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 “flexible portion” and “flexible finger” in claims 3-10, 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 Objections
Claim 7 objected to because of the following informalities: “drive mechanism” should be “the drive mechanism”. Appropriate correction is required.
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.
Claims 2-6 are 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 2 recites the limitation "the drive member" in line 2. There is insufficient antecedent basis for this limitation in the claim. “the drive member” will be interpreted as a driving structure that connects and moves at least a portion of the device.
Specifically, claim 3 recites “a first end” when regarding apportion of the plunger, however, there are two ends to the plunger and neither is defined by a specific direction as well as the drawings lacking any reference numeral for a “flexible portion” or a “flexible finger”.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cowe (WO 2016/051168).
Regarding claim 1, Cowe discloses an injection device (Fig. 1, 1) comprising:
a housing (Fig. 4A, 30) comprising an inner wall having an inclined surface extending along the path of travel (Fig. 4A, where the portion 30 inclines towards the distal end near 77, see annotated figure below);
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a cartridge (Fig. 1, 5) arranged to contain a medicament (pg. 18, lines 18-21) and piston (Fig. 4A, 7)
a drive mechanism (Fig. 3, 40) arranged to move the piston from a first position where medicament is contained within the cartridge and a second position in which the medicament has been delivered from the cartridge to a user (pg. 21, lines 2-16); wherein the drive mechanism includes a flexible portion which co-operates with another part of the injection device such that the flexible portion is moved towards a central axis of the injection device during a portion of the movement of the drive mechanism from the first position to the second position and disengages from the inclined surface at or near the second position to contact a surface of the housing thereby audibly indicating that the medicament has been delivered from the cartridge (Fig. 5A, where the ribbon spring is flexible in the annotated figure below disengages from 77, Fig. 6A, shows the disengaged ribbon spring, see annotated figure below; pg. 30, lines 2-11).
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Regarding claim 2, Cowe discloses an injection device according to claim 1 wherein the drive member (Fig. 4A, 43) comprises a plunger (Fig. 4A, 42) configured to contact the piston (Fig. 4A, 7) at a distal end and a drive spring (Fig. 4A, 44b) configured to move the plunger to cause the piston to move from the first position to the second position (where the spring 44b drives the plunger 42 from a starting position to a finishing position).
Regarding claim 3, Cowe discloses an injection device according to claim 2 wherein the plunger includes the flexible portion (Fig. 4A, 60, where 60 is a latch that can engage or disengage based on movement triggered by 70, this engagement or disengagement is flexibility as the structure must move to disengage) and the flexible portion comprises a flexible finger (Fig. 4A, see annotated figure below) which is connected to the plunger at a first end and extends outwardly away from the central axis of the injection device (see annotated figure below).
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Regarding claim 4, Cowe discloses an injection device according to claim 3 wherein the plunger comprises a distal elongate portion (see annotated figure below) and a proximal head portion wherein the flexible finger (see annotated figure below) is connected to the plunger at a the distal end of the head portion (Fig. 4A, where 42 extends in a proximal direction and has a portion that is square and connected to at least a portion of the distal end through contact or other means, the flexible portion on the other side of the plunger is connected at least in part to the extension of 42, see annotated figure below ).
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Regarding claim 5, Cowe discloses an injection device according to claim 3 wherein the flexible finger includes a lateral projection (Fig. 4A, see annotated figure below where the projections of the finger are lateral).
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Regarding claim 6, Cowe discloses an injection device as claimed in claim 3 wherein the flexible portion extends rearwardly from the distal end of the plunger (where 60 extends at least partially past 42 below the elongate portion of 42 as shown in figure 4A).
Regarding claim 7, Cowe discloses an injection device as claimed in claim 1 wherein drive mechanism comprises a spring (Fig. 4A, 44a) and the flexible portion (Fig. 4A, 60) comprises an extension from the distal end of the spring (Fig. 4A, where 60 extends past the distal portion of the spring 44a).
Regarding claim 8, Cowe discloses an injection device as claimed in claim 7 wherein the flexible portion includes a lateral projection (Fig. 4A, 60, where the distal end of the flexible portion 60 is squared off and projects towards the central axis).
Regarding claim 9, Cowe discloses an injection device as claimed in claim 8 wherein the lateral projection is hook shaped (Fig. 4B, see annotated figure below).
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Regarding claim 10, Cowe discloses an injection device as claimed in claim 7 wherein the flexible portion extends rearwardly from the distal end of the spring (Fig. 4A, where the plunger 42 extends from a distal end of the spring 44a and the flexible portion is included with the plunger 42, see annotated figure below).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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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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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783