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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/27/23;7/7/23;8/2/23;9/12/23;11/13/23;3/29/24;6/6/24;10/8/24;4/9/25;10/9/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Allowable Subject Matter
Claims 17, 32 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. Claims 18-20 and 33-34 are further objected to based on their dependencies.
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, 21-31, 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krulevitch et al. (US 2011/0313349) (“Krulevitch”). Krulevitch discloses:
(claims 16,31) a data collection device (unit 202) for attachment to an injection device (drug delivery device 224) comprising a dose button (216,251) arranged to cause, upon being pressed, expulsion of a medicament from the injection device [0048], the data collection device comprising: a first portion comprising a sleeve configured to attach the data collection device to the injection device by engaging a dosage knob of the injection device (knob 278 and follower 240); a second portion (capture ring 244) rotatably attached to the first portion, the second portion configured to engage with the dose button of the injection device, wherein the second portion is arranged to press on the dose button when pressure is applied to the second portion [0060-0061](also see response to arguments below); a sensor arrangement (sensor 214 and slider 215) configured to detect rotation of the first portion (knob 278 and follower 240) relative to the second portion (capture ring 244) [0058, 60-61,71- 72]; and a processor arrangement (processor on processor board 270) configured to determine a medicament amount expelled by an injection device (drug delivery device 124) based on the detected rotation [0058, 60-61 ,71-72, 75].
Claim 21: Krulevitch further discloses: the data collection device (unit 202) is configured to switch between a first configuration (configuration where knob 278 and capture ring 244 are engaged) in which rotation of the first portion relative to the second portion is prevented and a second configuration (configuration where knob 278 and capture ring 244 are disengaged) in which the first portion can be rotated relative to the second portion [0060-61].
Claims 22-23,35: a transfer arrangement (knob 278 and follower 240) arranged to engage the dosage knob of the injection device, the transfer arrangement is configured to rotate the first portion relative to the second portion when the dosage knob rotates (drug delivery device 124 at dosage selector 220) (Fig. 6B and 6D). The transfer arrangement comprises a friction wheel (Fig. 6D)
Claims 24-29: Engagement and gripping features of the first portion and the dosage knob of the injection device are disclosed in [0060-71]
Claim 30: the sensor arrangement comprises one or more of an optical sensor, a magnetic sensor, a capacitive sensor, or a mechanical sensor [0018,0054]
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that the capture ring 244 of Krulevitch engages with rotatable knob 278—rather than the actuation button 216; therefore applicant arguing that Krulevitch does not teach or suggest a “data collection device” having a second portion configured to engage with a dose button of an injection device”. Examiner disagrees.
First, this argument by applicant confuses the claim language of claim 16 as applicant appears to argue here that the dose button is on the injection device 1; however, the claim language reads, (first clause claim 16) “a data collection device…comprising a dose button”, and (third clause claim 16) “second portion configured to engage with the dose button of the injection device”). Injection device in Krulevitch is 216 and 251. The capture ring 244 (second portion of data collection device) is coupled to dosage selector 220 [0060]. Capture ring 244 is in engagement with rotatable knob 278. Actuation button 251 is also coupled to knob 278 of the data collection device so that button 251 is in contact with pen button 216 once the components are assembled together [0071]. Thus, the second portion 244 through all interconnections engages with the dose button of both 216 and 251 to press on the dose button when pressure is applied to the second portion. See also [0085]
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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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