UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/280,159
`
`09/29/2016
`
`Eriko Yoshioka
`
`WASH2-50934US1
`
`8671
`
`Pearne & Gordon LLP
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`1801 East Ninth Street, Suite 1200
`Cleveland, OH 44114-3108
`
`MEKHLIN' ELI S
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`PAPER NUMBER
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`ART UNIT
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`1721
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`NOTIFICATION DATE
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`DELIVERY MODE
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`05/10/2019
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`ELECTRONIC
`
`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
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`following e—mail address(es):
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`patdoeket@pearne.eom
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`PTOL-90A (Rev. 04/07)
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`

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`0,7709 A0170” Summary
`
`Application No.
`15/280,159
`Examiner
`ELI S MEKHLIN
`
`Applicant(s)
`Yoshioka et al.
`Art Unit
`1721
`
`AIA (FITF) Status
`No
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS 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 (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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`Status
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`1). Responsive to communication(s) filed on 04/19/2019.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) C] This action is non-final.
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`3)[:] 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.
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`4)[:] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s) fl is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) fl is/are rejected.
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`[:1 Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabte. 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
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] objected to by the Examiner.
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`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):] 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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`a)D All
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`b)I:I Some**
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`c)CI None of the:
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`1.[:] Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`3.[:] 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)).
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`** 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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`1) C] Notice of References Cited (PTO-892)
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`2) E] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) D Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20190506
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
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`Page 2
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`DETAILED ACTION
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`(1)
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`Notice of Pre-AIA 0r AIA Status
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`The present application is being examined under the pre—AIA first to invent provisions.
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`Applicant’s response filed April 19, 2019,
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`is entered. Applicant amended claim 1. No new
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`matter is entered. Claims 1—4 remain pending before the Office for review.
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`(2)
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`Response to Arguments
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`Applicant’s amendment to the specification is insufficient to overcome the objection of
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`record. The objection is maintained. Applicant’s specification should be amended to include the
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`patent information for the parent case, which includes the patent number and the issue date.
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`Applicant’s amendment to claim 1 is sufficient to overcome the rejections under 35
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`U.S.C. Sec. 102(b) as being anticipated by Okuda et al. (U.S. Publication No. 2004/0232009)
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`and as being anticipated by Morita et al. (U.S. Publication No. 2005/0067301). The rejections
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`are withdrawn.
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`Applicant’s remaining arguments are not persuasive. Regarding the enablement
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`rejection, Applicant argues the specification describes the claimed “voltage application section,”
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`measurement section,” “determination section” and “control section” in paragraphs 37, 52, 62,
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`69, 74 and 86. Applicant argues this is sufficient for one ordinarily skilled in the art to
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`understand the above—quoted features are part of an electronic circuit or an integrated circuit,
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`such as a processor.
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`Applicant’s argument is not persuasive because it does not address all the substantive
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`aspects of the rejection. Even assuming Applicant’s argument is accurate, the mere fact that
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
`
`Page 3
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`these components are part of a processor is insufficient
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`to enable the claimed invention. The
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`claimed invention is directed toward a sophisticated measurement device and the components
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`therein would be understood to have specific circuit arrangements to perform their recited
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`functions in the manner claimed. The specification fails to enable these specific circuit
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`arrangements and one ordinarily skilled in the art at the time of invention would not be capable
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`of practicing the claimed invention with a processor, as argued by Applicant.
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`Applicant’s argument regarding the indefiniteness rejection is also not persuasive.
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`Applicant argues the description is clear there is a physical connection between the control
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`section, the voltage application section, the measurement section, the determination section and
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`other elements having a corresponding physical structure and it is understood that a processor
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`represents the corresponding structure. Again, similarly to the above arguments, Applicant’s
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`position fails to consider the relative complexity of the expected corresponding structure and the
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`generality of a processor. A processor alone is too general to serve as the corresponding
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`structure for the means—plus—function language identified above given the relative complexity of
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`these sections. The rejection is maintained.
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`Applicant’s remaining arguments are persuasive in view of Applicant’s amendment. The
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`prior art rejections are withdrawn.
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`(3)
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`Specification
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`The disclosure is objected to because of the following informalities:
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`the specification
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`should be amended to include the patent information for the parent case. Appropriate correction
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`is required.
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
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`Page 4
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`(4)
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`Claim Rejections - 35 USC § 112
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`The following is a quotation of the first paragraph of 35 USC. 112(a):
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`(a) lN GENERAL—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 the first paragraph of pre—AIA 35 USC. 112:
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`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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`Claims 1—4 are rejected under 35 USC. 112(a) or 35 USC. 112 (pre—AIA), first
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`paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject
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`matter which was not described in the specification in such a way as to enable one skilled in the
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`art to which it pertains, or with which it is most nearly connected, to make and/or use the
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`invention.
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`There are many factors to consider when determining whether a disclosure does not
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`satisfy the enablement requirement and whether under experimentation is necessary. The factors
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`include, but are not limited to:
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`(A)
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`The breadth of the claims;
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`The claimed invention and the specification contain similar language regarding the vital
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`information measurement device and its components. Accordingly,
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`there is parity between the
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`specification and the claimed invention.
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
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`(B)
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`The nature of the invention;
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`Page 5
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`The claimed invention is directed toward a vital information measurement device having
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`an input terminal connected to a biosensor, a voltage application section that applies a voltage to
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`the input terminal, a measurement section that measures values based on a value of electric
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`current flowing in the biosensor, a determination section, a control section and a display, wherein
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`the device is operated to confirm whether abiosensor is usable. Specifically,
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`the measurement
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`section measures first and second values based on a value of the electric current flowing in the
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`biosensor when voltage is applied thereto via the voltage application section through the input
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`terminal, the control section actuates the determination section to perform first and second
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`determinations to determine whether the biosensor is usable by comparing the first and second
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`measurement values to threshold values.
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`(C)
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`The state of the prior art;
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`Okuda et al. (U.S. Publication No. 2004/0232009) teaches a vital information
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`measurement device meeting the structural requirements of the claimed invention and further
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`discloses how the components of the device interact with one another to perform measurement
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`and calculation functions. Figures 1 and 5 and Paragraphs 42, 44, 48, 50, 53—55 and 60. The
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`written description fails to describe how the claimed device executes its recited functions with a
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`similar level of detail.
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`(D)
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`The level of one of ordinary skill;
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`The level of one ordinarily skilled in the artis an individual having experience with
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`biosensors and testing methodologies for determining whether the biosensor is in a useable state.
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
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`Page 6
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`(E)
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`The level of pre dictability in the art;
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`The predictability in the art is unclear. Vital information measurement devices and
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`similar diagnostic systems are well—known in the art, it’s unclear whether the various
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`permutations of components and how they are configured to perform diagnostic measurements is
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`predictable .
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`(F)
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`The amount of direction provided by the inventor;
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`The written description provides little substantive description regarding how the vital
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`information measurement device of the claimed invention is obtained to perform the recited
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`functions. Although the written description uses language found in the claimed invention,
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`the
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`substantive description of the vital information measurement device fails to provide any specific
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`instruction regarding the structure of the voltage application section, measurement section,
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`determination section and control section. Specifically, although the written description refers to
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`the voltage application section, measurement section, determination section and control section,
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`the description fails to include any guidance regarding how these components are designed
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`and/or built to obtain a vital measurement information device meeting the functional
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`requirements of the claimed invention.
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`(G)
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`The existence of working examples; and
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`The written description does not include a complete working example regarding how the
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`vital information measurement device of the claimed invention is practiced. The written
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`description, as noted above, refers to the voltage application section, measurement section,
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`determination section and control section but fails to provide any examples regarding how the
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`components of the measurement device are structured or otherwise designed to obtain the
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`claimed device.
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
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`Page 7
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`(H)
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`The quantity of experimentation needed to make 01‘ use the invention based
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`on the content 0fthe disclosure.
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`A complete analysis of the above—identified factors leads to a finding the claimed
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`invention is not enabled. Although the claimed invention uses language found in the written
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`description,
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`the written description, as explained above, lacks any guidance and working
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`examples regarding how the vital information measurement device of the claimed invention is
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`practiced. The written description merely uses generic terminology for the device components
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`without any underlying explanation or guidance regarding the structure of the components and
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`device needed to practice the claimed invention. Therefore, claims 1—4 are rejected for lack of
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`enablement.
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`(5)
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`Claim Rejections - 35 USC § 112
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`The following is aquotation of 35 U.S.C. 112(b):
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`(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
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`The following is a quotation of 35 U.S.C. 112 (pre—AIA), second paragraph:
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`The specification shall conclude with one or more claims particularly pointingout and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`Claims 1—4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre—AIA), second
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`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
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`matter which the inventor or a joint inventor, or for pre—AIA the applicant regards as the
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`invention.
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`The claim limitations “voltage application section that applies voltage to the input
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`terminal,” “measurement section that measurement a measurement value based on a value of
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
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`Page 8
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`electric current flowing in the biosensor,” “determination section” and “control section” invoke
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`35 U.S.C. 112(f) or pre—AIA 35 U.S.C. 112, sixth paragraph. However, the written description
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`fails to disclose the corresponding structure, material, or acts for performing the entire claimed
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`function and to clearly link the structure, material, or acts to the function. Specifically, although
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`the written description refers repeatedly to the voltage application section, measurement section,
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`determination section and control section, the written description is devoid of any disclosure as
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`to what structure performs the recited function. Therefore, the claim is indefinite and is rejected
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`under 35 U.S.C. 112(b) or pre—AIA 35 U.S.C. 112, second paragraph.
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`Applicant may:
`
`(a)
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`Amend the claim so that the claim limitation will no longer be interpreted as a limitation
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`under 35 U.S.C. 112(f) or pre—AIA 35 U.S.C. 112, sixth paragraph;
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`(b)
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`Amend the written description of the specification such that it expressly recites what
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`structure, material, or acts perform the entire claimed function, without introducing any
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`new matter (35 U.S.C. 132(a)); or
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`(c)
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`Amend the written description of the specification such that it clearly links the structure,
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`material, or acts disclosed therein to the function recited in the claim, without introducing
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`any new matter (35 U.S.C. 132(a)).
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`If applicant is of the opinion that the written description of the specification already
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`implicitly or inherently discloses the corresponding structure, material, or acts and clearly links
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`them to the function so that one of ordinary skill in the art would recognize what structure,
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`material, or acts perform the claimed function, applicant should clarify the record by either:
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`(a)
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`Amending the written description of the specification such that it expressly recites the
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`corresponding structure, material, or acts for performing the claimed function and clearly
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`

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`Application/Control Number: 15/280,159
`Art Unit: 1721
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`Page 9
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`links or associates the structure, material, or acts to the claimed function, without
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`introducing any new matter (35 U.S.C. 132(a)); or
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`(b)
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`Stating on the record what the corresponding structure, material, or acts, which are
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`implicitly or inherently set forth in the written description of the specification, perform
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`the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o)
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`and 2181.
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`Therefore, the claims are indefinite because their scope is unascertainable to one
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`ordinarily skilled in the art.
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`(6)
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`Conclusion
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(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 TWO
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`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE—MONTH shortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action.
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`In no event,
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`however, will the statutory period for reply expire later than SIX MONTHS from the mailing
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`date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to ELI S MEKHLIN whose telephone number is (571)270—7597.
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`The examiner can normally be reached on Monday—Friday 7:00 am to 5:00 pm EST.
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`