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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/18/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the preliminary amendment filed on 11/18/23. As directed by the amendment: Claims 24-181 have been cancelled.
Thus, claims 1-23 are pending in this application.
Specification
The disclosure is objected to because of the following informalities:
Para 0165, line 4, “deadspace” should read “dead space”.
Para 0174, line 7, “deadspace” should read “dead space”.
Para 0175, line 5 and 11, “follower pin 518” should read “follower pin 512”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the spiral cam assembly" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 2, the phrase "in a spiral cam recess" in line 4 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “in the spiral cam recess” that is recited previously. For the purpose of compact prosecution, this limitation is interpreted the same as “the spiral cam recess” recited previously in claim 2.
By virtue of dependency, claims 3-5 are also rejected.
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.
Claims 1, 2, 4-10, 13-18 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becker (US 4231368 A).
Regarding claim 1, Becker discloses an injection control device (see fig 1 and abstract), comprising: a base member (base 42), the base member comprising an elongate body (guideway 35) and a rack (rock rod 34); a chassis (casing 2) movably coupled to the base member (col 4, lines 26-29), the chassis comprising: a rear chassis movably engaged to the base member (see annotated figure below) and configured to engage a plunger (cap 30 is configured to engage with piston 7, see figs 4-6); a front chassis movably engaged to the rear chassis (see annotated figure below and figs 4-6) and configured to engage a syringe (syringe 4); and a spiral cam gear assembly (gear 38) interfaced with the rack (rack 34) of the base member and coupled to the chassis (col 4, lines 13-23).
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Regarding claim 2, Becker discloses the device of claim 1, wherein the spiral cam assembly comprises: a spiral cam gear (gear 38) coupled to the rear chassis (see annotated above), the spiral cam gear comprising a plurality of circumferential teeth (teeth of gear 38, see fig 1), a spiral cam recess (recess between teeth of gear 38), and a rotation axle (shaft 39); and a follower pin (tooth of rod 23) coupled to the front chassis (see annotated figure above) and located in a spiral cam recess of the spiral cam gear (see fig 1, one of the teeth of rod 23 is located in a recess of cam gear 38).
Regarding claim 4, Becker discloses the device of claim 2, wherein the rear chassis comprises at least one slot (groove 32) and the front chassis comprises at least one strut (rod 23) slidably located in the at least one slot (col 4, lines 6-12).
Regarding claim 5, Becker discloses the device of claim 4, wherein the follower pin (teeth of rod 23) is attached to the at least one strut (see fig 1).
Regarding claim 6, Becker discloses the device of claim 1, wherein the front chassis comprises a syringe cavity (shell 11) configured to engage a syringe (syringe 4, see fig 1).
Regarding claim 7, Becker discloses the device of claim 6, wherein the syringe cavity comprises a first opening (holder 9) from which a syringe body of a syringe is configured to extend distally (see fig 4); a second opening (proximal opening of shell 11) from which a plunger is configured to extend proximally (see figs 4-6), and a third opening (thread 10) configured to removably engage a syringe body flange of a syringe (see fig 1).
Regarding claim 8, Becker discloses the device of claim 7, wherein the first opening is a front opening, the second opening is a rear opening, and the third opening is a top opening (see figs 4-6).
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Regarding claim 9, Becker discloses the device of claim 1, wherein the rear chassis further comprises a plunger adjustment assembly (adjusting device 27, see fig 1).
Regarding claim 10, Becker discloses the device of claim 9, wherein the plunger adjustment assembly comprises: a chassis handle (bracket 26) movable relative to the rear chassis (col 4, lines 2-13, see figs 4-6); and a plunger engagement structure (spindle 28) comprising a plunger cavity (cap 30) and configured to be movable relative to the rear chassis and the chassis handle (see figs 4-6, col 5, lines 4-12).
Regarding claim 13, Becker discloses the device of claim 10, wherein the plunger engagement structure (spindle 28) further comprises a plunger engagement head (front end of spindle 28) in which the plunger cavity resides (see fig 1, cap 30 resides in the front end of spindle 28), and a plunger engagement body (body of spindle 28) with a helical interface (spindle 28 is threaded, a threaded spindle is helical, meaning it has a spiral shape).
Regarding claim 14, Becker discloses the device of claim 13, wherein the chassis handle (bracket 26) comprises a helical interface (clamping nut 31- a clamping nut has a thread to mate with another threaded part) complementary to the helical interface of the plunger engagement body (see fig 2).
Regarding claim 15, Becker discloses the device of claim 14, wherein the plunger engagement body (spindle 28) comprises a helical thread or groove (spindle 28 is threaded) on an outer surface of the plunger engagement body (see fig 1), and the chassis handle further comprises a lumen containing the helical interface (nut 31) of the chassis handle (see fig 1).
Regarding claim 16, Becker discloses the device of claim 10, wherein the plunger adjustment assembly (adjusting device 27) further comprises a chassis handle lock (rear end 23b) extending from the rear chassis (see annotated figure above) and wherein the chassis handle lock is configured to reversibly engage the chassis handle to resist separation of the chassis handle from the rear chassis (see fig 1, when rear end 23b is locked into handle 26 is capable of resisting separation of the chassis handle from the rear chassis).
Regarding claim 17, Becker discloses the device of claim 16, wherein the plunger adjustment assembly (adjusting device 27) further comprises a chassis handle stop (front end of heel 26 abutting nut 31) configured to resist further rotation of the chassis handle (see fig 1, clamping nut 31 is capable of resisting separation of the chassis handle from the rear chassis).
Regarding claim 18, Becker discloses the device of claim 10, wherein the plunger engagement structure (structure 28) is slidably engaged to the rear chassis (see annotated figure above).
Regarding claim 21, Becker discloses the device of claim 1, further comprising a main handle (grip 42) projecting from the base member (see fig 1).
Regarding claim 22, Becker discloses the device of claim 1, wherein the base member comprises a longitudinal recess (guideway 35) and the rack (rack 34) is located in the longitudinal recess (see fig 1).
Regarding claim 23, Becker discloses the device of claim 1, wherein the chassis comprises a bracket (screw 47) engaged to the base member and configured to resist separation of the chassis from the base member (see fig 3, col 4, lines 45-47).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Becker (US 4231368 A).
Regarding claim 3, Becker discloses the limitations of claim 1 but fail to teach wherein the spiral cam recess has a minimum radius and a maximum radius with a radius difference in the range 5 mm to 20 mm.
Becker teach said gear comprising a plurality of recess between the teeth (see fig 1).
It appears that the device of Becker would operate equally well with the claimed range 5 mm to 20 mm since the plurality of recess between the teeth can have different radius. Further, applicant has not disclosed that the range claimed solves any stated problem or is for any particular purpose, indicating simply that the with the radius difference between a smallest radius and a largest radius in the range of 5 mm to 15 mm (specification pp. [0008]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Becker to have a minimum radius and a maximum radius with a radius difference in the range 5 mm to 20 mm because it appears to be an arbitrary design consideration which fails to patentably distinguish over Becker.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Becker (US 4231368 A) in view of Kuroda (US 5176646 A).
Regarding claim 11, Becker discloses the limitations of claim 1 but fail to teach the device, wherein the plunger cavity comprises a first opening from which a plunger is configured to extend distally, and a second opening from which the plunger is configured to be removably engaged.
However, Kuroda discloses a syringe pump (see fig 1) comprises a base (base 1) and a plunger adjustment assembly (member 3 and rod 4) comprising a plunger cavity (movable member 3, see fig 3) comprises a first opening (opening where plunger is inserted) from which a plunger is configured to extend distally (see fig 2), and a second opening (groove 3A) from which the plunger is configured to be removably engaged (see fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Becker and incorporate the teachings of Kuroda to have said plunger cavity comprises a first opening from which a plunger is configured to extend distally, and a second opening from which the plunger is configured to be removably engaged. The modifications would provide the benefit of having an opening in which the flange of the plunger is retained for better securement when the device is actuated (see col 5, lines 26-32).
Regarding claim 12, Kuroda discloses the first opening of the plunger cavity is a front opening (see fig 2), and the second opening of the plunger cavity is a top opening (see fig 2).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Becker (US 4231368 A) in view of Sims et al (US 5722956 A ).
Regarding claim 19, Becker discloses the limitations of claims 1, 9, 10, 18 but fail to teach said device, wherein the rear chassis comprises at least one rail and the plunger engagement structure comprises at least one rail attachment that forms a slidable interface with the at least one rail of the rear chassis.
Sims et al disclose a syringe driver (see fig 1, device 10) comprises a chassis (frame 12) with at least one rail (rail 30, 32) and a plunger engagement structure (carriage 14) wherein the plunger engagement structure comprises at least one rail attachment (slot 60) that forms a slidable interface with the at least one rail of the rear chassis (see figs 2A-B and 4, col 6, lines 1-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Becker and incorporate the teachings of Sims et al to have the rear chassis comprises at least one rail and the plunger engagement structure comprises at least one rail attachment that forms a slidable interface with the at least one rail of the rear chassis. This modification would provide the benefit of having an engagement that allows the plunger engagement structure to slide freely on said rear chassis, while at the same time preventing any vertical, dislodging movement of the plunger engagement structure (see col 6, lines 1-9).
Regarding claim 20, Sims et al discloses the at least one rail (rail 30, 32) comprises two elongate grooves (interior 86) and the at least one rail attachment (slot 60) comprises two projections that have complementary mechanical interfit with the two elongate grooves to resist separation of the rear chassis and the plunger engagement structure (see figs 2A-B and 4, col 6, lines 1-9).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/Examiner, Art Unit 3783