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 .
Election/Restrictions
Applicant’s election without traverse of group I (claims 17-31) in the reply filed on 23 December 2025 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 17 is objected to because of the following informalities:
In line 16, “second component” should be “second elongated component”
In line 17, “first component” should be “first elongated component”
In line 18, “second component” should be “second elongated component”
Appropriate correction is required.
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 17, 23-25, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helmer et al (US 2011/0245780).
Regarding claim 17, Helmer discloses:
A dose limiting mechanism for an injection device (151; Fig. 1), the dose limiting mechanism being configured for arrangement inside a housing (154) of the injection device (151) and being operable to limit a total number of doses dispensable by the injection device (¶0087), the dose limiting mechanism comprising: a first elongated component (164) extending in a longitudinal direction and comprising a first profiled structure (166; ¶0073); a second elongated component (158) parallel to the first elongated component and comprising a second profiled structure (184) facing the first profiled structure (166); and a dose limiter (160) arranged between the first elongated component (164) and the second elongated component (158), the dose limiter (160) comprising a first profile section (161) and a second profile section (161’); wherein the first profile section (161) is engagable with the first profiled structure (166) to transfer a longitudinal movement of the first elongated component (164) to the dose limiter (160) when the first elongated component (164) is subject to a longitudinal movement in a distal direction relative to the second elongated component (158) during dispensing of a dose (¶0082); and wherein the second profile section (161’) is engagable with the second profiled structure (184) to retain a longitudinal position of the dose limiter (160) relative to the second component (158) when the first component (164) is subject to a longitudinal movement in a proximal direction relative to the second component (158) (¶0072).
Regarding claim 23, Helmer discloses:
The dose limiting mechanism according to claim 17, wherein the dose limiter (160) is rotationally locked to one of the first elongated component and the second elongated component (158) (¶0072); and wherein the dose limiter (160) is rotatable to the other one of the first elongated component (164) and the second elongated component (¶0073).
Regarding claim 24, Helmer discloses:
The dose limiting mechanism according to claim 17, wherein at least one of the first elongated component (164) and the second elongated component comprises an end stop (176) configured to engage with the dose limiter (160) (¶0086).
Regarding claim 25, Helmer discloses:
The dose limiting mechanism according to claim 24, wherein the end stop (176) of the first elongated component (164) is configured to prevent a proximally directed longitudinal movement of the first elongated component (164) relative to the dose limiter (160) or relative to the second elongated component when engaged with the dose limiter (¶0086).
Regarding claim 31, Helmer discloses:
The dose limiting mechanism according to claim 17, wherein the second elongated component (158) is coaxial to the first elongated component (164) (Fig. 1).
Allowable Subject Matter
Claims 18-22 and 26-30 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783