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 .
Acknowledgment
Claim(s) 1-4, 10-11 are amended and filed on 6/2/2026.
Claims 5-9, 14-15 are canceled.
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 1-4, 10-13 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 1 recites the limitation "a rotational lock" in last 3 lines of claim 1. It is unclear if it is referring to a gear 23 see ¶0083 of the current speciation or a retention member 13 as indicated in ¶0086 of the current speciation or it is reefing to cam 22 as in ¶00916 of the current speciation. For the purpose of examination, the applicant will interpret the limitation any element that engages the motor and the plunger and capable to lock the rotational movement of the plunger
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) 1-5, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lavi (US. 20160114109A1).
Re claim 1, Lavi discloses a drug delivery arrangement (Fig. 1-5), comprising: a drug delivery device (10, ¶0019, ¶0062, ¶0090) for dispensing a liquid drug from a reservoir (16, ¶0063), the delivery device comprising a device housing (13, 15), a rotatable drive member (19, of a dispensing mechanism (20, 19) adapted to be rotated in a dispensing direction to dispense the liquid drug at a distal end of the drug delivery device (upward motion of 20), and an injection button (control button on 54, ¶0071, ¶0098) joined to a proximal end of the device housing; (Fig. 4a) and an electronic module (50) releasably attachable to the device housing (Fig. 4c, Fig. 4a, ¶0090) and comprising a module housing ( housing of 50), an actuator ( motor 32, ¶0065), and a toothed wheel rotatable by the actuator (28, ¶0065), relative to the module housing (Fig, 4a), wherein the drive member comprises teeth (teeth on the plunger that engages with 37) configured to engage the toothed wheel (Fig, 4a, Fig. 5), wherein the toothed wheel can be brought into engagement with the teeth of the drive member (Fig. 1 the engagement by the wheel 26) such that a rotational movement of one of the toothed wheel and the drive member causes a rotational movement of the other of the toothed wheel and the drive member (¶0064), and wherein when the electronic module is attached to the drug delivery device (Fig, 4a), actuation of the injection button releases a rotational lock (39, see the 112 rejection above) of the dispensing mechanism such that a rotation of the toothed wheel by the actuator causes the dispensing mechanism to dispense the liquid drug (¶0098).
Re claim 2, Lavi discloses wherein the device housing comprises an opening ( opening for 28) and wherein the toothed wheel extends through the opening to the drive member (Fig. 4a) when the electronic module is attached to the delivery device (Fig. 4a).
Re claim 3, Lavi discloses wherein the toothed wheel is rotatable in a plane ( plane of 28) perpendicular to a longitudinal axis (19) of the electronic module or the drug delivery device (Fig. 4b).
Re claim 4, Lavi discloses that the rotational movement of the toothed wheel is relative to the module housing (Fig, 4b).
Re claim 10, Lavi discloses wherein the actuator is an electric motor adapted to drive the toothed wheel (¶0065).
Re claim 11, Lavi discloses wherein the electronic module comprises a sensing arrangement adapted to detect a movement of the toothed wheel (¶0069-¶0070).
Re claim 12, Lavi discloses wherein the electronic module comprises a radial coupling structure ( left portion of the housing 52) to attach the electronic module to a side of the device housing such that the electronic module is radially offset to a longitudinal axis of the delivery device (Fig, 4a).
Re claim 13, Lavi discloses wherein the delivery device is a pen- shaped injection device (Fig. 4a, ¶0098).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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