Medtronic Ablation Frontiers LLC

Patent Trials and Appeals Board

Oct 27, 2021

2020005800 (P.T.A.B. Oct. 27, 2021)

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.
14/930,048 11/02/2015 Mark T. STEWART P0040580.USC5(21819B-325C 1061
89554 7590 10/27/2021
Christopher & Weisberg, P.A.
1232 N. University Drive
Plantation, FL 33322
EXAMINER
VAHDAT, KHADIJEH A
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
10/27/2021 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):
docketing@cpaglobal.com
ptomail@cwiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARK T. STEWART and JORDON D. HONECK
____________

Appeal 2020-005800
Application 14/930,048
Technology Center 3700
____________

Before JEFFREY N. FREDMAN, DANIEL S. SONG, and
EDWARD A. BROWN, Administrative Patent Judges.

BROWN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks review under 35 U.S.C. § 134(a) of the Examiner’s
decision rejecting claims 1, 3–6, 8, 9, 13, and 14.2 We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Medtronic Ablation Frontiers LLC as
the real party in interest. Appeal Br. 1.
2 Claims 2 and 7 are cancelled, and claims 10–12 and 15–20 are withdrawn
from consideration. Final Act. 1 (Office Action Summary); Appeal Br. 9–10
(Claims App.).
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CLAIMED SUBJECT MATTER
“The present disclosure relates to medical systems and methods of use
thereof for treating tissue, and more particularly, towards the treatment of
cardiac tissue using high voltage energy delivery for irreversible
electroporation (IEP) ablation.” Spec. ¶ 3.
Claims 1 and 8 are independent. Claim 1 illustrates the claimed
subject matter, as follows:
1. An electrosurgical system, comprising:
a treatment energy source being configured to:
deliver at least one train of 10 to 60 biphasic
electroporation pulses, each of the at least one train of 10
to 60 biphasic electroporation pulses lasting at most
approximately 50 milliseconds, each of the 10 to 60
biphasic electroporation pulses of each of the at least one
train of 10 to 60 biphasic electroporation pulses having a
pulse width of between 3 μs and 5 μs, and delivery of the
electroporation energy at an output voltage that is
between 800 and 2000 volts.
Appeal Br. 9 (Claims App.).

REJECTION
Claims 1, 3–6, 8, 9, 13, and 14 are rejected under 35 U.S.C. § 103 as
being unpatentable over Francischelli (US 2010/0023004 A1, pub. Jan. 28
2010) and Swanson (US 2012/0310237 A1, pub. Dec. 6, 2012).

ANALYSIS
In rejecting claims 1 and 8, the Examiner finds that Francischelli
discloses an electrosurgical system comprising a treatment energy source
(pulse generator 22, pulse generator 22’) “configured to” meet all limitations
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except “delivery [of] the electroporation energy at an output voltage that is
between 800 and 2000 volts.” Final Act. 3–4, 7–8 (citing Francischelli
¶¶ 29, 31, 60, Fig. 4). As for the limitation “each of the 10 to 60 biphasic
electroporation pulses of each of the at least one train of 10 to 60 biphasic
electroporation pulses having a pulse width of between 3 μs and 5 μs,” the
Examiner finds that Francischelli discloses that “‘the pulse generator 22’ is
capable of delivering a wide range of burst pulses (e.g., minimum pulse
width of 1 [µ]s and inter-pulse interval of 10 [µ]s both in monophasic and
biphasic modes.’” Id. at 3, 7–8 (citing Francischelli ¶ 29) (emphasis added).
The Examiner determines that this “capability” shows that pulse generator
22’ is “configured to” deliver biphasic electroporation pulses having a pulse
width in the claimed range. Id. at 3–4, 8 (“3–5 μs lies between the prior art
range of above 1 μs ‘minimum pulse width of 1 [µ]s’; therefore, the power
source is configured to deliver the claimed range”).
Additionally, the Examiner acknowledges that Francischelli is
directed to delivering pulses having a higher pulse width range than claimed
(e.g., “a pulse width in the range of 50–200 microseconds”), but submits that
a prima facie case of obviousness exists because Francischelli teaches a
broad pulse width range that overlaps the claimed range. Final Act. 3 (citing
In re Wertheim, 541 F.2d 257 (CCPA 1976); Manual of Patent Examining
Procedure (“MPEP”) § 2144.05(I)); Ans. 5. The Examiner concludes that it
would have been obvious to one of ordinary skill in the art to set
Francischelli’s pulse generator to deliver each of the at least one train of 10
to 60 biphasic electroporation pulses as having a pulse width of between 3
μs and 5 μs “for a specific treatment.” Final Act. 3–4; Ans. 5. The
Examiner states, “where the general conditions of a claim are disclosed in
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the prior art, discovering the optimum or workable ranges involves only
routine skill in the art.” Final Act. 4 (citing In re Aller, 220 F.2d 454 (CCPA
1955)).
Appellant contests the rejection of claims 1 and 8 for several reasons.
First, Appellant contends that Francischelli generally discloses that a wide
range of pulse widths may be used, but provides no additional guidance as to
which pulse width to use. Appeal Br. 5 (citing Francischelli ¶¶ 29, 31, 60).
Claim 1 recites, in pertinent part, “a treatment energy source being
configured to . . . deliver . . . each of the 10 to 60 biphasic electroporation
pulses of each of the at least one train of 10 to 60 biphasic electroporation
pulses having a pulse width of between 3 μs and 5 μs.” Appeal Br. 9
(Claims App.) (emphasis added). Claim 8 recites similar language. Id. at
10. We construe the phrase “configured to” in claims 1 and 8 to mean that
the treatment energy source is programmed to deliver the biphasic
electroporation pulses having the recited pulse width. This construction is
consistent with the Specification. For example, the Specification describes
that “the treatment energy source may be programmed to deliver a series of
pulse trains . . . .” See Spec. ¶ 40. The Specification also describes that “the
treatment energy source 54 may include one or more controllers, processors,
and/or software modules containing instructions or algorithms to provide for
the automated operation and performance of the features, sequences,
calculations, or procedures described herein.” See id. ¶ 41. When functional
language is associated with programming or some other structure required to
perform the function, that programming or structure must be present in the
prior art in order to meet the claim limitation. Typhoon Touch Techs., Inc. v.
Dell, Inc., 659 F.3d 1376, 1380 (Fed. Cir. 2011); see also Ultramercial, LLC
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v. Hulu, LLC, 657 F.3d 1323, 1328–29 (Fed. Cir. 2011) (“Programming
creates a new machine, because a general purpose computer in effect
becomes a special purpose computer once it is programmed to perform
particular functions pursuant to instructions from program software.”)). The
Examiner has not shown by a preponderance of the evidence that the pulse
generator of Francischelli would have the programming or structure needed
to meet the claim limitation. Moreover, even if Francischelli’s pulse
generator could be modified to perform the claimed function, this still fails
to satisfy the “configured to” language, which requires that the prior art
structure perform the function recited.
The Examiner relies on Swanson as teaching the output voltage
limitation. Final Act. 4 (citing Swanson ¶¶ 12–15, 67). As such, the
Examiner’s application of Swanson does not cure the above-discussed
deficiency in Francischelli. Accordingly, the Examiner has not established a
prima facie case of obviousness for claims 1 and 8.
Second, Appellant contends that the rejection should be reversed
because it “has shown unexpected results when delivering biphasic
electroporation pulses with the narrow pulse width of between 3 μs and 5
μs.” Appeal Br. 2. Appellant submits that “it would not have been obvious
to select the narrow range of pulse widths from the broader range contained
in the cited references.” Id. at 2–3. Appellant points out that a prima facie
case of obviousness based on overlapping ranges can be rebutted by showing
the criticality of the claimed range. Id. at 3 (citing MPEP § 716.02).
Particularly, “the ‘[A]pplicant must show that the particular range is critical,
generally by showing that the claimed range achieves unexpected results
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relative to the prior art range.’” Id. (citing Iron Grip Barbell Co., Inc. v.
USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004)).
In support of its position, Appellant provides a Declaration Under
37 C.F.R. § 1.132 of Mark T. Stewart (hereinafter, “Stewart Declaration” or
“Decl.”).3 Appeal Br. 3. Appellant points out that Mr. Stewart is a named
inventor in both the present application and Francischelli. Reply Br. 3.
Appellant asserts that “there are an infinite number of possibilities and
combinations of different parameters that can be used to deliver biphasic
electroporation pulses to cells regardless of the orientation of the cells,” and
that “[t]hese parameters include looking at different numbers of pulses,
different time periods for the delivery of a train of biphasic electroporation
pulses, varying pulse widths, and different output voltages to determine how
these variables would affect achieving irreversible electroporation of cells
regardless of the orientation of cells.” Appeal Br. 4 (citing Decl. ¶¶ 7–9).
Appellant states, “[d]uring the course of research and development, it was
unexpectedly found that the critical parameter in achieving uniform
irreversible electroporation of cells, regardless of the orientation of the cells,
was the use of a short pulse width of between three (3) μs and five (5) μs.”
Id. (citing Decl. ¶ 9).
Appellant submits that “[p]rior to this research, it was believed that
short pulse widths of less than five (5) μs would not be effective in
producing irreversible electroporation in tissue unless much higher electric
field gradients were used.” Id. (citing Decl. ¶ 10; Eliel Ben-David et al.,
“Characterization of Irreversible Electroporation Ablation in In Vivo

3 As noted by Appellant, the Stewart Declaration was made of record in the
present application on September 13, 2019. Appeal Br. 3.
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Porcine Liver,” 198 Am. J. Roentgenology 1–16 (Jan. 2012)). Appellant
states, “in the prior art, it was observed that pulse widths of 20 μs were less
effective than pulse widths of 50 μs or a greater pulse width in producing
irreversible electroporation in tissue.” Id. As for Francischelli, Appellant
contends that “when the research was conducted that formed the basis for
making the statements in ¶¶ [0029], [0060], and [0031] of [Francischelli] . . .
it was believed that short pulse widths of less than 5 μs would not be
effective in producing irreversible electroporation in tissue unless
substantially higher pulsed voltage gradients were to be applied.” Id. at 4–5
(citing Decl. ¶ 11).
Appellant contends that during research it was found that using a
pulse width of more than 5 μs to achieve irreversible electroporation of cells,
regardless of cell orientation, causes: (1) an increase in bubble formation
(Appeal Br. 5 (citing Decl. ¶ 12–14, Fig. 1)), and (2) spasms and T-wave
elevation when used near coronary arteries (id. (citing Decl. ¶ 15–16, Fig.
2)). Appellant submits that a skilled artisan would not have expected the
recited narrow pulse width range could achieve irreversible electroporation
of cells regardless of their orientation. Id. at 6.
In response, the Examiner states:
Although in the affidavit, applicant points to unexpected
results regarding the pulse width and discovered that a very
narrow range of [3 µs to 5 µs] would be sufficient to
irreversible electroporation of cardiac cells regardless of the cell
orientation, the disclosure and specification give a preferred
range and not a critical range.
Ans. 3 (emphasis added).
Appellant’s position is persuasive. We agree that the Examiner seems
to concede that the Stewart Declaration provides evidence of unexpected
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results associated with the recited pulse width of 3 to 5 microseconds. Reply
Br. 2; see Ans. 3. We also agree with Appellant that the Specification is not
required to use the term “critical.” Reply Br. 3. Appellant submits that the
facts shown in the Stewart Declaration support that a person skilled in the art
would understand that the recited range was “critical.” Reply Br. 3 (citing
Clear Value, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340 (Fed. Cir.
2012)).
To demonstrate unexpected results, an Appellant must present
objective evidence (i.e., comparative test results) to show that the results are
unexpected as compared to the closest prior art. See In re Baxter Travenol
Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). See also In re Wood, 582 F.2d
638, 642 (CCPA 1978) (objective evidence is needed to establish
unexpected results). The showing of unexpected results must also be
commensurate in scope with the claims. See In re Grasselli, 713 F.2d 731,
743 (Fed. Cir. 1983). Here, Appellant has provided objective evidence to
show how the use of values falling within the recited pulse width compares
to using higher values. For example, as shown in Figure 1 in the Stewart
Declaration, pulse widths of 3 μs, 4 μs, 5 μs, and 7 μs were used in
combination with an applied voltage range of 1300–1500 volts. See Decl.
¶ 13, Fig. 1. As explained by Mr. Stewart:
A dramatic rise in bubble formation was observed to
occur at above a five (5) microsecond pulse width. See FIG. 1.
At three (3) or four (4) microsecond pulse widths, the
microbubble volumes were all less than half a microliter. See
FIG. 1. At a five (5) microsecond pulse width, the gas volume
rose to over one microliter. See FIG. 1. When the pulse width
was increased to seven (7) microseconds, the bubble volume
dramatically increased to well over ten (10) microliters, which
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would appear as a “bubble storm” when viewed using an
intracardiac echo. See FIG. 1.
See id. ¶ 14, Fig. 1. We agree that this result is consistent with Appellant’s
position.
We have considered all of the evidence presented by Appellant
against obviousness and weighed all the evidence anew. We conclude that
the evidence against obviousness outweighs the evidence for it. See In re
Fenton, 451 F.2d 640, 643 (CCPA 1971) (the court balanced the Patent
Office’s case against the strength of Appellant’s objective evidence of non-
obviousness). Thus, we do not sustain the rejection of claims 1 and 8, and
claims 3–6, 9, 13, 14 depending therefrom, as unpatentable over
Francischelli and Swanson.

CONCLUSION
We reverse the Examiner’s rejection.

DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–6, 8, 9,
13, 14
103(a) Francischelli,
Swanson
1, 3–6, 8, 9,
13, 14

REVERSED