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
The Amendment filed on 7/29/2026 has been entered. Claims 1-2, 7-8, 10-15, and 17-19 remain pending in the application. Claims 23-28 are new.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 5/1/2026.
Examiner called the attorney of record on 8/19/2026 in attempt to resolve the remaining issues (see below) over the phone, but was unable to reach them.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/30/2026 and 6/30/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 19 objected to because of the following informalities:
Line 4 recites “on first interior surface thereof”. This is grammatically incorrect. Appropriate correction is required. Examiner suggests replacing “on first interior surface thereof” in line 4 of claim 19 with “on a first interior surface thereof”.
Line 10-11 recites “the second keyed connector comprise a second thread form”. This is grammatically incorrect. Appropriate correction is required. Examiner suggests replacing “the second keyed connector comprise a second thread form” in line 10-11 of claim 19 with “the second keyed connector comprising a second thread form”.
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 23, 25, and 27 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 23,
Line 1-3 recites “wherein the first and second thread forms have the same core diameter to enable the first keyed connector and the second keyed connector to be molded from a same mold”. There is not support in the original disclosure for this limitation. The disclosure is completely silent regarding the first keyed connector and the second keyed connector being enabled to be molded from a same mold. The disclosure is completely silent regarding molding. Appropriate correction is required. Examiner suggests canceling claim 23.
In regard to claim 25,
Line 1-3 recites “wherein the first and second thread forms have the same core diameter to enable the first keyed connector and the second keyed connector to be molded from a same mold”. There is not support in the original disclosure for this limitation. The disclosure is completely silent regarding the first keyed connector and the second keyed connector being enabled to be molded from a same mold. The disclosure is completely silent regarding molding. Appropriate correction is required. Examiner suggests canceling claim 25.
In regard to claim 27,
Line 1-3 recites “wherein the first and second thread forms have the same core diameter to enable the first keyed connector and the second keyed connector to be molded from a same mold”. There is not support in the original disclosure for this limitation. The disclosure is completely silent regarding the first keyed connector and the second keyed connector being enabled to be molded from a same mold. The disclosure is completely silent regarding molding. Appropriate correction is required. Examiner suggests canceling claim 27.
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.
Claim 17 is 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,
Line 1-2 recites “wherein the thread form of each of the first and second keyed connectors is a female thread form”. Claim 17 depends on claim 1. Claim 1 introduces a first thread form and a second thread form. It is unclear if the thread form of each of the first and second keyed connectors refers to the first thread form and the second thread form. For examination purposes Examiner construes “wherein the thread form of each of the first and second keyed connectors is a female thread form” to be “wherein the first thread form and the second thread form are female thread forms”. Examiner suggests replacing “wherein the thread form of each of the first and second keyed connectors is a female thread form” in line 1-2 of claim 17 with “wherein the first thread form and the second thread form are female thread forms”.
Allowable Subject Matter
Claims 1-2, 7-8, 10-15, 18, 24, and 26 are allowed.
The following is an examiner’s statement of reasons for allowance:
In regard to claim 1,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a collection of two or more dose delivery mechanisms and two or more holders as claimed in claim 1 comprising the first and second thread forms having a same core diameter in combination with the first outer thread diameter being greater than the second outer thread diameter, and the first thread width being less than the second thread width and in combination with a first keyed connector on a first external surface thereof, a second keyed connector on a second external surface thereof, a third keyed connector on a first internal surface thereof, and a fourth keyed connector on a second internal surface thereof.
Avery (U.S. PG publication 20130090602) discloses a first thread form and a second thread form (see figure 13 below and paragraph [0048] and [0119]).
PNG
media_image1.png
324
441
media_image1.png
Greyscale
Avery is silent as to the first and second thread forms as specifically claimed in combination with a first keyed connector on a first external surface thereof, a second keyed connector on a second external surface thereof, a third keyed connector on a first internal surface thereof, and a fourth keyed connector on a second internal surface thereof. As shown in figure 13 above, the first keyed connector and the second keyed connector of the first and second dose delivery mechanism would be located on an internal surface and the third keyed connector and the fourth keyed connector of the first and second holder would be located on an external surface. Accordingly, claim 1 is allowed.
Dependent claims 2, 7-8, 10-15, and 24 are allowed by virtue of being dependent upon allowed independent claim 1.
In regard to claim 18,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a collection of two or more dose delivery mechanisms as claimed in claim 18 comprising the first and second thread forms having a same core diameter in combination with the first outer thread diameter being greater than the second outer thread diameter, and the first thread width being less than the second thread width and in combination with a first keyed connector on a first outer surface thereof and a second keyed connector on a second outer surface thereof. Claim 18 requires similar limitations as claim 1 and is therefore allowed for similar reasons as claim 1 detailed above.
Dependent claim 26 is allowed by virtue of being dependent upon allowed independent claim 18.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim 17 would be allowable if rewritten 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. Claim 17 depends on claim 1 and would be allowable if rewritten 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 by virtue of its dependency on claim 1.
Claims 19 and 28 would be allowable. It is noted that claim 19 has outstanding claim objections as detailed above.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 19,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations a collection of two or more medicament container holders as claimed in claim 19 comprising the first and second thread forms having a same core diameter in combination with the first outer thread diameter being greater than the second outer thread diameter, and the first thread width being less than the second thread width and in combination with a first keyed connector on first interior surface thereof and a second keyed connector on a second interior surface thereof. Claim 19 requires similar limitations as claim 1 and would therefore be allowable for similar reasons as claim 1 detailed above.
Dependent claim 28 would be allowable by virtue of being dependent upon allowable independent claim 19.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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, Kevin Sirmons can be reached at (571) 272-4965. 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.
/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights