Ex Parte Hoey et al

Patent Trial and Appeal Board

Aug 3, 2017

12768544 (P.T.A.B. Aug. 3, 2017)

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.
12/768,544 04/27/2010 Michael Hoey 10837-705.200 5817
66854 7590 08/07/2017
SHAY TtT FNN T T P
EXAMINER
2755 CAMPUS DRIVE DELLA, JAYMI E
SUITE 210
SAN MATEO, CA 94403 ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
08/07/2017 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
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
Appeal 2016-000621
Application 12/768,544
Technology Center 3700
Before LYNNE H. BROWNE, THOMAS F. SMEGAL, and
LISA M. GUIJT, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Michael Hoey and John H. Shadduck (Appellants) appeal under 35
U.S.C. § 134 from the Non-Final Rejection of claims 1—9, 11, 12, 14, 20—23,
25, 26, and 28—36. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
CLAIMED SUBJECT MATTER
The claims are directed to methods for prostate treatment. Spec. 13.
Claims 1, 20, 29, and 30 are independent. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A method for treating benign prostatic hyperplasia (BPH),
comprising:
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Application 12/768,544
introducing a vapor delivery member into a transition zone
of a prostate; and
injecting a condensable vapor media from the vapor
delivery member into the transition zone, wherein the
condensable vapor media propagates interstitially in the
transition zone and is confined in the transition zone by a
boundary tissue adjacent the transition zone.
REFERENCES AT ISSUE
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Mulier US 2002/0177846 A1 Nov. 28,2002
Edwards US 2005/0010203 A1 Jan. 13,2005
Shadduck US 2006/0224154 A1 Oct. 5,2006
REJECTIONS
I. Claims 1—6, 9, 11, 12, 14, 20, 23, 25, 26, 28, and 29 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over Mulier
and Edwards.
II. Claims 1—9, 11, 12, 14, 20-23, 25, 26, and 28—36 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over Shadduck and
Edwards.
III. Claims 1—3, 11, 20, 25, 28, and 29 stand rejected on the ground
of nonstatutory obviousness-type double patenting as
unpatentable over claims 1—12 ofU.S. Patent No. 8,251,985 in
view of Mulier and Shadduck.
IV. Claims 1, 11, 20, 25, and 29 stand rejected on the ground of
nonstatutory obviousness-type double patenting as unpatentable
over claims 1—15 ofU.S. Patent No. 8,273,079 in view of
Mulier and Shadduck.
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V. Claims 1, 20, and 29 stand rejected on the ground of
nonstatutory obviousness-type double patenting as unpatentable
over claims 1 ofU.S. Patent No. 8,419,723 in view of Mulier
and Shadduck.
VI. Claims 1—9, 11, 12, 14, and 20—29 stand rejected on the ground
of nonstatutory obviousness-type double patenting as
unpatentable over claims 1—26 ofU.S. Application No.
12/843,581 in view of Mulier and Shadduck.
VII. Claims 1, 20, and 29 stand rejected on the ground of
nonstatutory obviousness-type double patenting as unpatentable
over claim 35 ofU.S. Application No. 13/229,997 in view of
Mulier and Shadduck.
DISCUSSION
Rejection I
Claims 1—6, 9, 11, 12, and 14
Claims 2—6, 9, 11, 12, and 14 depend from claim 1. Appellants do not
present separate arguments for the patentability of these claims. See Appeal
Br. 4—6. Thus, claims 2—6, 9, 11, 12, and 14 stand or fall with claim 1. See
37C.F.R. §41.37(c)(l)(iv).
The Examiner finds that Mulier and Edwards disclose or suggest all of
the limitations of claim 1. Non-Final Act. 4—5. Specifically, the Examiner
finds that Mulier discloses
a method for treating benign prostatic hyperplasia (BPH)
(medical vapor delivery system can be used to treat benign
prostatic hyperplasia; [0116]), comprising:
introducing a vapor delivery member into tissue (vapor
needle 196 is inserted into tissue site 20; [0110]); and
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injecting a condensable vapor media from the vapor
delivery member into the tissue (needle 196 emits pressurized
vapor sprays 22 from its distal end into tissue site 20; [0110]).
Id. at 4 (emphasis omitted). The Examiner further finds that Edwards
discloses “energy delivery members introduced into the prostate transition
zone (428) to deliver energy in the transition zone.” Id. Based on these
findings, the Examiner reasons that it would have been obvious “to
introduce the vapor delivery members into the transition zone and delivery
energy in the transition zone to treat BPH in order to provide the benefit of
treating the glandular and stromal nodules associated with BPH that are
primarily concentrated within the transition zone.” Id. at 4—5 (citations
omitted). In addition, the Examiner finds that Mulier “teaches that the
vaporous medium provides penetration of thermal energy into interstitial
channels between tissue cells and that the volume and temperature of
vaporous media can be controlled based on the microanatomy of the cells to
cause desired tissue effects in different types and volumes of tissue.” Id. at
5. Based on this additional finding, the Examiner further reasons that it
would have been obvious
to confine treatment to the transition zone tissue by interstitially
propagating condensable vapor media of a controlled volume and
temperature such that the condensable vapor media is confined
by a boundary tissue having different anatomical characteristics
adjacent the transition zone tissue since Mulier teaches that the
volume and temperature of vaporous media can be controlled to
cause desired tissue effects in different types and volumes of
tissue.
Id.
Appellants contend that “[njeither Mulier nor Edwards suggests that
confinement of vapor to the transition zone would be possible or desirable.”
Appeal Br. 5. In support of this contention, Appellants argue that rather than
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mentioning “the transition zone or any boundary tissue surrounding the
transition zone,” Mulier describes “a fibrous capsule surrounding the
prostate . . . able to retain the high temperature vapor from the vapor
delivery system.” Id.
Responding to this argument, the Examiner finds that “the ‘fibrous
capsule’ of the prostate is also a ‘boundary tissue surrounding the transition
zone’” and reasons that:
While Mulier fails to specifically disclose confining to the
transition zone tissue, Mulier clearly teaches confining vapor
within a natural boundary tissue ([0118]) by delivering the vapor
at “desired levels of temperature, pressure, or volume” ([0051])
and that “vaporous medium may be able to exploit the
microanatomy of tissue to increase the efficiency of heat transfer
to the cells” ([0022]).
Ans. 4—6. The Examiner further reasons that it would have been obvious “to
look at the teachings of Mulier, to determine, through routine
experimentation, the penetration, or lack thereof and thus, confinement, of
various vapor energy delivered to different tissues of the prostate using
different vapor parameters.” Id. at 6. Based on this reasoning, the Examiner
concludes that “it would have been obvious to try various parameters since
the prior art discloses vapor having . . . effects based upon the tissue
anatomy.” Id. We note that the Examiner’s reasoning is supported by the
instant Specification which attributes that ability of the claimed method to
confine the vapor to the transition zone to the density of the naturally
occurring tissue surrounding the transition zone. See Spec. 168.
In the Reply Brief, Appellants do not respond to the Examiner
reasoning. Rather, Appellants merely repeat their contention that “[t]he
Examiner has . . . failed to provide a teaching of confining vapor in the
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transition zone.” Reply Br. 2. Thus, as Appellants do not explain why the
Examiner’s reasoning is flawed, Appellants do not apprise us of error.
Noting that in paragraphs 17 and 22, Mulier describes the “vapor as
traveling ‘within interstitial channels between tissue cells’ so that the vapor
‘can penetrate deep into the tissue site ...,’” Appellants argue that “[t]he
claim limitation in question pertains to vapor confinement, however, not
vapor propagation as described by Mulier.” Appeal Br. 5, 6. However,
Appellants’ argument misconstrues the Examiner’s reasoning. As discussed
supra, the Examiner’s reasoning is based on Mulier’s teachings that different
vapor parameters achieve different results (i.e., confinement or penetration)
based on the microanatomy of the tissue. See Ans. 5—6. Thus, Appellants’
argument is unconvincing.
Finally, Appellants argue that Mulier “describes ablation of the entire
prostate—not just the transition zone—as the goal of the procedure.”
Appeal Br. 6. However, Appellants’ argument again misconstrues the
rejection articulated by the Examiner. First, this argument attacks the
references separately which cannot apprise us of nonobviousness. See In re
Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Second, this
argument ignores the Examiner’s reasoning, discussed supra, which relies
upon Edwards’ teaching of treatment in the transition zone and Mulier’s
disclosure of treatment confined to an area by a natural anatomical
boundary. See Ans. 6. Thus, Appellants do not apprise us of error.
For these reasons, we sustain the Examiner’s decision rejecting claim
1, and claims 2—6, 9, 11, 12, and 14, which fall therewith.
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Claims 20, 23, 25, 26, and 28
Claim 20 is similar to claim 1 with the main difference being that
claim 20 requires injecting the vapor “into the transition zone tissue so as to
ablate transition zone tissue adjacent a urethra without ablating transition
zone tissue adjacent a fibromuscular stroma” rather than simply “into the
transition zone.” Cf. Appeal Br. 16, 17. The Examiner’s findings and
reasoning are similar to those pertaining to claim 1 quoted supra. See Non-
Final Act. 6—8.
Appellants contend that:
while Mulier discloses the facts that vapor travels interstitially,
tissue has microanatomy, different types of tissue have different
specific heats, and vapor can ablate prostate tissue, none of these
disclosures suggests the possibility or the desirability of ablating
transition zone tissue adjacent a urethra without ablating
transition zone tissue adjacent a fibromuscular stroma.
Appeal Br. 7.
Responding to this argument, the Examiner essentially repeats the
same explanations discussed supra, with respect to claim 1. However, the
Examiner never explains why it would have been obvious to ablate transition
zone tissue adjacent the urethra without ablating transition zone tissue
adjacent a fibromuscular stroma as required by claim 20. Although Edwards
fairly teaches ablation of transition zone tissue, neither Edwards nor Mulier
discuss ablation of some transition zone tissue while not ablating other
transition zone tissue. See, e.g., Edwards 178. Moreover, although routine
experimentation may make such distinction possible, routine
experimentation does not suggest this distinction. Thus, the Examiner’s
reasoning lacks rational underpinning.
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For these reasons, we do not sustain the Examiner’s decision rejecting
claim 20 and claims 23, 25, 26, and 28 depending therefrom.
Claim 29
Regarding claim 29, Appellants argue that “neither Mulier nor
Edwards describes the desirability or possibility of confining energy delivery
to transition zone tissue” and that “the Examiner has not shown how
confinement of the energy to the transition zone necessarily flows from the
combined disclosures of Mulier and Edwards.” Appeal Br. 7.
These arguments are essentially the same as the arguments pertaining
to claim 11 discussed supra, and are not convincing for the same reasons.
Accordingly, we sustain the Examiner’s decision rejecting claim 29.
Rejection II
Claims 1—9, If 12, and 14
Claims 2—9, 11, 12, and 14 depend from claim 1. Appellants do not
present separate arguments for the patentability of these claims. See Appeal
Br. 7—8. Thus, claims 2—9, 11, 12, and 14 stand or fall with claim 1.
The Examiner finds that Shadduck discloses
A method for treating the prostate (treating abnormal
prostate tissue T; [0062]), comprising:
introducing a vapor delivery member into a tissue of a
prostate (needle 211 penetrates abnormal tissue T; [0062]); and
injecting a condensable vapor media from the vapor
delivery member into the tissue (needle ports/outlets 207
introduce vapor into abnormal tissue T; [0059], [0061]).
Non-Final Act. 9—10 (emphasis omitted). The Examiner further finds that
“Edwards et al. disclose energy delivery members introduced into the
prostate transition zone (428) to deliver energy in the transition zone.” Id.
1 We note that in the Reply Brief, Appellants address claims 1, 29, and 30
together. Reply Br. 2.
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Based on these findings, the Examiner determines that it would have been
obvious
to introduce the vapor delivery members into the transition zone
and delivery energy in the transition zone to treat BPH in order
to provide the benefit of treating the glandular and stromal
nodules associated with BPH that are primarily concentrated
within the transition zone as taught by Edwards et al. ([0073],
[0119]; Fig. 38)
and
to confine treatment to the transition zone tissue by interstitially
propagating condensable vapor media of a controlled volume and
temperature such that the condensable vapor media is confined
by a boundary tissue having different anatomical characteristics
adjacent the transition zone tissue since Shadduck et al. teach that
the vapor injection is controlled such that a specific type of tissue
(i.e., transition zone tissue) confined by different tissue types
(i.e., boundary tissue) can be targeted.
Id. at 10—11.
Appellants contend that “neither Shadduck nor Edwards describes
confinement of the vapor to the transition zone of the prostate, as recited by
claim 1.” Appeal Br. 7. In support of this contention, Appellants argue that
“Shadduck’s general discussion of the ability to select vapor delivery
parameters to provide a different effect on different types of tissue . . . does
not. . . disclose vapor delivery parameters enabling the discrimination of
disk annulus tissue from disk nucleus tissue.” Id. at 8.
Responding to this argument, the Examiner explains that “Shadduck
teaches that vapor energy levels can be modified depending on the type of
tissue targeted” and “that it would have been obvious to one of ordinary skill
in the art at the time of the invention through routine experimentation to
modify the energy parameters to treat the desired tissue.” Ans. 10. The
Examiner further reasons that:
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Since Edwards teaches that the nodules associated with BPH are
found mostly in the transition zone tissue, it would have been
obvious to one of ordinary skill in the art to inject energy with
different parameters to the target tissue of transition zone tissue
to determine which energy parameters treated only the transition
zone tissue containing the BPH nodules.
Id.
In the Reply Brief, Appellants do not contest the Examiner’s
reasoning. Instead Appellants merely repeat their argument that Shadduck’s
general discussion of modifying vapor energy levels is insufficient. See
Reply Br. 3. Thus, as Appellants do not explain why the Examiner’s
reasoning is flawed, they fail to apprise us of error.
Appellants further contend that “the Examiner has not indicated why
the disclosure of Shadduck or Edwards would motivate a skilled artisan to
try to confine vapor to the transition zone.” Appeal Br. 8. In support of this
contention, Appellants argue that “[njeither Shadduck nor Edwards mentions
the desire or the ability to confine vapor to the prostate transition zone, and
neither reference discloses device operation parameters enabling the
confinement of vapor to the transition zone.” Id.
Responding to this argument, the Examiner finds that “Edwards
clearly discloses the transition zone tissue containing the nodules associated
with BPH, and thus is the main target tissue to treat BPH.” Ans. 10. Based
on this finding, “[t]he Examiner maintains that non-targeted tissue would be
tissue outside of the BPH nodule area, which would be exterior to the
transition zone.” Id. Thus, we understand the Examiner’s position to be that
confinement of the treatment to the transition zone would follow from the
fact that the tissue to be treated is located in the transition zone.
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Again, Appellants do not respond to the Examiner’s reasoning and
merely repeat their allegation that the Examiner fails to provide such
reasoning. See Reply Br. 3. In the absence of any explanation as to why the
Examiner’s reasoning is flawed, Appellants fail to apprise us of error.
For these reasons, we sustain the Examiner’s decision rejecting claim
1, and claims 2—9, 11, 12, and 14, which fall therewith.
Claims 20-23, 25, 26, and 28
Claims 21—23, 25, 26, and 28 depend from claim 20. Appellants do
not provide separate arguments for the patentability of these claims.
Accordingly, claims 21—23, 25, 26, and 28 stand or fall with claim 20.
As discussed supra, claim 20 is similar to claim 1 with the main
difference being that claim 20 requires injecting the vapor “into the
transition zone tissue so as to ablate transition zone tissue adjacent a urethra
without ablating transition zone tissue adjacent a fibromuscular stroma”
rather than simply “into the transition zone.” Cf. Appeal Br. 16, 17. The
Examiner’s findings and reasoning are similar to those pertaining to claim 1
quoted supra. See Non-Final Act. 12—13.
Appellants argue that “[njeither Edwards nor Shadduck suggests that
ablation of transition zone tissue adjacent a urethra without ablating
transition zone tissue adjacent a fibromuscular stroma would be desirable or
even possible.” Appeal Br. 8. This argument is persuasive because as
discussed supra, the Examiner does not explain why one skilled in the art
would ablate transition zone tissue adjacent the urethra and not ablate
transition zone tissue adjacent a fibromuscular stroma. See Ans. 11.
We do not sustain the Examiner’s decision rejecting claim 20, and
claims 21—23, 25, 26, and 28, which depend therefrom.
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Claims 29
Appellants’ arguments pertaining to claim 29 are essentially the same
as the arguments pertaining to claim 12 discussed supra and are not
convincing for the same reasons. See Appeal Br. 9. Accordingly, we sustain
the Examiner’s decision rejecting claim 29.
Claims 30-36
Claims 31—36 depend from claim 30. Appellants do not present
separate arguments for the patentability of claims 31—36. Accordingly,
claims 31—36 stand or fall with claim 30.
Appellants’ arguments pertaining to claim 30 are essentially the same
as the arguments pertaining to claim l.3 See Appeal Br. 9-10. These
arguments are not persuasive for the reasons discussed supra. Accordingly,
we sustain the Examiner’s decision rejecting claim 30, and claims 31—36
which fall therewith.
Rejections III—V
For each of these double patenting rejections, Appellants essentially
provide the same arguments. See Appeal Br. 10—13. Specifically, with
respect to claims 1 and 29, Appellants argue that neither Mulier nor
Shadduck teach confining vapor to transition zone tissue. Appeal Br. 10, 11,
12. With respect to claim 20, Appellants argue that neither Mulier nor
Shadduck teach ablating transition zone tissue adjacent a urethra without
ablating transition zone tissue adjacent a fibromuscular stroma. See id.
2 We note that in the Reply Brief, Appellants address claims 1, 29, and 30
together. Reply Br. 3.
3 See n.2.
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These, arguments are also essentially the same as the arguments discussed
supra contesting the rejection of claims 1, 20, and 29 as unpatentable over
Mulier and Shadduck.
For the reasons discussed supra, Appellants’ arguments with respect
to claims 1 and 29 are unconvincing and Appellants’ arguments with respect
to claim 20 are convincing. Appellants do not separately address any of the
dependent claims; accordingly, the dependent claims, if any, for each
rejection stand or fall with their respective independent claim.
We sustain the Examiner decision in Rejections III—V for claims 1—3,
11, and 29 and do not sustain the Examiner’s decision in these rejections for
claims 20, 25, and 28.
Rejection VI
In contesting this provisional double patenting rejection, Appellants
present essentially the same arguments as for Rejections III—V discussed
supra. These arguments are unconvincing with respect to claims 1—9, 11,
12, 14, and 29, and convincing with respect to claims 20—28 for the reasons
discussed above.
We sustain the Examiner’s decision rejecting claims 1—9, 11, 12, 14,
and 29 on the ground of provisional nonstatutory double patenting and do
not sustain the Examiner’s decision rejecting claims 20—28 on that same
ground.
Rejection VII
Claims 1, 20, and 29 are provisionally rejected on the ground of non­
statutory obviousness-type double patenting as being unpatentable over
claim 35 of co-pending U.S. Application No. 13/229,997. Non-Final Act.
31-34.
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Claim 35 ofU.S. Application No. 13/229,997 depends from
independent claim 29. Claim 29, and therefore dependent claim 35, was
amended on April 8, 2015, after the Examiner’s Non-Final Rejection4 that is
the subject of the instant Appeal. For that reason, we decline to reach this
rejection. See Ex parte Moncla, 95 USPQ2d 1884, 1885 (BP AI2010)
(Precedential) (Panels have the flexibility to not reach provisional
obviousness-type double-patenting rejections.).
DECISION
The Examiner’s rejection of claims 1—6, 9, 11, 12, 14, and 29 as
unpatentable over Mulier and Edwards is AFFIRMED.
The Examiner’s rejection of claims 20, 23, 25, 26, and 28 as
unpatentable over Mulier and Edwards is REVERSED.
The Examiner’s rejection of claims 1—9, 11, 12, 14, and 29-36 as
unpatentable over Shadduck and Edwards is AFFIRMED.
The Examiner’s rejection of claims 20—23, 25, 26, and 28 as
unpatentable over Shadduck and Edwards is REVERSED.
The Examiner’s rejection of claims 1—3, 11, and 29 on the ground of
non-statutory obviousness-type double patenting as unpatentable over U.S.
Patent No. 8,251,985 is AFFIRMED.
The Examiner’s rejection of claims 20, 25, and 28 on the ground of
non-statutory obviousness-type double patenting as unpatentable over U.S.
Patent No. 8,251,985 is REVERSED.
4 Dated September 29, 2014.
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The Examiner’s rejection of claims 1,11, and 29 on the ground of
non-statutory obviousness-type double patenting as unpatentable over U.S.
Patent No. 8,273,079 is AFFIRMED.
The Examiner’s rejection of claims 20 and 25 on the ground of non-
statutory obviousness-type double patenting as unpatentable over U.S.
Patent No. 8,273,079 is REVERSED.
The Examiner’s rejection of claims 1 and 29 on the ground of non-
statutory obviousness-type double patenting as unpatentable over U.S.
Patent No. 8,419,723 is AFFIRMED.
The Examiner’s rejection of claim 20 on the ground of non-statutory
obviousness-type double patenting as unpatentable over U.S. Patent No.
8,419,723 is REVERSED.
The Examiner’s rejection of claims 1—9, 11, 12, 14, and 29 on the
ground of provisional non-statutory obviousness-type double patenting as
unpatentable over U.S. Application No. 12/843,581 is AFFIRMED.
The Examiner’s rejection of claims 20—28 on the ground of
provisional non-statutory obviousness-type double patenting as unpatentable
over U.S. Application No. 12/843,581 is REVERSED.
We do not reach the Examiner rejection of claims 1, 20, and 29 on the
ground of provisional non-statutory obviousness-type double patenting as
unpatentable over U.S. Application No. 13/229,997.
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)(l)(iv).
AFFIRMED-IN-PART
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