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 .
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 actuating member that extends axially from the piston head must be shown or the feature(s) canceled from the claim(s). The written description describes the actuating member as element 344, which is shown in Fig. 5 as a sleeve positioned radially outside of the piston, and not extending axially from the piston head 343. 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 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 12 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.
Claim 12 recites the limitation "…the at least one indicator aperture…" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as "…an aperture of the injector body…”.
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)(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 1-8 and 11-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enfoux WO 2010/035056 A1 (reference #14 on IDS, on IDS received 14 September 2023).
Regarding claim 1, Enfoux discloses an injection device (device 1, P0024 and shown in Figs. 1-4) 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; and a piston (piston rod 9 and piston 8, P0024) configured to move through the injector body to expel a medicament out of the medicament reservoir and to sequentially activate a plurality of status indicators (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 that indicates conclusion of the injection step).
Regarding claim 2, Enfoux discloses the injection device of claim 1, wherein the injector body has a longitudinal axis (longitudinal axis through the lumen of needle 5), and at least one status indicator of the plurality of status indicators (mobile part 20) is configured to be pushed radially out of the injector body as the piston moves axially through the injector body (radial projection 22 of mobile part 20, P0040 and shown in Fig. 4).
Regarding claim 3, Enfoux discloses the injection device of claim 1, wherein at least one status indicator of the plurality of status indicators (mobile part 20) is positioned such that the at least one status indicator is to be moved 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 4, Enfoux discloses the injection device of claim 1, wherein at least one status indicator of the plurality of status indicators (mobile part 20) is positioned to indicate 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).
Regarding claim 5, Enfoux discloses the injection device of claim 1, wherein the piston comprises: a stopper (piston 8, P0024) disposed in the medicament reservoir to expel the medicament; a piston shaft (piston shaft, see annotated Fig. 2 below wherein the distal portion of 9 is the piston shaft) extending out of the medicament reservoir; and a piston head (piston head, see annotated Fig. 2 below wherein the proximal portion of 9 is the piston head) configured to push the one or more status indicators out of the injector body (via recess 12 through window 17 of housing 14, P0037-0038 and P0040).
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Regarding claim 6, Enfoux discloses the injection device of claim 5, wherein the piston further comprises an actuating member (recess 12, P0037) that extends axially from the piston head, and wherein the actuating member is arranged to be outside of the medicament reservoir as the piston moves axially through the injector body (Figs. 1-4).
Regarding claim 7, Enfoux discloses the injection device of claim 6, wherein at least one status indicator of the plurality of status indicators (needle 5) is axially aligned with the medicament reservoir (Figs. 1-4).
Regarding claim 8, Enfoux discloses the injection device of claim 1, wherein at least one status indicator of the plurality of status indicators (mobile part 20) comprises: a finger element (finger element, see annotated Fig. 4 below wherein the finger element is the portion of mobile part 20 indicated by the arrow below) that is pivotably mounted (pivotally mounted via flexible tongue P0031 and P0037) to extend radially into the injector body in a first position (first position shown in Figs. 1-2) and to extend parallel to an internal surface of the injector body in a second position (Fig. 4 showing the second position of the finger element parallel to the internal surface of the injector body indicated, see annotated Fig. 4 below); and an elevated portion (radial projection 22, P0040) that projects from the finger element so as to pass through an indicator aperture (window 17, P0040) defined in the injector body when the finger element is in the second position (Fig. 4), wherein a movement of the piston pushes the finger element from the first position to the second position (via recess 12, see Figs. 3-4 and P0037-0038 and P0040).
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Regarding claim 11, Enfoux discloses the injection device of claim 1, further comprising a medicament (product 6 to be injected, P0024, may be drugs P003) that is contained within the medicament reservoir and arranged to be expelled by movement of the piston.
Regarding claim 12, Enfoux discloses the injection device of claim 1, wherein at least one status indicator of the plurality of status indicators (mobile part 20) is configured to produce an auditory signal or a vibration (tactile indicator, P0042 which includes vibration P0012) when pushed through the at least one indicator aperture (window 17, P0040).
Regarding claim 13, Enfoux discloses an auto-injector (self-injection device where the injection is realized via automatic means such as biasing means, P0044) 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; and a piston (piston rod 9 and piston 8, P0024) configured to move through the injector body to expel a medicament out of the medicament reservoir and to sequentially activate a plurality of status indicators (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 that indicates conclusion of the injection step).
Regarding claim 14, Enfoux discloses the auto-injector of claim 13, wherein the injector body has a longitudinal axis (longitudinal axis through the lumen of needle 5), and at least one status indicator of the plurality of status indicators (mobile part 20) is configured to be pushed radially out of the injector body as the piston moves axially through the injector body (radial projection 22 of mobile part 20, P0040 and see Fig. 4).
Regarding claim 15, Enfoux discloses the injection device of claim 13, wherein at least one status indicator of the plurality of status indicators (mobile part 20) is positioned such that the at least one status indicator is to be moved 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 16, Enfoux discloses the injection device of claim 13, wherein at least one status indicator of the plurality of status indicators (mobile part 20) is positioned to indicate 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).
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), and a plurality of status indicators (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 that indicates conclusion of the injection step), the method comprising: moving the piston through the injector body to expel a medicament out of a medicament reservoir in an injector body and sequentially activating the plurality of status indicators (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 status indicator of the plurality of status indicators (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 status indicator of the plurality of status indicators (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 status indicator of the plurality of status indicators (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).
Allowable Subject Matter
Claims 9-10 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 Allowance
The following is an Examiner's statement of reasons for allowance: the claims in this application are allowed because the prior art of record fails to disclose either singularly or in combination the claimed injection device.
The closest prior art is Enfoux WO 2010/035056 A1.n
Regarding claim 9, Enfoux fails to teach among all the limitations or render obvious an injection device as claimed, which includes wherein the finger element is defined by one or more cuts through an inner sleeve that is disposed internally within the injector body, with an uncut portion of the inner sleeve joining the finger element to a cylindrical body of the inner sleeve as a hinge, in combination with the total structure and function of the injection device as claimed.
Regarding claim 10, Enfoux fails to teach among all the limitations or render obvious an injection device as claimed, which includes wherein each status indicator of the plurality of status indicators 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.
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
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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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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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783