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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, and 5-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michels et al (US 8,608,728) in view of Blomme et al (US 2018/0154074).
Regarding claim 1, Michels discloses a system for treating ailments associated with a liver 32 of a subject (fig 1), comprising: an implantable infusion pump, comprising: a reservoir 34/74 (fig 3) configured to house a liquid formulation; an outlet 82 in fluid communication with the reservoir (fig 3).
While Michels substantially discloses the invention as claimed, it does not disclose a monitoring device monitoring data comprising a concentration of a liquid formulation in the liver of a subject; a drive mechanism configured to control a rate at which the liquid formulation is delivered to the outlet from the reservoir; and one or more electronic components operably coupled to the drive mechanism, the one or more electronic components storing data for processing, wherein the data, when processed, causes the one or more electronic components to: transmit instructions to the drive mechanism to deliver the liquid formulation from the reservoir to the outlet at a programmable flow rate for a period of time, wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data, to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver.
Blomme discloses a monitoring device monitoring data comprising a concentration of a liquid formulation in a subject (¶118); an implantable infusion pump: comprising which has a reservoir 27 configured to house a liquid formulation; an outlet 4 in fluid communication with the reservoir (fig 1), a drive mechanism 26 configured to control a rate at which the liquid formulation is delivered to the outlet from the reservoir (¶116); and one or more electronic components 28 operably coupled to the drive mechanism (fig 1A, ¶116), the one or more electronic components storing data for processing, wherein the data, when processed, causes the one or more electronic components to: transmit instructions to the drive mechanism to deliver the liquid formulation from the reservoir to the outlet at a programmable flow rate for a period of time (¶116, ¶117), wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data (¶25, ¶47) to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver (to achieve desired amount of formulation). This allows for delivery of fluid continuously over a period of time without having to inject the fluid each time, as opposed to Michels, which is just an access port and each fluid delivery has to be injected each time. Further, as Michels teaches targeting the liver specifically, it follows that one of ordinary skill in the art would monitor a liquid concentration in the liver of a subject.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michels such that it includes a monitoring device monitoring data comprising a concentration of a liquid formulation in the liver of a subject; a drive mechanism configured to control a rate at which the liquid formulation is delivered to the outlet from the reservoir; and one or more electronic components operably coupled to the drive mechanism, the one or more electronic components storing data for processing, wherein the data, when processed, causes the one or more electronic components to: transmit instructions to the drive mechanism to deliver the liquid formulation from the reservoir to the outlet at a programmable flow rate for a period of time, wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data, to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver as taught by Blomme to allow for delivery of fluid over a period responsive to said fluid’s levels in a patent over time without having to inject the fluid each time.
Regarding claim 2, wherein the liquid formulation comprises a therapeutic molecule (Ccol.3 ll 22-23) comprising a parent molecule that has a molecular weight less than 5 kilodaltons (kDa), greater than 5 kDa, between about 5 kDa and about 15 kDa, between about 15 kDa and about 200 kDa, or greater than about 200 kDa (Applicant has claimed the entire range from less than 5kDa and greater than 5kDa such that every therapeutic molecule will meet this claim).
Regarding claim 5, while Michels substantially discloses the invention as claimed, it does not disclose the programmable flow rate comprises a flow rate of less than 500 microliters per hour. It would have been obvious to one of ordinary skill in the art, at the time of filing, to make the pump of the combined system capable of a programmable flow rate which may include a rat of less than 500 microliters per hour since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955) and so as to allow for the greatest flexibility in programming a delivery regimen.
Regarding claim 6, further comprising: a catheter 36 comprising a proximal end and a distal end (fig 1), wherein the proximal end is coupled to the outlet of the implantable infusion pump and the distal end is configured to be implanted in a target location of the subject (fig 1).
Regarding claim 7, wherein the target location of the subject comprises a hepatic artery 41 of the subject (fig 1).
Regarding claim 8, wherein the liquid formulation is delivered to the liver of the patient based at least in part on the distal end of the catheter being implanted in the hepatic artery of the subject (fig 1).
Regarding claim 9, wherein the ailment associated with the liver of the patient comprises a non-alcoholic fatty liver disease (device is capable of such, depending on which liquid formulation is used).
Regarding claim 10, while Michels substantially discloses the invention as claimed, it does not disclose an interface communicatively coupled to the one or more electronic components of the implantable infusion pump, wherein the data stored in the one or more electronic components is programmed via the interface.
Blomme discloses an interface 301 communicatively coupled to the one or more electronic components of the implantable infusion pump (¶109), wherein the data stored in the one or more electronic components is programmed via the interface (¶109).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michels such that it includes an interface communicatively coupled to the one or more electronic components of the implantable infusion pump, wherein the data stored in the one or more electronic components is programmed via the interface as taught by Blomme to allow for the programming of the device to be changed without having to remove the device.
Regarding claim 11, Michels discloses a system for treating ailments associated with a liver of a subject, comprising: an implantable infusion pump 34; a catheter 36 comprising a proximal end and a distal end (fig 1), wherein the proximal end is coupled to the implantable infusion pump and the distal end is configured to be implanted in a target location of the subject (fig 1)
While Michels substantially discloses the invention as claimed, it does not disclose a monitoring device monitoring data comprising a concentration of a liquid formulation in the liver of a subject; a processor; and a memory storing data from the monitoring device for processing by the processor, the data, when processed, causes the processor to: transmit instructions to the implantable infusion pump to deliver a liquid formulation to the liver of the subject via the catheter based at least in part on the distal end being implanted in the target location, wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or decrease the flow rate, based on the monitored data, to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver.
Blomme discloses a monitoring device monitoring data comprising a concentration of a liquid formulation in a subject (¶118); an implantable infusion pump: comprising which has a reservoir 27 configured to house a liquid formulation; an outlet 4 in fluid communication with the reservoir (fig 1), a drive mechanism 26 configured to control a rate at which the liquid formulation is delivered to the outlet from the reservoir (¶116); and one or more electronic components 28 operably coupled to the drive mechanism (fig 1A, ¶116), the one or more electronic components storing data for processing, wherein the data, when processed, causes the one or more electronic components to: transmit instructions to the drive mechanism to deliver the liquid formulation from the reservoir to the outlet at a programmable flow rate for a period of time (¶116, ¶117), wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data (¶25, ¶47) to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver (to achieve desired amount of formulation). This allows for delivery of fluid continuously over a period of time without having to inject the fluid each time, as opposed to Michels, which is just an access port and each fluid delivery has to be injected each time. Further, as Michels teaches targeting the liver specifically, it follows that one of ordinary skill in the art would monitor a liquid concentration in the liver of a subject.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michels such that it includes a monitoring device monitoring data comprising a concentration of a liquid formulation in the liver of a subject; a processor; and a memory storing data from the monitoring device for processing by the processor, the data, when processed, causes the processor to: transmit instructions to the implantable infusion pump to deliver the liquid formulation to the liver of the subject via the catheter based at least in part on the distal end being implanted in the target location, wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data, to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver as taught by Blomme to allow for delivery of fluid over a period responsive to said fluid’s levels in a patent over time without having to inject the fluid each time.
Regarding claims 12-17, see claims 2, 5 and 7-10 above.
Regarding claim 18, Michels discloses a system for treating ailments associated with a liver of a subject, comprising: an implantable infusion pump, comprising: a reservoir 34 configured to house a liquid formulation; an outlet 35/42 in fluid communication with the reservoir (fig 1)
While Michel substantially discloses the invention as claimed, it does not disclose a drive mechanism configured to control a rate at which the liquid formulation is delivered to the outlet from the reservoir; and one or more electronic components operably coupled to the drive mechanism, wherein the one or more electronic components are programmed with instructions configured to cause the liquid formulation to be delivered from the reservoir to the outlet at a programmable flow rate for a period of time to reach a steady state concentration in the liver of the subject for providing a treatment for an ailment associated with the liver.
Blomme discloses a monitoring device monitoring data comprising a concentration of a liquid formulation in a subject (¶118); an implantable infusion pump: comprising which has a reservoir 27 configured to house a liquid formulation; an outlet 4 in fluid communication with the reservoir (fig 1), a drive mechanism 26 configured to control a rate at which the liquid formulation is delivered to the outlet from the reservoir (¶116); and one or more electronic components 28 operably coupled to the drive mechanism (fig 1A, ¶116), the one or more electronic components storing data for processing, wherein the data, when processed, causes the one or more electronic components to: transmit instructions to the drive mechanism to deliver the liquid formulation from the reservoir to the outlet at a programmable flow rate for a period of time (¶116, ¶117), wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data (¶25, ¶47) to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver (to achieve desired amount of formulation). This allows for delivery of fluid continuously over a period of time without having to inject the fluid each time, as opposed to Michels, which is just an access port and each fluid delivery has to be injected each time. Further, as Michels teaches targeting the liver specifically, it follows that one of ordinary skill in the art would monitor a liquid concentration in the liver of a subject.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michels such that it includes a monitoring device monitoring data comprising a concentration of a liquid formulation in the liver of a subject; a drive mechanism configured to control a rate at which the liquid formulation is delivered to the outlet from the reservoir; and one or more electronic components operably coupled to the drive mechanism, wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data, to reach a steady state concentration in the liver of the subject for providing a treatment for an ailment associated with the liver as taught by Blomme to allow for delivery of fluid over a period responsive to said fluid’s levels in a patent over time without having to inject the fluid each time.
Regarding claim 19, further comprising: a catheter 36 comprising a proximal end and a distal end, wherein the proximal end is coupled to the outlet of the implantable infusion pump and the distal end is configured to be implanted in a hepatic artery 41 of the subject (fig 1).
Regarding claim 20, wherein the liquid formulation is delivered to the liver of the patient based at least in part on the distal end of the catheter being implanted in the hepatic artery of the subject (fig 1).
Claim(s) 3, 4, 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michels et al (US 8,608,728) in view of Blomme et al (US 2018/0154074) and Houchin et al (US 2011/0212138).
Regarding claim 3, 4, 9 and 16, while Michels substantially discloses the invention as claimed, it does not disclose the therapeutic molecule comprises a free base, a salt or a peptide; nor the therapeutic molecule comprises peroxisome proliferator-activated receptor (PPAR) gamma agonists; glucagon-like peptide-1 (GLP-1) agonists; dipeptidyl peptidase 4 (DPP4) inhibitors; apoptosis signal-regulating kinase 1 (ASK1) inhibitors; dual C-C motif chemokine receptor type 2 and 5 (CCR2/CCR5) antagonists; dual PPAR alpha and gamma agonists; cytokine inhibitors that include tumor necrosis factor (TNF) alpha; farnesoid X receptor (FXR) agonists; PPAR alpha agonists; steroyl-Co-A desaturase 1 (SCD1) inhibitors; pan caspase inhibitors; combined antagonists of leukotriene receptors, phosphodiesterases, and 5- Page 22 of 26 lipoxygenase; galectin-3 inhibitors; 5' adenosine monophosphate-activated protein kinase (AMPK)/Sirtuin 1 (Sirtl) pathway activators; or a combination thereof.
Houchin discloses non-alcoholic fatty liver disease can be treated by a GLP-1 receptor agonist (GLP-1 being a peptide).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Michels such that the therapeutic molecule comprises a GLP-1 agonist as taught by Houchin to assist in treating non-alcoholic fatty liver disease.
Response to Arguments
Applicant argues none of the references teach “a monitoring device monitoring data comprising a concentration of a liquid formulation in the liver of a subject or measuring a concentration of liquid formulation in the liver of a subject, or electronic components that “transmit instructions to the drive mechanism to deliver the liquid formulation from the reservoir to the outlet at a programmable flow rate for a period of time, wherein the instructions comprise instructions to start or stop delivery of the liquid formulation or increase or decrease the flow rate, based on the monitored data, to reach a steady state concentration in the liver for providing a treatment for an ailment associated with the liver”. While there is not explicit teaching of targeting the liver and a concentration in the liver specifically, the examiner disagrees that there is no teaching. References are not read in a vacuum, but for what they teach one of ordinary skill in the art. In the instant application, Michels discloses a desire for targeting the liver specifically for treatment via an implanted device and secondary reference Blomme teaches automatic fluid delivery via an implanted device. Among Blomme’s teachings include sensors for controlling the pump (¶118), said delivery is determined based on desired medical substance amount and the signal from the sensor (¶25, ¶47). Blomme gives glucose (¶25) and insulin (¶13) as an exemplary embodiment, but one of ordinary skill in the art would recognize that such teachings of basing drug delivery via a pump on sensor data applies to other diseases and the drugs effective to treat said diseases.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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