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 07/07/2025 has been entered. Claims 1-2, 7, 10-11, 23, 26, 28, 30, 32, 66-75 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 05/07/2025.
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.
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 1-2, 7, 10-11, 23, 26, 28, 30, 66-69, 71, 73 are rejected under 35 U.S.C. 103 as being unpatentable over Hood (US 2007/0135798) in view of Carlisle (US 2002/0018720).
Regarding claim 1, Hood discloses an active implantable medical device (AIMD) (1950, Fig 37), comprising: a) a tubular structure comprising a first end and a second end, the first end comprising a permeability module (1964 Fig 37) to allow ingress of a fluid into an osmotic agent chamber (1956, Fig 37), b) a drug chamber module (1952, 1956, Fig 37) comprising the osmotic agent chamber, a drug chamber (1952, Fig 37) comprising a drug (1954, Fig 37) or adapted to receive a drug, and a piston (1960, Fig 37; the pressure-responsive movable barrier can be a piston as detailed in Para 0081 and Para 0157) in between the osmotic agent chamber and the drug chamber, wherein the piston is configured to slide linearly within the tubular structure (Para 0081); d) a valve module (1968, Fig 37) to allow unidirectional flow of the drug from the drug chamber to outside the AIMD through one or more drug outlet orifices present within the AIMD (Para 0153), and wherein:(i) the AIMD is electrically powered (Para 0153-0154); (ii) the permeability module allows ingress of a fluid into the osmotic agent chamber to generate an osmotic pressure (Para 0153); (iii) the valve module is configured to open and close to regulate flow of the drug from the drug chamber (Para 0153-0154).
Hood is silent regarding c) a piston position displacement module configured to measure real-time data of a linear displacement of the piston, e) an electronic module configured to control the valve module based on the real-time data of the linear displacement; (iv) a volume of the drug discharged from the AIMD is equal to the linear displacement of the piston times a cross-sectional area of the piston; and (vi) the AIMD is configured, using the piston position displacement module, the valve module and the electronic module, to provide a variation of ±25% or less in the volume of the drug discharged during successive discharges.
Carlisle teaches fluid delivery device (100, Fig 1) comprising a piston position displacement module (116, Fig 1) configured to measure a linear displacement of the piston (104, 106, Fig 2) (Para 0011, 0018), the valve module (210, Fig 2) configured to allow unidirectional flow of the drug from the drug chamber (108, Fig 2) to outside the medical device through one or more drug outlet orifices present within the medical device based on the linear displacement of the piston to regulate a dose size of the drug and an electronic component (118, Fig 1) operatively coupled to the piston position displacement module and the valve (Para 0018, 0022); and wherein; (iv) a volume of the drug discharged from the medical device is equal to the linear displacement of the piston times a cross-sectional area of the piston; and (vi) the medical device is configured, using the piston position displacement module, the valve module and the electronic component, to provide a variation of ±25% or less relative to a target dose volume of the drug discharged during successive discharges (Para 0018, 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to include a sensor and electronic component (processor) that care electrically linked to the valve as taught by Carlisle in order to provide a desired flow rate and reduce variation in flow rate (Para 0020, 0022).
Regarding Claim 2, the modified invention of Hood and Carlisle discloses the AIMD is configured to be implanted subcutaneously in a mammal (Para 0014, 0071).
Regarding Claim 7, the modified invention of Hood and Carlisle discloses all of the elements of the invention as discussed above, however, is silent regarding the AIMD further comprises a sensor module comprising a pressure sensor configured to detect changes in the osmotic pressure.
Hood further teaches in the embodiment seen in Fig 43, the AIMD further comprises a sensor module (2210, Fig 43) comprising a pressure sensor configured to detect changes in the osmotic pressure (Para 0165, “ pressure within or around the osmotic pump device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to include a pressure sensor as taught by Hood in order to better control the electromagnetic control signal and in turn better control the pumping rate (Para 0165, 0168).
Regarding Claim 10, the modified invention of Hood and Carlisle discloses the osmotic pressure generated within the osmotic agent chamber is at least equal to a predetermined value and is configured to push the piston toward the drug chamber (Para 0074 -Hood)
Regarding Claim 11, the modified invention of Hood and Carlisle discloses the sensor module is configured to detect change in an osmotic pressure (Para 0165, 0168 -Hood).
Regarding Claim 23, Hood discloses an active implantable medical device (AIMD) (1950, Fig 37), comprising: a tubular structure comprising a first end and a second end, the first end comprising a permeability module (1964 Fig 37) to allow ingress of a fluid into an osmotic agent chamber (1956, Fig 37), a drug chamber module (1952, 1956, Fig 37) comprising the osmotic agent chamber, a piston (1960, Fig 37; the pressure-responsive movable barrier can be a piston as detailed in Para 0081 and Para 0157) and a drug chamber (1952, Fig 37) comprising a drug (1954, Fig 37) or adapted to receive a drug, a valve module (1968, Fig 37) to allow flow of the drug from the drug chamber to outside the AIMD through one or more drug outlet orifices present in the AIMD (Para 0153), wherein the piston is in between the osmotic agent chamber and the drug chamber and configured to slide linearly within the tubular structure (Para 0081), wherein the AIMD has dimensions that allow the AIMD to be implanted subcutaneously in a human body (Para 0071), wherein a volume of the drug discharged from the AIMD is equal to the linear displacement of the piston times a cross-sectional area of the piston, and wherein the AIMD is configured, using the piston position displacement module, the valve module and the electronic module, to provide a variation of ±25% or less in the volume of the drug discharged during successive discharges.
Hood is silent regarding an electronic module configured to control the valve module based on real-time data of a linear displacement of the piston and a piston position displacement module configured to measure the real-time data of the linear displacement of the piston, wherein a volume of the drug discharged from the AIMD is equal to the linear displacement of the piston times a cross-sectional area of the piston, and wherein the AIMD is configured, using the piston position displacement module, the valve module and the electronic module, to provide a variation of ±25% or less in the volume of the drug discharged during successive discharges.
Carlisle teaches fluid delivery device (100, Fig 1) comprising a piston position displacement module (116, Fig 1) configured to measure a linear displacement of the piston (104, 106, Fig 2) (Para 0011, 0018), the valve module (210, Fig 2) configured to allow unidirectional flow of the drug from the drug chamber (108, Fig 2) to outside the medical device through one or more drug outlet orifices present within the medical device based on the linear displacement of the piston to regulate a dose size of the drug and an electronic component (118, Fig 1) operatively coupled to the piston position displacement module and the valve (Para 0018, 0022); and wherein; (iv) a volume of the drug discharged from the medical device is equal to the linear displacement of the piston times a cross-sectional area of the piston; and (vi) the medical device is configured, using the piston position displacement module, the valve module and the electronic component, to provide a variation of ±25% or less relative to a target dose volume of the drug discharged during successive discharges (Para 0018, 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to include a sensor and electronic component (processor) that care electrically linked to the valve as taught by Carlisle in order to provide a desired flow rate and reduce variation in flow rate (Para 0020, 0022).
Regarding Claim 26, the modified invention of Hood and Carlisle discloses electronic module is configured to control opening and closing of the valve module as according to a predetermined program set within the AIMD to regulate flow of the drug from the drug chamber.
Regarding Claim 28, the modified invention of Hood and Carlisle discloses a power module comprising a power source to power one or more components of the AIMD.
Regarding Claim 30, the modified invention of Hood and Carlisle discloses all of the elements of the invention as discussed above, however, is silent regarding the AIMD further comprises a sensor module comprising a pressure sensor configured to detect an osmotic pressure generated within the AIMD due to ingress of the fluid within the AIMD.
Hood further teaches in the embodiment seen in Fig 43, the AIMD further comprises a sensor module (2210, Fig 43) comprising a pressure sensor configured to detect changes in the osmotic pressure (Para 0165, “ pressure within or around the osmotic pump device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to include a pressure sensor as taught by Hood in order to better control the electromagnetic control signal and in turn better control the pumping rate (Para 0165, 0168).
Regarding Claim 66, the modified invention of Hood and Carlisle discloses the valve module comprises a relief valve (Para 0153 -Hood; opening of the valve relieves pressure created by the pressure generating material 1958).
Regarding Claim 67 the modified invention of Hood and Carlisle discloses the AIMD is configured to provide a variation of ±15% or less in the volume of the drug discharged during successive discharges (Para 0015, 0019 -Carlisle; the volume and dosage is precisely metered through the valve).
Regarding Claim 68, the modified invention of Hood and Carlisle discloses the valve module comprises a relief valve (Para 0153 -Hood; opening of the valve relieves pressure created by the pressure generating material 1958).
Regarding Claim 69, the modified invention of Hood and Carlisle discloses the AIMD is configured to provide a variation of ±15% or less in the volume of the drug discharged during successive discharges (Para 0015, 0019 -Carlisle; the volume and dosage is precisely metered through the valve).
Regarding Claim 71, the modified invention of Hood and Carlisle discloses the valve module is free of a motor (Para 0154 -Hood).
Regarding Claim 73, the modified invention of Hood and Carlisle discloses the valve module is free of a motor (Para 0154 -Hood).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Hood (US 2007/0135798) in view of Carlisle (US 2002/0018720) and further in view of Balaban (US 5,209,746).
Regarding Claim 32, the modified invention of Hood and Carlisle discloses all of the elements of the invention as discussed above, however, is silent regarding a diameter of the tubular structure of the AIMD is about 3 mm to 5mm.
Balaban discloses an analogous active implantable medical device (71, Fig 5) having a tubular structure wherein a diameter of the tubular structure of the AIMD is about 3 mm to 5mm (Col 9, lines 34-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer diameter of the device as taught by Balaban in order to be sized for subcutaneous implantation (Col 15, lines 6-10). Further, Hood states that the size of the device can be adapted for specific target location of the device (Para 0071).
Claims 70, 72, 74-75 are rejected under 35 U.S.C. 103 as being unpatentable over Hood (US 2007/0135798) in view of Carlisle (US 2002/0018720) and further in view of Netzel (US 2016/0220798).
Regarding Claim 70, the modified invention of Hood and Carlisle discloses all of the elements of the invention as discussed above, however, is silent regarding the valve module further comprises a stepper motor or a vibratory motor.
Netzel teaches a medical device (Device of Fig 1) comprising: a drug chamber (38, Fig 1) configured to hold a drug, and a piston (34, Fig 1) located between the drug chamber and the actuator (28, Fig 1), wherein the piston is configured to slide linearly within the tubular structure, and a valve (50, Fig 1) to allow unidirectional flow of the drug from the drug chamber to outside the medical device through one or more drug outlet orifices present within the medical device, wherein the valve further comprises a stepper motor or a vibratory motor (Para 0137-0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve to include a stepper motor in order to have a valve assembly that can provide dose control with limited range or motion, limited number of positions, or only specific positions (Para 0137).
Regarding Claim 72, the modified invention of Hood and Carlisle discloses all of the elements of the invention as discussed above, however, is silent regarding the valve module further comprises a motor.
Netzel teaches a medical device (Device of Fig 1) comprising: a drug chamber (38, Fig 1) configured to hold a drug, and a piston (34, Fig 1) located between the drug chamber and the actuator (28, Fig 1), wherein the piston is configured to slide linearly within the tubular structure, and a valve (50, Fig 1) to allow unidirectional flow of the drug from the drug chamber to outside the medical device through one or more drug outlet orifices present within the medical device, wherein the valve further comprises a stepper motor or a vibratory motor (Para 0137-0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve to include a stepper motor in order to have a valve assembly that can provide dose control with limited range or motion, limited number of positions, or only specific positions (Para 0137).
Regarding Claim 74, the modified invention of Hood and Carlisle discloses all of the elements of the invention as discussed above, however, is silent regarding the valve module further comprises a motor.
Netzel teaches a medical device (Device of Fig 1) comprising: a drug chamber (38, Fig 1) configured to hold a drug, and a piston (34, Fig 1) located between the drug chamber and the actuator (28, Fig 1), wherein the piston is configured to slide linearly within the tubular structure, and a valve (50, Fig 1) to allow unidirectional flow of the drug from the drug chamber to outside the medical device through one or more drug outlet orifices present within the medical device, wherein the valve further comprises a stepper motor or a vibratory motor (Para 0137-0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve to include a stepper motor in order to have a valve assembly that can provide dose control with limited range or motion, limited number of positions, or only specific positions (Para 0137).
Regarding Claim 75, the modified invention of Hood and Carlisle discloses all of the elements of the invention as discussed above, however, is silent regarding the valve module further comprises a stepper motor or a vibratory motor.
Netzel teaches a medical device (Device of Fig 1) comprising: a drug chamber (38, Fig 1) configured to hold a drug, and a piston (34, Fig 1) located between the drug chamber and the actuator (28, Fig 1), wherein the piston is configured to slide linearly within the tubular structure, and a valve (50, Fig 1) to allow unidirectional flow of the drug from the drug chamber to outside the medical device through one or more drug outlet orifices present within the medical device, wherein the valve further comprises a stepper motor or a vibratory motor (Para 0137-0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve to include a stepper motor in order to have a valve assembly that can provide dose control with limited range or motion, limited number of positions, or only specific positions (Para 0137).
Response to Arguments
Applicant’s argument filed 07/07/2025, on pages 7-9, regarding Hood failing to teach all of the elements of the independent claims have been fully considered but are moot in view of the current rejection that relies on Carlisle to teach the new limitations.
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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