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
This office action is responsive to the amendment filed on April 16, 2026. As directed by the amendment: claims 1-8, 10, 12-14 and 17-20 have been amended, claim 15 has been cancelled, and claim 21 has been added. Thus, claims 1-14 and 16-21 are presently pending in this application. Applicant’s amendments are sufficient to overcome the drawing objection and §112(b) rejection of the previous action.
Response to Arguments
Applicant’s arguments, see Remarks, filed April 16, 2026, with respect to the rejections of newly amended independent claims 1 and 13 under 35 U.S.C. §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dennis, JR. et al. (Dennis) US 2017/024926 A1.
It is noted that although independent claim 17 was amended, it did not include all of the amendments that were made to independent claims 1 and 13, specifically the recitation regarding the second status indicator arranged distally of the first status indicator. Therefore, the prior art of the previous action still reads on claim 17, see below.
Claim Rejections - 35 USC § 102
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, 3-4, 11, 13, 16 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dennis, JR. et al. (Dennis) US 2017/0224926 A1.
Regarding claim 1, Dennis discloses an injection device (Figs. 1-9) comprising: an injector body (housing 23, P0028); a medicament reservoir (syringe 50, P0030) disposed within the injector body; and a piston (plunger element 62 P0033 having a flag element on bar 102 P0037-0038, as well as sealing plunger 58 P0033) configured to move distally through the injector body to expel a medicament out of the medicament reservoir and to sequentially (Figs. 4-9) activate a first status indicator (flag element in window 82) and then a second status indicator (flag element in window 85), wherein the second status indicator is arranged distally of the first status indicator (Fig. 1).
Regarding claim 3, Dennis discloses the injection device of claim 1, wherein at least one of the first status indicator and the second status indicator is positioned to be moved when all or substantially all of the medicament has been propelled out of the medicament reservoir (window 85 completely filled by surface 100 indicates complete medication delivery, P0043).
Regarding claim 4, Dennis discloses the injection device of claim 1, wherein at least one of the first status indicator and the second status indicator is positioned to indicate that a predetermined amount of the piston movement is complete (window 85 completely filled by surface 100 indicates complete medication delivery and that plunger element 62 has reached the end of its stroke, P0043).
Regarding claim 11, Dennis discloses the injection device of claim 1, further comprising a medicament (medication, P0030) that is contained within the medicament reservoir and arranged to be expelled by movement of the piston.
Regarding claim 21, Dennis discloses the auto-injector of claim 1, wherein activation of each of the first and second status indicators produces a visual change observable from outside of the injector body (Fig. 10-12).
Regarding claim 13, Dennis discloses an auto-injector (automatic injection device, P0025) comprising: an injector body (housing 23, P0028); a medicament reservoir (syringe 50, P0030) disposed within the injector body; and a piston (plunger element 62 P0033 having a flag element on bar 102 P0037-0038, as well as sealing plunger 58 P0033) configured to move distally through the injector body to expel a medicament out of the medicament reservoir and to sequentially (Figs. 4-9) activate a first status indicator (flag element in window 82) and then a second status indicator (flag element in window 85), wherein the second status indicator is arranged distally of the first status indicator (Fig. 1).
Regarding claim 16, The injection device of claim 13, wherein at least one of the first status indicator and the second status indicator is positioned to indicate that a predetermined amount of the piston movement is complete (window 85 completely filled by surface 100 indicates complete medication delivery and that plunger element 62 has reached the end of its stroke, P0043).
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enfoux WO 2010/035056 A1 (reference #14 on IDS received 14 September 2023, provided in the parent case 17/099,700 on January 19, 2021).
Regarding claim 17, Enfoux discloses a method of operating an injection device (device 1, P0024 and shown in Figs. 1-4), the injection device comprising an injector body (housing 14, P0026), a medicament reservoir (container 2 P0024, having product 6 to be injected P0024, may be drugs P003) disposed within the injector body, a piston (piston rod 9 and piston 8, P0024), a first status indicator and a second status indicator (a first status indicator is the needle 5 as shown in Figs. 1-2 and described in P0033-0034 indicating the insertion step, and a second status indicator is the mobile part 20 as shown in Figs. 3-4 and described in P0037-0038 and P0040-0042 that indicates conclusion of the injection step), the method comprising: moving the piston distally through the injector body to expel a medicament out of a medicament reservoir and sequentially activate the first status indicator and then the second status indicator (Figs. 1-4 showing the claimed steps).
Regarding claim 18, Enfoux discloses the method of claim 17, wherein the injector body has a longitudinal axis (longitudinal axis through the lumen of needle 5), the method further comprising pushing at least one of the first status indicator and the second status indicator (mobile part 20) radially out of the injector body as the piston moves axially through the injector body (Figs. 3-4 showing mobile part 20 being pushed distally and moving radially out of the injector body 14 through window 17).
Regarding claim 19, Enfoux discloses the method of claim 17, further comprising moving at least one of the first status indicator and the second status indicator (mobile part 20) when all or substantially all of the medicament has been propelled out of the medicament reservoir (when piston 8 reaches the distal end of the container 2, the radial projection 22 of mobile part 20 comes in regard with the window 17 of housing 14, P0040).
Regarding claim 20, Enfoux discloses the method of claim 17, further comprising indicating, by at least one of the first status indicator and the second status indicator (mobile part 20), that a predetermined amount of the piston movement is complete (when piston 8 reaches the distal end of the container 2, the radial projection 22 of mobile part 20 comes in regard with the window 17 of housing 14, P0040).
Potentially Allowable Subject Matter
Claims 2, 5-10, 12 and 14 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.
Reasons for Potential Allowance
The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed injection device of claims 2, 5-10 and 12, and the claimed auto-injector of claim 14.
The closest prior art is (Dennis) US 2017/024926 A1.
Regarding claim 2, Dennis fails to teach among all the limitations or render obvious an injection device as claimed, which includes wherein at least one of the first status indicator and the second status indicator is configured to be pushed radially out of the injector body as the piston moves axially through the injector body, in combination with the total structure and function of the injection device as claimed.
Regarding claim 5, Dennis fails to teach among all the limitations or render obvious an injection device as claimed, which includes a piston head configured to push the first status indicator and the second status indicator out of the injector body, in combination with the total structure and function of the injection device as claimed.
Regarding claim 8, Dennis fails to teach among all the limitations or render obvious an injection device as claimed, which includes wherein at least one of the first status indicator and the second status indicator comprises: a finger element that is pivotably mounted to extend radially into the injector body in a first position and to extend parallel to an internal surface of the injector body in a second position; and an elevated portion that projects from the finger element so as to pass through an indicator aperture defined in the injector body when the finger element is in the second position, wherein a movement of the piston pushes the finger element from the first position to the second position, in combination with the total structure and function of the injection device as claimed.
Regarding claim 10, Dennis fails to teach among all the limitations or render obvious an injection device as claimed, which includes wherein each of the first status indicator and the second status indicator is defined by a flexible sheet that is deformed to provide the status indicator as an inner bulge that is directed radially inward into an interior region of the injector body in a first position of the status indicator, and wherein axial movement of the piston pushes the flexible sheet to invert the inner bulge into an outer bulge that passes through a respective indicator aperture of the injector body in a second position of the status indicator, in combination with the total structure and function of the injection device as claimed.
Regarding claim 12, Dennis fails to teach among all the limitations or render obvious an injection device as claimed, which includes wherein at least one of the first status indicator and the second status indicator is configured to produce an auditory signal or a vibration when pushed through at least one indicator aperture, in combination with the total structure and function of the injection device as claimed.
Regarding claim 14, Dennis fails to teach among all the limitations or render obvious an auto-injector as claimed, which includes wherein the injector body has a longitudinal axis, and at least one of the first status indicator and the second status indicator is configured to be pushed radially out of the injector body as the piston moves axially through the injector body, in combination with the total structure and function of the auto-injector as claimed.
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.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783
/James D Ponton/Primary Examiner, Art Unit 3783
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