`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`
`
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`CONF {MATION NO.
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`12/676,022
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`03/02/2010
`
`Tetsuya Takashima
`
`P3 8061
`
`9037
`
`52123
`7590
`10/16/2013
`GREENBLUM & BERNSTEIN, P.L.C.
`1950 ROLAND CLARKE PLACE
`RESTON, VA 20191
`
`EXAMINER
`SMITH, FANGEMONIQUE A
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`ART UNIT
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`3736
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`PAPER NUMBER
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`
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`NOT *ICATION DATE
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`DELIVERY MODE
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`10/ 1 6/201 3
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`
`gbpatent @ gbpatent.c0m
`greenblumbernsteinplc @ gmail.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 12/676,022 TAKASHIMA ET AL.
`
`
`AIA (First Inventorto File)
`Art Unit
`Examiner
`Office Action Summary
`
`
`FANGEMONIQUE SMITH first“ 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).
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`-
`-
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`Status
`
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`1)IXI Responsive to communication(s) filed on 4/11/12.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)lX| This action is non-final.
`a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)|XI Claim(s) 13-5 and 7-14 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)|:l Claim(s) _ is/are allowed.
`7)IZ| Claim(s) 1, 3--5, 7- 14 is/are rejected.
`8)I:I Claim(s) _ is/are objected to.
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`9)|:l Claim((s)
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usoto. ov/ atents/init events"
`
`
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`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).
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`Priority under 35 U.S.C. § 119
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some * c)I:I None of the:
`a)|:l All
`1.|:| Certified copies of the priority documents have been received.
`2.|:| Certified copies of the priority documents have been received in Application No.
`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
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`1) E Notice of References Cited (PTO-892)
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`3) I] Interview Summary (PTO-413)
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`Paper NOISI/Ma” Date —
`PTO/SB/08
`t
`St t
`I
`D'
`t'
`f
`2 I:l I
`)
`4) I:I Other:
`a emen (s)(
`Isc osure
`n orma Ion
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`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL-326 (Rev. 08-13)
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`Part of Paper No./Mai| Date 20131001
`
`Office Action Summary
`
`

`

`Application/Control Number: 12/676,022
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`Page 2
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`Art Unit: 3736
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`l.
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`The present application is being examined under the pre—AIA first to invent provisions.
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`DETAILED ACTION
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`2.
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`This Office Action is responsive to the Request for Continued Examination filed on April
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`ll, 2012. The Office acknowledges the amendment of claim 1, 7 and 10—12 and the cancelation
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`of claims 2, 6 and 15—20. Claims 1, 3—5, and 7—14 are pending.
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`Claim Rejections - 35 USC § 112
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`3.
`
`The following is a quotation of 35 USC. ll2(b):
`(b) CONCLUSION.7The 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 USC. 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.
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`4.
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`Claims 1, 5, and ll—l3 are rejected under 35 USC. ll2(b) or 35 USC. 112 (pre—AIA),
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`second paragraph, as being indefinite for failing to particularly point out and distinctly claim the
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`subject 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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`5.
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`Claim 1 is an apparatus claim with functional language which defines method steps
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`within the apparatus claim. It is unclear whether the apparatus is intended to be claimed or if the
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`method step which governs how the apparatus operates is intended to be claimed, rendering the
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`claim indefinite. Upon rejection of claim 1, any claim depending from claim 1 is also rejected.
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`6.
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`Claim 5 is an apparatus claim with functional language which defines method steps
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`within the apparatus claim. It is unclear whether the apparatus is intended to be claimed or if the
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`

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`Application/Control Number: 12/676,022
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`Page 3
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`Art Unit: 3736
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`method step which governs how the apparatus operates is intended to be claimed, rendering the
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`claim indefinite.
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`7.
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`Claim ll is an apparatus claim with functional language which defines method steps
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`within the apparatus claim. It is unclear whether the apparatus is intended to be claimed or if the
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`method step which governs how the apparatus operates is intended to be claimed, rendering the
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`claim indefinite.
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`8.
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`Claim 12 is an apparatus claim with functional language which defines method steps
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`within the apparatus claim. It is unclear whether the apparatus is intended to be claimed or if the
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`method step which governs how the apparatus operates is intended to be claimed, rendering the
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`claim indefinite.
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`9.
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`Claim 13 is an apparatus claim with functional language which defines method steps
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`within the apparatus claim. It is unclear whether the apparatus is intended to be claimed or if the
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`method step which governs how the apparatus operates is intended to be claimed, rendering the
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`claim indefinite.
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`10.
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`35 USC. 101 reads as follows:
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`Claim Rejections - 35 USC § 101
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`Whoever invents or discovers any new and useful process, machine, manufacture, or composition of
`matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the
`conditions and requirements of this title.
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`ll.
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`Claims l—l4 are rejected under 35 USC. 101 because the claimed invention is directed
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`to non—statutory subject matter. Claim 1 recites, "a finger cover that covers a finger". This
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`recites a positive relationship to the living body. However, the living body is non—statutory
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`

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`Application/Control Number: 12/676,022
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`Page 4
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`Art Unit: 3736
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`subject matter and cannot be positively recited. Therefore, applicant should amend the claim to
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`recite —— a finger cover adapted to cover a finger——. Upon rejection of Claim 1, any claim
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`depending from claim 1 is also rejected.
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`12.
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`Claim 1 recites, "a blood sampling section that punctures the finger ". This recites a
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`positive relationship to the living body. However, the living body is non—statutory subject matter
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`and cannot be positively recited. Therefore, applicant should amend the claim to recite —— a
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`blood sampling section adapted to puncture the finger ——. Upon rejection of Claim 1, any claim
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`depending from claim 1 is also rejected.
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`13.
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`Claim 5 recites, "generates laser light that punctures a finger ". This recites a positive
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`relationship to the living body. However, the living body is non—statutory subject matter and
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`cannot be positively recited. Therefore, applicant should amend the claim to recite —— generates
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`laser light adapted to puncture a finger ——.
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`Claim Rejections - 35 USC § 103
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`14.
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`The following is a quotation of 35 USC. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in
`section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the
`manner in which the invention was made.
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`15.
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`Claims 1, 3—5, 7—10, 12, and 13 are rejected under 35 USC. 103(a) as being unpatentable
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`over Alroy (US. Patent Number 7,374,545) in view of Fletcher et al. (US. Patent Application
`
`Publication Number 2003/0220663) and in further view of George (JP Patent Application
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`Publication Number 2007/ 125383).
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`

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`Application/Control Number: 12/676,022
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`Page 5
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`Art Unit: 3736
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`In regard to claims 1, 3—5, 7—10, 12, and 13, Alroy discloses a blood extraction device (100). The
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`device disclosed by Alroy includes a casing that has a blood sampling window (150) which is an
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`opening for sampling blood. The casing is capable of being held in one hand. The Alroy device
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`further includes a finger cover (120) that covers a finger facing and touching the blood sampling
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`window. A blood sampling section is disclosed which includes a lancing member (144) which
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`punctures the finger inserted in the concave finger cover to sample the blood.
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`FREE. 3
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`The finger cover is integrally formed with the casing as shown in Figure 3 above. Figure 3 also
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`shows the center of the finger cover is provided below a center line of the casing in a vertical
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`direction. Alroy discloses another means to perform puncturing of the skin to include a laser
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`Application/Control Number: 12/676,022
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`Page 6
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`Art Unit: 3736
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`type that generates laser light and performs a puncturing operation and a blood sampling
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`operation (col. 6, lines 50—53). The finger cover of the Alroy device would block the laser light
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`generated by the laser type, if the finger does not touch the finger cover (Figure 3). Upon
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`inserting a finger in the apparatus disclosed by Alroy, the finger holder may be resiliently biased
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`to exert slight pressure on the finger of the patient pushing the inserted finger toward the blood
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`sampling window. Ahoy discloses a pushing operation section (110) that is provided opposite
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`the finger cover to operate the pushing section. The pushing operation occurs in a two—step
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`process where the finger is pushed toward the blood sampling window in a first step and the
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`blood sampling section is activated to pierce skin in a second step. The casing of the device may
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`include an LCD display (1 12) to display the results of the analysis (col. 3, lines 56—67). In regard
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`to the claims, Alroy disclose the features of the Applicant’s invention as described above.
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`Although Alroy discloses having a cover which positions the finger by exerting slight pressure
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`on the finger of the patient pushing the inserted finger toward the blood sampling window, the
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`Alroy reference does not disclose the use of a pushing operation section as claimed by Applicant.
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`Fletcher et al. disclose a lancet device which includes an armable element having an element for
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`constricting the finger during lancing.
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`the Fletcher device includes a pushing operation section
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`which allows the user to apply increasing pressure on the end face in effort to compress the
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`finger, pressing the finger toward the blood sampling portion of the device (paragraph [0036]). It
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`would have been obvious to one having ordinary skill in the art at the time the Applicants'
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`invention was made to modify a blood extraction device, similar to that disclosed by Alroy, to
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`include a pushing operation section , similar to that disclosed by Fletcher et al., to assist with
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`blood collection from the finger during use of the device. The combined references of Alroy and
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`Application/Control Number: 12/676,022
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`Page 7
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`Art Unit: 3736
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`Fletcher et al. disclose features of Applicant’s invention as described above. The combined
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`references do not disclose the use of one hand in operation of the device. George discloses a
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`lancing device which includes a housing sized to allow the operation of the device using a single
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`hand.
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`
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`It would have been obvious to one having ordinary skill in the art at the time the Applicants'
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`invention was made to modify a blood extraction device, similar to that disclosed by the
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`combined references of Alroy and Fletcher et al., to include a compact design, similar to that
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`

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`Application/Control Number: 12/676,022
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`Page 8
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`Art Unit: 3736
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`disclosed by George, to provide another way to actuate the device while facilitating portability of
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`the device.
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`16.
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`Claims ll and 14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Alroy
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`(US. Patent Number 7,374,545) as modified by Fletcher et al. (US. Patent Application
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`Publication Number 2003/0220663) in view of George (JP Patent Application Publication
`
`Number 2007/ 125383) and in further view of Shulze et al. (US. Patent Number 6,364,847).
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`In regard to claims ll and 14, the combined references of Alroy, Fletcher et al. and George
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`disclose the features of the Applicant’s invention as described above. The combination does not
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`disclose having an actuator that rotates about an aXis provided at one end of the casing.
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`Additionally, the combination fails to disclose a casing having a strap attachment. Shulze et al.
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`disclose a blood sampling device for mounting on a patient’s forearm. The device disclosed by
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`Shulze includes a strap attachment which allows the device to be mounted and maintain its
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`positioning during use of the device (col. 3, lines 55—67; col. 4, lines 1—18).
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`Application/Control Number: 12/676,022
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`Page 9
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`Art Unit: 3736
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`The Shulze et al. reference also discloses the device including an actuator which rotates about an
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`axis of the casing (col. 6, lines 63—67; col. 7, lines 1—9). It would have been obvious to one
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`having ordinary skill in the art at the time the Applicants' invention was made to modify a blood
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`extraction device, similar to that disclosed by the combined references of Alroy, Fletcher et al.
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`and George, to include a rotating actuating means and a strap, similar to that disclosed by Shulze
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`et al., to provide the user with better control of the collection of fluid.
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`Response to Arguments
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`17.
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`Applicant argues the prior art references fail to disclose having a pushing section which
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`allows the finger cover to push the finger toward the blood sampling window as described by
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`Applicant. The Office submits Applicant’s arguments with respect to the claims have been
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`considered but are moot in view of the new ground(s) of rejection.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to FANGEMONIQUE SMlTH whose telephone number is
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`(571)272—8160. The examiner can normally be reached on Mon — Fri 8am — 4:30pm.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jeffrey Hoekstra can be reached on 571—272—7232. The fax phone number for the
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`organization where this application or proceeding is assigned is 571—273—8300.
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`

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`Application/Control Number: 12/676,022
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`Page 10
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`Art Unit: 3736
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`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
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`
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`
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`
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`
`FS
`
`/Brian Szmal/
`
`Primary Examiner, Art Unit 3736
`
`