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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to National Stage App. No. PCT/US2021/042625 filed July 21, 2021 and to U.S. Provisional App. No. 63/055,510 filed July 23, 2020.
Status of Claims
This Office Action is responsive to the amendment filed on January 26, 2026. As directed by the amendment: claims 1 been amended; claims 16-21 have been cancelled; and claims 35-39 have been added. Thus, claims 1-15 and 22-39 are presently pending in this application.
Claim(s) 1-5, 9-16, 20-28, and 34 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gupta et al. (WO 2020/058823 A1). Claim(s) 6-8 were previously rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (WO 2020/058823 A1) in view of Christie et al. (WO 2016/092252 A1). Claim(s) 29-31 were previously rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (WO 2020/058823 A1) in view of Augustyn (WO 2005/079727 A2). Claim(s) 32-33 were previously rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (WO 2020/058823 A1) in view of Howgill (U.S. Pub. No. 2017/0173280). Claims 17-19 were previously 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.
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
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.
Claim(s) 1-5, 9-15, 22-28, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gupta et al. (WO 2020/058823 A1; hereinafter: “Gupta”).
Regarding Claim 1, Gupta discloses a dose counter assembly (Fig. 1-30B) for use with a medicament dispenser, the dose counter assembly comprising: a) a units dose display means (6, 17, 18, 19; Fig. 2, 3, 5A, 8A-8D; 22-27) comprising a first count indicia (19; Fig. 2, 3, 5A, 8A-8D, 22, 25A, 25B) and one or more driver teeth (103; Fig. 25B); b) a tens dose display means comprising a second count indicia (17; Fig. 2, 3, 5A, 8A-8D; 22, 26A, 26B); and c) a driver (2, 6, 18; Fig. 2, 3, 5A, 8A-8D; 22-24), wherein the first count indicia and second count indicia align at a common viewing area (48; Fig. 10, 15, 16) to collectively display a count sequence (¶¶ 0178, 0184-0188); wherein the units dose display means and the tens dose display means are non-coaxial [113, 117; Fig. 16; Examiner notes: The units dose display means has an axis along 117 (Fig. 16) and the tens dose display means has an axis along 113 (Fig. 16). Axis 113 and 117 are not coaxial.], wherein a central axis (an axis along 117; Fig. 16) of the units dose display means and a central axis (an axis along 113; Fig. 16) of the tens dose display means are arranged side by side (A, Fig. A annotated below; Examiner notes: ) when a mouth cover (3; Fig. 8C) of the medicament dispenser is oriented to be upward [Fig. 8C; Examiner notes: The limitation “side by side” does not require directionality and term “upward” is a relative term, that the claim has not specifically defined. Thus, for this Office Action boardiest reasonable interpretation has been applied. Gupta discloses when the mouth cover is oriented upward (B, Fig. A annotated below) the central axis of the units dose display means and the central axis of the tens dose display means are arranged side by side.].
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Figure A, Adapted from Figure 8C of Gupta.
Regarding Claim 2, Gupta discloses the dose counter assembly wherein at least the units dose display means or the tens dose display means is in the form of a wheel (Fig. 2, 3, 5A, 8A-8D; 22-27; ¶¶ 0178, 0185-0188).
Regarding Claim 3, Gupta discloses the dose counter assembly wherein at least the units dose display wheel or the tens dose display wheel is in the form of a disc or a ring (Fig. 2, 3, 5A, 8A-8D; 22-27; ¶¶ 0178, 0185-0188).
Regarding Claim 4, Gupta discloses the dose counter assembly wherein the units dose display wheel is in the form of a disc (Fig. 2, 3, 5A, 8A-8D; 22-27; ¶¶ 0178, 0185-0188).
Regarding Claim 5, Gupta discloses the dose counter assembly wherein the tens dose display wheel is in the form of a disc (Fig. 2, 3, 5A, 8A-8D; 22-27; ¶¶ 0178, 0185-0188).
Regarding Claim 9, Gupta discloses the dose counter assembly wherein at least the units dose display means or tens dose display means is arranged to move rotationally (¶¶ 0178, 0185-0188).
Regarding Claim 10, Gupta discloses the dose counter assembly wherein the units dose display means is arranged to rotate about a first axis of rotation [Fig. 16; 117; ¶¶ 0178, 0185-0188; Examiner notes: The units dose display means rotates about the axis along 117 (Fig. 16) and the tens dose display means has an axis along 113 (Fig. 16).].
Regarding Claim 11, Gupta discloses the dose counter assembly wherein the tens dose display wheel is arranged to rotate about a second axis of rotation [Fig. 16; 113; ¶¶ 0178, 0185-0188; Examiner notes: The tens dose display means rotates about the axis along 113 (Fig. 16).]
Regarding Claim 12, Gupta discloses the dose counter assembly wherein dose counter assembly further comprises a mount plate (25; Fig. 20; ¶ 0181).
Regarding Claim 13, Gupta discloses the dose counter assembly wherein the mount plate comprises a locking arm (59, 105; Fig. 21A, 26A; ¶¶ 0178, 0182, 0187, 0188).
Regarding Claim 14, Gupta discloses the dose counter assembly wherein the tens dose display means further comprises a locking key (106; Fig. 16, 27).
Regarding Claim 15, Gupta discloses the dose counter assembly wherein the locking key of the tens dose display means engages with the locking arm of the mount plate to lock the dose counter assembly at the end of the count sequence (Fig. 27; ¶¶ 0178, 0187, 0188, 0199).
Regarding Claim 22, Gupta discloses the dose counter assembly wherein the driver is arranged to rotate about a third axis of rotation (axis of 2; Fig. 2, 5A; ¶¶ 0178-0184).
Regarding Claim 23, Gupta discloses the dose counter assembly wherein the driver is in meshed relationship with the units dose display means (Fig. 2; ¶¶ 0178-0184).
Regarding Claim 24, Gupta discloses the dose counter assembly wherein the driver is adapted to couple with a dispensing mechanism (7, 8; Fig. 2) of the medicament dispenser (¶¶ 0182-0183).
Regarding Claim 25, Gupta discloses the dose counter assembly wherein the tens dose display means comprises a set of teeth (104; Fig. 26B; ¶ 0187).
Regarding Claim 26, Gupta discloses the dose counter assembly wherein one or more driver teeth of the unit dose display means is arranged for intermittent meshing with the teeth of the tens dose display means (Fig. 8A-8D; ¶¶ 0184-0188).
Regarding Claim 27, Gupta discloses the dose counter assembly wherein the tens dose display means further comprises an end location wherein the teeth are absent (104; Fig. 26B; ¶ 0187; Examiner notes: Gupta discloses the teeth may extend at least partially around the tens dose display means. Thus, the tens dose display means has an end location where teeth are absent.)
Regarding Claim 28, Gupta discloses the dose counter assembly wherein the teeth of the tens dose display means disengage with one or more driver teeth at the end location (¶¶ 0187, 0188; Examiner notes: Gupta discloses the teeth may extend at least partially around the tens dose display means. Thus, the tens dose display means has an end location where teeth are absent and disengage with one or more driver teeth.).
Regarding Claim 34, Gupta discloses a medicament dispenser (1; Fig. 1A-1C) incorporating the dose counter assembly according to claim 1 (See above.).
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) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta in view of Christie et al. (WO 2016/092252 A1; hereinafter: “Christie”).
Regarding Claims 6-8, Gupta discloses the dose counter assembly of claim 1, shown above.
Gupta does not specifically disclose the dose counter assembly wherein the tens dose display means is polygonal with central axis of rotation..
Christie teaches a dose counter assembly comprising a tens dose display means (230; Fig. 2A, 2C) is polygonal with central axis of rotation (at 234; Fig. 2A, 2C; Pg. 16-18) for the purpose of indexing in unequal spacing such that they are distributed at different angular positions leaving an end location (Pg. 16-18).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify XX of Smith to include the tens dose display means being polygonal with central axis of rotation as taught by Christie for the purpose of indexing in unequal spacing such that they are distributed at different angular positions leaving an end location (Pg. 16-18.
Claim(s) 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta in view of Augustyn (WO 2005/079727 A2).
Regarding Claims 29-31, Gupta discloses the dose counter assembly of claim 1, shown above.
Gupta does not specifically disclose the dose counter assembly wherein the tens dose display means further comprises a shutter; wherein the shutter appears at the common viewing area at the end of the count sequence; and wherein the units dose display means continues to rotate without rotating the tens dose display means at the end of the count sequence.
Augustyn teaches a dose counter assembly a tens dose display means (30; Fig. 4-6) further comprises a shutter (80; Fig. 4, 5); wherein the shutter appears at a common viewing area (73; Fig. 4-6) at the end of the count sequence (Pg. 36, ln 30 to Pg. 37, ln 8; Pg. 38, ln 5 to Pg. 39, ln 13); and wherein the units dose display means continues to rotate without rotating the tens dose display means at the end of the count sequence (Pg. 36, ln 30 to Pg. 37, ln 8; Pg. 38, ln 5 to Pg. 39, ln 13) for the purpose of indicating end of use of a medical dispenser (Pg. 38, ln 5 to Pg. 39, ln 13)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dose counter of Gupta to include the tens dose display means further comprises a shutter; wherein the shutter appears at the common viewing area at the end of the count sequence; and wherein the units dose display means continues to rotate without rotating the tens dose display means at the end of the count sequence as taught by Augustyn for the purpose of indicating end of use of a medical dispenser (See Augustyn: Pg. 38, ln 5 to Pg. 39, ln 13).
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gupta in view of Howgill (U.S. Pub. No. 2017/0173280).
Regarding Claims 32-33, Gupta discloses the dose counter assembly of claim 12, shown above.
Gupta does not specifically disclose the dose counter assembly wherein the mount plate further comprises a pawl; and wherein the pawl prevents reverse movement of the tens dose display means.
Howgill teaches a dose counter comprising a mount plate (“chassis”; ¶¶0060-0063) having a pawl (80; Fig. 1); wherein the pawl prevents reverse movement of a dose display means (33; Fig. 1; ¶ 0063) for the purpose of preventing backwards movement of the dose display means and helps urge it into a count-indicating position in which the display indicia are aligned with the common viewing area (¶ 0063).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the dose counter assembly of Gupta to include the mount plate further comprises the pawl; and wherein the pawl prevents reverse movement of the tens dose display means as taught by Howgill for the purpose of preventing backwards movement of the dose display means and helps urge it into a count-indicating position in which the display indicia are aligned with the common viewing area (See Howgill: ¶ 0063).
Allowable Subject Matter
Claims 35-39 are allowed.
The following is an examiner’s statement of reasons for allowance: Prior art of record Gupta, Christie, Augustyn, and Howgill alone or in combination fail to disclose or render obvious the dose counter assembly wherein the units dose display means and the tens dose display means are non-coaxial; and wherein, the tens dose display means is in the form of a slider arranged to move linearly, as recited in independent claim 35.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to “wherein a central axis of the units dose display means and a central axis of the tens dose display means are arranged side by side when a mouth cover of the medicament dispenser is oriented to be upward.” Recited in independent claim 1 have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the 35 U.S.C. 102 rejection over Gupta, shown above.
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 ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785