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. Information Disclosure Statement The information disclosure statement (IDS) submitted on 12/8/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification The amendment filed 12/8/2023 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/EU2022/066818 and of the *foreign* patent application EPO 21180787.0 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 12/8/2023 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 Objections Claim 15 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only . See MPEP § 608.01(n). Here, claim 15 refers to claim 1 and claim 14. Accordingly , the claim 15 has not been further treated on the merits. Claims 1-14 objected to because of the following informalities: In regards to claim 1, the term “relatively” in line 26 should be changed to “relative”. Claims 2-13 are objected to by virtue of depending on an objected claim. In regards to claim 12 , the term “ the nut element and the housing structure ” in line 3-4 should be changed to “ the nut element or the housing structure ”. In regards to claim 13, the term “the assembled state” in line 2 should be changed to “an assembled state”. In regards to claim 14 , the term “ relatively ” in line 26 should be changed to “ relative ”. In regards to claim 14, the term “relatively” in line 33 should be changed to “relative”. In regards to claim 14 , the term “ to an adjusted position wherein the piston rod structure ” in line 34 should be changed to “ to an adjusted position where the piston rod structure ”. Appropriate correction is required. 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 the first paragraph of pre-AIA 35 U.S.C. 112: 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 of carrying out his invention. Claim s 2 -6 are is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 2 recites “ wherein the engaging structure between the piston rod and the nut element comprises a number of radial arms provided on either the piston rod or the nut element engaging the other of the piston rod or the nut member . ” ( emphasis added ). Here, a n original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved . See , e.g. MPEP 2163.03(V) and MPEP 2163. Here, claim 2 recites that the engagement structure that releasably secures the piston rod structure to the nut element in a start position and allows the plunger to be moved a travel distance from the start to a stop position during dose ejection is in one recited embodiment a number of radial arms on the nut element engaging the piston rod. This embodiment is lacks original description support because the disclosure fails to structurally identify how this function is performed or the result is achieved for this embodiment. Outside of merely repeating this claim language in ipsis verbis (see Applicant’s specification pg 4, lns 27-28) , the original disclosure does not describe this claimed invention so that one of ordinary skill can recognize the applicant had possession of this claimed invention. The specification fails to describe and illustrate the claimed invention where a number of radial arms (e.g. 53 are provided on the nut (e.g. 60) that engage the piston rod (50). Further, one of ordinary skill in the art would not have recognized applicant has possession of this claimed invention because the disclosed and claimed nut (e.g. 60) is adjustably coupled to the housing (e.g. 1) such that the nut’s axial position can be adjusted relative to the housing to set a starting and stopping position of the piston rod during dose ejection based on the position of the plunger within the cartridge (see e.g. Figs 1-9c). Each and every drawing and the entirety of the disclosure, but for merely repeating the cla i m language, described the piston rod structure having the radial arms that engage the nut element. A person of ordinary skill in the art would recognize that the arrangement of parts cannot be merely reversed such that the radial arms are placed on the nut that engage the piston. The piston and the nut perform different functions, e.g. the nut is movably fixed to the housing and the piston moves relative to both the housing and the nut to eject a dose. As set forth in Figs 1-9c and accompanying disclosure, the radial arms are designed to slide in/out of engagement with the nut in specific manner with specific structures of the nut to set the start and stopping points of the plunger movement. It is not clear how such radial arms would be moved from a movable plunger as disclosed, to a fixed nut, for the claimed function to occur (e.g. as shown in Figs 9a-c) . Thus, one of ordinary skill in the art would not recognize that applicant has possession of the claimed subject matter in claim 2 of the engagement structure being a number of radial arms provided on the nut engaging the piston rod as applicant has failed to set forth the structure for arrangement and how the function would be achieved/result. Applicant is strongly advised to delete the alternative embodiment of the plurality of arms on the nut engaging the piston rod structure from claim 2 . Claims 3-4 are rejected by virtue of depending on claim 2 (see 112(b) discussion below). Regarding claim 5, similar to the analysis above for claim 2. Claim 5 recites “ wherein the engaging structure between the piston rod and the nut element comprises a number of radial gripping teeth provided on either the piston rod or the nut element engaging the other of the piston rod or the nut member . ” ( emphasis added ). Again, as discussed above for claim 2, the original disclosure merely repeats the claim language (see pg 5, lns 10- 11) and the remainder of disclosure and Figures 1-9c disclose the embodiment of a number of radial gripping teeth (56) provided on the piston rod (e.g. Fig 6b-c) that engage an angled front (64) on the nut (60). This engagement sets the start position of piston rod relative to the housing (e.g. see Fig 3, 9c). As discussed above, it is unclear how these elements can be merely reversed since the nut and piston perform entirely different functions, e.g. the nut is movably fixed relative to the housing while the piston rod moves relative to the housing during dose ejection. It is not clear how such radial gripping teeth (56) would be moved from a movable plunger as disclosed, to a fixed nut, for the claimed function to occur (e.g. as shown in Figs 9a-c) . Thus, one of ordinary skill in the art would not recognize that applicant has possession of the claimed subject matter in claim 5 of the engagement structure being a number of radial gripping teeth provided on the nut engaging the piston rod as applicant has failed to set forth the structure of the arrangement and how the function would be achieved/result. Applicant is strongly advised to delete the alternative embodiment of the plurality of radial gripping teeth on the nut engaging the piston rod structure from claim 5 . Claim 6 is rejected by virtue of depending on claim 5. 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 appl icant regards as his invention. Claims 1-14 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. Claim 1 recites “ A single dose injection device …, comprising: … and wherein the axial position of the nut element relatively to the housing structure is individually adjustable for each individual injection device during assembly of the individual injection device … in the individual cartridge .” ( emphasis added ). Here, the scope of the claim is drawn to a single dose injection device. One device. However, the body of the claims recites that the axial position of the nut in the single injection device is adjustable relative to the housing structure in the single injection device for each individual injection device . This requires more than one injection device, e.g. requiring a function to occur in each one requires more than one device. However, t he claim is not drawn to an assembly or kit, but rather a single injection device. Thus, it is unclear how a nut and a housing in a single device can be adjustable in more than one device when the claim is drawn to a single injection device. Applicant is strongly advised to amend the claims to clearly reference just a single injection device. For purposes of examination , the limitation has been interpreted to mean “ … and wherein an axial position of the nut element relative to the housing structure is adjustable for the single dose injection device during assembly … in the cartridge.” Claims 2-13 are rejected by virtue of depending on a rejected base claim. Additionally, claim 1 recites “ to thereby adjust the axial position of the travel distance of the piston rod structure to an adjust position” in lines 28-29. However, “the travel distance of the piston rod structure is defined as the axial distance the piston rod structure is translationally movable when moving the plunger from the start position to the stop position during dose ejection” (lines 22-25). Here, “the axial position” in line 28 lacks proper antecedent basis. Further, the travel distance as a distance (e.g. 10 mm) the piston moves from start to stop during a dose ejection. It is unclear how a distance can have an axial position . A distance is a value, e.g. 10 mm, not a physical element capable of having a position relative to another physical element. Thus, thi s limitation renders the claim unclear. Applicant is strongly advised to amend the claim to reference the adjustment of position in terms of physical structure. E.g.: For purposes of examination , the recitation has been interpreted to mean “wherein the axial position of the nut element relative to the housing structure is adjustable for the single dose injection device during assembly to a position where the piston rod structure abuts the plunger such that the start position and stop position of the piston rod structure during dose ejection is adjusted based on a start position of the plunger in the cartridge.” Regarding claim 4, the claim recites in line 3 “comprises a number of further radial arms…”. However, claim 4 depends on claim 1 which does not recite a number of radial arms. Thus, it is unclear whether claim 4 should depend on claim 1 or claim 2 or claim 3. For purposes of examination , claim 4 has been interpreted to depend on claim 3. Similar to the above discussion for claim 1, independent c laim 1 4 recites “ A method of assembling a single dose injection device comprising: … wherein the axial position of the nut element relatively to the housing structure is individually adjustable for each individual injection device during assembly of the individual injection device … in the individual cartridge .” ( emphasis added ). Here, the scope of the claim is drawn to a method of assembling a single dose injection device. One device. However, the body of the claims recites that the axial position of the nut in the single injection device is adjustable relative to the housing structure in the single injection device for each individual injection device . This requires more than one injection device, e.g. requiring a function to occur in each one requires more than one device. However, the claim is not drawn to an assembly or kit, but rather a single injection device. Thus, it is unclear how a nut and a housing in a single device can be adjustable in more than one device when the claim is drawn to assembling a single injection device. Applicant is strongly advised to amend the claims to clearly reference just a single injection device. For purposes of examination , the limitation has been interpreted to mean “… and wherein an axial position of the nut element relative to the housing structure is adjustable for the single dose injection device during assembly … in the cartridge.” Additionally, claim 14 recites “ wherein the method comprises the step of individually adjusting the axial position of the nut element for each individual injection device during assembly to thereby adjust the axial position of the travel distance of the piston rod structure relatively to the housing structure to an adjusted position wherein the piston rod structure abuts the plunger. ” Similar to the above discussion for claim 1, this limitation renders the claim indefinite because it is unclear how a nut and a housing in a single device can be adjustable in more than one device when the claim is drawn to assembling a single injection device. Further, “the axial position” in line 28 lacks proper antecedent basis. Further, the travel distance as a distance (e.g. 10 mm) the piston moves from start to stop during a dose ejection. It is unclear how a distance can have an axial position . A distance is a value, e.g. 10 mm, not a physical element capable of having a position relative to another physical element. Thus, thi s limitation renders the claim unclear. Applicant is strongly advised to amend the claim to reference the adjustment of position in terms of physical structure. E.g.: For purposes of examination , the recitation has been interpreted to mean “wherein an axial position of the nut element relative to the housing structure is adjustable for the single dose injection device during assembly to a position where the piston rod structure abuts the plunger such that the start position and stop position of the piston rod structure during dose ejection is adjusted based on a start position of the plunger in the cartridge , wherein the method comprises the step of individually adjusting the axial position of the nut element for the single dose injection device during assembly to a position where the piston rod structure abuts the plunger such that the start position and stop position of the piston rod structure during dose ejection is adjusted based on a start position of the plunger in the cartridge .” 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. Claim(s) 1 , 8-9, 12-14 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Goldberg (2753867) . Regarding claim 1, Goldberg discloses a single dose injection device (Figs 1-3) for delivering a predetermined volume of a liquid drug, comprising: a housing structure (10) securing a cartridge (23) containing the liquid drug which cartridge is axially locked to the housing structure (Fig 1-2) and which cartridge has a distal end (24) sealed by a pierceable septum (24 pierced by 13; Fig 2) and a proximal end (23a) closed by a movable plunger (26) having a distal front surface (Fig 3; front surface of 26 contacting drug) , a piston rod structure comprising a piston rod (19) and a piston rod foot (22; Fig 3) , which is translationally movable in the distal direction in relation to the housing structure to thereby move the plunger in the distal direction inside the cartridge (Fig 1-3; e.g. col 3, lns 61-65) , the plunger being movable from a first position to a second position ( Fig 1-3; e.g. col 3, lns 61-65 ; e.g. initial position in Fig 2 to second position where flange 20 abuts lugs 17 ) , wherein the predetermined volume of liquid drug to be ejected being defined by an inner surface of the cartridge and the length the distal front surface of the plunger is moved during movement of the plunger from the first position to the second position (Fig 1-3; e.g. col 3, lns 61-65; where the volume delivered is equal to the length the plunger 26 moves under force of piston 19) , and wherein a nut element (14; Fig 1-3) guiding the piston rod structure is adjustable coupled to the housing structure (14 is threadedly engaged via threads 15 with corresponding threads 16 on barrel 11 to allow for axial movement via threaded engagement) , wherein: the piston rod structure and the nut element are provided with engagement structure for releasable securing the piston rod structure to the nut element in a start position of the piston rod structure wherein the piston rod structure abuts the plunger at least in use ( the distal surface of 14 engages the proximal surface of 22 of 19 preventing 19 from being withdrawn further, thus releasably securing the piston 19 to the nut 14 in a start position. E.g , a proximal most position. Applicant is advised to further structurally define the engagement structure to distinguish over abutting surfaces as taught by Goldberg ) , and wherein a stop position of the piston rod structure is defined by stop structure (20) on the piston rod operationally engaging the nut element (e.g. 20 on 19 engages lugs 17 on nut 14 to stop distal movement of the piston) , such that a travel distance of the piston rod structure is defined as the axial distance the piston rod structure is translationally movable when moving the plunger from the start position to the stop position during dose ejection (the travel distance is the distance the plunger 19 is capable of movement from an start position, e.g. Fig 2, to a distal stop position where 20 abuts 17 during dose ejection) , and wherein the axial position of the nut element relative to the housing structure is adjustable for the single dose injection device during assembly to a position where the piston rod structure abuts the plunger such that the start position and stop position of the piston rod structure during dose ejection is adjusted based on a start position of the plunger in the cartridge (see 112(b) discussion above ; Fig 2; col 3, lns 30-35; here the threaded connection of 14 and 11 allows for 14 to be axially translated along 11 as needed to position the piston rod in engagement with the plunger in the start position. The position of 14 relative to 11 determines the distance the plunger 19 will axially travel from a start position, e.g. Fig 2, to a distal stop position where 20 abuts 17 ) . Regarding claim s 8-9, Goldberg discloses wherein the nut element (14) is axially adjusted in relation to the housing structure (11) via a threaded connection via the housing structure having a thread (16) on an inner surface (16 on inner surface of 11) engaging a corresponding thread on an outer surface of the nut (via outer threads 15 on 14 engages corresponding threads 16 on 11). Regarding claim 1 3 , Goldberg discloses wherein the nut element and the housing structure are irreversible connected in an assembled state ( col 3, lns 35-42; where once assembled the fictional forces of the threaded engagement of 15 with 16 suffice to resist reverse motion of 14 relative to 11. Webster’s defines “ irrevisible ” as “not being able to be changed to a previous state”. Here, the frictional engagement is disclosed as being sufficient to prevent reverse motion to previous unthreaded state and thus meets the broadest reasonable interpretation of the claim. Applicant is advised to further structurally define the connection between the nut and housing ) . Regarding claim 14, Goldberg discloses a method of assembling a single dose injection device (Figs 1-3) comprising: a housing structure (10) securing a cartridge (23) containing the liquid drug which cartridge is axially locked to the housing structure (Fig 1-2) and which cartridge has a distal end (24) sealed by a pierceable septum (24 pierced by 13; Fig 2) and a proximal end (23a) closed by a movable plunger (26) having a distal front surface (Fig 3; front surface of 26 contacting drug) , a piston rod structure comprising a piston rod (19) and a piston rod foot (22; Fig 3) , which is translationally movable in the distal direction in relation to the housing structure to thereby move the plunger in the distal direction inside the cartridge (Fig 1-3; e.g. col 3, lns 61-65) , the plunger being movable from a first position to a second position (Fig 1-3; e.g. col 3, lns 61-65; e.g. initial position in Fig 2 to second position where flange 20 abuts lugs 17) , wherein the predetermined volume of liquid drug to be ejected being defined by an inner surface of the cartridge and the length the distal front surface of the plunger is moved during movement of the plunger from the first position to the second position (Fig 1-3; e.g. col 3, lns 61-65; where the volume delivered is equal to the length the plunger 26 moves under force of piston 19) , and wherein a nut element (14; Fig 1-3) guiding the piston rod structure is adjustable coupled to the housing structure (14 is threadedly engaged via threads 15 with corresponding threads 16 on barrel 11 to allow for axial movement via threaded engagement) , wherein: the piston rod structure and the nut element are provided with engagement structure for releasable securing the piston rod structure to the nut element in a start position of the piston rod structure wherein the piston rod structure abuts the plunger at least in use (the distal surface of 14 engages the proximal surface of 22 of 19 preventing 19 from being withdrawn further, thus releasably securing the piston 19 to the nut 14 in a start position. E.g , a proximal most position. Applicant is advised to further structurally define the engagement structure to distinguish over abutting surfaces as taught by Goldberg) , and wherein a stop position of the piston rod structure is defined by stop structure (20) on the piston rod operationally engaging the nut element (e.g. 20 on 19 engages lugs 17 on nut 14 to stop distal movement of the piston) , such that a travel distance of the piston rod structure is defined as the axial distance the piston rod structure is translationally movable when moving the plunger from the start position to the stop position during dose ejection (the travel distance is the distance the plunger 19 is capable of movement from an start position, e.g. Fig 2, to a distal stop position where 20 abuts 17 during dose ejection) , and wherein the axial position of the nut element relative to the housing structure is adjustable for the single dose injection device during assembly to a position where the piston rod structure abuts the plunger such that the start position and stop position of the piston rod structure during dose ejection is adjusted based on a start position of the plunger in the cartridge (see 112(b) discussion above; Fig 2; col 3, lns 30-35; here the threaded connection of 14 and 11 allows for 14 to be axially translated along 11 as needed to position the piston rod in engagement with the plunger in the start position. The position of 14 relative to 11 determines the distance the plunger 19 will axially travel from a start position, e.g. Fig 2, to a distal stop position where 20 abuts 17) ; wherein the method comprises the step of individually adjusting the axial position of the nut element for the single dose injection device during assembly to a position where the piston rod structure abuts the plunger such that the start position and stop position of the piston rod structure during dose ejection is adjusted based on a start position of the plunger in the cartridge (see 112(b) discussion above; Fig 2; col 3, lns 30-35; here the threaded connection of 14 and 11 allows for 14 to be axially translated along 11 as needed to position where the piston rod is in engagement with the plunger in the start position as shown in Fig 2 . The position of 14 relative to 11 determines the distance the plunger 19 will axially travel from a start position, e.g. Fig 2, to a distal stop position where 20 abuts 17) . 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, 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 2 is/are FILLIN "Enter appropriate claim identification information" \* MERGEFORMAT rejected under 35 U.S.C. 103 as being unpatentable over Goldberg, as applied to claim 1 above, in view of Legendre et al (4367738). Goldberg discloses the invention substantially as claimed except for expressly disclosing wherein the engaging structure between the piston rod and the nut element comprises a number of radial arms provided on either the piston rod or the nut element engaging the other of the piston rod or the nut member . Legrendre teaches that it is known to have a non-reusable injector (Figs 1-3) having an engaging structure comprises a number of radial arms (14) provided on the piston rod (13) engaging the barrel (Figs 1-3) for the purpose of preventing the plunger from being withdrawn from the syringe to aspire a foreign substance to prevent reuse and refiling of the syringe (col 2, lns 31-33; col 3, lns 30-34) . 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 injection device as taught by Goldberg with the piston rod having radial arms as taught by Legrendre for the purpose of preventing the plunger from being withdrawn from the syringe to aspire a foreign substance to prevent reuse and refiling of the syringe (col 2, lns 31-33; col 3, lns 30-34) . In the modified device of Goldberg, the radial arms on piston rod 19 would engage with the proximal face of nut member 14 to prevent withdrawal of the piston rod. Claim s 5-6 is/are FILLIN "Enter appropriate claim identification information" \* MERGEFORMAT rejected under 35 U.S.C. 103 as being unpatentable over Goldberg , as applied to claim 1 above, in view of Haber et al ( 5423752 ). Goldberg discloses the invention substantially as claimed except for expressly disclosing wherein the engaging structure between the piston rod and the nut element comprises a number of radial gripping teeth provided on either the piston rod or the nut element engaging the other of the piston rod or the nut member and wherein the radial gripping teeth are provided on the piston rod and the nut element is provided with an angled surface which is engaged by the radial gripping teeth when the piston rod is in its start position. Haber et al teaches that it is known to have an injection device (Fig 1-2) having a piston rod (e.g. 36, 37) and a nut element (58, 59), and having an engaging structure between the piston rod and the nut element comprises a number of radial gripping teeth (serrated teeth on outer surface or 36, 37) provided on either the piston rod or the nut element engaging the other of the piston rod ( serrated teeth on 36, 37 engage corresponding serrations/teeth on engaging end 62 of nut 58, 59 ) or the nut member and wherein the radial gripping teeth ( serrated teeth on outer surface or 36, 37) are provided on the piston rod and the nut element is provided with an angled surface which is engaged by the radial gripping teeth when the piston rod is in its start position (serrated teeth on 36, 37 engage corresponding serrations/teeth on engaging end 62 of nut 58, 59 . The serrations on 62 form a corresponding angled surface that receives the corresponding teeth on 36, 37 ) for the purpose of providing a one way ratchet manner driving the piston in the distal direction but preventing reverse movement (col 7, lns 27-46) . 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 engagement structure as taught by Goldberg with the radial gripping teeth and corresponding angled surfaces as taught by Haber et al for the purpose of providing a one-way ratchet manner driving the piston in the distal direction but preventing reverse movement (col 7, lns 27-46) . The modified device of Goldberg would allow the piston 19 to have serrations/teeth that engage with corresponding serrations/teeth in 14 at the distal end so that the piston 19 can be moved distally to deliver a drug but prevented from being moved proximally due the engagement. Claim s 11-12 is/are FILLIN "Enter appropriate claim identification information" \* MERGEFORMAT rejected under 35 U.S.C. 103 as being unpatentable over Goldberg , as applied to claim 1 or 8 above, in view of Hewson et al ( 11338089 ). Goldberg discloses the invention substantially as claimed except for expressly disclosing wherein a one-way ratchet interface is provided between the nut element and the housing structure or wherein one of the nut element or the housing structure are provided with a flexible ratchet carrier and the other of the nut element and the housing structure are provided with an axial rib structure . Hewson et al teaches that it is known to have an injector (Fig 7-7c) having a one-way ratchet interface is provided between the nut element and the housing structure (Figs 7-7c; housing 112 has teeth 113 engaging ratch arms 146 on a nut 140) or wherein one of the nut element (140) or the housing structure (112) are provided with a flexible ratchet carrier (ratchet arms 146) and the other of the nut element and the housing structure are provided with an axial rib structure (teeth 113; Figs 7-7c) for the purpose of allowing an incremental selection of a dose for delivery (col 10, lns 24-35) . 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 nut element and housing structure as taught by Goldberg with the one-way ratchet interface/flexible ratchet carrier as taught by Hewson et al for the purpose of allowing for an incremental selection of a dose for delivery (col 10, lns 24-35) . Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 Form. Specifically: Dose limiters via a nut-like structure: 2648334, 3815785, 4444335, 4475905, 5611783, 5833669, 20040162528, 20160008548, 20160008783, 20180280622, 20210196898, 20230014860 Pistons having flexible arms: 6371941, 6712788, 20100087799, 20100241067, WO2011/003979; 20140343511, 20150105754, 10850044 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 FILLIN "Examiner name" \* MERGEFORMAT Andrew M. Gilbert whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-7216 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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