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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`13/496,694
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`03/ 16/2012
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`Airi Takagi
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`WASH1—49320
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`8125
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`03/14/2014
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`7590
`52054
`pEARNE&GORDONLLp
`1801 EAST 9TH STREET
`SUITE 1 200
`CLEVELAND, OH 44114-3108
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`D ABREU, MICHAEL JOSEPH
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`3762
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`PAPER NUMBER
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` NOT *ICATION DATE
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`DELIVERY MODE
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`03/ 14/2014
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
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`patdocket @ peame.c0m
`dchervenak@ peame.c0m
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`PTOL—90A (Rev. 04/07)
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`

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`
`
`Applicant(s)
`Application No.
` 13/496,694 TAKAGI ET AL.
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`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
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`3762MICHAEL D ABREU first“
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`In no event, however, may a reply be timely filed
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`-
`-
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`Status
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`1)IXI Responsive to communication(s) filed on 11/15/2013.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|:| This action is non-final.
`2a)IZ| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`3) D Interview Summary (PT0_413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
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`.
`—
`4) I:I Other'
`2) D Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
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`Paper No(s)/Mai| Date .
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20131201
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`Disposition of Claims*
`5)|XI C|aim(s) L20 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`s L20 is/are rejected.
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`is/are objected to.
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`I )
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`_
`
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`are subject to restriction and/or election requirement.
`9)|:l C|aim(s
`I
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://w1rvw.usoto. ov/ atents/init events"
`h/index.‘s
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`, or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
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`Application Papers
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`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
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`b)I:I Some” c)I:I None of the:
`a)|:l All
`1.|:| Certified copies of the priority documents have been received.
`2.|:| Certified copies of the priority documents have been received in Application No.
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`Application/Control Number: 13/496,694
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`Page 2
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`Art Unit: 3762
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`DETAILED ACTION
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`1.
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`This Office action is responsive to communications filed on 15 November 2013.
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`Claims 11-20 are pending and examined under the pre-AIA first to invent provisions.
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`Priority
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`2.
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`Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C.
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`119(a)-(d), which papers have been placed of record in the file.
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`Claim Rejections - 35 USC § 1 12
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`3.
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`The following is a quotation of 35 U.S.C. 112(a):
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`(a) IN GEN ERAL.—The specification shall contain a written description of the invention,
`and of the manner and process of making and using it, in such full, clear, concise, and
`exact terms as to enable any person skilled in the art to which it pertains, or with which
`it is most nearly connected, to make and use the same, and shall set forth the best
`mode contemplated by the inventor or joint inventor of carrying out the invention.
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`The following is a quotation of 35 U.S.C. 112 (pre-AIA), first paragraph:
`The specification shall contain a written description of the invention, and of the manner
`and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly
`connected, to make and use the same and shall set forth the best mode contemplated
`by the inventor of carrying out his invention.
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`4.
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`Claims 11-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA),
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`first paragraph, as failing to comply with the written description requirement. The
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`claim(s) contains subject matter which was not described in the specification in such a
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`way as to reasonably convey to one skilled in the relevant art that the inventor or a joint
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`inventor, or for pre-AIA the inventor(s), at the time the application was filed, had
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`possession of the claimed invention.
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`In claim 11, the phrase “arranged on skin behind a
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`Page 3
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`Art Unit: 3762
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`sacral bone” in combination with other elements of the claim is considered new matter.
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`The specification indicates that the stimulus applying electrodes may be placed on a
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`surface of the back near the sacral bone, but does not specify “on skin”. This is
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`contrary to the ground electrode which is specifically indicated as arranged on a given
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`skin surface.
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`It is suggested to amend the claims to consistently claim the location of
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`the stimulus applying electrodes with the appropriate terminology as used in the
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`originally filed specification. Additionally, the originally filed disclosure fails to support
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`the claim limitation of “a stimulus-response detecting electrode which is arranged on
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`skin near a tissue connected to a nerve..”. The disclosure indicates that the only time a
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`stimulus-response detecting electrode is arranged on skin near tissues, it is connected
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`to sciatic nerves, and accordingly does not support the broad arrangement on a skin
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`near a tissue connected to any nerve that passes through or near the sacral bone as
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`currently claimed.
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`It is suggested to amend the claims in line with the language
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`presented in the originally filed disclosure or specifically indicate where support lies.
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`Lastly, dependent claims 14-17 all specify electrodes arranged on "skin behind";
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`however, the specification fails to support the placement of electrodes “behind” the skin,
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`and it is unclear as to what specific location the claims are attempting to identify.
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`Appropriate clarification is required.
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`Claim Rejections - 35 USC § 103
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`5.
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`Page 4
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`Art Unit: 3762
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`6.
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`This application currently names joint inventors.
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`In considering patentability of
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`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
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`prior art under 35 U.S.C. 103(a).
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`7.
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`Claims 11-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Mann et al. (US 2002/0055761; hereinafter “Mann”) in view of Tippey et al. (USP#
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`5,562,717; hereinafter “Tippey”) further in view of Spinelli et al. (US 2005/0113877;
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`hereinafter "Spinelli").
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`8.
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`Regarding claim 11, Mann discloses a urination disorder treatment apparatus for
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`treating a urination disorder of a patient, the urination disorder treatment apparatus
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`comprising: at least a pair of stimulus applying electrodes arranged on a back of a
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`sacral bone of the patient ([43, 77]) with a predetermined distance between the stimulus
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`applying electrodes and which supplies a stimulus signal to the back of the sacral bone
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`(e.g. Fig. 1, #14/16, where the device is a set length); a stimulus signal supply source
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`that causes the pair of stimulus applying electrodes to supply a stimulus signal (e.g. Fig.
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`1, #10); a stimulus response detecting electrode which is arranged near a tissue
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`Page 5
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`connected to a nerve that passes through the sacral bone and which detects a
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`biological signal generated in response to the stimulus signal ([154] — pudendal nerve);
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`a section which measures a biological signal detected by the stimulus response
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`detecting electrode (as the signal from the pudendal nerve is measured and the
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`strength of electrical stimulation is adjusted/determined); a control section which is
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`connected to the measuring section and controls magnitude of the stimulus signal
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`according to an operation of a user (e.g. [56]; Fig. 1, #20); and a display section which
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`displays the measurements ([157]). The examiner notes that it is unclear whether the
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`subcutaneous electrodes of Mann are distinct and positioned differently than the
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`present invention as claimed and presented; however, it is noted that in the same field
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`of endeavor, Tippey employed surface electrodes to stimulation similar regions to treat
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`an individual suffering from urination disorders as well. Accordingly, the examiner notes
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`that it would have been an obvious design choice to one of ordinary skill in the art at the
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`time of the invention to modify the device of Mann with the well known use of surface
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`electrodes as exemplified by Tippey in order to yield the predictable results of providing
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`a less invasive method of treating urinary incontinence.
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`Mann in view of Tippey fail to specify a ground electrode arranged on a skin of a
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`patient; however, in the same field of endeavor, Spinelli employs a ground electrode to
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`provide unipolar stimulation of distal portions of the pudendal nerve effectively (e.g. Fig
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`8, #57). Accordingly, it would have been an obvious design choice to one of ordinary
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`skill in the art at the time of the invention to incorporate a ground electrode on the skin
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`of the patient as in Spinelli in order to provide the predictable results of ensuring that the
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`Page 6
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`proper regions of the pudendal nerve were stimulated appropriately in a unipolar
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`fashion.
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`9.
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`With respect to claims 12-13 & 18, it is noted that the measuring section
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`measures the evoked potential corresponding to the stimulus signal applied and
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`controls a magnitude by determining the effective stimulation parameters ([154]).
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`It is
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`further noted that the pudendal nerve is near a urethral sphincter muscle as "near" is a
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`relative term and the regions are in close proximity with one another.
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`10.
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`Regarding claims 14-17, Mann indicates that a the stimulus response detecting
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`electrodes can be placed in a plurality of locations, but fails to specify the biceps
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`femoris, semitendinosus, gastrocnemius, or soleus muscles. The examiner notes that
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`all these muscles have nerves which stem from the sacral region. Accordingly,
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`stimulation applied to the sacral region, depending on the parameters, would
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`necessarily result in propagation of actions potentials along the sciatic and tibial nerves
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`which innervate these muscles. Accordingly, it would have been obvious to one of
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`ordinary skill in the art at the time of the invention to measure the stimulus response at
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`these locations in order to ensure that the stimulation to treat incontinence is not
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`negatively causing side effects (i.e. stimulation of secondary muscles such as leg
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`muscles).
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`11. With respect to claims 19 & 20, Mann indicates the use of a display which
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`provide programming and status information of the stimulator; however, it is unclear as
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`to whether this information includes whether the arrangement of and the stimulus from
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`the electrodes is appropriate. However, it is noted that Mann clearly states that the
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`Page 7
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`device can be connected to a personal computer and that the interface can be used by
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`a clinician to monitor the status of the implant in order to prescribe new stimulation
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`parameters (e.g. [158]). Accordingly, it would be obvious to one of ordinary skill in the
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`art at the time of the invention to incorporate such vital information such as the level and
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`effectiveness/appropriateness of the stimulus and arrangement of the electrodes (e.g.
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`[161-165]), especially during implantation.
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`12.
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`The prior art made of record and not relied upon is considered pertinent to
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`applicant's disclosure. Siegel et al. (USP# 7,763,034).
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`Response to Arguments
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`13.
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`Applicant's arguments filed 15 November 2013 have been fully considered but
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`they are not found persuasive. With respect to claims 14-17, Applicant asserts that
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`Mann fails to teach particular parameters to guide selection of parameters which would
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`provide stimulation resulting in propagation of action potentials along the sciatic and
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`tibial nerves. As an initial point, the examiner notes that the claim language is extremely
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`broad, only requiring that the stimulus response electrodes are arranged on skin
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`"behind" the respective muscle, which is connected to the respective nerve. This
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`location is still unclear as to where exactly the electrodes are positioned. The applicant
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`further contends that it cannot be concluded that such broad innervation would
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`necessarily occur as the result of stimulus provided in the sacral region; however, the
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`examiner disagrees and notes that propagation of action potentials down a nerve
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`pathway does occur and is a common concern in the art, regardless of directional
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`stimulation (e.g. [75-78] of Mann). The applicant further argues that Mann fails to teach
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`measuring response for the purposes of evaluating potential negative side effects;
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`however, in [154] it is clear that the patient’s response to the treatment is sensed in
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`order to help determine the strength and duration of the electrical stimulation.
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`It is
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`common in the art to use the patient's response to determine the ideal stimulation
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`parameters in order to any negative side effects such as pain or discomfort, as appears
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`to be the case in Mann.
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`14.
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`Applicant's remaining arguments with respect to the claims have been
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`considered but are moot in view of the new ground(s) of rejection, necessitated by
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`amendment.
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`Conclusion
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`15.
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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