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 Election/Restrictions Claims 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/19/26. 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. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “ injection mechanism configured for administering a drug formulation from a reservoir through a delivery needle ” in claim 1, “ an activation mechanism configured to selectively lock the pump or injection mechanism to prevent administration of the drug formulation ” in claim 1, “ a magnetic or mechanical coupling mechanism for combining a reusable component and a disposable component making up the delivery device ” in claim 1 Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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- 4 and 6-10 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. As to claim 1, the wording of “a pump or injection mechanism…” is ambiguous as it could be read in multiple ways . It is not clear if a “pump” is an alternative to an “injection mechanism”, if the mechanism could be a pump mechanism or an injection mechanism, or if applicant is using “pump” as a synonym to “injection”. Claim 3 recites “ wherein the delivery device is a single part prefilled injector, a two part prefilled injector, or a three part injector …”. At least the first option is unclear however because claim 1 specifically requires “ wherein the delivery device comprises a magnetic or mechanical coupling mechanism for combining a reusable component and a disposable component making up the delivery device ”. In other words, it is contradictory for a delivery device to be considered “ a single part prefilled injector ” as well include a magnetic or mechanical coupling mechanism for combining a reusable component and a disposable component . Claim 4 recites “ wherein the delivery device comprises one or more of a reusable injector component comprising an electronic control module or a disposable component comprising the reservoir containing the drug formulation ”, however claim 1 already introduced a reusable component and a disposable component, making claim 4 unclear if the applicant intends to recite an additional reusable component and/or an additional disposable component. Claim 7 recites “ one or more cartridges containing the reservoir ”. What the applicant likely intends to say, however, is “one or more cartridges , each cartridge containing a reservoir containing the reservoir ”. The current wording could be read as if multiple cartridges collectively contain a singular reservoir. Regarding claim 8, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The examiner will assume that the limitations that follow are not required. Claim 8 recites the limitation "the plurality of cartridges" in line 3. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that a “ plurality ” is inconsistent with “one or more cartridges” introduced earlier. Regarding claim 10, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The examiner will assume that the limitations that follow are not required. Dependent claims inherit the deficiencies of the claims from which they depend. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of pre-AIA 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1 , 3, 4, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mounce et al. (US 2008/0077081 A1, hereafter “Mounce”). As to claim 1, Mounce discloses a drug delivery system (10; see Fig. 1) comprising a delivery device (12) comprising: (a) a pump or injection mechanism (motor 44, lead shaft 42 & associated components for moving the drug) configured for administering a drug formulation from a reservoir (26) through a delivery needle (see Fig. 4, para 0085, 0088) ; and (b) an activation mechanism (motor control circuit 52 and/or control electronics 514) configured to selectively lock the pump or injection mechanism to prevent administration of the drug formulation (para 0098, 0214) , wherein the delivery device comprises a magnetic or mechanical coupling mechanism for combining a reusable component (22) and a disposable component (20) making up the delivery device (para 0010-0012, 0068) . As to claim 3, Mounce discloses the drug delivery system of claim 1, wherein the delivery device is a two part prefilled injector (20 and 22 constituting two parts that are releasably attached – see para 0064, 0065, 0187 ). As to claim 4, Mounce discloses the drug delivery system of claim 1, wherein the delivery device comprises a disposable component (20) comprising the reservoir (26) containing the drug formulation (para 0073, 0075, 0183) . As to claim 9, Mounce discloses the drug delivery system of claim 1, further comprising a cap assembly (103; see Figs. 33-34) , optionally wherein the cap assembly comprises a decontamination sponge (optional limitation considered not required). 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 of this title, 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. Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce in view of Brandt et al. (US 2011/0196337 A1, hereafter “Brandt”) . As to claim 2, Mounce discloses the drug delivery system of claim 1 as described above, but does not expressly recite wherein the activation mechanism is configured to allow setting of a dosage of the drug formulation . Brandt discloses an activation mechanism (user interface/display), wherein the activation mechanism is configured to allow setting of a dosage of the drug formulation (para 0026, 0055) . It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Mounce (which already teaches that “ information (or other information, warnings, etc., associated with the stored information) may be displayed on a display device on the durable housing portion 22 ” – para 0187) an incorporate a user interface which includes button and/or a display as part of the activation mechanism and configure the activation mechanism to allow setting of a dosage of the drug formulation. One would have been motivated to do so for the purpose of allowing a user to modify setting of a dose before administration (see para 0026, 0055 of Brandt). Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce in view of Both et al. (US 2011/0166512 A1, hereafter “Both”). As to claim 6, Mounce discloses the drug delivery system of claim 1 as described above , but is silent to wherein the delivery device comprises a shield activated trigger for unlocking the delivery device for administration of the drug formulation. Both discloses a shield activated trigger (24) for unlocking the delivery device for administration of the drug formulation (see Fig. 3 & para 0039, 0042) . It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Mounce to include a shield activated trigger for unlocking the delivery device for administration of the drug formulation. One would have been motivated to do so as a way to prevent activation of the device before it is placed on skin (see Fig. 3 & para 0039, 0042 of Both). Claim(s) 7 -8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce in view of Tamtoro et al. (US 2020/0289740 A1). As to claims 7-8, Mounce discloses the drug delivery system of claim 1 as described above, but is silent to a tamper resistant package comprising one or more cartridges containing the reservoir (claim 7) and wherein the drug delivery system is configured to cause the tamper resistant package to release a cartridge from the one or more cartridges upon obtaining user authorization, optionally wherein the plurality of cartridges are individually locked prior to obtaining user authorization (claim 8). Tamtoro discloses a tamper resistant package (302) comprising one or more cartridges containing reservoir s (see Figs. 3, 5, & para 0027, 0065, 0129, 0131, 0156, 0161 teaching storage compartments 310 and a controller 314 that may be used to prevent tampering) and wherein the drug delivery system is configured to cause the tamper resistant package to release a cartridge from the one or more cartridges upon obtaining user authorization (para 0015, 0027, 0065, 0143, 0156, 0161). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mounce to include a tamper resistant package comprising one or more cartridges containing the reservoir (claim 7) and wherein the drug delivery system is configured to cause the tamper resistant package to release a cartridge from the one or more cartridges upon obtaining user authorization (claim 8) based off of Tamtoro. One would have been motivated to do so in order to provide a secure way of storing cartridges to be used with Mounce (see Figs. 3, 5, & para 0027, 0065, 0129, 0131, 0143, 0156, 0161 of Tamtoro). Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mounce in view of James et al. (US 2013/0281962 A1, hereafter “James”) . As to claim 10, Mounce discloses the drug delivery system of claim 1 as described above. Mounce is silent to a controlled cartridge septum lockout function, optionally wherein the controlled cartridge septum lockout function is configured to open or close an iris to control access to the reservoir. James discloses a controlled cartridge septum lockout function (“ the tear-away feature 206 prevents access to a septum 127 near the distal end of the drug cartridge 200, and therefore the medicament 125, until the tear-away feature 206 is removed or tampered with in some other way ” – para 0114). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Mounce such that cartridges used by Mounce include a septum (for the motivation of sealing the cartridge unless pierced by a needle), and further to include a controlled cartridge septum lockout function , such as a tear-away feature as taught by James, for the motivation of providing tamper-evident access to the septum/ contents of the cartridge (see para 0014, 0107, 0114 of James). 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