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 § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 repeats limitations now incorporated into claim 1 and as such does not further limit the subject matter. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1, 4, 5, 10, 13, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruddocks et al. (US 2018/0117256 A1) in view of Mismar et al. (US 2021/0060258 A1 with reference to provisional application 62/901,179).
With regard to claims 1, 4, and 5, Ruddocks et al. teach a grip for a syringe barrel to be attached to a syringe barrel that includes a tubular body, and a flange provided on the tubular body and projecting outward, the grip comprising: a flange receiving portion configured to receive the flange (Fig. 3C at 62); and a side wall portion extending in a distal end direction from the flange receiving portion and configured to partially cover a proximal end portion of the tubular body adjacent to the flange, wherein the side wall portion includes a fitting portion configured to be fitted to the proximal end portion of the tubular body (Fig. 3B at 66), the side wall portion is a tubular portion having an attachment slit for attaching the proximal end portion of the tubular body, the attachment slit having an opening width configured to be smaller than an outer diameter of the tubular body of the barrel such that, in a process of attaching the grip to the barrel, the attachment slit is elastically deformed by the barrel to be widened, and that, when the grip has been attached to the barrel, the grip is firmly attached to the barrel by the elastic restoring force (Figs. 3-6 at 64). Ruddocks et al. do not disclose an airflow portion. However, Mismar teaches providing ridges on the inner surface of a side wall portion which result in recesses for air flow for sterilizing gases about the syringe so that all surfaces may be exposed to the gas (see provisional Figs. 2a and 4, [0041], [0044]). 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 ridges on the side wall of Ruddocks et al. as in Mismar as this is beneficial for sterilizing the syringe.
With regard to claim 10, Ruddocks et al. teach a device substantially as claimed. Ruddocks et al. do not explicitly disclose the percentage of the contact area. However, Ruddocks et al. disclose various numbers of ridges may be used ([0041], [0044]) which result in different contact areas. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have contact in Ruddocks et al. as recited as Ruddocks et al. teach the constructions may vary providing necessary sterilization pathways. Further, Applicant has not disclosed such contact to provide a particular advantage or criticality but rather a range of values are disclosed as preferable, and given that Haffner et al. teach various constructions, 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.
With regard to claim 13, Ruddocks et al. teach a barrel assembly comprising: a syringe barrel including a tubular body (Fig. 1 member 22) and a flange provided at a proximal end of the tubular body and projecting outward (Fig. 1 member 30); and the grip for a syringe barrel according to claim 1 attached to the barrel (see the rejection above).
With regard to claim 17, see [0003].
With regard to claim 18, see the plates on either side of 61 (Fig. 3C). As Mismar et al. teach the purpose is to ensure all portions of the syringe are sterilized ([0041]) it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a gap so the gas can reach the flange in Ruddocks et al.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruddocks et al. (US 2018/0117256 A1) and Mismar et al. (US 2021/0060258 A1 with reference to provisional application 62/901,179) as applied to claim 13 above, and further in view of Bryant et al. (US 2015/0105734 A1).
With regard to claims 14-16, Ruddocks et al. each a device substantially as claimed. Ruddocks et al. teach a plunger rod 24 (Fig. 1) but do not disclose a stopper portion, details of the connection between the gasket and the plunger, or the contents of the barrel. However, Bryant et al. teach using a stopper on the plunger to interact with the grip to prevent the plunger from being removed ([0046], Figs. 2 and 3 stop 32 interacts with 34 provided on member 6). Bryant et al. teach the plunger rod has a face 22 for contacting the stopper without coupling to expel fluid (Fig. 3, [0044]). Bryant et al. teach syringes are beneficial for delivering medicaments to a patient (see at least [0002]). 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 stopper in Ruddocks et al. as Bryant et al. teach this is beneficial for preventing removal of the plunger. 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 gasket and plunger in Ruddocks et al. as Bryant et al. teach this is an art effective means for delivery and would yield the same predictable result. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to deliver a drug with the syringe of Haffner et al. as Bryant et al. teach such is an art effective substance for syringe delivery.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783