`
`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
`
`10/11/2013
`
`WENDEROTH,L1ND&p0NACK L112.
`1030 15th Street, NW.
`Suite 400 East
`Washington, DC 20005- 1503
`
`PANI, JOHN
`
`3736
`
`PAPER NUMBER
`
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`10/1 1/2013
`
`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 Inventor to File)
`Office Action Summary
`
`JOHN PANI its“ 3736
`
`-- 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)IZI Responsive to communication(s) filed on 5/25/2010 and 7/1/2010.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|:l 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)|:| 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZI Claim(s) Wis/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`7)|Z| Claim(s) Wis/are rejected.
`8)|:I Claim(s)
`is/are objected to.
`
`
`
`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
`
`
`
`:/'/\W¢W.LISI>I‘.0. ovI’ atentS/init events/
`hI/index.‘s orsend an inquiryto PPI-iieedback{®usgtc.00v.
`
`hit
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)I:l 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:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some * c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`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)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) E Notice of References Cited (PTO-892)
`
`3) D Interview Summary (PTO-413)
`
`Paper N°ISI/Ma" Date' —
`PTO/SB/Os
`t
`t
`St
`I
`D'
`I'
`f
`2 IZI I
`
`)
`4) I:I Other:
`Isc osure
`n orma Ion
`)
`a emen (s) (
`Paper No(s)/Mai| Date 6/23/10 6/4/13.
`
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 08-13)
`
`Part of Paper No./Mai| Date 20131006
`
`Office Action Summary
`
`

`

`Application/Control Number: 12/267,045
`
`Page 2
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`Art Unit: 3736
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`DETAILED ACTION
`
`1.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Continued Examination Under 37 CFR 1. 1 14
`
`2.
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`5/25/2010 has been entered.
`
`Information Disclosure Statement
`
`3.
`
`The information disclosure statements (IDS) submitted on 6/23/2010 and
`
`6/04/2013 were filed prior to a first action after filing the RCE 6/23/2010 The
`
`submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the
`
`information disclosure statements are being considered by the examiner.
`
`Claim Interpretation - 35 USC § 112, Sixth Paragraph
`
`4.
`
`The following is a quotation of 35 U.S.C. 112(f):
`
`(f) Element in Claim for a Combination. — An element in a claim for a combination may be
`expressed as a means or step for performing a specified function without the recital of
`structure, material, or acts in support thereof, and such claim shall be construed to cover the
`
`

`

`Application/Control Number: 12/267,045
`
`Page 3
`
`Art Unit: 3736
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`corresponding structure, material, or acts described in the specification and equivalents
`thereof.
`
`The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
`
`An element in a claim for a combination may be expressed as a means or step for performing
`a specified function without the recital of structure, material, or acts in support thereof, and
`such claim shall be construed to cover the corresponding structure, material, or acts
`described in the specification and equivalents thereof.
`
`5.
`
`Use of the word “means” (or “step for”) in a claim with functional language
`
`creates a rebuttable presumption that the claim element is to be treated in accordance
`
`with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that
`
`§ 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is
`
`recited with sufficient structure, material, or acts within the claim itself to entirely perform
`
`the recited function.
`
`Absence of the word “means” (or “step for”) in a claim creates a rebuttable
`
`presumption that the claim element is not to be treated in accordance with 35 U.S.C. §
`
`112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA
`
`§ 112, sixth paragraph) is not invoked is rebutted when the claim element recites
`
`function but fails to recite sufficiently definite structure, material or acts to perform that
`
`function.
`
`Claim elements in this application that use the word “means” (or “step for”) are
`
`presumed to invoke § 112(f) except as otherwise indicated in an Office action.
`
`Similarly, claim elements that do not use the word “means” (or “step for”) are presumed
`
`not to invoke § 112(f) except as otherwise indicated in an Office action.
`
`

`

`Application/Control Number: 12/267,045
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`Page 4
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`Art Unit: 3736
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`Claim Objections
`
`6.
`
`Claims 63 and 67 are objected to because of the following informalities:
`
`In line 3
`
`of claim 63, it appears the word “to” has been omitted between “fixed” and “the rear end
`
`portion”.
`
`In line 2 of claim 67, it appears “includes" has been misspelled as “include”.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 1 12
`
`7.
`
`The following is a quotation of 35 U.S.C. 112(b):
`(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.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`8.
`
`Claims 53-67 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
`
`second paragraph, as being indefinite for failing to particularly point out and distinctly
`
`claim the subject matter which the inventor or a joint inventor, or for pre-AIA the
`
`applicant regards as the invention.
`
`9.
`
`Regarding Claim 53-67
`
`10.
`
`Lines 1-6 of claim 53, and lines 1-5 of claim 61, recite "[a] measuring device fo_r
`
`performing a measurement using a lancet-integrated sensor that is 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
`
`

`

`Application/Control Number: 12/267,045
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`Page 5
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`Art Unit: 3736
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`collect bodily fluid, and a sensor for analyzing the collected bodily fluid, the measuring
`
`device including: a drive unit. .
`
`. and a case. .
`
`.
`
`11.
`
`It is unclear whether the “lancet-integrated sensor” as detailed in lines 1-6 is a
`
`positively recited structural element of the claimed “measuring device,” or merely part of
`
`a functional limitation that requires that the device is capable of performing a
`
`measurement using a lancet-integrated sensor that, as a part of that function, is
`
`attached to the measuring device. The detailed nature of the description suggests the
`
`former interpretation, but the plain language, and the fact that the "lancet-integrated
`
`sensor" is listed only in the preamble of the claim, and not as one of the structures that
`
`the "measuring device includ[es]," suggests the latter interpretation. This lack of clarity
`
`regarding the scope of the independent claims 53 and 61 renders claims 53-67
`
`indefinite.
`
`12.
`
`Note that for purposes of applying prior art, the latter interpretation has been
`
`applied herein, as it appears to be the broadest reasonable interpretation consistent
`
`with the specification.
`
`In other words, 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 claims 53 and 61, but which could, without
`
`modification of the device, accept attachment of a "lancet-integrated sensor" for
`
`performing a measurement as claimed.
`
`13.
`
`Regarding Claim 56
`
`14.
`
`Line 2 refers to “the side where the lancet lances the skin,” which lacks
`
`antecedent basis in the claims. Line 3 refers to “the end of the shaft toward the side
`
`

`

`Application/Control Number: 12/267,045
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`Page 6
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`Art Unit: 3736
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`opposite to the side where the lancet lances the skin,” with “the end of the shaft” and
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`“the side opposite” lacking antecedent basis in the claims.
`
`15.
`
`Regarding Claim 58
`
`16.
`
`The term "approximately" in claim 58 is a relative term which renders the claim
`
`indefinite. The term "approximately" is not defined by the claim, the specification does
`
`not provide a standard for ascertaining the requisite degree, and one of ordinary skill in
`
`the art would not be reasonably apprised of the scope of the invention. The
`
`specification does not provide an explicit range of deviation from "cylindrical in shape,"
`
`nor does it provide a listing of shapes that do and do not fall within the claimed range
`
`such that one of ordinary skill would have been able to ascertain it. Nor is a function
`
`disclosed suggesting what shapes would be appropriate and which would not. Nor is a
`
`figure provided suggesting appropriate shapes. Nor is there any evidence that the
`
`common knowledge of one of ordinary skill in the art would understand what is and is
`
`not within the claimed range.
`
`17.
`
`Regarding Claim 61
`
`18.
`
`Lines 14-15 recite “the direction opposite the lancing direction," which lacks
`
`antecedent basis in the claims.
`
`19.
`
`Lines 10 and 11 include two instances of “the receiver connector,” which lack
`
`antecedent basis in the claims.
`
`

`

`Application/Control Number: 12/267,045
`
`Page 7
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`Art Unit: 3736
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`Claim Rejections - 35 USC § 102
`
`20.
`
`The following is a quotation of the appropriate paragraphs of pre-AlA 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.
`
`21.
`
`Claims 53-57 and 59-67 are rejected under both pre-AlA 35 U.S.C. 102(a) and
`
`35 U.S.C. 102(e) as being anticipated by US Pat. No. 6,228,100 to Schraga
`
`(“Schraga”).
`
`22.
`
`Schraga discloses:
`
`23.
`
`Regarding Claim 53
`
`24.
`
`A measuring device (10; the device is used in the process of measuring blood
`
`glucose, see col. 1 lines 15-28; the claim does not positively recite any sensing circuitry)
`
`for performing a measurement using a lancet-integrated sensor that is 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
`
`(please note the claim has been interpreted to read upon a “measuring device” that
`
`

`

`Application/Control Number: 12/267,045
`
`Page 8
`
`Art Unit: 3736
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`does not currently include attached thereto a “lancet-integrated sensor” with all features
`
`detailed in claim 53, but which could, without modification of the device, accept
`
`attachment of such a "lancet-integrated sensor" for performing a measurement as
`
`claimed; the fact that the device of Schraga could be used in this manner is evidenced
`
`by Schraga’s disclosure of a state in which cartridge 46 is removed from the device, see
`
`col. 5 lines 1-25, combined with its structure, which accepts a lancet 70 comprising a
`
`lancet connector body, 75 and 76, having a connector end, end near 76, and a needle
`
`end, end near 74, opposite the connector end, and a needle, 74, projecting from the
`
`needle end of the lancet connector body in a lancing direction for lancing skin to collect
`
`bodily fluid; see Figs. 1-4 and col. 3-7; a similar cartridge with a sensor somehow
`
`integrated therewith could be placed in Schraga in the empty state in a manner
`
`consistent with the claimed functional limitation), the measuring device including: a drive
`
`unit (at least 24) including a connector receiver (25 and 26) configured to have the
`
`connector end of the lancet connector body fitted therein (within 26), and a shaft (shaft
`
`of 24) fixed to the connector receiver (see Figs. 1-4 and col. 3-7), the drive unit being
`
`configured for moving the lancing connector body via the connector receiver in the
`
`lancing direction (see col. 5-7 and Figs. 1-4), along a longitudinal direction of the sensor
`
`(note that this limitation is similarly interpreted to be part of the functional requirement
`
`that the device could be used with a lancet-integrated sensor, particularly one which has
`
`a longitudinal direction along which the lancing connector body moves; Schraga could
`
`be used with such a lancet-integrated sensor), from a standby position of the lancet
`
`connector body (see e.g. Fig. 2 and col. 3-7); and a case (42 and exterior of 20) to
`
`

`

`Application/Control Number: 12/267,045
`
`Page 9
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`Art Unit: 3736
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`which the drive unit is attached (see Figs. 1-4 and col. 3-7), 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. 1-4 and col. 3-7).
`
`25.
`
`Regarding Claim 54
`
`26.
`
`The measuring device of claim 53 (see above) wherein the drive unit further
`
`includes: a spring (27) provided on the shaft (see Fig. 2) to move the connector receiver
`
`in the direction in which the lancet lances the skin (see col. 5-7); and a pull stick (at
`
`least 32 and gripping portion of 30) engaged with the shaft for moving the lancet back in
`
`a direction opposite to the Iancing direction (see Fig. 2 and col. 5-7); 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 Fig. 2 and col. 5-7); wherein
`
`the pull stick is disposed at a rear end portion of the shaft opposite the front end of the
`
`shaft (see Fig. 2), and wherein the connector receiver has a claw portion (29) that stops
`
`motion of the connector receiver from a force applied by the spring (see Figs. 2-3 and
`
`col. 5-7).
`
`27.
`
`Regarding Claim 55
`
`28.
`
`The measuring device of claim 54 (see above) further comprising a support
`
`member (structure located between spring 27 and fingers 32, which includes a gap in
`
`which the shaft of 24 rides) located in an internal cavity of the case, the support member
`
`

`

`Application/Control Number: 12/267,045
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`Page 10
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`Art Unit: 3736
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`for slidably supporting the shaft, wherein the spring is a coil spring (see Fig. 2) which is
`
`located between the support member of the shaft and the connector receiver (see Fig.
`
`2).
`
`29.
`
`Regarding Claim 56
`
`30.
`
`The measuring device of claim 54 (see above) wherein the pull stick has an
`
`opening (see Fig. 2; opening in 32 in which 24 rides) at an end toward the side where
`
`the lancet lances the skin, the end of the shaft toward the side opposite to the side
`
`where the lancet lances the skin is slidably housed in the pull stick through the opening
`
`(see Fig. 2 and col. 5-7), and the end of the shaft toward the side opposite to the side
`
`where the lancet lancet lances the skin has a slip-out prevention member (28) for
`
`preventing the end of the shaft from slipping out of the pull stick toward the side where
`
`the lancet lances the skin (see Figs. 1-4 and col. 5-7).
`
`31.
`
`Regarding Claim 57
`
`32.
`
`The measuring device of claim 54 (see above) wherein the lancet includes a
`
`needle (note this is interpreted as a modification of the functional limitation of claim 53,
`
`but the lancets removed from Schraga have a needle 74'), and the measuring device
`
`further comprises a lancet projection amount adjuster (92 and 94) for adjusting an
`
`amount of projection of the needle of the lancet that lances the skin (see Figs. 1-6 and
`
`col. 4 lines 1-15; note that if this device were flipped down, a lesser projection would be
`
`allowed than if it were flipped up).
`
`33.
`
`Regarding Claim 59
`
`

`

`Application/Control Number: 12/267,045
`
`Page 11
`
`Art Unit: 3736
`
`34.
`
`The measuring device of claim 53 (see above) wherein the connector receiver
`
`has a front end (end near 26) and a rear end (end to which shaft attaches) 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.
`
`1-4).
`
`35.
`
`Regarding Claim 60
`
`36.
`
`The measuring device of claim 54 (see above) wherein the pull stick is fixed to
`
`the shaft within said case (see Fig. 2 and col. 5-7), and projects to an exterior of said
`
`case for manipulation by a user (see Figs. 1-4 and col. 5-7).
`
`37.
`
`Regarding Claim 61
`
`38.
`
`A measuring device (1 O; the device is used in the process of measuring blood
`
`glucose, see col. 1 lines 15-28; the claim does not positively recite any sensing circuitry)
`
`for performing a measurement using a lancet-integrated sensor that is 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
`
`(please note 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 claim 53, but which could, without modification of the device, accept
`
`attachment of such a "lancet-integrated sensor" for performing a measurement as
`
`claimed; the fact that the device of Schraga could be used in this manner is evidenced
`
`

`

`Application/Control Number: 12/267,045
`
`Page 12
`
`Art Unit: 3736
`
`by Schraga’s disclosure of a state in which cartridge 46 is removed from the device, see
`
`col. 5 lines 1-25, combined with its structure, which accepts a lancet 70 comprising a
`
`lancet connector body, 75 and 76, having a connector end, end near 76, and a needle
`
`end, end near 74, opposite the connector end, and a needle, 74, projecting from the
`
`needle end of the lancet connector body in a lancing direction for lancing skin to collect
`
`bodily fluid; see Figs. 1-4 and col. 3-7; a similar cartridge with a sensor somehow
`
`integrated therewith could be placed in Schraga in the empty state in a manner
`
`consistent with the claimed functional limitation), the measuring device including: a case
`
`(42 and exterior of 20); and a drive unit attached to the case, said drive unit comprising
`
`a connector receiver (25 and 26) having front (end near 26) and rear (end to which shaft
`
`attaches) end portions, the front end portion of the connector receiver having a fitting
`
`recess (26) to receive the connector end of the lancet connector body (see Fig. 2 and
`
`col. 5-7), a spring (27) urging the connector receiver in the lancing direction relative to
`
`the case (see Fig. 2 and col. 5-7), an engaging part (29) configured to hold the receiver
`
`connector in a standby position and to release the receiver connector from the standby
`
`position to move in the lancing direction to provide for lancing of the skin by the needle
`
`(see Figs. 2-3 and col. 5-7), and a shaft (shaft portion of 24) fixed to the rear end portion
`
`of the connector receiver and projecting in a direction opposite the lancing direction for
`
`use in pulling the connector receiver in the direction opposite the lancing direction
`
`against urging of the spring (see Figs. 1-6 and col. 5-7).
`
`39.
`
`Regarding Claim 62
`
`

`

`Application/Control Number: 12/267,045
`
`Page 13
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`40.
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`The measuring device of claim 61 (see above) wherein the spring is disposed
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`about the shaft (see Fig. 2).
`
`41.
`
`Regarding Claim 63
`
`42.
`
`The measuring device of claim 62 (see above) wherein the shaft has a front end
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`portion (end of shaft of 24 fixed to 25) and a rear end portion (opposite end of shaft of
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`24)(see Figs. 1-6), and the front end portion of the shaft is fixed to the rear end portion
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`of the connector receiver (see Figs. 1-6 and col. 5-7) and the driving unit further
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`includes a pull stick (at least 32 and gripping portion of 30) engaged with a rear end
`
`portion of the shaft and projecting outwardly of the case for manipulation by a user (see
`
`Figs. 1-4 and col. 5-7).
`
`43.
`
`Regarding Claim 64
`
`44.
`
`The measuring device of claim 63 (see above) wherein the pull stick is hollow,
`
`and has an opening at a front end thereof; the shaft projects through the opening of the
`
`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).
`
`45.
`
`Regarding Claim 65
`
`46.
`
`The measuring device of claim 64 (see above) wherein the shaft has a slip-out
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`prevention member (28) at the rear end portion thereof to prevent disengagement of the
`
`shaft from the pull stick (see Figs. 1-4 and col. 5-7).
`
`47.
`
`Regarding Claim 66
`
`48.
`
`The measuring device of claim 61 (see above) wherein the measuring device
`
`further comprises a lancet projection amount adjuster (92 and 94) for adjusting an
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`amount of projection of the needle of the lancet that lances the skin (see Figs. 1-6 and
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`col. 4 lines 1-15; note that if this device were flipped down, a lesser projection would be
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`allowed than if it were flipped up).
`
`49.
`
`Regarding Claim 67
`
`50.
`
`The measuring device of claim 61 (see above) wherein said case includes a claw
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`portion (34); the engaging part of the driving unit further comprises a claw portion (29)
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`engageable with the claw portion of the case; and said case further includes a push
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`button (35)
`
`for disengaging the claw portion of the engaging part from the claw portion
`
`of the case (see Figs. 1-6 and col. 5-7).
`
`Claim Rejections - 35 USC § 103
`
`51.
`
`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.
`
`52.
`
`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
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`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.
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`Art Unit: 3736
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`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
`
`53.
`
`This application currently names joint inventors. In considering patentability of the
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`claims under pre-AIA 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
`
`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
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`consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C.
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`102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
`
`54.
`
`Claim 58 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
`
`Schraga as applied to claim 57 above, and further in view of US Pat. No. 5,971,941 to
`
`Simons et al (“Simons”).
`
`55.
`
`Schraga discloses the device of claim 57 (see above) wherein the pull stick has a
`
`part (e.g. 32) that is approximately cylindrical in shape (see Fig. 2; note a square shape
`
`is a first approximation of a cylinder; note also that if the shape were not considered
`
`approximately cylindrical, it would have been an obvious design choice to make the
`
`shape cylindrical, e.g. for aesthetic or gripping purposes, as the Applicant’s disclosure
`
`provides no criticality to the shape; see MPEP 2144.04(l) and 2144.04(IV)(B)), and an
`
`end (gripping portion sticking out of casing) of the pull stick toward the side opposite to
`
`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 approximately
`
`cylindrical in shape (see Fig. 2; note a square shape is a first approximation of a
`
`cylinder; note also that if the shape were not considered approximately cylindrical, it
`
`would have been an obvious design choice to make the shape cylindrical, e.g. for
`
`aesthetic or gripping purposes, as the Applicant’s disclosure provides no criticality to the
`
`shape; see MPEP 2144.04(l) and 2144.04(|V)(B)); the part of the pull stick that is
`
`approximately cylindrical in shape is slidably housed through an opening (see Figs. 1-
`
`2).
`
`56.
`
`However, Schraga does not explicitly disclose a lancet projection amount
`
`adjuster that is approximately cylindrical in shape, and an end of the lancet projection
`
`amount adjuster toward the side opposite to the side where the lancet lances the skin
`
`has an opening with a diameter equal to the diameter of the part of the pull stick that is
`
`approximately cylindrical in shape, and the part of the pull stick that is approximately
`
`cylindrical in shape is slidably housed through the opening, and the lancet projection
`
`amount adjuster is screwed into a screw hole that is formed on a side surface of the
`
`case toward the side opposite to the side where the lancet lances the skin, toward an
`
`inside of the case, whereby the lancet projection amount adjuster is rotatable in a screw
`
`direction and an unscrew direction to adjust the amount of projection of the lancet.
`
`57.
`
`Simons discloses a measuring device wherein a lancet projection amount
`
`adjuster (560) for adjusting an amount of projection of a needle tip of the lancet that
`
`lances the skin (see col. 9 line 63 - col. 11 line 46) is approximately cylindrical in shape
`
`(see Figs. 4A-4B and col. 9 line 63 — col. 11 line 46), and an end of the lancet projection
`
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`amount adjuster toward the side opposite to the side where the lancet lances the skin
`
`has an opening with a diameter equal to the diameter of the part of the pull stick that is
`
`approximately cylindrical in shape (see Figs. 4A-4B and col. 9 line 63 - col. 11 line 46);
`
`and the part of the pull stick that is approximately cylindrical in shape is slidably housed
`
`through the opening (see Figs. 4A and 4B and col. 9 line 63 — col. 11 line 46), and the
`
`lancet projection amount adjuster is screwed into a screw hole (see Figs. 4A and 4B
`
`and col. 9 line 63 - col. 11 line 46) that is formed on a side surface of the case toward
`
`the side opposite to the side where the lancet lances the skin, toward an inside of the
`
`case, whereby the lancet projection amount adjuster is rotatable in a screw direction
`
`and an unscrew direction to adjust the amount of projection of the lancet (see Figs. 4A-
`
`4B and col. 9 line 63 - col. 11 line 46).
`
`58.
`
`It would have been obvious to one having ordinary skill in the art at the time of
`
`the invention to have modified Schraga to include a lancet projection amount adjuster
`
`that is approximately cylindrical in shape, and an end of the lancet projection amount
`
`adjuster toward the side opposite to the side where the lancet lances the skin has an
`
`opening with a diameter equal to the diameter of the part of the pull stick that is
`
`approximately cylindrical in shape, and the part of the pull stick that is approximately
`
`cylindrical in shape is slidably housed through the opening, and the lancet projection
`
`amount adjuster is screwed into a screw hole that is formed on a side surface of the
`
`case toward the side opposite to the side where the lancet lances the skin, toward an
`
`inside of the case, whereby the lancet projection amount adjust