Ex Parte Hoey et al

Patent Trial and Appeal Board

May 31, 2018

12843581 (P.T.A.B. May. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/843,581 07/26/2010
66854 7590
SHAY GLENN LLP
2755 CAMPUS DRIVE
SUITE 210
SAN MATEO, CA 94403
06/04/2018
FIRST NAMED INVENTOR
Michael Hoey
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.
10837-705.300 6457
EXAMINER
DELLA,JAYMIE
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
06/04/2018 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):
info@shayglenn.com
shayglenn_pair@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL HOEY and JOHN H. SHADDUCK
Appeal2016-000870
Application 12/843,581
Technology Center 3700
Before JOHN C. KERINS, KEVIN F. TURNER, and
ARTHUR M. PESLAK, Administrative Patent Judges.
KERINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Michael Hoey and John H. Shadduck ("Appellants") appeal under
35 U.S.C. § 134(a) from a final rejection of claims 1-3, 5-16, 20-24, and
26. Claims 4, 17-19, and 25 are canceled. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
Appeal2016-000870
Application 12/843,581
THE INVENTION
Appellants' invention is directed to a method for treating benign
prostatic hyperplasia. Claims 1, 14, 20, and 22 reproduced below, are
illustrative:
1. A method for treating benign prostatic hyperplasia (BPH),
compnsmg:
introducing an energy delivery member transurethrally into a
transition zone tissue adjacent a patient's prostatic urethra; and
injecting a condensable vapor media from the energy delivery
member into the transition zone tissue at a depth of less than 12
mm outward from the patient's prostatic urethra so as to confine
the condensable vapor media in the transition zone tissue and to
ablate the transition zone tissue adjacent to and less than 12 mm
outward from the prostatic urethra.
14. A method for treating benign prostatic hyperplasia (BPH),
compnsmg:
introducing a probe into a prostatic urethra;
extending a vapor delivery member from the probe into a
plurality of sites in a transition zone tissue of a prostate; and
delivering a condensable vapor media from the vapor delivery
member at each of the plurality of sites for 20 seconds or less and
confining the condensable vapor media in the transition zone
tissue.
20. A method for treating benign prostatic hyperplasia (BPH),
compnsmg:
introducing an energy delivery member into a transition tissue
adjacent a patient's prostatic urethra; and
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applying energy into a plurality of transition zone sites in left and
right prostate lobes with a condensable vapor media, wherein a
rate of energy delivery is between 1 cal/sec and 40 cal/sec.
22. A method for treating benign prostatic hyperplasia (BPH),
compnsmg:
introducing a probe into a prostatic urethra;
extending a vapor delivery member from the probe into a
transition zone tissue of a prostate at a depth of less than 12 mm
outward from the prostatic urethra; and
delivering a condensable vapor media from the vapor delivery
member to the transition zone tissue at a delivery pressure
ranging from approximately 20 mm Hg to 200 mm Hg.
REJECTIONS
The Examiner rejects:
(i) claims 1-3, 5-8, 11, 12, and 22 under 35 U.S.C. § I03(a) as being
unpatentable over Edwards (US 2005/0010203 Al, published Jan. 13, 2005)
in view ofMulier (US 2002/0177846 Al, published Nov. 28, 2002);
(ii) claims 1-3, 5, 6, 8-12, and 22-24 under 35 U.S.C. § I03(a) as
being unpatentable over Edwards and Shadduck (US 2006/0224154 Al,
published Oct. 5, 2006);
(iii) claims 13 and 26 under 35 U.S.C. § I03(a) as being unpatentable
over Edwards in view of Mulier or Shadduck, and further in view of Barry
(US 2009/0138001 Al, published May 28, 2009);
(iv) claims 14--16 under 35 U.S.C. § I03(a) as being unpatentable
over Shadduck in view of Edwards;
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(v) claims 20 and 21 under 35 U.S.C. § I03(a) as being unpatentable
over Mulier in view of Edwards and Barry, or over Edwards in view of
Mulier and Barry;
(vi) claim 14 is rejected on the ground of nonstatutory double
patenting over claim 5 of Hoey '079 (US 8,273,079 B2, issued Sept. 25,
2012) in view ofMulier or Shadduck;
(vii) claims 14 and 16 are provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 7, 21, and
31, of Hoey '544 (US Application No. 12/768,544, filed Apr. 27, 2010); and
(viii) claims 1 and 2 are provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claim 1 of
Edwards.
Rejections of claims 16 and 21 under 35 U.S.C. § I03(a) that relied in
part on a printed publication to Hoey '326 (US 2010/0145326 Al, published
June 10, 2010) were withdrawn by the Examiner in the Answer. Ans. 4.
ANALYSIS
Claims 1-3, 5---8, 11, 12, and 22--Edwards/Mulier
Appellants present arguments directed to claims 1 and 22, and do not
present separate arguments for claims 2, 3, 5-8, 11, and 12. Those claims
stand or fall with representative claim 1.
Claim 1
The Examiner finds that Edwards teaches a method for treating BPH
that involves introducing an energy delivery member transurethrally into a
transition zone tissue adjacent a patient's prostatic urethra, and applying
energy into the transition zone to ablate transition zone tissue adjacent to the
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prostatic urethra. Final Act. 3--4. The Examiner finds that Edwards does not
explicitly disclose that the energy is to be delivered to the transition zone
tissue at a depth of less than 12 mm outward from the prostatic urethra, so as
to confine the vapor media in the transition zone tissue and to ablate only to
that depth, nor that the ablating media is a condensable vapor media. Id. at
4--5.
The Examiner finds that Mulier discloses the use of a condensable
vapor media in treating BPH, and that a vaporous medium can be directed
with relative precision to effect ablation of a selected portion of a tissue site.
Final Act. 4--5. The Examiner concludes that it would have been obvious to
employ a condensable vapor media as the energy source in the Edwards
method, to take advantage of the precision in ablating tissue afforded by the
vaporous media, so that the ablation can be confined to the regions in which
abnormal or diseased tissue is present. Id.
The Examiner additionally finds that Edwards includes a teaching that
the glandular nodules associated with BPH are found in transition zone
tissue, and that transition zone tissue is to be targeted to treat BPH. Ans. 6,
citing Edwards, para. 73; Final Act. 29; Edwards, para. 119. The Examiner
concludes that it would have been obvious to confine the condensable vapor
media to ablate only transition zone tissue, and that, based on the anatomy of
the prostate and surrounding tissues, limiting the depth to 12 mm or less
would have been obvious as discovering an optimum value of a result-
effective variable. Final Act. 4; Ans. 5.
Appellants argue that, because Edwards does not mention any needle
insertion depth, nor a range of depths, the Examiner's reliance on In re
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Boesch 1 for the proposition that discovering an optimum value for a result
effective variable involves only routine skill in the art is misplaced. Appeal
Br. 4--5. Appellants, however, ignore that Edwards teaches that glandular
nodules giving rise to BPH are present in the transition zone tissue, and that
it is desired to confine treatment to the transition zone. Edwards, paras. 89,
119, 120, Fig. 38. Appellants also do not address the Examiner's further
position that the desired depth of vapor injection is informed by the anatomy
of the prostate and surrounding tissues. Further, the language of claim 1 is
to the effect that the 12 mm upper limit as to the depth of injection of vapor
media is "so as to confine the condensable vapor media in the transition zone
tissue" and to limit tissue ablation to that depth. We therefore are not
apprised of error in the Examiner's position that the claimed range of vapor
injection depth would have been obvious.
Appellants also argue that the Examiner's articulated reason to modify
Edwards in view of Mulier, namely to obtain greater ablation precision such
that only regions containing abnormal or diseased tissue, falls short of
establishing a prima facie case of obviousness. Appeal Br. 5; Reply Br. 3.
The reason presented is supported by the Mulier disclosure, and Appellants
bald assertion does not apprise us of error.
According to Appellants, "[t]he Examiner has not provided any
rationale at all, ... , for the obviousness of confining Mulier's condensable
vapor to prostrate transition zone tissue." Appeal Br. 5. Appellants posit
that the question to be answered in the obviousness analysis is, "how, in the
absence of any suggestion in either Edwards or Mulier that the ablation
effect can or should be limited to the prostate transition zone ... , Mulier's
1 617 F.2d272 (CCPA 1980).
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disclosure of general water vapor and tissue principles would have
motivated a skilled artisan to confine vapor delivery and the ablation effect
to the transition zone." Appeal Br. 5---6. Appellants again tum a blind eye to
the Edwards disclosure that glandular nodules that can be the cause of BPH
are primarily concentrated in the transition zone, and the further exemplary
procedure in Edwards that specifically limits the procedure to treating tissue
in the transition zone. Thus, the premise of Appellants' rhetorical question
1s erroneous.
Appellants' final Appeal Brief argument is that their showing of
unexpected results is evidence of nonobviousness, regardless of the
modification proposed by the Examiner. Appeal Br. 6. Appellants note that
a Declaration Under 37 C.F.R. § 1.132 of Roger Hastings ("Hastings
Declaration" or "Hastings Deel.") avers that a person of ordinary skill in the
art would not have expected to be able to confine condensable vapor to the
prostate transition zone and to ablate transition zone tissue adjacent to and
less than 12 mm outward from the prostatic urethra. Id., citing Hastings
Deel., para. 22. This statement lacks any underlying factual support or
technical reasoning, and is, indeed, undermined by the Mulier and Edwards
disclosures. The Edwards procedure discussed above employs RF energy
intended to treat tissue only in the transition zone of the prostate. Edwards,
paras. 119--120. Mulier, for its part, recognizes RF ablation as a then-
existing ablation technique, that can potentially kill normal surrounding
tissue, and, by comparison, notes that the use of vapor in ablation procedures
allows for sufficient precision to ablate a selected portion of a tissue site, and
can be directed to heat a relatively confined area at the tissue site, thereby
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reducing undesired heating of adjacent tissues. See, e.g., Mulier, paras. 7,
49. As such, we afford little weight to the Hastings averment.
In the Reply Brief, Appellants again argue that the Examiner has
failed to provide a teaching of confining vapor in the transition zone,
asserting that Edwards "describes delivering RF energy to the transition
zone, but does not describe confining that energy to the transition zone."
Reply Br. 2. We again note that Edwards discloses that the transition zone is
where the glandular nodules responsible for BPH are principally located, and
discloses at least one exemplary procedure in which "[t]he tissues to be
treated for the treatment of BPH are located in the transition zone 428 of the
prostate." Edwards, paras. 73, 89, 119, Fig. 38. These portions of the
Edwards disclosure would inform a person of ordinary skill in the art that the
energy (vaporous energy in the modification to Edwards) would be confined
to the transition zone.
Appellants repeat the allegation that no rationale has been provided to
support the position that it would have been obvious to confine the
condensable vapor to the transition zone tissue. Reply Br. 2. This assertion
is addressed thoroughly above.
Appellants take issue with the Examiner's mention that it would have
been "obvious to try," or determine through routine experimentation, various
parameters associated with the delivery of condensable vapor, such that the
vapor ablation is confined to the transition zone, in order to ablate the
nodules causing the presence of BPH. Reply Br. 3; Ans. 6-7. Appellants
specifically argue that an assertion that such would have been obvious to try
is improper, in that "Mulier gives no indication of which parameters would
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be critical in confining vapor to a specific zone within the prostate." Reply
Br. 3.
Contrary to the position advanced by Appellants, Mulier specifically
mentions a correlation between the pressure of the vapor spray and depth of
ablation. 2 Mulier, para. 52. Mulier notes that if the pressure is insufficient
to produce a desired depth of ablation, either the level of heat to produce the
vapor may be increased to increase the pressure of the vapor, or a pressure
regulator may be adjusted to do the same. Id.; see also id., para. 107 (more
pressure may produce a greater ablation depth). Accordingly, Mulier
advises the person of ordinary skill in the art that achieving a desired depth
of ablation may be accomplished by adjusting a pressure of the vapor as
necessary.
Appellants' arguments do not apprise us of error in the Examiner's
position relative to the unpatentability of claim 1 over Edwards and Mulier.
The rejection of claim 1 over Edwards and Mulier is therefore sustained.
Claims 2, 3, 5-8, 11, and 12 fall with claim 1.
Claim 22
Appellants reference the arguments advanced for claim 1 in arguing
against the rejection of claim 22. For the reasons discussed in detail above,
the arguments do not apprise us of Examiner error.
Claim 22 includes the further limitation that the vapor be delivered to
the transition zone tissue at a delivery pressure ranging from approximately
20 mm Hg to 200 mm Hg. The Examiner takes the position that it would
have been obvious to operate the Edwards procedure as modified by Mulier
2 This additionally supports the Examiner's position, discussed earlier, that
treatement depth is a result effective variable.
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to deliver condensable vapor, at a delivery pressure within the claimed
range, in that this amounts to discovering an optimum value of a result
effective variable that involves only routine skill in the art. Final Act. 9.
Appellants cite to the Hastings Declaration as support for the
proposition that "the vapor delivery pressure is very important to the
effectiveness of the therapy," and that pressures that are too high may extend
the vapor ablation effects beyond the target tissue, with pressures that are too
low potentially not achieving the desired effect of reducing tissue volume.
Appeal Br. 7. We note that this position, not unlike the discussion of the
correlation between vapor pressure and ablation depth found in paragraph 52
of Mulier, support the Examiner's position that vapor pressure is, and was
known to be, a result-effective variable.
Appellants further argue that Mulier does not disclose any value, or
range of values, of vapor delivery pressure for treating BPH. Appeal Br. 7.
Appellants maintain that Mulier discusses vapor pressure only in the context
of a vapor generation system, in which the pressure is 25 pounds per square
inch, which translates to 1293 mmHg, well outside the claimed range. Id.,
citing Mulier, para. 69.
That paragraph in Mulier does not appear to be especially pertinent to
vapor delivery pressures to perform tissue ablations inside a patient's body.
Mulier, however, includes further disclosure pertinent to vapor delivery
pressures for ablating tissue. Although admittedly not specific to treatment
of BPH, Mulier provides an example, given in the context of calculating a
vapor mass required to attain a target temperature, of introducing the steam
into tissue at atmospheric pressure, namely, 7 6 mmHg, which is squarely in
the claimed range. Mulier, para. 61. A person of ordinary skill in the art, in
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view of this disclosure, would regard delivery of vapor pressure at or around
atmospheric pressure to be at least a viable starting point for determining, for
a particular procedure such as treating for BPH, a particularly desired vapor
delivery pressure. As such, arriving at a vapor delivery pressure within the
claimed range would have been, according to the Examiner's position, a
determination of an optimum value for a result-effective variable.
Appellants' arguments do not apprise us of error in the Examiner's
position. The rejection of claim 22 as being unpatentable over Edwards and
Mulier is sustained.
Claims 1-3, 5, 6, 8-12, and 22-24--Edwards/Shadduck
Edwards is applied in this rejection in the same manner as in the
rejection over Edwards and Mulier addressed above, and Shadduck is relied
on much in the same manner as is Mulier. Final Act. 9-15.
Appellants present arguments for independent claims 1 and 22, which
are substantively the same arguments as presented traversing the rejection
over Edwards and Mulier. Appeal Br. 8, 10-11; Reply Br. 4, 6.
For the reasons presented in the foregoing section, we do not find that
Appellants' arguments apprise us of error in the Examiner's position that
claims 1 and 22 are unpatentable over Edwards and Shadduck. Dependent
claims 2, 3, 5, 6, 8-12, 23, and 24, are not separately argued, and these
claims fall with the independent claim from which they depend.
Claims 13 and 26--Edwards/Mulier or Shadduck/Barry
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Claim 13 depends from claim 1, and claim 26 depends from claim 22.
Each recites that the condensable vapor media is configured to apply energy
ranging from 1 to 40 calories per second to the transition zone tissue.
The Examiner finds that none of Edwards, Mulier, and Shadduck
discloses this limitation directed to the range of energy applied. Final Act.
15. The Examiner cites to Barry as disclosing treating tissue using vaporous
energy in the claimed range, and discloses selecting treatment parameters in
order to cause a specific degree of injury to the tissue. Id. The Examiner
concludes that it would have been obvious to employ the range of energies
disclosed by Barry in the method resulting from modifying Edwards in view
of Mulier or Shadduck, to provide the benefit of causing a specific degree of
injury to tissue to be treated, and as a matter of discovering an optimum
value of a result-effective variable involving only routine skill in the art. Id.
at 15-16.
Appellants argue that Barry is directed to ablating or otherwise
injuring lung tissue in the treatment of lung cancer, and does not disclose
appropriate values or ranges for energy delivery rates in treating the prostate.
Appeal Br. 11. The Examiner has failed to produce evidence or provide
adequate reasoning as to why a person of ordinary skill in the art would look
to energy rates used in causing specific degrees of damage to cancerous lung
cells in determining an appropriate range of energy rates for use in ablating
prostate transition zone tissue in the treatment of BPH.
Accordingly, the rejection of claims 13 and 26 is not sustained.
Claims 14-16--Shadduck/Edwards
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Independent claim 14 includes limitations requiring that a vapor
delivery member be extended from a probe into a plurality of sites in a
transition zone tissue of a prostate, and that a condensable vapor media be
delivered from the delivery member for 20 seconds or less at each of the
plurality of sites. Appeal Br. 17, Claims Appendix. As to the former
limitation, the Examiner takes the position that Shadduck discloses a needle
211 having a plurality of vapor outlets 207 thereon, and that "the needle
penetrates 'a plurality of sites' within the prostate, where each site is
associated with a respective vapor outlet." Ans. 11-12. As to the latter, the
Examiner cites to paragraphs 56, 58, and 61 of Shadduck as together
teaching a treatment time of 20 seconds when treating tissue such as prostate
tissue. Id. at 12.
The Examiner's position that a plurality of vapor outlets on a needle
results in the needle being regarded as penetrating a plurality of sites within
the prostate falls short of meeting the actual language of claim 14. As
pointed out by Appellants (Reply Br. 4--5), the claim requires extending the
vapor delivery member into a plurality of sites in the transition zone tissue,
not simply having vapor delivered to a plurality of sites as a result of the
needle having a plurality of vapor outlets thereon.
We also agree with Appellants that the Examiner's reliance on the
treatment times disclosed in paragraph 58 of Shadduck as rendering obvious
the claim 14 limitation directed to treatment time, is in error. Appeal Br. 9.
Appellants point out that paragraph 58 of Shadduck is not directed to
treatment times for ablating prostate tissue, whereas mention of treating
prostate tissue is discussed in connection with a different embodiment, for
which no treatment times are disclosed. Id.
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Shadduck discloses that the treatment times of between 1-3 0 seconds
and preferably 5-20 seconds are involved in a process for engaging and
sealing tissue, with a so-called working end of the apparatus being optimized
for performing that function. Shadduck, para. 5 8 ( referring to an instrument
disclosed in paragraphs 48-5 8). The Examiner has not pointed to any
evidence or provided any viable technical reasoning tending to show that
treatment times disclosed as being suitable for a tissue sealing operation,
would as well be suitable for ablating prostate transition zone tissue in
treating BPH.
Accordingly, the rejection of claim 14, and claims 15 and 16
depending therefrom, over Shadduck and Edwards, is not sustained.
Claims 20 and 21--Mulier/Edwards/Barry, or Edwards/Mulier/Barry
The Examiner relies on Barry in rejecting claims 20 and 21 in the
same manner as in the rejection of claims 13 and 26 discussed above.
For the same reason noted above, the rejection of claims 20 and 21,
which improperly relies on the teachings of Barry, is not sustained.
Claim 14--Nonstatutory Double Patenting--Hoey '079/Mulier or Shadduck
The Examiner acknowledges that neither claim 5 of Hoey '079, nor
the disclosure of Hoey '079, addresses confining a condensable vapor media
in the transition zone tissue of the prostate. Final Act. 25. The Examiner
cites to Mulier and Shadduck as providing evidence that this aspect of claim
14 on appeal would have been obvious. Id.
Appellants argue that neither Mulier nor Shadduck provides a
teaching of confining the vapor ablation to the transition zone tissue. Appeal
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Br. 14. As noted in the prior discussions of the rejections in view of
Edwards in combination with Mulier or Shadduck, it is Edwards that
provides a person of ordinary skill in the art with the teaching that
confinement of the ablation to the transition zone tissue is desirable. As
such, we agree with Appellants that Mulier and Shadduck do not remedy the
deficiency in claim 5 of Hoey '079 identified by the Examiner.
The rejection of claim 14 on grounds of double patenting over Hoey
'079 in view of Mulier or Shadduck is not sustained.
Claims 14 and 16--Provisional Nonstatutory Double Patenting--Hoey '544
Because this rejection is provisional in nature, we decline to reach this
rejection. See Ex parte Moncla, 95 USPQ2d 1884, 1885 (BP AI
201 O)(Precedential) (panel have flexibility to not reach provisional
obviousness-type double patenting rejections).
Claims 1 and 2--Provisional Nonstatutory Double Patenting-Edwards
Because this rejection is provisional in nature, we decline to reach this
rejection. See Ex parte Moncla, 95 USPQ2d 1884, 1885 (BP AI
201 O)(Precedential) (panel have flexibility to not reach provisional
obviousness-type double patenting rejections).
DECISION
The rejection of claims 1-3, 5-8, 11, 12, and 22 under 35 U.S.C.
§ 103(a) as being unpatentable over Edwards and Mulier is AFFIRMED.
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The rejection of claims 1-3, 5, 6, 8-12, and 22-24 under 35 U.S.C.
§ 103(a) as being unpatentable over Edwards and Shadduck is AFFIRMED.
The rejection of claims 13 and 26 under 35 U.S.C. § 103(a) as being
unpatentable over Edwards in view of Mulier or Shadduck, and further in
view of Barry, is REVERSED.
The rejection of claims 14--16 under 35 U.S.C. § 103(a) as being
unpatentable over Shadduck in view of Edwards is REVERSED.
The rejection of claims 20 and 21 under 35 U.S.C. § 103(a) as being
unpatentable over Mulier in view of Edwards and Barry, or over Edwards in
view ofMulier and Barry, is REVERSED.
The rejection of claim 14 on the ground of nonstatutory double
patenting over claim 5 of Hoey '079 in view of Mulier or Shadduck is
REVERSED.
We do not reach the provisional rejection of claims 14 and 16 on the
ground of nonstatutory double patenting as being unpatentable over claims
7, 21, and 31, of Hoey '544.
We do not reach the provisional rejection of claims 1 and 2 on the
ground of nonstatutory double patenting as being unpatentable over claim 1
of Edwards.
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-IN-PART
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