`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwusptogov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`12/267,045
`
`11/07/2008
`
`Shinichi KOJIMA
`
`200871974
`
`5351
`
`52349
`
`7590
`
`05/09/2014
`
`WENDEROTH,L1ND&p0NACK LLP.
`1030 15th Street, NW.
`Suite 400 East
`Washington, DC 20005- 1503
`
`PANI, JOHN
`
`3736
`
`PAPER NUMBER
`
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`05/09/2014
`
`ELECTRONIC
`
`Please find below and/0r 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):
`ddalecki @wenderoth.com
`eoa@ wenderoth.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 12/267,045 KOJIMA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`3736JOHN PANI first“
`
`-- 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 g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions 0137 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).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 1/8/2014.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`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
`
`
`; 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.
`
`3) I] Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date 11/27/13.
`4) D Other: —-
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20140503
`
`Disposition of Claims*
`5)|XI Claim(s) Wis/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`s L67 is/are rejected.
`
`is/are objected to.
`
`) )
`
`_
`
`
`are subject to restriction and/or election requirement.
`9)|:l Claim(s
`)
`* 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)I:I All
`1.I:I Certified copies of the priority documents have been received.
`2.I:I 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
`
`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.
`
`Attach ment(s)
`
`
`
`

`

`Application/Control Number: 12/267,045
`
`Page 2
`
`Art Unit: 3736
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`DETAILED ACTION
`
`1.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Information Disclosure Statement
`
`2.
`
`The information disclosure statement (IDS) submitted on 11/27/13 was filed after
`
`the mailing date of the Non-Final Rejection on 10/11/13. The submission is in
`
`compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure
`
`statement is being considered by the examiner.
`
`Claim Rejections - 35 USC § 102
`
`3.
`
`The following is a quotation of the appropriate paragraphs of pre-AIA 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 —
`
`(a) the invention was known or used by others in this country, or patented or described in a
`printed publication in this or a foreign country, before the invention thereof by the applicant for
`a patent.
`
`(e) the invention was described in (1) an application for patent, published under section
`122(b), by another filed in the United States before the invention by the applicant for patent or
`(2) a patent granted on an application for patent by another filed in the United States before
`the invention by the applicant for patent, except that an international application filed under
`the treaty defined in section 351 (a) shall have the effects for purposes of this subsection of an
`application filed in the United States only if the international application designated the United
`States and was published under Article 21(2) of such treaty in the English language.
`
`

`

`Application/Control Number: 12/267,045
`
`Page 3
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`Art Unit: 3736
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`4.
`
`Claims 53-55, 57, 59-61, 66, and 67 are rejected under pre-AIA 35 U.S.C. 102(a)
`
`and 35 U.S.C. 102(e) as being anticipated by US Pat. No. 6,197,040 to LeVaughn et al.
`
`(“LeVaughn”).
`
`5.
`
`6.
`
`7.
`
`LeVaughn discloses:
`
`Regarding Claim 53
`
`A measuring device (10; the device is used in the process of measuring blood
`
`samples, see col. 1 ; the claim does not positively recite any sensing circuitry) for
`
`performing a measurement using a lancet-integrated sensor that is capable of being
`
`attached thereto, the lancet-integrated sensor including a lancet comprising a lancet
`
`connector body having a connector end and a needle end opposite the connector end, a
`
`needle projecting from the needle end of the lancet connector body in a lancing
`
`direction for lancing skin to collect bodily fluid, and a sensor for analyzing the collected
`
`bodily fluid (the claim has been interpreted to read upon a "measuring device" that does
`
`not currently include attached thereto a "lancet-integrated sensor" with all features
`
`detailed in the preamble of claim 53, but which could, without modification of the device,
`
`accept attachment of such a "lancet-integrated sensor" for performing a measurement
`
`as claimed; that fact that the device of LeVaughn could be used in this manner is
`
`evidenced by LeVaughn's disclosure of the lancet 40 and needle 42 being removable
`
`from the opening in lancet holder 20; a similarly shaped cartridge with a sensor
`
`integrated therewith could be placed in LeVaughn in the empty state in a manner
`
`consistent with the claimed functional limitation), the measuring device including: a drive
`
`unit including a connector receiver (distal portion of 20 that accepts lancet 40)
`
`

`

`Application/Control Number: 12/267,045
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`Page 4
`
`Art Unit: 3736
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`configured to have the connector end of the lancet connector body fitted therein (see
`
`Figs. 1-6 and col. 2—5), and a shaft (proximal portion of 20 connecting the portion
`
`between the lancet and drive spring 22) fixed to the connector receiver (see Figs. 1-6
`
`and col. 2-5), the drive unit being configured for moving the lancet connector body via
`
`the connector receiver in the Iancing direction, along a longitudinal direction of the
`
`sensor, from a standby position (Fig. 2) of the lancet connector body (see Figs. 1-6 and
`
`col. 2—5); an ejection lever (26C) configured to eject the lancet-integrated sensor from
`
`the device (see col. 4); and a case (16) to which the drive unit and the ejection lever are
`
`attached (see Figs. 1-6 and col. 2-5), wherein the drive unit is configured such that after
`
`the drive unit has moved the lancet connector body in the Iancing direction, the lancet
`
`connector body is moved back to the standby position while maintaining a state where
`
`the lancet-integrated sensor is attached to the connector receiver (see col. 3-4).
`
`8.
`
`9.
`
`Regarding Claim 54
`
`A measuring device as defined in claim 53 (see above) wherein the drive unit
`
`further includes: a spring (22) provided on the shaft to move the connector receiver in
`
`the direction in which the lancet lances the skin; and a pull stick (26) engaged with the
`
`shaft for moving the lancet back in a direction opposite to the Iancing direction (see
`
`Figs. 1-6 and col. 3-4); wherein the connector receiver has a front end (distal end) and a
`
`rear end (proximal end) opposite the front end, the front end being configured to receive
`
`the connector end of the lancet connector body, and the rear end having a front end of
`
`the shaft fixed thereto (see Figs. 1-6 and col. 3-4); wherein the pull stick is disposed at a
`
`rear end portion of the shaft opposite the front end of the shaft, and wherein the
`
`

`

`Application/Control Number: 12/267,045
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`Page 5
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`Art Unit: 3736
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`connector receiver has a claw portion (44) that stops motion of the connector receiver
`
`from a force applied by the spring (see Figs. 1-6 and col. 3-4).
`
`10.
`
`Regarding Claim 55
`
`11.
`
`A measuring device as defined in claim 54 (see above) further comprising: a
`
`support member (proximal structure against which spring 22 abuts so that it can be
`
`compressed; see Figs. 1-6 and col. 3-4) located in an internal cavity of the case, the
`
`support member for slidably supporting the shaft (allows 20 to slide), wherein the spring
`
`is a coil spring which is located between the support member of the shaft and the
`
`connector receiver (see Figs. 1-6 and col. 3-4).
`
`12.
`
`Regarding Claim 57
`
`13.
`
`A measuring device as defined in claim 54 (see above) wherein the lancet
`
`includes a needle (42) and the measuring device further comprises a lancet projection
`
`amount adjuster for adjusting an amount of projection of the needle of the lancet that
`
`lancets the skin (at least 18; see col. 2-4).
`
`14.
`
`Regarding Claim 59
`
`15.
`
`A measuring device as defined in claim 53 (see above) wherein the connector
`
`receiver has a front end and a rear end opposite the front end, the front end being
`
`configured to receive the connector end of the lancet connector body, and the rear end
`
`having a front end of the shaft fixed thereto (see Figs. 1-6 and col. 2-4).
`
`16.
`
`Regarding Claim 60
`
`

`

`Application/Control Number: 12/267,045
`
`Page 6
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`Art Unit: 3736
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`17.
`
`A measuring device as defined in claim 54 (see above) wherein the pull stick is
`
`fixed to the shaft within said case, and projects to an exterior of said case for
`
`manipulation by a user (see Figs. 1-6 and col. 2-4).
`
`18.
`
`Regarding Claim 61
`
`19.
`
`A measuring device (1 O; the device is used in the process of measuring blood
`
`samples, see col. 1 ; the claim does not positively recite any sensing circuitry) for
`
`performing a measurement using a lancet-integrated sensor capable of being attached
`
`thereto, the lancet-integrated sensor comprising a lancet connector body having a
`
`connector end and a needle end opposite the connector end, a needle projecting from
`
`the needle end of the lancet connector body in a lancing direction for lancing skin to
`
`collect bodily fluid, and a sensor for analyzing the collected bodily fluid (the claim has
`
`been interpreted to read upon a "measuring device" that does not currently include
`
`attached thereto a "lancet-integrated sensor" with all features detailed in the preamble
`
`of claim 61, but which could, without modification of the device, accept attachment of
`
`such a "lancet-integrated sensor" for performing a measurement as claimed; that fact
`
`that the device of LeVaughn could be used in this manner is evidenced by LeVaughn's
`
`disclosure of the lancet 40 and needle 42 being removable from the opening in lancet
`
`holder 20; a similarly shaped cartridge with a sensor integrated therewith could be
`
`placed in LeVaughn in the empty state in a manner consistent with the claimed
`
`functional limitation), the measuring device including: a case (16); a drive unit attached
`
`to the case, said drive unit comprising a connector receiver having front and rear end
`
`portions, the front end portion of the connector receiver having a fitting recess (front
`
`

`

`Application/Control Number: 12/267,045
`
`Page 7
`
`Art Unit: 3736
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`recess of 20) to receive the connector end of the lancet connector body (see Figs. 1-6
`
`and col. 2-4), a spring (22) urging the connector receiver in the lancing direction relative
`
`to the case (see Figs. 1-6 and col. 2-4), an engaging part (44) configured to hold the
`
`connector receiver in a standby position and to release the connector receiver from the
`
`standby position to move in the Iancing direction to provide for Iancing of the skin by the
`
`needle (see Figs. 1-6 and col. 2-4), and a shaft (portion of 20 between lancet and spring
`
`22) fixed to the rear end portion of the connector receiver and projecting in a direction
`
`opposite the Iancing direction for use in pulling the connector receiver in the direction
`
`opposite the Iancing direction against urging of the spring (see Figs. 1-6 and col. 2-4);
`
`and an ejection lever (26C) attached to the case, said ejection lever being configured to
`
`eject the lancet-integrated sensor from the device (see col. 4 and Figs. 1-6).
`
`20.
`
`Regarding Claim 66
`
`21.
`
`A measuring device as defined in claim 61 (see above) wherein the measuring
`
`device further comprises a lancet projection amount adjuster (18) for adjusting an
`
`amount of projection of the needle of the lancet that lances the skin (see Figs. 1-6 and
`
`col. 2-4).
`
`22.
`
`Regarding Claim 67
`
`23.
`
`A measuring device as defined in claim 61 (see above) wherein said case
`
`includes a claw portion (46); the engaging part of the driving unit further comprises a
`
`claw portion (44) engageable with the claw portion of the case (see Figs. 1-6 and col. 2-
`
`4); and said case further includes a push button (30) for disengaging the claw portion of
`
`the engaging part from the claw portion of the case (see Figs. 1-6 and col. 2-4).
`
`

`

`Application/Control Number: 12/267,045
`
`Page 8
`
`Art Unit: 3736
`
`24.
`
`Claims 53, 54, and 61 -63 are rejected under pre-AIA 35 U.S.C. 102(e) as being
`
`anticipated by US 2002/0130042 to Moerman et al. (“Moerman”).
`
`25. Moerman discloses:
`
`26.
`
`Regarding Claim 53
`
`27.
`
`A measuring device (device of Figs. 1-20) for performing a measurement using a
`
`lancet-integrated sensor that is capable of being attached thereto, the lancet-integrated
`
`sensor including a lancet comprising a lancet connector body having a connector end
`
`and a needle end opposite the connector end, a needle projecting from the needle end
`
`of the lancet connector body in a lancing direction for lancing skin to collect bodily fluid,
`
`and a sensor for analyzing the collected bodily fluid (the claim has been interpreted to
`
`read upon a "measuring device" that does not currently include attached thereto a
`
`"lancet-integrated sensor" with all features detailed in the preamble of claim 53, but
`
`which could, without modification of the device, accept attachment of such a "lancet-
`
`integrated sensor" for performing a measurement as claimed; that fact that the device of
`
`Moerman could be used in this manner is evidenced by Moerman’s disclosure in
`
`paragraphs [0025-0028] of the lancets and electrochemical sensors being removable
`
`from the opening in lancet holder 29; a similarly shaped cartridge with a sensor
`
`integrated therewith could be placed in Moerman in the empty state in a manner
`
`consistent with the claimed functional limitation), the measuring device including: a drive
`
`unit including a connector receiver (29) configured to have the connector end of the
`
`lancet connector body fitted therein (see Figs. 1-20 and [0024-0028]), and a shaft (24)
`
`

`

`Application/Control Number: 12/267,045
`
`Page 9
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`Art Unit: 3736
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`fixed to the connector receiver (see Figs. 1-20 and [0024-0028]), the drive unit being
`
`configured for moving the lancet connector body via the connector receiver in the
`
`Iancing direction, along a longitudinal direction of the sensor, from a standby position of
`
`the lancet connector body (see Figs. 1-20 and [0024-0028]); an ejection lever (7)
`
`configured to eject the lancet-integrated sensor from the device (see Figs. 1-20 and
`
`[0024-0028]); and a case (1) to which the drive unit and the ejection lever are attached
`
`(see Figs. 1-20 and [0024-0028]), wherein the drive unit is configured such that after
`
`the drive unit has moved the lancet connector body in the Iancing direction, the lancet
`
`connector body is moved back to the standby position while maintaining a state where
`
`the lancet-integrated sensor is attached to the connector receiver (see Figs. 1-20 and
`
`[0024-0028]).
`
`28.
`
`Regarding Claim 54
`
`29.
`
`A measuring device as defined in claim 53, wherein the drive unit further includes
`
`a spring (20) provided on the shaft to move the connector receiver in the direction in
`
`which the lancet lances the skin (see Figs. 1-20 and [0024-0028]); and a pull stick
`
`(portion of 27 gripped by user) engaged with the shaft for moving the lancet back in a
`
`direction opposite to the Iancing direction (see Figs. 1-20 and [0024-0028]); Wherein the
`
`connector receiver has a front end and a rear end opposite the front end, the front end
`
`being configured to receive the connector end of the lancet connector body, and the
`
`rear end having a front end of the shaft fixed thereto; wherein the pull stick is disposed
`
`at a rear end of the shaft opposite the front end of the shaft, and wherein the connector
`
`

`

`Application/Control Number: 12/267,045
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`Page 10
`
`Art Unit: 3736
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`receiver has a claw portion (portion of 27 that engages 29) that stops motion of the
`
`connector receiver from a force applied by the spring (see Figs. 1-20 and [0024-0028]).
`
`30.
`
`Regarding Claim 61
`
`31.
`
`A measuring device (device of Figs. 1-20) for performing a measurement using a
`
`lancet-integrated sensor capable of being attached thereto, the lancet-integrated sensor
`
`comprising a lancet connector body having a connector end and a needle end opposite
`
`the connector end, a needle projecting from the needle end of the lancet connector
`
`body in a lancing direction for lancing skin to collect bodily fluid, and a sensor for
`
`analyzing the collected bodily fluid (the claim has been interpreted to read upon a
`
`"measuring device" that does not currently include attached thereto a "lancet-integrated
`
`sensor" with all features detailed in the preamble of claim 61, but which could, without
`
`modification of the device, accept attachment of such a "lancet-integrated sensor" for
`
`performing a measurement as claimed; that fact that the device of Moerman could be
`
`used in this manner is evidenced by Moerman’s disclosure in paragraphs [0025-0028]
`
`of the lancets and electrochemical sensors being removable from the opening in lancet
`
`holder 29; a similarly shaped cartridge with a sensor integrated therewith could be
`
`placed in Moerman in the empty state in a manner consistent with the claimed
`
`functional limitation), the measuring device including: a case (1); a drive unit attached to
`
`the case, said drive unit comprising a connector receiver having front and rear end
`
`portions, the front end portion of the connector receiver having a fitting recess (recess in
`
`29) to receive the connector end of the lancet connector body (see Figs. 1-20 and
`
`[0024-0028]), a spring (20) urging the connector receiver in the lancing direction relative
`
`

`

`Application/Control Number: 12/267,045
`
`Page 11
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`Art Unit: 3736
`
`to the case (see Figs. 1-20 and [0024-0028]), an engaging part (27) configured to hold
`
`the connector receiver in a standby position and to release the connector receiver from
`
`the standby position to move in the Iancing direction to provide for Iancing of the skin by
`
`the needle (see Figs. 1-20 and [0024-0028]), and a shaft (24) fixed to the rear end
`
`portion of the connector receiver and projecting in a direction opposite the Iancing
`
`direction for use in pulling the connector receiver in the direction opposite the Iancing
`
`direction against urging of the spring (see Figs. 1-20 and [0024-0028]); and an ejection
`
`lever (7) attached to the case, said ejection lever being configured to eject the lancet-
`
`integrated sensor from the device (see Figs. 1-20 and [0024-0028]).
`
`32.
`
`Regarding Claim 62
`
`33.
`
`A measuring device as defined in claim 61 (see above) wherein the spring is
`
`disposed about the shaft (see Figs. 2A-2C).
`
`34.
`
`Regarding Claim 63
`
`35.
`
`A measuring device as defined in claim 62 (see above) wherein the shaft has a
`
`front end portion and a rear end portion, and the front end portion of the shaft is fixed to
`
`the rear end portion of the connector receiver; and the driving unit further includes a pull
`
`stick (portion of 27 gripped by user) engaged with a rear end portion of the shaft and
`
`projecting outwardly of the case for manipulation by the user (see Figs. 1-20 and [0024-
`
`OO28D.
`
`

`

`Application/Control Number: 12/267,045
`
`Page 12
`
`Art Unit: 3736
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`Claim Rejections - 35 USC § 103
`
`36.
`
`The following is a quotation of pre-AIA 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.
`
`37.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating
`
`obviousness or nonobviousness.
`
`38.
`
`Claims 56, 64, and 65 are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over US 2002/0130042 to Moerman et al. (“Moerman”) in view of US Pat.
`
`No. 6,228,100 to Schraga (“Schraga”).
`
`39.
`
`Regarding Claim 56
`
`40. Moerman discloses a measuring device (device of Figs. 1-2C; the device is used
`
`in the process of measuring blood samples, see full disclosure; the claim does not
`
`positively recite any sensing circuitry) for performing a measurement using a lancet-
`
`integrated sensor that is capable of being attached thereto, the lancet-integrated sensor
`
`

`

`Application/Control Number: 12/267,045
`
`Page 13
`
`Art Unit: 3736
`
`including a lancet comprising a lancet connector body having a connector end and a
`
`needle end opposite the connector end, a needle projecting from the needle end of the
`
`lancet connector body in a lancing direction for lancing skin to collect bodily fluid, and a
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`sensor for analyzing the collected bodily fluid (the claim has been interpreted to read
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`upon a "measuring device" that does not currently include attached thereto a "lancet-
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`integrated sensor" with all features detailed in the preamble of claim 53, but which
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`could, without modification of the device, accept attachment of such a "lancet-integrated
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`sensor" for performing a measurement as claimed; that fact that the device of Moerman
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`could be used in this manner is evidenced by Moerman’s disclosure in paragraphs
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`[0025-0028] of the lancets and electrochemical sensors being removable from the
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`opening in lancet holder 29; a similarly shaped cartridge with a sensor integrated
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`therewith could be placed in Moerman in the empty state in a manner consistent with
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`the claimed functional limitation), the measuring device including: a drive unit including
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`a connector receiver (29) configured to have the connector end of the lancet connector
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`body fitted therein (see Figs. 1-20 and [0024-0028]), and a shaft (24) fixed to the
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`connector receiver (see Figs. 1-20 and [0024-0028]), the drive unit being configured for
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`moving the lancet connector body via the connector receiver in the lancing direction,
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`along a longitudinal direction of the sensor, from a standby position of the lancet
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`connector body (see Figs. 1-20 and [0024-0028]); an ejection lever (7) configured to
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`eject the lancet-integrated sensor from the device (see Figs. 1-20 and [0024-0028]);
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`and a case (1) to which the drive unit and the ejection lever are attached (see Figs. 1-
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`20 and [0024-0028]), wherein the drive unit is configured such that after the drive unit
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`has moved the lancet connector body in the Iancing direction, the lancet connector body
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`is moved back to the standby position while maintaining a state where the lancet-
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`integrated sensor is attached to the connector receiver (see Figs. 1-20 and [0024-
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`0028p.
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`41.
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`However, Moerman does not disclose the pull stick has an opening at an end
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`toward the side where the lancet lances the skin, the end of the shaft toward the side
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`opposite to the side where the lancet lances the skin is slidably housed in the pull stick
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`through the opening, and the end of the shaft toward the side opposite to the side where
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`the lancet lancet lances the skin has a slip-out prevention member for preventing the
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`end of the shaft from slipping out of the pull stick toward the side where the lancet
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`lances the skin.
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`42.
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`Schraga discloses a measuring device where the pull stick (at least 32 and
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`gripping portion of 30) has an opening (see Fig. 2; opening in 32 in which 24 rides) at an
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`end toward the side where the lancet lances the skin, the end of the shaft toward the
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`side opposite to the side where the lancet lances the skin is slidably housed in the pull
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`stick through the opening (see Fig. 2 and col. 5-7), and the end of the shaft toward the
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`side opposite to the side where the lancet lancet lances the skin has a slip-out
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`prevention member (28) for preventing the end of the shaft from slipping out of the pull
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`stick toward the side where the lancet lances the skin (see Figs. 1-4 and col. 5-7).
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`43.
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`One of ordinary skill in the art at the time of the invention could have modified
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`Moerman by simply substituting the actuation system of Schraga (Le. 30, 32, 35, 34, 29,
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`and 28) for that of Moerman (27 and 29), and the results of the substitution would have
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`been predictable, because it merely would have resulted in a slightly different means of
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`cocking, and then holding the shaft against the spring bias, and then allowing for the
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`bias to be released to lance, as is evident from the otherwise similar nature of the
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`devices. The claimed invention is obvious because a claim is obvious when substitution
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`of one known element for another yields predictable results to one of ordinary skill in the
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`art. See MPEP 2143(I)(B).
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`44.
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`Regarding Claims 64 and 65
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`45. Moerman discloses the device of claim 63 (see above) but does not explicitly
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`disclose the pull stick is hollow, and has an opening at a front end thereof; the shaft
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`projects throught the opening of the pull stick so that the rear end portion of the shaft is
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`disposed in an interior of the pull stick, wherein the shaft has a slip-out prevention
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`member at the rear end portion thereof to prevent disengagement of the shaft from the
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`pull stick.
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`46.
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`Schraga discloses a measuring device where the pull stick (30 and 32) is hollow,
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`and has an opening at a front end thereof; the shaft projects through the opening of the
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`pull stick so that the rear end portion of the shaft is disposed in an interior of the pull
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`stick (see Figs. 1-4 and col. 5-7) and the shaft has a slip-out prevention member (28) at
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`the rear end portion thereof to prevent disengagement of the shaft from the pull stick
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`(see Figs. 1-4 and col. 5-7).
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`47.
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`One of ordinary skill in the art at the time of the invention could have modified
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`Moerman by simply substituting the actuation system of Schraga (Le. 30, 32, 35, 34, 29,
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`and 28) for that of Moerman (27 and 29), and the results of the substitution would have
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`been predictable, because it merely would have resulted in a slightly different means of
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`cocking, and then holding the shaft against the spring bias, and then allowing for the
`
`bias to be released to lance, as is evident from the otherwise similar nature of the
`
`devices. The claimed invention is obvious because a claim is obvious when substitution
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`of one known element for another yields predictable results to one of ordinary skill in the
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`art. See MPEP 2143(|)(B).
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`48.
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`Claims 57 and 58 are rejected under pre-AIA 35 U.S.C. 103(a) as being
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`unpatentable over Moerman in view of Schraga as applied to claim 56 above, and
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`further in view of US Pat. No. 5,971,941 to Simons et al (“Simons”).
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`49. Moerman in view of Schraga discloses the device of claim 56 (see above)
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`wherein the pull stick has a cylindrical part (e.g. 32; see Fig. 2; note a square shape is a
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`first approximation of a cylinder; note also that if the shape were not considered
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`approximately cylindrical, it would have been an obvious design choice to make the
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`shape cylindrical, e.g. for aesthetic or gripping purposes, as the Applicant’s disclosure
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`provides no criticality to the shape; see MPEP 2144.04(l) and 2144.04(IV)(B)), and an
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`end (gripping portion sticking out of casing) of the pull stick toward the side opposite to
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`the side where the lancet lancets the skin has a handle part having a portion with a
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`diameter larger than a diameter of the part of the pull stick that is square in shape (see
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`Fig. 2; note a square shape is a first approximation of a cylinder; note it would have
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`been an obvious design choice to make the shape cylindrical, e.g. for aesthetic or
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`gripping purposes, as the Applicant’s disclosure provides no criticality to the shape; see
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`MPEP 2144.04(l) and 2144.04(|V)(B)); the part of the pull stick thus modified to be
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`cylindrical in shape is slidably housed through an opening (see Figs. 1-2).
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`50.
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`However, Moerman in view of Schraga does not explicitly disclose a lancet
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`projection amount adjuster that is approximately cylindrical in shape, and an end of the
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`lancet projection amount adjuster toward the side opposite to the side where the lancet
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`lances the skin has an opening with a diameter equal to the diameter of the part of the
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`pull stick that is approximately cylindrical in shape, and the part of the pull stick that is
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`approximately cylindrical in shape is slidably housed through the opening, and the
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`lancet projection amount adjuster is screwed into a screw hole that is formed on a side
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`surface of the case toward the side opposite to the side where the lancet lances the
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`skin, toward an inside of the case, whereby the lancet projection amount adjuster is
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`rotatable in a screw direction and an unscrew direction to adjust the amount of
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`projection of the lancet.
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`51.
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`Simons discloses a measuring device wherein a lancet projection amount
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`adjuster (560) for adjusting an amount of projection of a needle tip of the lancet that
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`lances the skin (see col. 9 line 63 - col. 11 line 46) is approximately cylindrical in shape
`
`(se