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 6/24/2026 has been entered. Claims 77-79, 81, 84-87, 89, 91-93 and 95-102 remain pending in the application.
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.
Claims 85 and 93 are 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 original disclosure does not appear to be disclosing “device status” or “reservoir status” as being transmitted in the manner disclosed in claims 85 and 93. Therefore, original disclosure fails to provide adequate support for the claimed subject matter.
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 85 and 93 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.
Regarding claims 85 and 93, the recitation “device status, or reservoir status” is not disclosed in the original disclosure therefore, the claim is unclear if this information is being transmitted in the manner claimed in claim 85 and 93.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 80 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 80 recites the limitation which is already recited in claim 77 and therefore fails to further limit the scope of the claimed limitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 77-79, 81, 86, 87, 89, 91, 97 and 98 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2013/0184640 A1) in view of Lofgren et al. (US 2007/0060820 A1) and further in view of Hood (US 2007/0135801 A1).
Regarding claims 77 and 97, Li discloses an implantable drug delivery system 100 (paragraph 0052, lines 17-19, while examiner mostly uses figure 1, examiner will also refer to other figures as needed since figure 1 discloses main components of the drug delivery device), comprising:
an implantable device 100 (paragraph 0052, lines 17-19) configured for implantation within a body of a subject;
a drug reservoir 102 disposed within the implantable device 100 and configured to contain a drug formulation (paragraph 0043, lines 7-11);
an osmotic drive assembly 104 (paragraph 0108, lines 10-15) configured to generate osmotic pressure on a movable displacement member 204 (figure 2A) associated with the drug reservoir 210 (paragraph 0055);
a sensing assembly 113, 114; and
electronics 118, 112 (paragraph 0104, lines 10-15) configured to determine an amount of delivered drug formulation adjust at least one subsequent dosing operation based at least in part on the determined amount of delivered drug formulation (paragraph 0104, lines 15-24). Li is silent regarding a sensing assembly configured to determine displacement of the movable displacement member and electronics (are) configured to determine an (the) amount of delivered drug formulation based at least in part on displacement of the movable displacement member.
However, Lofgren teaches a design of a drug delivery system (figure 1) comprising a sensing assembly (paragraph 0049, lines 6-8) configured to determine displacement of the movable displacement member and electronics (are) (paragraph 0080, lines 4-8) configured to determine an (the) amount of delivered drug formulation based at least in part on displacement of the movable displacement member for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify a sensing assembly and electronics of Li to incorporate a sensing assembly configured to determine displacement of the movable displacement member and electronics (are) configured to determine an (the) amount of delivered drug formulation based at least in part on displacement of the movable displacement member as taught by Lofgren for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Li is further silent regarding the osmotic drive assembly comprising an osmotic agent and a semi-permeable membrane configured to permit ingress of a liquid to generate the osmotic pressure; a delivery control assembly comprising an electrically actuated valve configured to regulate release of the drug formulation from the implantable device, wherein the electrically actuated valve is located at an end of the drug reservoir wherein the liquid is a bodily fluid.
However, Hood teaches a design of an implantable device wherein the osmotic drive assembly (figure 5A) comprising an osmotic agent 70 and a semi-permeable membrane 66 configured to permit ingress of a liquid to generate the osmotic pressure; a delivery control assembly (figure 36) comprising an electrically actuated valve 1772 (paragraph 0147) configured to regulate release of the drug formulation from the implantable device, wherein the electrically actuated valve 1772 is located at an end of the drug reservoir 1756 wherein the liquid is a bodily fluid (paragraph 0071, lines 19-22, 28-30) for the purpose of delivering the drug formulation to the patient using an osmotic pump (paragraph 0070, lines 15-28) and 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 delivery control assembly of modified Li to incorporate the osmotic drive assembly comprising an osmotic agent and a semi-permeable membrane configured to permit ingress of a liquid to generate the osmotic pressure; a delivery control assembly comprising an electrically actuated valve configured to regulate release of the drug formulation from the implantable device, wherein the electrically actuated valve is located at an end of the drug reservoir wherein the liquid is a bodily fluid as taught by Hood for the purpose of delivering the drug formulation to the patient using an osmotic pump (paragraph 0070, lines 15-28) and regulating the pumping of the material (paragraph 0146, lines 19-31).
Regarding claim 78, Li discloses wherein the movable displacement member comprises a piston 204.
Regarding claim 79, Li is silent regarding wherein the sensing assembly comprises a sensor.
However, Lofgren teaches wherein the sensing assembly comprises a sensor (paragraph 0065) for the purpose of determining the piston position thereby determining the volume of the fluid delivered to the patient (paragraph 0065, paragraph 0047, lines 1-4).
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 sensing assembly to incorporate wherein the sensing assembly comprises a sensor as taught by Lofgren for the purpose of determining the piston position thereby determining the volume of the fluid delivered to the patient (paragraph 0065, paragraph 0047, lines 1-4).
Regarding claim 81, Li discloses wherein the implantable device (paragraph 0105, lines 18-23) is configured to deliver a plurality of discrete doses over a treatment period.
Regarding claim 86, Li discloses an implantable drug delivery system 100, 200 (paragraph 0052, lines 17-19, figure 2A), comprising:
an implantable housing (housing of element 200, paragraph 0052, lines 17-19) configured for implantation within a body of a subject;
a drug chamber 210 disposed within the implantable housing (housing of element 200);
an osmotic chamber 212 (paragraph 0108, lines 10-15, replacing the type of pumping to osmotic will make the chamber as an osmotic chamber) disposed within the implantable housing (housing of element 200);
a piston 204 (figure 2A) separating the drug chamber 210 and the osmotic chamber 212;
a delivery control assembly 110, 112 configured to regulate release of a drug from the drug chamber;
a sensing assembly 113, 114; and
electronics 118, 112 (paragraph 0104, lines 10-15) configured to determine an amount of delivered drug formulation; and adjust at least one dosing operation based at least in part on the determined amount of delivered drug formulation (paragraph 0104, lines 15-24). Li is silent regarding a sensing assembly being a piston-position sensing assembly configured to determine displacement of the piston and electronics configured to determine an amount of delivered drug formulation based at least in part on displacement of the piston.
However, Lofgren teaches a design of a drug delivery system (figure 1) comprising a sensing assembly which is a piston-position sensing assembly (paragraph 0049, lines 6-8) configured to determine displacement of the piston and electronics (paragraph 0080, lines 4-8) configured to determine an amount of delivered drug formulation based at least in part on displacement of the piston for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify a sensing assembly and electronics of Li to incorporate a piston-position sensing assembly configured to determine displacement of the piston and electronics configured to determine an amount of delivered drug formulation based at least in part on displacement of the piston as taught by Lofgren for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Li is further silent regarding wherein the osmotic chamber comprising an osmotic agent and a semi-permeable membrane configured to permit ingress of a liquid into the osmotic chamber.
However, Hood teaches wherein the osmotic chamber 62 (figure 5A) comprises an osmotic agent 70 and a semi-permeable membrane 66 configured to permit ingress of a liquid into the osmotic chamber for the purpose of delivering the drug formulation to the patient using an osmotic pump (paragraph 0070, lines 15-28).
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 drug delivery system of modified Li to incorporate wherein the osmotic chamber comprises an osmotic agent and a semi-permeable membrane configured to permit ingress of a liquid into the osmotic chamber as taught by Hood for the purpose of delivering the drug formulation to the patient using an osmotic pump (paragraph 0070, lines 15-28).
Regarding claim 87, modified Li discloses the claimed invention substantially asl claimed, as set forth above in claim 86. While Li discloses wherein the adjusting the at least one dosing operation comprises adjusting at least one of: dose amount, dose timing, valve actuation duration, or delivery rate (paragraph 0046, lines 1-12), Li is teaching the application in electrolysis pump instead of osmosis pump and therefore, Li is silent regarding wherein the adjusting the at least one dosing operation comprises adjusting at least one of: dose amount, dose timing, valve actuation duration, or delivery rate.
However, Hood teaches wherein the adjusting the at least one dosing operation comprises adjusting at least one of: dose amount, dose timing, valve actuation duration, or delivery rate (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 at least one dosing operation of modified Li to incorporate wherein the adjusting the at least one dosing operation comprises adjusting at least one of: dose amount, dose timing, valve actuation duration, or delivery rate as taught by Hood for the purpose of regulating the pumping of the material (paragraph 0146, lines 19-31).
Regarding claim 89, Li is silent regarding wherein the piston-position sensing assembly is configured to determine piston displacement in real time.
However, Lofgren teaches wherein the piston-position sensing assembly (paragraph 0065, capacitance changes as piston moves) is configured to determine piston displacement in real time for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the sensing assembly of Li to incorporate wherein the piston-position sensing assembly is configured to determine piston displacement in real time as taught by Lofgren for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Regarding claim 91, Li discloses wherein the implantable housing (housing of element 200) has a tubular form (see figure 2A where element 200 has a tubular form) configured for subcutaneous implantation (using an appropriate size, the device 200 could be implanted subcutaneously, alternatively at least a portion of the device could be implanted subcutaneously).
Regarding claim 98, Li is silent regarding wherein the electrically actuated valve comprises a solenoid valve.
However, Hood teaches wherein the electrically actuated valve comprises a solenoid valve (paragraph 0075) for the purpose of using a well-known valve structure to remotely actuate the valve (paragraph 0075).
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 drug delivery system of Li to incorporate wherein the electrically actuated valve comprises a solenoid valve as taught by Hood for the purpose of using a well-known valve structure to remotely actuate the valve (paragraph 0075).
Claims 84, 85, 92, 93, 96, 101 and 102 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2013/0184640 A1) in view of Lofgren et al. (US 2007/0060820 A1) in view of Hood (US 2007/0135801 A1) and further in view of Shekalim (US 2018/0200451 A1).
Regarding claim 84, Li/Lofgren/Hood (hereinafter referred as “modified Li”) discloses the claimed invention substantially as claimed, as set forth above in claim 77. Li further discloses further comprising wireless telemetry circuitry 124 but is silent regarding configured to transmit information associated with the determined amount of delivered drug formulation.
However, Shekalim teaches a design of a drug delivery device (figure 1) teaching wireless telemetry circuitry (paragraph 0074, lines 1-21) configured to transmit information associated with the determined amount of delivered drug formulation for the purpose of transmitting the information to the external device if needed (paragraph 0074, lines 1-21).
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 wireless telemetry circuitry of modified Li to incorporate configured to transmit information associated with the determined amount of delivered drug formulation as taught by Shekalim for the purpose of transmitting the information to the external device if needed (paragraph 0074, lines 1-21).
Regarding claim 85, modified Li discloses the claimed invention substantially as claimed, as set forth above in claim 77. Li further discloses displaying information regarding the device (paragraph 0048, lines 1-6) but is silent regarding wherein the transmitted information comprises at least one of: delivery information, dosing information, device status, or reservoir status.
However, Shekalim teaches wherein the transmitted information comprises at least one of: delivery information, dosing information, device status (paragraph 0074, lines 1-21), or reservoir status for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
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 transmitted information of modified Li to incorporate wherein the transmitted information comprises at least one of: delivery information, dosing information, device status, or reservoir status as taught by Shekalim for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
Regarding claim 92, Li discloses an implantable drug delivery system 100, 200 (paragraph 0052, lines 17-19, figure 2A), comprising:
an implantable drug delivery device 200 (paragraph 0052, lines 17-19) comprising:
a drug reservoir 210 disposed within the implantable drug delivery device 200;
a movable piston 204 (figure 2A) configured to displace a drug formulation from the drug reservoir 210;
a sensing assembly 113, 114;
wireless telemetry circuitry 124; and
electronics 118, 112 (paragraph 0104, lines 10-15) configured to: determine an amount of delivered drug formulation. Li is silent regarding a sensing assembly configured to determine piston displacement and electronics configured to determine an amount of delivered drug formulation based at least in part on displacement of the piston.
However, Lofgren teaches a design of a drug delivery system (figure 1) comprising a sensing assembly (paragraph 0049, lines 6-8) configured to determine piston displacement and electronics (paragraph 0080, lines 4-8) configured to determine an amount of delivered drug formulation based at least in part on displacement of the piston for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify a sensing assembly and electronics of Li to incorporate a piston-position sensing assembly configured to determine piston displacement and electronics configured to determine an amount of delivered drug formulation based at least in part on displacement of the piston as taught by Lofgren for the purpose of using a well-known alternative means to calculate the flow rate and/or volume delivered to the patient (paragraph 0049, lines 6-8, paragraph 0080, lines 4-8).
Li is further silent regarding electronics configured to transmit a wireless notification comprising information associated with the determined amount of the delivered drug formulation.
However, Shekalim teaches electronics (paragraph 0074, lines 1-21) configured to transmit a wireless notification comprising information associated with the determined amount of the delivered drug formulation for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify electronics of Li to incorporate electronics configured to transmit a wireless notification comprising information associated with the determined amount of the delivered drug formulation as taught by Shekalim for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
Li is further silent regarding wherein the drug delivery system further comprises one or more biosensors configured to detect at least one physiological parameter of a subject.
However, Hood teaches wherein the implantable drug delivery device (figure 21) further comprises one or more biosensors 1062 (claim does not require the biosensor to be present inside the drug delivery device, paragraph 0123, lines 1-11) configured to detect at least one physiological parameter of the subject for the purpose of delivering the drug formulation in response to the specific body condition to thereby treat the body condition (paragraph 0123).
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 drug delivery device of modified Li ’40 to incorporate wherein the implantable drug delivery device further comprises one or more biosensors configured to detect at least one physiological parameter of the subject as taught by Hood for the purpose of delivering the drug formulation in response to the specific body condition to thereby treat the body condition (paragraph 0123).
Regarding claim 93, Li discloses displaying information regarding the device (paragraph 0048, lines 1-6) but is silent regarding wherein the wireless notification comprises at least one of: delivery information, dosing information, device status, or reservoir status.
However, Shekalim teaches wherein the wireless notification comprises at least one of: delivery information, dosing information, device status (paragraph 0074, lines 1-21), or reservoir status for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
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 transmitted information of modified Li to incorporate wherein the wireless notification comprises at least one of: delivery information, dosing information, device status, or reservoir status as taught by Shekalim for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
Regarding claim 96, Li discloses wherein the implantable drug delivery device 200 is configured to deliver the drug formulation within ±25% of a target delivery amount (if target delivery amount is entire volume of contents filled in element 210 then the device 200 could be emptied to the target site and would be able to deliver within the claimed range).
Regarding claim 101, Li is silent regarding wherein the electronics are further configured to detect an anomaly associated with the implantable drug delivery device and to transmit, via the wireless telemetry circuitry, a notification of the anomaly.
However, Shekalim teaches wherein the electronics are further configured to detect an anomaly (paragraph 0074, lines 27-32, “empty cartridge”) associated with the implantable drug delivery device and to transmit, via the wireless telemetry circuitry, a notification of the anomaly for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
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 drug delivery device of Li to incorporate wherein the electronics are further configured to detect an anomaly associated with the implantable drug delivery device and to transmit, via the wireless telemetry circuitry, a notification of the anomaly as taught by Shekalim for the purpose of transmitting the necessary information to the external device (paragraph 0074, lines 1-21).
Regarding claim 102, Li is silent regarding wherein the one or more biosensors are configured to monitor at least one of heart rate, blood pressure, body temperature, respiratory rate, or oxygen saturation.
However, Hood teaches wherein the one or more biosensors are configured to monitor at least one of heart rate, blood pressure, body temperature (paragraph 0179, lines 1-12), respiratory rate, or oxygen saturation for the purpose of controlling the operation of the drug delivery device in response to the sensed body parameter (paragraph 0179, 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 drug delivery system of Li to incorporate wherein the one or more biosensors are configured to monitor at least one of heart rate, blood pressure, body temperature, respiratory rate, or oxygen saturation as taught by Hood for the purpose of controlling the operation of the drug delivery device in response to the sensed body parameter (paragraph 0179, lines 1-12).
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2013/0184640 A1) in view of Lofgren et al. (US 2007/0060820 A1) in view of Shekalim (US 2018/0200451 A1) in view of Hood (US 2007/0135801 A1) and further in view of Yodfat et al. (US 2012/0220939 A1).
Regarding claim 95, modified Li/Hood (hereinafter referred as “modified Li’ 40”) discloses the claimed invention substantially as claimed, as set forth above in claim 92. Modified Li ’40 is silent regarding wherein the electronics are configured to determine at least one of a dose amount, dose timing, or valve actuation duration based at least in part on: the determined amount of delivered drug formulation; and sensing data generated by the one or more biosensors.
However, Yodfat teaches wherein the electronics (paragraph 0062, lines 1-11, paragraph 0020, paragraph 0063, lines 1-11) are configured to determine at least one of a dose amount, dose timing, or valve actuation duration based at least in part on: the determined amount of delivered drug formulation; and sensing data generated by the one or more biosensors for the purpose of delivering therapeutically effective amount to the patient to treat the patient’s condition (paragraph 0020, lines 0063, lines 1-11, paragraph 0002).
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 drug delivery device to incorporate wherein the electronics are configured to determine at least one of a dose amount, dose timing, or valve actuation duration based at least in part on: the determined amount of delivered drug formulation; and sensing data generated by the one or more biosensors as taught by Yodfat for the purpose of delivering therapeutically effective amount to the patient to treat the patient’s condition (paragraph 0020, lines 0063, lines 1-11, paragraph 0002).
Allowable Subject Matter
Claims 99 and 100 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Li (US 2013/0184640 A1) in view of Lofgren et al. (US 2007/0060820 A1) in view of Hood (US 2007/0135801 A1) and further in view of Shekalim (US 2018/0200451 A1), is silent regarding wherein the sensing assembly comprises a pressure sensor configured to detect the osmotic pressure in combination with other claimed limitations of claim 99.
The closest prior art of record, Li (US 2013/0184640 A1) in view of Lofgren et al. (US 2007/0060820 A1) in view of Hood (US 2007/0135801 A1) and further in view of Shekalim (US 2018/0200451 A1), is silent regarding wherein the delivery control assembly comprises a relief valve and an actuator comprising a stepper motor or a vibration motor configured to actuate the relief valve in combination with other claimed limitations of claim 100.
Response to Arguments
Applicant's arguments filed 6/24/2026 have been fully considered but they are not persuasive.
Applicant argues on page 10, lines 1-10 that the rejection of claims 85 and 92 under 112(a) and 112(b) are moot in view of amendment involving removal of “device status” and “reservoir status”. Examiner respectfully disagrees because claims 85 and 92 are not amended in the manner discussed in the response to arguments.
Applicant argues on page 77, lines 1-last line that the amended claims overcome the prior because Li is, by its own terms, directed to “electrolysis pump” and uses the term “osmotic” one time only in the entire reference. Furthermore, applicant argues that Li does not describe structure of the osmotic pump and therefore, applicant requests to withdraw the rejection under the amended claims. Examiner respectfully disagrees. While Li is referring to “electrolysis pump” in the entire reference, Li does disclose to use osmotic pump as an option thereby indicating the one of ordinary skill in the art to use an alternative pump instead of an electrolysis pump. While Li does not describe the details of the osmotic pump, examiner has not relied upon Li for teaching additional osmotic pump structural details. Therefore, applicant’s arguments are not found persuasive. If claim is further amended to include structural details regarding how the subsequent dosing operation is adjusted then the claim could overcome the prior art of record.
Applicant further argues on page 12, lines 1-20 that Lofgren is manually operated diagnostic syringe and does not determine an amount of delivered drug. Applicant further argues that a person of ordinary skill in the art seeking to improve Li’s implanted pump would have no reason to turn to a manually-actuated intra-operative diagnostic instrument such as Lofgren since Li already determines delivered amount using its own integrated pressure/flow sensing. Examiner respectfully disagrees. Examiner views the technology for determining the amount delivered disclosed by Lofgren as being equivalent to Li’s integrated pressure/flow sensing. Therefore, according to MPEP 2144.06 (II), it is well-known to substitute equivalents known for the same purpose.
Applicant argues on page 12, line 21-page 13, line 6 that combination of Li-Lofgren and Hood fails to disclose electrically actuated valve and osmotic membrane limitation because Li’s solve valve is passive check valve preventing backflow whereas Hood’s valve is active valve and furthermore Li supplies no agent or membrane. Examiner respectfully disagrees. Li does disclose the use of osmotic pump instead of electrolysis pump without supplying any further details. Hood provides details on an osmotic pump and therefore, one of ordinary skill in the art would consider Hood to design an osmotic pump.
Applicant argues on page 13, lines 7-20 that Li fails to disclose osmotic chamber, osmotic agent and semi-permeable membrane and importing the features from Hood requires articulation to reconstruct Li’s electrolysis pump. Examiner respectfully disagrees. As stated above, in the response to arguments, Li discloses that instead of electrolysis pump, one of ordinary skill in the art could use osmotic pump but fails to disclose the details of the osmotic pump. Hood discloses the details of designing an osmotic pump. Therefore, one will be motivated to use Hood to design the Li’s device with osmotic pump.
Applicant’s arguments regarding claim 92 on page 13, line 21-page 14, line 2 are considered but are moot in view of the current 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
Prosecution Insights