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 .
Response to Amendment
Examiner acknowledges the reply filed 11/20/2025. Claims 2-12, 14-16, 18-20, 22 and 27 were amended. Claims 33-37 were newly added. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
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 12, 15, 22 and 27, and all claims depending therefrom, 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.
Regarding claims 2, 15, 22 and 27, the new matter is that the auto-injector is configured to automatically deliver a dose of medicament from the auto-injector upon the inner part moving to a predetermined position relative to the housing. This feature is not disclosed in the original disclosure with specificity necessary for a person of ordinary skill in the art to conclude that the Applicant possessed this invention at the time of filing. Although the original disclosure discusses that "the delivery device 1 is an autoinjector designed to automatically deliver a dose of a medicament by means of a needle 2 upon sleeve-driven actuation" (see specification at para [0089]). But the original disclosure does not disclose specifically automatically delivering a dose of medicament when the inner part moves to a predetermined position relative to the housing.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered.
A new ground of rejection has been applied to the pending independent claims. While the claims were amended to incorporate the rejected feature, this feature was recited in a previous claim set(s) but was not rejected at the time of consideration of the previous claim set(s). For this reason, this action has been made NON-FINAL.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 03/04/2026
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