CTNF 18/572,923 CTNF 81759 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on 12/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification 07-28 AIA The amendment filed 12/23/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The incorporation by reference of the international patent application PCT/EP2022/066910 and of the *foreign* patent application EPO 21305882.9 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 6/21/2022, see MPEP 1893.03(b). Therefore, the specification amendment of 12/21/2023 to include the incorporation by reference is new matter, per MPEP 608.01(p) . Applicant is required to cancel the new matter in the reply to this Office Action. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 3 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 3 recites the limitation "the ring portion" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 3 was amended to depend from claim 1. However, claim 1 does not recite a ring portion. Presently, claim 2 recites that the locker has a ring portion. Thus, it is unclear whether claim 3 should depend from claim 2 or claim 1. For purposes of this examination , claim 3 has been interpreted to depend from claim 2. Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1, 9-10 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kramer et al (2013/0289491) . Regarding claim 1, Kramer et al discloses an autoinjector (100; e.g. Fig 1A), for automatic injection of a product into an injection site (P9), said autoinjector having a proximal end (e.g. 106; Fig 1A) and a longitudinal axis A (Fig 1A), the autoinjector comprising: a housing (102 and 106; Fig 1A-1B) configured to receive a medical container (114), said medical container having a barrel (114) defining a reservoir for containing a medical product (Fig 1B), and said barrel having a distal end provided with a needle (116) and an opened proximal end configured to receive a plunger rod (e.g. 1132; Fig 1B) for pushing a stopper (1140) arranged inside the barrel, a needle cover (108) coupled to and movable with respect to said housing between a first extended position (e.g. position shown in Figs 9a-b; P55), wherein the needle cover at least partially shields the needle (e.g. position shown in Figs 9a-b; P55), a retracted position (e.g. position shown in Figs 10a-b; P56), wherein the needle cover moves proximally inside the housing to unshield the needle (e.g. position shown in Figs 10a-b; P56), and a second extended position (e.g. position shown in Figs 12a-b; P59) wherein the needle cover moves back in the distal direction to shield the needle (e.g. position shown in Figs 12a-b; P59), an injection mechanism (112) configured to move the plunger rod distally inside the barrel in order to expel the medical product contained inside the barrel, a holder (1120) movable with respect to the housing between a passive position wherein the holder does not trigger the injection mechanism and an active position wherein the holder triggers the injection mechanism, a locker (1134; e.g. Fig 6a) coupled to the holder (Webster’s defines “coupled” as “to connect for consideration together”, “to join for combined effect”, and “to fasten together”. Here, 1134 is coupled to 1120 under the broadest reasonable interpretation as it is joined with 1120 so as to be fastened together and joined for combine effect so that they move together), the locker being rotationally movable with regard to the housing (e.g. P54, P57), between a locking position, in which a proximal abutment surface of the locker (projections 1134 of latch tabs form a proximal abutment surface) abuts against a first abutment surface of the housing (lateral sides of 1022 in position 1022a of housing 102 that engage with the lateral sides of 1134; 1022 is the trigger member retaining portion that engages 1134 preventing activation in position 1022a by preventing 1134 from splaying open – see P42; Fig 2b) so that the locker prevents the holder from moving to the activated position, and an unlocking position, in which the proximal abutment surface (projections 1134 of latch tabs form a proximal abutment surface) of the locker is moved away from the first abutment surface of the housing (P42; Fig 2c; where in the firing position of 1022b the projections 1134 are rotated such that they are moved away from the first abutment surface into openings to splay apart, thereby permitting firing mechanism to fire) a thereby allowing the holder to move to the activated position, rotation of the locker from the locking to the unlocking position being caused by the needle cover moving towards the retracted position (Fig 2b-2b, 10b; P42; P54, P57; here engagement of needle cover 108 when displaced toward the retracted position causes rotation of 1120 via engagement of respective camming surfaces 1084 and 1024a to rotate 1134 from locking position 1022a to unlocked position 1022b). Applicant is strongly advised to further structurally define (i) the respective abutment surfaces, while noting that the ram holding member 1062 in Fig 3 and P43 can also presently read on first abutment surface of the housing; (ii) the structure of the holder; and (iii) the structure of the locker. Regarding claim 9, Kramer et al discloses wherein the locker (1134) has a spring mechanism for urging the locker back towards the locking position (e.g. P42, P54; here the locker has an arm/leg coupled to the projection that is resiliently biased to splay outwards when moved between positions 1022a and 1022b; Figs 2a-b). This resilient biasing is capable of being urged (e.g. radially compressed) to move from radially inwards from the position of 1022b back towards the position of 1022a). Regarding claim 10, Kramer et al discloses wherein the locker (1134) is made of a single piece (e.g. Fig 6a). Here, 1134 are formed as a single unit with 1126 (P52). Additionally, and/or alternatively, one of the projections 1134 also reads on the limitation as it is one piece and the use of open-ended “comprising” language allows for more than one projection . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al, as applied to claim 1 above, in view of Gabriel (6544234). Kramer et al discloses the invention substantially as claimed except for expressly disclosing wherein the locker is made of a first material including acrylonitrile butadiene styrene (ABS) and the holder is made of a second material including polyoxymethylene (POM). Gabriel teaches that it is known to have an autoinjector (10; Fig 1-5) where the parts of the injector may be made of a first material including acrylonitrile butadiene styrene (ABS) a second material including polyoxymethylene (POM) (col 5, lns 55-59) for the purpose providing a simple substitution, e.g. selection of ABS and POM as a material for syringe parts for an autoinjector, to parts of an autoinjector to obtain predictable results. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the autoinjector as taught by Kramer et al with the ABS and POM materials for the locker and holder as taught by Gabriel for the purpose of providing a simple substitution, e.g. selection of ABS and POM as a material for syringe parts for an autoinjector, to parts of an autoinjector to obtain predictable results . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim s 3, 4-8 are 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. 07-43-02 AIA Claim 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 Form. Specifically: Autoinjectors with a lock release via retraction of needle cover and employing cammed surfaces and/or rotation to release the lock: 5843036, 20130324934, 20160015896, 20190030248, 20220362483, 12453822, 20100268170, 20120253289, 20130317435, 20140303556, 10569017, 20230158249. Autoinjectors with a cammed lock release: 20100049125, 20100280460, 20140228769. To expedite prosecution in the event the applicant has any questions or proposed claim amendments to discuss the applicant is invited to contact the examiner at the telephone number listed below. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew M. Gilbert whose telephone number is (571)272-7216. The examiner can normally be reached 9:00 am - 5:30 pm (EST), Monday - Friday. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4726. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANDREW M GILBERT/Primary Examiner, Art Unit 3700