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 statements (IDS), submitted on 10/17/2024 and 10/21/2025, have been considered by the examiner.
Claim Objections
Claim 16 is objected to because of the following informalities: Line 14 of the claim appears to have a grammatical error (“wherein the driven part, the driven part extending”). Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The word “and” should be removed between the words “comprises” and “a” in the 1st line of the 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.
Claim 16 is 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 16] The claim recites the limitation of “wherein the outer cap” in the 10th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “tubular outer cap,” or if a new structure is being introduced into the claim limitations. For purposes of examination, it is interpreted that the limitation refers to the previously recited “tubular outer cap.”
[Claims 17-30] The claims are rejected based upon their dependence from independent claim 16.
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 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fabbri et al. (EP 1,002,737 A1).
[Claim 16] Fabbri teaches a sub-assembly of a medicament delivery device (figure 1, item 1), the sub-assembly comprising:
a tubular outer cap extending along a longitudinal axis (figure 5, item 3);
an inner cap (figure 3, item 4) at least partially surrounded by the tubular outer cap (figure 5, item 3) (figure 2), wherein the inner cap (figure 3, item 4) is configured to be removably attached to a housing (figure 2, item 7) of the medicament delivery device (figure 1, item 1) via a rotational attachment (figure 4, item 8) (paragraph [0003]); and
a clutch formed by a driving part (figure 6, item 16) and a driven part (figure 3, item 15),
wherein the driven part (figure 3, item 15) is attached to the inner cap (figure 3, item 4) and positioned between the tubular outer cap (figure 5, item 3) and the inner cap (figure 3, item 4) in a direction transverse to the longitudinal axis (figure 2),
wherein the outer cap (see 112b interpretation above) (figure 5, item 3) is axially movable relative to the inner cap (figure 3, item 4) between a proximal position and a distal position (paragraph [0005]),
wherein the tubular outer cap (figure 5, item 3) comprises the driving part (figure 6, item 16), the driving part (figure 6, item 16) extending from a body (“protrusion”) of the tubular outer cap (figure 5, item 3) (figure 6),
the driven part (figure 3, item 15) extending in the direction transverse to the longitudinal axis towards the tubular outer cap (figure 5, item 3) (figures 3 and 4),
wherein the driving part (figure 6, item 16) is spaced apart from the driven part (figure 3, item 15) in the direction of the longitudinal axis when the tubular outer cap (figure 5, item 3) is in the proximal position (figure 2), and
wherein the driving part (figure 6, item 16) is adjacent to the driven part (figure 3, item 15) when the tubular outer cap (figure 5, item 3) is in the distal position so that the inner cap (figure 3, item 4) can be detached from the housing (figure 2, item 7) of the medicament delivery device (figure 1, item 1) via a rotation of the outer cap (figure 5, item 3) relative to the housing (figure 2, item 7) of the medicament delivery device (figure 1, item 1) (paragraph [0021]).
[Claims 18 and 19] Fabbri teaches the limitations of claim 16, upon which claims 18 and 19 depend. In addition, Fabbri discloses one of the driving part and the driven part (figure 3, item 15) is a recess (“radial slot”) (paragraph [0021]), and wherein the other one of the driving part (figure 6, item 16) (“protrusions”) and the driven part is a protrusion positioned in the recess when the tubular outer cap (figure 5, item 3) is in the distal position (paragraph [0021]); wherein the recess faces towards the direction transverse to the longitudinal axis (figure 3).
[Claim 20] Fabbri teaches the limitations of claim 16, upon which claim 20 depends. Fabbri further discloses the sub-assembly comprises a retainer (figure 4, items 6/19), wherein the retainer (figure 4, items 6/19) comprises a retainer body (figure 4, item 6) and an attachment (figure 4, item 19) extending from the retainer body (figure 4, item 6) (figure 4; paragraph [0023]), wherein the attachment (figure 4, item 19) is configured to attach to a counter attachment (figure 2, item 18) of the medicament delivery device (figure 1, item 1), wherein the inner cap (figure 3, item 4) is removable attached (via item 14) (“preweakened bridges”) to the retainer (figure 4, items 6/19) via the rotational attachment (paragraph [0020]), thereby the inner cap (figure 3, item 4) is removable attached to the medicament delivery device (figure 1, item 1) via the retainer (figure 4, items 6/19) (paragraph [0021]).
Allowable Subject Matter
Claims 17 and 21-30 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 09/20/2026
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