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 .
Response to Amendment
This office action is responsive to the amendment filed on 9/30/25. As directed by the amendment: claims 1, 3, and 4 have been amended, claim 2 has been cancelled, and new claim 6 has been added. Thus, claims 1 and 3-6 are presently pending in this application.
The amendments are sufficient to overcome the rejections under 35 U.S.C. 112 from the prior action.
Drawings
The drawings were received on 9/30/25. These drawings are accepted.
Election/Restrictions
Newly submitted claim 6 is directed to an invention that is independent or distinct from the invention originally claimed in claims 1 and 3-5 for the following reasons:
The inventions of Group I (claims 1 and 3-5) and Group II (claim 6) do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Group I and II lack unity of invention because even though the inventions of these groups require the technical feature of dosage setting part comprising (generically only) a setting operation part and a setting restriction part comprising (generically only) a restriction operation part, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Haber et al. (US 5300041). See the rejection under 102 below for details. The specific characteristics of the setting operation part and the restriction operation part are not shared technical features between the two Groups.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 6 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 and 3-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haber et al. (US 5300041).
Regarding claim 1, Haber et al. discloses a dosage adjuster for a syringe (fig. 2) comprising: a dosage setting part configured to set an amount of dosage dischargeable out of a liquid medicine filled in the syringe (combination of 40 and 52; col. 5, ln. 10-37); and a setting restriction part 72 configured to switch between a restricted state in which change in setting of the amount of dosage set by the dosage setting part is restricted (72 pulled off of 40 and 52, with 76 being removed from 78 and 82; col. 5, ln. 39-58) and a permissible state in which the change in the setting of the amount of dosage by the dosage setting part is permissible (72 placed over/around 40 and 52 with 76 situated within 78 and 82; col. 5, ln. 39-58); wherein the dosage setting part comprises a setting operation part 52 configured to rotate in a circumferential direction around a central axis of a plunger of the syringe to thereby initiate the change in the setting of the amount of dosage (col. 5, ln. 10-37), the setting restriction part comprises a restriction operation part 76 configured to move in a moving direction in which the plunger moves forward and rearward to thereby switch between the restricted state and the permissible state (col. 5, ln. 59-85), and the restriction operation part is configured to restrict rotation of the setting restriction part by the movement toward one side in the moving direction (restricts normal rotation of 52 by not operably connected to 52; see in particular col. 5, ln. 53-56), and permit the rotation of the setting restriction part by the movement toward another side in the moving direction (permits rotation by being operably connected to 52).
Regarding claim 3, Haber et al. discloses the moving direction toward the one side of the restriction operation part coincides with the rearward direction in which the plunger is moved rearward (72 pulled rearward in this state; col. 5, ln. 39-58), and the moving direction toward the other side of the restriction operation part coincides with the forward direction in which the plunger is moved forward (72 moved forward in this state; col. 5, ln. 39-58), and the restriction operation part comprises a stopper flange that extends radially outward and orthogonal to the central axis of the plunger (rearmost face of 72 visible in fig. 2).
Regarding claim 4, Haber et al. discloses an operation cylinder that has a cylindrical shape and is configured to, in a state where the syringe is inserted through the operation cylinder, be rotatable in the circumferential direction around the plunger and slidable in the moving direction in which the plunger is moved forward and rearward, wherein the operation cylinder comprises the dosage setting part and the setting restriction part (elements 52, 40, and 72 in combination form an operation cylinder movable as claimed and comprise the dosage setting part 40 & 52 and the setting restriction part 72).
Regarding claim 5, Haber et al. discloses the dosage setting part comprises a movable receiving part 52 that is arranged on an opposite side of a front surface of a flange of the plunger of the syringe (relative to 48, 50) and is movable forward in the moving direction of the plunger from a position in contact with the front surface of the flange (col. 5, ln. 10-37), and the movable receiving part is configured to set the amount of dosage on the basis of a distance away from the flange in the forward direction (col. 5, ln. 10-37).
Response to Arguments
Applicant's arguments filed 9/30/25 have been fully considered but they are not persuasive.
Applicant argues, on pages 6 and 7 of the Remarks, regarding claim 1, that element 72 of Haber et al. does not restrict the motion/rotation of element 52. Examiner respectfully disagrees. Element 72, when not operably connected to 52, restricts motion/rotation of 52 by being relatively arranged such that element 52 cannot be moved in normal operation. See, in particular, col. 5, ln. 59-85.
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783