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 .
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) 1-4, 10-12, 15, and 16 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”).
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;
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);
a power supply (80) used to supply power to the linear actuator;
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.
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 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 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) 5-9, 13, 14, and 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 further in view of U.S. Publication No. 2009/0012359 (“Tanaka”).
Regarding Claims 5-9, 13, and 17, Garribotto discloses the invention substantially as claimed except that that the device further comprises an “electrical contact point, which is used to determine the end point of the movement of the driving unit in the driving direction, wherein the driving unit contacts the electrical contact point to trigger the first signal which is an electrical signal. However, Tanaka discloses means for controlling the cycling of a linear actuator comprising an electrical contact point (re: “contact sensor”) which is used to determine the end point of the movement of the linear actuator and wherein contact with the contact sensor creates an electrical signal to trigger the controller to adjust operation of the linear actuator (Par. 154), the electrical contact point being electrically connected with a switch/controller to form a connection circuit which is understood to induce a change of voltage in response to cycling of the switch and deliver that change in voltage information to a program unit so that it may be used to control activation of the linear actuator. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an electrical contact sensor switch to determine the end of the delivery stroke of the linear actuator of Garribotto, as disclosed by Tanaka, in order to allow for accurate control over the cycling of the linear actuator via a known, predictable means for achieving an expected outcome.
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
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 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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 03/02/2026