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 .
Claims 1-11 are examined in this office action.
Claims 12-20 have been withdrawn.
Claim Objections
Claims 1, 4, and 6 objected to because of the following informalities:
in claim 1 line 4, “the first prong is operable interact” should read “the first prong is operable to interact”
In claim 5 line 5, “a spring operable to the ratchet arm” should read “a spring operable to move the ratchet arm”
In claim 6 line 5 “a spring operable to the ratchet arm” should read “a spring operable to move the ratchet arm”
Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of claims 1-11 in the reply filed on 6/01/2026 is acknowledged. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/01/2026.
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, 2, 6, and 9-11 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Auld et al. (EP 2654859 B1).
Regarding claim 1, Auld discloses a drug delivery device mechanism (device 100, Fig. 2), comprising:
a ratchet wheel (ratchet gear 118, Fig. 7) including a plurality of teeth (plurality of teeth 119, Fig. 7);
a ratchet arm (frame 136, Fig. 6) including a first prong (pawl 140, Fig. 7) and a second prong (pawl 138, Fig. 7), wherein the first prong is operable interact with a tooth of the plurality of teeth ("The pawls 138 and 140 of the frame 136 may cooperatively engage teeth 119 formed on ratchet gear 118." - Para [0061])
to rotate the ratchet wheel in a circular direction ("… the pawl 140 causes the ratchet gear 118 to rotate in a clockwise direction …), and the second prong is operable to interact with another tooth of the plurality of teeth ("The pawls 138 and 140 of the frame 136 may cooperatively engage teeth 119 formed on ratchet gear 118." - Para [0016]) to further rotate the ratchet wheel in the circular direction ("… the pawl 138 engages the trailing surface 153 of tooth 19b so as the continue rotating the ratchet gear 118 in the clockwise direction." - Para [0031]).
Regarding claim 2, Auld discloses the drug delivery device (device 100, Fig. 2) as recited above, further comprising:
a biasing member (frame 136, Fig. 6) coupled to the ratchet arm (resilient members 139 and 141, Fig. 6), wherein:
the biasing member is operable to move the ratchet arm (resilient member 141, Fig. 7) and the first prong (pawl 140, Fig. 7) in a first substantially linear direction (arrow 146, Fig. 7), and
to subsequently move the ratchet arm (resilient member 139, Fig. 8) and the second prong (pawl 138, Fig. 7) in a second substantially linear direction, opposite the first substantially linear direction (arrow 144, Fig. 8), enabling the rotation of the ratchet wheel in the circular direction ("… the oscillating motion of the frame 136 causes rotation of the ratchet gear 118 in a single direction." - Para [0031]).
Regarding claim 6, Auld discloses the drug delivery device (device 100, Fig. 2) as recited above, further comprising:
a ratchet arm constraining structure (frame 136, Fig. 6) that is operable to maintain movement of the ratchet arm (resilient members 139, 140, Fig. 6) in a back and forth linear direction (arrows 144 and 146, Fig. 6) with respect to the ratchet wheel (ratchet gear 118, Fig. 6).
Regarding claim 9, Auld discloses the drug delivery device (device 100, Fig. 2) as recited above, wherein the ratchet arm (frame 136, Fig. 6) comprises:
a ratchet arm length (See annotated Fig. 6) that extends along a diameter of the ratchet wheel and protrudes from opposite sides of the ratchet wheel beyond the number of teeth (See annotated Fig. 6), with each respective end of the ratchet arm having a biasing mechanism engagement point (resilient members 139 and 141, See annotated Fig. 6) and a respective initial point for one of either the first prong or the second prong (See annotated Fig. 6).
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Regarding claim 10, Auld discloses the drug delivery device (device 100, Fig. 2) as recited above, further comprising:
a pump mechanism coupling (ring 120, Fig. 6) ("… the lead screw 112 may be coupled to the ratchet gear 118 … the lead screw may include a channel 124, and the ratchet gear 124 may include a protrusion 122 that is retained within the slot 124 … the protrusion 122 may be formed on a ring 120 coupled to the ratchet gear." - Para [0018]) operable to connect the ratchet wheel (ratchet wheel 118, Fig. 2) to a drive element (actuation mechanism 111, Fig. 2).
Regarding claim 11, Auld discloses the drug delivery device (device 100, Fig. 2) as recited above, wherein
the drive element (actuation mechanism 111, Fig. 2) includes a lead screw (lead screw 112, Fig. 6) coupled to a plunger ("The lead screw may be coupled to a plunger …" - Col. 2 Line 7), and the pump mechanism (ratchet gear 118, Fig. 6) is operable to rotate the lead screw ("… the ratchet gear causes rotation of the lead screw," - Col. 2 Line 9) and move the plunger ("… to displace the plunger 110 through the cavity 108." - Para [0016]) to expel a liquid drug ("… to expel the fluid within the cavity 108 …" - Para [0015]) from a reservoir (cavity 108, Fig. 2).
Claim Rejections - 35 USC § 103
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 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) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auld et al. (EP 2654859 B1) in view of Gray et al. (US Pub No. 20120209207 A1).
Regarding claim 3, Auld in view of Gray discloses the drug delivery device (Auld, device 100, Fig. 2) as recited above, wherein
the biasing member (Auld, frame 136, Fig. 6) is operable to move the ratchet arm (Auld, resilient members 139 and 141, Fig. 6) in the first linear direction (Auld, arrow 146, Fig. 7).
Auld does not expressly disclose that the biasing member comprises: a pulley mechanism; and a smart memory alloy wire.
Gray teaches that the biasing member comprises: a pulley mechanism (pulley 286, Fig. 16); and a smart memory alloy wire (shape memory wire 278, Fig. 16).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Auld to include that the biasing member comprises: a pulley mechanism; and a smart memory alloy wire as taught by Gray for adjustment of the pumping force (Gray, Para [0284]).
Regarding claim 4, Auld in view of Gray discloses the drug delivery device (Auld, device 100, Fig. 2) as recited above, wherein
the biasing member (Auld, frame 136, Fig. 6) is operable to move the ratchet arm (Auld, resilient member 141, Fig. 8) in the first linear direction (Auld, arrow 146, Fig. 7) and is operable to move the ratchet arm (Auld, resilient member 139, Fig. 8) in the second linear direction (Auld, arrow 144, Fig. 8).
Auld does not expressly disclose that the biasing member comprises: a first smart memory alloy wire and a second smart memory alloy wire.
Gray teaches that the biasing member comprises: a first smart memory alloy wire (shape memory wire 278, Fig. 16) and a second smart memory alloy wire (shape memory wire 278, "… two separate pieces of shape memory wire …" - Para [0284], Fig. 16).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Auld to include that the biasing member comprises: a first smart memory alloy wire and a second smart memory alloy wire as taught by Gray for adjustment of the pumping force (Gray, Para [0284]).
Regarding claim 5, Auld in view of Gray discloses the drug delivery device (Auld, device 100, Fig. 2) as recited above, wherein
the biasing member (Auld, frame 136, Fig. 6) is operable to move the ratchet arm (Auld, resilient member 141, Fig. 8) in the first linear direction (Auld, arrow 146, Fig. 7), and is operable to the ratchet arm (Auld, resilient member 139, Fig. 8) in the second linear direction (Auld, arrow 144, Fig. 8).
Auld does not expressly disclose that the biasing member comprises: a first smart memory alloy wire and a spring.
Gray teaches that the biasing member comprises: a first smart memory alloy wire (shape memory wire 278, Fig. 16) and a spring (spring 130, Fig. 7).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Auld to include that the biasing member comprises: a first smart memory alloy wire and a spring as taught by Gray for adjustment of the pumping force (Gray, Para [0284]).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auld et al. (EP 2654859 B1) in view of Gross et al. (US Patent No. 6595956 B1).
Regarding claim 7, Auld in view of Gross discloses the drug delivery device (Auld, device 100, Fig. 2) as recited above, wherein
Auld does not expressly disclose that the first prong is longer than the second prong.
Gross teaches that the first prong (longer half 31 of the pawl 18, Fig. 2) is longer than the second prong (shorter half 32, Fig. 2).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Auld to include that the first prong is longer than the second prong as taught by Gross for the delivery of a quantity of drug (Gross, Col. 11 Line 8).
Regarding claim 8, Auld in view of Gross discloses the drug delivery device (Auld, device 100, Fig. 2) as recited above, wherein
Auld does not expressly disclose that the first prong and the second prong provide an out-of-phase ratcheting effect.
Gross teaches that the first prong (longer half 31 of the pawl 18, Fig. 2) and the second prong (shorter half 32, Fig. 2) provide an out-of-phase ratcheting effect ("this results in the situation shown in Fig. 3, in which the shorter half 32 has been pushed back up the sloped surface 35 of tooth 34, and the longer half 31 has passed the peak 36 of tooth 33 to rest in the trough 37 of adjacent tooth 34 …" - Col. 11 Line 46).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the device of Auld to include that the first prong and the second prong provide an out-of-phase ratcheting effect as taught by Gross for the delivery of a quantity of drug (Gross, Col. 11 Line 8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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