Ex Parte Dzekunov

Patent Trial and Appeal Board

Nov 25, 2016

13147165 (P.T.A.B. Nov. 25, 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
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/147,165 12/14/2011 Sergey Dzekunov MAXC.P0032US/11107561 1317
32425 7590 11/29/2016
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
EXAMINER
LONG, SCOTT
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
11/29/2016 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):
aoipdocket @ nortonrosefulbright .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SERGEY DZEKUNOV
Appeal 2014-007261
Application 13/147,1651
Technology Center 1600
Before TONI R. SCHEINER, DONALD E. ADAMS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to electroporation methods. The
Examiner rejected the claims under 35 U.S.C. § 102 and § 103(a). We have
jurisdiction under 35 U.S.C. § 134. The Examiner’s decision is affirmed.
STATEMENT OF THE CASE
The claims in this appeal are directed to a method of electroporation.
The Application explains that electroporation is a process of using an
electrical field to load living cells, cell particles, or lipid vesicles, with
extracellular material. ’165 Application 13.
1 “The ’165 Application.” The real party in interest is listed in the Appeal
Brief as Maxcyte, Inc. Appeal Br. 1.
Appeal 2014-007261
Application 13/147,165
Appellant appeals from the Examiner’s final rejection of claims 1—9
and 11. The claims stand finally rejected by the Examiner as follows:
1. Claims 1, 2, 6, 7, 9, and 11 under 35 U.S.C. § 102(b) (pre-AIA) as
anticipated by Hui and Li (In Vitro and Ex Vivo Gene Delivery to Cells by
Electroporation, 37 Methods in Molecular Medicine 157-171 (2000))
(“Hui”). FinalRej.3
2. Claims 2—5 and 8 under 35 U.S.C. § 103(a) (pre-AIA) as obvious
in view of Hui. Final Rej. 6.
Claim 1, the only independent claim on appeal, is reproduced below:
1. An electroporation method comprising:
(a) determining electroporation parameters such that
during an electrical pulse a first time constant representative of
electrical conductivity increase in electroporation medium (ti)
during the pulse is not less than a second time constant
representative of capacitor discharge (t?), wherein the pulse
duration is less than either ti or t2; and
(b) applying one or more electrical pulses under the
electroporation parameters to a sample to be electroporated.
CLAIM INTERPRETATION
The anticipation rejection in this appeal turns on the interpretation of
claim 1. Consequently, we begin with claim interpretation. During patent
examination:
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.
In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
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Application 13/147,165
Claim 1 recites two steps. In the first step (a), “electroporation
parameters” are determined. In the second step (b), electrical pulses are
applied to a sample “under the electroporation parameters.”
Step (a) has a “determining” step of the electroporation parameters.
We interpret “determining” to mean that a parameter is ascertained. This
interpretation is consistent with the written description of the ’165
Application which discloses that the “dimension of the electroporation
chambers will be considered in determining the parameter for optimal
electroporation.” ’165 Application 1119. In other words, the “determining”
step can merely be selecting a component of the process that possesses a
value that constitutes a parameter of the electroporation method.
Claim 2, which depends from claim 1, further recites “wherein the
electroporation parameters comprise buffer conductivity, power supply
capacitance, electroporation chamber geometry, and electric field strength.”
Thus, selecting a buffer, a power supply, and an electroporation chamber to
be used in the electroporation method is “determining” electroporation
parameters.
The claim requires that the electroporation parameters are determined
“such that during an electrical pulse” [ 1 ] a first time constant is not less than
a second time constant; and [2] the pulse duration is less than the first time
constant or the second time constant.
We interpret that phrase “such that”2 to indicate that, as a result of
“determining electroporation parameters,” conditions [1] and [2] are met.
2 Definition 2 (attached) from
http ://www.macmillandictionary. com/us/dictionary/american/ such.
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Application 13/147,165
The Application discloses equations for calculating the recited time
constants. Appeal Br. 1 (citing ’165 Application || 75, 81.) However, we
do not interpret the claim to require that the time constants be calculated by
such equations, or even ascertained, because there is no active step recited in
the claim that would require it. The claim does not recite an equation or
algorithm that must be performed to calculate the time constants for the
electroporation parameters. The only requirement of the claim is that, when
the parameters are determined, conditions [1] and [2] must be met.
The claim also does not require recognition that conditions [1] and [2]
have been met when the pulse is applied in step (b) under the electroporation
parameters of step (a). The “such that” language in the claim indicates that
as result of determining the parameters conditions [1] and [2] are met, but
the language does not dictate that it would have been recognized.
In sum, we discern no language in the claim that would require the
time constants to be calculated, ascertained, or even explicitly recognized by
the skilled worker when carrying out the electroporation method.
ANTICIPATION REJECTION
The Examiner found that Hui describes an electroporation process in
which electroporation parameters are optimized in order to improve the
efficiency of transfecting DNA into cells. Final Rej. 4—5. Hui recognized
that field strength E (at p. 159 (3); p. 160,11. 7—9, 21—23; paragraph spanning
pp. 160-161; p. 161; p. 167: “Since the transfection efficiency is
proportional to ET, there is a choice of optimizing either E or 7”) and
capacitance (p. 163: “Many electroporation protocols give electric
parameters in terms of voltage and capacitor value”) are electroporation
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Application 13/147,165
parameters, both of which are expressly recited in dependent claim 2. See
Final Rej. 5.
The Examiner found that Hui provided an example in which the field
strength E was 0.5—2kV/cm and the pulse time was T=0.14 milliseconds
(Hui, p. 163, Fig. 2 legend). Final Rej. 3, 5. See also Hui, p. 162, Fig. 1.
Since these values fall within the ranges recited in dependent claims 6 and 7,
the Examiner found that Hui anticipated the claims. Final Rej. 3—4, 5.
Appellant contends that Hui does not anticipate the claims because
Hui does not disclose the first and second time constants recited in claim 1.
Appeal Br. 3^4. Appellant states that “[wjhile Hui may disclose altering
electroporation parameters, it does not disclose determining electroporation
parameters in the way described by claim 1, nor does it suggest such a
determination.” Id. at 4—5. Appellant contends that the phrase “such that”
means that the time constants must be determined to meet all the claim
requirements. Reply Br. 1, 3^4.
Appellant’s argument does not persuade us that the Examiner erred.
While we agree with Appellant that the time constants [1] and pulse duration
[2] must be met in order for the claim to be anticipated, Appellant did not
provide sufficient support for the position that Hui must explicitly disclose
the time constants to anticipate the claim. Id. at 3. We have not been
directed to language in the claim that would require the time constants to be
calculated or ascertained when the claimed process is accomplished. As
explained in the Claim Interpretation section, we interpreted the claim to
require that the time constants must be met under the specific parameters
utilized during electroporation. However, based on the plain language of the
claim, we did not interpret the claim to require recognition by the person
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Application 13/147,165
carrying out the recited method that the time constant conditions were
achieved. The issue is whether the Examiner met the burden of providing a
sound basis for believing that Hui’s parameters met the conditions of claim
1.
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). When the limitations of a
claim are not expressly described in the prior art, the PTO must show “sound
basis for believing” that despite the failure of the prior art to describe them,
the limitations are inherently there and “the products of the applicant and the
prior art are the same.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
In this case, as discussed above, the Examiner established that Hui
disclosed electrical fields and pulse times that meet the corresponding
parameter values in claims 6 and 7. Final Rej. 3—4, 5. The parameters are
determined “such that during an electrical pulse” [1] a first time constant is
not less than a second time constant; and [2] the pulse duration is less than
the first time constant or the second time constant. Because the claimed
electric field parameter is met by Hui, it is logical that the time constants
would also be met because the parameters appear to determine the time
constants. Under such disclosed electric field parameter and utilizing a
pulse time of claim 7, it would also be logical that the time constants are met
for the same reason. Thus, the Examiner had a sound basis for believing that
Hui inherently utilized the time constant conditions recited in claim. Spada,
911 F.2d at 708; Schreiber, 128 F.3d at 1477. When such circumstances are
met, the burden shifts to applicant to show that the limitations are not met by
the prior art. Id.
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Appellant did not provide persuasive argument or rebuttal evidence
that the Examiner’s fact-based determination was in error. Appellant argues
that the Examiner has not pointed to any disclosure in Hui where such a
relationship between time constants is taught. Appeal Br. 4; Reply Br. 3^4.
However, Appellant failed to acknowledge that anticipation can be found
when a process “inherently” meets a claim limitation (Schreiber, 128 F.3d at
1477), namely, when the recited limitation is a necessary result of carrying
out the process.
Appellant states that “is entirely possible that one of ordinary skill in
the art practicing Hui could apply a pulse to a sample for the allegedly
anticipatory duration (i.e., 140 microseconds) while the allegedly
anticipatory duration is greater than ti or t2.” Appeal Br. 5.
Appellant did not provide factual support for this statement. It is
well-established that an argument made by counsel in a brief does not
substitute for evidence lacking in the record. Estee Lauder, Inc. v. L ’Oreal,
S.A., 129 F.3d 588, 595 (Fed. Cir. 1997).
Because Hui carries out electroporation and describes parameters and
pulse times that fall within the scope of the claims, the Examiner reasonably
shifted the burden on Appellant to show that Hui’s operating conditions did
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not utilize the time constant conditions recited in the claim. As held in In re
Best, 562 F.2d 1252, 1255 (CCPA 1977) (footnote omitted).
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
. . . Whether the rejection is based on “inherency” under 35
U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C.
§ 103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO’s inability to
manufacture products or to obtain and compare prior art
products.
As Appellant did not meet the burden, we affirm the rejection
of claim 1.
Claim 2
Appellant contends that “Hui does not disclose buffer conductivity,
power supply capacitance, and electroporation chamber geometry as
potential electroporation parameters - each of which is required by claim 2.”
Appeal Br. 6. The Examiner fully explained on pages 6—7 of the Answer
how each of these parameters are present in Hui. We adopt these findings.
As discussed in the Claim Interpretation section, merely selecting one of the
recited parameters to use in the electroporation process meets the claim
limitation. Consequently, the rejection of claim 2 is affirmed.
Claims 6, 7, 9, and 11
The Examiner identified disclosure in Hui that meets the limitations
recited in dependent claims 6, 7, 8, and 11. Final Rej. 3, 5; Ans. 6—8.
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Application 13/147,165
Appellant contends “the Office arbitrarily selects an electric field strength
and pulse duration from Hui without showing that the limitations of claims
6—7, 9, and 11, including the implicit limitations of claim 1, claim 2, and/or
claim 9, exist in a single embodiment.” Appeal Br. 6.
We do not agree.
Claim 6, depends from claim 2. Since Hui’s process satisfies all the
limitations of claim 2 (see above), carrying out the electroporation process
utilizing an electric field value that falls within the scope of claim 6 would
satisfy the claim without the need for any picking or choosing. The fact Hui
may disclose a list of possible values that may be utilized in the process is
not inconsistent with a finding that Hui is anticipatory to claim 6. A species
which is specifically disclosed in a prior art reference is anticipatory even
though it appears “without special emphasis in a longer list.” Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1376 (Fed. Cir. 2005). This same
reasoning applies to claims 7, 9, and 11, each which depend from claim 1.
The only claim that requires two different limitations is claim 11, but Hui
explicitly teaches cells (claim 9) and loading them with DNA (“a chemical
or biological agent” of claim 11). Hui 157, 160. Consequently, Appellant
did not demonstrate reversible error in the Examiner’s rejection.
OBVIOUSNESS REJECTION
The Examiner rejected claims 2—5 and 8 as obvious in view of Hui.
Final Rej. 6. The Examiner found that the parameters recited in these claims
were known optimizable variables. Id. at 7. The Examiner determined that
it would have been obvious to the ordinary skilled worker to “optimize
certain electroporation conditions related to buffer conductivity, power
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Application 13/147,165
supply capacitance, electroporation chamber geometry.” Id. at 8. The
Examiner stated optimization of ranges is prima facie obvious. Id.
Appellant contends that the portion of Hui cited by the Examiner
“never suggests optimizing each of buffer conductivity, power supply
capacitance, electroporation chamber geometry, and electric field strength
for the purpose of achieving the limitations described in claim 1.” Appeal
Br. 7.
The claim does not require “optimizing” the parameters as asserted by
Appellant. The claim limitations are satisfied if the parameters recited in the
claim are met by Hui, or would have been obvious to one of ordinary skill in
the art based on Hui’s teachings. The Examiner explained how buffer
conductivity (claim 3), capacitance (claim 4), chamber dimensions (claim 5),
and pulse duration (claim 8) would either be inherent or optimizable based
on explicit teachings in Hui. Ans. 9—12. We adopt the Examiner’s findings
and reasoning. Id. We also agree with the Examiner that Appellant has the
burden to show that the ranges recited in the claims are “critical” to the
claimed process, rather than simply being a range routinely selected by
following Hui’s teachings.
The law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims. These cases have consistently held
that in such a situation, the applicant must show that the
particular range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior
art range.
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). (Internal citations
omitted.)
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In reaching the determination that claims 3, 4, 5, and 8 would have
been obvious to one of ordinary skill in the art, we have not ignored the time
constant requirement of claim 1. However, because the Examiner had sound
basis for believing the time constants are met (Final Rej. 3), Appellant has
the burden of showing that the Examiner erred. This was discussed in the
anticipation rejection. Appellant has not provided adequate fact-based
evidence that such time constants would not be achieved when following
Hui’s teachings.
SUMMARY
The anticipation rejection of claims 1, 2, 6, 7, 9, and 11 is affirmed.
The obviousness rejection of claims 2—5 is affirmed.
To the extent any of the claims were not separately argued, they fall
with claims 1 and 2. 37 C.F.R. § 41.37(c)(l)(iv).
TIME PERIOD
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
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