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
The amendment filed on 10/16/25 has been entered in the case. Claims 1-21 are pending for examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “at least one emergency element is separate and distinct from the force element…” in claim 21 is failing to comply with the written description requirement.
In the para [0035] of the original specification describes that: … Emergency element 350 may include an SMA wire, motor, spring, or other force element operably coupled to piston 370 via a connection 352. In addition, the claim 2 states that the force element is at least one spring. In other words, the force element is a part of the emergency element 350. How is possible that the emergency 350 is being separated (or unattached) and distinct from the force element?
The Figs. 7A-7B show that the emergency element, i.e. SMA wire) being attached to the force element, i.e. spring 576. In other words, the emergency element, i.e., SMA wire is not being separated from the force element, i.e. spring.
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, 3-4, 6-11, 13-14, 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moberg et al. (US 8,647,296).
Regarding claim 1, Moberg discloses a fluid delivery system, in Fig. 21-23, comprising:
at least one force element 2304;
at least one moveable element 2307 or/and 2306 configured to be moved in a dispensing direction by the at least one force element during a pump cycle to expel a fluid from the fluid delivery system; and
an occlusion management system comprising at least one emergency element (including gears 2303, bearing support 2305, drive shaft 2302 and motor 2301) operably coupled to the at least one moveable element 2307/2306 (via element 2304), the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force/pressure to move the at least one moveable element in the dispensing direction, col. 16, lines 44-56, col. 20, lines 49-56; col. 23, lines 38-39 and also see Figs. 26, 30-13, col. 32, lines 66-67.
Note: Moberg states in col. 16, lines 44-56 that: when the occlusion was not removed, additional pressure will be generated within the fluid system… In fact, the load on the entire drive train increases as force is transferred from the motor to the slide, and the slide is constrained from movement by the stopper pressing against the fluid. Moberg further states in col 20, liens 49-50 that: when an occlusion develops within the fluid path system, the fluid pressure increases due to force applied on the fluid by the motor and drive train. An occlusion is declared if a serios of data points indicate that the force required for fluid delivery is increasing, col. 23, lines 38-39. An occlusion has occurred, the force would increase as the pressure increases, col. 32, lines 66-67.
In other words, while the pressure increases from an occlusion, the force required to move the slide forward increases. The increased pressure result in an increased force reading by the force sensor. The increased force also results in an increased drive count necessary to reach the target encoder count for each delivery pulse. Multiplying drive count and force or adding these variables increases the magnitude of occlusion indication, col. 31, lines 63- col 32, line 3.
Therefore, when the fluid pressure increase, the system (or the motor and the drive train) must be provided an extra/additional force to move the moveable element in the dispensing direction so that forcing the fluid out of the pump.
For example: there are multiple evidence to show that an occlusion is declared when the measured force increases/exceeds a threshold, see below.
The Fig. 26 shows that when the occlusion 2601 is detected, the additional force 2602 (the lowest data line in the graph) is being provided (the data force is increasingly). In other words, the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction.
The Fig. 30 shows that the occlusion is detected at vertical line 4007 by software algorithm, and then the additional force being provided (e.g. the force 4001 is still increasing) to delivery drug. In other words, the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction.
Similarly, the Fig. 31 shows that the occlusion is determined and provides an alarm at line 4027; however, the addition force is provided (force 4021 is still increasing). Therefore, the Fig. 31 also shows that the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction.
Regarding claim 3, the at least one moveable element comprising a piston 2307.
Regarding claim 4, the at least one emergency element comprising at least one of a shape memory allow (SMA) wire, a motor, or a spring. In this case, the at least one emergency element comprising a motor 2301.
Regarding claim 6, further comprising at least one two-bar link 2409 (and/or 2403/2404) configured to operably couple the at least one emergency element (motor) and the at least one moveable element.
Regarding claim 7, as seen in Figs. 21-22, the movable element, i.e., piston 714/2307 or/and slide 711/2306; wherein the at least one emergency element (including gears 2303, bearing support 2305, drive shaft 2302 and motor 2301) operably coupled to a moveable wall 713 (an interior space of the piston 714, see Fig. 21) via the lead 710/2304, wherein activation of the at least one emergency element operates to move the movable wall in the dispensing direction.
Regarding claim 8, the logic, i.e. software algorithm to determine an occlusion threshold for activation of the at least one emergency element, col. 16, lines 28-33; col. 34, lines 13-53; col. 36,line 41-col. 37, line 24.
Regarding claim 9, the occlusion threshold based on one of a number of pump cycles or a timed duration, col. 23, lines 8-29.
Regarding claim 10, the logic to, responsive to expiry of the occlusion threshold, i.e. after four consecutive force measurements exceed 2lbs, perform one or more of initiating an alarm (occlusion is declared) or stopping performance of pump cycles, col. 22, line 58-col. 23, line 29. For example: fluid delivery is allowed for one or more measurements that exceed a threshold, but fluid delivery is not allowed, and an occlusion is declared after a predetermined number of consecutive measurement exceed the threshold.
In addition, the logic, i.e. software algorithm to determine an occlusion threshold, to responsive to expiry of the occlusion threshold, perform one or more of initiating an alarm (col. 23, lines 8-29) or stopping performance of pump cycles (col. 17, line 65-col. 18, line 9). In addition, as seen in Fig. 31, another approach to determining an occlusion is looking for a point of inflection or the rate of change of the slope. This can be the change from constant force or other variable to a new rate of change. For example, FIG. 31 shows force measurements 4021 taken over time. The constant force shown by line 4023 changes to a new rate of change shown by line 4025. An alarm 4027 is triggered by this change. In other words, the line 4025 is equivalent to the claimed limitation, i.e., a responsive to expiry (at 350 in between 200-400 timeline, or x-axis in Fig. 31) of the occlusion threshold, the system performs an alarm, as shown in vertical line 4027 in Fig. 31. In other the logic to, responsive to expiry of the occlusion threshold, perform one or more of initiating an alarm or stopping performance of pump cycles.
Regarding claims 11, 13-14, 16-20, these claims are being rejected using same analysis as noted the above with regards to claims 1, 3-4, 6-10.
Regarding claim 21, Moberg discloses that wherein: the force element 2304 provides an operating force to expel the fluid from the fluid delivery system during a normal, un-occluded operation of the fluid delivery system, and the at least one emergency element (gears 2303, bearing support 2305, drive shaft 2302 and motor 2301) is separate and distinct from the force element 2304 (lead screw), and provides the additional force beyond the operating force in an attempt to dislodge the occlusion.
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 1-2 & 11-12 & 21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Moberg et al. (US 8,647,296).
Regarding claims 1-2 & 11-12, Moberg discloses a fluid delivery system, in Fig. 4, comprising:
at least one force element, i.e., plunger 405 or/and gearbox 501;
at least one moveable element, i.e.., piston 407 configured to be moved in a dispensing direction by the at least one force element during a pump cycle to expel a fluid from the fluid delivery system; and
an occlusion management system, i.e., including motor 403, circuitry 422, power supply 420, see Fig. 4, comprising at least one emergency element operably coupled to the at least one moveable element, the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction, col. 16, lines 44-46 and also see Figs. 26, 30-13.
Note: Moberg states in col. 16, lines 44-56 that: when the occlusion was not removed, additional pressure will be generated within the fluid system… In fact, the load on the entire drive train increases as force is transferred from the motor to the slide, and the slide is constrained from movement by the stopper pressing against the fluid. Moberg further states in col 20, liens 49-50 that: when an occlusion develops within the fluid path system, the fluid pressure increases due to force applied on the fluid by the motor and drive train. An occlusion is declared if a serios of data points indicate that the force required for fluid delivery is increasing, col. 23, lines 38-39. An occlusion has occurred, the force would increase as the pressure increases, col. 32, lines 66-67.
In other words, while the pressure increases from an occlusion, the force required to move the slide forward increases. The increased pressure result in an increased force reading by the force sensor. The increased force also results in an increased drive count necessary to reach the target encoder count for each delivery pulse. Multiplying drive count and force or adding these variables increases the magnitude of occlusion indication, col. 31, lines 63- col 32, line 3.
Therefore, when the fluid pressure increase, the system (or the motor and the drive train) must be provided an extra/additional force to move the moveable element in the dispensing direction so that forcing the fluid out of the pump.
For example: there are multiple evidence to show that an occlusion is declared when the measured force increases/exceeds a threshold, see below.
The Fig. 26 shows that when the occlusion 2601 is detected, the additional force 2602 (the lowest data line in the graph) is being provided (the data force is increasingly). In other words, the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction.
The Fig. 30 shows that the occlusion is detected at vertical line 4007 by software algorithm, and then the additional force being provided (e.g. the force 4001 is still increasing) to delivery drug. In other words, the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction.
Similarly, the Fig. 31 shows that the occlusion is determined and provides an alarm at line 4027; however, the addition force is provided (force 4021 is still increasing). Therefore, the Fig. 31 also shows that the occlusion management system comprising logic (software algorithm or programming) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one moveable element in the dispensing direction.
With aspect to the limitation, i.e., the at least one force element comprising at least one spring, as required in the claims 2 & 12, Moberg states that: the end of the plunger slide 405 may include a detente or ridge to engage with a corresponding formation in the reservoir piston 407 …; the detente or ridge may be spring loaded or activated to grasp the reservoir piston 407 once the drive mechanism has been moved forward (or extended), col. 13, lines 12-14, lines 24-26. Therefore, at least one force element (including détente or ridge, as stated the above) comprising at least one spring.
Regarding claim 21, Moberg discloses that wherein: the force element 2304 provides an operating force to expel the fluid from the fluid delivery system during a normal, un-occluded operation of the fluid delivery system, and the at least one emergency element (gears 2303, bearing support 2305, drive shaft 2302 and motor 2301) is separate and distinct from the force element 2304 (lead screw), and provides the additional force beyond the operating force in an attempt to dislodge the occlusion.
Claims 5 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moberg et al. (US 8,647,296).
Regarding claims 5 & 15, Moberg discloses all the claimed subject matter as required. Moberg states in the Background of the invention that that the reservoir, piston head and threaded piston member are removable, col. 3, lines 37-39; also see col. 7, line 22-29, col. 10, lines 42-54. Therefore, a person skilled in the art would recognize that the reservoir, piston head and threaded piston member in the fluid delivery device in Figs. 21-22 is removable also. When the reservoir and moveable/piston being removed from the pump mechanism, therefore, during the at least one emergency element configured to be operably disconnected from the at least one moveable element when deactivated, and operably coupled to the at least one moveable element when activated.
Response to Arguments
Applicant's arguments filed 10/16/25 have been fully considered but they are not persuasive. Applicant argues that Moberg does not activate this emergency element responsive to a determination of an occlusion to provide additional force, as required in claim 1. Applicant further states that Moberg does not teach logic operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least one movable element in the dispensing direction, as required by the independent claims.
In response, Examiner provides evidence to show that Moberg clearly discloses that when the occlusion happens, the fluid pressure increases as well as the force increases. Therefore, in order to push the fluid moving forward, the system must be provided an additional force to push the fluid moving in dispensing direction.
Moberg states in col. 16, lines 44-56 that: when the occlusion was not removed, additional pressure will be generated within the fluid system… In fact, the load on the entire drive train increases as force is transferred from the motor to the slide, and the slide is constrained from movement by the stopper pressing against the fluid. Moberg further states in col 20, liens 49-50 that: when an occlusion develops within the fluid path system, the fluid pressure increases due to force applied on the fluid by the motor and drive train. An occlusion is declared if a serios of data points indicate that the force required for fluid delivery is increasing, col. 23, lines 38-39. An occlusion has occurred, the force would increase as the pressure increases, col. 32, lines 66-67.
In other words, while the pressure increases from an occlusion, the force required to move the slide forward increases. The increased pressure result in an increased force reading by the force sensor. The increased force also results in an increased drive count necessary to reach the target encoder count for each delivery pulse. Multiplying drive count and force or adding these variables increases the magnitude of occlusion indication, col. 31, lines 63- col 32, line 3.
Therefore, when the fluid pressure increase, the system (or the motor and the drive train) must be provided an extra/additional force to move the moveable element in the dispensing direction so that forcing the fluid out of the pump.
The Figs. 26, 30-31 are another evidence to show that the occlusion management system comprising logic (programming, software shows in the graphs) operative to activate the at least one emergency element responsive to a determination of an occlusion to provide additional force to move the at least moveable element so that to move the fluid in the dispensing direction.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783