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 .
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6-10, and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arinbone et al. (WO 2019/182031 A1 Arinbone et al. US 2021/0001049 A1 used as translation).
With regard to claim 1, Arinbone et al. teach a syringe assembly comprising: a syringe that includes a distal nozzle portion and a lumen (Fig. 9 syringe 90 nozzle 48); a cap fixed to the distal nozzle portion (Fig. 9 member 40); a seal member arranged between the cap and the distal nozzle portion and made of an elastic body that seals the distal nozzle portion, the seal member including a distal end facing towards the cap and a proximal end facing away from the cap (Fig. 9 seal 41, [0059]); the cap including a pressing surface (inner surface in the area of 56d opposite the indicated sealing surface, Fig. 9 and Reference Figure 1 below) that is in surface contact with the distal end of the seal member and presses the seal member toward a proximal side, the distal nozzle portion including a distal end at which is located a sealing surface, the sealing surface of the distal nozzle portion opposing the pressing surface and being in surface contact with the proximal end of the seal member, the distal nozzle portion including a distal opening on an inner peripheral side of the sealing surface, the distal opening of the distal nozzle portion being in communication with the lumen in the syringe, the distal nozzle portion also including an outer peripheral surface that extends away from the sealing surface (see Fig. 9 and Reference Figure 1 below, the sealing surface includes the top and side surface of 92 which are in contact with the seal); the sealing surface having an inner edge at which the sealing surface intersects an inner surface of the distal opening and also having an outer edge at which the sealing surface intersects the outer peripheral surface of the distal nozzle portion; the seal member closing the distal opening and being pressed and held in an axial direction in a pressing space over a whole region of an opposing portion between the pressing surface and the sealing surface so that an entirety of the sealing surface between the inner and outer edges is in contact with and presses the seal member (see Fig. 9 and Reference Figure 1 below); and a gap between the pressing surface and the sealing surface in the pressing space is narrowest on an inner peripheral side (see Figs. 9, 10, and Reference Figure 1 below, gap is narrower at the upper surface of 92 as compared to along the sides).
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With regard to claim 2, the ring-shaped protrusion is taken as an upper portion of 92.
With regard to claims 6-8, see Fig. 9 central portion 41a, see projecting portions 41a and 41b in exemplary Fig. 3 ([0059], [0061]).
With regard to claim 9, Arinbone et al. teach a syringe assembly comprising: a syringe that includes a distal nozzle portion, the syringe including a lumen extending throughout the distal nozzle portion and opening to a distal opening at a distal end of the distal nozzle portion, the distal end of the distal nozzle portion including a sealing surface that surrounds the distal opening at the distal end of the distal nozzle portion (Fig. 9 syringe 90 nozzle 48, see Reference Figure 1 above); a cap fixed to the distal nozzle portion, the cap including a pressing surface that faces toward the sealing surface at the distal end of the distal nozzle portion, the sealing surface extending radially outwardly from the distal opening to a radially outermost portion of the sealing surface (Fig. 9 member 40, see Reference Figure 1 above, generally from the inner edge to the outer edge indicated); a seal member made of elastic material and positioned between the sealing surface of the distal nozzle portion and the pressing surface of the cap (Fig. 9 seal 41, [0059]); the seal member including both a proximal end surface in direct contact with a contact portion of the sealing surface of the distal nozzle portion and a distal end surface in direct contact with a contact portion of the pressing surface of the cap so that the seal member closes and seals the distal opening at the distal end of the distal nozzle portion (see Fig. 9 and Reference Figure 1 above); the seal member being pressed and held in an axial direction in a pressing space between the pressing surface and the sealing surface so that the outermost portion of the sealing surface is in contact with and presses the seal member (see Fig. 9 and Reference Figure 1 above); the contact portion of the pressing surface and the contact portion of the sealing surface being configured so that a first straight line distance between the contact portion of the pressing surface and the contact portion of the sealing surface is less than a second straight line distance between the contact portion of the pressing surface and the contact portion of the sealing surface (see distance between two points of the sealing surface to the pressing surface in Reference Figure 1 above, generally at the upper and side surfaces of 92); and the first straight line distance and the second straight line distance both being parallel to the central axis of the distal nozzle portion, the first straight line distance being spaced from the second straight line distance, the first straight line distance being located closer to the central axis of the distal nozzle portion than the second straight line distance (the first straight line distance is from the point on protrusion 92).
With regard to claim 10, the annular protrusion is taken as an upper portion of 92.
With regard to claims 14-16, see Fig. 9 central portion 41a, see projecting portions 41a and 41b in exemplary Fig. 3 ([0059], [0061]).
With regard to claim 17, see Fig. 9 claws engage projecting portion 48a, claw 62 as in exemplary Fig. 7.
With regard to claim 18, Arinbone et al. teach a liquid-medicine administration device comprising: a syringe assembly comprising: a syringe that includes a distal nozzle portion and a lumen (Fig. 9 syringe 90 nozzle 48); a cap fixed to the distal nozzle portion (Fig. 9 member 40); and a seal member arranged between the cap and the distal nozzle portion and made of an elastic body that seals the distal nozzle portion, the seal member including a distal end facing towards the cap and a proximal end facing away from the cap, the cap including a pressing surface that is in surface contact with a distal end of the seal member and presses the seal member toward a proximal side, the distal nozzle portion including a distal end at which is located a sealing surface, the sealing surface of the distal nozzle portion opposing the pressing surface and being in surface contact with the proximal end of the seal member, the distal nozzle portion including a distal opening on an inner peripheral side of the sealing surface, the distal opening of the distal nozzle portion being in communication with the lumen in the syringe, the distal nozzle portion having an outer peripheral surface that extends away from the sealing surface, the sealing surface having an inner edge at which the sealing surface intersects an inner surface of the distal opening and also having an outer edge at which the sealing surface intersects the outer peripheral surface of the distal nozzle portion (see Fig. 9 and Reference Figure 1 above), the seal member closing the distal opening and being pressed and held in an axial direction in a pressing space over a whole region of an opposing portion between the pressing surface and the sealing surface so that an entirety of the sealing surface between the inner and outer edges is in contact with and presses the seal member (see Fig. 9 and Reference Figure 1 above), and a gap between the pressing surface and the sealing surface in the pressing space being narrowest on an inner peripheral side (Fig. 9 seal 41, [0059] and Reference Figure 1 above); a gasket slidably positioned inside the syringe (Fig. 1 member 26); a plunger assembly configured to press the gasket in a distal direction to slidably move the gasket in the distal direction inside the syringe (Fig. 1 member 14); and a drive mechanism driving the plunger assembly (Fig. 2 member 28).
With regard to claim 19, see Fig. 1 member 34.
With regard to claim 20, see Fig. 1 member 36.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arinbone et al. (WO 2019/182031 A1 Arinbone et al. US 2021/0001049 A1 used as translation) as applied to claim 2 above.
With regard to claim 21, Arinbone et al. teach portion 92 is beneficial for providing an increase in a force for crushing the seal member to improve pressure resistance ([0109]). As such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a protrusion with a height as claimed as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One of ordinary skill would be able to determine the height as necessary to achieve the desired pressure resistance.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection has been clarified to address the amended claim limitations, however, Arinbone et al. is still relied upon. Applicant argues that the seal is not pressed over a whole region between the pressing and sealing surface. The Examiner does not consider portions of the distal nozzle which are not in contact with the seal as part of the sealing portion. The sealing portion is identified as described in the rejection and Reference Figure above. The structure of the sealing portion would need to be further clarified. The amendments to the drawings are sufficient to overcome the previous objections.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783