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 .
Acknowledgment
Claims 16, 18-20, 25, 28, are amended and filed on 2/4/2026.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,512,727B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 16 recites an activating mechanism ( Patent, claim 1) comprising: an outer body ( Patent, claim 1), a cartridge (claim 1), a needle safety mechanism (Patent, claim 1), an inner needle sleeve (Patent, claim 1), an outer needle sleeve (Patent, claim 1), and a double-ended hollow needle (Patent, claim 1) , a cartridge carrier (claim 1).
Also, limitation of claim 17 found in the patent (Patent, claim 2), claim 18 ( claim 5), claim 19 ( claim 5), claim 20 (claim 6), claim 21 (claim 1), claim 22 ( claim 1), claim 23 ( claim 7), claim 24 ( claim 9), claim 25 ( claim 11), claim 26 ( claim 21), claim 27 ( claim 13).
Claims 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-16 of U.S. Patent No. 10,512,727B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 28 recites a medicament delivery device ( claim 14) comprising: an activating mechanism (claim 14) comprising: an outer body ( claim 14), a cartridge (claim 14), a needle safety mechanism (claim 14), an inner needle sleeve ( claim 14), an outer needle sleeve (claim 14), a cartridge carrier (claim 14), and a double-ended hollow needle (claim 14).
Also, limitation of claim 29 found in the patent (claim 15), claim 30 ( claim 16).
Claims 33-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,512,727B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 33 recites an activating mechanism (claim 1) comprising: an outer body (claim 1), a cartridge (claim 1), a cartridge carrier (claim 1), a needle safety mechanism (claim 1), an inner needle sleeve (claim 1), an outer needle sleeve (claim 1), a double-ended hollow needle (claim 1), and at least one resilient arm ( claim 1).
Also, limitation of claim 34 found in the patent (claim 13), limitation of claim 35 found in the patent (claim 1).
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.
Claims 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtsson in view of Kirchhofer and further in view of Ruan et al. (US. 20110160675A1) (“Ruan”).
Re claim 33, Bengtsson discloses an activating mechanism (Figs. 1, 14-16) for a medicament delivery device (Figs.14-16) comprising: an outer body (2, Fig. 1, outer body), a cartridge (10) containing a dosage of a medicament (abstract, Fig. 1), the cartridge being sealed with a sealing element (11) that is arranged across an open distal end of the cartridge (top end of the cartridge Fig. 3), a cartridge carrier to hold the cartridge (7annotated Fig. 14 of Bengtsson, similar to 70 in Fig. 17 ), a needle safety mechanism comprising an inner needle sleeve (67, 65, Fig. 14) and an outer needle sleeve (30), the inner needle sleeve is configured to contact and hold a double-ended hollow needle (needle 20 Fig. 14-16), and the needle safety mechanism configured to move along a longitudinal axis of inner sleeve (axis of the needle 20, Fig. 14-16) relative to the cartridge and to the outer body to cover or to expose a distal end of the double-ended hollow needle (Fig. 14-15 to expose the needle, Fig. 15-16 to cover the needle), wherein the medicament delivery device is configured such that in an initial position of the medicament delivery device, a proximal end of the double-ended hollow needle (lower end of 20) is distally spaced from the cartridge (Fig. 14), and when the needle safety mechanism is pressed into the outer body (Fig. 15), such that the needle safety mechanism is at least partially received in the outer body (Fig. 15), the proximal end of the double-ended hollow needle pierces the sealing element (Fig. 15, pg. 17, lines 6-18); wherein the outer needle sleeve is configured to move proximally relative to the outer body(Fig. (15, pg. 17, lines 6-18),wherein the outer needle sleeve is configured to move proximally relative to the outer body and the double-ended hollow needle to expose the double-ended hollow needle ( Fig. 14 to Fig. 15), but it fails to disclose wherein the outer needle sleeve comprises at least one resilient arm configured to move outwards into a recess defined by an inner surface of the outer body as the outer needle sleeve moves proximally relative to the outer body and wherein the sealing element is pierced before the double-ended hollow needle is exposed for the first time during operation of the medicament delivery device and wherein an engagement of the outer needle sleeve and the inner needle sleeve limits a relative axial movement between the outer needle sleeve and the inner sleeve, and wherein the engagement is releasable to allow relative axial movement between the outer sleeve and the inner sleeve when the at least one resilient arm moves outwards in the recess defined by the inner surface of the outer body.
However, Kirchhofer discloses a pen injector (Figs. 1-3) and wherein inner needle sleeve (2 and Fig. 1) , outer needle sleeve (22, Fig. 3, Fig, 4) and a sealing element (31) and wherein the sealing element is pierced before the double-ended hollow needle (1) is exposed for the first time during operation of the medicament delivery device (¶008, ¶0039-¶0040).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bengtsson so that the sealing element is pierced before the double-ended hollow needle is exposed for the first time during operation of the medicament delivery device as taught by Kirchhofer for the purpose of ensuring that the needle is sterilized but ready for injection (Kirchhofer, ¶0026).
The modified Bengtsson in view of Kirchhofer fails to disclose the outer needle sleeve comprises at least one resilient arm configured to move outwards into a recess defined by an inner surface of the outer body as the outer needle sleeve moves proximally relative to the outer body and wherein an engagement of the outer needle sleeve and the inner needle sleeve limits a relative axial movement between the outer needle sleeve and the inner sleeve, and wherein the engagement is releasable to allow relative axial movement between the outer sleeve and the inner sleeve when the at least one resilient arm moves outwards in the recess defined by the inner surface of the outer body.
However, Ruan discloses a needle sleeve (Fig. 1, Fig. 18-20) and wherein an outer needle sleeve (14) comprises at least one resilient arm (38) configured to move outwards into a recess (30, Fig. 3) defined by an inner surface of the outer body (12, Fig. 18) as the outer needle sleeve moves proximally relative to the outer body (Fig. 18 to Fig. 20) and an engagement of the outer needle sleeve and the inner needle sleeve limits a relative axial movement between the outer needle sleeve and the inner sleeve(Figs. 18-20, ¶0040) and wherein the engagement is releasable to allow relative axial movement between the outer sleeve and the inner sleeve when the at least one resilient arm moves outwards into the recess defined by the inner surface of the outer body (Figs. 18-20, ¶0040).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bengtsson to include a resilient arm on the outer needle sleeve and a recess on the outer body so that the outer needle sleeve comprises at least one resilient arm configured to move outwards into a recess defined by an inner surface of the outer body as the outer needle sleeve moves proximally relative to the outer body and wherein an engagement of the outer needle sleeve and the inner needle sleeve limits a relative axial movement between the outer needle sleeve and the inner sleeve, and wherein the engagement is releasable to allow relative axial movement between the outer sleeve and the inner sleeve when the at least one resilient arm moves outwards in the recess defined by the inner surface of the outer body as taught by Ruan for the purpose of easily engaging the two tubular structures during the assembling and capable to be replaceably locked before usage (Ruan, ¶0040).
Re claim 34, Bengtsson discloses wherein the medicament comprises a pharmaceutically active compound (Fig. 14-Fig.15, pg. 17, lines 6-18).
Re claim 35, Bengtsson discloses wherein the medicament delivery device and the activating mechanism are capable such that pressing the needle safety mechanism into the outer body causes the needle safety mechanism to move into the outer body (Fig. 14 to Fig. 15).
Response to Arguments
Applicant’s arguments, see remark, filed 10/7/2028, with respect to newly added limitation and to the rejection(s) of claim(s) 16, 28 under 103 have been fully considered and are persuasive.
Applicant’s arguments, see remark, filed 10/7/2028, with respect to newly added limitation and to the rejection(s) of claim(s) 33 under 103 have been fully considered and are not persuasive. The applicant argues that Bengtsson fails to show a recess in the inner surface of the outer body. This is found not persuasive Ruan discloses an outer needle sleeve (14) comprises at least one resilient arm (38) configured to move outwards into a recess (30, Fig. 3) defined by an inner surface of the outer body (12).
The argument that the arm of Ruan is the opposite is not inward. This is found not persuasive as the claimed there is no direction in claim 33.
The argument that modifying Bengtsson with Kirchhofer for piercing the septum would change the sterility of the needle as Bengtsson . This is found not persuasive as inner end will pierce the septum is still sterilized as it is inserted in the cartridge and ready for injection.
Note: the applicant Michaek Benson called on 3/2/2026 with regards to a terminal disclaimer, and stated that the applicant will let the case abandoned naturally.
Conclusion
THIS ACTION IS MADE FINAL. 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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783