DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hasegawa (US 2007/0161961).
Regarding claim 1, Hasegawa discloses a pre-filled syringe 1 comprising: a tubular container 2 formed to have a tubular shape (¶38); a front end gasket 8 provided in the tubular container, the front end gasket being slidable with respect to the tubular container along an axial direction of the tubular container (figs 2 and 3); a rear end gasket 4 provided rearward with respect to the front end gasket in the tubular container so as to define a space in the tubular container together with the front end gasket (fig 1), the rear end gasket being slidable with respect to the tubular container along the axial direction of the tubular container (not shown, ¶34 describes movement); an intermediate gasket 6 provided between the front end gasket and the rear end gasket in the tubular container so as to partition the space into a front chamber 7 adjacent to the front end gasket and a rear chamber 5 adjacent to the rear end gasket (fig 1), the intermediate gasket being slidable with respect to the tubular container along the axial direction of the tubular container (figs 2-4); a medicine accommodated in the front chamber (¶30); a liquid medicine 6 accommodated in the rear chamber (¶30); and a plunger 12 connected to the rear end gasket (fig 1), the plunger being capable of pushing the rear end gasket toward a front end side of the tubular container along the axial direction (figs 2-4; ¶7), wherein the tubular container has a barrel capable of accommodating the front end gasket, the rear end gasket, and the intermediate gasket (fig 1), and a nozzle portion (nozzle member 24 in fig 2) connected to a front end portion of the barrel (fig 2), the barrel has an inner peripheral surface in contact with an outer peripheral surface of the front end gasket, an outer peripheral surface of the intermediate gasket, and an outer peripheral surface of the rear end gasket (fig 1), and a protruding inner side surface 11 having a shape that protrudes from the inner peripheral surface in a direction orthogonal to the axial direction and that extends along the axial direction (fig 1), a groove 62 communicating the front chamber and the rear chamber with each other is formed in the outer peripheral surface of the intermediate gasket at a position at which the intermediate gasket faces the protruding inner side surface (¶34), the front end gasket has a rear-end pressure-contact portion that is formed at a rear end portion of the front end gasket in the axial direction and that is in pressure contact with the inner peripheral surface of the barrel (figs 1 and 2, also see annotated figure below), the nozzle portion has an accommodation portion 23 capable of accommodating the front end gasket (fig 3), the accommodation portion has a bottom wall having a receiving surface that receives the front end gasket in the axial direction (fig 3), a peripheral wall rising from an edge portion of the bottom wall (fig 3), and a supporting portion provided on an inner peripheral surface of the peripheral wall at a region separated from the receiving surface in the axial direction, the supporting portion being capable of supporting a front end portion of the front end gasket (fig 3, unlabeled but can be seen to left and right of flow passage 21), and the rear-end pressure-contact portion is in pressure contact with the inner peripheral surface of the barrel in an abutment state in which the liquid medicine is introduced in the front chamber and the front end portion of the front end gasket is in abutment with the supporting portion (fig 3), the front end gasket includes a rear end surface (see annotated figure), and a recess connected to the rear end pressure contact portion (see annotated figure), the recess has a shape that is curved to protrude inward in a radial direction of the barrel and that is connected annularly in a peripheral direction of the barrel (see annotated figure, connected in that open end of recess faces barrel), and a front end that is connected to the recess (see annotated figure); and the rear end pressure contact portion has a shape that is curved to protrude outward in the radial direction (see annotated figure).
PNG
media_image1.png
144
353
media_image1.png
Greyscale
Regarding claim 2, wherein an amount of overlap between the rear-end pressure-contact portion and the barrel in the abutment state is set to an amount by which the liquid medicine in the front chamber is regulated from reaching the accommodation portion through a clearance between the rear-end pressure-contact portion and the barrel (fig 3 – fluid in front chamber but none in nozzle, as opposed to fig 4 where additional pressure is applied and fluid can be seen in nozzle) and gas in the front chamber is permitted to reach the accommodation portion through the clearance between the rear-end pressure-contact portion and the barrel in such a posture that the front end portion of the barrel faces upward (¶20 – air bubbles in front chamber are discharged during preparation for injection; one of ordinary skill in the at would appreciate that the exit path will be via passages 21/22 which are in the accommodation portion and allow clearance between the rear-end pressure-contact portion and the barrel).
Response to Arguments
Applicant's arguments have been considered but are considered moot as a different Hasegawa reference is applied.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
