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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/05/2026 has been entered.
Response to Amendment
The examiner acknowledges the reply filed on 07/28/2026 in which claims 24, 39, and 43, were amended. Claims 28 and 38 have been cancelled. Currently, claims 24-27, 29-37, and 39-43, are pending for examination in this application.
Response to Arguments
Applicant’s arguments with respect to claims 24-27, 29-37, and 39-43, have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “at least one pin extending perpendicular to the longitudinal axis” (claim 1), in combination with a housing cover assembly comprising “two separate housing covers” (claim 29), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 29 is 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. The claim, which is directly dependent from independent claim 24, recites the limitation of “wherein the housing cover assembly comprises two separate housing covers.” However, the newly amended claim limitations within independent claim 24 now requires “wherein the housing cover assembly comprises at least one pin extending perpendicular to the longitudinal axis.” The originally filed specification does not support a medicament delivery device sub-assembly which contains both these limitations in combination. As such, the limitations of claim 29 are now considered to be new matter.
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 24-27, 30-35, 42, and 43, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stillman (PGPub 2016/0082201).
[Claims 24, 30, and 43] Stillman teaches a medicament delivery device (figure 5) comprising:
a housing (figure 5, item 102) extending along a longitudinal axis from a proximal end to a distal end (figure 5), where the housing (figure 5, item 102) comprises a tubular section (figure 5, item 113; paragraph [0017]) with an internal surface facing towards the longitudinal axis and an external surface facing away from the longitudinal axis (figure 5);
an aperture (figure 5, item 120) extending through the tubular section (figure 5, item 113) from the internal surface to the external surface (figure 5; paragraph [0017]);
a syringe carrier (figure 5, items 106/108) axially fixed within the housing (figure 5, item 102);
a syringe (figure 5, item 10) positioned within the syringe carrier (figure 5, items 106/108) and having a shoulder (figure 5, item 20) located at a proximal end of the syringe (figure 5, item 10); and
a housing cover assembly (figure 5, item 104) attached in the aperture (figure 5, item 120) of the housing (figure 5, item 102) (paragraph [0018]), where the housing cover assembly (figure 5, item 104) engages (figure 5, via item 151) the shoulder (figure 5, item 20) to axially fix the syringe (figure 5, item 10) relative to the housing (figure 5, item 102) (paragraph [0033]),
wherein the housing cover assembly (figure 5, item 104) comprises at least one pin (figure 5, item 151) (alternatively, one of the two “retention tabs” 148 could be interpreted as a “pin”) extending perpendicular to the longitudinal axis (figure 5).
[Claims 25, 26, and 34] Stillman teaches the limitations of claim 24, upon which claims 25, 26, and 34, depend. In addition, Stillman discloses the housing cover assembly (figure 5, item 104) comprises a protrusion (figure 5, item 148) (the examiner notes only 1 of the 2 “retention tabs” 148 would be required) extending towards the longitudinal axis (figure 5);
wherein the protrusion (figure 5, item 148) of the housing cover assembly (figure 5, item 104) comprises a surface (figure 5) facing the distal end of the housing (figure 5, item 102), wherein the surface (figure 5) is shaped to fit between a medicament delivery shield and a shoulder of said syringe so as to support said shoulder of said syringe (the examiner notes both the “medicament delivery shield” and the “syringe” are only functionally recited within claims 24/26; as such, the “surface” taught by Stillman is functionally capable of meeting this limitation);
wherein the housing cover assembly (figure 5, item 104) comprises an arm (figure 5, item 140), where the protrusion (figure 5, item 148) of the housing cover assembly (figure 5, item 104) is attached to the arm (figure 5, item 140).
[Claims 27 and 42] Stillman teaches the limitations of claim 24, upon which claim 27 depends. Stillman also teaches a syringe (figure 5, item 10) in the housing (figure 5, item 102), and wherein the syringe (figure 5, item 10) is held relative to the housing (figure 5, item 102) by the housing cover assembly (figure 5, item 104) (paragraphs [0018], [0033]).
[Claims 31-33] Stillman teaches the limitations of claim 24, upon which claims 31-33 depend. Stillman further discloses the housing cover assembly (figure 5, item 104) comprises a rigid arm (figure 5, item 148) which extends in a direction parallel (the examiner notes the arm has a thickness with is parallel to the longitudinal axis) to the longitudinal axis (figure 5).
[Claim 35] Stillman teaches the limitations of claim 24, upon which claim 35 depends. In addition, Stillman discloses the external surface of the tubular section (figure 5, item 113) is configured to be held by a user during use of a medicament delivery device comprising the medicament delivery device sub-assembly (figure 5; the examiner notes the structure is capable of meeting this functional limitation).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Stillman (PGPub 2016/0082201), in view of Lerner (PGPub 2014/0039456).
[Claim 29] Stillman teaches the limitations of claim 24, upon which claim 29 depends. Although disclosing one or more features may be implemented into the device (paragraph [0035]), Stillman does not specifically disclose the housing cover assembly consists of two separate housing covers.
However, Lerner teaches a medicament delivery device sub-assembly (figure 28, item 100) comprising a housing cover assembly (figure 28, items 112) consisting of two separate housing covers (figures 29 and 30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Stillman, to have utilized two separate housing covers, as taught by Lerner, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Stillman (PGPub 2016/0082201), in view of Roervig et al. (PGPub 2015/0174335).
[Claims 36 and 37] Stillman teaches the limitations of claim 24, upon which claims 36 and 37 depend. Stillman does not specifically disclose the housing cover assembly comprises a window.
However, Roervig teaches a medicament delivery device sub-assembly (figure 9) comprising a housing cover assembly (figure 9, item 3a) having a window (figure 9, item 6), wherein a window frame (figure 9, item 11) extends around the window (paragraphs [0081], [0112]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Stillman, to have utilized a window in the housing cover assembly, as taught by Roervig, in order to provide increased functionality and versatility, by allowing for an easy means by which a user might visually inspect the contents of the syringe within the housing (Roervig; paragraph [0081]).
Allowable Subject Matter
Claims 39-41 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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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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.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 09/01/2026
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