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 .
DETAILED ACTION
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.
Claims 5 and 15 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. “a first angle boundary” and “a second angle boundary” are indefinite because it is unclear how they relate to “the at least one angle boundary” (if they are included or separate from).
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) 1-5, 8-9, 11-15, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0055834 (Cassebee) in view of US 2022/0143303 (Russo) and DE202016003139 (Lorenz).
Regarding claim 1, 11, Cassebee teaches a drug delivery device (Fig 1), comprising: a drug container (24); a pump engaged with the drug container and adapted to deliver a therapeutic substance from the drug container to a subject (pump 26, 28; para 71); a drive system adapted to drive the pump to move the therapeutic substance from the drug container (drive system construed as the “motor” – para 71); an orientation sensor adapted to detect an orientation of the drug container relative to gravity (sensor 50 – para 70, 79-81, Fig 3; it is noted that the container 24 is part of the “pump” 20 – see para 68; thus sensing orientation of the “pump” 20 also senses orientation of the container 24); and an operation processor configured to acquire a pre-set program, and configured to determine at least one angle boundary according to a total initial volume of the therapeutic substance inside the drug container, and provide an output signal to control delivery of the therapeutic substance according to a comparison of the orientation of the drug container with the at least one angle boundary (processor of controller 36 – para 3-4, 70, 79-81, 84-104; Fig 3; the “program” is construed as the set of instructions that determine and indicate acceptable or unacceptable orientation; the at least one angle boundary includes the limits of the “predefined range of predetermined acceptable orientation”; output signal would control the indication – e.g. the light, sound, or vibration; as shown in Fig 3, the range of acceptable orientations depends on the fill volume of the substance inside the container; for the purposes of the claim, the acceptable orientation range at the start – e.g. the “total initial volume” – includes the “at least one angle boundary), and an alarm system, based on the output signal from the operation processor, and adapted to provide an interface output to inform users a delivery status of the therapeutic substance (para 84-104; alarm system comprising the indication – e.g. the light, sound, or vibration; interface output comprising the display 40 – para 97), wherein the at least one angle boundary defines a boundary curve having a delivery initiation angle and a delivery ending angle (implicit; there is an initiation angle – e.g. the angle where initiation occurs – and an ending angle – e.g. the angle where delivery ends; the claim does not define what those values are or how they limit the structure of the apparatus); wherein an angle difference between the delivery initiation angle and the delivery ending angle is smaller than a predefined threshold for the at least one angle boundary (implicit; the difference between the delivery initiation angle and the delivery ending angle is smaller than a “predefined threshold”; the claim does not define what the predefined threshold is, how it is calculated, or how the difference or the predefined threshold limit the structure of the apparatus; the “predefined threshold”, may be construed as some chosen value that is greater than the difference between the delivery initiation angle and the delivery ending angle). Further, it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" (see MPEP 2114 [R-1]). In this case, the delivery initiation angle, the delivery ending angle, and the angle difference between the delivery initiation angle and the delivery ending angle is smaller than a predefined threshold for the at least one angle boundary does not differentiate the claimed apparatus.
Cassebee fails to teach the pump being a peristaltic pump. However, Russo teaches a drug delivery device comprising a peristaltic pump and a drive system (para 16-17, 75, drive motor 244). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the pump a peristaltic pump driven by a drive motor, as taught by Russo. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the pump a peristaltic pump driven by a drive motor, yields predictable results (drug delivery).
Cassebee teaches an operation processor acquired a pre-set program, and configured to determine at least one angle boundary according to a total initial volume of the therapeutic substance inside the drug container, and provide an output signal to control delivery of the therapeutic substance according to a comparison of the orientation of the drug container with the at least one angle boundary as discussed above. However, Lorenz is further cited for teaching that it was known in the art to provide an operation processor acquired a pre-set program, and configured to determine at least one angle boundary according to a total initial volume of the therapeutic substance inside the drug container, and provide an output signal to control delivery of the therapeutic substance according to a comparison of the orientation of the drug container with the at least one angle boundary (see pages 4-8 of the translation; “at least one inclination sensor can in this case be arranged such that an orientation of the active substance container relative to the vertical is detected”; “the determined level in the drug container 13 but also be used to change the limits of the aforementioned allowable slope range, in particular such that the lower the level is set, the lower the allowable inclination relative to the vertical”). It would have been obvious to one of ordinary skill in the art at the time of the invention to determine at least one angle boundary according to a total initial volume of the therapeutic substance inside the drug container, and provide an output signal to control delivery of the therapeutic substance according to a comparison of the orientation of the drug container with the at least one angle boundary in order to determine the proper orientations and allow for proper delivery of the drug, as taught by Lorenz.
Regarding claim 2-3, 12-13, Cassebee in view of Russo and Lorenz further teaches the drug container is a vial made by hard materials, and the peristaltic pump takes out the therapeutic substance from the vial by suction (Cassebee para 73-75, 80-81; Russo para 8, 10), the orientation sensor acquires the orientation of the drug container by detecting an angle difference between a longitudinal direction of the drug container and a direction of the gravity (Cassebee para 70, 81, Fig 3; orientation relative to gravity implicitly comprises the angle difference between a longitudinal direction of the drug container 24 and direction of gravity g; as annotated below). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the drug container a vial made by hard materials, in order to save time, money, and resources, as taught by Russo.
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Regarding claim 4, 14, Cassebee in view of Russo and Lorenz further teaches the operation processor acquires the pre-set program containing specific parameters, comprises the delivered volumes and/or time progression of the delivery of the therapeutic substance (Cassebee, para 3-4, 79-81, 84-104; Fig 3; the “program” is construed as the set of instructions that determine and indicate acceptable or inacceptable orientation, which is a function of delivered volume of the therapeutic substance and the orientation in order to determine when conduit 38 is in communication with the drug 22 inside the container; positions A-E have a different volume/delivered volume than F-J, and thus different ranges of acceptable orientation).
Regarding claim 5, 15, Cassebee in view of Russo and Lorenz further teaches wherein the operation processor defines a first angle boundary and a second angle boundary in accordance with the specific parameters (para 84-104; Cassabee teaches multiple levels of alerts; for example, “a bullseye level including concentric rings, with illumination of a center-most one of the rings (or a central circle within concentric rings) being indicative of the pump 20 being determined to be within the predefined range of predetermined acceptable orientations with each one of the rings successively closer to the center ring (or center circle) being indicative of the pump 20 being determined to be closer to the predefined range of predetermined acceptable orientations” – para 86; each ring of the concentric rings would represent a different angle boundary; for example, the “first angle boundary” may be the inner, center-most ring and the “second angle boundary” may be the outermost ring – e.g. farthest from an acceptable orientation; the same can be applied to the other modes – e.g. sound alerts or vibration alerts, each having multiple levels/boundaries).
Regarding claim 8-9, 17-19, Cassebee in view of Russo and Lorenz further teaches the operation processor acquires the pre-set program containing the specific parameters, the operation processor maintains the delivery of the therapeutic substance when the orientation of the drug container is smaller than or equal to the first angle boundary (as discussed above, being within/smaller than the inner center-most ring is indicative of being within the acceptable orientation range, thereby allowing delivery), the alarm system comprises a single or a plurality of alarm units, the operation processor activates the alarm units to output an alarm signal or a combined alarm signal in response to the orientation greater than the first angle boundary but smaller than or equal to the second angle boundary, and the operation processor maintains the delivery of the therapeutic substance (para 84-104; Cassabee teaches multiple levels of alerts; the alerts at a middle level – e.g. a middle ring between the first boundary and the second boundary – are construed as “an alarm signal” in response to the orientation greater than the first angle boundary but smaller than or equal to the second angle boundary; it is noted that the claim does not require maintaining delivery in response to the orientation greater than the first angle boundary but smaller than or equal to the second angle boundary), wherein the operation processor is further adapted to maintain the delivery of the therapeutic substance and not actuate the alarm system in response to the orientation smaller than or equal to the first angle boundary (Cassabee para 94; “an audio signal is provided to indicate that the pump 20 is determined to be within the predefined range of predetermined acceptable orientations, the control circuitry 36 can be configured to stop the audio signal in response to the start of drug delivery, e.g., in response to a ‘start’ button being pushed on the pump 20, since the pump 20 is at the desired orientation”), the drug delivery device further comprises a memory unit electrically connected to the operation processor, the operation processor acquires the specific parameters for searching the first angle boundary and the second angle boundary in accordance with the specific parameters from the memory unit (para 79, 93, 152; acceptable orientations stored in a memory of the controller 36).
Claim(s) 6, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0055834 (Cassebee) in view of US 2022/0143303 (Russo) and DE202016003139 (Lorenz), and further in view of US 2022/0233757 (Visser).
Regarding claim 6, 16, Cassebee in view of Russo and Lorenz teaches the operation processor acquires the pre-set program containing the specific parameters and the alarm system comprises a single or a plurality of alarm units, the operation processor activates the alarm units to output an alarm signal or a combined alarm signal in response to the orientation greater than the second angle boundary (Cassabee; para 91; “the vibrating mechanism can be configured as an electronic level with vibration of the vibrating mechanism being greater the farther the pump 20 is from the predefined range of predetermined acceptable orientations and the vibrating mechanism not vibrating when the pump 20 is determined to be within the predefined range of predetermined acceptable orientations”; in this case, processor activates the alarm unit – e.g. a greater vibration – in response to orientation greater than the second angle boundary – e.g. farther from the acceptable orientation) but fails to explicitly teach, the operation processor pauses the delivery of the therapeutic substance when the orientation of the drug container is greater than the second angle boundary. However, Visser teaches that it was known in the art to pause delivery when orientation is unacceptable (para 19). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the processor pause the delivery of the therapeutic substance when the orientation of the drug container is greater than the second angle boundary, as taught by Visser. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, the processor pausing the delivery of the therapeutic substance when the orientation of the drug container is greater than the second angle boundary yields predictable results (drug delivery during desired conditions/orientations).
Claim(s) 7, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0055834 (Cassebee) in view of US 2022/0143303 (Russo) and DE202016003139 (Lorenz), and further in view of US 2013/0085443 (Lowery).
Regarding claim 7, 17, Cassebee in view of Russo and Lorenz further teaches the operation processor acquires the pre-set program containing the specific parameters (Cassebee para 3-4, 79-81, 84-104; Fig 3; the “program” is construed as the set of instructions that determine and indicate acceptable or inacceptable orientation, which is a function of delivered volume of the therapeutic substance and the orientation in order to determine when conduit 38 is in communication with the drug 22 inside the container), the alarm system comprises a single or a plurality of alarm units, the operation processor activates the alarm units to output an alarm signal or a combined alarm signal in response to the orientation greater than the first angle boundary but smaller than or equal to the second angle boundary (para 84-104; Cassabee teaches multiple levels of alerts; the alerts at a middle level – e.g. a middle ring between the first boundary and the second boundary – are construed as “an alarm signal” in response to the orientation greater than the first angle boundary but smaller than or equal to the second angle boundary) but fails to explicitly teach the operation processor maintains the delivery of the therapeutic substance when the orientation of the drug container is smaller than or equal to the second angle boundary. However, Lowery teaches that it was well known in the art to continue delivery of a therapeutic substance after a first angle boundary but before a second angle boundary (Fig 6, para 76-80; tilt/orientation angle exceeds a first angle boundary – e.g. the warning threshold – but is less than a second angle boundary – the “alarm condition”, which stops flow). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the operation processor maintains the delivery of the therapeutic substance when the orientation of the drug container is smaller than or equal to the second angle boundary, as taught by Lowery. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, the operation processor maintaining the delivery of the therapeutic substance when the orientation of the drug container is smaller than or equal to the second angle boundary yields predictable results (drug delivery during desired conditions/orientations). Furthermore, Cassabee teaches that it was known in the art to take different actions at different levels of orientation (para 84-104). Determining the appropriate levels of warnings, alerts, and control of the therapeutic substance would have been within the level of ordinary skill in the art and obvious in order to deliver the therapeutic substance, provide information to the user, and prevent air entry.
Response to Arguments
Applicant's arguments filed 9/1/26 have been fully considered but they are not persuasive.
With regards to Applicant’s argument that “Cassebee is directed to determining whether the pump 20 is in the desired orientation and providing the user feedback”, Examiner respectfully asserts that Cassebee implicitly comprises an initiation angle – e.g. the angle where initiation occurs – and an ending angle – e.g. the angle where delivery ends; the claim does not define what those values are or how they limit the structure of the apparatus.
With regards to Applicant’s argument that “Cassebee does not disclose or suggest the technical feature of ‘the boundary-curve having a delivery initiation angle and a delivery ending angle, with an angle difference between the delivery initiation angle and the delivery ending angle being smaller than a predefined threshold’ of the present application”, Examiner respectfully disagrees. The claims do not define how any of the values are defined or how they limit the structure of the apparatus. For example, a “predefined threshold” may be construed as some number that is greater than the difference between the delivery initiation angle and the delivery ending angle. Furthermore, it is noted that a “curve” was well known in the art as a function that can remain constant, increase, and/or decrease (see for example US 2020/0147301 para 161: “the drive threshold curve can remain constant, increase, and/or decrease as a function of time”). The “boundary curve” may therefore comprise a delivery initiation angle and a delivery ending angle that are constant, increasing, or decreasing.
Allowable Subject Matter
Claims 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW NGUYEN whose telephone number is (571)270-5063. The examiner can normally be reached 8 am - 4 pm, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat (Pat) Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741
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