaden. Because claims 3---6 and 8-14 were not
separately argued (see Appeal Br. 17-19), we also affirm their rejection over
Schaden. See 37 C.F.R. § 4I.37(c)(l)(iv).
Rejection 4
The Examiner rejected claims 4---6 and 14 under 35 U.S.C. § 103 as
unpatentable over Schaden and Tyler. Final Act. 4. Appellant argues these
claims together. See Appeal Br. 19-20. Accordingly, we select claim 4 as
representative. See 37 C.F.R. § 4I.37(c)(l)(iv).
Claim 4 recites "wherein the administered acoustic shock waves cause
an increase in nitric oxide in the treatment zone after the patient is treated."
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Application 14/180,007
The Examiner found that Schaden fails to explicitly disclose this
result of its method ( although the Examiner found it to be inherent as
discussed above).
The Examiner found that Tyler discloses using "ultrasound
( considered to be a form of acoustic shock waves) [to] induce[] vasodilation
or vasoconstriction in peripheral tissues by activating nitric oxide/nitric
oxide synthetase." Final Act. 4 (citing Tyler i-flOl).
The Examiner concluded that it "would have been obvious to one with
ordinary skill in the art to have further modified Schaden et al to include the
nitric oxide creation method, as taught by Tyler et al, in order to facilitate
the vascularization of tissue." Id.
Appellant argues that "[t]he technology of acoustic shock waves is a
different wave form from ultrasonic wave forms and those of ordinary skill
in the art would understand these to be not comparable." Appeal Br. 19.
This is attorney argument unsupported by any citation to evidence. Id.; see
also In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) ("attorney argument
[is] not the kind of factual evidence that is required to rebut a prima facie
case of obviousness.")
Accordingly, we affirm the rejection of claim 4 as unpatentable over
Schaden and Tyler. Because claims 5, 6, and 14 were not separately argued
(see Appeal Br. 19-20), we also affirm their rejection over Schaden and
Tyler. See 37 C.F.R. § 4I.37(c)(l)(iv).
Rejection 5
The Examiner rejected claims 8-13 under 35 U.S.C. § 103 as
unpatentable over Schaden and Freund. Final Act. 4. Appellant argues
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these claims together. See Appeal Br. 20-21. Accordingly, we select
claim 8 as representative. See 37 C.F.R. § 4I.37(c)(l)(iv).
Claim 8 recites:
wherein the patient has a reduced pulmonary function or has lost
the ability to perspire in any portion of the body, typically below
the site of a spinal injury prior to treating and the response is
confirmed after treating by the patient exhibiting increased
pulmonary function or regaining the ability to perspire.
The Examiner found that Freund discloses, for pulmonary-
compromised patients, using a "garment that may include at least one
percussive mechanism to transmit at least one of (a) ultrasonic waves and (b)
a directed percussive effect, to the wearer's lungs." Appeal Br. 5 (citing
Freund i-fi17, 17).
The Examiner concluded that "it would have been obvious to one with
ordinary skill in the art to have further modified Schaden et al to include the
pulmonary treatment method, as taught by Freund et al, in order to provide a
device and method for facilitating pulmonary function while reducing the
need for nurses and pulmonary therapists to provide such treatment." Id.
( citing Freund i-fi17, 8).
Although we find no error in the Examiner's rejection of claim 8 as
unpatentable over Schaden alone, we do not see how the Examiner's
application of Freund's teaching is relevant to the patentability of claim 8.
More specifically, we do not see how Schaden's teaching of administering
ultrasonic waves to a patient's lungs is relevant to the patentability of claim
8, which, via its dependence from claim 1, requires "administering an
effective exposure of acoustic shock waves ... directly onto a treatment
zone at the spinal nerve injury."
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However, in affirming a multiple reference rejection under 35 U.S.C.
§ 103, we may rely on fewer than all of the references relied on by the
Examiner in an obviousness rationale without designating it as a new ground
of rejection. See In re Bush, 296 F.2d 491,496 (CCPA 1961). Here, we do
not rely upon Freund.
Accordingly, we affirm the rejection of claim 8. Because claims 9-13
were not separately argued (see Appeal Br. 20-21 ), we also affirm their
rejection. See 37 C.F.R. § 4I.37(c)(l)(iv).
DECISION
The Examiner's rejection of claims 1, 3-6, and 8-14 is affirmed.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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