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`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
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`13/496,694
`
`03/16/2012
`
`Airi Takagi
`
`WASH1—49320
`
`8125
`
`06/21/2013
`
`7590
`52054
`pEARNE&GORDONLLp
`1801 EAST 9TH STREET
`SUITE 1 200
`CLEVELAND, OH 44114-3108
`
`D ABREU, MICHAEL JOSEPH
`
`3762
`
`PAPER NUMBER
`
`
`
`
` NOT *ICATION DATE
`
`DELIVERY MODE
`
`06/21/2013
`
`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):
`
`patdocket @ peame.c0m
`dchervenak@ peame.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 13/496,694 TAKAGI ET AL.
`
`
`AIA (First Inventorto File)
`Art Unit
`Examiner
`Office Action Summary
`
`
`MICHAEL D ABREU first“ 3762
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`
`
`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).
`
`-
`-
`
`Status
`
`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
`
`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
`
`
`; the restriction requirement and election have been incorporated into this action.
`
`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.
`
`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.
`
`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
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usoto. ov/ atents/init events"
`
`
`
`h/index.‘s or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
`
`Application Papers
`
`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).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`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:
`
`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
`
`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.
`
`Interim copies:
`
`a)|:l AII
`
`b)I:I Some
`
`c)I:I None of the:
`
`Interim copies of the priority documents have been received.
`
`Attachment(s)
`
`1) E Notice of References Cited (PTO-892)
`
`3) I] Interview Summary (PTO-413)
`
`Paper NOISI/Ma” Date —
`PTO/SB/08
`t
`St t
`I
`D'
`t'
`f
`2 IXI I
`)
`4) I:I Other:
`a emen (s)(
`Isc osure
`n orma Ion
`)
`Paper No(s)/Mai| Date 3/16/12.
`US. Patent and Trademark Office
`PTOL-326 (Rev. 03-13)
`
`Part of Paper No./Mai| Date 20130614
`
`Office Action Summary
`
`

`

`Application/Control Number: 13/496,694
`
`Page 2
`
`Art Unit: 3762
`
`DETAILED ACTION
`
`1.
`
`This Office action is responsive to communications filed on 16 March 2012.
`
`Claims 11-20 are pending and under examination.
`
`Claim Rejections - 35 USC § 102
`
`2.
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(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.
`
`3.
`
`Claims 11-13 & 18-20 are rejected under 35 U.S.C. 102(b) as being anticipated
`
`by Mann et al. (US 2002/0055761; hereinafter “Mann”).
`
`4.
`
`Regarding claim 11, Mann discloses a urination disorder treatment apparatus for
`
`treating a urination disorder of a patient, the urination disorder treatment apparatus
`
`comprising: at least a pair of stimulus applying electrodes arranged on a back of a
`
`sacral bone of the patient ([43, 77]) with a predetermined distance between the stimulus
`
`applying electrodes and which supplies a stimulus signal to the back of the sacral bone
`
`(e.g. Fig. 1, #14/16, where the device is a set length); a stimulus signal supply source
`
`that causes the pair of stimulus applying electrodes to supply a stimulus signal (e.g. Fig.
`
`1, #10); a stimulus response detecting electrode which is arranged near a tissue
`
`connected to a nerve that passes through the sacral bone and which detects a
`
`biological signal generated in response to the stimulus signal ([154] — pudendal nerve);
`
`a measuring section which is connected to the stimulus response detecting electrode
`
`

`

`Application/Control Number: 13/496,694
`
`Page 3
`
`Art Unit: 3762
`
`and a ground electrode which measures a biological signal detected by the stimulus
`
`response detecting electrode (the examiner is of the position that there must necessarily
`
`be some ground electrode in order to effectively measure the feedback from the
`
`pudendal nerve and adjust/determine the strength of electrical stimulation required); a
`
`control section which is connected to the measuring section and controls supply of the
`
`stimulus signal based on the measured result of the measuring section (e.g. Fig. 1,
`
`#20); and a display section which displays the measurements ([157]).
`
`5.
`
`With respect to claims 12-13, 18-20, it is noted that the measuring section
`
`measures the evoked potential corresponding to the stimulus signal applied and
`
`controls a magnitude by determining the effective stimulation parameters ([154]).
`
`It is
`
`further noted that the pudendal nerve is near a urethral sphincter muscle as "near" is a
`
`relative term and the regions are in close proximity with one another.
`
`Claim Rejections - 35 USC § 103
`
`6.
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(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.
`
`7.
`
`This application currently names joint inventors.
`
`In considering patentability of
`
`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
`
`the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`

`

`Application/Control Number: 13/496,694
`
`Page 4
`
`Art Unit: 3762
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
`
`prior art under 35 U.S.C. 103(a).
`
`8.
`
`Claims 14-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Mann. Mann indicates that a the stimulus response detecting electrodes can be placed
`
`in a plurality of locations, but fails to specify the biceps femoris, semitendinosus,
`
`gastrocnemius, or soleus muscles. The examiner notes that all these muscles have
`
`nerves which stem from the sacral region. Accordingly, stimulation applied to the sacral
`
`region, depending on the parameters, would necessarily result in propagation of actions
`
`potentials along the sciatic and tibial nerves which innervate these muscles.
`
`Accordingly, it would have been obvious to one of ordinary skill in the art at the time of
`
`the invention to measure the stimulus response at these locations in order to ensure
`
`that the stimulation to treat incontinence is not negatively causing side effects (i.e.
`
`stimulation of secondary muscles such as leg muscles).
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Michael D'Abreu whose telephone number is (571 )270-
`
`3816. The examiner can normally be reached on Monday - Friday, 0600 - 1630 EST.
`
`lf attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Christopher Koharski can be reached on (571) 272-7230. The fax phone
`
`

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