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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 16-28) in the reply filed on 07/14/2026 is acknowledged.
Claims 29-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventive group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/14/2026.
Claim Objections
Claim 21 is objected to because of the following informalities: Line 2 reading “circurar” should read --circular--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 28 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 28 recites the limitation “wherein the sidewall of the receptacle comprises an outside surface, the outside surface comprising a first flat section and a second flat section radially opposite the first flat section, wherein a first imaginary straight line intersecting the first flat section and the second flat section extends substantially perpendicular to a second imaginary straight line intersecting the counter fastening element and the second counter fastening element.” The term “imaginary line” is being found indefinite as it is subjective and is not a term of art which can be defined. Examiner recommends using scientific or engineering terminology in the claims. Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 102
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.
Claims 16-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rekaya et al. (USPGPub 2019/0269855).
Re Claim 16, Rekaya teaches a housing (20, 30) of a drug delivery device (10) (Rekaya Figs. 1-4), the housing (20, 30) comprising: a first housing component (20) configured to accommodate a cartridge (50) filled with a medicament (Rekaya ¶ 0121), the first housing component (20) comprising a first connecting end (23) (Rekaya Fig. 4), a second housing component (30) configured to accommodate a drive mechanism (80, 110) of the drug delivery device (10) (Rekaya Figs. 1 and 3), the second housing component (30) comprising a second connecting end (33), an insert (21) provided on one of the first connecting end (23) and the second connecting end (33) (as seen in Rekaya Fig. 4), a receptacle (31) provided on the other one of the first connecting end (23) and the second connecting end (33) (Rekaya Fig. 3; ¶ 0125), wherein the insert (21) is insertable into the receptacle (31) along a longitudinal direction for mutually fastening the first housing component (20) and the second housing component (30), a fastening element (24, 120) provided on the insert (21) (Rekaya ¶ 0127; Fig. 4), a counter fastening element (34, 130) complementary shaped to the fastening element (24, 120) and provided in the receptacle (31) (Rekaya ¶ 0127; Fig. 3), a groove (130) provided on one of the insert (21) and the receptacle (31) and extending along the longitudinal direction (as seen in Rekaya Fig. 3), a protrusion (120) provided on the other one of the insert (21) and the receptacle (31) and configured to slide along the groove (130) upon insertion of the insert (21) into the receptacle (31) thereby rotationally locking the first housing component (20) relative to the second housing component (30) (Rekaya ¶ 0125), a mechanical coding (24) provided on the insert (21) and comprising a coding feature (Rekaya ¶ 0127), a mechanical counter coding (34) provided in the receptacle (31) and comprising a counter coding feature (Rekaya ¶ 0127 - describing first and second latch elements 24, 34 as correspondingly shaped), wherein the mechanical coding (24) and the mechanical counter coding (34) are operable to prevent an engagement of the fastening element (24, 120) with the counter fastening element (34, 130) when the mechanical coding (24) does not match the mechanical counter coding (34) (Rekaya ¶ 0014).
Re Claim 17, Rekaya teaches wherein the mechanical coding (24) is defined by a cross-sectional geometry of a coding portion of a sidewall (22) of the insert (21) (Rekaya Figs. 4-5; ¶ 0127).
Re Claim 18, Rekaya teaches wherein the mechanical coding (24) is defined by a cross-sectional geometry of a longitudinal end face of the insert (21) (Rekaya Figs. 4-5; ¶ 0127).
Re Claim 19, Rekaya teaches wherein the cross-sectional geometry of the coding portion comprises one of a circular shape, an oval-shape, a triangular shape, a rectangular shape and a polygonal shape (Rekaya Figs. 3-4).
Re Claim 20, Rekaya teaches wherein the mechanical counter coding (34) is defined by a cross-sectional geometry of a counter coding portion of a sidewall (32) of the receptacle (31) (Rekaya Figs. 4-5; ¶ 0127).
Re Claim 21, Rekaya teaches wherein the cross-sectional geometry of the counter coding portion comprises one of a circular shape, an oval shape, a triangular shape, a rectangular shape and a polygonal shape (Rekaya Figs. 3-4).
Re Claim 22, Rekaya teaches wherein the receptacle (31) comprises an inner sidewall portion co-axial with the counter coding portion and forming a circumferential, longitudinally extending counter coding slot with the counter coding portion (Rekaya Figs. 3-5).
Re Claim 23, Rekaya teaches wherein the receptacle (31) comprises an insert opening with a first cross section (as seen in Rekaya Fig. 3 - non-circular cross-section), wherein the counter coding portion is located longitudinally offset from the insert opening and comprises a second cross section (Rekaya Fig. 4 - circular cross-section), wherein the second cross section is smaller than the first cross section, and wherein an inside surface of the sidewall (22) extending longitudinally from the insert opening towards the counter coding portion comprises a beveled surface section (28) (Rekaya Fig. 6; ¶ 0136).
Re Claim 24, Rekaya teaches wherein the mechanical coding (24) comprises at least one of a coding recess and a coding protrusion extending in the longitudinal direction, and wherein the mechanical counter coding (34) comprises at least one of a counter coding recess matching with the coding protrusion and a counter coding protrusion matching with the coding recess (Rekaya ¶ 0127 - describing double hooked latch mechanism).
Re Claim 25, Rekaya teaches wherein the fastening element (24, 120) comprises a snap element (Rekaya ¶ 0009-0010), and wherein the mechanical coding (24) is defined by at least one of a longitudinal position and a longitudinal extent of the snap element on the insert (21) (Rekaya ¶ 0009-0010, 0127).
Re Claim 26, Rekaya teaches wherein the counter fastening element (34, 130) comprises a counter snap element (Rekaya ¶ 0009-0010), and wherein the mechanical counter coding (34) is defined by at least one of a longitudinal position and a longitudinal extent of the counter snap element in the receptacle (31) (Rekaya ¶ 0009-0010, 0127).
Re Claim 27, Rekaya teaches wherein the receptacle (31) comprises a second counter fastening element located diametrically opposite to the counter fastening element (34, 130) (as seen in Rekaya Fig. 5), and wherein a sidewall (32) of the receptacle is elastically deformable to increase a radial distance between the counter fastening element (34, 130) and the second counter fastening element, wherein the radial distance is larger than or equal a radial distance between the fastening element (24, 120) and a second fastening element located diametrically opposite on the insert (21) (Rekaya ¶ 0010. 0022-0023).
Re Claim 28, Rekaya teaches wherein the sidewall (32) of the receptacle (31) comprises an outside surface (Rekaya Fig. 5), the outside surface comprising a first flat section and a second flat section radially opposite the first flat section, wherein a first imaginary straight line intersecting the first flat section and the second flat section extends substantially perpendicular to a second imaginary straight line intersecting the counter fastening element (34, 130) and the second counter fastening element (Rekaya Fig. 5).
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.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 16 of copending Application No. 18/289008 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 16 of the present case is more broad where Claim 16 of reference application includes language “a counter fastening element complementary shaped to the fastening element, wherein the counter fastening element is provided in the receptacle and comprises a counter snap element configured to engage with the snap element through a deflection or deformation of at least one of the fastening element or the counter fastening element along a radial direction.” This limitation was anticipated by Rekaya above in Claim 27 above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Terminal Disclaimer
A terminal disclaimer may be effective to overcome a provisional nonstatutory double patenting rejection over a pending application (37 CFR 1.321(b) and (c)). 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. 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/PatentForms. The filing date of the application will determine what form 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/TerminalDisclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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