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 .
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 17, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,023,469. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claims can be found in the patent claims.
Regarding claim 17 of the application, claim 3 of the patent, which includes claim 1, recites 17 an auto-injection apparatus for receiving a syringe (claim 1, lines 5-6), comprising: an outer casing which encloses: a syringe carrier comprising a barrel housing configured to hold a barrel of the syringe, the syringe carrier having a stowed position and a delivery position (claim 1, lines 7-10); an insertion actuator configured to move the syringe carrier forwards within the outer casing to insert a needle of the syringe into an injection site (claim 1, lines 31-33); an interlock which extends between the syringe carrier and a syringe carrier housing which at least partially surrounds the syringe carrier, the interlock preventing the forward motion of the syringe carrier under the influence of the insertion actuator whilst in the stowed position (claim 1, lines 11-16); and an interlock release mechanism comprising: interlock release mechanism features configured to release the interlock on actuation thereof such that the insertion actuator is released to drive the syringe carrier forward (claim 1, lines 17-20), and a shield moveable relative to the syringe carrier and configured to provide a pressure activated trigger to actuate the interlock release mechanism (claim 1, lines 21-23), wherein the barrel housing of the syringe carrier is received at least partially within the shield and provides an interface therebetween incorporating the interlock release mechanism features (claim 3), and wherein rearward movement of the shield into the outer casing and relative to the syringe carrier activates the interlock release mechanism features to release the insertion actuator to drive the syringe carrier forward (claim 1, lines 33-38). The difference between the application claim and the patent claim lies in the fact that the patent claim includes more features and is therefore more specific. It has been held that the generic claim is anticipated by the specific claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claim is anticipated by the patent claim it is not patentably distinct therefrom.
Regarding claim 18 of the application, claim 1 of the patent recites wherein the interlock release mechanism features comprise a track and a protrusion, wherein one of the track and the protrusion is located on the barrel housing, and the other of the track and protrusion is located on the shield (claim 1, lines 24-27).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 17-23, 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karlsen et al (US 8,864,718).
Regarding claim 17, Karlsen discloses an auto-injection apparatus for receiving a syringe (container 50 and needle 26: col. 11, lines 65-66; fig. 9), comprising: an outer casing (proximal end of 12 fig. 9) which encloses: a syringe carrier 46 comprising a barrel housing configured to hold a barrel 50 of the syringe (fig. 10; col. 6, lines 66-67), the syringe carrier having a stowed position (fig. 14(a)) and a delivery position (fig. 14(b)); an insertion actuator configured to move the syringe carrier forwards within the outer casing to insert a needle of the syringe into an injection site (col. 11, lines 59-67); an interlock which extends between the syringe carrier and a syringe carrier housing which at least partially surrounds the syringe carrier (distal end of 12: fig. 9; col. 11, lined 54-60: second injection lock), the interlock preventing the forward motion of the syringe carrier under the influence of the insertion actuator whilst in the stowed position (col. 11, lines 55-60); and an interlock release mechanism comprising: interlock release mechanism features configured to release the interlock on actuation thereof such that the insertion actuator is released to drive the syringe carrier forward (col. 11, lines 58-67), and a shield 38 moveable relative to the syringe carrier and configured to provide a pressure activated trigger to actuate the interlock release mechanism (col. 11, lines 54-67), wherein the barrel housing of the syringe carrier is received at least partially within the shield and provides an interface therebetween incorporating the interlock release mechanism features (fig.14), and wherein rearward movement of the shield into the outer casing and relative to the syringe carrier activates the interlock release mechanism features to release the insertion actuator to drive the syringe carrier forward (col. 11, lines 54-52).
Regarding claim 18, Karlsen discloses that the interlock release mechanism features comprise a track 25 and a protrusion 56, wherein the track is located on the barrel housing, and the protrusion is located on the shield (fig. 12; col. 10, lines 42-66).
Regarding claim 19, Karlsen discloses that the track comprises a release portion (fig. 13(c): the straight portion of the track) and wherein the subsequent rearward movement of the shield causes the protrusion to move within the release portion to disengage the interlock (fig. 13(d)).
Regarding claim 20, Karlsen discloses that movement of the protrusion within the release portion causes rotation of the syringe carrier to disengage the interlock (fig. 13(d)).
Regarding claim 21, Karlsen discloses that the release portion comprises a release surface which is inclined axially, and wherein the protrusion slides against the release surface to rotate the syringe carrier (figs. 13(a)- 13(d)).
Regarding claim 22, Karlsen discloses that the track comprises an anti-rotation feature configured to allow a predetermined amount of axial movement of the shield without rotation of the syringe carrier (fig. 13(d)).
Regarding claim 23, Karlsen discloses that the anti-rotation feature comprises an axial surface of the track (fig. 13(d)).
Regarding claim 25, Karlsen discloses that the shield 38 is slidably arranged between the outer casing 36 and the syringe carrier 46 (fig. 7).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlsen.
Claim 24 calls for the protrusion to be located on the barrel housing and the track to be located on the shield. Karlsen discloses the reverse configuration. Per MPEP 2144.04(VI)(A), a mere reversal of parts has been held to be an obvious modification. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Karlsen to have the track on the shield and the protrusion on the barrel housing because doing so would have been an obvious reversal of parts.
Allowable Subject Matter
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 26, Karlsen teaches a carrier housing stop 68 and a syringe carrier stop, but the shield intervenes so they do not abut one another.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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