DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 May 2026 has been entered.
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.
Claim(s) 5, 7, and dependents is/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.
Regarding Claim 5, Applicant recites “further comprising an electrical contact point…” However, it is noted that amended Claim 1 now incorporates an electrical contact point and it is unclear if this electrical contact point of Claim 5 is the same or different from that of Claim 1.
Regarding Claim 7, Applicant recites “a controller”. However, based on the disclosure it is unclear if this “a controller” is the same or different from the “program unit” previously recited in Claim 1. Specifically, a “controller” is mentioned, nominally, in the Brief Summary (see Par. 13) for its utility in order to effect the electrical signal controls for the switch. However, this function is also prescribed to the program unit (see Clm. 1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-13 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0153032 (“Garribotto”) in view of U.S. Publication No. 2010/0198182 (“Lanigan”) and U.S. Publication No. 2009/0105649 (“Rush”).
Regarding Claim 1, Garribotto discloses a drive structure of a drug infusion device, comprising:
at least one driving unit (266) and at least one driving wheel (202), wherein the driving unit, moving in a driving direction (see e.g. Fig. 15), drives the driving wheel to rotate (i.e. when moving to the left, finger 266 engages gear teeth 262 causing clockwise rotation of the wheel);
a linear actuator (290), electrically connected with the driving unit, pulling the driving unit to move in the driving direction after being powered (Par. 72 – i.e. application of an electrical current causes the length of the linear actuator to decrease from an uncharged length to a charged length which causes linear movement of the driving unit);
a power supply (80) used to supply power to the linear actuator (Par. 48);
a program unit (50) and a first switch unit, wherein the power supply, the program unit, the first switch unit and the linear actuator are electrically connected to form a power supply circuit, when the linear actuator is powered, the driving unit implements driving, and the driving unit triggers a first signal, indicating an end point of the driving direction, which controls the first switch unit to turn off the power to the linear actuator (see Figs. 13-15; Par. 14, 47, 60, 62, 66, 72).
Specifically, while a “switch unit” is not explicitly referenced the device of Garribotto is described as using “programming, electronic circuitry and memory to properly activate the dispenser 40 at the needed time intervals” by switching, repeatedly, from a charged and uncharged state of the linear actuator via signaling by the processor, wherein in order to coordinate the strokes of the linear actuator – see Fig. 13-15, where Garribotto discloses that the system may include “all the computer programs and electronic circuitry needed… Such circuitry can include one or more microprocessors, digital and analog integrated circuits, resistors, capacitors, transistors and other semi-conductors and other electronic components known to those skilled in the art” (Par. 47). As such, it is clear that Garribotto envisages some switching means used to provide the necessary signaling and controls for indicating when the charge is to be switched off to the linear actuator at the end of the expansion stroke to permit the actuator to return to the uncharged length configuration and affect cycling of the system – although it is not immediately clear whether this switching means would include a “physical switch” such as a MOS field effector transistor, an analog switch, a relay or some physical analog thereof.
However, Lanigan discloses a related drug delivery device (100) which like that of Garribotto uses an actuator constructed of a shape memory material actuator (112, 632 - see Fig. 115) which can be selectively cycled to permit delivery (Par. 179, 389), wherein timing of the operation of the shape memory material actuators can be controlled via a processor (1608, 1800) and a physical relay/switch (1716, 1804, 1806) which regulate the application of a voltage signal to the shape memory actuator (Par. 718, 728, 736, 737, 738 – Fig. 114, 114A, 115). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the controller of Garribotto to communicate to a physical switch/relay to control the timed application of voltage to the linear actuator, as disclosed by Lanigan, in order to permit the control of the linear actuator via a known, predictable, and recognized prior art means to ensure that cycling of the pump is optimized and complete.
Garribotto, in view of Lanigan, discloses the invention substantially as claimed except that that the drive structure includes an “electrical contact point” electrically connected with the program unit, wherein when the driving unit is in contact with the electrical contact point, a voltage of the electrical contact point changes to control the physical switch to turn off. Rather Lanigan operates the switch (1716) using timing of the circuit (Par. 179, 719, 720, 721). However, Rush discloses that it is useful in such shape memory based, linear actuating pumps it can be useful to provide electrical contacts (e.g. 709, 710) for contact with the the driving unit (704) such that the stroke position of the linear actuator (705) can be “known” and confirmed irrespective of the timing circuit (Par. 33, 42; see also Par. 57-58 for additional applications of such electrical contact points in coordinating cyclic operation of the linear actuator and preventing misfires). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the drive structure of the invention of Garribotto to include an electrical contact point as part of the drive structure, the electrical contact point electrically connected to the program unit and the switch in order to ensure the switch is in the off position when the driving unit is in contact with the electrical contact point thereby to confirm proper timing of the pump and prevent misfiring of the pump.
Regarding Claim 2, Garribotto discloses the driving unit includes at least one driving portion (i.e. the tooth of 266), the driving wheel is provided with wheel teeth (262) which are pushed by the driving portion to drive the driving wheel.
Regarding Claim 3, Garribotto discloses a movement mode of the driving unit includes a linear reciprocating movement or a rotary reciprocating movement (see Figs. 13-15).
Regarding Claim 4, Garribotto discloses an elastic member (268 or 270 – in alternative embodiments), which applies a resetting and resilience force to the driving unit, wherein the elastic member cooperates with the linear actuator to make the driving unit reciprocate.
Regarding Claim 5, Garribotto, as modified by Lanigan and Rush, discloses an electrical contact point (generally 909 and 910, Rush), which is used to determine the end point of the movement of the driving unit in both the driving and reciprocating direction, wherein the driving unit contacts the electrical contact point to trigger the first signal to uncharge the linear actuator (see generally Par. 57, Rush)
Regarding Claim 6, Garribotto, as modified by Lanigan and Rush, discloses wherein the electrical contact point is electrically connected with the first switch unit to form a connection circuit, and the electrical signal controls the first switch unit to turn off (see generally Par. 57).
Regarding Claim 7, Garribotto, as modified by Rush, discloses a controller (see the control circuit 800, Rush; see also the processor 50, Garribotto; and controller 1608, Lannigan), which is electrically connected to the first switch unit and the electrical contact point (see Rush – Par. 57 when considered in the context of the switch of Lannigan), wherein the electrical signal controls the first switch unit to turn off through the controller.
Regarding Claims 8 and 17, Garribotto, as modified by Lannigan and Rush, discloses before and after the driving unit contacts the electrical contact point, voltages of the electrical contact point are different, and the electrical signal is a voltage changing signal (see Rush, Par. 57; Garribotto, Par. 14, 72).
Regarding Claim 9, Garribotto, as modified by Rush, discloses the program unit is electrically connected with the electrical contact point to receive the electrical signal (see Fig. 8 and 9, Rush).
Regarding Claim 10, Garriboto discloses that the program unit operates to coordinate operation of the power supply circuit (inclusive to the modified switch unit in view of Lanigan) (see Garriboto – Par. 47 – re: “[t]he local processor 50 also includes programming, electronic circuitry and memory to properly activate the dispenser 40 at the needed time intervals; see Lanigan – Par. 719, “voltage may be applied for a fixed amount of time”, see also Par. 179, 720, 721), i.e. the program unit disconnect the power supply circuit after a period of time (T), where it must be understood that if the duration at which the linear actuator is being powered is represented by time (t) then time (t) is necessarily equal to time (T) – since actuation of the linear actuator is dependent upon the electrical signal received through the switch/relay.
Regarding Claim 11, since T and t are understood to be equal then T-t is equal to 0ms.
Regarding Claim 12, Garriboto discloses the invention substantially as claimed except that that the system further comprises a “second switch unit” which is arranged on the power supply circuit to control the disconnection of the power supply by the program unit. However, Lanigan discloses such a switch (1810) which is controlled via the processor to disconnect the power supply independently of the first switch/relay (Par. 728) in order to serve to require signal agreement as a fail-safe. It would have been obvious for one having ordinary skill in the art at the time the invention was made to include a second switch unit to the invention of Garriboto to control the power from the power supply circuit independently of the first switch relay, as disclosed by Lanigan, in order to create a signaling redundancy to help prevent malfunction of the system.
Regarding Claim 13, Garribotto, as modified by Lanigan and Rush, discloses an electrical connection point located on the power supply circuit between the linear actuator and the first switch unit, wherein the program unit is electrically connected to the electrical connection point to obtain a second signal, a voltage changing signal, of the electrical connection point (see Lanigan, Fig. 114, Rush – Fig. 7 and 9).
Regarding Claim 15, Garriboto, as modified by Lanigan, discloses that the first and second switch units may comprise relays (see Par. 728 – Lanigan).
Regarding Claim 16, Garribotto discloses the linear actuator is a shape memory alloy (290).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2004/0153032 (“Garribotto”) in view of U.S. Publication No. 2010/0198182 (“Lanigan”) and U.S. Publication No. 2009/0105649 (“Rush”) as applied above, and further in view of U.S. Publication No. 2009/0012359 (“Tanaka”).
Regarding Claim 14, Garribotto discloses the invention substantially as claimed except that a pressure sensor is used to determine the end point of the movement of the driving unit in the driving direction, and the first signal is a pressure changing signal. However, Tanaka discloses that pressure sensors can be used to determine the displacement of a linear actuator for controlling the timed operation of the actuator (Par. 154). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a pressure sensor to measure the displacement of the linear actuator(s) of Garribotto, as disclosed by Tanaka, in order to permit the system to accurately control the interval of pumping cycles in an accurate and predictable manner.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/24/2026
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