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
Amendments filed 01/05/2026 have been entered.
Claims 1 and 14 have thereby been amended.
Claims 1-3, 5-7, 10-12, 14-16, 18-20, and 23-27 are being examined in this office action.
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.
Claims 1-3, 5 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 20160287785) embodiment with flow regulator 482 in view of Hung (US 10188850).
Regarding claim 1, Isaacson discloses a drug delivery system (100) comprising: a delivery container including a container body (120) adapted to accommodate a drug therein (122), an outlet port (130), and a hanging portion adjacent to a top of the delivery container (Fig. 1: triangular hanging portion at the top of 120), the delivery container configured to be supported by the hanging portion such that gravitational forces urge the drug from the outlet port (page 2, para. [0029], sentence 2); a supply line (106) operably coupled to the outlet port to deliver the drug to a user (106 coupled to 130 via drip chamber 134); a flow rate monitor (170, para. [0036], sentence 1) comprising: a user interface (190, para. [0050]); a flow rate sensor (180) that senses a flow rate of the drug within the supply line (page 3, para. [0038], sentence 3, 180 located on 106); and a flow controller (182, specified as 482 flow controller embodiment) operatively coupled to at least the flow rate sensor (186; page 3, para. [0036], sentence 2), wherein the flow controller is configured to regulate a flow rate of the drug (page 3, para. [0037], sentences 2-3), the flow controller comprising: a supply line restrictor (pinching member 412; page 7, para. [0075], sentence 2) movable between at least a first setting (first setting 434; page 7, para. [0078], sentence 1) and a second setting (second setting 436; page 7, para. [0078], sentence 2), where the supply line is more restricted when the supply line restrictor is in the second setting than in the first setting (page 7, para. [0079], sentences 3-6); and a controller (184), receiving inputs from the user interface (para. [0057], sentence 2), for adjusting the supply line restrictor between at least the first setting and the second setting in response to input from the flow rate sensor (page 5, para. [0061]). However, although Isaacson discloses the flow rate sensor as being able to be located at various other locations along the system (para. [0038], sentence 3), Isaacson fails to disclose the flow rate sensor and flow controller being located within a single housing together.
Hung teaches an analogous drug delivery system which comprises a housing (Fig. 6: housing 36) with a flow rate sensor in the housing (Fig 6: 22 within 36; col. 6, lines 14-15), and a flow controller in the housing (Fig. 6: 20 within 36; col. 6, lines 14-15). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Isaacson drug delivery system by incorporating the flow rate sensor and flow controller into a housing, as taught by Hung, in order to provide a more compact system and provide protection to the sensor and controller components.
Regarding claim 2, Isaacson in view of Hung teaches the drug delivery system of claim 1, as described above, wherein the controller is adapted to receive the input from the flow rate sensor and compare the input to a desired flow rate to calculate a difference value (page 5, para. [0060]), wherein upon the difference value exceeding a threshold value, the controller is adapted to adjust an operational parameter of the supply line restrictor (page 5, para. [0061]).
Regarding claim 3, Isaacson in view of Hung teaches the drug delivery system of claim 1, as described above, wherein the flow restrictor includes a ramped surface (430: angled relative to slot surface at arrow 432 on Fig. 4, length of 430 corresponding to length of 432) and a movable clamp (412), wherein a portion of the supply line is positioned between the ramped surface and the movable clamp (Fig. 4: 106 between 430 and 412), and wherein the flow controller includes a controller arm (418) coupled with the movable clamp and configured to move the movable clamp between at least a first position and a second position, wherein the controller arm is optionally configured to move the movable clamp along at least a length of the ramped surface (page 7, para. [0078]).
Regarding claim 5, Isaacson in view of Hung teaches the drug delivery system of claim 1, as described above, wherein the flow restrictor further includes: a ramped surface (430: angled relative to slot surface at arrow 432 on Fig. 4); and a track (slot surface at arrow 423 on Fig. 4) extending adjacent to the ramped surface; wherein the supply line restrictor is a movable clamp (412) operatively engaged with the track (Fig. 4: 412 moves along 432), wherein a portion of the supply line is positioned between the ramped surface and the movable clamp (Fig. 4: 106 between 430 and 412), and wherein the flow controller includes a motor (416) configured to rotate the movable clamp (page 7, “rolling motion” para. [0078], last sentence) and transversely move the movable clamp along the track (page 7, para. [0078]).
Regarding claim 11, Isaacson in view of Hung teaches the drug delivery system of claim 1, as described above, wherein the flow rate sensor further comprises: 1) an interface coupled to the controller to receive at least one input (190; page 4, para. [0050]); and 2) a display coupled to the controller (192).
Regarding claim 12, Isaacson in view of Hung teaches the drug delivery device of claim 1, as described above, wherein the supply line restrictor is at least one of (a) movable continuously between a plurality of non-discreet settings between the first setting and the second setting (page 7, para. [0080], sentences 1-3), or (b) movable from the first setting to the second setting, and from the second setting to the first setting.
Claims 1 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 20160287785) embodiment with cam flow regulator 582 in view of Hung (US 10188850).
Regarding claim 1, Isaacson discloses a drug delivery system (100) comprising: a delivery container including a container body (120) adapted to accommodate a drug therein (122), an outlet port (130), and a hanging portion adjacent to a top of the delivery container (Fig. 1: triangular hanging portion at the top of 120), the delivery container configured to be supported by the hanging portion such that gravitational forces urge the drug from the outlet port (page 2, para. [0029], sentence 2); a supply line (106) operably coupled to the outlet port to deliver the drug to a user (106 coupled to 130 via drip chamber 134); a flow rate monitor comprising: a user interface (190, para. [0050]); a flow rate sensor (180) that senses a flow rate of the drug within the supply line (page 3, para. [0038], sentence 3, 180 located on 106); and a flow controller (182, specified as 582 flow controller embodiment) operatively coupled to at least the flow rate sensor (186; page 3, para. [0036], sentence 2), wherein the flow controller is configured to regulate a flow rate of the drug (page 3, para. [0037], sentences 2-3), the flow controller comprising: a supply line restrictor (514 + 520) movable between at least a first setting (first setting 530; page 7, para. [0084]) and a second setting (second setting 532; page 7, para. [0084]), where the supply line is more restricted when the supply line restrictor is in the second setting than in the first setting (page 7, para. [0085]); and a controller (184) for adjusting the supply line restrictor between at least the first setting and the second setting in response to input from the flow rate sensor (page 5, para. [0061]). However, although Isaacson discloses the flow rate sensor as being able to be located at various other locations along the system (para. [0038], sentence 3), Isaacson fails to disclose the flow rate sensor and flow controller being located within a single housing together.
Hung teaches an analogous drug delivery system which comprises a housing (Fig. 6: housing 36) with a flow rate sensor in the housing (Fig 6: 22 within 36; col. 6, lines 14-15), and a flow controller in the housing (Fig. 6: 20 within 36; col. 6, lines 14-15). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Isaacson drug delivery system by incorporating the flow rate sensor and flow controller into a housing, as taught by Hung, in order to provide a more compact system and provide protection to the sensor and controller components.
Regarding claim 6, Isaacson in view of Hung teaches the drug delivery system of claim 1, as described above, wherein the flow restrictor includes a rotary dial (514), wherein a portion of the supply line is positioned adjacent to the rotary dial (Fig 5: 106 adjacent to 514), and wherein the flow controller includes an eccentric portion (522; Fig. 5) coupled with the rotary dial (522 around 514) and configured to move the rotary dial between (pages 7-8, para. [0085]) at least a first position (530) and a second position (532).
Regarding claim 7, Isaacson in view of Hung teaches the drug delivery system of claim 6, as described above, wherein the flow restrictor further includes a controller arm (524) configured to rotate the rotary dial, wherein the controller arm is configured to rotate the rotary dial along at least a rotational profile of at least 30 degrees (Fig. 5: end of 532 and end of 530 are 360 degrees from each other, therefore, 514 can rotate at least 30 degrees).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 20160287785) embodiment with flow regulator 482 in view of Hung (US 10188850) in view of Peterfreund (US 20140303591).
Regarding claim 10, Isaacson in view of Hung teaches the drug delivery system of claim 2, as described above, which further comprises an alarm operably coupled to the controller (page 8, para. [0089], last sentence) and the controller being adapted to detect the difference value exceeding a predetermined value (page 8, para. [0090]). However, Isaacson fails to explicitly disclose this alarm located on the flow controller itself, or that the alarm is triggered upon a detected rate diverging from the intended/predetermined rate.
While Isaacson-Hung does not explicitly teach the location of the alarm as on the flow controller, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have placed the alarm of Isaacson (page 8, para. [0089], last sentence) on the flow controller (182), since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device (see MPEP 2144.04 VI.C), and would allow clear and visible alerting of an undesired/unsafe flow.
Peterfreund teaches an analogous drug delivery system wherein the controller being adapted to activate the alarm upon the difference value exceeding an alarm value for the flow rate (page 5, para. [0048], sentences 3-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Isaacson-Hung alarm system by incorporating the alarm system taught by Peterfreund in order to incorporate additional safety parameters and notify users not only of completed infusions, but also if the infusion rate is too fast or too slow to ensure patient safety (page 5, para. [0048], sentences 1-2 and 4).
Claims 14-16, 18, 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 20160287785) embodiment with flow regulator 482 in view of Hung (US 10188850) in view of Schaffer (US 20180280614).
Regarding claim 14, Isaacson discloses a drug delivery system comprising (100): a delivery container including a container body (120) adapted to accommodate a drug therein (122) and an outlet port (130); a supply line (106) operably coupled to the outlet port to deliver the drug to a user (106 coupled to 130 via drip chamber 134); a flow rate monitor (170, para. [0036], sentence 1) comprising: a user interface (190, para. [0050]); a flow rate sensor (180) that senses a flow rate of the drug within the supply line (page 3, para. [0038], sentence 3, 180 located on 106); and a flow controller (182, specified as 482 flow controller embodiment) operatively coupled to at least the flow rate sensor (186; page 3, para. [0036], sentence 2), wherein the flow controller is configured to regulate a flow rate of the drug (page 3, para. [0037], sentences 2-3), the flow controller comprising: a supply line restrictor (pinching member 412; page 7, para. [0075], sentence 2) movable between at least a first setting (first setting 434; page 7, para. [0078], sentence 1) and a second setting (second setting 436; page 7, para. [0078], sentence 2), where the supply line is more restricted when the supply line restrictor is in the second setting than in the first setting (page 7, para. [0079], sentences 3-6); and a controller (184), receiving inputs from the user interface (para. [0057], sentence 2), for adjusting the supply line restrictor between at least the first setting and the second setting in response to input from the flow rate sensor (page 5, para. [0061]). However, although Isaacson discloses the flow rate sensor as being able to be located at various other locations along the system (para. [0038], sentence 3), Isaacson fails to disclose the flow rate sensor and flow controller being located within a single housing together. Isaacson also fails to disclose the container body being made of a resilient material used to urge the drug out for delivery.
Hung teaches an analogous drug delivery system which comprises a housing (Fig. 6: housing 36) with a flow rate sensor in the housing (Fig 6: 22 within 36; col. 6, lines 14-15), and a flow controller in the housing (Fig. 6: 20 within 36; col. 6, lines 14-15). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Isaacson drug delivery system by incorporating the flow rate sensor and flow controller into a housing, as taught by Hung, in order to provide a more compact system and provide protection to the sensor and controller components. However, Isaacson-Hung fails to disclose the container body being made of a resilient material used to urge the drug out for delivery.
Schaffer teaches an analogous drug delivery system with the container body (102, 110) being constructed from a resilient material (page 2, para. [0026], sentence 4) such that the container body is adapted to exert an urging force on the drug to expel the drug from the outlet port (page 2, para. [0024], sentences 2-3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery container of the Isaacson drug delivery system by incorporating the pressurized delivery container taught by Schaffer in order to deliver the drug at better controlled and predictable rates over long periods of time (page 2, para. [0027] and para. [0026], sentence 4) rather than merely relying on gravity.
Regarding claim 15, Isaacson in view of Hung in further view of Schaffer teaches the drug delivery system of claim 14, as described above, wherein the controller is adapted to receive the input from the flow rate sensor and compare the input to a desired flow rate to calculate a difference value (Isaacson: page 5, para. [0060]), wherein upon the difference value exceeding a threshold value, the controller is adapted to adjust an operational parameter of the supply line restrictor (Isaacson: page 5, para. [0061]).
Regarding claim 16, Isaacson in view Hung in further view of Schaffer teaches the drug delivery system of claim 14, as described above, wherein the flow restrictor includes a ramped surface (Isaacson: 430: angled relative to slot surface at arrow 432 on Fig. 4, length of 430 corresponding to length of 432) and a movable clamp (Isaacson: 412), wherein a portion of the supply line is positioned between the ramped surface and the movable clamp (Isaacson: Fig. 4: 106 between 430 and 412), and wherein the flow controller includes a controller arm (Isaacson: 418) coupled with the movable clamp and configured to move the movable clamp between at least a first position and a second position, wherein the controller arm is optionally configured to move the movable clamp along at least a length of the ramped surface (Isaacson: page 7, para. [0078]).
Regarding claim 18, Isaacson in view Hung in further view of Schaffer teaches the drug delivery system of claim 14, as described above, wherein the flow restrictor further includes: a ramped surface (Isaacson: 430: angled relative to slot surface at arrow 432 on Fig. 4); and a track (Isaacson: slot surface at arrow 423 on Fig. 4) extending adjacent to the ramped surface; wherein the supply line restrictor is a movable clamp (Isaacson: 412) operatively engaged with the track (Isaacson: Fig. 4: 412 moves along 432), wherein a portion of the supply line is positioned between the ramped surface and the movable clamp (Isaacson: Fig. 4: 106 between 430 and 412), and wherein the flow controller includes a motor (Isaacson: 416) configured to rotate the movable clamp (Isaacson: page 7, “rolling motion” para. [0078], last sentence) and transversely move the movable clamp along the track (Isaacson: page 7, para. [0078]).
Regarding claim 25, Isaacson in view Hung in further view of Schaffer teaches the drug delivery system of claim 14, as described above, wherein the flow rate sensor further comprises: 1) an interface coupled to the controller to receive at least one input (Isaacson: 190; page 4, para. [0050]); and 2) a display coupled to the controller (Isaacson: 192).
Regarding claim 26, Isaacson in view Hung in further view of Schaffer teaches the drug delivery system of claim 14, as described above, wherein the delivery container comprises a balloon (Schaffer: Fig. 1: 102).
Regarding claim 27, Isaacson in view Hung in further view of Schaffer teaches the drug delivery device of claim 14, as described above, wherein the supply line restrictor is at least one of (a) movable continuously between a plurality of non-discreet settings between the first setting and the second setting (page 7, para. [0080], sentences 1-3), or (b) movable from the first setting to the second setting, and from the second setting to the first setting.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 20160287785) embodiment with flow regulator 482 in view of Hung (US 10188850) in view of Schaffer (US 20180280614), in further view of Peterfreund (US 20140303591).
Regarding claim 23, Isaacson in view Hung in further view of Schaffer teaches the drug delivery system of claim 15, as described above, which further comprises an alarm operably coupled to the controller (Isaacson: page 8, para. [0089], last sentence) and the controller being adapted to detect the difference value exceeding a predetermined value (Isaacson: page 8, para. [0090]). However, Isaacson in view of Schaffer fails to explicitly disclose this alarm located on the flow controller itself, or that the alarm is triggered upon a detected rate diverging from the intended/predetermined rate.
While Isaacson in view of Hung in further view of Schaffer does not explicitly disclose the location of the alarm as on the flow controller, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have placed the alarm of Isaacson (page 8, para. [0089], last sentence) on the flow controller (182), since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device (see MPEP 2144.04 VI.C), and would allow clear and visible alerting of an undesired/unsafe flow.
Peterfreund teaches an analogous drug delivery system wherein the controller being adapted to activate the alarm upon the difference value exceeding an alarm value for the flow rate (page 5, para. [0048], sentences 3-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Isaacson alarm system by incorporating the alarm system taught by Peterfreund in order to incorporate additional safety parameters and notify users not only of completed infusions, but also if the infusion rate is too fast or too slow to ensure patient safety (page 5, para. [0048], sentences 1-2 and 4).
Regarding claim 24, Isaacson in view Hung in further view of Schaffer in further view of Peterfreund teaches the drug delivery system of claim 23, as described above, wherein the alarm value is at least partially based on a risk profile of the drug contained in the delivery container (Peterfreund: page 5, para. [0048], sentences 3-4; drug-library being the risk profile of the drug). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Isaacson alarm system by incorporating the alarm system taught by Peterfreund in order to incorporate preset drug safety parameters and notify users not only of completed infusions, but also if the infusion rate is too fast to prevent toxic overdosing (page 5, para. [0048], sentences 1-2 and 4).
Claims 14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 20160287785) embodiment with cam flow regulator 582 in view of Hung (US 10188850) in view of Schaffer (US 20180280614).
Regarding claim 14, Isaacson discloses a drug delivery system comprising (100): a delivery container including a container body (120) adapted to accommodate a drug therein (122) and an outlet port (130); a supply line (106) operably coupled to the outlet port to deliver the drug to a user (106 coupled to 130 via drip chamber 134); a flow rate monitor comprising: a user interface (190, para. [0050]); a flow rate sensor (180) that senses a flow rate of the drug within the supply line (page 3, para. [0038], sentence 3, 180 located on 106); and a flow controller (182, specified as 582 flow controller embodiment) operatively coupled to at least the flow rate sensor (186; page 3, para. [0036], sentence 2), wherein the flow controller is configured to regulate a flow rate of the drug (page 3, para. [0037], sentences 2-3), the flow controller comprising: a supply line restrictor (514 + 520) movable between at least a first setting (first setting 530; page 7, para. [0084]) and a second setting (second setting 532; page 7, para. [0084]), where the supply line is more restricted when the supply line restrictor is in the second setting than in the first setting (page 7, para. [0085]); and a controller (184) for adjusting the supply line restrictor between at least the first setting and the second setting in response to input from the flow rate sensor (page 5, para. [0061]). However, although Isaacson discloses the flow rate sensor as being able to be located at various other locations along the system (para. [0038], sentence 3), Isaacson fails to disclose the flow rate sensor and flow controller being located within a single housing together. Isaacson also fails to disclose the container body being made of a resilient material used to urge the drug out for delivery.
Hung teaches an analogous drug delivery system which comprises a housing (Fig. 6: housing 36) with a flow rate sensor in the housing (Fig 6: 22 within 36; col. 6, lines 14-15), and a flow controller in the housing (Fig. 6: 20 within 36; col. 6, lines 14-15). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Isaacson drug delivery system by incorporating the flow rate sensor and flow controller into a housing, as taught by Hung, in order to provide a more compact system and provide protection to the sensor and controller components. However, Isaacson-Hung fails to disclose the container body being made of a resilient material used to urge the drug out for delivery.
Schaffer teaches an analogous drug delivery system with the container body (102, 110) being constructed from a resilient material (page 2, para. [0026], sentence 4) such that the container body is adapted to exert an urging force on the drug to expel the drug from the outlet port (page 2, para. [0024], sentences 2-3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery container of the Isaacson drug delivery system by incorporating the pressurized delivery container taught by Schaffer in order to deliver the drug at better controlled and predictable rates over long periods of time (page 2, para. [0027] and para. [0026], sentence 4) rather than merely relying on gravity.
Regarding claim 19, Isaacson in view Hung in further view of Schaffer teaches the drug delivery system of claim 14, as described above, wherein the flow restrictor includes a rotary dial (Isaacson: 514), wherein a portion of the supply line is positioned adjacent to the rotary dial (Isaacson: Fig 5: 106 adjacent to 514), and wherein the flow controller includes an eccentric portion (Isaacson: 522; Fig. 5) coupled with the rotary dial (Isaacson: 522 around 514) and configured to move the rotary dial between (Isaacson: pages 7-8, para. [0085]) at least a first position (Isaacson: 530) and a second position (Isaacson: 532).
Regarding claim 20, Isaacson in view Hung in further view of Schaffer teaches the drug delivery system of claim 19, as described above, wherein the flow restrictor further includes a controller arm (Isaacson: 524) configured to rotate the rotary dial, wherein the controller arm is optionally configured to rotate the rotary dial along at least a rotational profile of 30 degrees or 45 degrees (Isaacson: Fig. 5: end of 532 and end of 530 are 360 degrees from each other, therefore, 514 can rotate at least 30-45 degrees).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Su (CN 202397899).
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783