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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 29th 2026 has been entered.
Response to Amendment
The amendment filed January 29th 2026 has been entered. Claims 1-3 and 6-20 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and the 112(a) rejection previously set forth in the Final Office Action mailed November 20th 2025.
Claim Objections
Claim 1 is objected to because of the following informalities: Regarding claim 1, all recitations of “the concentration” should be corrected to “the concentration of the ionic material” for clarity. 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.
Claim(s) 1-3, 6, 8-9, 11-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rizk (US 4639244 A), in view of Smith (US 20080058756 A1), in view of Heldal (US 20170232404 A1), and further in view of Hyde (US 20090259217 A1).
Regarding claim 1, Rizk discloses a device for delivering an ionic material (abstract), the device comprising: a storage module (reservoir 2, Fig. 1) comprising a reservoir configured to store the ionic material (reservoir chamber 4, Fig. 1); a membrane configured to pass the ionic material in a single direction based on an ionic current (membrane 8, Col 3 lines 57-67 and Col 4 lines 1-3 & Fig. 1; membrane 8 configured to pass ionic drugs in direction D caused by electrophoresis with electrodes 10 and 12 energized; membrane 8 may be an ion exchange membrane, see Col 13 lines 64-68); electrodes, disposed on a lower end of the reservoir and an upper end of the membrane, respectively, configured to form an electric field generating the ionic current (electrode 12 is being interpreted as provided on a lower end of chamber 4 and electrode 10 is being interpreted as provided on upper end of membrane 8, Fig. 1; electrodes configured to direct ions through membrane 8 under the influence of an electric field, Col 3 lines 50-60 & Fig. 1); and
a control module (electronics compartment 58, Fig. 5-6) configured to control a release amount and a release period of the ionic material passing through the membrane (“In general, such systems involve setting a basal program based on timing principals such that the batteries 60, 62 of the present system will energize the electrodes adjacent membrane 52 at a certain current level for a predetermined period of time at predetermined times during the day”, Col 10 lines 30-35; membrane 8 and 52 are synonymous; “At the end of the cycle of operation, energization of the electrodes will be terminated. Information regarding the initial quantity of the ionic drug present in the reservoir as well as the amount discharged through basal or bolus action may be stored in a separate counter. It is also desirable to have the programmer receive, upon request, signals providing information regarding the amount of material left in the reservoir. This is determined by counting the delivery pulses. This register is cleared only after refilling of the reservoir in order to give a cumulative reading of the amount of material remaining. In this way the demands for individual patients for insulin can be established,” Col 13 lines 14-27; also see Col 12 lines 54-65) by adjusting a direction and an intensity of the electric field (”If desired, for certain materials, means may be provided for reversing remotely the polarity of electrodes 10, 12 thereby causing the electrophoresis to retard the amount of ionic flow effected through diffusion” Col 4 lines 3-7; “Similarly, when the polarity of the electrodes is reversed, the current imposes a retarding effect as electrophoresis action tends to oppose the diffusion. As a result, the net delivery area drops below the rate for diffusion without any imposed current.” Col 8 lines 54-58 & Fig. 3; Fig. 3 depicts adjustments in the current imposed, intensity of the electric field, and direction and the subsequent changes in rate of delivery); and
a sensing module configured to detect a concentration of a material in a human body into which the device is inserted (a glucose sensor may be provided to sense the glucose content of blood, see Col 13 lines 59-63; based on glucose content sensed by the sensor, the pump operation may be adjusted to bring glucose content into a desired range; the glucose sensor is detecting glucose content of blood, or a concentration of glucose, in the human body; the device being implantable, see abstract), and
wherein the control module is further configured to provide feedback control by: comparing the concentration of the material with a reference concentration according to a detection result of the sensing module (“a glucose sensor may be provided so as to permit sensing of the glucose content of blood and providing a servo control to adjust the operation of the pump for departures from desired glucose blood level ranges”, Col 13 lines 59-63, the sensor providing servo control to adjust pump operation is being interpreted as providing feedback control, see Col 12 lines 54-68 and Col 13 lines 1-26; also see Col 10 lines 65-68-Col 11 line 1 and Col 8 lines 54-56; adjustment of pump operations for departures from desired glucose blood level ranges necessitates a detection result of the glucose sensor being compared to a desired glucose blood level range/set of values, a reference concentration).
Rizk further discloses that, if it is desired to provide a pump wherein diffusion is extinguished during a period when the pump is not energized electrically, an active membrane such as an ion exchange membrane may be used instead of the diffusion membrane 8 (Col 13 lines 64-68) and that the pump is particularly useful for ionic drugs such as insulin, blood thinners, antibiotics and the like, “the term "ionic drug" means ionically charged materials adapted for medical uses within a human or animal and shall expressly include, but not be limited to, insulin, peptide hormones, blood thinners, neurotrophics, antibiotics, analgesics, immunosuppresive agents and pharmaceutical materials modified to carry a charge” (Col 3 lines 11-18 and abstract).
However, Rizk fails to explicitly disclose a sensing module configured to detect a concentration of the ionic material in a human body into which the device is inserted, the membrane as a bipolar membrane,
wherein the bipolar membrane comprises a cationic polymer and an anionic polymer joined at a bonding portion, and is further configured to form a depletion layer at the bonding portion between the cationic polymer and the anionic polymer to block the ionic current when a reverse bias voltage is applied to the electrodes, and
wherein the control module is further configured to provide feedback control by: comparing the concentration of the ionic material with a reference concentration according to a detection result of the sensing module; determining any one or any combination of any two or more of a release time, a release rate, or the release amount to release the ionic material in proportion to a difference between the concentration and the reference concentration in response to the concentration being less than the reference concentration; and determining to block a release of the ionic material in response to the concentration being greater than or equal to the reference concentration.
However, Smith teaches the use of ion exchange membranes 130 and 138 in a drug delivery device (see abstract, [0003] and [0052] & Fig. 2) and that ion exchange membranes may take the form of a bipolar membrane (see [0023]), wherein the bipolar membrane comprises a cationic polymer and an anionic polymer joined at a bonding portion (“a bipolar membrane may take the form of a unitary membrane structure, a multiple membrane structure, or a laminate…. The multiple membrane structure (e.g., two film structure) may include a cation exchange membrane laminated or otherwise coupled to an anion exchange membrane.”, [0024]; the laminated connection between the cation exchange membrane and the anion exchange membrane is being interpreted as the bonding portion), and is further configured to block the ionic current (Rizk, as noted above, disclose that an ion exchange membrane may be used instead of the diffusion membrane, if it is desired to provide a pump wherein diffusion is extinguished, which is being interpreted as blocking, Col 13 lines 64-68 of Rizk; Smith teaches bipolar membranes, a type of ion exchange membrane, “substantially blocks ions based on the polarity or charge carried by the ion”, which is also being interpreted as blocking, see [0023]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the ion exchange membrane of Rizk with Smith to include a bipolar membrane wherein the bipolar membrane comprises a cationic polymer and an anionic polymer joined at a bonding portion and is further configured to block the ionic current since Smith teaches a bipolar membrane to be a suitable configuration for an ion exchange membrane, and the modification would yield predictable results pertaining to ion passage or blockage (see [0023]-[0024] of Smith).
Further, Heldal teaches a bipolar membrane capable of use with a drug delivery system (ionic diode regions 4 being bipolar ion exchange membranes comprising cation exchange membrane 10 and anion exchange membrane 12, [0195]-[0196] and [0132] & Fig. 5; “The porous membrane for electroosmotic transport may be used in a number of different applications... The pump may be used in drug delivery to or through skin.” and see [0002]; structure of the bipolar membrane, including both ion exchange membranes, may be a polymer structure, see [0067]) configured to form a depletion layer at the bonding portion between the cationic polymer and the anionic polymer to block the ionic current when a reverse bias voltage is applied to the electrodes (creating a reverse bias voltage using electrodes 6 and 8 across the bipolar membrane resulting in an ion depletion creating an area of increased resistance to the flow of ionic current, see [0196] & Fig. 5; an area of “ion depletion” is being interpreted as blockage of ionic current, as is seen and annotated in Fig. 5 below as the “DEPLETION LAYER”; the bonding portion being the area where connection between membranes 10 and 12 occurs, this connection also annotated below in annotated Fig. 5 as “BONDING PORTION”).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to configure the membrane of Rizk, as modified, with Heldal to form a depletion layer at the bonding portion between the cationic polymer and the anionic polymer to block the ionic current when a reverse bias voltage is applied to the electrodes since such a modification would provide a membrane capable of creating resistance to flow when a reverse voltage bias is applied compared to when a forward voltage bias is applied and yield predictable results pertaining to ionic current control (see [0196] of Heldal).
As modified, a bipolar membrane would be substituted in for the membrane of Rizk. The bipolar membrane, as taught by Smith, includes a cation exchange membrane, like cation exchange membrane 10 of Heldal, and an anion exchange membrane, like anion exchange membrane 12 of Heldal. The cation exchange membrane of the bipolar membrane could be provided on the same side as electrode 12, connected to cathode lead 18, of Rizk and the anion exchange membrane could be provided on the same side as electrode 10, connected to anode lead 16, of Rizk.
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Further, Hyde teaches a device for delivering an ionic material (system 100 for delivering one or more agents 162, [0086]-[0088] and [0060] & Fig. 1; agent 162 may comprise analgesics, antibiotics, hormones, peptides, and neurotrophic, which are ionic, [0086]-[0088] and [0060] and Col 3 lines 11-18 of Rizk) comprising a sensing module configured to detect a concentration of the ionic material in a human body into which the device is inserted (implantable sensor 102 configured to detect a concentration of agent 162 in the human body, [0060], [0064]-[0065], and [0091] & Fig. 1);
a control module (agent delivery control unit 146, [0072] & Fig. 1) wherein the control module is further configured to provide feedback control by:
comparing the concentration of the ionic material with a reference concentration according to a detection result of the sensing module;
determining a release time or the release amount to release the ionic material in proportion to a difference between the concentration and the reference concentration in response to the concentration being less than the reference concentration; and
determining to block a release of the ionic material in response to the concentration being greater than or equal to the reference concentration (see [0093], [0109], and [0134]-[0144] & Fig. 1-2 and 11; "one or more sensors 102 and one or more agent delivery devices 128 may act in association to maintain one or more agent 162 concentrations substantially at one or more setpoints within an individual… one or more sensors 102 may transmit one or more signals at time intervals that include information associated with the concentration of one or more agents 162 within an individual… such signals may be received by one or more agent delivery devices 128 that may administer the one or more agents 162 in response to the one or more signals… if one or more sensors 102 detect that one or more agents 162 are within a selected concentration range, then one or more agent delivery devices 128 that receive the one or more signals will not administer the one or more agents 162 to the individual. However, in some embodiments, if one or more sensors 102 detect that one or more agents 162 are below a selected concentration range, then one or more agent delivery devices 128 that receive the one or more signals will administer the one or more agents 162 to the individual." [0095]; "one or more agent delivery devices 128 may include one or more agent delivery control units 146 that are configured to maintain one or more agents 162 substantially, at one or more setpoints within an individual… an agent delivery device 128 may be configured to receive one or more signals from one or more sensors 102 and then administer one or more agents 162 in response to the one or more signals.", [0138]; "one or more agent delivery devices 128 may be calibrated to administer an amount of one or more agents 162 to an individual that will cause the concentration of the one or more agents 162 within the individual to reach a concentration that is substantially at one or more setpoints within an individual… one or more agent delivery devices 128 may be calibrated to administer an amount of one or more agents 162 to an individual that will cause the concentration of the one or more agents 162 within the individual to reach one or more concentrations that are substantially at one or more setpoints within an individual.", [0139]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Rizk, as modified, with Hyde to include a sensing module configured to detect a concentration of the ionic material, and
wherein the control module is further configured to provide feedback control by: comparing the concentration of the ionic material with a reference concentration according to a detection result of the sensing module; determining any one or any combination of any two or more of a release time, a release rate, or the release amount to release the ionic material in proportion to a difference between the concentration and the reference concentration in response to the concentration being less than the reference concentration; and determining to block a release of the ionic material in response to the concentration being greater than or equal to the reference concentration since such a modification would provide means for maintaining a desired concentration of the ionic material in the patient/user and yield the same predictable results pertaining to controlled delivery of ionic material (see [0109] and [0138]-[0140]). As modified, one or more sensors 102 of Hyde would be included with the device of Rizk and electronic unit 58 of Rizk would be modified to operate like control unit 146 of Hyde.
Regarding claim 2, Rizk, as modified, discloses all the limitations of claim 1. Rizk, as modified, further discloses the device wherein the control module is further configured to: control the ionic material to be released through the bipolar membrane (”Wires 68, 70 permit the batteries 60, 62 to energize the electrodes by way of electronics unit 58”, Col 9 lines 33-36; electronics unit 58 controlling the pump) by generating the ionic current based on a forward bias voltage provided by applying a cathode voltage to a region adjacent to a cationic polymer of the bipolar membrane and applying an anode voltage to a region adjacent to an anionic polymer of the bipolar membrane through the electrodes (“A battery 14, by means of anode lead 16 and cathode lead 18, energizes the respective electrodes 10, 12. In this arrangement, if insulin were contained within the chamber 4, as insulin is a negative ion, the membrane 8 will permit passage of the ions through the same. The direction of movement caused by electrophoresis with the electrodes energized as shown is indicated by the arrow "E".” Col 3 lines 53-60 & Fig. 1). The direction of movement E caused by energized electrodes 10 and 12 creates flow synonymous to the forward bias voltage described in Heldal (see [0196] of Heldal & Fig. 5).
As modified, a cathode voltage generated from electrode 12 and cathode lead 18 would be applied to a region adjacent to cation exchange membrane 10 and an anode voltage generated from electrode 10 and anode lead 10 would be applied to a region adjacent to anion exchange membrane 12.
Regarding claim 3, Rizk, as modified, discloses all the limitations of claim 1. Rizk further discloses the device wherein the control module is further configured to: control the ionic material not to pass through the bipolar membrane (providing means for reversing the polarity of electrodes 10 and 12 causing the electrophoresis to retard the amount of ionic flow, see Col 4 lines 4-7 and Col 8 lines 54-60 & Fig. 5; electronics unit 58 controlling the pump, see Col 9 lines 33-36). However, Rizk fails to explicitly disclose the device wherein the control module is further configured to: control the ionic material not to pass through the bipolar membrane based on the reverse bias voltage provided by applying an anode voltage to a region adjacent to a cationic polymer of the bipolar membrane and applying a cathode voltage to a region adjacent to an anionic polymer of the bipolar membrane through the electrodes.
However, Heldal further teaches blocking generation of the ionic current based on the reverse bias voltage provided by applying an anode voltage to a region adjacent to a cationic polymer of the bipolar membrane and applying a cathode voltage to a region adjacent to an anionic polymer of the bipolar membrane through the electrodes (creating a reverse bias voltage using electrodes 6 and 8 across the bipolar membrane resulting in an ion depletion creating an area of increased resistance to the flow of ionic current, see [0196] & Fig. 5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Rizk, as modified, with Heldal to include controlling the ionic material not to pass through the bipolar membrane based on a reverse bias voltage provided by applying an anode voltage to a region adjacent to a cationic polymer of the bipolar membrane and applying a cathode voltage to a region adjacent to an anionic polymer of the bipolar membrane through the electrodes since such a modification would increase resistance to the flow of ionic current, essentially “closing” the direction of current flow and yield predictable results pertaining to the control of ionic charge(see [0191]-[0192] and [0196] of Heldal).
As combined, reversing the polarity of electrodes 10 and 12 of Rizk would create the reverse bias voltage as described by Heldal and generate the depletion layer in the bonding portion of the bipolar membrane. An anode voltage would be applied to the side of bipolar membrane containing cationic exchange membrane 10 and a cathode voltage would be applied to the side of bipolar membrane containing anion exchange membrane 12.
Regarding claim 6, Rizk, as modified, discloses all the limitations of claim 1. Rizk, as modified, further discloses the device wherein the bipolar membrane comprises an anionic polymer having a first permeability to ions having same charges and a cationic polymer having a second permeability to ions having opposite charges (as modified, the bipolar membrane includes cation exchange membrane 10 and anion exchange membrane 12, see [0196] & Fig. 2a of Heldal; the membranes made of a polymer, [0068]; anion exchange membrane 12 inherently being permeable to ions having negative charge, this is being interpreted as the first permeability, and cation exchange membrane 10 inherently being permeable to ions having a positive charge, this is being interpreted as the second permeability).
However, Rizk fails to explicitly discloses the second permeability being greater than the first permeability. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second permeability be greater than the first permeability of Rizk, as modified, since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Heldal teaches that the porous layer may be formed of two porous membrane sheets having pores filled with variable percentages of cation or anion exchange material (see [0086]). Depending on the chosen percentage of filled pores, the cation exchange membrane could have a greater percentage of filled pores compared to the anion exchange membrane resulting in a greater permeability to cations – a greater second permeability compared to the first permeability.
Regarding claim 8, Rizk, as modified, discloses all the limitations of claim 1. Rizk further discloses device further comprising: a drug receptor accommodated in the reservoir, the drug receptor comprising the ionic material and an aqueous sodium chloride solution (“The reservoir is secured in the housing and has about 1 gram of insulin in slurry form in its chamber. The insulin may be crystalline insulin suspended in NaCl based buffer”, Col 4 lines 20-23; “The pump is particularly useful for ionic drugs such as insulin, blood thinners, antibiotics and the like”, abstract; “the term "ionic drug" means ionically charged materials adapted for medical uses within a human or animal and shall expressly include, but not be limited to, insulin, peptide hormones, blood thinners, neurotrophics, antibiotics, analgesics, immunosuppresive agents and pharmaceutical materials modified to carry a charge”, Col 1 lines 11-18).
Regarding claim 9, Rizk, as modified, discloses all the limitations of claim 1. Rizk, as modified, further discloses the device wherein the storage module is further configured to store an "ionic drug" or therapeutic factor (Col 3 lines 26-28), and the bipolar membrane is further configured to release the therapeutic factor based on the ionic current (see abstract). An ionic drug being ionically charged materials adapted for medical uses within a human or animal and shall expressly include, but not be limited to, insulin, peptide hormones, blood thinners, neurotrophics, antibiotics, analgesics, immunosuppressive agents and pharmaceutical materials modified to carry a charge (see Col 3 lines 14-17). Chamber 4 of Rizk would be capable of storing a cell generating and secreting a therapeutic factor.
Regarding claim 11, Rizk, as modified, discloses all the limitations of claim 1. Rizk further discloses the device wherein the electrodes comprise silver, silver chloride, or carbon (electrodes are composed of “silver/silver chloride, carbon, carbon mesh...”, Col 3 lines 48-49).
Regarding claim 12, Rizk, as modified, discloses all the limitations of claim 1. Rizk further discloses the device further comprising: a communication module (“As is shown the wires 68, 70 are preferably wound around reservoir 56. These wires are used as antennas to transmit and receive information from an external programmer. Internally the signals may be fed through blocking capacitors to the communication circuitry.”, Col 9 lines 36-41) configured to receive a control signal based on the release amount and the release period of the ionic material (“Each working register 172, 178, 184 cooperates with an associated communication register and communicates respectively by paths 174, 180, 186 with registers 170, 176, 182, which in turn are in receipt of signals from the external programmer. This system will permit the batteries to energize the electrodes so as to impose the current desired for the predetermined period of time which will be governed by the real time clock 210”, Col 13 lines 6-14 & Fig. 15; “the programmer will send a radio signal which will be received by the basal (regular) demand communication register 170 and the bolus (unusual) communication register 176”, Col 12 lines 59-62).
Regarding claim 14, Rizk, as modified, discloses all the limitations of claim 1. Rizk further discloses the device further comprising: a power supply module (batteries 60,62, Fig. 6) configured to supply power inducing the electric field (“Wires 68, 70 permit the batteries 60, 62 to energize the electrodes by way of electronics unit 58”, Col 9 lines 33-34).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rizk (US 4639244 A), in view of Smith (US 20080058756 A1), in view of Heldal (US 20170232404 A1), in view of Hyde (US 20090259217 A1), and further in view of He (CN 101264427 A).
Regarding claim 7, Rizk, as modified, discloses all the limitations of claim 6. However, Rizk fails to explicitly disclose the device wherein the anionic polymer comprises one of sulfonated polyphenylene oxide, sulfonated polyethersulfone, sulfonated polyether ether ketone, sulfonated polystyrene, phosphorylated polyphenylene oxide, phosphorylated polysulfone, and carboxylated polyethylene, and the cationic polymer comprises one of quaternized polyphenylene oxide, quaternized polysulfone, imidazolated polyphenylene oxide, quaternized polyether ether ketone, amidated polyphenylene oxide, amidated polysulfone, and amidated polyether ether ketone.
However, He teaches an anionic polymer comprises one of sulfonated polyether ether ketone or sulfonated polystyrene (“…anion exchange material containing sulfonate group or carboxylic acid group with sulfonated group or a carboxylic acid group on the chain of the polymer, wherein the polymer can be… specifically a sulfonate group or a carboxylic acid group of the anion exchange material is sulfonated polyether ether ketone, sulfonated polystyrene”, page 3 lines 15-24), and the cationic polymer comprises one of quaternized polysulfone or quaternized polyether ether ketone (”…cation exchange material containing quaternary ammonium groups is the polymer of quaternized, wherein polymer can be…the quaternary ammonium groups of the cation exchange material such as quaternized polysulfone, quaternized polyether-ether-ketone, quaternized polysulfone…”, page 3 lines 7-14).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the composition of the anionic polymer and cationic polymer of Rizk, as modified, with He to include sulfonated polyether ether ketone or sulfonated polystyrene and quaternized polysulfone or quaternized polyether ether ketone since He teaches these materials to be suitable components for anion exchange and cation exchange material (see page 3 of He).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rizk (US 4639244 A), in view of Smith (US 20080058756 A1), in view of Heldal (US 20170232404 A1), in view of Hyde (US 20090259217 A1), and further in view of Roorda (US 6283949 B1).
Regarding claim 10, Rizk, as modified, discloses all the limitations of claim 1. However, Rizk fails to explicitly discloses the device wherein the storage module comprises one of polybutylene adipate terephthalate (PBAT), polyurethane, polyethylene, polysulfone, polydimethylsiloxane, and polymethyl methacrylate.
However, Roorda teaches a storage module (drug reservoir 14, Fig. 1) comprises one of polyurethane or polyethylene (”Reservoir 14 may be made of a drug compatible material, such as silicone, polyurethane, polyacrylate, polymethacrylate, or polyethylene…”, Col 3 lines 18-23).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the storage module of Rizk, as modified, with Roorda to include the module made of polyurethane or polyethylene since Roorda teaches these materials to be suitable for use with a drug reservoir and such a modification would allow the reservoir to expand and collapse as fluid is withdrawn or added (see Col 3 lines 18-23 of Roorda).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rizk (US 4639244 A), in view of Smith (US 20080058756 A1), in view of Heldal (US 20170232404 A1), in view of Hyde (US 20090259217 A1), and further in view of Perryman (US 20140275847 A1).
Regarding claim 13, Rizk, as modified, discloses all the limitations of claim 1. However, Rizk fails to explicitly disclose the device further comprising: a wireless power reception module configured to wirelessly receive power inducing the electric field. However, Perryman teaches a device further comprising: a wireless power reception module (an implantable wireless power receiver 110 for use with a controlled drug release device, [0074] & Fig. 7; receiver 110 may also be tethered to a drug pump unit 910, [0109] & Fig. 9) configured to wirelessly receive power inducing the electric field (power receiver 110 receives radiated energy which is converted into DC power supply to provide power to the drug release device, [0074] and [0112]; power supply capable of opening a reservoir for distribution of drugs). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Rizk, as modified, with Perryman to include a wireless implantable power receiver since such a modification would extend the life of the implanted device considering the device is no longer limited by the life of a battery or the device’s ability to store charge and yield predictable results pertaining to power reception ([0004] and [0023] of Perryman).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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