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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/25/2026 has been entered.
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.
Claims 1, and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dilanni et al. (WO 2006104806 A2) in view of Gross et al. (US 20030236498 A1) in view of Mahoney et al. (US 2003199824 A1).
Regarding Claim 1, Dilanni discloses a unilaterally driven drug infusion device (fluid delivery device 200, Fig 1; [0038] Device is driven unilaterally by the linear actuator at different time instances) with multiple infusion modes ([0040]), the drug infusion device (200) comprising: a reservoir (reservoir 230, Fig 10), a piston (plunger 236, Fig 5) and a screw (threaded drive rod 252, Fig 5), wherein the piston (236) is connected with the screw (252), and is arranged in the reservoir (230) ([0032]: “a threaded drive rod 252 coupled to a plunger 236. The plunger 236 is received in the fluid reservoir 230”); a driving unit (drive engaging member 262 and pivot point 162, Fig 4) including at least one rotating shaft (pivot point 162, Fig 4) and at least one driving member (drive engaging member 262, Fig 5) ([0035]: “the pivotable drive engaging member 262 may only include one arm and one leg.”), wherein the driving member (262) includes at least one driving end (arm 264a, [0035]), and the driving member (262) is able to rotate around the rotating shaft (162) ([0036]: “The pivotable drive engaging member 262 may be pivotably coupled to a pivot point 162”) to advance or reset the driving end (264a) ([0038]: “When the pivotable drive engaging member 262 pivots in the first direction 20, the arm 264a engages a tooth on the ratchet wheel portion 258a causing the drive wheel 256 to rotate one increment”; at least one driving wheel (drive wheel 256, Fig 5) provided with wheel teeth (wheel teeth 1000, Annotated Fig 1), the driving end (264a), which advances is able push the wheel teeth (1000) to rotate the driving wheel (256), and drive the screw (252) to move forward ([0032],[0038]) ; a linear actuator (First SMA wire portion 260a) and a reset unit (second SMA wire portion 260b) respectively connected to the driving member (262) (Fig 5 shows the connection of 260b to 262), wherein the linear actuator (260a) and the reset unit (260b) respectively apply driving power to the driving member (262) to advance ([0038]: “When charged, the first SMA wire portion 260a contracts and pulls the pivotable drive engaging member 262 in a first direction indicated by arrow 20”) and reset ([0038]; Engagement member 262 has one arm 264 and a leg 268; which is rotatable between the contacts; when the current is disable the shape memory alloy wire 260a return to its initial position and 260b contracts; since member 262 has only one arm contraction of 260b will not cause movement of wheel 256) the driving end (264; [0035]); and a control unit (control circuitry ,not shown; [0038]), connected to the linear actuator (260a) or the reset unit (260b), wherein the control unit (control circuitry ,not shown; [0038]) controls the linear actuator (260a) or the reset unit (260b) ([0038]) to apply different driving powers ([0038]) on the driving member (262) to make the driving member (262) have a variety of different operating modes ([0040]), such that the infusion device has various different infusion increments or infusion rates ([0040]: “the discrete amount of fluid to be dispensed is between about 0.25 μL and about 0.5 μL. The control circuitry alternates energizing the SMA wire portions 260a, 260b until a desired amount of fluid has been dispensed”), wherein the variety of different operating modes include different rotation amplitudes of the driving member ([0040]:The total distance traveled by each rotational movement actuated by SMA wire 260a in the first direction 20 of the driving unit, which also represents the distance the piston is being moved. SMA wire 260b will contribute to resetting because only one arm 264 is present. The total distance or amplitude traveled differs based on desired injection amount and therefore different infusion mode), different amplitude or frequency of reciprocating movement, or include various different movement rates ([0041]; The fluid delivery device 200 may be used to delivery having a variable flow rate delivery; Examiner notes that only one of operating modes must be disclosed, Dilanni is being relied upon to disclose both the first and third variety of different operating modes); a base (chassis 100, Fig 9), wherein the driving wheel is movably assembled on the base (100) ([0014]), and the base (100) and the driving wheel (256) are frictional fit ([0014]; Since the hub is supported by bearing surfaces on the chassis 100, there is contact between these components; therefore, there is friction fit between the chassis bearing surfaces and the wheel 256.), during reset, the driving end (264; [0035]) only slides on a surface of the wheel (256) teeth (1000, Annotated Fig 1) without pushing ([0038]; Engagement member 262 has one arm 264 and a leg 268; which is rotatable between the contacts; when the current is disabled the shape memory alloy wire 260a return to its initial position and 260b contracts, comprising the reset motion; rotation of the arm 264 in the second direction does not push the driving wheel); and a position limited member (tilt nut 242, Fig 11A-B), wherein the position limited member (242) is movably assembled on the base (100) to limit a position of the driving wheel (256), and the position limited member (242) and the driving wheel (256) are frictional fit (tilt nut 242 is in frictional fitment in relation of the drive wheel 256, when the tilt nut 242 is in the closed position movement of the drive wheel is being transferred to the tilt nut which threads engages the drive rod 252 to dispense the medicine; [0046]); when the linear actuator (260a and 260b) pulls the driving member (262), the driving member (262) rotates in an advancing direction (direction 20, Fig 5) around the rotating shaft (162); and the driving direction (20) is opposite to the reset direction (22).
PNG
media_image1.png
502
852
media_image1.png
Greyscale
Dilanni is silent regarding wherein the driving wheel stops rotating when the driving end is sliding on the surface of the wheel teeth; wherein the driving member includes two driving ends disposed at a same side and disposed up and down and cooperating with the same driving wheel, the driving ends are able to reciprocate synchronously, front ends of the driving ends are not level with a distance, the two driving ends cannot simultaneously push the wheel teeth forward; the reset unit is pressed by the driving member to build a gradually increasing elastic force, when the linear actuator stops applying force and under the action of only the elastic force, the driving member rotates in a reset direction around the rotating shaft, at this time, the driving ends slides on the surface of the wheel teeth.
Gross teaches a drug infusion device (precision of device 10, Fig 1) comprising a driving member (pawl 18, Fig 4-5) including two driving ends (31, 32, Fig 4-5) disposed at a same side (distal side of the pawl 18 towards the first end 15, Fig 1) and disposed up and down and cooperating with the same driving element (Fig 4-5 shows the pawls ends 31 and 32 disposed up and down cooperating with the same ratchet bar), the driving ends (31, 32) are able to reciprocate synchronously (both pawl ends 31, 32 reciprocate synchronously when the pawl 18 is being driven; [0103]), front ends of the driving ends are not level with a distance (distal end of 31 is longer than distal end of 32 by a distance; [0103]), and the two driving ends cannot simultaneously push the driving element teeth forward ([0103]; reciprocating motion of pawl 18 only engages one end 31 or 32 at time with teeth 33, 33); a reset unit (return spring 29, Fig 1) is pressed by the driving member (lever 19, Fig 1) to build a gradually increasing elastic force, when the linear actuator (gas generator 25, Fig 1) stops applying force ([0102]) and under the action of only the elastic force (elastic force of return spring 29, Fig 1), the driving member (19) rotates in a reset direction around the rotating shaft (axis 20, Fig 1)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the arm of device of Dilanni with similar pawl ends and reset unit as taught by Gross for delivering small volumes in a stepwise fashion, increasing the accuracy of the volumes being dispensed ([107];[0126]).
Dilanni/Gross discloses the driving ends (modified arm of Dilanni with teaching of Gross as combined) slides on the surface of the wheel teeth (1000, Annotated Fig 1 Dilanni) (arm 264 of Dilanny, including driving ends as modified with teaching of Gross slides over the wheel 256 when moved in direction 22 because only one arm is present).
Dilanni/Gross are silent the driving wheel stops rotating when the driving end is sliding on the surface of the wheel teeth.
Mahoney teaches an infusion device (infusion devise dispenser 10, Fig 2) comprising: a reservoir (reservoir 30, Fig 6), a piston (plunger 204, Fig 6) and a screw (threaded lead screw 202, Fig 3), the piston (204), connected with the screw (202), is arranged in the reservoir (30) ([0082]); a driving member (moveable pawl 222, Fig 4).
Mahoney further teaches the driving wheel (gear 214) stops rotating when the driving end (end of pawl 222) is sliding on a surface of the wheel teeth (surface of teeth of gear 214) ([0080]: “The moveable pawl 222 and the teeth of the gear 214 are also shaped such that linear movement of the moveable pawl 222 in a second direction past the gear 214, as shown by arrow "B" in FIG. 4, causes no rotation of the gear 214 (i.e., the moveable pawl and the teeth are shaped to slide over each other as the moveable pawl 222 moves past the gear 214 in the second direction)”).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of Dilanni/Gross with the teaching of teeth shape of Mahoney to allow the driving end to slide on the second direction without movement of the wheel ([0080]).
Regarding Claim 3, Dilanni/Gross/Mahoney discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 1. Dilanni discloses wherein the linear actuator includes an electrically driven linear actuator (260a) or an electrically heated linear actuator ([0038]).
Regarding Claim 4, Dilanni/Gross/Mahoney discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 1. Dilanni discloses wherein the reset unit includes an electrically driven linear actuator, an electrically heated linear actuator (SMA wire 260b is an electrically driven linear actuator, an electrically heated linear actuator) or an elastic member ([0038]: actuator 260a and 260b are being energized in an alternating way, SMA are well known in the art, heating as result of being energized is a key part of its functionality to induce a shape change; since the SMA change shape under specific conditions can be considered an elastic member).
Gross teaches wherein the reset unit includes an elastic member (return spring 29, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dilanni/Gross/Mahoney with similar reset spring as taught by Gross for the purpose of move the driving part in the opposite direction related to the direction of movement of the actuator to reset the system by completing one reciprocation ([0096]).
Regarding claim 5, Dilanni/Gross/Mahoney discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 4. Dilanni discloses wherein the reset unit is an elastic conductive member ([0038]; since the SMA change shape under specific conditions can be considered an elastic member).
Gross teaches a wherein the elastic member (return spring 29, Fig 1) is conductive ([0040] spring is made of metal which is conductive).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the material of spring of device of Dilanni/Gross/Mahoney with a similar metal material as taught by Gross for the purpose of achieving higher tolerances at relatively low cost ([0040]).
Regarding Claim 6, Dilanni/Gross/Mahoney the unilaterally driven drug infusion device with multiple infusion modes of claim 5. Dilanni is silent wherein the elastic conductive member includes a metal spring.
Gross teaches a wherein the elastic conductive member (return spring 29, Fig 1) includes a metal spring ([0040] spring is made of metal which is conductive).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the material of spring of device of Dilanni/Gross/Mahoney with a similar metal material as taught by Gross for the purpose of achieving higher tolerances at relatively low cost ([0040]).
Regarding claim 7, Dilanni/Gross/Mahoney discloses the unilaterally driven drug infusion device with multiple infusion modes of claim 1. Dilanni discloses the drug infusion device further comprising at least one blocking wall (contact point 164b, Fig 4), wherein when the driving member (262) is in contact with the blocking wall (164a), the driving member stops rotating ([0035];[0038]: 262 contacts 164b or 164a and stop rotating in one direction).
Response to Arguments
Applicant's arguments filed 03/25/2026 have been fully considered but they are not persuasive. Applicant submits that amended claim 1 is not taught by Dilanni et al. (WO 2006104806 A2). Please see relevant portion of claim 1 below:
“(…)different amplitude or frequency of reciprocating movement, or include various different movement rates ([0041]; The fluid delivery device 200 may be used to delivery having a variable flow rate delivery) (…)”.
“(…) wherein the position limited member (242) is movably assembled on the base (100) to limit a position of the driving wheel (256), and the position limited member (242) and the driving wheel (256) are frictional fit (tilt nut 242 is in frictional fitment in relation of the drive wheel 256, when the tilt nut 242 is in the closed position movement of the drive wheel is being transferred to the tilt nut which threads engages the drive rod 252 to dispense the medicine; [0046]) (…)”
Applicant submits that the tilt nut 242 of Dilanni does not provide braking friction to the drive wheel 256. The position limited member (191 in Fig. 7b) of the present application is disposed to increase friction during resetting to prevent the drive wheel from rotating. Applicant submits that Dilanni does not disclose "the position limited member is movably assembled on the base to limit a position of the driving wheel, and the position limited member and the driving wheel are frictional fit" recited in the amended claim 1 of the present application.
Examiner notes that functional claim language describing the friction having a braking effect as well as limitations of causing an increase friction during resetting to prevent the drive wheel from rotating are not present in the claim. Additionally, since tilt nut 242 is being retained in the drive wheel 256, it is in frictional fit engagement with the wheel on one end ,with the chassis 100, clip 1201 on other surfaces and with drive rod thread when moved in the close position this frictional engagement exert a braking force against movement, being static and dynamic friction present.
Applicant submits that applying the pawl 18 designed for linear motion of Gross, directly to the drive wheel 256 for rotary motion of Dilani would create geometric interference and angle of action issues, making it not an obvious direct replacement and indicate there is not sufficient motivation. Examiner respectfully disagrees. Modification of the end of arm of device of Dilanni to have similar ends as device of Gross will be adapted to the rotational motion of device of Dilanni. This would be beneficial to provide an even smaller injection amount representative of half the length of teeth ([0104]). Smaller injection amounts is one of the goals disclosed by Dilanni; therefore a person of ordinary skill in the art would have been motivated to pursue the stated modification with a reasonable expectation of success.
Applicant submits that dual SMA line system of Dilanni is already capable of completing a full cycle of operation (forward and reset). Those skilled in the art would have no motivation to use the spring 29 of Gorss to improve an already well-functioning Dilanni, and therefore no motivation to combine Dilanni and Gross. Examiner respectfully disagrees. Spring 29 of Gross is a known alternative for mechanism reset. Spring are well known biasers and conventionally implemented to move biased elements to original position. The substitution of known alternatives would achieve predictable results of allowing resetting of the mechanism [0096].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yang (WO 2017181324 A1) teaches a linear actuator (piezoelectric actuator 1, Fig 2) pulls the driving member (swinging part 2, Fig 1), the driving member (2) rotates in an advancing direction (direction 2001 towards actuator (1); Annotated Fig 2) around the rotating shaft (2000, Annotated Fig 2), at this time, a reset unit (compression spring 6, Fig 1) is pressed by the driving member (2) to build a gradually increasing elastic force (elastic force is gradually increase as the driving member is progressively rotates and compresses the compression spring 6; Fig 1), when the linear actuator (1) stops applying force and under the action of only the elastic force (elastic force from spring 6), the driving member rotates (2) in a reset direction (direction 2002, Annotated Fig 2) around the rotating shaft (2000, Annotated Fig 2).
PNG
media_image2.png
598
868
media_image2.png
Greyscale
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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 on (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.
/GUILLERMO G PAZ ESTEVEZ/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights