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 11/4/2025 has been entered. Claims 1-21 are pending in the application. Claims 3-5, 8-10, and 13-19 remain withdrawn. The amendments to the claims and specification overcome each and every objection previously set forth in the Non-Final Office Action mailed on 5/5/2025.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Paragraphs [0037] and [0047] of the Specification include references which have not been listed on an IDS.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6-7, 11-12, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mojarrad et al. (US 2022/0288305 A1).
Regarding claim 1, Mojarrad discloses an auto-injector (drug delivery device 10) for administering a beneficial agent (drug 102) (see Figs. 1-2, par. [0026] and [0028]), the auto-injector (drug delivery device 10) comprising:
a pressure chamber (pressure chamber 100) defined by a pressure chamber wall (wall 101) (see Figs. 1-2, par. [0027] and [0042]), and the pressure chamber wall (wall 101) configured to define a boundary of the pressure chamber (wall 101) (see Figs. 1-2, par. [0042]); and
a primary container (container 110) comprising a sidewall (wall 112), a stopper (plunger 120), and an inner surface (interior surface 112a) (see Figs. 1-2, par. [0027]-[0028]), the primary container (container 110) being completely housed within the pressure chamber (pressure chamber 100) with an entirety of the sidewall (wall 112) of the primary container (container 110) within the boundary of the pressure chamber (pressure chamber 100) (see Figs. 1-2, par. [0006] and [0042]), the sidewall (wall 112) and the pressure chamber (pressure chamber 100) being in fixed position relative to one another (see Figs. 1-2, par. [0040]), the sidewall (wall 112) of the primary container (container 110) forming no portion of the boundary of the pressure chamber (pressure chamber 100) (see Figs. 1-2, par. [0006] and [0042]), the entirety of the sidewall (wall 112) configured to receive a balanced pressure exposure within the pressure chamber (pressure chamber 100) (see Figs. 1-2, par. [0042]), the stopper (plunger 120) being disposed relative to the inner surface (interior surface 112a) and sealingly engaged to the inner surface (interior surface 112a) (see Figs. 1-2, par. [0027]-[0028] and [0040]), the primary container (container 110) further comprising a containment volume (reservoir 114) defined by the stopper (plunger 120) and the inner surface (interior surface 112a) (see Figs. 1-2, par. [0028]);
wherein an increase in a pressure within the pressure chamber (pressure chamber 100) increases the pressure within the containment volume (reservoir 114) such that the stopper (plunger 120) moves relative to the inner surface (interior surface 112a) to reduce the containment volume (reservoir 114) (see Figs. 1-2, par. [0035] and [0042]).
Regarding claim 2, Mojarrad discloses the auto-injector of claim 21, further comprising:
an administration device (container needle 132, fluid conduit 18, needle insertion mechanism 20, needle 22, and cannula 24 form an administration device) disposed relative to the primary container (container 110) to establish fluid communication with the containment volume (reservoir 114) (see Figs. 1-2, par. [0031]-[0032] and [0036]), wherein the beneficial agent (drug 102) is expelled through the administration device (container needle 132, fluid conduit 18, needle insertion mechanism 20, needle 22, and cannula 24 form an administration device) (see Figs. 1-2, par. [0031]-[0032] and [0036]).
Regarding claim 6, Mojarrad discloses the auto-injector of claim 1, further comprising:
an energy source (actuator 16 and mechanical or electrical means, see par. [0031]) selectively activatable to increase the pressure within the pressure chamber (pressure chamber 100) upon activation (see Figs. 1-2, par. [0031]-[0035]).
Regarding claim 7, Mojarrad discloses the auto-injector of claim 6, wherein the pressure within the pressure chamber (pressure chamber 100) equals the pressure within the containment volume (reservoir 114) (see Figs. 1-2, par. [0035] and [0042]).
Regarding claim 11, Mojarrad discloses the auto-injector of claim 1, wherein an energy source comprises one of compressed gas or liquefied gas (see par. [0035]).
Regarding claim 12, Mojarrad discloses the auto-injector of claim 2, wherein the administration device (container needle 132, fluid conduit 18, needle insertion mechanism 20, needle 22, and cannula 24 form an administration device) is one of a needle, a dispenser, or a connector (see Figs. 1-2, the administration device formed from container needle 132, fluid conduit 18, needle insertion mechanism 20, needle 22, and cannula 24 includes a needle 22 and structures which can be considered a dispenser/connector).
Regarding claim 20, Mojarrad discloses the auto-injector of claim 1, wherein the increase in the pressure within the pressure chamber (pressure chamber 100) acts upon an exterior surface (second end 120b) of the stopper (plunger 120) to increase the pressure within the containment volume (reservoir 114) (see Figs. 1-2, par. [0028], [0035], and [0042]).
Regarding claim 21, Mojarrad discloses the auto-injector of claim 1, further comprising:
the containment volume (reservoir 114) comprising the beneficial agent (drug 102) such that reduction of the containment volume (reservoir 114) expels the beneficial agent (drug 102) (see Figs. 1-2, par. [0035] and [0042]).
Response to Arguments
Applicant's arguments filed 11/4/2025 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Mojarrad fails to teach the limitations “a pressure chamber defined by a pressure chamber wall, and the pressure chamber wall configured to define a boundary of the pressure chamber; and a primary container comprising a sidewall…the primary container being completely housed within the pressure chamber with an entirety of the sidewall of the primary container within the boundary of the pressure chamber…the sidewall of the primary container forming no portion of the boundary of the pressure chamber, the entirety of the sidewall configured to receive a balanced pressure exposure within the pressure chamber”. Specifically, Applicant argues that Mojarrad fails to show or describe that the primary container is completely housed within the pressure chamber in the manner described above, because (1) Mojarrad’s figures are recited as being schematic representations and (2) Mojarrad’s specification only describes the primary container being at least partially disposed within the pressure chamber. These arguments are not found persuasive.
Regarding argument (2), the disclosure’s recitation of “a container at least partially disposed in the pressure chamber” in par. [0006] contemplates two possible configurations: a container partially disposed in the pressure chamber and a container fully disposed in the pressure chamber. Regarding argument (1), Mojarrad’s Figure 2 does show the container 110 being housed entirely within the pressure chamber 100. Because this figure shows the structures which are claimed and how they are put together, the above claim limitations are anticipated (see MPEP 2125(I)). Further, the aforementioned recitations in par. [0006] of the disclosure, in combination with what is shown in Fig. 2, can be relied upon for what they would reasonably teach one of ordinary skill in the art (see MPEP 2125(II)), which includes a configuration in which the primary container 110 is housed entirely within the pressure chamber 100. For these reasons, the Examiner maintains their position that Mojarrad anticipates the claim.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783