Ex Parte Puskas

Patent Trial and Appeal Board

Dec 22, 2016

13961832 (P.T.A.B. Dec. 22, 2016)

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
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/961,832 08/07/2013 William L Puskas 571270 1070
30955 7590 12/27/2016
T ATHROP ^ GAGV. T T P EXAMINER
4845 PEARL EAST CIRCLE CLEVELAND, TIMOTHY C
SUITE 201
BOULDER, CO 80301 ART UNIT PAPER NUMBER
1774
NOTIFICATION DATE DELIVERY MODE
12/27/2016 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):
patent @ lathropgage. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM L. PUSKAS
Appeal 2017-000266
Application 13/961,832
Technology Center 1700
Before ADRIENE LEPIANE HANLON, CATHERINE Q. TIMM, and
DONNA M. PRAISS, Administrative Patent Judges.
PRAISS, Administrative Patent Judge.
DECISION ON APPEAL1
Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision
rejecting claims 24 and 25. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
The claims are directed to a method of causing cancer cells in the blood of a
patient to act as cavitation nuclei. Claim 24, the sole independent claim on appeal,
is illustrative of the invention and is reproduced below from the Claims Appendix
to the Appeal Brief (numbering of steps and italics added):
1 In this decision, we refer to the Specification filed Aug. 7, 2013 (“Spec.”), the
Non-final Office Action mailed Jan. 13, 2016 (“Act.”), the Appeal Brief filed June
13, 2016 (“App. Br.”), the Examiner’s Answer mailed Aug. 4, 2016 (“Ans.”), and
the Reply Brief filed Oct. 4, 2016 (“Reply Br.”).
2 Appellant identifies the real party in interest as William L. Puskas. App. Br. 3.
Appeal 2017-000266
Application 13/961,832
24. A method of causing cancer cells in blood of a patient to
act as cavitation nuclei, comprising the steps of:
[1] sequentially depositing a plurality of test blood samples from
the patient with first cancer cells in a single chamber;
[2] exposing each of said test blood samples, when in the single
chamber, to sound energy at a different respective one of a plurality of
sweeping frequencies generated by a sound energy source, wherein the
entire volume of each of said test blood samples is exposed;
[3] determining an inactivation efficiency of the first cancer cells
for each of said test blood samples;
[4] determining a resonant sweeping frequency that (a) within the
range spanned by the plurality of sweeping frequencies, optimally
destroys the first cancer cells and (b) has center frequency in the range
350 kHz to 15 MHz and sweep frequency bandwidth between 0.1
percent and 7 percent of the center frequency;
[5] circulating the blood of the patient out of the patient via a first
catheter, through a vessel coupled with a second sound energy source,
and back into the patient through a second catheter; and
[6] exposing the blood to sound energy generated by the second
sound energy source at said resonant sweeping frequency to cause
second cancer cells in the blood and of same type as the first cancer
cells to act as a cavitation nuclei and implode while untargeted cells in
the blood remain viable, wherein the entire volume of the blood
contained by said vessel is exposed to said resonant sweeping
frequency.
Appellant requests review of the Examiner’s rejection of claims 24 and 25
under 35 U.S.C. § 103 over Drewes3 in view of Kline4 and Puskas.5 App. Br. 4.
The Examiner finds Drewes (1) “discloses a method for inactivating cancer
cells in blood (such as leukemia cells) by resonating the cells using ultrasonic
energyf,]” (2) “discloses that the resonate frequencies of the cancer cells can be
3 Drewes et al., US 6,156,549, issued Dec. 5, 2000 (“Drewes”).
4 Kline, US 2013/0131432 Al, published May 23, 2013 (“Kline”).
5 Puskas, US 6,538,360 B2, issued Mar. 25, 2003 (“Puskas”).
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Application 13/961,832
determined through iterative . . . testing on blood samples . . . and that the
optimum destructive resonant frequency ... is determined by observation^” (3)
“teaches that a frequency sweep may be used in order to apply a range of
frequencies to the cellular components[,]” (4) “discloses frequencies in the range
of 5 to 20 MHz or higher are considered[,]” and (5) “recognizes that the targeted
cells will have multiple and varying resonant frequencies and a single frequency
will not [] effectively destroy [all of] the cancer cells desired to be destroyed.”
Act. 2—3. The Examiner concedes Drewes does not disclose “determining an
inactivation efficiency for each sweeping frequency” or “causing the targeted cells
to act as cavitation nuclei or wherein the resonant sweeping frequency has a
bandwidth between 0.1 percent and 7 percent of the center frequency.” Id. at 3.
The Examiner finds that “one of ordinary skill in the art is capable of determining
an optimal or workable bandwidth from the teachings of Drewes as it is taught that
the sweeping frequency range is progressively narrowed down in order to optimize
the range of the damaging frequencies.” Id.
The Examiner further finds that Kline teaches “sampling . . . neoplastic cells
via biopsy or blood sample, identifying and characterizing the neoplastic cells in
the sample, calculating the resonant frequency ranges of the cells and applying the
frequency to the cancerous region of the body” where “[t]he frequency can be
between 1 and 1,500 MHz, have a passband between 0.5 to 3.0 times the frequency
fundamental (i.e. a range of frequencies are applied), and can be applied with
known ultrasonic generators (i.e. sonic generators and piezoelectric transducers).”
Id. at 4. The Examiner finds that “[t]he resonant frequencies function to destroy
cells through the mechanism of inducing cavitation and the collapse of the cavity
(i.e. ‘implosion’) creates a strong local mechanical shock wave.” Id. The
Examiner also finds “an inactivation rate measurement would necessarily be
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Application 13/961,832
calculated or used from known data to determine the treatment time for clinically
efficacious results.” Id. The Examiner additionally finds that Puskas teaches a
sweeping frequency generator with a frequency spectrum ranging from 9kHz to
5MHz. Id. at 4—5. The Examiner determines it would have been obvious to
combine “the teaching of Kline for inducing cavitation by resonating cancer cells
with the method of Drewes for the purpose of using the cavitation shock wave to
mechanically destroy the cell along with the resonating of the cell and cellular
structures.” Id. at 5. The Examiner also determines it would have been obvious
“to have used the sweeping frequency generator of Puskas with the combined
method of Drewes and Kline for the purpose of applying multiple sweeping
frequencies to the blood in order to target the cancer cells having different resonant
frequencies and to apply more than one of the resonant frequencies of the cells as
recognized by Drewes.” Id.
Appellant argues that “there is no suggestion in Drewes that a range of
frequencies is required to effectively destroy cancer cells in blood” because
“Drewes carefully outlines a method for determining these resonance frequencies
and selecting a single optimum resonance frequency for use in treatment.” App. Br.
5 (citing Drewes 12:45—46, 13:14—17, 13:33—38, 14:23—45) (emphasis omitted); id.
at 6—7 (“Drewes uses frequency ranges solely to determine the single fixed
frequency for treatment. Drewe’s application of frequency ranges does not result
in the determination of an optimum frequency range.”). According to Appellant,
with no suggestion of a range of frequencies, there is no motivation to combine
Drewes with Puskas. Id. at 5—6. Appellant also contends that Puskas is non-
analogous art, it does not contemplate cancer treatment, or suggest causing cancer
cells to act as cavitation nuclei. Id. at 6, 7—8. Appellant further contends that
Kline fails to provide motivation to modify Drewes because frequency sweeping
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Application 13/961,832
“is not a viable method for achieving Kline’s frequencies” in view of the wide
range of frequencies disclosed in Kline “suggesting a frequency range is 0.5 to 3.0
times the average maximum diameter of the target cell” that “[a] transducer would
be incapable of generating sound energy over such a wide range.” Id. Appellant
also submits the Declaration of inventor William L. Puskas dated September 15,
2015 as evidence of long-felt need to further support non-obviousness of claim 24.
Id. at 9.
The Examiner responds that “it would have been obvious for one of ordinary
skill to have substituted the experimental determination of a resonant frequency
range disclosed by Drewes for the theoretical determination of a resonant
frequency range as disclosed by Kline to achieve predictable results.” Ans. 6. The
Examiner further responds that “Appellant has not established criticality of the
claimed range [from 0.1 to 7 percent of the center frequency].” Id. at 7. The
Examiner also responds that “as Drewes and Kline recognize the need to target
cancer cells with multiple resonant frequencies and that a frequency sweep can be
used to apply multiple frequencies, one of ordinary skill in the art would have
looked towards ultrasonic transducers which are capable of producing multiple
frequencies in order to effectively destroy cancer cells.” Id. at 8. Regarding
Appellant’s declaration evidence, the Examiner finds Appellant’s evidence of a
long-felt need of killing leukemia cells is not commensurate in scope with the
pending claims or that the evidence shows the invention is actually effective in
satisfying the need of treating leukemia. Id.
The Examiner has not directed us to any evidence to support a finding that
Drewes and Kline suggest exposing blood to sound energy of a resonant sweeping
frequency meeting the limitations of (a) and (b) in the determining step of claim 24
for destroying cancer cells. Ans. 8. Appellant’s assertion that Drewes discloses
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treatment using only a single optimum frequency is supported by the record.
Drewes, 7:43^14, 12:45^16, 13:14—17, 13:30, 13:35, 14:40-41. Appellant’s
contention that Drewes discloses using a sweeping frequency on samples of
cancerous cells for determining the single fixed frequency for treatment rather than
for determining a sweeping frequency treatment is also supported by the record.
Id. at 4:41—5:45, 14:33—58. The Examiner’s combination of “Kline for inducing
cavitation by resonating cancer cells with a resonant frequency range with the
method of Drewes” is not supported by sufficient reasoning. Although Kline
suggests using multiple frequencies, the Examiner has not established that the
multiple frequencies are a resonant sweeping frequency of the properties required
by claim 24 or that Kline would have suggested using such a resonant sweeping
frequency to the ordinary artisan. We are persuaded by Appellant that the
Examiner has not shown that Drewes’ resonant frequency sweeping method for
experimentally determining an optimum single frequency would have been
equivalent to the effect of applying a resonant frequency of the parameters required
by claim 24 for causing the required cavitation and implosion of cancer cells.
Reply Br. 9.
We also are persuaded by Appellant that the Examiner has not established
that the ultrasonic device of Puskas would have been reasonably pertinent to the
problem addressed by the inventor. App. Br. 7—8. The Examiner finds that
“appellant was concerned with supplying a sweep frequency” (Ans. 7) and “one of
ordinary skill in the art would have looked towards ultrasonic transducers which
are capable of producing multiple frequencies in order to effectively destroy cancer
cells” (id. at 8). Puskas is directed to an ultrasonic cleaning process, which
Appellant contends “is an indirect mechanism, wherein the target is contaminants
on a surface of a workpiece and energy is transferred indirectly from an ultrasound
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source to the contaminant via generation of gas bubbles in a liquid in contact with
the workpiece. The physical mechanism relied upon in ultrasonic cleaning is that
of generating air bubbles in a liquid, in contact with a workpiece, to make these air
bubbles implode and generate a shock wave that is sufficiently strong to knock a
contaminant off of the workpiece.” App. Br. 8.
“A reference is reasonably pertinent if, even though it may be in a different
field from that of the inventor’s endeavor, it is one which, because of the matter
with which it deals, logically would have commended itself to an inventor’s
attention in considering his problem.” In re Clay, 966 F.2d 656, 659 (Fed. Cir.
1992). In other words, “familiar items may have obvious uses beyond their
primary purposes.” KSRInt’l Co. v. Teleflex, Inc., 550 U.S. 398, 402 (2007).
Based on the record before us, we are not persuaded that the transducer of Puskas
would have commended itself for use in causing cancer cells to implode.
Moreover, the combination of Drewes and Kline lacks a rationale for using
resonant sweeping frequency of the properties required by claim 24 for treating
cancer cells, let alone for causing a cancer cell to act as a cavitation nuclei.
Furthermore, there is no evidence in this record to suggest optimizing the cancer
cell treatment method of either Drewes or Kline with the specific capabilities of the
device of Puskas.
Appellant has, therefore, persuasively argued the Examiner’s obviousness
determination is based on improper hindsight reasoning. Because we determine
the facts and reasons relied upon by the Examiner are insufficient to support the
rejection of claim 24, and because the Examiner’s rejection of dependent claim 25
is based on the same reasons for combining the cited art, the Examiner’s decision
to reject claims 24 and 25 is:
REVERSED
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