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 10/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the preliminary amendment filed on 10/10/2024. As directed by the amendment: claims 1-15 have been amended.
Thus, claims 1-15 are pending in this application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The abstract of the disclosure is objected to because paragraph exceeds the range of 50 to 150 words in length.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The abstract of the disclosure is objected to
Line 1, “The cap” should read “A cap”.
Line 5, “the needle shield” should read “a needle shield”.
Line 14, “the proximal direction” should read “a proximal direction”.
The disclosure is objected to because of the following informalities:
Page 5, line 29, “for attachement” should read “for attachment”.
Page 6, line 2, “fexible legs” should read “flexible legs”.
Page 7, line 1, “the distal surface” should read “the distal surface”.
Page 8, line 5, “the the axial abutment surface” should read “the axial abutment surface”.
Page 8, line 8, “the axial abutement” should read “the axial abutment”.
Page 10, line 8, “the the axial abutment surface” should read “the axial abutment surface”.
Page 10, line 11, “the axial abutement” should read “the axial abutment”.
Page 11, lines 15-16, “the the axial abutment surface” should read “the axial abutment surface”.
Page 11, line 19, “the axial abutement” should read “the axial abutment”.
Page 11, line 27, “inserted inserted” should read “inserted”.
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 1-14 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 the limitation "the proximal direction". There is insufficient antecedent basis for this limitation in the claim.
For purpose of examination, examiner is interpreting the proximal direction as “a proximal direction”.
By virtue of dependency, claims 2-14 are also rejected.
Allowable Subject Matter
Claim 1-15 would be allowable if rewritten or amended 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.
The closest prior art is Liversidge (US 20070173772 A1).
Regarding claim 1, Liversidge discloses a cap (20 in fig 1D) for removing a needle shield (17) attached to a medical container (12) provided with an injection needle (14), the cap (10) comprising: a tubular body (21) extending along a longitudinal axis (fig 1D), the tubular body (21) having a distal end (see annotated figure below) and an opposite proximal end (see annotated figure below) for attachment to a bottom housing of an autoinjector (11), an inner sleeve (22) proximally extending inside the tubular body (21) from said distal end (fig 1D), the inner sleeve (22) defining an inner cavity for receiving the needle shield (17), the inner sleeve (21) having clamping means (33) for clamping the needle shield (17) when the needle shield (17) is inserted inside the inner cavity (para 0037), the clamping means comprising an axial abutment surface (32) for abutting against a proximal end of the needle shield (see annotated figure below), a plug (35) at least partially extending inside the inner cavity (fig 1C), the plug (35) having a distal end portion (36), a proximal end portion (top portion of 35) and an intermediate portion (portion between top portion and bottom portion) extending between the distal end portion and the proximal end portion (figs 1B-C), wherein at least the proximal end portion of the plug is movable between a first position (fig 1B) and a second position (fig 1C) but fails to teach/discloses or render obvious “in the first position, the proximal end portion allows the proximal end of the needle shield to distally pass the axial abutment surface of the clamping means, and in the second position, proximal to the first position, in which the proximal end portion of the plug moves in the proximal direction to push the needle shield back towards the axial abutment surface” in addition to other limitations.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 10/01/2026
