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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`wwwusptogov
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`
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`14/3 60,625
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`05/26/2014
`
`Seiji Kikuchi
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`PHC—US120868
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`6929
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`Shinjyu Global IP
`1 -4- 19 Minamimori-machi, Kita-ku
`South Forest Building, 11th Floor
`Osaka, 530-0054
`JAPAN
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`SCHM )T’ EMILY LOUISE
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`3763
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`02/22/2016
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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):
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`teammurai @ giplaw-osaka.co.jp
`shinj yuefiling @ gmail.com
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`PTOL—90A (Rev. 04/07)
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`

`

`
`
`Applicant(s)
`Application No.
` 14/360,625 KIKUCHI ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`EMILY SCHMIDT its“ 3763
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`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).
`
`In no event, however, may a reply be timely filed
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`Status
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`1)IZI Responsive to communication(s) filed on 26 May 2014.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|ZI This action is non-final.
`2a)|:l This action is FINAL.
`3)|: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)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)IZI Claim(s) 1-4 6 79-13 and 15 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
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`6)|:I Claim(s)
`is/are allowed.
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`7)|Z| Claim(s) 1 -4 6 79- 13 and 15is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
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`are subject to restriction and/or election requirement.
`9)|:I Claim((s)
`* 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
`hit z/thvvvtlsnto. ovI’ atentS/init events/
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`
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`h/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
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`Application Papers
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`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 26 May 2014 is/are: a)IZl 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).
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`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
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`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)IZl All
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`b)|:l Some” c)I:l None of the:
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`1.IXI 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
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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.
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`Attachment(s)
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`
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`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) E InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
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`Part of Paper No./Mai| Date 20160216
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`

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`Application/Control Number: 14/360,625
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`Page 2
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`Art Unit: 3763
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`1.
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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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`Claim Objections
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`2.
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`Claim 1 is objected to because of the following informalities: claim 1 recites “the
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`cylindrical syringe cover” there is insufficient antecedent basis for this limitation in the claim.
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`Appropriate correction is required.
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`Claim Rejections - 35 USC § 103
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`3.
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`The following is a quotation of pre—AIA 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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`4.
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`Claims 1—4, 6, 7, 9—13, and 15 are rejected under pre—AIA 35 USC. 103(a) as being
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`unpatentable over 110 et al. (EP 2 253 348 A1) in view of Dowds et al. (US 2011/0054411 A1).
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`With regard to claim l, 110 et al. teach a pharmaceutical syringe unit to be mounted on a
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`main body of a pharmaceutical injeetimi device for injecting a, drug filled therein into a lmdy,
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`comprising: a pharmaceutical syringe including an outer snrfnee and configured to be loaded in a
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`syringe cover (Fig. 28 member 422); the cylindrical syringe cover is cylindrical (Fig. 28 member
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`423) and includes a first end. a needie mount (Fig, 28 member 42321), a piston inserting portion
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`(Fig. 28 at end \s'itei'e Isl-23c is located}, a second end side, a llange pm‘tion (Fig. ’28 at 423d). an
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`outer surface; the needie inonnt configured to mount an injection needle and disposed at the first
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`end side of the syringe cover (Fig. 28 member 423a); the piston-inserting portion disposed at the
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`Application/Control Number: 14/360,625
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`Page 3
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`Art Unit: 3763
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`second end side of the syringe cover (Fig. 28 at end where 423C is Eoeated); the flange portion
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`protruding ontwardiy front the outer surface of the syringe cover in a radiai manner, the flange
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`portion defining a first side and a second side (Fig. 28 at 423d),
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`iio et ai. teach a device
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`substantially as claimed.
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`in the embodiment of Fig. 28, he et ai. do not expiicitiy diseiose a
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`discrimination rnarh.
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`i-iovv'ever, in the embodiment of, for examnie, Fig. 14 he et ai. teach a
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`discrimination mark and identifying features @0034}, [0046}, Fig. E4, 15d} it wouid have been
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`ohvious to a person having ordinary shiil in the art at the time the invention was made to use a
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`syringe and identificatirni feature in the embodiment of Fig. 28 of ii o et ai. since it has been held
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`that combining two embodiments disclosed adjacent to each other in a prior art patent does not
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`require a leap of inventiveness and involves only routine skill in the art, Boston Scientific V.
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`Cordis Fed. Cir. 2009. Further, this is beneficial for safety.
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`iio et ai, do not speeiiicaliy disciose
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`a rotation marker.
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`i-iowever, Dow‘ds et at. teach using an arrow indication on a syringe to
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`indicate to the user the direction for rotation for use (3003523).
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`it would have been obvious to a
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`person having ordinary shiil in the art at the time the invention was ntade to use a rotation marker
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`in he et al. heeause Dowds et ai. teach such is hertefieiai for aiding the user in device operation.
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`With regard to ciairns ‘2 and 4, Ho et at. and Dowds et ai, do not specificaiiy disciose the
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`ioeation of the marker in relation to the discrimination niarh. However, as there is a iimited.
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`number of marks and availahie space one or the other would be closer to the first side or forward
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`or rearward of. Further, the discrin‘iihation mark is iocated aln‘iost at the edge of the second side
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`and as such it wouid have been obvious to a person having ordinary skiii in the art at the tirne the
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`invention was made to place the rotation mark eioser to the first side and rearward the
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`discrimination mark as there are a iimited number of positioning options,
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`Application/Control Number: 14/360,625
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`Page 4
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`Art Unit: 3763
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`With regard to eizn'rn 3, as; the markers are fixed they wit} both be shifted in the rotation
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`direction.
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`With regard to eiaiin 6, Ho et a1. teach a pharmaceutical injeetion device eoinprising the
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`pi‘iztrrnneentieai Syringe unit aecm‘ding to claim 1 (see rejection above), the main body further
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`inchn’iing a first end side and a eyiindrieai syringe mount (Fig. ‘28 member 42 i :i; the syringe
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`monnt disposed at the first end side of the main body and configured to mount the
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`pharinaeeutieai Syringe unit (Fig 28); a detecting portion provided on the syringe mount and.
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`camiignred to detect the discrirnination rnarir {[0836}, {GO-46], [0i 33L Fig. i4 '31); a controller
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`opemhie to determine a I'SSt'iii detected by the detecting, portion {[0046}, {(3071}. term); an inner
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`ease disposed in the main body, the inner ease configured to he siidahie and to accommodate the
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`pharnieeentieai syringe unit {Fig 28 member 425). He et 211, in Figs; 28 do not expiieitiy show an
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`opening. However, as. eon‘ihined with the identification features of the en‘ihodinient of at ieant
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`Fig. 14, it wonid have been obvious to a person having ordinary shit} in the art at the tirne the
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`invention was made that an opening would neeeasariiy he needed to aeeoininodate the identifier
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`so that it can read the it) mfii’tibfiil
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`With regard to eiairn 7. see Fig. 15.
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`With regard to claim 9, see Fig. '28 niemher 421b,
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`‘With regard to eiaini it), see Figs; 30, Ho et a1. and Dowds et 211, do not explicitly disclose
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`the rotation n‘iarker is arranged to be exposed hammer; it wouid have been obvious to a perntni
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`having. ordinary Shiii in the ant at the time the invention was made to have the rotation marker
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`exposed so that it is vigihie to the user.
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`Application/Control Number: 14/360,625
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`Page 5
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`Art Unit: 3763
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`With regard to claims 11—13, see fig. 28 protrusions 4225b and grooves 425e, additionaily
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`see 26a and 34a (Fig. 3).
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`With regard to claim i5, Fig. 28 member 42id {[0172}, [0173]).
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`lio et al. do not
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`specifically disclose that the display indicates information indicating the cmnpletion of
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`mounting, however, as ilo et ai. discloses the dispiay indicates various: infomiation for operation
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`it wouid have been obvious to a person having ordinary skiil in the art at the time the invention
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`was made to display information when the mark is detected so that the user can confirm the 1D
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`information as iio et 211. discloses displaying inflirination for operation.
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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 EMILY SCHMIDT Whose telephone number is (571)270—3648.
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`The examiner can normally be reached on Monday through Thursday 7:00 AM to 4:30 PM
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`(EST).
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Kevin Sirmons can be reached on (571) 272—4965. 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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