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 on 2/23/26. As directed by the amendment: claim 1 has been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-11 are presently pending in this application.
The amendments are sufficient to overcome the claim objection from the previous action.
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) 1 and 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garribotto et al. (US 20040153032) in view of Rush et al. (WO 2004032994) and Lavi et al. (US 6364865).
Regarding claim 1, Garribotto et al. discloses a drug infusion device (abstract; fig. 2; dispenser embodiment of fig. 7-9), comprising: a drug storage unit 30 including a drug outlet (connection between 30 and 40 illustrated in fig. 2); a screw 202 connected to a piston 204 and a driving wheel 254 provided with wheel teeth (see fig. 7), wherein the driving wheel rotates to drive the screw to move, pushing the piston, provided in the drug storage unit, forward (par. 0059, describing the embodiment of fig. 6, also applies to the functionality of the embodiment of fig. 7-9); at least one driving unit (comprising 244 and 256) cooperating with the driving wheel (see fig. 7), wherein the driving unit comprises at least one driving portion 256; a power unit 246 and a reset unit 248 connected to the driving unit (see fig. 7), wherein the reset unit comprises an elastic reset component (spring; par. 0064-0067), and the elastic reset component alone applies a force to control a reset movement of the driving unit (par. 0064-0067), and, when the power unit outputs a force on the driving unit, the driving unit rotates around a pivot shaft, driving the driving portion to push the wheel teeth, thus rotating the driving wheel (par. 0064-0068); when the reset unit outputs the force on the driving unit alone, the driving unit performs a reset rotation without the driving portion pushing the wheel teeth, thus making the driving wheel stop rotating (par. 0064-0068); and an infusion tube 210, used as a drug infusion channel (par. 0051), and comprising a connection end (end towards 30/40/200 in fig. 2) and a subcutaneous end (end projecting outwardly from 70 in fig. 2), wherein the connection end is configured to be connected to the drug outlet and the subcutaneous end is configured to enter a subcutaneous tissue (see fig. 2), a drug is configured to be delivered subcutaneously through the infusion tube (par. 0051).
Although Garribotto et al. teaches utilizing a linear-actuated reset component 290 as an alternative to an elastic reset component (see fig. 13-15 embodiment), Garribotto et al. fails to specifically disclose the reset unit comprises an elastic reset component in combination with a linear-actuated reset component, wherein when one of the elastic reset component and the linear-actuated reset component fails, the other one of the elastic reset component and the linear-actuated reset component controls the reset movement of the driving unit. Garribotto et al. also fails to disclose an assembly structure configured to support the infusion tube, wherein the assembly structure is movable from an initial position to a working position relative to the drug storage unit; wherein in the initial position, the connection end is disconnected from the drug outlet; and wherein when the assembly structure is moved to the working position, the connection end connects to the drug outlet, and the subcutaneous end extends for subcutaneous entry.
However, Rush et al. teaches utilizing an elastic reset mechanism in the form of a spring in combination with other biasing means, such as a linear actuator in the form of a shape memory alloy (par. 0049; in particular: “Those of reasonable skill in this field will appreciate that a multitude of other biasing means exist, one or more of which can be used in place of or in addition to the spring” (emphasis added)), which would result in redundant biasing structures that are individually capable of controlling reset movement. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Garribotto et al. to utilize both an elastic reset component and a linear-actuated reset component, including to utilize them together to apply a force to control a reset movement of the driving unit, as taught by Rush et al., since both Garribotto et al. and Rush et al. identify these two types of elements as appropriate reset components, and since Rush et al. specifies that using multiple reset components in combination is known for achieving a reset actuation (par. 0049). Additionally, such a modification is the result of combining prior art elements (linear actuated reset components and elastic reset components, both of which are identified in Garibotto et al. and Rush et al.) according to known methods (as discussed in par. 0049 of Rush et al.) to yield predictable results (performing a reset actuation required by Garribotto et al. and Rush et al.).
Additionally, Lavi et al. teaches an assembly structure 174 configured to support an infusion tube 130-1 (see at least fig. 4A), wherein the assembly structure is movable from an initial position to a working position relative to the drug storage unit (see at least fig. 4A; col. 11, ln. 25-36); wherein in the initial position, the connection end is disconnected from the drug outlet (illustrated in fig. 4A); and wherein when the assembly structure is moved to the working position, the connection end connects to the drug outlet, and the subcutaneous end extends for subcutaneous entry (col. 11, ln. 25-36). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Garribotto et al.’s apparatus to utilize an assembly structure as taught by Lavi et al. for the purpose of providing sufficient structure to prevent premature release of fluid while maintaining its sterility.
Regarding claims 5 and 6, Garribotto et al., as modified by Rush et al. above, teaches each of the power unit and the linear-actuated reset component an electrically driven linear actuator or an electrically heated linear actuator, wherein the electrically driven linear actuator includes a shape memory alloy (246 of Garribotto et al. is a shape memory element, see par. 0060 for its operation; par. 0049 of Rush et al.).
Regarding claims 7 and 8, Garribotto et al. discloses the elastic reset component at least comprises or is a spring (par. 0064-0067) and the at least one driving portion includes one driving portion (at least one driving portion inherently includes one driving portion).
Regarding claim 9, Garribotto et al. discloses a transitional connection member (comprising at least 200 and tubing from 200 to 40) which is disposed outside the drug outlet (see fig. 2), wherein one end of the transitional connection member connects with the drug outlet, while an other end of the transitional connection member is used to connect the connection end (see fig. 2).
Regarding claim 10, Garribotto et al. discloses the transitional connection member comprises a connection cavity or a connection port (element 200 is part of the flow path and inherently will require a cavity for flow to move therethrough; additionally, the portion of tubing visibly connecting 200 to 40 functions as a connection port; see fig. 2).
Regarding claim 11, Garribotto et al. discloses a program unit 50, which is connected to the power unit and the linear-actuated reset component, and according to infusion requirements, the program unit controls to output the force from the power unit or the linear-actuated reset component (par. 0042-0049).
Claim(s) 2-4 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Garribotto et al. in view of Rush et al. and Lavi et al., and further in view of Yang (WO 2017181324).
Regarding claims 2-4, Garribotto et al., as modified by Rush et al., discloses/teaches the claimed device, except for the at least one driving portion comprises two driving portions, and under a cooperative operation of the power unit and the reset unit, the two driving portions alternately push the wheel teeth; wherein the two driving portions alternately push the wheel teeth disposed on the driving wheel; and wherein the driving wheel includes two sub-wheels provided with the wheel teeth, and the two driving portions respectively alternately push the wheel teeth disposed on the two sub-wheels. However, Yang teaches (see fig. 1-3) utilizing two driving portions (arms on either side of 2) which alternately push the wheel teeth (pg. 7) disposed on the driving wheel (gears 4; fig. 1-3 and pg. 7), wherein the driving wheel includes two sub-wheels (each of 4) alternately pushed by the driving portions (pg. 7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Garribotto et al. in view of Rush et al. to utilize two driving portions and two driving wheels, as taught by Yang, for the purpose of providing sufficient structure to achieve small volume infusion with high precision (abstract).
Response to Arguments
Applicant's arguments filed 2/23/26 have been fully considered but they are not persuasive.
Applicant argues, on pages 6-8 of the Remarks, that the newly amended limitations of claim 1 regarding the assembly structure are not taught by the combination of Garribotto et al. in view of Rush et al. In response, examiner cites Lavi et al. as set forth in the updated grounds of rejection under 35 U.S.C. 103(a) above.
Applicant argues, on pages 8-9 of the Remarks, that the other amended limitations of claim 1 regarding the functionality of the two reset components is not taught by the combination of Garribotto et al. in view of Rush et al. However, examiner interprets Rush et al. in par. 0049 to describe utilization of multiple reset components that are each capable of performing a reset operation, given that the first component is described as fully performing the function, and others are described as additional components to perform the function. Thus, the disclosed mechanism of Rush et al. is fully capable of performing the newly claimed functionality.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gonnelli et al. (US 6939324) discloses a similar mechanism to that cited in Lavi et al.
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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