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 .
Status of Claims
This office action is responsive to the amendment filed 7 January 2026.
Claims 1, 11, and 12 are amended.
Claim 24 is canceled.
Claims 1-23 and 25 are presently pending in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the engagement of the retainer with the plunger rod and the rearward portion must be shown or the features canceled from the claims. No new matter should be entered. Furthermore, it is not clear from the figures how reference numbers 132, 134, 130, and 110 for Fig. 2C are engaged. A person of ordinary skill in the art would not be able to determine how these parts interact in three dimensions.
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.
Claim Objections
Claim 21 is objected to because of the following informalities:
“(…) and the rearward portion forwards on the insertion stroke (…)” – missing verb. Examiner interprets the claim to read –(…) and the rearward portion moves forward on the insertion stroke--.
“(…) forwards on the insertion stroke disengages the retainer (…)” – missing conjunction. Examiner interprets the claim to read –(…) forwards on the insertion stroke and disengages the retainer (…)--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 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.
Claims 9 and 10 recite the limitation “at which the retainer disengages from the firing assembly” in lines 2-3 and 2 of the claims respectively. This statement contradicts a previous limitation recited in claim 1 “to disengage from the plunger rod” in line 10 of the claim. It is unclear whether the retainer is to disengage from the firing assembly or the plunger rod or both. For the purposes of examination, examiner interprets “at which the retainer disengages from the firing assembly” to mean –at which the retainer disengages from the plunger rod—in both claims 9 and 10.
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.
(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.
Claims 1-23 and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shabudin et al. (Foreign Patent Publication No. WO 2018167493 A1), hereinafter Shabudin.
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Regarding claim 1, Shabudin teaches an apparatus (Shabudin: Fig. 11, comprising insertion tube 306, plunger 302, delivery spring 301, delivery spring housing 303, release collar 304, and insertion spring 305) for use with an auto-injector (Fig. 10a-d, device 300; pg. 14, ln 15-30) configured to receive a syringe (Fig. 11, syringe body 311), the apparatus (301-306) comprising: a firing assembly (Fig. 11 and 12, comprising delivery spring 301, plunger 302, and delivery spring housing 303) comprising a rearward portion (Fig. 12 above, rearward portion A), a plunger rod (Fig. 12, plunger 302) moveable forward relative to the rearward portion (Fig. 13a-d, plunger 302 is movable forward relative to rearward portion A) and a plunger rod driver (Fig. 11, delivery spring 301) configured to drive the plunger rod (302) forward relative to the rearward portion (Fig. 10d-g, plunger 302 is driven forward relative to the rearward portion A by spring 301); an insertion driver (Fig. 11, insertion spring 305) configured to drive the syringe (311) forwards on an insertion stroke (Fig. 10a-b, spring 305 drives the syringe body 311 forward during insertion; pg. 14, ln 15-30) for inserting a needle of the syringe (Fig. 11, syringe body 311 comprises a needle) into an injection site (pg. 1, ln 10-20); and wherein the firing assembly (301-303) further comprises a retainer (Fig. 12, release collar 304) engaged with the plunger rod (302) and the rearward portion (Fig. 13a-d, collar 304 is engaged with the plunger 302 and the rearward portion A) and configured to prevent forward movement of the plunger rod (302) relative to the rearward portion (Fig. 13a, release collar 304 prevents the plunger 302 from rotating and, thus, prevents forward movement of the plunger 302; pg. 14, ln 15 – pg. 15, ln 15), and to disengage from the plunger rod (302) at a point on the insertion stroke (Fig. 13c-d, release collar 304 disengages from the plunger 302 during insertion); wherein the retainer (304) is configured to be moveable with respect to the insertion driver (305) during insertion of the apparatus (301-306) into an auto-injector (Fig. 10a-13d, collar 304 is movable with respect to the spring 305).
Regarding claim 2, Shabudin teaches the apparatus above, wherein the insertion driver (305) is further configured to drive at least the plunger rod (302), the plunger rod driver (301) and the rearward portion (A) forwards on the insertion stroke (Fig. 10a-b, spring 305 is shown driving 301-306 forward during insertion).
Regarding claim 3, Shabudin teaches the apparatus above, wherein the disengagement of the retainer (304) is caused by relative axial movement between the retainer (304) and the plunger rod (302), the plunger rod driver (301) and the rearward portion (Fig. 13a-d, collar 304 disengages from the plunger 302, caused by axial and rotational movement of the plunger 302, driver 301, and portion A).
Regarding claim 4, Shabudin teaches the apparatus above, wherein the retainer (304) is axially fixed relative to a housing (Fig. 11, outer casing) of the auto-injector (Fig. 10d-10g, upon reaching step 4, collar 304 is shown axially fixed relative to the outer casing of device 300).
Regarding claim 5, Shabudin teaches the apparatus above, wherein the plunger rod driver (301) biases the plunger rod (302) forwards relative to the rearward portion (Fig. 10f-g, plunger 302 is biased forward by spring 301; pg. 15, ln 16-20).
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Regarding claim 6, Shabudin teaches the apparatus above, wherein the plunger rod (302) comprises an angled surface (Fig. 11 shown above, angled surface B) configured to interact with a corresponding feature on the rearward portion (Fig. 13a-d above, surface B is shown interacting with a rearward feature C) under the bias of the plunger rod driver (Fig. 10a-g and 13a-d above, plunger 302 is constantly biased forward by spring 301, and, therefore, surface B interacts with feature C due to the biasing force of spring 301) for relative rotation between the rearward portion (A) and plunger rod (Fig. 13a-d above, angled surface B rotating relative to the portion A), and wherein the retainer (304) is configured to prevent relative rotation between the rearward portion (A) and plunger rod (Fig. 13a above, collar 304 prevents rotational movement of the plunger 302 by blocking surface B from moving into the disengage position).
Regarding claim 7, Shabudin teaches the apparatus above, wherein the retainer (304) comprises a prong (Fig. 13a-d above, prong D) configured to abut a surface (B) of the plunger rod (Fig. 13a above, collar 304 blocks surface B from moving into the disengage position via prong D) to prevent relative rotation between the rearward portion (A) and plunger rod (Fig. 13a above, collar 304 prevents rotational movement of the plunger 302 by blocking surface B from moving into the disengage position).
Regarding claim 8, Shabudin teaches the apparatus above, wherein forward movement of the firing assembly (301-303) on the insertion stroke draws the prong (D) out of abutment with the surface (B) of the plunger rod (Fig. 10a-b and 13a-d above, upon movement of the housing 303 forward during insertion, the delivery process begins, eventually leading to prong D disengaging from surface B).
Regarding claim 9, Shabudin teaches the apparatus above, wherein the axial length of the prong (D) defines the point on the insertion stroke at which the retainer (304) disengages from the plunger rod (Fig. 13a-c above, the length of prong D determines when the plunger is unlocked and, therefore, defines the point on the insertion stroke at which collar 304 disengages from the plunger 302).
Regarding claim 10, Shabudin teaches the apparatus above, wherein the point on the insertion stroke at which the retainer (304) disengages from the plunger rod (302) is at substantially the end of the insertion stroke (Fig. 13c-d, collar 304 is disengaged from plunger 302 at the final delivery step).
Regarding claim 11, Shabudin teaches an auto-injector sub-assembly (Fig. 11, comprising 301-306 and the outer casing) comprising an apparatus (301-306) and a housing (Fig. 11, outer casing), the auto-injector sub-assembly (301-306 and outer casing) comprising: a firing assembly (Fig. 11 and 12, delivery spring housing 303) comprising a rearward portion (Fig. 12 above, rearward portion A), a plunger rod (Fig. 12, plunger 302) moveable forward relative to the rearward portion (Fig. 13a-d, plunger 302 is movable forward relative to rearward portion A) and a plunger rod driver (Fig. 11, delivery spring 301) configured to drive the plunger rod (302) forward relative to the rearward portion (Fig. 10d-g, plunger 302 is driven forward relative to the rearward portion A by spring 301), the firing assembly (301-303) insertable within the housing (Fig. 11, housing 303 is inserted into the outer casing); an insertion driver (Fig. 11, insertion spring 305) configured to drive the syringe (311) forwards on an insertion stroke (Fig. 10a-b, spring 305 drives the syringe body 311 forward during insertion; pg. 14, ln 15-30) for inserting a needle of the syringe (Fig. 11, syringe body 311 comprises a needle) into an injection site (pg. 1, ln 10-20); and wherein the firing assembly (301-303) further comprises a retainer (Fig. 12, release collar 304) engaged with the plunger rod (302) and the rearward portion (Fig. 13a-d, collar 304 is engaged with the plunger 302 and the rearward portion A) and configured to prevent forward movement of the plunger rod (302) relative to the rearward portion (Fig. 13a, release collar 304 prevents the plunger 302 from rotating and, thus, prevents forward movement of the plunger 302; pg. 14, ln 15 – pg. 15, ln 15), and to disengage from the plunger rod (302) at a point on the insertion stroke (Fig. 13c-d, release collar 304 disengages from the plunger 302 during insertion); wherein the retainer (304) is configured to be moveable with respect to the insertion driver (305) during insertion of the apparatus (301-306) into an auto-injector (Fig. 10a-13d, collar 304 is movable with respect to the spring 305).
Regarding claim 12, Shabudin teaches an apparatus (301-306) for use with an auto-injector (300) configured to receive a syringe (311), the apparatus (301-306) comprising: a firing assembly (Fig. 11 and 12, delivery spring housing 303) comprising a rearward portion (Fig. 12 above, rearward portion A), a plunger rod (Fig. 12, plunger 302) moveable forward relative to the rearward portion (Fig. 13a-d, plunger 302 is movable forward relative to rearward portion A), a plunger rod driver (Fig. 11, delivery spring 301) configured to drive the plunger rod (302) forward relative to the rearward portion (Fig. 10d-g, plunger 302 is driven forward relative to the rearward portion A by spring 301), wherein the firing assembly (301-303), and a retainer (304) engaged with the plunger rod (Fig. 13a-d, retainer 304 is engaged with plunger 302) and the rearward portion (Fig. 13a-d above, retainer 304 engages with rearward portion A) to prevent forward movement of the plunger rod (302) relative to the rearward portion (Fig. 13a above, release collar 304 prevents the plunger 302 from rotating and, thus, prevents forward movement of the plunger 302 relative to portion A; pg. 14, ln 15 – pg. 15, ln 15), wherein the firing assembly (301-303) is configured for insertion into the auto-injector (Fig. 11, spring 301, plunger 302, and housing 303 are shown inserted into device 300) such that the plunger rod (302) is received within a barrel of the syringe (Fig. 10a-g, plunger 302 is shown received within the barrel of syringe body 311), and wherein the retainer (304) is configured to engage an axial lock (Fig. 13a-d above, axial lock E) for axially fixing a position of the retainer (304) relative to the auto-injector (300) when a forward end of the plunger rod (302) is at a particular position relative to a bung (Fig. 10a-g, bung 312) located within the barrel (Fig. 10d-g and 13d above, when delivery commences and the plunger is unlocked, retainer 304 is shown fixed axially relative to device 300); wherein the retainer (304) is configured to be moveable with respect to an insertion driver (305) during insertion of the apparatus (301-306) into an auto-injector (Fig. 10a-13d, collar 304 is movable with respect to the spring 305).
Regarding claim 13, Shabudin teaches the apparatus above, further comprising an actuator (Fig. 11, comprising delivery housing 303 and insertion tube 306) coupled to the firing assembly (301-303) and configured to be received in a housing (Fig. 11, spring 301, plunger 302, and housing 303 are received within the outer casing) of the auto-injector (300) for insertion of the firing assembly (301-303) into the auto-injector (300), wherein the actuator (303 and 306) comprises the axial lock (E).
Regarding claim 14, Shabudin teaches the apparatus above, wherein the retainer (304) is configured to engage the axial lock (E) on relative rotation between the actuator (303 and 306) and the retainer (Fig. 13a-d above, collar 304 engages lock E upon rotation of the housing 303 and the collar 304).
Regarding claim 15, Shabudin teaches the apparatus above, wherein the actuator (303 and 306) comprises a plurality of locking features (Fig. 13a-d above, comprising locking feature F and lock E), and wherein relative rotation between the actuator (303 and 306) and the retainer (304) causes engagement between a retaining feature (Fig. 13a-d above, prong D) of the retainer (304) and one of the plurality of locking features (Fig. 13a-d, rotation of the housing 303 and retainer 304 after the plunger is unlocked causes engagement with the locking feature F).
Regarding claim 16, Shabudin teaches the apparatus above, wherein the firing assembly (301-303) comprises a ramped surface (Fig. 13a-d above, plunger 302 comprises ramped surface B) configured to interact with a corresponding feature (Fig. 13a-d above, feature C) on the actuator (303 and 306) to cause the relative rotation between the retainer (304) and the actuator (Fig. 10a-g, plunger 302 is constantly biased forward by spring 301, and, therefore, surface B interacts with feature C due to the biasing force of spring 301, thus, rotating the collar 304 upon the plunger being unlocked).
Regarding claim 17, Shabudin teaches the apparatus above, wherein the actuator (303 and 306) comprises a sleeve (Fig. 11, insertion tube 306) configured to receive the firing assembly (301-303) therein (Fig. 11, insertion tube 306 receives spring 301, plunger 302, and housing 303 within).
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Regarding claim 18, Shabudin teaches the apparatus above, wherein the actuator (303 and 306) further comprises an end cap (Fig. 10a-b above, end cap G) configured to abut a surface (Fig. 10a-b, surface H) of the housing (Fig. 11, outer casing) to fix the axial position of the actuator (303 and 306) relative to the housing (Fig. 10a-b above, when end cap G abuts surface H, tube 306 is fixed axially).
Regarding claim 19, Shabudin teaches the apparatus above, wherein the retainer (304) is configured to engage the axial lock (E) when the end cap (G) abuts the surface (H) of the auto-injector (Fig. 10a-d above and 13a-d above, when the end cap G abuts surface H, collar 304 begins the unlocking operation and engages lock E).
Regarding claim 20, Shabudin teaches the apparatus above, wherein the insertion driver (305) is configured to drive the syringe (311), the plunger rod (302), the plunger rod driver (305) and the rearward portion (A) forwards on an insertion stroke (Fig. 10a-b, spring 305 is shown driving 301-306 forward during insertion) for inserting a needle of the syringe (Fig. 11, syringe body 311 comprises a needle) into an injection site (pg. 1, ln 10-20).
Regarding claim 21, Shabudin teaches the apparatus above, wherein the axial lock (E) is configured to prevent forward movement of the retainer (Fig. 13a-d above, when collar 304 is engaged with lock E, collar 304 can no longer move forward) such that the forward movement of the syringe (311), the plunger rod (302), the plunger rod driver (301) and the rearward portion (A) moves forwards on the insertion stroke and disengages the retainer (304) from the plunger rod (Fig. 13a-d, forward movement of the syringe 311, plunger 302, and driver 301 via the spring 305 causes the unlocking action of the collar 304 and releases the plunger rod 302 from engagement with the collar 304).
Regarding claim 22, Shabudin teaches the auto-injector sub-assembly (Fig. 11, 301-306 and the outer casing) comprising an apparatus (301-306) according to claim 12, and further comprising a housing (Fig. 11, outer casing) configured to receive the apparatus (Fig. 11, outer casing receives 301-306).
Regarding claim 23, Shabudin teaches the auto-injector (300) comprising the apparatus (301-306) of claim 1.
Regarding claim 25, Shabudin teaches the auto-injector (300) comprising the apparatus (301-306) of claim 12.
Response to Arguments
Applicant’s arguments, see page 7-8, filed 7 January 2026, with respect to the rejections of claims 1-23 and 25 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Shabudin cited above.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783