Ex Parte Mackool

Patent Trial and Appeal Board

Sep 19, 2012

12350294 (P.T.A.B. Sep. 19, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/350,294 01/08/2009 Richard J. Mackool 2839A 6657
63704 7590 09/19/2012
HESS PATENT LAW FIRM, P.C.
9 MIRAMAR LANE
STAMFORD, CT 06902
EXAMINER
KISH, JAMES M
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
09/19/2012 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
PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ALCON, INC.1
(Application 12/350,294)
____________

Appeal 2011-006283
Technology Center 3700
James M. Kish, Examiner
____________

Before RICHARD TORCZON, SALLY C. MEDLEY and JOSIAH C. COCKS,
Administrative Patent Judges.

Opinion by TORCZON, Administrative Patent Judge.

DECISION ON APPEAL
The appellant (Alcon) seeks relief under 35 U.S.C. 134(a) from the final
rejection of claims 1-18. We AFFIRM-IN-PART.

1 Office records show an assignment to Novartis AG of Basel, Switzerland.
Reel 026376, Frame 0076.
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OPINION
BACKGROUND
Related appeal
The application from which Alcon claims benefit was the subject of an
earlier appeal. Ex parte Alcon, Inc., App. No. 2008-1025 (BPAI, dec'd 17 June
2008) (affirming rejection of different claims).
Claimed invention
Alcon's disclosure relates to slowing or stopping the vibratory speed
of an ultrasonic needle tip of a surgical instrument during ocular surgery or to
withdrawing the needle, depending upon whether a medically unsafe thermal
condition is likely to be reached if the ultrasonic needle tip is permitted to continue
to vibrate at the same rate of speed and at the same location.2 Alcon explains that
one aspect of the invention is to measure infrared radiation at a location "along the
surgical instrument other than at the needle tip, such as proximal to the needle tip,
at the needle hub or at the needle driver."3
Alcon's Figure 1 (right) shows a schematic representation of a thermal
imaging or recognition source 12,
surgical operating microscope 18 and
surgical instrument 24.4 The surgical
instrument has a needle 26. The needle
has a tip 30 with a suction port 28 and a
hub 34 with an aspiration-flow passage 32

2 Spec. ¶0001.
3 Id. ¶0008.
4 Id. ¶¶0011 & 0013.
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from the suction port 28.5 In the figure, the needle tip is the distal (closest to the
eye) terminus of the needle hub. The figure does not demarcate the extent of the
portion of the hub that is proximal to the needle tip.
Claim 1 defines the invention as follows:6
1. A method of detecting and responding to a thermal condition
during phacoemulsification, comprising
performing phacoemulsification with a surgical instrument
operative to vibrate a hollow needle with a driver at a speed of
vibration and to aspirate fluid under suction through the hollow
needle, the hollow needle terminating at a distal end into a tip and
having a hub spaced from the tip,
aiming a thermal imaging or thermal recognition source at a
location selected from a group consisting of
along the hub of the hollow needle of the surgical
instrument and
at the driver of the hollow needle of the surgical
instrument
so as to detect infrared radiation wavelengths emanating from the
location,
evaluating the detected infrared radiation wavelengths to make
a determination as to whether a thermal condition has been reached;
generating command signals in response to the determination
being that the thermal condition has been reached; and
varying at least one of the speed of vibration and a relative
position of the hollow needle of the surgical instrument in response to
the command signals.

Phacoemulsification is a cataract surgery technique in which a diseased lens
is ultrasonically liquefied and removed.7
The location targeted by the thermal imaging or recognition source is a
contested limitation. One problem in interpreting the claim is odd grammar:8

5 Id. ¶0020.
6 Emphasis added. All claim language is reproduced from Br. 28 (Claims Apdx.).
Indenting is added as needed for compliance with 37 C.F.R. § 1.75(i).
7 Reply 5.
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location—a noun—is defined by two prepositional phrases (along… and at…).
For purposes of this appeal, the ambiguity may be resolved9 by interpreting the
limitation broadly along the following lines:
aiming a thermal imaging or thermal recognition source at a
location selected from a group consisting of
at least part of along the hub of the hollow needle of the
surgical instrument and
at least part of the driver of the hollow needle of the surgical
instrument
so as to detect infrared radiation wavelengths emanating from the
location[.]

The other independent claim, claim 10, uses similar language.
A second problem is that "along the hub of the hollow needle" does not
exclude the portion of the hub that is proximal to the tip of the needle or even the
tip itself, which appears in Figure 1 to be simply the terminus of the hub (with the
suction port being the terminus of the aspiration passage). Indeed, during
operation, the location of the tip or the tip-proximal part of the hub could also
adjoin the affected tissue, which means sensing at the tissue/hub intersection would
meet the broadest reasonable interpretation of the claim. A similar claim
interpretation issue arose in an appeal in the parent application.10 Alcon urges
that:11
The present inventor, Dr. Richard Mackool, found that the
temperature condition was higher at the driver and along the hub than
at the target site so that, upon detection of such temperatures, action

8 In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983) (explaining that grammar
precepts apply to claims).
9 The claims were not rejected as indefinite.
10 Alcon, slip op. 7 (explaining "that the operative field would be the location on
the eye where the needle penetrates the tissue[, which] is either proximal to the tip
or along the hub of the needle of the surgical instrument").
11 Reply 3.
Appeal 2011-006283 Application 12/350,294

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can be taken before such higher temperatures spread to the needle tip
to result in thermal tissue damage.

The essential problem with Alcon's position is that the claim language itself does
not limit sensing to a location away from the tip or from the target site12 because
the sensed part of the needle can be anywhere "along the hub", including proximal
to the tip or at the target site, as was explained in the previous appeal.
While the claim requires "a location selected from a group", this language
does not distinguish between "preselected" or "user selected"; nor does it exclude
switching between selections or even (in a broadest reasonable interpretation
context) simultaneous selection of more than one location.13
Rejections
The examiner maintains rejections under 35 U.S.C. 103 against all pending
claims as follows:
Claims 1-3, 8-13 and 18 are rejected over the combination of a published
application of Baerveldt14 and patents to Kadziauskas15 and Laird;16
Claims 4 and 14 are rejected over the combination of Kadziauskas,
Baerveldt, Laird and patents to Poppas17 and Hughes;18

12 In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997) (explaining that the
appellants never particularly distinguish their claimed invention from the prior art).
13 Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342-43 (Fed. Cir.
2008) (explaining that limiting "a" to "one" requires a clear indication in the
record).
14 G. Baerveldt & R. Chuck, Minimally invasive glaucoma surgical instrument and
method, US 2002/0111608 A1 (pub'd 15 August 2002).
15 K.E. Kadziauskas & P.W. Rockley, Thermal mode phaco apparatus and method,
U.S. Patent 6,083,193 (granted 4 July 2000).
16 R.J. Laird et al., Ribbed electrodes and methods for their use, US 6,533,780 B1
(granted 18 March 2003).
Appeal 2011-006283 Application 12/350,294

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Claims 5, 6, 15 and 16 are rejected over the combination of Kadziauskas,
Baerveldt, Laird and Poppas;
Claims 7 and 17 are rejected over the combination of Kadziauskas,
Baerveldt, Laird, Poppas, Hughes and a patent to Ono.19
FACTS AND FINDINGS
Kadziauskas
[1] Kadziauskas teaches a medically recognized technique—
phacoemulsification—that generally includes making a corneal incision and
inserting a handpiece with an ultrasonic driven needle that emulsifies the lens,
which is then aspirated along with irrigating fluids.20
[2] Excessive power delivered to the handpiece can cause local eye
temperatures to rise to a level causing trauma.21
[3] Tissue damage can occur within one or two seconds under adverse heating
conditions.22
[4] Kadziauskas teaches a control that monitors energy removed from the eye by
aspirated irrigation fluid and energy provided to the handpiece.23
[5] Kadziauskas teaches a control that will modulate the phacoemulsification
power level or duty cycle based on energy balance information.24

17 D.P. Poppas et al., Laser tissue welding control system, U.S. Patent 5,409,481
(granted 25 April 1995).
18 S.E. Hughes, Retinal cell transplant, U.S. Patent 5,962,027 (granted 5 October
1999).
19 K. Ono, Microscopic objective lens, US 6,392,814 B1 (granted 21 May 2002).
20 Kadziauskas 1:13-21.
21 Id. 1:62-65.
22 Id. 2:4-6.
23 Id. 2:23-29.
24 Id. 4:1-3.
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[6] The examiner found that Kadziauskas does not teach the use of infrared
radiation readings to determine temperature at the operation site.25
Baerveldt
[7] Baerveldt discloses a surgical instrument and method for treating glaucoma
in which tissue is destroyed and aspirated.26
[8] Baerveldt Figure 17 (detail, right) shows a cauterization
probe 1700 for ocular surgery with a radiofrequency cautery
element 1730 and a sensor 1740.27
[9] The sensor 1740 may be a thermocouple to
provide temperature feedback, permitting precise
regulation of the temperature during cauterization
without causing intraocular heating.28
[10] Other types of temperature sensors, including infrared detectors, can be used
instead.29
[11] More than one sensor can be used at more than one location.30
[12] A temperature regulator 1746 can reduce power to the probe if temperature
exceeds an acceptable limit.31
A person having ordinary skill in the art would have appreciated from
Baerveldt that other temperature sensors, including infrared detectors, could be

25 Final Rej. 7.
26 Baerveldt ¶0003.
27 Id. ¶¶0048, 0117 & 0177.
28 Id. ¶¶0180-0183.
29 Id. ¶0184.
30 Id. ¶0185.
31 Id. ¶0186.
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used to detect hazardous temperatures during eye surgery, such as the
phacoemulsification of Kadziauskas.
Laird
[13] Laird discloses an invention that generally relates to medical devices,
methods and systems, particularly techniques for selectively heating and shrinking
tissues.32
[14] Laird is concerned about maintaining the temperature of non-target tissue
below a safe maximum.33
[15] Tissue cooling and heating can be verified and controlled by sensing
temperature directly from the target tissue and adjacent tissue.34
[16] Temperature may be sensed using a needle containing two temperature
sensors: one sensor at the tip to be positioned at the center of the treatment zone
and a second sensor along the shaft of the needle so as to be positioned at the edge
of the desired protection zone.35
[17] Alternatively, two needles may be used.36
[18] A controller may provide signals to a cooling system to chill non-target
tissue continually and to electrodes so a radiofrequency (RF) current is pulsed to
increase the temperature of the treatment zone incrementally, while at the same
time limiting heating of the intermediate tissue to below the safe maximum using
the feedback from the needles.37

32 Laird 1:23-28.
33 Id. 9:35-40.
34 Id. 10:39-42.
35 Id. 10:42-47.
36 Id. 10:57-58.
37 Id. 10:58-65.
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[19] The examiner finds a person having ordinary skill in the art would have
appreciated the value of placing two temperature sensors along the shaft of a
needle to calculate temperature accurately.38
Poppas
[20] Poppas teaches a control for a tissue-welding laser that senses the
temperature of the region to be treated.39
[21] Poppas teaches an infrared radiation wavelength detector for detecting the
infrared radiation emanating from the region to be welded.40
[22] The infrared radiation wavelength detector sends a signal to the control in
accordance with the infrared radiation sensed.41
[23] A person of ordinary skill in the art knew that the amplitude of the infrared
radiation emanating from the surface of an object is proportional to the temperature
of the object.42
Hughes
[24] Hughes discloses "a surgical tool for transplanting retinal cells, epithelium
and choroidea within their normal planar configuration, a graft for transplantation
to the subretinal region of the eye, a method for preparing such grafts for
transplantation, and a method for reconstructing dystrophic retinas, retinal pigment
epithelial layers and choroids."43

38 Final Rej. 8.
39 Poppas 5:54-59.
40 Id. 2:48-50.
41 Id. 5:29-31.
42 Id. 5:19-22.
43 Hughes 1:10-15.
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[25] In Hughes Example 8, an "infrared video camera was focused on the eye
through an operating microscope and the eye illuminated with infrared light" to
record pupillary response at graded light intensities.44
Ono
[26] Ono discloses "an objective lens having a long working distance and a
magnification of about 50, and more particularly to an objective lens used in
optical systems such as microscopes which utilize ultraviolet light."45
[27] Ono's disclosure is not limited to ultraviolet light, however; it contemplates
that its lenses will be used for near-infrared as well while ensuring sufficient
transmittance.46
Analogous art
Alcon contends that Laird is not analogous art.47 Case law directs the scope
of analogous art be construed broadly so that, whether or not the prior art is in the
exact same field of endeavor, those skilled in the art are not denied access to
technical know-how that is reasonably pertinent to the problem they face.48
Laird's methods to heat and shrink tissues are unquestionably different from
phacoemulsification. The final rejection, however, uses Laird only for the narrow
proposition that those in the medical device art would have apprehended that
temperature sensing at more than one location along the needle could facilitate
more accurate temperature determination. While the use of the needle is different,
the need for accurate temperature determination to avoid damage to untargeted

44 Id. 19:65-67.
45 Ono 1:10-13.
46 Id. 2:16-23.
47 Br. 12-16.
48 Wyers v. Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010).
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tissue is the same. Consequently, on the record before us, we cannot find that a
person having ordinary skill in the art would have considered Laird's two-sensor
teaching to be irrelevant to the problem facing Alcon's inventor.
Alcon also argues that Poppas, Hughes and Ono are not analogous art
because they are not directed to phacoemulsification.49 As with Laird, the
examiner's use of the references does not require that they be directed to
phacoemulsification. Poppas teaches monitoring infrared emanations from tissue
undergoing heat-generating surgery and controlling the surgical device accordingly
to avoid tissue damage. The examiner only relies on Poppas to teach the infrared
monitoring and control feedback loop, not the specifics of the surgery in which it is
used. While Poppas as a whole is concerned with a different type of surgery than
phacoemulsification, the concern about overheating tissue under treatment and
controlling the surgical instrument accordingly is common both to Poppas and to
Alcon.
Hughes shows the use of an infrared video camera with an operating
microscope in an eye surgery context. The fact that Hughes uses the combination
after a surgery other than phacoemulsification does not take the combination out of
the scope of relevant teachings known to skilled designers of optical surgery
equipment or procedures.
Ono's microscope lens improvements are relevant to a system or process
using a microscope. Ono is particularly relevant to systems and processes using
infrared frequencies with the microscope because Ono specifically addresses
preserving transmittance in the near-infrared range. The examiner's limited use of
the relevant teachings of these references was appropriate.

49 Br. 21-24.
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Inherency
The examiner found that "it is inherent that the infrared radiation given off
in a procedure where a needle is driven ultrasonically is present because of the
friction created by the motion of the needle."50
The examiner found "it is inherent that certain infrared wavelengths
correspond to certain temperatures as seen by the blackbody distribution curve. It
is also inherent that the varying of the needle's position would thereby cause the
temperature to cease from increasing in the needle's original position."51
As noted above, Kadziauskas is concerned with controlling heat from
phacoemulsification, which suggests that those skilled in the art understood an
ultrasonically driven needle generates heat.
We find the examiner's findings to be facially reasonable.
Alcon does not offer evidence to contradict these findings.
In view of the record before us, we adopt the examiner's inherency findings.
ANALYSIS
Claims 1-3, 8-13 and 18
Except as noted below, Alcon presents argument for these claims as a group
so they stand or fall as a group.
Claim construction and analogous art
Much of Alcon's argument rests on an overly narrow claim interpretation
and on a misapprehension of the limited use the final rejection makes of the Laird
teachings. As explained above, the contested claim language does not exclude
temperature sensing at a location right by the needle tip or right by the intersection
of the needle and the targeted tissue. Consequently, Alcon's arguments based on

50 Final Rej. 8.
51 Id. 8-9. The simplest case regarding position would be removal of the needle.
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the value of sensing temperature away from these locations is inapposite.
Similarly, while most of Laird is directed to a very different kind of heat treatment,
the limited teaching of the value of sensing temperature at more than one location
along the needle to avoid collateral tissue damage is just as pertinent to
phacoemulsification.
Alcon also contends that the final rejection does not explain how Laird
would assist in identifying locations for sensing temperature in a modified
phacoemulsification device.52 Because Laird is not concerned with
phacoemulsification, it naturally follows that the broader teachings of Laird would
be of little interest to the designer of a phacoemulsification device.
Sensing at more than one location
Alcon correctly notes that its independent claims do not require sensing at
more than one location; rather, they require thermal imaging or recognition at a
location associated with the needle.53 Consequently, the final rejection's insistence
on proofs involving multi-location temperature sensing is curious. Nevertheless,
the claims do not exclude multi-location sensing and so the proofs remain relevant.
Moreover, to the extent that Alcon relies on this argument to show a lack of
motivation to combine, the argument is two-edged: if the multi-location teaching
of Laird is not necessary, then putative weaknesses stemming from its inclusion are
not prejudicial.
The combination of Kadziauskas and Baerveldt suggests the use of an
infrared detector to determine temperature hazards during phacoemulsification.
The contested claim language does not exclude aiming the infrared detector at the
target site, where both the target tissue and portions of the needle are located. To

52 Br.16-19.
53 Id. 18.
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the extent that Laird is used to suggest sensing at more than one point on the
needle, it simply reinforces the concern already clear in the art for carefully
controlling needle temperature to avoid collateral tissue damage.
Claims 2 and 3
For claim 2, Alcon argues that "there is nothing inherent about detection of
infrared radiation given off in a procedure where a needle is driven
ultrasonically."54 For claim 3, Alcon argues that "there is nothing inherent about
varying at least one of the speed of vibration and a relative position of the hollow
needle of the surgical instrument so that corresponding temperature stops rising
further."55 Alcon provides no evidence to rebut the examiner's finding.
We have adopted the examiner's inherency findings in view of the present
record. In particular, the examiner's finding is consistent with the teachings of
Kadziauskas, whereas Alcon has not pointed us to contrary evidence. Moreover,
the examiner's inherency finding is consistent with Alcon's disclosure.56
Claims 11-13
The entirety of the final rejection for these claims is "Regarding claims 11-
13, these claims contain functional language and the prior art must be capable of
performing such limitations."57 Claim 11 requires a reduction in the needle
vibration speed when a critical temperature is reached. This limitation would have
been obvious from Kadziauskas, in which "the computer may modulate the phaco
power level or duty cycle based upon the level of a 'heat factor' determined by the

54 Id. 24.
55 Id.
56 See In re Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009) (explaining that the
disclosure may be used to show that a claimed property or function is inherent).
57 Final Rej. 9
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energy balance,"58 subject to the modifications necessary to use infrared detection
instead.
Claim 12 requires withdrawal of the needle. The examiner argues in the
answer59 that the needle is ultrasonically driven back and forth and that "withdraw"
does not mean withdraw from the tissue. The examiner does not point to any
support for "withdraw" meaning "partially withdraw". Moreover, if the needle is
still in the tissue, it can still transmit heat to the tissue. The examiner's claim
interpretation is strained in view of the specification and the ordinary meaning of
withdraw. While withdrawing the needle is in itself an obvious expedient for
reducing tissue heating, the examiner has not provided a basis in the cited art for
the driver to withdraw the needle based on a command signal from the controller.
Claim 13 requires stopping needle vibration. Similarly, stopping needle
vibration would be an obvious expedient for addressing overheating, but the
examiner has not provided a basis for finding that the driver would do so in
response to a command signal. Kadziauskas teaches modulation of the power or
duty cycle, but does not expressly teach stopping. While "modulate" could include
"modulate to zero", the examiner has not provided a basis for finding that a person
having ordinary skill in the art would read Kadziauskas that way.
Claims 4-7 and 14-17
For these claims, Alcon principally argues that Poppas, Hughes and Ono are
not analogous art. As we found above, these references are relevant to the problem
facing Alcon's inventor.

58 Kadziauskas 4:1-3.
59 Ans. 20.
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For claims 4 and 14, Alcon also argues that Poppas and Hughes do not teach
the limitation of detecting infrared through the surgical microscope.60 The
examiner uses Poppas for teaching infrared sensing of tissue overheating and uses
Hughes for teaching using an infrared camera through a microscope. While neither
teaches what Alcon claims, the examiner is correct that together they suggest
monitoring tissue overheating by detecting infrared radiation through a
microscope. Poppas suggests the use and Hughes, the means. Alcon does not give
a reason why the examiner's proposed combination is unreasonable.
For claims 7 and 17, Alcon also argues that the examiner uses impermissible
hindsight in applying Ono's teachings regarding an improved lens.61 In particular,
Alcon argues that one of Ono's goals (durability) is inapplicable to the problem
facing Alcon's inventor. A person having ordinary skill in the art need not have the
same motivation that the applicant had.62 In any case, Ono teaches a lens with both
durability and sufficient transmittance in the near-infrared range, which would
naturally appeal to a person having ordinary skill in the art working with an
infrared microscope.
HOLDING
The rejection of claims 12 and 13 is reversed. The rejection of the other
claims is affirmed.
AFFIRMED-IN-PART
bar

60 Br. 25.
61 Id. 26.
62 In re Dillon, 919 F.2d 688, 692-94 (Fed. Cir. 1990) (en banc); see also KSR Int'l
v. Teleflex Inc., 550 U.S. 398, 420 (2007) (stating that it is error to look "only to
the problem the patentee was trying to solve").
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For the appellant: ROBERT HESS, Hess Patent Law Firm, P.C., of Stamford,
Connecticut.