CTNF 18/566,312 CTNF 85504 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 statements (IDS), submitted on 12/01/2023 and 01/08/2026, have been considered by the examiner. 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 Claims 1-13 and 16-20 are 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. [Claims 1 and 13] The claims recite the limitation of “the housing shell” in the 7 th and 8 th lines, respectively. There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if this limitation is intended to refer to the previously recited “first housing shell,” or if a new structure is being introduced into the claim limitations. For purposes of examination, it is interpreted that “the housing shell” refers to the previously recited “first housing shell.” [Claims 2-12 and 16-20] The claims are rejected based upon their dependency from independent claims 1 and 13. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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 Claim s 1-9 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Wozencroft (PGPub 2013/0331796) . [Claim 1] Wozencroft teaches a subassembly (figure 1, items 10/12) for a medical injection device (“autoinjector”) (paragraph [0030]) comprising: a first housing shell (figure 4, item 56); a drive assembly (figure 4, items 58/60/74/76) configured to move a stopper (“piston”) (figure 2, item 11) of a syringe assembly (figure 2, item 13) (paragraph [0034]), the drive assembly (figure 4, items 58/60/74/76) comprising a drive member (figure 4, item 58), a plunger body (figure 4, item 60), and a lever actuation member (figure 13, items 74/76) moveable between a locked position where actuation of the drive assembly (figure 4, items 58/60/74/76) is prevented (paragraphs [0030], [0034]) and a released position where actuation of the drive assembly (figure 4, items 58/60/74/76) is allowed (paragraph [0042]), the drive assembly (figure 4, items 58/60/74/76) configured to be received at least partially within the housing shell (see 112b interpretation above) (figure 4, item 56) (figures 14a/14b/15a/15b); a motor body (figure 2, item 12), the motor body (figure 2, item 12) receiving at least a portion of the drive assembly (figure 4, items 58/60/74/76) therein (figures 14a/14b/15a/15b) and configured to be received at least partially within the housing shell (figure 4, item 56) (figure 1); and a safety clip (figure 1, items 16/18) configured to couple to the motor body (figure 2, item 12) and to secure the lever actuation member (figure 13, items 74/76) in the locked position (paragraphs [0030], [0034]). [Claim 2] Wozencroft teaches the limitations of claim 1, upon which claim 2 depends. In addition, Wozencroft discloses the safety clip (figure 1, items 16/18) is configured to secure the lever actuation member (figure 13, items 74/76) in the locked position when the drive assembly (figure 4, items 58/60/74/76) and motor body (figure 2, item 12) are received within the housing shell (figure 4, item 56) (figure 1; paragraphs [0030], [0034]). [Claim 3] Wozencroft teaches the limitations of claim 1, upon which claim 3 depends. Wozencroft also teaches the safety clip (figure 1, items 16/18) comprises a proximal end and a distal end (figure 4), a first member (figure 4, items 16/18) arranged at the proximal end (figure 4), second (figure 12, item 134) and third (figure 12, item 134) (the examiner notes figure 12 shows two “134” members) members extending distally from the first member (figure 4, items 16/18) (paragraph [0042]), and a fourth member (figure 12, item 126) connected to the second (figure 12, item 134) and third (figure 12, item 134) members (paragraph [0042]). [Claim 4] Wozencroft teaches the limitations of claim 3, upon which claim 4 depends. Wozencroft further discloses the first member (figure 4, items 16/18) is substantially u-shaped (figures 4 and 12) and comprises a base (figure 12, item 18) and a plurality of arms (figure 12, item 125) extending radially substantially perpendicular to the base (figure 12, item 18) (figure 12). [Claim 5] Wozencroft teaches the limitations of claim 4, upon which claim 5 depends. In addition, Wozencroft teaches the plurality of arms (figure 12, item 125) comprise a first end (figure 12; proximal ends of items 125) connected to the base (figure 12, item 18) and a second end spaced from the first end (figure 12), the second end comprising an angled surface (figure 12; distal ends of items 125). [Claim 6] Wozencroft teaches the limitations of claim 5, upon which claim 6 depends. Wozencroft also teaches the angled surface (figure 12; distal ends of items 125) is complimentary to (the examiner notes “complimentary to” does not require any particular structure or orientation between the two structures) at least a portion of the lever actuation member (figure 13, items 74/76) (figures 12 and 13). [Claim 7] Wozencroft teaches the limitations of claim 3, upon which claim 7 depends. Wozencroft further discloses the second (figure 12, item 134) and third (figure 12, item 134) members are arranged substantially perpendicular to the first member (figure 4, items 16/18) (figure 12). [Claim 8] Wozencroft teaches the limitations of claim 3, upon which claim 8 depends. Wozencroft also discloses the second member (figure 12, item 134) and third member (figure 12, item 134) are arranged substantially parallel to each other (figure 12). [Claim 9] Wozencroft teaches the limitations of claim 3, upon which claim 9 depends. In addition, Wozencroft teaches the fourth member (figure 12, item 126) is arranged between the proximal end and the distal end of the safety clip (figure 1, items 16/18) (figures 12 and 15a) . Allowable Subject Matter 07-43-02 AIA Claim s 10-12 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. 07-43-01 AIA Claim s 13-20 would be allowable if rewritten or amended 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. 12-151-07 AIA 07-97 12-51-07 Claim s 14 and 15 are allowed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time. 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, Bhisma Mehta can be reached at 571-272-3383. 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. /JASON E FLICK/Primary Examiner, Art Unit 3783 03/23/2026 Application/Control Number: 18/566,312 Page 2 Art Unit: 3783 Application/Control Number: 18/566,312 Page 3 Art Unit: 3783 Application/Control Number: 18/566,312 Page 4 Art Unit: 3783 Application/Control Number: 18/566,312 Page 5 Art Unit: 3783 Application/Control Number: 18/566,312 Page 6 Art Unit: 3783 Application/Control Number: 18/566,312 Page 7 Art Unit: 3783