DETAILED ACTION
Response to Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-20, 22, 25, 27, 29-31 and are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to claim 17, there is no original disclosure of a donut-shaped reflective surface with a base portion and cylindrical shaped inner surface extending from the base portion as is now recited. This limitation appears to be an attempt to capture the features of the embodiment in Figures 7-8 but this embodiment does not include a base portion with a cylindrical shaped inner surface extending from the base portion. The embodiment includes an adapter 252 that defines a cylindrical inner surface 253 but these features do not cover the recited limitations.
The dependent claims are rejected by virtue of their dependency on the rejected independent claim.
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 17-20, 22, 25, 27, 29-31 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.
In regard to claim 17, the limitation “a cylindrical shaped inner surface extending from the base portion” in combination with the limitation “a reflective surface extending from the base portion” renders the claim indefinite. The claim would appear to make more sense if the reflective surface is recited as extending from the cylindrical shaped inner surface instead of the base portion because the inner surface extends from the base. See Figure 2 of the instant application.
The dependent claims are rejected by virtue of their dependency on the rejected independent claim.
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.
Claim(s) 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rudin (US 4,208,588).
In regard to claim 17, Rudin discloses an accessory (6) for a drug delivery device (2; the examiner notes that the drug delivery device is functionally claimed; 2 is highlighted for illustrative purposes only), comprising: a base portion (20); a cylindrical shaped inner surface (10) extending from the base portion along a longitudinal axis, the base portion configured to be operably coupled with the drug delivery device (see at least col. 3, line 40- col. 4, line 7), the drug delivery device having: an injector housing having a body with a proximal end, a distal end, and at least one window, a needle assembly at least partially disposed within the body, the needle assembly comprising a syringe barrel containing a medicament and a needle or a cannula, at least a portion of the syringe barrel positioned such as to be visible through the at least one window[[;]], and a drive assembly at least partially disposed within the body and operably coupled with the needle assembly to urge the medicament through the needle or cannula during an injection sequence (drug delivery device is functionally recited); and a reflective surface (16,17) extending from the base portion and positioned with respect to the window such as to increase visibility of the syringe barrel (see at least col. 4, lines 3-7), wherein (b) the reflective surface is donut shaped (see at least Figs. 2-3 and 5; the examiner maintains that any curved shaped is donut-shaped).
Allowable Subject Matter
Claims 18-20, 22, 25, 27, and 31 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. Claim 17 would be allowable if the (b) option of the claim was cancelled and furthermore the 112(b) rejection was resolved by reciting that the reflective surface extends from the cylindrical shaped inner surface.
In regard to claims 29-30, Rudin does not disclose the features of the base. These claims are still subject to a 112(a) rejection.
Response to Arguments
Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive.
The applicant’s argument that Rudin fails to disclose a donut shaped reflective surface is not persuasive. Any curved shape can be considered donut shaped.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783