Manfred Franke et al.

Patent Trials and Appeals Board

Sep 16, 2019

14597131 - (D) (P.T.A.B. Sep. 16, 2019)

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.
14/597,131 01/14/2015 Manfred Franke 279.L56US1 8680
45458 7590 09/16/2019
SCHWEGMAN LUNDBERG & WOESSNER/BSC
PO BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
WU, TONG E
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
09/16/2019 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):
SLW@blackhillsip.com
uspto@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MANFRED FRANKE, BRYAN ALLEN CLARK,
AIDEN FLANAGAN, JUAN GABRIEL HINCAPIE ORDONEZ,
and DAVID J. TERNES
____________

Appeal 2018-0089451
Application 14/597,1312
Technology Center 3700
____________

Before HUBERT C. LORIN, NINA L. MEDLOCK, and
MATTHEW S. MEYERS, Administrative Patent Judges.

MEDLOCK, Administrative Patent Judge.

DECISION ON APPEAL

1 Our decision references Appellants’ Appeal Brief (“App. Br.,” filed
March 16, 2018) and Reply Brief (“Reply Br.,” filed September 17, 2018),
and the Examiner’s Answer (“Ans.,” mailed July 17, 2018) and Final Office
Action (“Final Act.,” mailed August 23, 2017).
2 Appellants identify Cardiac Pacemakers, Inc. as the real party in interest.
App. Br. 2.
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STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1–4, 8, 10–13, 16, 17, and 19–21.3 We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
CLAIMED INVENTION
Appellants’ claimed invention “relates generally to medical devices,
and more particularly, to systems, devices and methods for delivering
pulmonary therapies using a synaptic junction block” (Spec. ¶ 3).
Claims 1, 16, and 20 are the independent claims on appeal. Claim 1,
reproduced below with bracketed notations and indentation added, is
illustrative of the claimed subject matter:
1. A system for delivering depletion block stimulation to a
neural target that innervates airways using an implantable
electrode near the neural target where the depletion block
stimulation at a measurable activation threshold (AT) begins to
increase nerve activity with increasing current amplitude and the
depletion block stimulation at a measurable saturation threshold
is where all or nearly all nerve fibers propagate action potentials
such that nerve activity does not significantly increase in
response to further increases in current amplitude, the system
comprising:
[(1)] the electrode which is configured to be implanted
near the neural target that innervates airways; and
[(2)] a pulse generation system configured to be operably
connected to the electrode and programmed to deliver through
the electrode

3 Claims 5–7, 9, and 18 are withdrawn. Final Act. 1. Claims 14 and 15 are
canceled. App. Br. 28 (Claims Appendix).
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[(2.f)] a full depletion block stimulation where a
current amplitude is at or above the saturation threshold
followed by
[(2.p)] a partial depletion block where a stimulation
intensity is reduced to a level below the saturation
threshold and above the activation threshold to alleviate
symptoms of pulmonary disease,
[(3)] the programmed pulse generation system and the
electrode configured to cooperate to
[(3.p)] capture only some of the axons in the neural
target when the partial depletion block is delivered to
cause those captured axons to propagate action potentials
and to
[(3.f)] capture all or almost all of the axons in the
neural target when the full depletion block stimulation is
delivered to cause those captured axons to propagate
action potentials
[(4)] wherein both the full depletion block stimulation
and the partial depletion block stimulation include a series of
pulses within a depletion frequency range between about 100 Hz
to about 1 kHz such that the series of pulses generate action
potentials in the captured axons but block communication across
synaptic clefts.
REJECTIONS
Claims 1–4, 8, 10–13, 16, 17, and 19–21 are rejected under 35 U.S.C.
§ 112(a) as failing to comply with the written description requirement.
Claims 1, 16, 20, and 21 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Boveja et al. (US 2005/0216070 A1, pub. Sept. 29, 2005)
(“Boveja”) and Kilgore et al. (US 2004/0127953 A1, pub. July 1, 2004)
(“Kilgore”).
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Claims 2–4, 8, 17, and 19 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Boveja, Kilgore, and Rezai (US 2009/0155336 A1,
pub. June 18, 2009).
Claims 10 and 11 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Boveja, Kilgore, and Shuros (US 2010/0228310 A1,
pub. Sept. 9, 2010).
Claims 10 and 12 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Boveja, Kilgore, and Swoyer et al. (US 2010/0217347 A1,
pub. Aug. 26, 2010).
Claim 13 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Boveja, Kilgore, and Parnis et al. (US 2007/0027496 A1, pub. Feb. 1, 2007).
Claims 1, 16, and 20 are provisionally rejected on the ground of non-
statutory obviousness-type double patenting as unpatentable over
Hlavka et al. (US 8,483,831 B1, iss. July 9, 2013) (“Hlavka”) and claims 1
and 15 of co-pending application Serial No. 14/597,145.4
Claims 1, 16, and 20 are provisionally rejected on the ground of non-
statutory obviousness-type double patenting as unpatentable over Hlavka
and claims 1, 9, and 13 of co-pending application Serial No. 14/597,137.5
ANALYSIS
Written Description
Whether a Specification complies with the written description
requirement of 35 U.S.C. § 112, first paragraph (now 35 U.S.C. § 112(a)), is

4 Application Serial No. 14/597,145 has issued as U.S. Patent
No. 10,413,731.
5 Application Serial No. 14/597,137 has issued as U.S. Patent
No. 10,201,709.
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a question of fact and is assessed on a case-by-case basis. See, e.g., Purdue
Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (citing
Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)). The
disclosure, as originally filed, need not literally describe the claimed subject
matter (i.e., using the same terms or in haec verba) in order to satisfy the
written description requirement. But the Specification must convey with
reasonable clarity to those skilled in the art that, as of the filing date,
Appellants were in possession of the claimed invention. See id.
Independent Claims 1, 16, and 20 and Dependent claims 2–4, 8, 10–13, 17,
and 19
The Examiner maintains here that the Specification lacks written
description support for “a full depletion block . . . followed by a partial
depletion block,” as recited in independent claim 1, and similarly recited in
independent claims 16 and 20 (Final Act. 7–8; see also Ans. 3–8).6,7 We,
however, agree with Appellants that the Specification provides the requisite
written description support such that a person skilled in the art would
understand that Appellants were in possession of the claimed invention,
including the requirement that a full depletion block stimulation be followed
by a partial depletion block, at the time the application was filed (see App.
Br. 14–16 (discussing paragraph 73 of the Specification)).

6 Each of claims 16 and 20 recites “delivering a partial depletion block
stimulation after delivering the full depletion block.” App. Br. 28, 29
(emphasis added).
7 The question of whether changing the word “matters” to “parameters” in
paragraph 73 constitutes new matter (Ans. 4–5; Reply Br. 3) is not before us
on appeal.
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Paragraph 73 describes that “a full or partial depletion block of a
nerve [is provided] . . . by finding a saturation threshold (ST) of nerves
driving muscle using force and/or EMG, and [that] the nerves may be
depolarized using about a 200 Hz frequency or higher frequency at 100% to
200% of the ST.” Paragraph 73 discloses that “[f]or a full block, the
depletion signal may be kept at 100% to 200% of the ST and at 200 Hz” and
that “[f]or a partial block, the depletion signal may continue to be delivered
at 200 Hz but the intensity of the stimulation may be reduced to 10 to 90%
of ST” (emphasis added). A person of ordinary skill in the art would
understand that the words “continue” and “reduced” refer back to the
previously-mentioned signal by which “the nerves may be depolarized using
about a 200 Hz frequency or higher frequency at 100% to 200% of the ST,”
i.e., a full block. In other words, a person of ordinary skill in the art would
understand from paragraph 73 that the process of providing a partial block
begins by providing a full block, i.e., that “a full depletion block . . . [is]
followed by a partial depletion block,” as called for in independent claims 1,
16, and 20.
Therefore, we do not sustain the Examiner’s rejection of claims 1–4,
8, 10–13, 16, 17, 19, and 20 under 35 U.S.C. § 112(a), as failing to comply
with the written description requirement.
Dependent Claim 21
The Examiner further maintains that the Specification lacks adequate
written description support for “wherein the full depletion block is delivered
for less than one second before delivering the partial depletion block,” as
recited in claim 21 (Final Act. 8; see also Ans. 8).
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Appellants assert that the Specification provides the requisite written
description support in paragraphs 50–56, 61, 73, and Table 2 (App. Br. 17–
18; Reply Br. 11). We, however, agree with the Examiner that although the
Specification discloses that a 90% depletion block may be obtained in less
than one second (e.g., a mean time of 0.53 seconds for a 200 Hz signal, as
shown in Table 2), there is nothing in the cited portions of the Specification,
including the highlighted portion of paragraph 61 to which Appellants refer
(see App. Br. 17), that describes switching from a full depletion block to a
partial depletion block within any particular timeframe, such as immediately
after the mean time to a 90% block has elapsed. Rather than disclosing
switching to a partial block within a one-second timeframe, paragraph 61
merely discloses that a 90% depletion may be achieved in less than one
second; there is no discussion of switching to a partial block. And, although
we agree with Appellants that paragraph 73 broadly describes that a partial
block may occur at some time after a full block, we see no disclosure in
paragraph 73 of any particular timeframe for switching from a full block to a
partial block.
We are not persuaded for the reasons set forth above that the
Examiner erred in rejecting claim 21 under 35 U.S.C. § 112(a). Therefore,
we sustain the Examiner’s rejection.
Obviousness
Although the parties address independent claims 1, 16, and 20
together, we reach different conclusions as to the system and method claims.
Independent Claim 1 and Dependent Claims 2–4, 8, and 10–13
Claim 1 is directed to a system for delivering depletion block
stimulation to a neural target, and recites that the system comprises, inter
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alia, “a pulse generation system configured to be operably connected to the
electrode and programmed to deliver through the electrode a full depletion
block stimulation where a current amplitude is at or above the saturation
threshold followed by a partial depletion block.”
In rejecting claim 1 under 35 U.S.C. § 103(a), the Examiner found
that Boveja discloses substantially all of the limitations of claim 1 except the
Examiner acknowledged that Boveja does not explicitly disclose
“configuring current amplitude for full or partial block” (Final Act. 10). The
Examiner cited Kilgore to cure the deficiency of Boveja (id. (finding that
Kilgore teaches nerve blocking “wherein full or partial block can be
selectively achieved by modifying stimulus amplitude” at paragraphs 32–
39)). And the Examiner concluded that it would have been obvious to a
person of ordinary skill in the art at the time of Appellants’ invention to
“modify Boveja as taught by Kilgore to include configuring for full or
partial block as recited, in order to selectively block the neural target” (id.).
The Examiner conceded that Boveja and Kilgore “do not explicitly
disclose a pulse generation system programmed to specifically deliver a
combination of full depletion block followed by partial depletion block”
(id.). The Examiner, nonetheless, found that “the modified system of Boveja
and Kilgore is capable of being programmed to deliver full and/or partial
depletion block therapies as needed” (id.). Citing In re Burhans, 154 F.2d
690 (CCPA 1946), the Examiner, thus, reasoned that “[s]election of any
order of performing process steps is prima facie obvious in the absence of
new or unexpected results” (id.).
The law is well settled that where, as here, a claim recites that an
element is “configured to” perform a particular function, the specific
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element in the prior art, on which the Examiner relies, to disclose the
claimed element, must be not only capable of performing the claimed
function but must also be designed specifically to accomplish the function
claimed. See Aspex Eyewear, Inc. v. Marchan Eyewear, Inc., 672 F.3d.
1335, 1349 (Fed. Cir. 2012) (The court indicated that claim language
“configured to” is construed more narrowly than “capable of,” and held that
where claim language is construed consistent with “configured to,” the claim
language requires that the structure must be “designed or configured to
accomplish the specified objective, not simply that [it] can be made to serve
that purpose.”).
The Examiner determined here, as described above, that the modified
system of Boveja and Kilgore is capable of being programmed to deliver full
and/or partial depletion block therapies as needed. However, as Appellants
observe, and we agree, “‘capable of being programmed’ does not indicate
that a system is in fact programmed” (App. Br. 20), i.e. designed or
configured, to deliver full and partial depletion block therapies sequentially,
as claimed. The Examiner has not adequately established on the present
record that the combination of Boveja and Kilgore discloses a pulse
generating system that is designed to specifically deliver a full depletion
block followed by a partial depletion block, as opposed to a system that is
merely capable of being programmed to perform the required function.
Therefore, we do not sustain the Examiner’s rejection of claim 1
under 35 U.S.C. § 103(a). For the same reasons, we also do not sustain the
Examiner’s rejection of claims 2–4, 8, and 10–13, each of which ultimately
depends from claim 1. Cf. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir.
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1992) (“dependent claims are nonobvious if the independent claims from
which they depend are nonobvious”).
Independent Claims 16 and 20 and Dependent Claims 17 and 19
In rejecting the independent claims under 35 U.S.C. § 103(a), the
Examiner additionally observed that full and partial depletion block
therapies were known in the prior art, and the Examiner took the further
position that “one of ordinary skill in the art could have combined the
therapies sequentially as claimed with no change in their respective
functions, and the combination would have yielded nothing more than the
predictable results of [a] full block followed by [a] partial block” (Final
Act. 10). Therefore, according to the Examiner, it would have been obvious
at the time of Appellants’ invention “to modify Boveja and Kilgore to
include a combination of [a] full depletion block followed by [a] partial
depletion block as recited, in order to deliver full and/or partial block[s] as
needed” (id. at 11).
Paragraph 33 of Kilgore discloses:
Larger nerve fibers have a lower threshold for membrane
depolarization, and are therefore blocked at low stimulus
amplitudes. As a result, it is possible to block only the largest
nerve fibers in a whole nerve, while allowing conduction in the
smaller fibers. At higher stimulus amplitudes, all sizes of fibers
can be blocked completely.
Kilgore further discloses that it is possible to achieve a full block by
“gradually [increasing] the stimulus amplitude over time with each
successive pulse, until even the smallest nerve fibers are blocked” (Kilgore
¶ 39; see also id. (“The amplitude can be progressively increased until all
nerve fibers are blocked. This progressive increase can occur rather quickly,
probably within a few hundred milliseconds.”)). In other words, Kilgore
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discloses that a full block is achieved by starting with a partial block and
increasing the amplitude.
We agree with the Examiner that Burhans is applicable to Appellants’
method claims, and that the selection of any particular sequence of
performing process steps is prima facie obvious in the absence of new or
unexpected results. Appellants have the burden to establish unexpected
results. See In re Geisler, 116 F.3d 1465 1469–70 (Fed. Cir. 1997). In
doing so, Appellants must establish “(1) that there actually is a difference
between the results obtained through the claimed invention and those of the
prior art, . . . and (2) that the difference actually obtained would not have
been expected by one skilled in the art at the time of invention.” In re
Freeman, 474 F.2d 1318, 1324 (CCPA 1973) (citation omitted). See also In
re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (“It is well settled that
unexpected results must be established by factual evidence. Mere argument
or conclusory statements in the specification does not suffice.”); In re Baxter
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.”).
As discussed above, Kilgore discloses providing a partial block before
increasing amplitude to deliver a full block. On this record, we are not
persuaded that reversing the order disclosed in Kilgore, i.e., “delivering a
partial depletion block stimulation after delivering the full depletion block
stimulation” as set forth in claims 16 and 20, results in a patentable
distinction.
Citing paragraphs 56 and 73 of the Specification, Appellants assert
that “[t]he blocking effect may be quickly implemented by implementing a
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high frequency depletion block before transitioning into a lower energy
(e.g.[,] lower frequency) depletion block” (App. Br. 20). We have reviewed
the cited portions of the Specification and we find no discussion of any
unexpected result or benefit of performing a full block followed by a partial
block. We agree with the Examiner (Ans. 3) that the discussion of changing
the frequency of stimulation cited by Appellants is not germane to switching
from a full block to a partial block. As the Specification makes clear, the
controlling characteristic of the signal for determining whether a full block
or partial block is achieved is amplitude or pulse width, not frequency. See,
e.g., Spec. ¶ 58 (“The current amplitude and pulse width may be controlled
to select only larger fibers for the depletion block. For example, the current
amplitude and pulse width may be controlled to deplete the A fibers and not
the smaller fibers, or may be controlled with higher amplitudes and/or wider
pulse widths to deplete both A and B fibers.”); id. ¶ 59 (“the amplitude of
the depletion stimulation signal may be approximately 125% of the
saturation threshold of the fibers that are intended to be blocked.”).
Appellants further argue:
benefits may also include that, after quickly instituting the
depletion block as a full block, the depletion block can accurately
transition into a partial block using the intensity of the signal at
the saturated threshold as a benchmark. As evidenced on
page 152 of Manfred Franke’s thesis entitled “Translating
Electric KHFAC and DC Nerve Block from Research to
Application,” this may increase selectivity of the stimulation.

Id.8

8 A thesis entitled “Translating Electric KHFAC and DC Nerve Block from
Research to Application” by Manfred Franke (hereinafter “Franke thesis”)
was entered into the record on March 28, 2016.
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Responding to Appellants’ argument in the Answer, the Examiner
reproduces pages 152 and 24 of the Franke Thesis (Ans. 12–13). According
to the Examiner, the pertinent portion of page 152 “is not even about
depletion block” but rather “concerns Charge-Balanced DC block (CBDC)
and Kilohertz-Frequency Alternating Current block (KHF AC), which the
author recognizes as different from depletion block on Page 24 of the same
thesis” (id. at 12).
Page 152 of the Franke Thesis provides a bullet-point list of
“[p]otential applications for electric nerve block include in the future”
including, as reproduced below and on page 17 of the Reply Brief:
Increase of stimulation selectivity (e.g. fiber size) and specificity
(e.g. target location). Partial CBDC and KHFAC nerve block;
see [51] – starting KHFAC above block threshold, then lowering
it to e.g. 70% block, later increase without onset.
We do not see, and Appellants do not explain, how the above disclosure is
germane to “delivering a partial depletion block stimulation after delivering
the full depletion block,” as recited in independent claims 16 and 20. In
particular, we see no discussion of any “transition into a partial block,” as
argued. Appellants assert that “[t]his provides evidence that selectivity is a
reason why one would start with a full block and then progress to the partial
block” (Reply Br. 17). But, the cited portion of the Franke Thesis does not
state that starting with a full block and then progressing to a partial block
improves selectivity or specificity. Nor does the cited portion indicate any
unexpected result or benefit of “delivering a partial depletion block
stimulation after delivering the full depletion block.” At best, it indicates
that lowering the stimulation from some unspecified block level to “e.g.,
70% block” can be used with “later increase without onset.” It is unclear
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how this relates to the claimed subject matter. Accordingly, we find that
Appellants have not persuasively shown how the claimed order of steps
produces results that are unexpected compared with the closest prior art.
In view of the foregoing, we sustain the Examiner’s rejection of
claims 16 and 20 under 35 U.S.C. § 103(a). We also sustain the Examiner’s
rejection of dependent claims 17 and 19, which are not argued separately.
Dependent Claim 21
In rejecting dependent claim 21, the Examiner determined that “it
would have been obvious to one with ordinary skill in the art before the
effective filing date of the claimed invention to modify Boveja and Kilgore
to include a full depletion stimulation duration of less than one second, in
order to optimize the desired amount of therapy delivered to the patient”
(Final Act. 11 (citing In re Aller, 220 F.2d 454, 456 (CCPA 1955))).
Appellants argue, and we agree, that “the assertion that ‘less than one
second’ is only discovering an optimum or workable range by routine
experiment is improper as the rejection does not provide the required basis
for that conclusion” (App. Br. 22). We find no disclosure or suggestion in
Boveja or Kilgore that the claimed duration of delivering a full depletion
block before switching to delivering a partial depletion block is a result-
effective variable. Cf. In re Antonie, 559 F.2d 618, 620 (CCPA 1977) (One
exception to “the rule that the discovery of an optimum value of a variable in
a known process is normally obvious” applies where “the parameter
optimized was not recognized to be a result-effective variable.”).
Accordingly, we do not sustain the Examiner’s rejection of claim 21
under 35 U.S.C. § 103(a).
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Double Patenting
Double patenting is a matter of what is claimed. General Foods Corp.
v. Studiengesellschaft Kohle, 972 F.2d 1272, 1277 (Fed. Cir. 1992). At the
time the Final Office Action was mailed, application Serial Nos 14/597,137
and 14/597,145 were both still pending before the USPTO. The claims in
these applications have subsequently been amended, and the applications
have issued as patents.
We do not have before us any discussion regarding the merits of the
Examiner’s provisional double-patenting rejections with regard to the issued
claims of application Serial Nos 14/597,137 and 14/597,145. As such, the
Examiner’s provisional double-patenting rejections are not ripe for decision
by the Board. Therefore, we do not reach the double patenting rejections of
claims 1, 16, and 20. Cf. Ex parte Moncla, 95 USPQ2d 1884 (BPAI 2010)
(precedential) (Panels have the flexibility to reach or not reach provisional
obviousness-type double patenting rejections).
DECISION
The Examiner’s rejection of claims 1–4, 8, 10–13, 16, 17, 19, and 20
under 35 U.S.C. § 112(a) as failing to comply with the written description
requirement is reversed.
The Examiner’s rejection of claim 21 under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement is affirmed.
The Examiner’s rejections of claims 1–4, 8, 10–13, and 21 under
35 U.S.C. § 103(a) are reversed.
The Examiner’s rejections of claims 16, 17, 19, and 20 under
35 U.S.C. § 103(a) are affirmed.
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We do not reach the Examiner’s provisional rejections of claims 1, 16,
and 20 on the ground of non-statutory obviousness-type double patenting.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART