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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/02/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 07/02/2026. As directed by the amendment: claim 1 has been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-3 and 8-12 are presently pending in this application, with claims 8-12 being withdrawn from consideration.
Response to Arguments
Applicant’s arguments, see p.4, lines 10-21 of “Remarks”, filed 07/02/2026, with respect to the 103 rejection of record have been fully considered and are persuasive. The 103 rejection of 05/01/2026 has been withdrawn.
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 1-3 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 claim 1, the phrase “And a display that displays a countdown during the injection that lasts the predetermined period of time” in lines 24-25 fails to comply with the written description requirement and contains new matter. Examiner notes that claim 1 is drawn towards “A dose measuring device for use with a pen injector” which the specification, esp. para. 0002, supports as “the present invention relates to a cap for a pen injector”. Thus, examiner is interpreting the dose measuring device as the cap in the disclosure. The specification further discloses a system (900) in Fig. 9 and para. 0026 stating “the system 900 comprises a pen injector 106 with a cap 100 substantially as described above, a mobile device 904 and a remote server or cloud storage 906.” Further, the specification only has support for a display having a countdown timer on the mobile device (see para. 0024). Thus, the disclosure does not have support for a dose measuring device comprising a display that displays a countdown as claimed in claim 1, but rather supports a system comprising the dose measuring device in communication with a mobile device that comprises the display and its capabilities. Therefore, the limitation is new matter.
Regarding claims 2-3, these claims are rejected due to their dependency upon a rejected base 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 1-3 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.
Regarding claim 1, the phrase “the pen injector comprising a proximal end having a dispensing button and a distal end opposite the proximal end” in lines 4-5 renders the claim indefinite because it is unclear whether the pen injector is intended to be functionally recited as stated in the preamble of claim 1 or positively recited from the limitation above. Examiner is interpreting the pen injector as functionally recited, and thus, the dose measuring device is interpreted as being capable of being configured for use with a pen injector comprising a proximal end having a dispensing button and a distal end opposite the proximal end.
Regarding claim 1, the phrase “wherein the fixed cap part comprises a locking nut and chuck clamping mechanism, the locking nut being rotatable relative to the fixed cap part, the locking nut and chuck clamping mechanism adapted to clamp the fixed cap part onto the body of the pen injector arranged at a proximal end of the fixed cap part and configured to fix the fixed cap part to the body of the pen injector” in lines 6-9 renders the claim indefinite because the limitation “arranged at a proximal end of the fixed cap part and configured to fix the fixed cap part to the body of the pen injector” creates confusion with its placement in the phrase. It is unclear whether the pen injector is arranged at a proximal end of the fixed cap part as stated or the chuck clamping mechanism is arranged at a proximal end of the fixed cap part as supported by the disclosure. Examiner suggests amended the phrase to state “wherein the fixed cap part comprises a locking nut and chuck clamping mechanism arranged at a proximal end of the fixed cap part and configured to fix the fixed cap part to the body of the pen injector, the locking nut being rotatable relative to the fixed cap part, the locking nut and chuck clamping mechanism adapted to clamp the fixed cap part onto the body of the pen injector.”
Regarding claims 2-3, these claims are rejected due to their dependency upon a rejected base claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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