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 22 June 2026. As directed by the amendment: claims 5 and 8 are cancelled. The amendments to the claims have overcome the previous 35 USC 112(b) rejections as well as the objections to the drawings and claims in the office action mailed 23 February 2026.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 22 June 2026, with respect to the rejection(s) of claim(s) claims 1-10 rejected under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ogawa (US 10,625,025) and Bergens et al. (US 2001/0005781).
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 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ogawa (US 10,625,025).
Regarding claim 1, Ogawa discloses an injection device comprising:
a housing (Fig. 1, 30) comprising an inner wall having an inclined surface (Fig. 2A, 36) extending along the path of travel (Col. 6, lines 35-49, where the inner wall of 30 has upraised portions 36 on either side)
a cartridge (Fig. 1, 40) arranged to contain a medicament (Fig. 1, 100) and piston (Fig. 1, 43)
a drive mechanism (Fig. 1, 51) arranged to move the piston (43) from a first position (Fig. 2A, where the part 43 is in a first position) where medicament is contained within the cartridge (Fig. 2A, where the liquid 100 is still in the cartridge) and a second position in which the medicament has been delivered from the cartridge to a user (Fig. 2C, where the part 43 is in a second, forward position and the liquid 100 has been discharged);
wherein the inclined surface (36) is configured such that the distance between the inclined surface and a central axis of the device decreases from a proximal end of the inclined surface to a distal end of the inclined surface (Fig. 2A, where the inclined surface of 36 inclines towards a central axis and towards the distal end, see annotated figure below); and
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wherein the drive mechanism (51) includes an extension (60) which co-operates with the inclined surface (36) such that the extension is moved towards the central axis of the injection device during a portion of the movement of the drive mechanism from the first position to the second position and disengages from the inclined surface at or near the second position to contact a surface of the housing thereby audibly indicating that the medicament has been delivered from the cartridge to a use (Col. 9, lines 20-44, where the clicker 60 travels over the part of 36, 36c, until it goes over 36b as shown in figure 2c, and produces a clicking sound to indicate the dose has been delivered), and
wherein the extension (60) comprises a free end (Fig. 2b, 60b) and wherein the free end comprises a lateral projection extending away from the central axis of the extension (Fig. 2B, 63a, where 63a projects outward from the central axis of 60).
Regarding claim 9, Ogawa discloses an injection device as claimed in claim 1 wherein the lateral projection is hook shaped (Fig. 2B, where 63a along with 61 and 62 forms a hook shape for the projection).
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) 2-4 and 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ogawa (US 10,625,025) in view of Bergens et al. (US 2001/0005781).
Regarding claim 2, Ogawa discloses an injection device according to claim 1 wherein the drive mechanism (51) comprises a plunger (Fig. 1, 50) configured to contact the piston (43) at a distal end (Fig. 2A-B, where 50 contacts 43 at a distal end of the plunger).
Ogawa does not specifically teach a drive spring configured to move the plunger to cause the piston to move from the first position to the second position. Bergens teaches an autoinjector with replaceable containers, configured to deliver a substance. Bergens teaches a drive spring (Fig. 1A, 141) configured to move the plunger to cause the piston to move from the first position to the second position (¶[0031]-[0033]). It is a common feature to many auto-injectors to include a drive spring to drive the device. The drive spring 141 of Bergens would improve the device of Ogawa by allowing for less energy to be expended by an operator as the spring releasing potential energy would more easily move the injection device from first to second position (¶[0031] from Bergens). Additionally, the spring has a set amount of length and energy to be released which would standardize the dosing and usage of the device (¶[0031] from Bergens).
Regarding claim 3, the combination of Ogawa and Bergens teaches an injection device according to claim 2, Ogawa further teaches wherein the plunger (Fig. 1, 50) includes the extension (60).
Regarding claim 4, the combination of Ogawa and Bergens teaches an injection device according to claim 3, Ogawa further teaches wherein the plunger comprises a distal elongate portion and a proximal head portion (see annotated figure below) wherein the extension is connected to the plunger at the distal end of the head portion (see annotated figure below).
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Regarding claim 6, the combination of Ogawa and Bergens teaches an injection device as claimed in claim 3, Ogawa further teaches wherein the extension extends rearwardly from the distal end of the plunger (Fig. 2, where the extension 60 extends from a distal end towards a proximal end, see annotated figure below).
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Allowable Subject Matter
Claims 7 and 10 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
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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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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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
