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 17 December 2025. As directed by the amendment: claim 3 is cancelled. Claims 1-2 and 4-5 are presently pending in this application. The amendments to claims 2 and 4 overcome the previous 35 USC 112 rejection regarding antecedent basis.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2 and 4-5 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.
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, 4, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bilton et al. (US 2016/0206826).
Regarding claim 1, Bilton discloses a drug injection control device (Fig. 1) comprising:
a housing being hollow (Fig. 1, 4, where the housing is hollow as to contain parts),
a dose dial (Fig. 1, 14) rotatably coupled to a first side of the housing (where the dial 14 is on the side of the housing and rotates), a cartridge holder (Fig. 1, 2) fixedly coupled to an opposite side of the housing the cartridge holder configured to receive a cartridge (Fig. 1, 3) containing a drug and to couple to an injection needle to deliver the drug (¶[0076]);
an injection button (Fig. 1, 15) positioned in the dose dial;
a spring base non-rotatably coupled to the housing (Fig. 1, where spring 12 sits within the housing);
an injection amount setting module (Fig. 1, 1) configured to set an amount of the drug to be injected by storing a twisting moment in a torsion spring positioned in the housing (¶[0080]), the injection amount setting module (1) comprising a ratchet tube (Fig. 1, 6) configured to rotate simultaneously with rotation of the dose dial (¶[0073]), the torsion spring has two ends coupled to the spring base (Fig. 1, 5) and the ratchet tube (Fig. 1, 6), respectively, and during rotation of the dose dial, a side of the torsion spring fixed to the ratchet tube (6) rotates while an opposite side of the torsion spring fixed to the spring base is kept in a fixed state to twist the torsion spring (¶[0073], where the rotation of 6 rotates the spring relative to the plate 5 and winds up spring 12); and
a drug delivery module (Fig. 2, where the interior of the device is the delivery drive module that works together to deliver the drug) configured to deliver the drug from the cartridge by moving through release of the twisting moment applied to the torsion spring (¶[0088]-[0089]), wherein the spring base includes a ratchet (Fig. 1, 19) configured to engage with ratchet protrusions formed on a surface of an internal partition wall of the dose dial (¶[0067]), the ratchet protrusions being radially arranged, and feedback on the set injection amount of the drug is provided by an audible sound generated by sequential contact between the ratchet and the of ratchet protrusions during rotation of the dose dial (¶[0071] & [0082], where the second clutch 19 engages with 6 through teeth that are present on 6 and the protrusions match which then creates audible feedback by sequential contact during rotation).
Regarding claim 4, Bilton discloses the drug injection control device according to claim 1, wherein a button plate (Fig. 2, where there is a surface on 4 that the button rests on) is fixed to a plate fixing step formed along a circumferential direction on an inner surface of the dose dial on a first dial chamber formed through a partition wall in the dose dial (Fig. 2, where the button is fixed within two partitions on the sides of the housing).
Regarding claim 5, Bilton discloses the drug injection control device according to claim 1, wherein the injection amount setting module includes a button plate fixed and positioned in the dose dial to perform a function of supporting the button spring (Fig. 2, where there is a surface on 4 that the button rests on and allows from rotation and pressing actions), wherein the injection buttons slidably coupled through the button plate (where the button 15 is configured to be pressed down), wherein the drug delivery module includes:
a rod guide (Fig. 1, 9) switchably coupled to the injection amount setting module by the operation of the injection button (¶[0074]), and
a piston rod (Fig. 1, 8) screw coupled to an outer side of the rod guide to deliver the drug from the cartridge embedded in the cartridge holder by making a linear motion with a rotational motion of the rod guide (Fig. 1, ¶[0074]) , and
wherein the injection button rotates simultaneously with the rotation of the dose dial , but allows a stable pushing motion through the button plate (¶[0065]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bilton et al. (US 2016/0206826) in view of Jakobsen et al. (US 2023/0248917).
Regarding claim 2, Bilton discloses the drug injection control device according to claim 1,
the ratchet tube (Fig. 1, 6) coupled to an outer side of the reset tube to rotate at the same time;
a scale drum (Fig. 1, 7) which slidably rotates along an axial direction on an outer surface of the ratchet tube (¶[0068]); and
a rod guide (Fig. 1, 9) coupled to the reset tube, the rod guide connected to an inside of a piston rod (Fig. 1, 8) by screw rotation coupling to allow a sub-linear motion of the piston rod through the rotation of the rod guide (where drive member 8 uses rotation motion to drive the device upon delivery), thereby having a cartridge drug release structure through the screw coupling between the piston rod and the rod guide (Fig. 1, where the cartridge release structure is within the housing as the cartridge holder is on a distal end and the rod and guide are proximal to this).
Bilton does not specifically teach a reset tube.
Jakobsen teaches a reset tube (Fig. 1, 25). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Bilton to include a reset tube (Fig. 1, 25 from Jakobsen) as it is a known feature in the art and would not destroy the function of the device.
The ratchet tube 6 from Bilton can be outside of the reset tube that is now modified into the device from Jakobsen.
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 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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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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