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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 34 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 34 is rejected for indefiniteness because it lacks antecedent basis for “the clutch teeth of the dose setting drum,” as claim 34 depends on claim 33. Claim 32 defines “a dose setting drum having clutch teeth” and that “at least one set of optical IR emitters/detectors located coincident with at least a portion of the clutch teeth of the dose setting drum.” For compact prosecution purposes, the clutch teeth will be interpreted as having the same structural relationships defined in claim 32. However, preceding claim 33 will still be interpreted as depending on claim 30.
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 16, 17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Windum et al (US 2018/0161503).
Regarding claim 16, Windum discloses:
A drug delivery device (Fig. 1) for setting and dispensing doses of a liquid drug (Abstract), the device comprising: a dose setting and drive mechanism (Fig. 5) comprising a dose setting member (430), the dose setting member (430) comprising a distal end (end of dose setting member 430 visible in Fig. 7) and a set of axially directed stop teeth (431) formed at the distal end; a housing (425) at least partially encasing the dose setting and drive mechanism (Fig. 5), the housing (425) comprising a set of counterstop teeth (421); wherein the dose setting and drive mechanism (Fig. 5) is configured to perform a dose setting operation for setting a dose to be delivered (¶0068-0070) by moving the dose setting member (430) relative to the housing (425), and to perform a dose delivery operation for delivering the set dose (¶0070) by pushing the dose setting member (430) axially towards the housing (425) without relative rotation therebetween; wherein the set of axially directed stop teeth (431) are configured to engage with the set of counterstop teeth (421) at an end of the dose delivery operation (Fig. 8A to Fig. 8C).
Regarding claim 17, Windum discloses:
The drug delivery device of claim 16, wherein the axially directed stop teeth (431) are formed on an outer rim of the dose setting member (430).
Regarding claim 19, Windum discloses:
The drug delivery device of claim 16, wherein the dose setting member (430) comprises two separate components (430, 490) permanently fixed to each other to function as a single component (¶0063).
Regarding claim 20, Windum discloses:
The drug delivery device according to claim 19, wherein the dose setting member (430) comprises at least one of (i), (ii), (iii) or (iv); (i) a tubular sleeve comprising the axially directed stop teeth and a ring of clutch teeth extending radially inwards; (ii) a ring of ramp teeth extending radially inwards; (iii) a profiling (the equivalent structure 125 in Fig. 1 shows the outer surface of the dose setting member has profiling to allow gripping) as a gripping surface; or (iv) a button having a proximal end face and a stem extending distally from the end face, wherein the stem comprises at least one axially extending spline.
Claims 16, 19-21, 23, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marsh et al (US 2017/0128673).
Regarding claim 16, Marsh discloses:
A drug delivery device (Fig. 1) for setting and dispensing doses of a liquid drug (Abstract), the device comprising: a dose setting and drive mechanism comprising a dose setting member (70, 80), the dose setting member comprising a distal end (Fig. 6) and a set of axially directed stop teeth (41; Fig. 18) formed at the distal end (¶0109); a housing (10) at least partially encasing the dose setting and drive mechanism (Fig. 3), the housing (10) comprising a set of counterstop teeth (14); wherein the dose setting and drive mechanism is configured to perform a dose setting operation for setting a dose to be delivered (¶0121) by moving the dose setting member (80) relative to the housing (10), and to perform a dose delivery operation for delivering the set dose (¶0147) by pushing the dose setting member (70) axially towards the housing (10) without relative rotation therebetween (¶0146); wherein the set of axially directed stop teeth (41) are configured to engage with the set of counterstop teeth (14) at an end of the dose delivery operation (¶0152).
Regarding claim 19, Marsh discloses:
The drug delivery device of claim 16, wherein the dose setting member (70, 80) comprises two separate components permanently fixed to each other to function as a single component (¶0120).
Regarding claim 20, Marsh discloses:
The drug delivery device according to claim 19, wherein the dose setting member (70, 80) comprises at least one of (i), (ii), (iii) or (iv); (i) a tubular sleeve (40) comprising the axially directed stop teeth (41) and a ring of clutch teeth (14) extending radially inwards (Fig. 18); (ii) a ring of ramp teeth extending radially inwards; (iii) a profiling as a gripping surface (¶0121); or (iv) a button having a proximal end face and a stem extending distally from the end face, wherein the stem comprises at least one axially extending spline.
Regarding claim 21, Marsh discloses:
The drug delivery device of claim 16, wherein the dose setting and drive mechanism comprises a dial clicker (Fig. 9) that defines discrete positions for the dose setting member (70, 80) with respect to the housing (10) when setting a dose (¶0127), wherein the dial clicker (Fig. 9) is formed by a flexible clicker arm (123) and a ring of axially extending splines (75).
Regarding claim 23, Marsh discloses:
The drug delivery device of claim 16, wherein the dose setting and drive mechanism comprises a dose setting drum (60); wherein the dose setting and drive mechanism is configured to perform the dose setting operation by rotating the dose setting member (70, 80) relative to the housing (10), and to perform the dose delivery operation during rotation of the dose setting drum (60) relative to at least one of the dose setting member or the housing (10); wherein a clutch (60b, 73) acts between the dose setting member (70, 80) and the dose setting drum (60) (¶0118); and wherein the clutch (60b, 73) is engaged during the dose setting operation so that the dose setting member (70, 80) and dose setting drum (60) rotate together (¶0115), and is disengaged during the dose delivery operation to allow relative rotational movement between the dose setting drum (60) and the dose setting member (70, 80) (¶0120).
Regarding claim 29, Marsh discloses:
The drug delivery device of claim 16, wherein the dose setting member (70, 80) is provided with attachment features (ridges on element 80 are fully capable of attaching to a separate module).
Claims 30, 31, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jorgensen et al (US 2011/0270214).
Regarding claim 30, Jorgensen discloses:
A dose recording system (Fig. 14) comprising: a drug delivery device (100; Fig. 1) comprising a dose setting and drive mechanism (200) comprising a dose setting member (260); and an electronic module (271) for attachment to the dose setting member (260) of the drug delivery device (100) (Fig. 10), the electronic module (271) comprising: at least one sensor (290; Fig. 15); a processor (MCU; Fig. 11) configured to control operation of the at least one sensor (290) and to at least one of process or store signals from the at least one sensor (290) (¶0118); and attachment features (283) for attaching the electronic module (283a; Fig. 9) to the dose setting member (260) (¶0120).
Regarding claim 31, Jorgensen discloses:
The dose recording system of claim 30, wherein the electronic module (271) comprises a cap (276) for receiving a proximal end of the dose setting member (260).
Regarding claim 33, Jorgensen discloses:
The dose recording system of claim 30, wherein the electronic module (271) comprises a chassis (270) holding the at least one sensor (290) and the processor (MCU) (¶0117).
Allowable Subject Matter
Claims 18, 22, 24-28, 32, and 35 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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm 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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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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