Ex Parte Mackool

Patent Trial and Appeal Board

Mar 9, 2018

13764815 (P.T.A.B. Mar. 9, 2018)

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.
PAT902839-US-CIP 7721
EXAMINER
KISH, JAMES M
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
13/764,815 02/12/2013
63704 7590
Hess Patent Law Firm
102 Ivy Tree Place
Cary, NC 27519
03/09/2018
Richard James Mackool
03/09/2018 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 RICHARD JAMES MACKOOL
Appeal 2016-006748
Application 13/764,815
Technology Center 3700
Before WILLIAM A. CAPP, LEE L. STEPINA, and
FREDERICK C. LANEY, Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 1—26. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies Novartis, AG as the real-party-in-interest. Appeal
Br. 4.
Appeal 2016-006748
Application 13/764,815
THE INVENTION
Appellant’s invention relates to instruments used in ocular surgery.
Spec. 12. Claim 6, reproduced below, is illustrative of the subject matter on
appeal.
6. An apparatus to detect and respond to infrared radiation
wavelengths that emanate from a surgical instrument during
phacoemulsification, comprising
a surgical instrument operative to perform phaco­
emulsification within a surgical field, the surgical instrument
including one hollow needle that has a shaft with a portion that
extends from a needle hub at a proximal end of the shaft to a tip
at a distal end of the shaft, the needle hub being wider in
dimension than both the tip and the portion of the shaft and
being spaced away from the tip by the portion of the shaft;
suction means for aspirating fluid through a the tip at the
distal end of the shaft;
at least one hollow sleeve having a port, the shaft extending
through the at least one hollow sleeve with the tip protruding
out of the at least one hollow sleeve and with the needle hub
upstream of the port and the needle tip downstream of the port;
irrigation means for channeling cooling fluid to flow
between an exterior of the one hollow needle and an interior of
the at least one hollow sleeve until discharging the cooling fluid
through a port in the at least one hollow sleeve and thereafter
immerse the tip with the cooling fluid;
a driver for developing friction-induced heat to elevate
temperature of a motionless surface by pressing the hollow
needle against a motionless surface as the driver vibrates the
hollow needle vibrates at a speed of vibration, the at least one
sleeve having the motionless surface;
a thermal imaging or thermal recognition source aimed and
arranged to detect infrared radiation wavelengths from the
developed friction-induced heat and from any location within
the surgical field;
means for evaluating the detected infrared radiation
wavelengths by making a comparison to determine whether the
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Application 13/764,815
speed of vibration of the hollow need needs to be slowed or
stopped and for generating at least one signal in response to the
evaluating making a determination that the speed of vibration of
the hollow needle needs to be slowed or stopped.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
Mackool US 5,084,009
Poppas US 5,409,481
Snook US 5,735,283
Hughes US 5,962,027
Jan 28, 1992
Apr. 25, 1995
Apr. 7, 1998
Oct. 5, 1999
Feb. 27, 2001
June 7, 2001
Ludin US 6,193,683 B1
Rockley US 2001/0003155 A1
Hiroko Bissen-Miyajima, et al, Thermal Effect On Corneal Incisions
With Different Phacoemulsification Ultrasonic Tips, J. Cataract
Refract. Surg. Vol 25, January 1999 (hereinafter “Bissen”).
The following rejections are before us for review:
1. Claims 1, 2, 6, 7, 11, 12, 16, 17, and 21—26 are rejected under 35
U.S.C. § 103(a), as being unpatentable over Ludin, Rockley, Bissen, and
Mackool.
2. Claims 3, 8, 13, and 18 are rejected under 35 U.S.C. § 103(a), as
being unpatentable over Ludin, Rockley, Bissen, Mackool, and Poppas.
3. Claims 4, 9, 14, and 19 are rejected under 35 U.S.C. § 103(a), as
being unpatentable over Ludin, Rockley, Bissen, Mackool, and Hughes.
4. Claims 5, 10, 15, and 20 are rejected under 35 U.S.C. § 103(a), as
being unpatentable over Ludin, Rockley, Bissen, Mackool, and Snook.
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Application 13/764,815
OPINION
Unpatentability of Claims 1, 2, 6, 7, 11, 12, 16, 17, and 21—26
over Ludin, Rockley, Bissen, and Mackool
Claims 1, 2, 6, 7, 11, 12, 16, and 17
Appellant argues claims 1, 2, 6, 7, 11, 12, 16, and 17 as a group.
Appeal Br. 11—40. We select claim 6 as representative. See 37 C.F.R.
§41.37(c)(l)(iv).
The Examiner finds that Ludin discloses controlling ultrasonic power
in response to temperature. Final Action 6—7. The Examiner relies on
Rockley for intermittently interrupting needle vibration to control
temperature and prevent corneal bums. Id. at 7. The Examiner relies on
Bissen as disclosing video thermography during ophthalmic use. Id. at 7—8.
The Examiner concludes that it would have been obvious to a person of
ordinary skill in the art at the time of the invention to use Bissen’s
thermography system in lieu of Ludin’s temperature sensors. Id. at 8.
According to the Examiner, a person of ordinary skill in the art would have
done this to (1) allow for use of any handpiece; and (2) allow for
temperature measurement over an expanded area during ophthalmic surgery.
Id. The Examiner relies on Mackool as disclosing a fluid infusion sleeve for
use during eye surgery. Id. The Examiner concludes that it would have
been obvious to a person of ordinary skill in the art at the time the invention
to use the Mackool needle tip in combination with the other references. Id.
at 10. According to the Examiner, a person of ordinary skill in the art would
have done this to cool the needle tip. Id.
Appellant traverses the Examiner’s rejection by advancing a plethora
of arguments, none of which is persuasive. Appeal Br. 11—40. While we
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Application 13/764,815
have considered all of Appellant’s arguments, the following discussion is
limited to those meriting explicit attention.
Appellant’s first argument relates to the limitation directed to thermal
imaging to detect heat “from any location within the surgical field.” Appeal
Br. 12—13. Appellant argues that the claim requires “proper mounting” of
the imaging equipment with respect to a surgical operating microscope that
requires a “modification or specialization.” Id. at 13. Appellant refers to
declaration testimony from Mikhail Ovchinnikov regarding a bracket that is
designed for using a thermal imaging camera during phacoemulsification.
Id. Appellant also refers to the Specification for the prospect that a
microscope lens “may” need to be modified to be transmissive to infrared
wavelengths. Id.
In response, the Examiner explains that Appellant’s arguments are not
commensurate with the scope of the claims as claim 6 does recite a
microscope or a mounting bracket. Ans. 2. We agree with the Examiner
that Appellant’s arguments are directed to unclaimed subject matter. We
also note that Bissen discloses an equipment arrangement in keeping with
the actual scope of claim 6. See Bissen, Fig. 3.
Next, Appellant argues that neither Ludin nor Rockley discloses
generating a signal to slow or stop needle vibration based “on a
comparison.” Appeal Br. 14—16. In response, the Examiner explains Ludin
teaches changing a power in response to needle temperature, which reads on
the limitation. Ans. 3 (“controlling the power in response to temperature
will obviously require a comparison”). In reply, Appellant argues:
Whatever comparison Ludin et al. may or may not be making
would not result in the evaluation of detected infrared radiation
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wavelengths, which is in stark contrast to the recitation of the
pending independent claims.
Reply Br. 5.
Ludin is directed to an apparatus for controlling power to a
phacoemulsification handpiece needle. Ludin, col. 1,11. 5—10.
[M]eans for sensing a temperature of the handpiece needle and
control means are provided for varying a power level provided
to the handpiece and electrical means from the power source
means in response to the needle temperature.
Id. at col. 1,11. 54—59. See also id. at col. 1,11. 41—43 (“The present
invention overcomes these problems by providing control of the
phacoemulsification apparatus through closed loop temperature control”).
We agree with the Examiner controlling an electrical means “in response” to
needle temperature using “closed loop” control is persuasive evidence that a
comparison is made by Ludin.2 With respect to Appellant’s argument that
Ludin does not evaluate and compare infrared radiation, we note the
Examiner relies on Bissen as disclosing the use of thermography, final
Action 7—8.
The temperature of the incision area where the tip was closest
was measured with a thermal vision infrared camera (Nikon)
and recorded simultaneously by video under an operating
microscope.
Bissen, 61. See also id. 63 (allowing quantitative measurements of
temperature in real time). It is well settled that non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references. See In re Merck & Co.,
2 There is no need that the references recite explicitly the word
“comparison.” See In re Cleave, 560 E.3d 1331, 1334 (Led. Cir. 2009) (a
reference need not satisfy an ipsissimis verbis test).
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800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 425
(CCPA 1981). Thus, Ludin teaches controlling temperature based on a
comparison and Bissen uses IR thermography to measure temperature in real
time. Together, the combination overcomes Appellant’s argument that
Ludin fails to evaluate and compare infrared radiation. Reply Br. 5.
Next, Appellant argues that Ludin teaches away from the claimed
invention. Appeal Br. 18. Appellant considers Ludin’s focus on
temperature of the needle tip as teaching away from monitoring heat at the
needle hub or driver. Id. In response, the Examiner explains that “any
location within the surgical field” includes the needle tip and, therefore,
Ludin does not teach away from the instant invention. Ans. 5. We agree. A
reference does not teach away if it merely discloses an alternative invention
but does not “criticize, discredit, or otherwise discourage” investigation into
the invention claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Appellant has not directed us to any language in Ludin that criticizes,
discredits, or otherwise discourages investigation into monitoring
temperature at “any location” in the surgical field.
Next, Appellant argues that Ludin envisions needle temperatures as
high as 500° F. Appeal Br. 19. Appellant concludes that Ludin, therefore,
contemplates using unsafe needle temperatures. Id. at 19—20 (“Ludin
seemingly disregards the risk of causing ocular tissue damage from
operating at excessively high needle temperatures”). In response, the
Examiner states that Appellant is guilty of mischaracterizing Ludin. See
Ans. 5—6. Ludin teaches that it is known that:
Vibration of the needle also causes heating thereof which can
be detrimental to corneal tissue. In fact, overheating of the
needle tip during phacoemulsification procedures can cause
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non-recoverable comeal bums. Accordingly, it is beneficial to
the ophthalmologist performing the phacoemulsification
procedure to be able to prevent these occurrences.
Ludin, col. 1,11. 31—37. The Examiner’s rejection is based on a combination
of references and does not contemplate controlling the apparatus in a manner
that exposes a patient to unsafe temperatures.
Appellant next argues that the Examiner’s rejection lacks rational
underpinning. Appeal Br. 25. In particular, Appellant argues that a person
of ordinary skill in the art would not combine Rockley’s technique of
stopping vibration with Ludin because “their approaches are so different
from each other.” Id. Appellant reiterates the previous argument that Ludin
contemplates temperatures of about 500° F. Id. In response, the Examiner
explains that the rejection is based, in part, on the fact that Ludin does not
explicitly state that control is by stopping or slowing vibration. Ans. 6. The
Examiner relies on Rockley as slowing/stopping duty cycles to eliminate
thermal BTU’s before the next pulse. Id. (“which is a way of preventing
overheating that can lead to non-recoverable damage”).
The Examiner provides at least two reasons for combining Ludin with
Rockley and Bissen: (1) to use any handpiece; and (2) to expand the
measurement area. Final Action 8. A reason to modify a prior art reference
may be found explicitly or implicitly in market forces; design incentives; the
“interrelated teachings of multiple patents”; “any need or problem known in
the field of endeavor at the time of invention and addressed by the patent”;
and the background knowledge, creativity, and common sense of the person
of ordinary skill. Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324,
1328—29 (Fed. Cir. 2009) (quoting KSR, 550 U.S. at 418—21)). An implicit
motivation to combine exists when the improvement is technology-
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independent and the combination of references results in a product or
process that is more desirable. Dystar Textilfarben GmBH & Co, v. C.H.
Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006). The Examiner’s stated
reasons are adequate to support the rejection. Final Action 8.
Appellant next argues that that the Bissen reference is not enabled.
Appeal Br. 22—34.3 Appellant argues that Bissen’s mention of
thermography “recently modified for ophthalmic use refers to a modification
that is beyond the skill and creativity of a person of ordinary skill in the art
to carry out modifying thermograph for ophthalmic use” because Bissen is
allegedly silent as to the modifications that were performed. Id. at 29.
Appellant’s non-enablement argument fails. Bissen is not proposed
by the Examiner as an anticipation reference under Section 102. Rather, the
rejection on appeal is under the obviousness provisions of Section 103.
Under Section 103, a reference need not be enabled, for it qualifies as prior
art for whatever is disclosed therein. See Amgen Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003); see also Beckman
Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989)
(“Even if a reference discloses an inoperative device, it is prior art for all
that it teaches”). In the case of Therasense, Inc. v. Becton, Dickinson & Co.,
593 F.3d 1289, 1297 (Fed. Cir. 2010), vacated-in-part on other grounds,
649 F.3d 1276 (Fed. Cir. 2011) (en banc), the Federal Circuit reiterated that
an individual prior art reference need not be enabled as it qualifies as prior
art for what is disclosed therein. Id. (citing Amgen, 314 F.3d at 1357).
3 Imbedded within this argument is an ancillary argument that Bissen is not
prior art because it entails a prior use in Japan. Id. at 32. This argument is
without merit. Bissen is a printed publication within the meaning of 35
U.S.C. § 102(b). Ans. 9.
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Furthermore, to the extent that Bissen must be enabling, the Examiner is
entitled to a presumption that it is enabling. See In re Antor Media Corp.,
689 F.3d 1282, 1288 (Fed. Cir. 2012) (prior art printed publication cited by
an examiner is presumptively enabling barring any showing to the contrary
by a patent applicant). Appellant relies on declaration testimony that a
bracket was used to render a thermal imaging camera suitable for use.
Appeal Br. 31, citing Ovchinnikov Dec. 14. Otherwise, Appellant offers no
persuasive evidence that Bissen is not enabling. Under the circumstances,
Appellant’s evidence is insufficient to overcome the presumption that Bissen
is enabling.
Finally, Appellant relies on additional declaration testimony from
Ovchinnikov as evidence that the application has overcome skepticism of an
expert. Appeal Br. 39. Appellant cites In re Dow Chemical Co., 837 F.2d
469 (Fed. Cir. 1988) for the proposition that we should consider the
“skepticism of an expert” in our patentability analysis. We find this aspect
of Appellant’s presentation unpersuasive for the following reasons.
First of all, the Dow case stands for the proposition that skepticism of
an expert that is expressed “before” the inventors proved him wrong, is
entitled to fair evidentiary weight. Id. at 473. Here, Appellant’s declaration
testimony describes problems that existed with earlier models of thermal
imaging cameras and then describes the usefulness of a newer model
camera. Ovchinnikov Dec. 5—10. We discern no skepticism regarding
the usefulness of thermal imaging after the advances in thermal imaging
reflected in the equipment used by Appellant and/or Bissell. Secondly, Mr.
Ovchinnikov is employed by Alcon, an affiliate of Appellant’s assignee. Id.
12. Mr. Ovchinnikov’s testimony is not offered from the standpoint of a
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disinterested, independent expert, much less an expert that is expressing
relevant skepticism “before” being proved wrong. At best, Mr.
Ovchinnikov’s testimony merely shows that Appellant took advantage of
recent advancements, by others, in the field of infrared thermography and
applied those advancements to phacoemulsification surgery in an otherwise
obvious manner.
In view of the foregoing, we sustain the Examiner’s unpatentability
rejection of claims 1, 2, 6, 7, 11, 12, 16, and 17.
Claims 21—26
Appellants argue claims 21—26 as a group. Appeal Br. 40-41. We
select claim 23 as representative. See 37 C.F.R. § 41.37(c)(l)(iv). Claim 23
depends from claim 6 and adds the limitation: “wherein the thermal imaging
or thermal recognition source is arranged to detect through infrared radiation
wavelengths emanating from the shaft at locations upstream of the port and
spaced away from the immersed tip.” Claims App.
Appellant argues that Bissen’s focus is on heat generation at the
needle tip, as opposed to locations spaced away from the tip or sleeve.
Appeal Br. 41. Thus, according to Appellant, Bissen would not lead a
person of ordinary skill in the art to respond to infrared radiation emanating
from areas spaced away from the needle tip. Id.
In response, the Examiner notes that Bissen’s illustrations reveal
thermographs that show the entire area under surgery, include the tip of the
handpiece as well as an area that is spaced away from the immersed tip or at
the needle sleeve. Ans. 10, citing Bissen, Figs. 6 and 7. This finding is not
challenged by Appellant. See generally Reply Brief.
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Having reviewed Figures 6 and 7 of Bissen, we determine that the
Examiner’s findings of fact are supported by a preponderance of the
evidence and sustain the rejection of claims 21—26.
Unpatentability of Claims 3, 8, 13, and 18
over Ludin, Rockley, Bissen, Mackool, and Poppas
Appellant argues claims 3, 8, 13, and 18 as a group from which we
select claim 8 as representative. Appeal Br. 42-45, 37 C.F.R.
§ 41.37(c)(l)(iv). Claim 8 depends from claim 6 and adds the limitation:
“further comprising means for triggering activation of an alarm in response
to the at least one signal, the alarm being selected from a group consisting of
visual, audible, vibratory and any combination thereof.” Claims App. The
Examiner relies on Poppas teaching the alarm limitation and concludes that
it would have been obvious to incorporate an alarm in the Ludin
combination of claim 1. Final Action 10—11.
In traversing the rejection, Appellant relies on the arguments that we
previously found unpersuasive with respect to claim 1 and find equally
unpersuasive here. Appeal Br. 42. Appellant also argues that the
Examiner’s reason for combining Poppas to the other references is
inadequate. Id. at 43, citing Dominion Dealer Solutions LLC v. Auto Alert,
Inc., IPR2013-00223, paper 9 (Aug. 15, 2013). In response, the Examiner
points out that Poppas is merely relied on for teaching an alarm or warning
to a user. Ans. 11.
Poppas teaches a surgical system that includes an indicator means 40
for indicating to the surgeon whether the sensed temperature in a region is
higher than, lower than, or equal to a predetermined temperature. Poppas,
col. 6,11. 10-26. One such indicator means is a two-tone buzzer powered by
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an integrated circuit. Id. We live in a day and age where warning and alarm
type displays are ubiquitous. It is commonplace in system design to
establish a specified condition or criterion in logic circuitry and, when the
condition or criterion is satisfied, cause the system to so inform an operator.
Warnings and alarms are merely one of many ways in which
system/machine information is communicated to a user in a man-machine
interface. We agree with the Examiner that it would have been obvious to
provide system feedback information to the user of a modified Ludin system
in the form of an audio and/or visual display. Poppas’s alarm is merely one
example of such a display and, in our opinion, an appropriate one for a
medical/surgery application.
We sustain the rejection of claims 3, 8, 13, and 18.
Unpatentability of Claims 4, 9, 14, and 19
over Ludin, Rockley, Bissen, Mackool, and Hughes
Appellant does not argue for the separate patentability of claims 4, 9,
14, and 19 apart from arguments presented with respect to claim 6 which we
have previously considered. Appeal Br. 46. Appellant merely argues that
Hughes fails to cure alleged deficiencies “as concerns the use of
thermography to actually control handpiece operation.” Id. Having found
no such deficiencies with the Examiner’s rejection of the independent
claims, as previously discussed, we sustain the rejection of claims 4, 9, 14,
and 19. See 37 C.F.R. § 41.37(c)(iv) (failure to separately argue claims).
Unpatentability of Claims 5, 10, 15, and 20
over Ludin, Rockley, Bissen, Mackool, and Snook
Appellant does not argue for the separate patentability of claims 5,10,
15, and 20 apart from arguments presented with respect to claim 6 which we
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have previously considered. Appeal Br. 46. Appellant merely argues that
Snook fails to cure alleged deficiencies “as concerns the use of
thermography to actually control handpiece operation.” Id. Having found
no such deficiencies with the Examiner’s rejection of the independent
claims, as previously discussed, we sustain the rejection of claims 5, 10, 15,
and 20. 37 C.F.R. § 41.37(c)(iv).
DECISION
The decision of the Examiner to reject claims 1—26 is affirmed.
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-IN-PART
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