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 .
This action is in response to Applicant’s amendments filed 06/12/2026.
Examiner notes the instant application is a continuation in parts of application 18/565243.
Claim 12 is cancelled.
Claims 6, 8, 13, and 15 are amended.
Claims 1-11 and 13-15 are being examined in this office action.
Election/Restrictions
Applicant’s election without traverse of claims 1-11 and 13-15 in the reply filed 06/12/2026 is acknowledged.
Drawings
The drawings are objected to because:
Reference numeral 132 in Fig. 1C appears to point to the same element as reference numeral 12 in Fig. 1A.
Reference numeral 227 is used twice to point to two separate elements in Fig. 21A.
The brackets in Figs 12B and 15 appear to need reference numerals.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 225A as seen in Fig. 12B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Reference numeral 212 is used to refer to both a syringe driver and a slider, Paragraphs [0129]-[0130].
Paragraphs [0087]-[0088], Figs 15 and 16 appear to be a view of the first sub-assembly and not the second sub-assembly.
Reference numeral 223 is used to refer to cut-out when in later iterations it is given the reference numeral 224.
Reference numeral 230 is used to refer to both a snap lock and a lock Paragraphs [0132], [0134]-[0135].
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: "tapered surface" as recited in claim 2 appears to correspond to ramped surface 226 in Paragraph [0133].
Appropriate correction is required.
Claim Objections
Claims 2-6, 9-11, and 13-15 are objected to because of the following informalities:
Claim 2 recites the limitation “wherein first sub-assembly” in line 1. This should read “wherein the first sub-assembly”.
Claim 3 recites the limitation “wherein second sub-assembly” in line 1. This should read “wherein the second sub-assembly”.
Claim 4 recites the limitation “the leg” in line 2, there is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the leg” to be referencing a distally projecting leg as recited in claim 3 and recommends keeping the language consistent across the claims.
Claim 10 recites the limitation “the housing” in line 3. Examiner recommends keeping the language used in claim 1 consistent across the claims, i.e.” a pre-filled syringe axially fixed relative to and within the outer housing”.
Claim 11 recites the limitation “the outer hosing”, this appears to be a typographical error and is believed to read “the outer housing”.
Claim 13 recites the limitation “a second sub-assembly comprising an outer housing having, a longitudinal axis”, this should read “a second sub-assembly comprising an outer housing having
All remaining claims are objected to by virtue of their dependence on an objected to claim.
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 1-11 and 13-15 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 the limitation “a rear cap having a flexible arm connected to a rear cap holder” in lines 3-4. It is unclear which element is connected to the rear cap holder, whether it is specifically the flexible arm, or another element of the rear cap.
Claim 1 recites the limitation “a lock positioned at a distal end” in lines 5-6, it is unclear where the distal end is in relation to the other components of the delivery device. Examiner interprets “a distal end” to be any component above the topmost portion of the protective cap 201.
Claim 1 recites the limitation “wherein axial relative movement between the first sub-assembly and the second sub-assembly causes the assembly to change from a shipping configuration to a disassembled configuration and then to an assembled configuration”. It is unclear how axial relative movement accomplishes this. Examiner recommends incorporating direction between each configuration, i.e. axial movement in a distal direction causes the assembly to change from a shipping to a disassembled configuration.
Claim 2 recites “a flexible arm” in line 2. It is unclear if this is the previously recited flexible arm in claim 1, or if this is a separate element. Examiner interprets “a flexible arm” in claim 2 to be referencing a separate element of the slider.
Claim 4 recites the limitation “the flexible finger” in line 3, there is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the flexible finger” in line 2, there is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “relative rotational and axial movement” in line 1, it is unclear how rotational movement is required to change the assembly from the disassembled configuration to the assembled configuration when claim 1 recites “axial relative movement… causes the assembly to change from a shipping configuration to a disassembled configuration and then to an assembled configuration”.
Claim 13 recites the limitation “a rear cap having a flexible arm connected to a rear cap holder” in lines 2-3. It is unclear which element is connected to the rear cap holder, whether it is specifically the flexible arm, or another element of the rear cap.
Claim 13 recites the limitation “a lock positioned at a distal end” in line 4. It is unclear where the distal end is in relation to the other components of the delivery device. Examiner interprets “a distal end” to be any component above the topmost portion of the protective cap 201.
Claim 14 recites the limitation “wherein the step of forming the assembled configuration comprises rotating the first sub-assembly relative to the second sub-assembly before relative axial movement”. It is unclear if this rotation is a separate rotation from the one recited in lines 16-17 in claim 13.
Claim 15 recites the limitation “the proximal direction” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
All remaining claims are rejected by virtue of their dependence on a rejected claim.
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.
(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 and 7-11 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Appy et al. (Pub. No. US 20210196894 A1, herein Appy).
Regarding Claim 1, Appy discloses an assembly for a medicament delivery device (Fig. 62), the assembly comprising:
a first sub-assembly (1300) comprising a rear cap (1316) having a flexible arm (1442, Paragraph [0486]) connected to a rear cap holder (1310, Fig. 62); and
a second sub-assembly (1100) comprising an outer housing (1108) having a longitudinal axis (Fig. 63) and a lock (1182, Paragraph [0492]) positioned at a distal end (Fig. 73b),
wherein axial relative movement between the first sub-assembly and the second sub-assembly causes the assembly to change from a shipping configuration (Examiner interprets a shipping configuration to be when subassemblies 1100 and 1300 are inserted together, but not locked) to a disassembled configuration (Examiner interprets a disassembled configuration to be when 1100 and 11300 are separated to allow syringe 1200 to be inserted) and then to an assembled configuration (Examiner interprets an assembled configuration to be when syringe 1200 is inserted, and assemblies are locked into a predetermined position [Paragraph [0449]), and
wherein when the assembly is in the shipping configuration, an inside surface of the distal end of the outer housing is releasably engaged with an outside surface of the flexible arm (Paragraph [0486]).
Regarding Claim 2, Appy discloses the assembly of claim 1, wherein first sub-assembly further comprises a slider (1312) having a tapered surface (right-most portion of 1384 in annotated Fig. 81a below) and a flexible arm (1374, Paragraph [0482]) circumferentially spaced from the tapered surface (Fig. 81a).
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Regarding Claim 3, Appy discloses the assembly of claim 2, wherein second sub-assembly further comprises a delivery member guard (1104) comprising a distally projecting leg (1114, 1116) having a cut-out (1124).
Regarding Claim 7, Appy discloses the assembly of claim 1, wherein relative rotational and axial movement between the first sub-assembly and the second sub-assembly causes the assembly to change from the disassembled configuration to the assembled configuration (Examiner interprets that a user is able to rotate, when disassembled, the power-pack 1300 to the syringe unit subassembly 1300 to align flexible arms 1442 before engaging with openings 1182).
Regarding Claim 8, Appy discloses the assembly of claim 1, wherein the lock and a locking surface (1354) on an outer surface of the rear cap holder are axially offset relative to each other along the longitudinal axis when the assembly is in the shipping configuration (Examiner interprets that when in the shipping configuration, 1310 is axially offset to 1182 since flexible arms 1442 are not yet engaged with 1182).
Regarding Claim 9, Appy discloses the assembly of claim 2, wherein the tapered surface is distally directed (1384 extending along longitudinal axis in Fig. 81a) and is angled relative to the longitudinal axis (see annotated Fig. 81a).
Regarding Claim 10, Appy discloses the assembly of claim 1, wherein when the assembly is in the assembled configuration, the assembly further comprises a pre-filled syringe axially fixed relative to and within the housing (Paragraph [0449]).
Regarding Claim 11, Appy discloses the assembly of claim 1, wherein when the assembly is in the assembled configuration, the assembly further comprises a protective cap (1050) releasably attached to a proximal end of the outer hosing (Paragraph [0445]).
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilmot et al. (Pub. No. US 20120101475 A1, wherein Wilmot).
Regarding Claim 1, Wilmot discloses an assembly for a medicament delivery device (auto-injector 100), the assembly comprising:
a first sub-assembly (release pin 120 and collet 430) comprising a rear cap (120) having a flexible arm (121a or 121b, Paragraph [0101]) connected to a rear cap holder (140 via collet 430, Fig. 1); and
a second sub-assembly (power pack 130 and cover member 150, less the collet 430) comprising an outer housing (230) having a longitudinal axis (Fig. 1) and a lock (cover member 150, Fig. 10) positioned at a distal end (Examiner interprets a distal end of the auto-injector to be any portion above the bottom most portion of 340 in Fig. 9),
wherein axial relative movement between the first sub-assembly and the second sub- assembly causes the assembly to change from a shipping configuration (configuration seen in Figs. 1-3) to a disassembled configuration (configuration with release pin 120 removed) and then to an assembled configuration (configuration in Fig. 9 after injection), and
wherein when the assembly is in the shipping configuration, an inside surface of the distal end of the outer housing is releasably engaged with an outside surface of the flexible arm (inside surfaces of retention recesses hold tabs 121a and 121b therein, Paragraphs [0101], [0105], Figs 25, 27).
Regarding Claim 2, Wilmot discloses the assembly of claim 1, wherein first sub-assembly further comprises a slider (342) having a tapered surface (347b) and a flexible arm (343, Paragraph [0121]) circumferentially spaced from the tapered surface (Fig. 16).
Regarding Claim 3, Wilmot discloses the assembly of claim 2, wherein second sub-assembly further comprises a delivery member guard (150) comprising a distally projecting leg (top-most portion of 151 in Fig. 54) having a cut-out (155).
Regarding Claim 6, Wilmot discloses the assembly of claim 3, wherein when the assembly is in the assembled configuration, the lock is engaged with a locking surface on an outer surface of the rear cap holder (locking surface 243 of 140, Fig. 10) such that the first sub-assembly and the second sub-assembly are undetachably attached to each other (“The locking wings 240 spring out such that the locking surface 243 engages the cover member 150 to prevent the needle cover 150 from being pushed backwards as shown in FIG. 10.” – Paragraph [0119]).
Allowable Subject Matter
Claims 4 and 5 and 13-15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 4 and 5 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 prior art of record fails to disclose or make obvious the claimed invention, including the following features.
Regarding Claim 4, wherein when the assembly is in the shipping configuration, the tapered surface is engaged with an inside surface of the leg and the cut-out is not engaged with the flexible finger.
Regarding Claim 5, wherein when the assembly is in the assembled configuration, the cut-out is engaged with the flexible finger.
Regarding Claim 13, an assembled configuration where the lock is engaged with a locking surface on an outside surface of the rear cap holder such that the first sub-assembly and the second sub-assembly are undetachably attached to each other, rotationally orienting the first and second sub-assemblies relative to each other such that the lock is aligned with the locking surface on the outside surface of the rear cap holder, and axially moving the first and second sub-assemblies relative to each other until the lock irreversibly engages with the locking surface to form the assembled configuration.
The combination of the claimed limitations is novel and found to be allowable over the prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant’s claimed invention.
Examiner notes that the limitations indicated as containing allowable subject matter above are done so in context of the claims as a whole – e.g. the cited portions of claim 4 are allowable in combination with the rest of the limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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