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 .
Response to Amendment
The amendment filed February 25, 2026 has been entered. Claims 2-8 and 13-23 remain pending in the application. Claims 1 and 9-12 have been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed November 26, 2025.
Claim Objections
Claim 20 is objected to because of the following informalities: there appears to be a typo regarding “a pre-filled syringe” in line 10 as opposed to “the pre-filled syringe”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2 and 7 each fail to further limit the subject matter of claim 21, from which they each depend. All of the limitations of claims 2 and 7 are found in lines 7-9 of claim 21. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-8 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vogt et al. (WO 2010136076, English Translation Provided with PTO-892 mailed 10/30/24).
Regarding claim 21, Vogt discloses an injection device (Figure 3, assemblies A and B) comprising a modular syringe holder (Figures 1-2) with a pre-filled syringe (product container 5) inserted therein (Figure 3), the modular syringe holder comprising:
an adapter holder (proximal half of needle guard 2 and holder member 10) separate from and configured to be arranged within an interior of a housing (housing 1) of the injection device (Figure 3; “The holding member 10 closes the proximal end of the housing 1 and is rotatably and axially fixed to the housing 1, in particular snapped.” [Page 7]; “a needle protection sleeve 2, which is accommodated longitudinally displaceably in the housing 1” [Page 7]); and
an adapter (product container holder 4) comprising an adapter body (body of product container holder 4) and a support element (engagement members 4a and 4g and fastening member 4b) flexibly coupled to the adapter body (“The engagement member 4g is resiliently arranged on the product container holder 4, namely by means of an arm 4a.” [Page 7]),
wherein the support element is flexibly coupled to the adapter body such that the support element is configured to be deflected in the radial direction by a needle protection cap (needle cap 6) of the pre-filled syringe prior to the adapter being received in the adapter holder (“The engagement member 4g is resiliently arranged on the product container holder 4, namely by means of an arm 4a. This arrangement has the advantage that a needle protection cap 6 can be used, which has a larger or the same diameter as the reservoir part 5a of the product container 5. As can be seen from Figure 1, the product container 5 is inserted into the product container holder 4 exposed in the circumferential direction, as long as until the engagement member 4a engages in the gap between the needle cap 6 and shoulder 5b. Since the product container holder 4 is exposed in the circumferential direction before final assembly, the engaging member 4a to the outside and thus pass the needle cap 6.” [Page 7-8]), wherein the support element of the adapter is configured to receive, along a longitudinal axis of the syringe holder, a syringe shoulder (shoulder 5a) of the pre-filled syringe (“The product container 5 is received in the product container holder 4, so that it is not movable in the distal direction relative to the product container holder 4 in particular. This is effected by an engaging member 4a formed by the product container 4 projecting radially inwardly and engaging a shoulder 5b of the product container 5 formed by a tapered portion at the distal end of a reservoir portion 5a of the product container 5.” [Page 7]),
wherein the adapter holder (proximal half of needle guard 2 and holder member 10) is configured to receive the adapter with the pre-filled syringe inserted therein (Figure 3a wherein the production container 5 and product container holder 4 are inserted the proximal half of needle guard 2) such that a holding portion of the adapter holder (holding portion 2c) blocks the support element from deflecting in a radial direction (“in the state shown in Figures 3a and 3b, the engagement member 4a can not deflect outwardly, since the product container holder 4 is surrounded by the needle guard 2, the needle guard 2 forms a holding portion 2c on its inner side, the engaging member 4a at a movement prevents radially outward and thus holds in engagement with the shoulder 5b.” [Page 8]; “The holding member 10 has at least one, in this example two resilient arms 10b, which extend in the longitudinal direction of the injection device and at its distal ends form a locking member 10a…The outward projection of the locking member 10a abuts against an inwardly facing surface of the needle guard 2, so that the locking member is held in engagement with the shoulder 7b and prevents movement of the locking member 10a radially outward.” [Page 9]), and
wherein the adapter holder (proximal half of needle guard 2 and holder member 10) is permanently axially nondetachable and rotationally fixed to the interior of the housing of the injection device by a plurality of securing elements (see Figure 2 for snaps on proximal end of holder member 10) of the adapter holder (“The holding member 10 closes the proximal end of the housing 1 and is rotatably and axially fixed to the housing 1, in particular snapped.” [Page 9]; wherein the holding member 10, forming a portion of the adapter holder, is permanently axially nondetachable and rotationally fixed to the housing. The claims as currently presented do not require that the entirety of the adapter holder is permanently axially fixed to the interior of the housing).
Regarding claim 2, Vogt discloses the injection device according to claim 21, wherein the support element (engagement member 4a) is flexibly coupled to the adapter body such that the support element is configured to be deflected in the radial direction by the needle protection cap (needle cap 6) of the pre-filled syringe prior to the adapter being received in the adapter holder (“The engagement member 4g is resiliently arranged on the product container holder 4, namely by means of an arm 4a. This arrangement has the advantage that a needle protection cap 6 can be used, which has a larger or the same diameter as the reservoir part 5a of the product container 5. As can be seen from Figure 1, the product container 5 is inserted into the product container holder 4 exposed in the circumferential direction, as long as until the engagement member 4a engages in the gap between the needle cap 6 and shoulder 5b. Since the product container holder 4 is exposed in the circumferential direction before final assembly, the engaging member 4a to the outside and thus pass the needle cap 6.” [Page 7-8]).
Regarding claim 3, Vogt discloses the injection device according to claim 21, wherein the adapter (product container holder 4) further comprises a flexible finger (arm 4g), and wherein the support element (engagement member 4a) is coupled to a distal end of the finger and protrudes from the finger in a direction transverse to the longitudinal axis (Figures 2 and 3a).
Regarding claim 4, Vogt discloses the injection device according to claim 21, wherein the adapter (product container holder 4) and the adapter holder (proximal half of needle guard 2 and holder member 10) are configured such that the support element (engagement members 4a and 4g and fastening member 4b) directly contacts the housing of the injection device in an axial direction (via fastening member 4b: “The product container holder 4 has an outwardly directed fastening member 4b, in the form of a recess, wherein the fastening member 4b engages in a projection formed on the inner circumference of the housing 1a and thus forms a positive locking.” [Page 8]; Figure 3a).
Regarding claim 5, Vogt discloses the injection device according to claim 21, wherein the adapter (product container holder 4) and the adapter holder (proximal half of needle guard 2 and holder member 10) are configured to enable a rotation of the pre-filled syringe about the longitudinal axis (Figures 2-8b showing no mechanism to inhibit rotation of the product container 5).
Regarding claim 6, Vogt discloses the injection device according to claim 5,
wherein the adapter (product container holder 4) and the adapter holder (proximal half of needle guard 2 and holder member 10) are configured such that the support element (engagement members 4a and 4g and fastening member 4b) directly contacts the housing of the injection device in an axial direction (via fastening member 4b: “The product container holder 4 has an outwardly directed fastening member 4b, in the form of a recess, wherein the fastening member 4b engages in a projection formed on the inner circumference of the housing 1a and thus forms a positive locking.” [Page 8]; Figure 3a).
Regarding claim 7, Vogt discloses the injection device according to claim 6, wherein the support element (engagement members 4a and 4g and fastening member 4b) is flexibly coupled to the adapter body such that the support element is configured to be deflected in the radial direction by a needle protection cap (needle cap 6) of the pre-filled syringe prior to the adapter being received in the adapter holder (“The engagement member 4g is resiliently arranged on the product container holder 4, namely by means of an arm 4a. This arrangement has the advantage that a needle protection cap 6 can be used, which has a larger or the same diameter as the reservoir part 5a of the product container 5. As can be seen from Figure 1, the product container 5 is inserted into the product container holder 4 exposed in the circumferential direction, as long as until the engagement member 4a engages in the gap between the needle cap 6 and shoulder 5b. Since the product container holder 4 is exposed in the circumferential direction before final assembly, the engaging member 4a to the outside and thus pass the needle cap 6.” [Page 7-8]).
Regarding claim 8, Vogt discloses the injection device according to claim 21, wherein the adapter (product container holder 4) further comprises two support elements (engaging members 4a; Figures 2 and 3a) and two flexible fingers (arms 4g; Figures 2 and 3a), and wherein each of the flexible fingers comprises one of the support elements (Figures 2 and 3a) and such support element is configured for receiving axial forces of the syringe shoulder (“The product container 5 is received in the product container holder 4, so that it is not movable in the distal direction relative to the product container holder 4 in particular. This is effected by an engaging member 4a formed by the product container 4 projecting radially inwardly and engaging a shoulder 5b of the product container 5 formed by a tapered portion at the distal end of a reservoir portion 5a of the product container 5.” [Page 7]).
Regarding claim 20, Vogt discloses an injection device (Figure 3, assemblies A and B) comprising a modular syringe holder (Figures 1-2) with a pre-filled syringe (product container 5) inserted therein (Figure 3), wherein the injection device is configured as an autoinjector (“The invention relates to an injection device, in particular an autoinjector” [Page 2]), the modular syringe holder comprising:
an adapter holder (proximal half of needle guard 2 and holder member 10) comprising a holder sleeve (proximal half of needle guard 2), the adapter holder separate from and configured to be arranged within an interior of a housing (housing 1) of the injection device (Figure 3; “The holding member 10 closes the proximal end of the housing 1 and is rotatably and axially fixed to the housing 1, in particular snapped.” [Page 7]; “a needle protection sleeve 2, which is accommodated longitudinally displaceably in the housing 1” [Page 7]); and
an adapter (product container holder 4) comprising an adapter body (body of product container holder 4) and a support element (engagement members 4a and 4g and fastening member 4b) flexibly coupled to the adapter body (“The engagement member 4g is resiliently arranged on the product container holder 4, namely by means of an arm 4a.” [Page 7]), wherein an outer diameter of the adapter corresponds to an inner diameter of the holder sleeve (Figures 3a-8b),
wherein the support element of the adapter is configured to receive, along a longitudinal axis of the syringe holder, a syringe shoulder (shoulder 5a) of the pre-filled syringe (“The product container 5 is received in the product container holder 4, so that it is not movable in the distal direction relative to the product container holder 4 in particular. This is effected by an engaging member 4a formed by the product container 4 projecting radially inwardly and engaging a shoulder 5b of the product container 5 formed by a tapered portion at the distal end of a reservoir portion 5a of the product container 5.” [Page 7]),
wherein the adapter holder (proximal half of needle guard 2 and holder member 10) is configured to receive the adapter with the pre-filled syringe inserted therein (Figure 3a wherein the production container 5 and product container holder 4 are inserted the proximal half of needle guard 2) such that the support element is blocked by a holding portion of the adapter holder (holding portion 2c) from deflecting in a radial direction (“in the state shown in Figures 3a and 3b, the engagement member 4a can not deflect outwardly, since the product container holder 4 is surrounded by the needle guard 2, the needle guard 2 forms a holding portion 2c on its inner side, the engaging member 4a at a movement prevents radially outward and thus holds in engagement with the shoulder 5b.” [Page 8]; “The holding member 10 has at least one, in this example two resilient arms 10b, which extend in the longitudinal direction of the injection device and at its distal ends form a locking member 10a…The outward projection of the locking member 10a abuts against an inwardly facing surface of the needle guard 2, so that the locking member is held in engagement with the shoulder 7b and prevents movement of the locking member 10a radially outward.” [Page 9]), and
wherein the adapter holder (proximal half of needle guard 2 and holder member 10) is permanently axially fixed to the injection device by securing arms (see Figure 2 for snaps on proximal end of holder member 10) of one of the injection device or the adapter holder engaging a recess (see Figure 3b for recess at the proximal end of housing 1) of the other of the injection device or the adapter holder (“The holding member 10 closes the proximal end of the housing 1 and is rotatably and axially fixed to the housing 1, in particular snapped.” [Page 9]; wherein at least a portion of the claimed adapter holder, holder member 10, is permanently axially fixed to the injection device).
Regarding claim 22, Vogt discloses the injection device according to claim 21, wherein the injection device further comprises a needle protection sleeve (distal half of needle guard 2) shiftable axially into the interior of the housing (Figures 4a-5b).
Regarding claim 23, Vogt discloses the injection device according to claim 20, wherein the injection device further comprises a needle protection sleeve (distal half of needle guard 2) shiftable axially into the interior of the housing (Figures 4a-5b).
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.
Additionally, Claims 20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (US 20140309591) in view of Fenlon et al. (US 20160022907).
Regarding claim 20, Holmqvist discloses an injection device (autoinjector device 10) comprising a modular syringe holder (syringe holder 40 and support surfaces 16, see annotated Figure 3c below) with a pre-filled syringe (pre-filled syringe 30) inserted therein (Figure 3c), wherein the injection device is configured as an autoinjector (autoinjector device 10), the modular syringe holder comprising:
an adapter holder (syringe holder 40) separate from and configured to be arranged within an interior of a housing (proximal housing section 13 and distal housing section 14) of the injection device (Figure 3b); and
wherein the adapter holder (syringe holder 40) is permanently axially fixed to the injection device by securing arms of one of the injection device or the adapter holder engaging a recess of the other of the injection device or the adapter holder (“The syringe holder 40 is arranged in the proximal housing section in order to support and maintain the syringe 30 in a pre-determined position in relation to the syringe holder and the autoinjector housing… corresponding snap-fitting fastening means 43 are arranged on the syringe holder 40 and the proximal housing section in order to permanently secure the syringe holder in the desired proximal position within the proximal housing section.” [0037]).
Holmqvist fails to explicitly disclose an adapter comprising an adapter body and a support element flexibly coupled to the adapter body, wherein an outer diameter of the adapter corresponds to an inner diameter of the holder sleeve, wherein the support element of the adapter is configured to receive, along a longitudinal axis of the syringe holder, a syringe shoulder of a pre-filled syringe, wherein the adapter holder is configured to receive the adapter with the pre-filled syringe inserted therein such that the support element is blocked by a holding portion of the adapter holder from deflecting in a radial direction.
Fenlon teaches a modular syringe holder (Figures 3-7) comprising: an adapter holder comprising a holder sleeve (container carrier 1) and an adapter (adapter 4) comprising an adapter body (Figure 4) and a support element (resilient arms 4.3) flexibly coupled to the adapter body (Figure 4; “the arm 4.3 is deflected in a first radial direction” [0031]), wherein an outer diameter of the adapter corresponds to an inner diameter of the holder sleeve (“The adapter 4 is also adapted to be retained within the container carrier 1 such that the adapter 4 is axially and rotationally fixed within the container carrier 1” [0028]), wherein the support element of the adapter is configured to receive, along a longitudinal axis of the syringe holder, a syringe shoulder (flange 3.5) of a pre-filled syringe (medicament container 3; Figure 5; “the adapter 4 may comprise at least one resilient arm 4.3 extending proximally and adapted to engage a proximal portion (e.g., the flange 3.5) of the container body 3.1.” [0031]), wherein the adapter holder is configured to receive the adapter with the pre-filled syringe inserted therein such that the support element (resilient arms 4.3) is blocked by a holding portion (inner surface of container carrier 1) of the adapter holder from deflecting in a radial direction (Figures 6 and 7, see all of [0032-0033]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the modular syringe holder of the injection device of Holmqvist to include an adapter comprising an adapter body and a support element flexibly coupled to the adapter body, wherein an outer diameter of the adapter corresponds to an inner diameter of the holder sleeve, wherein the support element of the adapter is configured to receive, along a longitudinal axis of the syringe holder, a syringe shoulder of a pre-filled syringe, wherein the adapter holder is configured to receive the adapter with the pre-filled syringe inserted therein such that the support element is blocked by a holding portion of the adapter holder from deflecting in a radial direction based on the teachings of Fenlon to allow the injection device to accommodate medicament containers of various sizes (Fenlon [0005]).
Regarding claim 23, modified Holmqvist discloses the injection device according to claim 20, wherein the injection device further comprises a needle protection sleeve (at proximal end 11) shiftable axially into the interior of the housing (“When the proximal end of the autoinjector is correctly positioned against the intended area of the skin of the patient, an activation means on the autoinjector is pressed in order to activate the autoinjector. When activated, a needle rapidly punctuates the skin and the drug is delivered via the needle automatically.” [0002]).
Allowable Subject Matter
Claims 13-19 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to anticipate or render obvious the limitations of dependent claim 13, specifically “the pre-filled syringe is axially nonshiftably held in the housing of the injection device by the modular syringe holder”. The closest prior art of record is Vogt et al. (WO 2010136076, as detailed in the rejections of claims 20 and 21 above. However, the injection device of Vogt is designed such that the pre-filled syringe (5) shifts axially within the housing in order to inject the product (see at least Figures 4a-8b).
Holmqvist (US 20140309591) in view of Fenlon et al. (US 20160022907) teaches an injection device having a modular syringe holder, as detailed in the rejection of claim 20 above. However, Holmqvist in view of Fenlon fails to explicitly teach the support element is flexibly coupled to the adapter body such that the support element is configured to be deflected in a radial direction by a needle protection cap of the pre-filled syringe prior to the adapter being received in the adapter holder, as required by claim 21, from which claim 13 depends.
Holmqvist discloses an injection device (10) comprising a modular syringe holder comprising: an adapter holder (16); an adapter (40) comprising a support element (45) flexibly coupled to the adapter body such that the support element is configured to be deflected in a radial direction by a needle protection cap (34) of the pre-filled syringe prior to the adapter being received in the adapter holder ([0038]), as detailed in the rejection of claim 13 in the Non-Final Rejection mailed 11/26/25. However, Holmqvist fails to explicitly disclose the adapter holder is separate from and configured to be arranged within an interior of a housing of the injection device as required as required by claim 21, from which claim 13 depends. The support surfaces 16 are part of the interior of the housing.
Response to Arguments
Applicant’s arguments with respect to claims 2-8 and 13-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that Vogt fails to disclose “the adapter holder is permanently axially fixed to the injection device” as required by independent claim 20 and “the adapter holder is permanently axially nondetachable and rotationally fixed to the interior of the housing of the injection device” as required by claim 21 (Remarks, page 7 and 9), the examiner respectfully disagrees. As detailed above, Vogt discloses an injection device (Figure 3, assemblies A and B) comprising a modular syringe holder comprising: an adapter holder (combination of the proximal half of needle guard 2 and holder member 10); and an adapter (4), wherein the adapter holder (proximal half of needle guard 2 and holder member 10) is permanently axially nondetachable and rotationally fixed to the interior of the housing of the injection device by a plurality of securing elements (see Figure 2 for snaps on proximal end of holder member 10) of the adapter holder (“The holding member 10 closes the proximal end of the housing 1 and is rotatably and axially fixed to the housing 1, in particular snapped.” [Page 9]). The holding member 10 forms a portion of the adapter holder and is permanently axially nondetachable and rotationally fixed to the housing. The claims as currently presented do not require that the entirety of the adapter holder is permanently axially fixed to the interior of the housing.
Regarding the argument that Vogt fails to disclose “the adapter holder is configured to receive the adapter with the pre-filled syringe inserted therein” as required by independent claims 20 and 21 (Remarks, page 10), the examiner respectfully disagrees. As detailed above, Vogt discloses a modular syringe holder comprising: an adapter holder (combination of the proximal half of needle guard 2 and holder member 10); and an adapter (4), wherein the adapter holder (proximal half of needle guard 2 and holder member 10) is configured to receive the adapter with the pre-filled syringe inserted therein (Figure 3a wherein the production container 5 and product container holder 4 are inserted the proximal half of needle guard 2). The proximal half of needle guard 2 is part of the adapter holder and, as shown at least in Figure 3a, is configured to receive both adapter (4) and pre-filled syringe (5).
Regarding the argument that Vogt does not disclose the limitations of new claims 22 and 23 of “the injection device further comprises a needle protection sleeve shiftable axially into the interior of the housing” (Remarks, page 10), the examiner respectfully disagrees. As detailed above, Vogt discloses an injection device (Figure 3) comprising both an adapter holder (proximal half of needle guard 2 and holder member 10) and a needle protection sleeve (distal half of needle guard 2) shiftable axially into the interior of the housing (Figures 4a-5b).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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