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. Drawings The drawings are objected to because: Fig. 2 has a lead line pointing to an arrow with no corresponding reference numeral. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification A pplicant is reminded of the proper language and format for an abstract of the disclosure : The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc. In addition, the form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. Claim Objections Claims 1-20 are objected to because of the following informalities : As to claim 1, the preamble should be amended to say “ A safety needle assembly for use with a medical injector , the safety needle assembly comprising: comprising; ” to replace the semicolon with a colon and to clarify that “comprising” applies to the safety needle assembly and not the medical injector . Claim 6 appears grammatically incorrect (should likely include the word “in” before “which”). Claims 2-20 are objected to as they depend from or require all the limitations of an objected-to claim. Appropriate correction is required. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 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. Claims 1-20 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 1 recites “ said axis ” in line 16, which is unclear because the claim previously introduced two different axes. Claim 1, lines 18-19 recite “ attachment of the safety needle assembly to the medical injector and the use thereof ”. The scope of “the use thereof” is unclear – i.e. whether it applies to the safety needle assembly or the medical injector and further what constitutes use (for example, is setting of a dose considered “use” of a medical injector or does “use” mean injection of a dose?). Claim 1, lines 28-29 recite “ in the operative position before use, the mounting member and the needle mount are arranged …”. However, the operative position was only discussed previously with regard to the needle and not with regard to the mounting member and/or the needle mount. This brings into question whether the applicant intends to instead refer to the needle, or if the mounting member and the needle mount at some point move into the operative position. As to claim 4, the wording of “ in the form of a shaped surface on an outer surface and wherein the shaped outer surface provides spherical surface ” is unclear. “The shaped outer surface” is not necessarily the same thing as “ a shaped surface on an outer surface ” and furthermore it is unclear what is meant by the phrase “ wherein the shaped outer surface provides spherical surface ”. As to claim 8, the scope of “ the use of the safety needle assembly with the medical injector ” is unclear – i.e. it is not apparent what is or is not considered “ use of the safety needle assembly with the medical injector ”. Claim 9 states “ in the set position, the spring means is partially or semi-preloaded or completely unloaded ”. However, the “set position” was only previously referred to regarding the mounting member and the needle mount and not the spring means. Dependent claims inherit the deficiencies of the claims from which they depend. Allowable Subject Matter Claims 1-20 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. The following is a statement of reasons for the indication of allowable subject matter: As to claim 1, firstly the examiner notes the rejections under 35 U.S.C. § 112(b) above which point out the lack of clarity in the claim, and that any amendments to the claim may affect the prior art considerations. As best understood, t he closest prior art of record is Schubert et al. (US 2012/0022461 A1, hereafter “Schubert”). Schubert discloses: a safety needle assembly (needle assembly of Figs. 1-3) for use with a medical injector (30) comprising; a tubular housing (hub 1) removably attachable to the medical injector (para 0040) , the tubular housing extending in a longitudinal direction from a proximal end (bottom end as seen in Figs. 2-4) to a distal end (top end) , the proximal end being arranged for attachment to the medical injector (see Fig. 4, para 0044) ; a needle mount (12) located within the tubular housing for directly or indirectly supporting a double ended needle (20) having a patient end (21) and a non-patient end (22) , the needle mount being arranged to allow movement of the needle from an operative position to a shielding position (see para 0042, Figs. 2-3) ; a spring means (60) to urge movement of the needle to the shielding position (para 0047) ; a releasable blocking means (4) arranged to prevent movement of the needle from the operative position whereat the needle extends in a direction along a longitudinal axis of the tubular housing and whereby release of the blocking means allows movement of the needle to the shielding position (para 0043-0045) ; the needle mount (12) is a unitary component inserted into the tubular housing and positioned so as to rotate around an axis and the spring means is arranged to urge rotation of the needle about said axis (see Figs. 1-2, para 0047) ; and the blocking means engages the needle mount to maintain the needle in the operative position before use (see Fig. 2 – release part 4 supports attachment part 12) , thereafter attachment of the safety needle assembly to the medical injector and the use thereof causes the blocking means to disengage from the needle mount and allow the spring means to rotate the needle to the shielding position (Figs. 2-3 & para 0047) and to move the non-patient end of the needle towards the distal end of the tubular housing whereat the needle extends at an angle oblique to the longitudinal axis of the tubular housing to place the non-patient end of the needle at a location adjacent to an interior wall of the tubular housing (Fig. 3) ; However, Schubert is silent to the safety needle assembly further comprises: a mounting member which moves relative to the needle mount and wherein the spring means is integral to the mounting member, and in the operative position before use, the mounting member and the needle mount are arranged at a set position relative to each other, thereafter use of the safety needle assembly with the medical injector causes a shift from the set position; said shift moves one of the mounting member or the needle mount relative to the other to preload the spring means to generate a force sufficient to enable the spring means to rotate the needle to the shielding position when the safety needle assembly is detached from the medical injector. The examiner acknowledges the International Search Report and Written Opinion for corresponding PCT/GB2022/051468 (hereafter “the ISR”) which was submitted by the applicant on 12/7/23. However, the examiner notes several things about the ISR. It appears to have interpreted the attachment part 12 of Schubert as both the needle mount and the mounting part, which claim 1 recites as two distinct components. Furthermore, the instant claim 1 contains additional limitations, i.e. the mounting member “ moves relative to the needle mount ” and “ said shift moves one of the mounting member or the needle mount relative to the other to preload the spring means to generate a force sufficient to enable the spring means to rotate the needle to the shielding position when the safety needle assembly is detached from the medical injector ” , which are not present in the claim that was examined as part of the ISR. Schubert does not appear to satisfy these limitations in combination with the rest of claim 1. The examiner has provided additional prior art (US 4,846,808, US 4,986,813, US 2015/0038922) which disclose safety needle assemblies. However, each of these references do not appear any closer than Schubert to satisfying claim 1. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT James D Ponton whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1001 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am-5pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Chelsea Stinson can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-1744 . 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. /James D Ponton/ Primary Examiner, Art Unit 3783