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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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`06/21/2013
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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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`06/21/2013
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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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`

`

`
`
`Applicant(s)
`Application No.
` 13/496,694 TAKAGI ET AL.
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`AIA (First Inventorto File)
`Art Unit
`Examiner
`Office Action Summary
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`MICHAEL D ABREU first“ 3762
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event however may a reply be timely filed
`after SIX () 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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`-
`-
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`Status
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`1)IXI Responsive to communication(s) filed on 16 March 2012.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)lX| This action is non-final.
`a)I:| 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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`Disposition of Claims
`5)IXI Claim(s) 11-20is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)|:l CIaim(s) _ is/are allowed.
`7)IZ| CIaim(s)1;20is/are rejected.
`8)I:I CIaim(s) _ is/are objected to.
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`9)|:l CIaim(s)
`are subject to restriction and/or election requirement.
`* 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
`://www.usoto. ov/ atents/init events"
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`
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`h/index.‘s 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 AII
`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 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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`Interim copies:
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`a)|:l AII
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`b)I:I Some
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`c)I:I None of the:
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`Interim copies of the priority documents have been received.
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`Attachment(s)
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`1) E Notice of References Cited (PTO-892)
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`3) I] Interview Summary (PTO-413)
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`Paper NOISI/Ma” Date —
`PTO/SB/08
`t
`St t
`I
`D'
`t'
`f
`2 IXI I
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`4) I:I Other:
`a emen (s)(
`Isc osure
`n orma Ion
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`Paper No(s)/Mai| Date 3/16/12.
`US. Patent and Trademark Office
`PTOL-326 (Rev. 03-13)
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`Part of Paper No./Mai| Date 20130614
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`Office Action Summary
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`

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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 16 March 2012.
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`Claims 11-20 are pending and under examination.
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`Claim Rejections - 35 USC § 102
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`2.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
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`3.
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`Claims 11-13 & 18-20 are rejected under 35 U.S.C. 102(b) as being anticipated
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`by Mann et al. (US 2002/0055761; hereinafter “Mann”).
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`4.
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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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`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 measuring section which is connected to the stimulus response detecting electrode
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`

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`Application/Control Number: 13/496,694
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`Page 3
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`Art Unit: 3762
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`and a ground electrode which measures a biological signal detected by the stimulus
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`response detecting electrode (the examiner is of the position that there must necessarily
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`be some ground electrode in order to effectively measure the feedback from the
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`pudendal nerve and adjust/determine the strength of electrical stimulation required); a
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`control section which is connected to the measuring section and controls supply of the
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`stimulus signal based on the measured result of the measuring section (e.g. Fig. 1,
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`#20); and a display section which displays the measurements ([157]).
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`5.
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`With respect to claims 12-13, 18-20, 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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`Claim Rejections - 35 USC § 103
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`6.
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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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`(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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`7.
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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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`

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`Application/Control Number: 13/496,694
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`Page 4
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`Art Unit: 3762
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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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`8.
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`Claims 14-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Mann. Mann indicates that a the stimulus response detecting electrodes can be placed
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`in a plurality of locations, but fails to specify the biceps femoris, semitendinosus,
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`gastrocnemius, or soleus muscles. The examiner notes that all these muscles have
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`nerves which stem from the sacral region. Accordingly, stimulation applied to the sacral
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`region, depending on the parameters, would necessarily result in propagation of actions
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`potentials along the sciatic and tibial nerves which innervate these muscles.
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`Accordingly, it would have been obvious to one of ordinary skill in the art at the time of
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`the invention to measure the stimulus response at these locations in order to ensure
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`that the stimulation to treat incontinence is not negatively causing side effects (i.e.
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`stimulation of secondary muscles such as leg muscles).
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Michael D'Abreu whose telephone number is (571 )270-
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`3816. The examiner can normally be reached on Monday - Friday, 0600 - 1630 EST.
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`lf attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Christopher Koharski can be reached on (571) 272-7230. The fax phone
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