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 3/19/2026 has been entered. Claims 40-49 and 67-76 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 2/12/2026.
Claim Objections
Claim 42 is objected to because of the following informalities:
Claim 42 recites the limitation “the electro-mechanical actuator” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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 40-42, 45, 49, 68-73 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 2018/0147343 A1) in view of Hood et al. (US 2007/0135801 A1).
Regarding claim 40, Tyson discloses a system 100 (figure 1), comprising: an implantable device 100 having a tubular form (see figure 1, paragraph 0024, lines 19-25) with a diameter from about 6 mm (paragraph 0024, lines 19-25, “0.25 inches” is about 6 mm) to about 12 mm (paragraph 0024, lines 19-25, “0.5 inches”), wherein the implantable device is configured to be inserted subcutaneously in a body of a subject (paragraph 0024, lines 6-11);
the implantable device 100 comprising a casing 110, a drug chamber 130 configured to hold a drug, a power source 140, electronics (electronics included in elements 150, 160, 170), a flow switch 112 comprising a valve (paragraph 0029, lines 3-7, “valve”) and at least one drug delivery orifice 111 for release of the drug from the implantable device into the body of the subject; wherein the electronics are configured to control the valve (paragraph 0034, lines 12-17, “activate drug release mechanism”, paragraph 0029, lines 3-7, “valve”, at least indirectly controlling the valve) to regulate flow of the drug from at least one drug delivery orifice; wherein the implantable device is configured to deliver the drug with a variation of no more than ±25% or less by volume (paragraph 0034, lines 12-17, “activate the drug release mechanism”); and wherein the implantable device is configured to provide a wireless notification (paragraph 0033, lines 1-10) to an external device.
However, Tyson does not expressly disclose a tubular form having a diameter from about 3 mm to about 6 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tyson to have a a tubular form having a diameter from about 3 mm to about 6 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Tyson would not operate differently with the claimed diameter and since device is intended to reside subcutaneously having a diameter between 6 mm and 12 mm, the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (specification pp. [0014]).
Tyson further discloses that the pump could be an osmotic pump (paragraph 0030, lines 5-6) but is silent regarding a semi-permeable membrane, a piston.
However, Hood teaches an implantable device (figures 5A-6B) comprising a semi-permeable membrane 66, a piston 206 for the purpose of delivering the drug using a well-known alternative pumping approach using an osmotic pump (paragraph 0070).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the implantable device of Tyson to incorporate a semi-permeable membrane, a piston as taught by Hood for the purpose of delivering the drug using a well-known alternative pumping approach using an osmotic pump (paragraph 0070).
Regarding claim 41, Tyson discloses wherein the implantable device 100 comprises:
A. the casing 110 has at least a first end (end where element 120a is present) and a second end (end where element 120b is present) opposite to the first end,
D. a second chamber (chamber where element 130 is present) comprising the drug chamber 130,
E. a third chamber (portion comprising element 111) comprising the flow switch 112 and the at least one drug delivery orifice 111,
G. a fourth chamber (chamber comprising elements 140, 150, 160, 170) comprising the electronics 140, 150, 160, 170 comprising an electronic control unit 170.
Tyson is silent regarding the semi-permeable membrane is at or near the first end, a first chamber comprising an osmotic agent, wherein one wall of the first chamber comprises the semi-permeable membrane, the piston separating the first chamber and the second chamber, wherein an osmotic pressure is configured to be built by ingress of a liquid into the first chamber through the semi-permeable membrane that displaces the piston towards the second chamber.
However, Hood teaches the semi-permeable membrane 66 is at or near the first end (end of element 200 where element 66 is present), a first chamber 62 comprising an osmotic agent 70, wherein one wall (wall formed by element 66) of the first chamber 62 comprises the semi-permeable membrane 66, the piston 206 separating the first chamber 62 and the second chamber 56, wherein an osmotic pressure (paragraph 0081, line 6-last line) is configured to be built by ingress of a liquid 71 into the first chamber through the semi-permeable membrane that displaces the piston 206 towards the second chamber for the purpose of delivering the drug using a well-known alternative pumping approach using an osmotic pump (paragraph 0070).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the implantable device of Tyson to incorporate the semi-permeable membrane is at or near the first end, a first chamber comprising an osmotic agent, wherein one wall of the first chamber comprises the semi-permeable membrane, the piston separating the first chamber and the second chamber, wherein an osmotic pressure is configured to be built by ingress of a liquid into the first chamber through the semi-permeable membrane that displaces the piston towards the second chamber as taught by Hood for the purpose of delivering the drug using a well-known alternative pumping approach using an osmotic pump (paragraph 0070).
Regarding claim 42, Tyson is silent regarding wherein the electro-mechanical actuator comprises one of an electroactive polymer and a piezo element.
However, Hood teaches wherein the electro-mechanical actuator comprises one of an electroactive polymer and a piezo element (paragraph 0075, “piezoelectric material”) for the purpose of designing control elements to control the drug delivery (paragraph 0081).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the implantable device of Tyson to incorporate wherein the electro-mechanical actuator comprises one of an electroactive polymer and a piezo element as taught by Hood for the purpose of designing control elements to control the drug delivery (paragraph 0081).
Regarding claim 45, Tyson discloses wherein the implantable device further comprises one or more biosensors 120a, 120b (paragraph 0025, lines 1-11) wherein the one or more biosensors are configured to detect at least one of a biomarker present in a human or an animal body, a concentration of the drug released from the implantable device and/or a bio-chemical parameter of the human or an animal body.
Regarding claim 49, Tyson discloses further comprising:
an implantable biosensor 120a, 120b that provides real-time monitoring of a drug level and/or a health-related biomarker (paragraph 0025); and
an artificial intelligence system (paragraph 0038) that integrates and analyzes data to optimize drug delivery in real-time; and
wherein the system 100 is configured to be an AI-based implantable drug delivery system (paragraph 0038).
Regarding claim 68, Tyson discloses wherein the wireless notification comprises transmission of at least one of a device status, a drug delivery status (paragraph 0033, lines 1-5), or a fault condition to the external device.
Regarding claim 69, Tyson discloses wherein the electronics comprise a communication module 160 (paragraph 0033, lines 1-5, “wirelessly transmitted signal”) configured for wireless communication with the external device.
Regarding claim 70, Tyson is silent regarding wherein the osmotic agent comprises a salt configured to generate osmotic pressure upon ingress of the liquid into the first chamber.
However, Hood teaches wherein the osmotic agent comprises a salt (paragraph 0155, lines 15-20) configured to generate osmotic pressure upon ingress of the liquid into the first chamber for the purpose of generating the osmotic pressure using osmotic agent to deliver the drug (paragraph 0081).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the implantable device of Tyson to incorporate wherein the osmotic agent comprises a salt configured to generate osmotic pressure upon ingress of the liquid in the first chamber as taught by Hood for the purpose of generating the osmotic pressure using osmotic agent to deliver the drug (paragraph 0081).
Regarding claim 71, Tyson is silent regarding wherein the semi-permeable membrane is configured to allow ingress of the liquid while preventing egress of the osmotic agent.
However, Hood teaches wherein the semi-permeable membrane 66 (paragraph 0106, lines 23-27) is configured to allow ingress of the liquid while preventing egress of the osmotic agent for the purpose of delivering the drug using an osmotic pump (paragraph 0081).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the implantable device of Tyson to incorporate wherein the semi-permeable membrane is configured to allow ingress of the liquid while preventing egress of the osmotic agent as taught by Hood for the purpose of delivering the drug using an osmotic pump (paragraph 0081).
Regarding claim 72, Tyson is silent regarding wherein the piston is configured to translate linearly within the casing in response to the osmotic pressure.
However, Hood teaches wherein the piston 206 is configured to translate linearly within the casing 200 in response to the osmotic pressure (paragraph 0081 and figures 5A-5B) for the purpose of delivering the drug in response to the osmotic pressure (paragraph 0081).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the implantable device of Tyson to incorporate wherein the piston is configured to translate linearly within the casing in response to the osmotic pressure as taught by Hood for the purpose of delivering the drug in response to the osmotic pressure (paragraph 0081)
Regarding claim 73, Tyson discloses wherein the flow switch is configured as an electrically controlled by the electronics (paragraph 0034, lines 12-17, “activate drug release mechanism”). However, Tyson is silent regarding an electrically actuated valve controlled by the electronics.
However, Hood teaches an electrically actuated valve controlled by the electronics (paragraph 0146, lines 19-31) for the purpose of regulating the pumping of the material (paragraph 0146, lines 19-31).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the implantable device of Tyson to incorporate an electrically actuated valve controlled by the electronics as taught by Hood for the purpose of regulating the pumping of the material (paragraph 0146, lines 19-31).
Regarding claim 76, Tyson discloses wherein the artificial intelligence system is configured to adjust a drug delivery regimen (paragraph 0056) based on data received from the implantable biosensor.
Claims 43, 44, 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 2018/0147343 A1) in view of Hood et al. (US 2007/0135801 A1) and further in view of Caffey et al. (US 2011/0270188 A1).
Regarding claim 43, Tyson/Hood (hereinafter referred as “modified Tyson”) discloses the claimed invention substantially as claimed, as set forth above in claims 40 and 41. Modified Tyson is silent regarding wherein the fourth chamber further comprises a piston position determination module, wherein the piston position determination module is configured to determine a real-time positioning of the piston and wherein the piston position determination module is based on a value comprising pressure measurement, conductance measurement, resistance measurement, reflection measurement, capacitance measurement, impedance measurement, radical measurement, image-based measurement, laser measurement, SONAR based measurement, ultrasound measurement, time of flight measurement or combinations thereof.
However, Caffey teaches a system (figure 1) wherein the fourth chamber (chamber within which electronics are located) further comprises a piston position determination module (paragraph 0080, module that calculates/determines the piston position based on element 1000), wherein the piston position determination module is configured to determine a real-time positioning of the piston and wherein the piston position determination module is based on a value comprising pressure measurement, conductance measurement (paragraph 0080, “electrically conductive”, “detectable open-circuit condition”), resistance measurement, reflection measurement, capacitance measurement, impedance measurement, radical measurement, image-based measurement, laser measurement, SONAR based measurement, ultrasound measurement, time of flight measurement or combinations thereof for the purpose of monitoring the volume inside the reservoir and reminding/alerting the user to refill when needed (paragraph 0078).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Tyson to incorporate wherein the fourth chamber further comprises a piston position determination module, wherein the piston position determination module is configured to determine a real-time positioning of the piston and wherein the piston position determination module is based on a value comprising pressure measurement, conductance measurement, resistance measurement, reflection measurement, capacitance measurement, impedance measurement, radical measurement, image-based measurement, laser measurement, SONAR based measurement, ultrasound measurement, time of flight measurement or combinations thereof as taught by Caffey for the purpose of monitoring the volume inside the reservoir and reminding/alerting the user to refill when needed (paragraph 0078).
Regarding claim 44, modified Tyson discloses the claimed invention substantially as claimed, as set forth above in claims 40 and 41. Modified Tyson is silent regarding wherein the piston position determination module interacts with the electro-mechanical actuator to control an ingress flow of the liquid inside the implantable device and an egress flow of the drug outside the implantable device.
However, Caffey teaches wherein the piston position determination module (paragraph 0077, lines 1-12, paragraph 0028, lines 1-6, “osmotic”, since the pump could include osmotic and the movement of piston is controlled based on the position of the piston, the modified Tyson in view of Caffey will have piston movement controlled through ingress of water/fluid and therefore, modified Tyson in view of Caffey will need to have the piston position determination module interacts with the electro-mechanical actuator to control an ingress flow of the liquid inside the implantable device to control an egress flow of the drug outside the implantable device) interacts with the electro-mechanical actuator to control an ingress flow of the liquid inside the implantable device and an egress flow of the drug outside the implantable device for the purpose of avoiding flow rate spikes and have the smooth flow of the drug (paragraph 0077).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Tyson to incorporate wherein the piston position determination module interacts with the electro-mechanical actuator to control an ingress flow of the liquid inside the implantable device and an egress flow of the drug outside the implantable device as taught by Caffey for the purpose of avoiding flow rate spikes and have the smooth flow of the drug (paragraph 0077).
Regarding claim 46, modified Tyson discloses the claimed invention substantially as claimed, as set forth above in claim 41. Modified Tyson is silent regarding wherein the implantable device comprises one or more sensors comprising a pressure sensor and/or conductivity sensor configured to measure the displacement of the piston.
However, Caffey teaches wherein the implantable device comprises one or more sensors comprising a pressure sensor and/or conductivity sensor (paragraph 0080, component/element that detects “open-circuit condition”) configured to measure the displacement of the piston for the purpose of monitoring the volume inside the reservoir and reminding/alerting the user to refill when needed (paragraph 0078).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Tyson to incorporate wherein the implantable device comprises one or more sensors comprising a pressure sensor and/or conductivity sensor configured to measure the displacement of the piston as taught by Caffey for the purpose of monitoring the volume inside the reservoir and reminding/alerting the user to refill when needed (paragraph 0078).
Regarding claim 47, modified Tyson discloses the claimed invention substantially as claimed, as set forth above in claim 41. Tyson further discloses an electric circuit (circuit that connects element 170 to element 112 and the component that controls the operation of element 112) connects the electro-mechanical actuator (paragraph 0034, lines 12-17, component that controls the operation of element 112) to the electronic control unit 170 in the fourth chamber to control the flow of the drug from the implantable device. Modified Tyson is silent regarding wherein an electric circuit connects the one or more sensors to the electronic control unit to control the flow of the drug from the implantable device.
However, Caffey teaches wherein an electric circuit (circuit that enables connection between element 1000 and other components that detects “open-circuit condition” to element 112, paragraph 0080) connects the one or more sensors (paragraph 0080, component/element that detects “open-circuit condition”) to the electronic control unit 112 to control the flow of the drug from the implantable device (paragraph 0077, lines 1-12) for the purpose of regulating the drug flow into the patient’s body at a desired flow rate (paragraph 0077, lines 1-12).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Tyson to incorporate wherein an electric circuit connects the one or more sensors to the electronic control unit to control the flow of the drug from the implantable device as taught by Caffey for the purpose of regulating the drug flow into the patient’s body at a desired flow rate (paragraph 0077, lines 1-12).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 2018/0147343 A1) in view of Hood et al. (US 2007/0135801 A1) and further in view of Theeuwes et al. (US 5,030,216).
Regarding claim 48, modified Tyson discloses the claimed invention substantially as claimed, as set forth above in claim 41. Modified Tyson is silent regarding wherein an egress rate of the drug release is substantially same as an ingress rate of the liquid.
However, Theeuwes discloses a design of an osmotically delivering drug delivery device wherein an egress rate of the drug release is substantially same as an ingress rate of the liquid (column 8, lines 30-50, since liquid is incompressible and pressure is kept constant to deliver constant rate of drug delivery, the egress rate and ingress rate are substantially same) for the purpose of delivering drug at a constant rate (column 8, lines 30-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Tyson ’43 to incorporate wherein an egress rate of the drug release is substantially same as an ingress rate of the liquid as taught by Theeuwes for the purpose of delivering drug at a constant rate (column 8, lines 30-50).
Modified Tyson is further silent regarding wherein the ingress rate of the liquid in the implantable device is in a range of about 0.5 µl/min to 2 µl/min.
There is no evidence of record that establishes that the ingress rate of the liquid would result in a difference in a function of modified Tyson ’43 device. Further, a person having ordinary skill in the art, being faced with modifying the ingress rate of liquid of modified Tyson would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed ingress rate of the liquid. Lastly, applicant has not disclosed that the claimed range solves any stated problem indicating that the ingress rate “may” be within the claimed range and therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 2018/0147343 A1) in view of Hood et al. (US 2007/0135801 A1) and further in view of Davey et al. (US 2018/0036522 A1).
Regarding claim 67, modified Tyson discloses the claimed invention substantially as claimed, as set forth above in claim 40. Tyson further discloses a body temperature stable drug formulation (paragraph 0017, lines 5-10). Modified Tyson is silent regarding a body temperature stable drug formulation that ensures that the drug does not degrade within the body of the subject at a body temperature of the subject for at least 6 months.
However, Davey teaches a body temperature stable drug formulation that ensures that the drug does not degrade within the body of the subject at a body temperature of the subject for at least 6 months (paragraph 0043, lines 5-7) for the purpose of using a drug that lasts longer period of time (paragraph 0043).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify a body temperature stable drug formulation of modified Tyson to incorporate a body stable drug formulation that ensures that the drug does not degrade within the body of the subject at a body temperature of the subject for at least 6 months as taught by Davey for the purpose of using a drug that lasts longer period of time (paragraph 0043).
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 2018/0147343 A1) in view of Hood et al. (US 2007/0135801 A1) in view of Caffey et al. (US 2011/0270188 A1) and further in view of Van Brunt et al. (US 2011/0020143 A1).
Regarding claim 74, modified Tyson/Van Brunt (hereinafter referred as “modified Tyson ‘43”) discloses the claimed invention substantially as claimed, as set forth above in claim 43. Modified Tyson ’43 is silent regarding wherein the piston position determination module is configured to determine the position of the piston based on pressure measurement within the implantable device.
However, Van Brunt teaches a method of controlling the fluid pump comprising wherein the piston position determination module is configured to determine the position of the piston based on pressure measurement within the device (paragraph 0041, lines 9-13) for the purpose of using a well-known alternative form of determining the piston position (paragraph 0041, lines 9-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the piston position determination module of modified Tyson ’43 to incorporate wherein the piston position determination module is configured to determine the position of the piston based on pressure measurement within the implantable device as taught by Van Brunt for the purpose of using a well-known alternative form of determining the piston position (paragraph 0041, lines 9-13).
Claim(s) 75 is rejected under 35 U.S.C. 103 as being unpatentable over Tyson (US 2018/0147343 A1) in view of Hood et al. (US 2007/0135801 A1) and further in view of Eicher et al. (US 6,132,755).
Regarding claim 75, modified Tyson discloses the claimed invention substantially as claimed, as set forth above in claims 40, 41 and 45. Modified Tyson is silent regarding wherein the one or more biosensors are configured to detect the concentration of the drug in the body of the subject.
However, Eicher teaches a design of a drug release system wherein the one or more biosensors are configured to detect the concentration of the drug of the subject (column 4, lines 53-64) for the purpose of monitoring and controlling the drug content into the patient’s bloodstream as needed (column 4, lines 53-64).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the implantable device of modified Tyson to incorporate wherein the one or more biosensors are configured to detect the concentration of the drug in the body of the subject as taught by Eicher for the purpose of monitoring and controlling the drug content into the patient’s bloodstream as needed (column 4, lines 53-64).
Response to Arguments
Applicant’s arguments with respect to claim 40 have been considered but are moot because the arguments do not apply in view of the present rejection.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783