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 2 and 15 are rejected on the ground of nonstatutory double patenting over claims 3, 9 and/or 18 of U.S. Patent No. 11,813,434 (hereinafter "the '434 patent") since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claims 2 and 15 recite that the retention surface of the covering cap deflects the barring means into a barring position; claims 3, 9 and/or 18 of the '434 patent recite that the covering cap deflects the barring means into the barring position but is silent to a "retention surface" performing this function. However, a skilled artisan would understand that the instant claims require a surface of the cap to perform the deflecting of the barring means into the barring position. This surface is not patentably different from the "retention surface" of instant claim 2.
Claim 18 is rejected on the ground of nonstatutory double patenting over claims 20 of the '434 patent, since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claims 18 recites limitations that are fully encompassed by claim 20 of the '434 patent. The claim of the '434 patent are narrower than instant claim 18. The only substantial difference is that claim 18 recites "the triggering member comprises a barring means" whereas claim 18 of the '434 patent recites that the barring means is "integrally formed by the triggering member". Claim 18 is therefore broader than the patent claim because it covers a barring means of the triggering member that can be either integrally or non-integrally formed by the triggering member. For this reason, claim 18 is an obvious variant of claim 20 of the '434 patent.
Claims 2, 15 and 18 are rejected on the ground of nonstatutory double patenting over claim1 of U.S. Pat. No. 10,894,127 B2 (hereinafter "the '127 patent"), in view of inventor Vogt (WO2010/0136078 A1, hereinafter "Vogt"; see corresponding U.S. Pub. 2012/0203186 A1), since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
Claims 2 and 15 recite limitations that are fully encompassed by claim 1 of the '127 patent, but the '127 patent is silent to a "retention surface" performing the function of deflecting the barring means into the barring position However, a skilled artisan would understand that the instant claims require a surface of the cap to perform the deflecting of the barring means into the barring position. This surface is not patentably different from the "retention surface" of instant claim 2.
Further, claim 1 of the '127 patent does not disclose a free end of the barring means extending in a proximal direction towards a proximal end of the housing.
Vogt discloses an autoinjector for dispensing a liquid product, comprising:
a housing 1 (Fig. 3a);
a product container 5 (Fig. 3a) configured to hold the liquid product and arranged in the housing, the product container comprising a piston 5f (Fig. 3a) shiftable in a distal direction by a drive member for product dispensing;
a covering cap 3 (Fig. 3a) removably arranged on a distal end of the housing; and
a triggering member 2 (Fig. 3a) configured to protrude beyond the distal end of the housing in a starting position (Fig. 4a), wherein:
when the covering cap 3 is removed from the housing, the triggering member is movable in a proximal direction relative to the housing from the starting position (Fig. 4a) into a triggering position (Fig. 5a) for triggering product dispensing, and
when the covering cap 3 is arranged on the distal end of the housing (as shown in Fig. 4a), the triggering member 2a is blocked against moving into the triggering position by way of spring-mounted barring means deflectable by the covering cap 3 into a barring position (the barring position corresponds to the barring means 2a being biased radially outward by the force of the holding portion 3c of the cap 3 in which the barring means 2a face the stop 1b, and so when the cap 3 is on the housing in the starting position, a holding portion 3c of the cap blocks the triggering member 2 from moving inwardly into its triggering position by biasing the barring means 2a outwardly into facing contact with the stop 1b), and the barring means shown to have a free end (see figures).
A skilled artisan would have found it obvious at the time of the invention to modify the claims of the '127 patent provide the barring means to have a free end, in order to prevent accidental automatic triggering of the device, with a reasonable expectation of success.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
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 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by inventor Vogt.
Regarding claim 2, Vogt discloses an autoinjector for dispensing a liquid product, comprising:
a housing 1 (Fig. 3a);
a product container 5 (Fig. 3a) arranged in the housing and configured to hold the liquid product
a covering cap 3 (Fig. 3a) removably arranged on a distal end of the housing and comprising a retention surface 4f (see Fig. 3b); and
a triggering member 2 (Fig. 3a) protruding beyond the distal end of the housing in a starting position (Fig. 4a) and configured to be moved to a triggering position for triggering product dispensing (see Fig. 5a),
wherein the triggering member comprises barring means 2a with a free end of the barring means extending in a proximal direction towards a proximal end of the housing (see Fig. 4a),
wherein when the covering cap is removed from the housing, the triggering member is movable in the proximal direction from the starting position into the triggering position (see Fig. 4a showing the starting position and Fig. 5a showing the triggering position), and
wherein when the covering cap is arranged on the distal end of the housing, the retention surface deflects the barring means into a barring position when the triggering member is moved in the proximal direction such that the triggering member is blocked against moving into the triggering position (by way of the spring-mounted barring means deflectable by the covering cap 3 into a barring position; the barring position corresponds to the barring means 2a being biased radially outward by the force of the holding portion 3c of the cap 3 in which the barring means 2a face the stop 1b, and so when the cap 3 is on the housing in the starting position, a holding portion 3c of the cap blocks the triggering member 2 from moving inwardly into its triggering position by biasing the barring means 2a outwardly into facing contact with the stop 1b).
Regarding claim 3, Vogt discloses the autoinjector according to claim 2, wherein in the barring position, the barring means faces a stop 1b (see Fig. 3a) formed by the autoinjector, and when the covering cap is removed, the barring means can be moved past the stop (see para [0078]).
Regarding claim 4, Vogt discloses the autoinjector according to claim 2, wherein the barring means is spring mounted (see rejection of claim 2, above).
Regarding claim 5, Vogt discloses the autoinjector according to claim 2, wherein the retention surface is configured for retaining the barring means in the barring position when the triggering member is in the starting position (as shown in Fig. 3a).
Regarding claim 6, Vogt discloses the autoinjector according to claim 2, wherein the retention surface is configured such that the barring means, which can be moved together with the triggering member, is retained by the retention surface when the barring means has been moved towards a stop formed by the autoinjector and the triggering member has been moved from the starting position in the proximal direction (see paras [0067], [0078]).
Regarding claim 8, Vogt discloses the autoinjector according to claim 2, wherein the retention surface deflects the barring means into the barring position when the triggering member is moved from the starting position in the proximal direction (i.e., as described above, when the cap 3 is removed to initiate moving the triggering member into the triggering position, the holding portion 3c is also removed, enabling the barring means 2a to move inwardly out of facial engagement with the stop 1b to enable the triggering member 2 to move proximally; see Fig. 5a-5b illustrating the proximal movement of the triggering member 2 relative to its position in Figs. 4a-4b).
Regarding claim 12, Vogt discloses the autoinjector according to claim 2, the product container further comprising a needle 5e (see Fig. 3a), and the triggering member protruding beyond a distal end of the needle when the triggering member is in the starting position and/or after the product dispensing occurs (see Figs. 2-4).
Regarding claim 13, Vogt discloses the autoinjector according to claim 2, the product container further comprising a needle 53 (see Fig. 3a), the needle covered by a needle covering cap 6 (see Fig. 3a) removably coupled to the product container, and the covering cap being coupled to the needle covering cap such that when the covering cap is removed from the housing, the needle covering cap is removed from the product container or needle.
Regarding claim 14, Vogt discloses the autoinjector according to claim 2, further comprising a dispensing spring 8 (see Fig. 2a) configured to act on a drive member arranged in the housing, the dispensing spring pre-tensioned such that it can dispense the product from the product container by shifting the drive member by a dispensing stroke, thereby shifting a piston 5f (see Fig. 3a) arranged in the product container (see para [0053])..
Regarding claim 15, Vogt discloses a safety mechanism for an autoinjector for dispensing a liquid product, the safety mechanism comprising:
a covering cap 3 (Fig. 3a) and a triggering member, the covering cap being removably arranged on a distal end of the autoinjector, the triggering member being adapted to protrude beyond the distal end of the autoinjector and be movable in a proximal direction of the autoinjector from a starting position (see Fig. 4a) into a triggering position for triggering product dispensing (see Fig. 5a)
wherein the triggering member comprises a barring means 2a with a free end of the barring means extending in the proximal direction towards a proximal end of the autoinjector,
wherein the covering cap comprises a retention surface 4f (see Fig. 3b);
wherein when the covering cap is removed from the autoinjector, the triggering member is movable in the proximal direction from the starting position into the triggering position (see Fig. 4a showing the starting position and Fig. 5a showing the triggering position), and
wherein when the covering cap is arranged on the distal end of the autoinjector, the retention surface deflects the barring means into a barring position when the triggering member is moved in the proximal direction such that the triggering member is blocked against moving into the triggering position (by way of the spring-mounted barring means deflectable by the covering cap 3 into a barring position; the barring position corresponds to the barring means 2a being biased radially outward by the force of the holding portion 3c of the cap 3 in which the barring means 2a face the stop 1b, and so when the cap 3 is on the housing in the starting position, a holding portion 3c of the cap blocks the triggering member 2 from moving inwardly into its triggering position by biasing the barring means 2a outwardly into facing contact with the stop 1b).
Regarding claim 16, Vogt discloses the autoinjector according to claim 2, wherein in the barring position, the barring means faces a stop 1b (see Fig. 3a) formed by the autoinjector, and when the covering cap is removed, the barring means can be moved past the stop (see para [0078]).
Regarding claim 17, Vogt discloses the autoinjector according to claim 2, wherein the barring means is spring mounted (see rejection of claim 2, above).
Regarding claim 18, Vogt discloses an autoinjector for dispensing a liquid product, comprising:
a housing 1 (Fig. 3a) configured to hold a product container 5 (Fig. 3a)
a covering cap 3 (Fig. 3a) removably arranged on a distal end of the housing or the autoinjector (see Fig. 3b); and
a triggering member 2 (Fig. 3a) configured to protrude beyond the distal end of the housing in a starting position (Fig. 4a);
wherein the triggering member comprises a barring means 2a with a free end of the barring means extending in a proximal direction towards a proximal end of the housing (see Fig. 4a),
wherein when the covering cap is removed from the housing, the triggering member is movable in the proximal direction from the starting position into the triggering position for triggering product dispensing (see Fig. 4a showing the starting position and Fig. 5a showing the triggering position), and
wherein when the covering cap is arranged on the distal end of the housing or the autoinjector, the covering cap is configured to contact the barring means such that the triggering member is blocked from movement into the triggering position by the barring means being deflected into a barring position (by way of the spring-mounted barring means deflectable by the covering cap 3 into a barring position; the barring position corresponds to the barring means 2a being biased radially outward by the force of the holding portion 3c of the cap 3 in which the barring means 2a face the stop 1b, and so when the cap 3 is on the housing in the starting position, a holding portion 3c of the cap blocks the triggering member 2 from moving inwardly into its triggering position by biasing the barring means 2a outwardly into facing contact with the stop 1b).
Allowable Subject Matter
Claims 7 and 9-11 recite allowable subject matter.
Response to Arguments
Applicant’s arguments with respect to claim 1 has been moot in view of the cancellation of claim 1. Claims 2-18 have been rejected (see above).
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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/27/2026
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