Ex Parte Kenny

Board of Patent Appeals and Interferences

Mar 24, 2011

11134011 (B.P.A.I. Mar. 24, 2011)

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.
11/134,011 05/20/2005 Daniele J. Kenny Kenny 9453
7590 03/24/2011
Bernard S. Hoffman
10 Colgate Street
Port Jefferson Station, NY 11776
EXAMINER
SMITH, RUTH S
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
03/24/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte DANIELE J. KENNY
____________________

Appeal 2009-008587
Application 11/134,011
Technology Center 3700
____________________

Before MURRIEL E. CRAWFORD, JENNIFER D. BAHR and
STEVEN D.A. McCARTHY, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2009-008587
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STATEMENT OF THE CASE 1
The Appellant appeals under 35 U.S.C. § 134 from the Examiner’s 2
decision finally rejecting claims 1-34. We have jurisdiction under 35 U.S.C. 3
§ 6(b). 4
We sustain the Examiner’s rejections of: 5
claims 1-34 under 35 U.S.C. § 101 as lacking utility; 6
claims 1-34 under § 112, first paragraph, as failing to 7
comply with the enablement requirement; 8
claims 1-5, 7, 11-15, 17 and 21-32 under 35 U.S.C. 9
§ 102(b) as being anticipated by Indech (US 4,343,301, issued 10
Aug. 10, 1982); 11
claims 6 and 16 under 35 U.S.C. § 103(a) as being as 12
being unpatentable over Indech and Castel (US 5,413,550, 13
issued May 9, 1995); and 14
claims 8 and 18 under § 103(a) a being unpatentable over 15
Indech and Mian (US 2001/0055812 A1, publ. Dec. 27 2001). 16
We do not sustain the Examiner’s rejections of: 17
claims 1-34 under § 112, first paragraph, as failing to 18
comply with the written description requirement; 19
claims 1-3, 5, 11-13, 15, 21-26 and 30-32 under § 102(b) 20
as being anticipated by Tofte (US 4,747,142, issued May 24, 21
1988); and 22
claims 9, 10, 19, 20, 33 and 34 under § 103(a) as being 23
unpatentable over Indech and Drewes (US 4,315,514, issued 24
Feb. 16, 1982). 25
Claims 1 and 21 are illustrative of the claimed subject matter: 26
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1. A neoplasm cell destruction device, 1
comprising: 2
a) at least one signal generator; and 3
b) at least one transducer; 4
wherein said at least one transducer is driven 5
by said at least one signal generator; 6
wherein each of said at least one transducer 7
produces low frequency sound waves; and 8
wherein said low frequency sound waves are 9
impacted upon a neoplastic target to damage 10
and ultimately destroy the neoplastic target. 11
12
21. A method of damaging and ultimately 13
destructing a neoplastic target, comprising 14
the step of impacting the neoplastic target 15
with low frequency sound waves. 16
We do not address the Examiner’s conclusion that the Appellant has 17
not complied with one or more conditions for receiving the benefit of an 18
earlier filing date (see Final Office Action mailed October 20, 2006 (Final 19
Rejection”) at 2); the Examiner’s objection to the Specification (see id.); the 20
Examiner’s objection to the Amendment filed May 19, 2006 (see id.); and 21
Examiner’s objection to claims 11-20 (see Final Rejection at 3). We do not 22
need to address these matters in order to fully review the rejections entered 23
by the Examiner. The matters may be addressed by petition, if timely. See, 24
e.g., Ex Parte Frye, 94 USPQ2d 1072, 1077-78 (BPAI 2010). 25
26
ISSUES 27
Only issues and findings of fact contested by the Appellant have been 28
considered. See Frye at 1075-76. Three issues raised in this appeal are: 29
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First, does the Specification provide a written description 1
of a method of a neoplasm cell destruction device using one or 2
more transducers for producing low frequency sound waves? 3
(See Ans. 4-5; App. Br. 25-26). 4
Second, is the subject matter of claims 1-34 inoperative 5
and thereby lacking in utility because the preponderance of 6
evidence supports the inference that neoplastic tissues lack 7
resonant frequencies in the audible range at which sound waves 8
might damage and ultimately destroy the neoplastic tissues? 9
(See Ans. 5-6; App. Br. 26-30; Reply Br. 2-4). 10
Third, does Indech describe the subject matter of claims 11
1-5, 7, 11-15, 17 and 21-32, including at least one transducer 12
which produces low frequency sound waves which are 13
impacted on a neoplastic target? (See Ans. 6 and 9; App. Br. 14
30-36; Reply Br. 5-10). 15
Fourth, does Tofte describe the subject matter of claims 16
1-3, 5, 11-13, 15, 21-26 and 30-32, including at least one signal 17
generator? (See Ans. 7 and 9; App. Br. 40-42). 18
Fifth, would it have been obvious from the combined 19
teachings of Indech and Castel to accommodate the structure 20
disclosed by Indech to modern electronics by means of digital 21
control using a microprocessor? (See Ans. 7-8; App. Br. 42-22
46). 23
Sixth, do the evidence and technical reasoning underlying 24
the rejections of claims 9, 10, 19, 20, 33 and 34 under § 103(a) 25
adequately support the conclusion that it would have been 26
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obvious to provide Indech’s device with a feedback sensor to 1
facilitate automatically adjusting the signal generators until the 2
sound waves produced by the transducers are at resonant 3
frequencies? (Ans. 8-9; App. Br. 50-51). 4
5
FINDINGS OF FACT 6
The record supports the following findings of fact (“FF”) by a 7
preponderance of the evidence. 8
1. Indech discloses a noninvasive method useful for destroying 9
tumors “through local heating.” (Indech, col. 1, ll. 22-25 and col. 2, ll. 9-10
10). The method positions a pair of transducers about the human skull. 11
(Indech, col. 1, ll. 46-51). One of the transducers produces sound waves in 12
the range of 1000 Hz or more. The other transducer produces sound waves 13
of 1100 Hz or more. (Indech, col. 1, ll. 56-60). The low frequency sound 14
waves from both transducers impact on the tumor at their point of 15
intersection. The beams interfere or heterodyne near the tumor, producing a 16
high energy beat of approximately 100 Hz. (Indech, col. 1, ll. 61-65; col. 2, 17
ll. 17-22 and 42-47). 18
2. Indech discloses actuating the transducers using signal 19
generators including a master modulator, amplifiers and an oscillator. The 20
oscillator communicates with each of the transducers through the master 21
modulator and one of the amplifiers. (Indech, col. 2, ll. 26-30 and fig. 2). 22
Indech teaches the use of a master timer to generate timing and control 23
signals. These timing and control signals induce analog switches associated 24
with the amplifiers to selectively enable the amplifiers, thereby activating 25
the signal generators. (Indech, col. 2, ll. 30-36). 26
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3. Castel discloses a therapeutic ultrasound system including a 1
microprocessor. (Castel, col. 7, ll. 60-66; col. 8, ll. 45-48; and fig. 1). A 2
treatment control routine run by the microprocessor sets oscillator and 3
amplifier portions of an ultrasound generator to output an ultrasound drive 4
frequency and power to a transducer. (Castel, col. 9, ll. 35-45). 5
4. Drewes teaches a method relying on the phenomenon of 6
resonance to destroy tumor cells. (Drewes, col. 2, ll. 30-32). Drewes also 7
teaches that neoplastic cells may exhibit several resonant frequencies. 8
(Drewes, col. 6, ll. 23-26). 9
5. Drewes describes determining the resonant frequencies of 10
tumor cells by surgically excising all or part of the tumor and subjecting the 11
excised tissue to ultrasound of varying frequency. (Drewes, col. 2, ll. 45-12
57). Drewes teaches looking for the resonant frequencies of neoplastic cells 13
only in the ultrasonic range, at frequencies on the order of 100,000 Hz to 14
4,000,000 Hz. (Drewes, col. 2, ll. 50-54; col. 6, ll. 16-23). 15
16
ANALYSIS 17
First Issue 18
The Examiner finds that the Specification fails to provide a written 19
description of a method of a neoplasm cell destruction device including one 20
or more transducers which produces low frequency sound waves. The 21
Examiner’s finding and the Appellant’s argument hinge on the interpretation 22
of the term “low frequency sound waves.” The word “low” in the term “low 23
frequency sound waves” is a term of degree. When interpreting a term of 24
degree, it is appropriate to turn to the Specification for guidance. See Seattle 25
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Box Co. v. Industrial Crate & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1
1984). 2
The Appellant is correct in asserting that the term “low frequency 3
sound waves” as used in claim 1 is limited to sound waves having 4
frequencies in the range of 20Hz to 20,000 Hz when interpreted in view of 5
the Specification. (See App. Br. 22). The sole embodiment discussed in the 6
Specification includes at least one transducer 32 driven to produce sound 7
waves having frequencies in a range of 20 Hz to 20,000 Hz (Spec. 20-21). 8
The range of 20 Hz to 20,000 Hz corresponds to the audible range of 9
frequencies and is low compared to the ultrasonic range. The sound waves 10
within the range of 20 Hz to 20,000 Hz generated by the sole embodiment 11
disclosed in the Specification impact on a neoplastic target 36 to damage and 12
ultimately destroy the target. The Appellant in the Specification states that 13
the use of sound waves having frequencies in a range of 20 Hz to 20 kHz 14
reduces lethality to surrounding healthy cells “due to lower energy than prior 15
treatment sources.” (Spec. 21). 16
The Appellant does not appear to formally define, or even mention, 17
the term “low frequency sound waves” in the Specification. Nevertheless, 18
the Specification as a whole indicates that the Appellant’s invention is 19
predicated on the use of sound waves in the range of 20 Hz to 20,000 Hz to 20
selectively damage or destroy neoplastic tissue. Consequently, the term 21
“low frequency sound waves” as used in the Specification is limited to 22
sound waves in the range of 20 Hz to 20,000 Hz. 23
The Examiner cites a patent, an article and various dictionary 24
definitions in as evidence of alternative uses of the term “low frequency 25
sound waves.” (See Ans. 4-5). Taken together or separately, the Examiner’s 26
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evidence is not persuasive of an ordinary usage of the term “low frequency 1
sound waves” in the pertinent art which should override the consistent usage 2
of the term in the Specification. Likewise, the Appellant’s recitation in 3
dependent claim 2 that “said low frequency sound waves have frequencies in 4
a range of about 20-20,000 Hz” cannot broaden the term “low frequency 5
sound waves” beyond the scope indicated by the Specification. 6
The Appellant’s Specification describes using low frequency sound 7
waves, that is, sound waves having frequencies in the range of 20 Hz to 8
20,000 Hz, to damage or destroy neoplastic tissue. (Spec. 20, l. 18 – 21, l. 9
1). We do not sustain the rejection of claims 1-24 and 26-34 under § 112, 10
first paragraph, for failing to comply with the written description 11
requirement.2 12
13
Second Issue 14
The Examiner finds that the subject matter of claims 1-34 lacks utility. 15
Independent claim 1 recites a neoplasm cell destruction device. Independent 16
claims 11 and 21 recite methods of damaging and ultimately destructing 17
neoplastic targets. Independent claim 24 recites a method of using a 18
neoplasm cell destruction device to damage and ultimately destruct a 19
neoplastic target. 20

2 Our refusal to sustain the rejection of claim 25 under § 112, first
paragraph as failing to comply with the written description requirement is
contingent on our understanding that there is a typographical error in claim
25 as reproduced in the Claims Appendix to the Appeal Brief. According to
the electronic file wrapper for this application, claim 25 as most recently
amended recites a range of “20-20,000 Hz.” Amendment filed May 19,
2006.
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The PTO has the initial burden of challenging a 1
patent applicant’s presumptively correct assertion 2
of utility . . . If the PTO provides evidence 3
showing that one of ordinary skill in the art would 4
reasonably doubt the asserted utility, however, the 5
burden shifts to the applicant to submit evidence 6
sufficient to convince such a person of the 7
invention’s asserted utility. 8
In re Swartz, 232 F.3d 862, 864 (Fed. Cir. 2000)(citations omitted). The 9
Examiner has borne the burden of showing that one of ordinary skill in the 10
art would reasonably doubt the utility asserted by the Appellant. 11
The Examiner finds (Ans. 5), and the Appellant does not appear to 12
contest (see generally App. Br. 26-30; Reply Br. 3-4), that one of ordinary 13
skill in the art would understand the Specification as teaching that the low 14
frequency, low energy sound waves must be delivered at or near a resonant 15
frequency of the neoplastic tissue to destroy the neoplastic tissue. The 16
Appellant’s Specification does not disclose values for resonant frequencies 17
of neoplastic cells within the audible range of frequencies. Neither does the 18
Specification provide a working example showing the existence of 19
neoplastic cell resonant frequencies in the audible range. Although the 20
Specification indicates generally that the claimed subject matter damages or 21
destroys neoplastic cells, conclusory assertions in the Specification are 22
entitled to little evidentiary weight. Cf. In re Geisler, 116 F.3d 1465, 1470 23
(Fed. Cir. 1997)(mere argument or conclusory statements in a specification 24
do not suffice to show secondary indicia such as unexpected results). 25
The only guidance provided by the Specification regarding how one 26
of ordinary skill in the art might find resonant frequencies of neoplastic 27
tissue incorporates Drewes by reference. (See Spec. 21). Drewes teaches 28
that neoplastic cells may exhibit several resonant frequencies. Nevertheless, 29
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Drewes teaches looking for the resonant frequencies of neoplastic cells only 1
in the ultrasonic range, at frequencies on the order of 100,000 Hz to 2
4,000,000 Hz. The Appellant identifies nothing in Drewes suggesting that 3
neoplastic cells might have resonant frequencies useful for damaging or 4
destroying the cells in the audible range. 5
The Appellant provides a declaration by Ted Milo, an independent 6
consulting engineer with experience in the field of medical instruments. Mr. 7
Milo concedes that Drewes teaches looking for cell resonant frequencies in 8
the range of 100,000 Hz to 4,000,000 Hz and does not teach looking for 9
resonant frequencies below the ultrasonic range. (Milo Declaration, para. 10
60). Nevertheless, Mr. Milo states that the range of 100,000 Hz to 4,000,000 11
Hz “is not necessarily the only range that cells will resonant [sic] at.” (Id.) 12
Mr. Milo goes on to state that, 13
If Drewes et al., however, used a frequency range 14
other than ultrasonic to destroy the aberrant cells, 15
the resonant frequencies would then be within this 16
other frequency range. . . . Thus, although Drewes 17
et al. teach subjecting the biopsy of cells to 18
ultrasound frequencies, this biopsy technique, 19
though, could be used to predict resonance in any 20
possible frequency range, including the audible 21
frequency range, and not just the ultrasound range 22
that Drewes et al. use as an example. 23
(Milo Declaration, paras. 63-64). Noticeably absent from these statements is 24
even a conclusory statement that there exist neoplastic cell resonant 25
frequencies in the audible range. 26
The evidence as a whole supports the Examiner’s finding that “using 27
frequencies in the range of 20-20,000 Hz would not cause the destruction of 28
a neoplastic target.” (Ans. 6). The Appellant has not discovered and 29
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disclosed a substantial or practical utility for the subject matter of claims 1-1
34. We sustain the rejections of claims 1-34 under § 101 as being 2
inoperative and thereby lacking utility. Since an application which fails as a 3
matter of fact to meet the utility requirement of § 101 also fails as a matter 4
of law to meet the “how to use” enablement requirement of § 112, first 5
paragraph, In re Ziegler, 992 F.2d 1197, 1201 (Fed. Cir. 1993), we also 6
sustain the rejections of claims 1-34 under § 112, first paragraph, for failure 7
to comply with the enablement requirement. 8
9
Third Issue 10
Claim 1, which is representative of claims 1-5, 7, 11-15, 17 and 21-32 11
for purpose of the rejection under § 102(b) as argued by the Appellant, 12
recites a device including at least one transducer, “wherein each of said at 13
least one transducer produces low frequency sound waves” and “wherein 14
said low frequency sound waves are impacted upon a neoplastic target.” 15
Indech teaches destroying a tumor using a pair of transducers. One of the 16
transducers produces sound waves in the range of 1000 Hz or more. The 17
other transducer produces sound waves of 1100 Hz or more. (FF 1). Both 18
transducers produce low frequency sound waves. The low frequency sound 19
waves from both transducers impact on the tumor. 20
The Appellant argues that Indech does not anticipate the subject 21
matter of representative claim 1 because Indech would not have placed one 22
of ordinary skill in the art in possession of a device which destroys tumors 23
using sound waves in the audible range of frequencies. More specifically, 24
Indech teaches destroying tumors “through local heating.” (FF 1). The 25
Appellant contends that one of ordinary skill in the art would have 26
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understood Indech to teach the use of sound waves in the ultrasound range of 1
frequencies, because only sound waves in the ultrasound range could destroy 2
tumor cells through local heating. (App. Br. 32; Reply Br. 6). 3
Rejection for anticipation or lack of novelty 4
requires, as the first step of the inquiry, that all the 5
elements of the claimed invention be described in a 6
single reference . . . Further, the reference must 7
describe the applicant’s claimed invention 8
sufficiently to have placed a person of ordinary 9
skill in the field of the invention in possession of 10
it. 11
In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990)(citations omitted). The 12
Appellant bears the initial burden of proving that Indech would not have put 13
one of ordinary skill in the art in possession of the subject matter of claim 1. 14
In re Sasse, 629 F.2d 675, 681 (CCPA 1980). 15
Indech might have mistaken the physical mechanism by which sound 16
waves in the audible range or below destroy tumors. Nevertheless, Indech 17
would have placed one of ordinary skill in the art in possession of a method 18
of destroying tumors wherein each of a pair of transducers produced low 19
frequency sound waves and wherein the low frequency sound waves were 20
impacted on a tumor. Indech discloses that the sound waves produced by 21
the transducers interfere or heterodyne near the tumor to produce a high 22
energy beat of approximately 100 Hz. (FF 1). The Appellant concedes that 23
the intensity of a sound wave depends on both frequency and amplitude. 24
(App. Br. 33-34). Consequently, a high energy beat, that is, a beat of high 25
amplitude, might carry sufficient energy to damage or destroy a tumor even 26
at a frequency below the ultrasonic range. Since the generalized statements 27
in the Appeal Brief and the Milo Declaration do not address the specific 28
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disclosure of Indech, the evidence supports a finding that Indech would have 1
put one of ordinary skill in the art in possession of the subject matter of 2
claim 1. We sustain the rejections of claims 1-5, 7, 11-15, 17 and 21-32 3
under § 102(b) as being anticipated by Indech. 4
5
Fourth Issue 6
Claim 1 recites a device including at least one signal generator. Claim 7
11 recites a method using a device including a signal generator. Claim 24 8
recites a method using a signal generator. Tofte does not disclose a signal 9
generator. The Examiner concedes that the FM tuner disclosed by Tofte is 10
not itself a signal generator (Ans. 9). The Examiner does not identify any 11
other structure expressly identified by Tofte or necessarily present in the 12
structure described by Tofte which might be a signal generator. We do not 13
sustain the rejections of claims 1-3, 5, 11-13, 15, 25, 26 and 30-32 under 14
§ 102(b) as being anticipated by Tofte. 15
Claim 21 recites a method including a step of impacting a neoplastic 16
target with low frequency sound waves. The Examiner has not explained 17
how Tofte might disclose this step. We do not sustain the rejections of 18
claims 21-23 under § 102(b) as being anticipated by Tofte. 19
20
Fifth Issue 21
Indech describes the use timing and control signals generated by a 22
master timer to selectively activate signal generators in a device using sound 23
waves to destroy tumors. (FF 1 and 2). Castel uses a microprocessor 24
controller to control a signal generator in a therapeutic ultrasound device. 25
(FF 3). It would have been obvious to substitute Castel’s microprocessor 26
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control for Indech’s master timer. See KSR Int’l Co. v. Teleflex, Inc., 550 1
U.S. 398, 416 (2007)( “[W]hen a patent claims a structure already known in 2
the prior art that is altered by the mere substitution of one element for 3
another known in the field, the combination must do more than yield a 4
predictable result.”). Such a substitution would have done no more than 5
accommodate the structure disclosed by Indech to modern electronics in a 6
predictable manner. See Leapfrog Enterp. v. Fisher-Price, Inc., 485 F.3d 7
1157, 1161 (Fed. Cir. 2007). 8
We sustain the rejections of claims 6 and 16 under § 103(a) as being 9
unpatentable over Indech and Castel. The Appellant provides no argument 10
suggesting that claims 8 and 18 might be patentable over Indech and Mian if 11
claims 1 and 11 are anticipated by Indech and claims 6 and 16 are 12
unpatentable over Indech and Castel. (See, e.g., App. Br. 48). We also 13
sustain the rejections of claims 8 and 18 under § 103(a) a being unpatentable 14
over Indech and Mian. 15
16
Sixth Issue 17
With regard to the rejections of claims 9, 10, 19, 20, 33 and 34 under 18
§ 103(a), the Examiner concludes that it would have been obvious “to have 19
modified Indech such that it includes a feedback sensor to ensure that the 20
frequency transmitted to the target is as the resonant frequency of [the] 21
target to increase the effectiveness of the treatment as disclosed by Drewes 22
et al.” (Ans. 9). Indech discloses producing sound waves within the audible 23
frequency range and impacting those waves on a tumor in order to destroy 24
the tumor. (FF 1). As discussed earlier, the Examiner has not identified any 25
description in Drewes teaching or suggesting that tumor cells have resonant 26
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frequencies in the audible range. (See FF 5). Consequently, the Examiner’s 1
reasoning in support of the conclusion that the subject matter of claims 9, 10, 2
19, 20, 33 and 34 would have been obvious lacks rational underpinning. We 3
do not sustain the rejections of claims 9, 10, 19, 20, 33 and 34 under § 4
103(a) as being unpatentable over Indech and Drewes. 5
6
DECISION 7
We AFFIRM the Examiner’s decision rejecting claims 1-34. 8
No time period for taking any subsequent action in connection with 9
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. 10
§ 1.136(a)(1)(iv) (2007). 11
12
AFFIRMED 13
14
15
16
Klh 17
18
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BERNARD S. HOFFMAN 20
10 COLGATE STREET 21
PORT JEFFERSON STATION, NY 11776 22