Ex Parte INUI et al

Patent Trial and Appeal Board

May 11, 2017

13023623 (P.T.A.B. May. 11, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/023,623 02/09/2011 Koji INUI Q123083 9082
05/15/201765565 7590
SUGHRUE-265550
2100 PENNSYLVANIA AVE. NW
WASHINGTON, DC 20037-3213
EXAMINER
HOEKSTRA, JEFFREY GERBEN
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
05/15/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KOJIINUI, YASUYUKI TAKESHIMA, JUN MOTOGI,
YOSHINOBU ONO, TAKESHI KOJIMA, RYOSUKE USHIJIMA,
KATSUMINAKAICHI, and KAZUWA SHIBUYA
Appeal 2015-001512
Application 13/023,623
Technology Center 3700
Before LYNNE H. BROWNE, WILLIAM A. CAPP, and
ERIC C. JESCHKE, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Koji Inui et al. (“Appellants”)1 seek review under 35 U.S.C. § 134(a)
of the Examiner’s decision, as set forth in the Non-Final Office Action dated
December 30, 2013 (“Non-Final Act.”), rejecting claims 1—3 and 5—15.2
1 Appellants identify INTER-UNIVERSITY RESEARCH
INSTITUTE CORPORATION and NIHON KOHDEN CORPORATION as
the real parties in interest. Appeal Br. 2.
2 Claim 14 is listed as rejected in the Office Action Summary (Non-
Final Act. 1) but is not listed in the “Claim Rejections” {see id. at 2—5) or the
“Grounds of Rejections” {see Ans. 2). Appellants take the position that
claim 14 is rejected. See Appeal Br. 4.
Appeal 2015-001512
Application 13/023,623
Claim 4 has been withdrawn. The Examiner objects to claim 16 but
indicates that it would be allowable if rewritten in independent form. Non-
Final Act. 6. The record includes a transcript of the oral hearing held on
April 19, 2017 (“Tr.”). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
BACKGROUND
The disclosed subject matter “relates to a pain sensory nerve
stimulation apparatus which, with respect to the primary pain sense
produced by stimulation of A8 fibers, and the secondary pain sense produced
by stimulation of C fibers, can perform only stimulation of C fiber.”
Spec. 1,11. 4—8. Claim 1, the sole independent claim, is reproduced below:
1. A pain sensory nerve stimulation apparatus
comprising:
an electrode portion including:
a first electrode, a tip end of which is adapted
to be inserted into a skin; and
at least one second electrode which is
disposed in a circumference of the first electrode
without being electrically conductive with the first
electrode, and which is adapted to be in contact with
a skin; and
a stimulation signal supplying unit
configured to supply a bipolar stimulation signal
between the first electrode and the second electrode,
the bipolar stimulation signal including a first
waveform signal and a second waveform, the first
waveform which is convex in a negative direction
in the first electrode, the second waveform signal
which is convex in a positive direction in the first
electrode.
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Application 13/023,623
EVIDENCE RELIED ON BY THE EXAMINER
Campos US 5,097,833 Mar. 24, 1992
Katims US 5,806,522 Sept. 15, 1998
Mower US 8,290,585 B2 Oct. 16,2012
Inui English Translation of WO June 8, 2006
2006/059430 A13
REJECTIONS
1. Claims 1—3, 5—7, 10, 12, 13, and 15 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Inui and Katims.
2. Claims 8 and 9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Inui, Katims, and Campos.
3. Claim 11 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Inui, Katims, and Mower.
DISCUSSION
Appellants argue the patentability of independent claim 1 and do not
separately argue the remaining claims, which depend from claim 1. Appeal
Br. 7—13. Thus, we address claim 1, with the remaining claims standing or
falling with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv) (2013).
For claim 1, the Examiner relied on Inui for certain limitations, but
stated that Inui “fail[s] to disclose a bipolar stimulation signal including a
first waveform signal and a second waveform, the first waveform which is
convex in a negative direction in the first electrode, the second waveform
signal which is convex in a positive direction in the first electrode.” Non-
Final Act. 3. The Examiner found, however, that Katims “discloses a
3 This translation was entered into the record on November 13, 2012.
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Application 13/023,623
bipolar stimulation signal including a first waveform signal and a second
waveform, the first waveform which is convex in a negative direction in the
first electrode, the second waveform signal which is convex in a positive
direction in the first electrode.” Id. at 3^4 (citing Katims, “whole document,
in particular, Figure 21”). According to the Examiner, it would have been
obvious “to modify the waveform of Inui... to include the use of a bipolar
stimulation signal, as per the teachings of Katims, since it would provide a
means of enhancing the sensation of the electrical stimulus to evoke a
desired response.” Id. at 4.
First, Appellants argue that Inui “fails to disclose the claimed
waveform signal for the first electrode that is inserted into the skin,
otherwise known as a needle electrode” and that Katims “discloses a
surface electrode that uses a sine waveform signal.” Appeal Br. 8.
Appellants argue that, contrary to the Examiner’s comments, “a surface
electrode is not equivalent to a needle electrode, both structurally and
functionally.” Id. (citing Non-Final Act. 7,11. 5—15). Appellants contend
that “the structures are clearly different” in that “a needle electrode includes
a tip end that is capable of being inserted to the papilla” whereas a surface
electrode does not. Id. Appellants also contend that “the functions are
different” because a surface electrode (1) “functions on the skin surface
rather than below the skin surface” and (2) “affects a larger surface area than
a needle electrode,” and thus, has a larger “simulation intensity ... as
compared to a needle electrode.” Id.', see also Reply Br. 5 (arguing that
needle electrodes and surface electrodes “perform their functions differently
from each other and obtain different results”).
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We are not apprised of error based on this argument. As an initial
matter, with certain contentions, Appellants attack the references
individually regarding limitations for which the Examiner relied on the
combination of Inui and Katims. See, e.g., Appeal Br. 9 (“Neither reference
discloses the feature of having the claimed waveform signal for an electrode
that is inserted into the skin. This element is missing from the cited
references.”); see In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986)
(“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references.”).
Moreover, as noted by the Examiner, although the structures of
surface electrodes and needle electrodes are different, the electrodes both
provide the same overall function: “applying] an electrical stimulus to
tissue to [ejlicit a response therefrom.” Ans. 3.4 For reasons discussed in
more detail below (regarding Appellants’ second argument), Appellants
have not shown that the differences between the surface electrodes of
Katims (not relied on in the Rejection) and the needle electrodes of Inui
(relied on in the Rejection) undermine the functionality of the modified
device proposed by the Examiner. In other words, Appellants have not
shown that the modified device—the needle electrode of Inui supplying the
stimulation signal of Katims—would fail to “apply an electrical stimulus to
tissue to [ejlicit a response therefrom.” See id.
Second, Appellants argue that if Inui “was modified in the alleged
manner, it would no longer operate in the manner in which it is intended”
4 We understand the Examiner’s use of “illicit” to mean “elicit.”
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and would be “inoperable for its intended purpose.” Appeal Br. 11, 12.
Appellants contend that Inui “is directed toward stimulating AS fibers’'’
whereas the proposed modification “would result in stimulating only C
fibers, which are much thinner than A8 fibers.” Id. at 11. Appellants argue
that “[i]f the proposed modification or combination of the prior art would
change the principle of operation of the prior art invention being modified,
then the teachings of the references are not sufficient to render the claims
prima facie obvious.” Id. at 12 (citing In re Ratti, 270 F.2d 810, 813 (CCPA
1959)). Appellants also contend that because Inui
is directed to stimulating AS fibers, and Katims is directed to
stimulating all of Cfibers, AS fibers andAfi fibers, the combined
teachings fail to provide any indication to one of ordinary skill in
the art to go against the teachings of [Inui] and Katims, to have a
resultant structure in which only C fibers are stimulated.
Appeal Br. 12.
We are not apprised of error based on Appellants’ second argument.
As an initial matter, we note, as does the Examiner, that “[t]he current
claims under appeal fail to disclose any specific type(s) of fiber(s) that are to
be stimulated by the applied stimulus waveform.” Ans. 5.5 We turn now to
the argument regarding the “intended purpose” of Inui. Where the proposed
modification would render the prior art invention being modified
unsatisfactory for its intended purpose, the proposed modification would not
have been obvious. See In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984).
5 Claim 16, which the Examiner indicates would be allowable if
rewritten in independent form, recites: “The pain sensory nerve stimulation
apparatus according to claim 1, wherein the stimulation signal supplying unit
is configured to stimulate only C fibers of a recipient receiving the
stimulation signal.”
6
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Here, Appellants have not shown that the proposed modification would
render Inui unsatisfactory for its intended purpose. We first note that the
record does not support that the intended purpose of Inui is “stimulating A8
fibers.” Appeal Br. 11, 12 (emphasis omitted). Appellants rely on
paragraphs 2 and 4 of Inui as showing that the “desired response” of the
disclosed invention is “to stimulate larger AS fibers.” Id. at 10. Although
paragraph 2 discloses, in the “Background of the Invention,” that the
inventors “succeeded in stimulating a skin A-delta fiber selectively by
carrying out electrical stimulation of the inside of epidermis using the needle
electrode created uniquely recently,” when describing the “object of the
invention,” paragraph 4 does not disclose stimulating AS fibers selectively:
Therefore, an object of this invention is to provide the multi­
electrode needle electrode which comprises the stimulus purpose
electrode (needle) and end electrode for stimulating only the
nociception of the skin selectively. By using this electrode, only
nociception can be stimulated and clear response potential
(induction brain potential) can be obtained.
Inui 14 (emphasis added). At the oral hearing, Appellants did not clarity
how paragraphs 2 or 4 indicated that the intended purpose of the invention in
Inui was to stimulate only AS fibers. Tr. 4,1. 21 — 7,1. 1. Thus, Appellants
have not shown that the proposed modification would render Inui
unsatisfactory for its intended purpose. Cf. Gordon, 733 F.2d at 902
(reversing a rejection because modifying the prior art by turning a filter
upside down would render it incapable of filtering, and thus, inoperable for
its intended purpose).6
6 For the same reasons, we do not agree with Appellants that the basic
principle of operation of Inui is stimulating AS fibers. See Ratti, 270 F.2d at
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Appellants have also not shown error in the Examiner’s statements
that (1) “the substitution of the triangular waveform of Inui. . . with that of
the sinusoidal waveform of Katims would not only have been obvious to one
of ordinary skill in the art, but would also yield a predictable result without
changing the operation of the system of Inui” or (2) that Inui “does not
disclose any specific requirements for the bipolar waveform that preclude
the use of a sinusoidal waveform [of Katims] in place of a triangular
waveform.” Ans. 4 (also stating that claim 1 fails to recite “any specific
frequency and/or magnitude of the bipolar waveform such that the disclosed
bipolar waveform of Katims cannot be reasonably applied to the needle
electrode of Inui... as a substitute waveform for eliciting a pain response”).
To the first statement, Appellants respond that “the alleged
modification would indeed change the operation of Inui because it would no
longer function or operate to stimulate A8 fibers” and that, because the
modified device “would stimulate different fibers than disclosed in Katims,
there is no evidence this is a predictable result.” Reply Br. 7. To the second
statement, Appellants respond that “if a different waveform is used in Inui, it
should still result in the same desired response and result of stimulating AS
fibers.” Id.
As discussed above, Appellants have not shown that Inui discloses
stimulating only AS fibers. Further, we consider the “predictable result”
referenced by the Examiner as provided by the modified device (Ans. 4) to
813 (stating that the proposed modification would “require a substantial
reconstruction and redesign of the elements shown in [the prior art] as well
as a change in the basic principles under which the [prior art] was designed
to operate”).
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Application 13/023,623
relate not to the specific type(s) of nerve fibers stimulated, but rather to
performing the function of applying a stimulation waveform to the skin to
elicit a pain response from a person. See Ans. 4 (stating that “a needle
electrode and a surface electrode are functional equivalents, and as such, the
bipolar waveform of Katims applied to the bipolar needle electrode would
perform the same function as that of the previously disclosed bipolar
waveform in Inui”)7; id. at 3 (stating that Inui discloses a “bipolar
stimulation waveform . . . that is applied to the skin to elicit a pain response
from a person”).
Here, Appellants have not demonstrated, with technical reasoning or
evidence, that the modified device—i.e., the needle electrode of Inui
supplying the stimulation signal of Katims—would fail to apply an electrical
stimulus to tissue to elicit a response therefrom. See Tr. 9,11. 1—18
(Appellants acknowledging that the modified device would “provide
stimulation”). Thus, we are not apprised of error in the reasoning provided.
See Ans. 3^4; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007) (“[W]hen a patent claims a structure already known in the prior art
that is altered by the mere substitution of one element for another known in
the field, the combination must do more than yield a predictable result.”).
Third, Appellants argue that “if one were to modify [Inui] to have the
claimed waveform for the needle electrode, [Inui] would not achieve its
desired response and would not achieve Katims’ desired response.” Appeal
Br. 10. Appellants argue that “[t]he ‘desired response’ in [Inui] and Katims
... is to stimulate larger A8 fibers (see paragraphs [0002] and [0004] of
7 Appellants view this as “an argument of substitution.” Reply Br. 6.
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[Inui]), or all the fibers (see col., 10, lines 12-45 of Katims),” and thus, “the
desired response in [Inui] and Katims is contradictory with the actual
response that would be achieved by the proposed modification.” Id.
(emphasis omitted). Appellants contend, “[a]s such, the alleged rationale to
combine the references is directly contrary to the structure that would be
obtained by the combination of references.” Id.
We are not apprised of error based on this argument. In the Answer,
the Examiner clarifies that the “desired response” referenced in the Office
Action (Non-Final Act. 4) relates not to the specific type of nerve fibers
stimulated, but rather to the functionality provided:
In the art, both needle electrodes and surface electrodes are used
to apply an electrical stimulus to tissue to [e]licit a desired
response, either for stimulating a muscle response to the
electrical stimulus, to elicit a pain response, or to perform an
impedance measurement on the tissue adjacent to the bipolar
electrode. The Examiner notes that while the structures of a
needle electrode and a surface electrode are different, the
function of both a needle electrode and a surface electrode are
functionally the same; both needle electrodes and surface
electrodes are used to apply an electrical stimulus to tissue to
[ejlicit a response therefrom.
Ans. 2—3 (emphasis added). Thus, Appellants have not shown error in the
Rejection in the context of the articulated meaning of “desired response.”
Fourth, Appellants argue that “neither reference ties ‘a desired
response’ to using the claimed waveform signal for an electrode that is
inserted into the skin.'” Appeal Br. 9. Appellants contend that “there is no
rationale in the main or secondary reference for the asserted combination”
and “[t]here is no suggestion in [Inui] for this combination.” Id. at 9, 10.
We are not apprised of error based on these or other statements that
argue a requirement for an express teaching-suggestion-motivation to
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Application 13/023,623
support the rejection. See, e.g., id. at 12 (arguing that “The cited references
fail to provide any rationale to change the operation of [Inui] in this
manner” and that “there is no rationale to modify [Inui] in the alleged
manner based on either of the cited references” (emphasis added)).
Although a conclusion of obviousness must be supported by findings and
analysis establishing a reason to combine or modify the known elements in
the manner proposed, the analysis “need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR, 550 U.S. at 418. Thus, the
fact that the prior art does not explicitly disclose the proposed modification
does not undermine the rejection.
Fifth, Appellants argue that “the sine waveform of Katims is used for
a completely different purpose and has a completely different function from
which it would allegedly be used in [Inui].” Appeal Br. 10. According to
Appellants, “[t]here is no rationale to modify [Inui] based on Katims,
wherein the waveform of Katims would be used for a different function and
provide a different result than that which it is disclosed for.” Id. at 11
(discussing MPEP § 2141). Appellants argue that “[t]he waveform signal of
Katims[’] surface electrode stimulates all of the fibers at the skin surface”
whereas “[t]he alleged modification requires that the waveform signal
stimulate only C fibers.” Id.
For the same reasons discussed above with regard to Appellants’
second argument, we see no error in the Examiner’s position that the
“function” and “result” of the invention in Katims (included the relied-upon
waveform) relate not to the specific type of nerve fibers stimulated, but
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rather to performing the function of applying a stimulation waveform to the
skin to elicit a pain response from a person. See, e.g., Ans. 4 (“Katims
discloses the utilization of such a waveform to stimulate tissue to [e]licit a
pain response utilizing a skin surface electrode.”). Thus, we are not apprised
of error in the rejection based on this argument.
For the reasons above, we sustain the rejection of independent claim 1
as unpatentable over the combined teachings relied on by the Examiner.
Claims 2, 3, and 5—15 fall with claim 1.
DECISION
We AFFIRM the decision to reject claims 1—3 and 5—15 under
35U.S.C. § 103(a).
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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