Ex Parte Slayton et al

Patent Trial and Appeal Board

May 15, 2018

13136541 (P.T.A.B. May. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/136,541 08/02/2011 Michael H. Slayton
26287 7590 05/17/2018
Quarles & Brady LLP/Guided Therapy Systems, LLC
Attn: IP Docket
411 E. WISCONSIN A VE
SUITE 2350
MILWAUKEE, WI 53202-4426
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.
148534.00094.GTS065USNP 7208
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
05/1712018 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):
pat-dept@quarles.com
1.ruggiero@guidedtherapy.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL H. SLAYTON and PETER G BARTHE 1
Appeal 2018-001898
Application 13/13 6,541
Technology Center 3700
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
DAVID COTTA, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treating a plantar fascia which have been rejected as not enabled
and as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
"Plantar fasciitis involves pain and inflammation of a thick band of
tissue, called the plantar fascia, which runs across the bottom of the foot and
connects the heel bone to the toes." Spec. i-f 2. The Specification describes a
1 Appellants identify the Real Party in Interest as Guided Therapy Systems,
LLC. Br. 2.
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Application 13/13 6,541
method for treating plantar fasciitis using conformal distribution of
ultrasound energy directed to the damage location. Spec. i-f 5.
Claims 1, 2, 4--8, 15-21, and 23-26 are on appeal. Claim 1 is
representative and reads as follows:
1. A non-invasive method of treating a plantar fascia using an
ultrasound treatment system, the method comprising:
locating a damage location within the plantar fascia; and
directing, non-invasively, using the ultrasound treatment
system, a conformal distribution of ultrasound energy to the
damage location within the plantar fascia or tissue within the
plantar fascia surrounding the damage location, thereby creating
a conformal region of elevated temperature in the plantar fascia,
thereby creating a micro-lesion in the plantar fascia.
The claims have been rejected as follows:
Claims 1, 2, 4--8, 15-21, and 23-26 have been rejected under
35 U.S.C. § 112, first paragraph as not enabled.
Claims 1, 2, 15, 19-21, 23, 24, and 26 have been rejected under
35 U.S.C. § 103(a) as unpatentable over Pepera2 in view of Slayton. 3
Claims 4, 5, and 25 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Pepera in view of Slayton in further view of Kaufman. 4
Claims 8 and 17 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Pepera in view of Slayton in further view of Johnson. 5
2 Pepera, US 6,499,485 Bl, issued Dec. 31, 2002 ("Pepera").
3 Slayton et al., US 2006/0074313 Al, published Apr. 6, 2006 ("Slayton").
4 Kaufman et al., US 6,251,088 Bl, issued June 26, 2001 ("Kaufman").
5 Johnson, US 2007 /0065420 Al, published Mar. 22, 2007 ("Johnson").
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Claims 6 and 18 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Pepera in view of Slayton in further view of Babaev I. 6
Claims 7 and 16 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Pepera in view of Slayton in further view of Babaev II. 7
ENABLEMENT
Issue
The issue with respect to this rejection is whether substantial evidence
supports the Examiner's conclusion that claims 1, 2, 4--8, 15-21, and 23-26
ae not enabled.
The Examiner finds that the claims are not enabled because the
Specification does not disclose the treatment time, intensity or frequency.
Final Act. 2-3. The Examiner also finds that knowing the location of the
damage is critical to the practice of the invention and the Specification fails
to teach how to locate the damage. Id.
Appellants contend that the claims are enabled. Appellants argue that
the Specification sets forth the parameters required to practice the invention.
Br. 8; Spec. i-fi-140-44. Appellants contend:
Even assuming that a person having ordinary skill in the art has
no idea how to direct ultrasound energy into a plantar fascia to
create a conformal region of elevated temperature and/or a
micro-lesion - a point which Appellant does not concede - then
the person could simply begin by introducing a low intensity
ultrasound for a short period of time, followed by increasing the
intensity and/or length of time that the ultrasound is applied
until the claimed effect is achieved.
6 Babaev, US 6,960, 173 B2, issued Nov. 1, 2005 ("Babaev I").
7 Babaev, US 2009/0254006 Al, published Oct. 8, 2009 ("Babaev II").
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Application 13/13 6,541
Br. 8. Appellants contend that even if some experimentation is required, it
does not rise to the level of undue experimentation. Br. 9.
With respect to locating the damage, Appellants contend that one
skilled in the art can readily determine the area to be treated by examining a
patient's foot. Br. 11.
Legal Principles
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.
In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993).
[A ]s part of the quid pro quo of the patent bargain, the
applicant's specification must enable one of ordinary skill in the
art to practice the full scope of the claimed invention. That is
not to say that the specification itself must necessarily describe
how to make and use every possible variant of the claimed
invention, for the artisan's knowledge of the prior art and
routine experimentation can often fill gaps, interpolate between
embodiments, and perhaps even extrapolate beyond the
disclosed embodiments, depending upon the predictability of
the art.
AK Steel Corp. v. Sollac and Ugine, 344 F.3d 1234, 1244 (Fed. Cir. 2003)
(citation omitted).
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Analysis
We agree with Appellants that the Examiner has failed to establish
that the claims are not enabled. The Specification provides guidance as to
the temperature of the tissue to be treated, the energy levels to be used, the
time duration of the treatments, the frequency to be used, and the depth of
the treatment. Spec. i-fi-1 40-44. The Examiner has offered no evidence to
support the proposition that the guidance in the specification is insufficient.
The Examiner contends that there are treatment parameters such as the
age and physical makeup of the patient that are not discussed in the
Specification that affect the results of the treatment. Ans. 8. The Examiner,
however, offers no evidence to support this position. Moreover, we find that
these are parameters that one skilled in the art would routinely consider in
any treatment and need not be specifically taught.
The Examiner contends that the Specification merely lists broad
ranges of values for the various parameters without providing specific
guidance as to how to adjust the parameters. Ans. 12. The Examiner
contends that undue experimentation would be required to practice the
invention.
We have considered the Examiner's argument and find it
unpersuasive. Again, the Examiner has failed to provide an evidentiary
basis to support the Examiner's specific reasoning as to why the claims are
not enabled. As discussed above, the Specification gives very specific
ranges for the various parameters that affect the treatment. Absent an
evidentiary basis to the contrary, we agree with Appellants that one skilled
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Application 13/13 6,541
in the art would know how to manipulate these parameters to achieve the
desired result. Br. 8.
Turing to the issue of the location of the damage, we again agree with
Appellants that one skilled in the art would know how to identify the area to
be treated. Claim 1 calls for the application of the conformal ultrasound to
"the damage location within the plantar fascia or tissue within the plantar
fascia surrounding the damage location." As shown in the Specification, the
location of the plantar fascia is well known in the art and a practitioner
would be able to determine the location of the damage or at least the tissue
within the plantar fascia surrounding the damage. See Spec. i-f 2.
Conclusion
We conclude that substantial evidence does not support the
Examiner's conclusion that the claims are not enabled.
OBVIOUSNESS
Issue
Each of the rejections for obviousness relies on the combined
teachings of Pepera and Slayton and Appellants have argued the rejections
together. Thus, the issue with respect to these rejections is whether a
preponderance of the evidence supports the Examiner's conclusion that the
subject matter of the claims would have been obvious over Pepera combined
with Slayton.
The Examiner finds that Pepera discloses identifying a damage
location within the plantar fascia and then applying ultrasound energy to
increase the temperature in the damage location. Final Act. 4. The
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Application 13/13 6,541
Examiner finds that Slayton discloses the use of conformal ultrasound
therapy to create micro-lesions in the target tissue. Id. The Examiner also
finds that Slayton teaches that conformal ultrasound therapy only treats the
target region and does not affect the surrounding healthy tissue. Id. The
Examiner concludes that
Id.
[i]t would have been obvious to one of ordinary skill in the art
at the time of the invention to modify Pepera to transmit
conformal ultrasound energy to the damage location that
result[s] in the creation of micro-lesion as taught by Slayton
because this would prevent undesirable damage to surrounding
normal tissue.
Appellants contend that the Examiner has not provided evidence or
reasoning to support the combination of the references. Br. 12-13.
Appellants also argue that modifying the references would render the
resulting devices unsuitable for their intended purposes. Br. 13-15.
Appellants also argue that there is evidence of secondary considerations
sufficient to rebut the Examiner's prima facie case of obviousness. Br. 15-
16.
Legal Principles
In proceedings before the Patent and Trademark Office,
the Examiner bears the burden of establishing a prima facie
case of obviousness based upon the prior art. "[The Examiner]
can satisfy this burden only by showing some objective
teaching in the prior art or that knowledge generally available to
one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references." The patent
applicant may then attack the Examiner's prima facie
determination as improperly made out, or the applicant may
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Application 13/13 6,541
present objective evidence tending to support a conclusion of
nonobviousness.
In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992) (alteration in original)
(footnotes omitted).
Analysis
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness. The Examiner has not persuasively shown,
nor have we discerned, any teaching in the prior art or general knowledge
that would have lead one skilled in the art to combine the references.
Pepera teaches that it was known in the art to use ultrasound to heat
the plantar fascia to help stretch the tissue. Pepera col. 1, 11. 21-33. Slayton
teaches the use of conformal ultrasound to increase fat metabolism and to
break up fat clusters. Slayton Abstract. There is nothing in either reference
to teach or suggest the use of conformal ultrasound to form micro-lesions or
that the formation of micro-lesions would help treat plantar fasciitis.
The Examiner contends that Slayton provides the motivation to
combine the references in that Slayton teaches the use of conformal
ultrasound only treats the region of interest and does not affect the
surrounding tissue. Ans. 14. The Examiner cites to paragraphs 6, 23, 29, 57
and 60-65 as well as claim 1 of Slayton as support for this proposition. Id.
We have considered the Examiner's argument and find it
unpersuasive. While Slayton does teach that the use of conformal
ultrasound allows for the treatment to be localized, there is nothing in either
Slayton or Pepera that teaches preventing damage to surrounding tissue.
Moreover, as Appellants point out, there is nothing in Slayton that teaches or
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suggests the conformal ultrasound can be used to create micro-lesions or that
creation of micro-lesions can be used to treat plantar fasciitis. Thus, we
agree with Appellants that the Examiner has filed to establish a motivation
to combine the references.
Conclusion
We conclude that a preponderance of the evidence does not support
the Examiner's conclusion that the subject matter of the claims would have
been obvious over Pepera combined with Slayton.
SUMMARY
We reverse the rejections under 35 U.S.C. § 112, first paragraph.
We reverse the rejections under 35 U.S.C. § 103(a).
REVERSED
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