DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Species B in the reply filed on July 2, 2026 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/252,378, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not disclose a middle portion. As such claims 2-6 are not entitled to the benefit of the prior filed application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “245” has been used to designate both a stop surface and a rim. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: [0094] 2225 should be 225.
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The claims refer to a latch member and a second latch. However, this appears inconsistent with terms in the specification. For example, in the first embodiment member 117 appears to function as the recited latch, however, this is referred to as a pawl while other components are named a latch. 222 is referred to as a click latch. The second latch may refer to 224 which is recited as a grip latch or 122 which is a housing latch. There are numerous components which are referred to as latches, clarification is requested as to which structures correspond to the claimed latches.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 2, 6, 7, and 12-16 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Carrel et al. (WO 2006/129196).
With regard to claims 1 and 12, Carrel et al. teach a device configured to administer a medication, the device comprising: a lower housing (Fig. 6 member 4) configured to support a syringe having a needle and configured to retain the medication; an upper housing (Fig. 6 member 21) supported relative to the lower housing and configured to move with respect to the lower housing along a direction toward the needle from a first position to a second position (see transition Fig. 6 to Fig. 10); a plunger rod carried by the upper housing and movable with the upper housing so as to advance relative to the syringe when the upper housing is moved along the direction, wherein advancement of the plunger rod relative to the syringe causes the syringe to deliver the medication out the needle (Fig. 6 member 10); and a latch member that is configured to lock the upper housing in the second position so as to prevent the upper housing from moving from the second position toward the first position after the upper housing has moved to the second position from the first position (Fig. 10 34 and 41 lock, the device is no longer able to be used member 21 is not able to be removed from 4).
With regard to claim 2, see Fig. 6 member 8 which includes 12.
With regard to claim 6, see Fig. 6 where exposed and Fig. 10 where covered.
With regard to claim 7, see Fig. 6 member 35.
With regard to claim 13, the latch extends in a distal direction from 21 (Fig. 10).
With regard to claim 14, 41 is radially inward of 21.
With regard to claim 15, 35 is further considered as a whole as part of the latch and flexes (see transition between Fig. 6 and Fig. 10).
With regard to claim 16, see 34 (Fig. 6).
Claim(s) 1 and 7-12 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Baney et al. (FR 2884722 A1).
With regard to claims 1 and 12, Baney et al. teach a device configured to administer a medication, the device comprising: a lower housing (Fig. 1 smaller diameter portion of 4) configured to support a syringe having a needle and configured to retain the medication; an upper housing (Fig. 1 member 6) supported relative to the lower housing and configured to move with respect to the lower housing along a direction toward the needle from a first position to a second position (see transition Fig. 2 to Fig. 5); a plunger rod carried by the upper housing and movable with the upper housing so as to advance relative to the syringe when the upper housing is moved along the direction, wherein advancement of the plunger rod relative to the syringe causes the syringe to deliver the medication out the needle (Fig. 2 member 46); and a latch member that is configured to lock the upper housing in the second position so as to prevent the upper housing from moving from the second position toward the first position after the upper housing has moved to the second position from the first position (Fig. 5 locked between 21 and 16).
With regard to claim 2, see the larger diameter portion of 4 containing 15 and 16 (Fig. 1).
With regard to claims 1 and 12, Baney et al. teach a device configured to administer a medication, the device comprising: a lower housing (Fig. 17 portion connected to 142 surrounding the syringe) configured to support a syringe having a needle and configured to retain the medication; an upper housing (Fig. 17 member 148) supported relative to the lower housing and configured to move with respect to the lower housing along a direction toward the needle from a first position to a second position (see transition Fig. 17 to Fig. 20); a plunger rod carried by the upper housing and movable with the upper housing so as to advance relative to the syringe when the upper housing is moved along the direction, wherein advancement of the plunger rod relative to the syringe causes the syringe to deliver the medication out the needle (Fig. 17 member 146); and a latch member that is configured to lock the upper housing in the second position so as to prevent the upper housing from moving from the second position toward the first position after the upper housing has moved to the second position from the first position (Fig. 20 locked via latch 137, device is no longer usable).
With regard to claim 7, see Fig. 17 member 104.
With regard to claims 8-11, see Fig. 17 second latch 135 interferes with upper housing via 136. The needle guard removes the interference as shown in Figs. 18-20 via ramped surface 141, 135 deflects away and then back towards the central axis.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, 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 negated by the manner in which the invention was made.
Claims 3, 4, and 13-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baney et al. (FR 2884722 A1) as applied to claim 2 above.
With regard to claims 3, 4, and 13-16 Baney et al. teach latch 16 on radially deflectable member 15 is carried by the middle housing and the recess 21 is on the upper housing, however, this is opposite what is claimed. It would have been obvious to a person having ordinary skill in the art at the time the invention was made to switch the protrusions and the groove such that the latch is on the upper housing and the groove is on the middle housing since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baney et al. (FR 2884722 A1) as applied to claim 4 above, and further in view of David-Hegerich et al. (US 2008/0228147 A1).
With regard to claim 5, Baney et al. teach a device substantially as claimed but do not disclose an audible click. However, David-Hegerich et al. teach a click when a projection is received in a slot in a loc-out position ([0068] last line). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to produce a click when the components latch in Baney et al. as David-Hegerich et al. teach this is a beneficial notification to the user that provides a safeguard to ensure the user knows the device is safely locked.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 8-18 of U.S. Patent No. 10,485,931. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are more specific and include additional limitations and therefore anticipate each limitation of the instant claims.
Conclusion
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
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