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 .
In light of the amendments to the claims filed 10/03/2025 in which claims 1, 4-7, 13, and 15-17 were amended, claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims no priority.
Claims 1-20 receive the filing date of the instant application, 05/10/2023.
Response to Arguments
Objections to the Drawings
The objections to the drawings are withdrawn in view of the applicant arguments filed 10/03/2025.
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 10/03/2025.
Rejections of the Claims under 35 U.S.C. 102(a)(1) and 103
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claims 1 and 17, the applicant asserts on pg. 9-12 that the prior art to Kim and Gutierrez fail to disclose the newly added limitations.
In response to the applicant’s argument, the examiner respectfully notes that the prior art to Kim and Gutierrez were not used in the previous rejection filed 07/03/2025 to read on the newly added limitations. Further, the applicant asserts that Kim encourages the exact opposite of creating an integrated device by separately installing the alleged PDCM and alleged ECM components while leaving a “wire receiving part” open for later installation of the wire. The applicant points to para. 0063 of Kim for the disclosure of later installation of the wire. There is no disclosure in Kim of when the wire is installed in the system. Further still, the installation of the wire may be considered to create the integrated device between the alleged PDCM and alleged ECM in Kim as supported by the applicant’s disclosure (para. 0004) that states “[a]n integrated device can be created by mating an interconnect interface of an ECM to a passive interconnect interface of a PDCM; and forming an electrical connection between the interconnect interface of the ECM to the passive interconnect interface of the PDCM.”
The amendments to the claims have necessitated new grounds of rejection.
Regarding amended claim 7, the applicant asserts on pg. 13 that the prior art to Gutierrez fails to disclose the newly added limitations.
In response to the applicant’s argument, the examiner respectfully notes that the prior art to Gutierrez was not used in the previous rejection filed 07/03/2025 to read on the newly added limitations. Further, the applicant asserts that as Gutierrez describes a fixed connection between the electronics module (270; a component part of the ECM) and the controlled release mechanism (280; a component part of the PDCM), these elements are not modular. As explained in the previous Office Action filed 07/03/2025, the components of the ECM may be provided on a separate substrate or within a housing on a separate substrate from the components of the PDCM (Gutierrez: para. 0058). These elements may be considered to be modular in manufacturing as they are separate components that may be combined into an integrated system by connection of the electronics module (270) to the controlled release mechanism (280) by the circuits (275).
The amendments to the claim have necessitated new grounds of rejection.
Claim Rejections - 35 USC § 112
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.
Claim 4 is 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.
Claim 4 recites the limitation “a substrate” in ln. 3. This limitation is indefinite in that it is unclear whether this is the same substrate as that discloses in claim 1, which claim 4 is dependent upon. For the sake of compact prosecution, the examiner is treating the claim as though it reads “the substrate”.
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.
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, 5, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US/2020/0138702 A1 to Kim in view of US/2020/0214887 A1 to Gutierrez.
Regarding claim 1, Kim discloses a method comprising:
providing a primary drug container module (PDCM), the PDCM comprising a substrate, a first interconnect interface, and at least one reservoir disposed within the substrate (para. 0014; para. 0064, elements of 220 will be understood with reference to Fig. 1C; Fig. 2A, first left side PDCM; Fig. 2A, PDCM comprising components of substrate 220 [referred to as reservoir in application because it comprises drug receiving reservoir as can be seen in Fig. 1C] and electrode 230 acts as an interconnect interface; Fig. 1C, substrate 20 comprising support surface 23, drug receiving reservoir 21, and supply surface 27 comprising supply holes 27a);
securing at least one drug in the at least one reservoir (para. 0038; para. 0044; para. 0064; Fig. 1C, drug is secured within substrate 20 between support surface 23 and supply surface 27 such that it can only be supplied through supply holes 27a);
creating an integrated device (Fig. 2A, integrated device 200) comprising:
mating a second interconnect interface of an electronic control module (ECM) to the first interconnect interface (para. 0014; Fig. 2A, electronic leads 245 provide a connection between activation chip 240 first interconnect interface of ECM and electrode 230 interconnect interface of first left side PDCM); and
forming an electrical connection between the interconnect interface of the ECM to the passive interconnect interface of the PDCM (para. 0014; Fig. 2A, electronic leads 245 provide a connection between activation chip 240 first interconnect interface of ECM and electrode 230 interconnect interface of first left side PDCM), wherein the ECM is active (para. 0014; para. 0077-0080; Fig. 2A, ECM comprising components of activation chip 240, transmitting structure 250, and power storage 260; components of ECM generate electronic activated stimulus to PDCM) and the PDCM is passive (para. 0064, elements of 220 will be understood with reference to Fig. 1C; Fig. 2A, first left side PDCM; Fig. 2A, PDCM comprising components of substrate 220 [referred to as reservoir in application because it comprises drug receiving reservoir as can be seen in Fig. 1C] and electrode 230 acts as an interconnect interface; Fig. 1C, substrate 20 comprising support surface 23, drug receiving reservoir 21, and supply surface 27 comprising supply holes 27a; without connection of PDCM components to ECM, PDCM components may not receive a stimulus to activate iontophoresis and are therefore dependent upon the active provision of stimulus from the ECM); and
integrating the ECM and the PDCM at least partially within a body of an ophthalmic device (para. 0033-0055, ophthalmic device 100; para. 0059-0074, ophthalmic device 200).
Kim differs from the instantly claimed method in that Kim fails to explicitly disclose creating an integrated device after securing the at least one drug in the at least one reservoir.
Kim seems to suggest the timing of creating an integrated device after securing the drug in the reservoir, as Kim discloses that the electrode (30/230) may be installed in the reservoir/substrate (20/220) to load the drugs from the reservoir/substrate (20/220) to the eye seemingly indicating that the drugs are already loaded in the electrode before installation to create the PDCM (para. 0038-0039; para. 0064-0065) and that the electrode (30/230) is electrically connected through wire (45/245) to the activation chip (40/240) to activate iontophoresis by creating the integrated device of the ECM and the PDCM (para. 0048; para. 0073; para. 0033-0055, ophthalmic device 100; para. 0059-0074, ophthalmic device 200).
Gutierrez teaches an integrated ophthalmic device comprising electronic components and drug reservoirs encapsulated entirely within an ophthalmic device to provide polymeric passive transport as an adjunct to iontophoresis to provide controlled release mechanisms (Fig. 7D showing integrated electronic components power source 760, capacitor 762, WiFi antenna 765, and electronics module 767 and drug reservoir components 725 filled with therapeutic agents 730 covered by thin film electrode 780 encapsulated within body of overmold polymer layer 775; para. 0061).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the integrated device of Kim to further be encapsulated entirely within a similar ophthalmic device as taught by Gutierrez, because Gutierrez teaches the use of a polymeric passive transport ophthalmic device as an adjunct to iontophoresis (which Kim uses for drug delivery) to provide controlled release in constant doses over long periods, cyclic dosage, and tunable release (para. 0061).
Regarding claim 5, the cited prior art suggests the method of claim 1. Kim further discloses: mating a third interconnect interface of the ECM with a passive interconnect interface of a second PDCM (para. 0014; Fig. 1A, electronic leads 45 provide a connection between activation chip 40 third interconnect interface of ECM and electrode 30 interconnect interface of second right side PDCM; Fig. 2A, electronic leads 245 provide a connection between activation chip 240 third interconnect interface of ECM and electrode 230 interconnect interface of second right side PDCM); and forming an electrical connection between the third interconnect interface of the ECM to the fourth interconnect interface of the second PDCM (para. 0014; Fig. 1A, electronic leads 45 provide a connection between activation chip 40 first interconnect interface of ECM and electrode 30 interconnect interface of second right side PDCM; Fig. 2A, electronic leads 245 provide a connection between activation chip 240 third interconnect interface of ECM and electrode 230 interconnect interface of second right side PDCM).
Regarding claim 17, Kim discloses a method comprising:
choosing a first primary drug container module (PDCM) for a patient based on a disorder of an eye of the patient and at least one drug stored in the first PDCM (para. 0004-0012, drugs are specific to eye disorders; para. 0064-0065, drug stored in receiving part of 220 reservoirs), the first PDCM comprising a substrate, a third interconnect interface, and at least one reservoir disposed within the substrate (para. 0014; para. 0064, elements of 220 will be understood with reference to Fig. 1C; Fig. 2A, first left side PDCM; Fig. 2A, PDCM comprising components of substrate 220 [referred to as reservoir in application because it comprises drug receiving reservoir as can be seen in Fig. 1C] and electrode 230 acts as an interconnect interface; Fig. 1C, substrate 20 comprising support surface 23, drug receiving reservoir 21, and supply surface 27 comprising supply holes 27a);
securing at least one drug in the at least one reservoir (para. 0038; para. 0044; para. 0064; Fig. 1C, drug is secured within substrate 20 between support surface 23 and supply surface 27 such that it can only be supplied through supply holes 27a);
choosing at least a second PDCM for the patient based on the disorder of the eye of the patient and at least one drug stored in the second PDCM (para. 0004-0012, drugs are specific to eye disorders; para. 0064-0065, drug stored in receiving part of 220 reservoirs; Fig. 1A or 2A, second right side PDCM);
mating the third interconnect interface of the first PDCM to a first interconnect interface of an electronic control module (ECM) to form an integrated device (para. 0014; Fig. 2A, 245 electronic leads provide a connection between 240 activation chip first interconnect interface of ECM and 230 electrode interconnect interface of first left side PDCM),
mating the at least the second PDCM to at least a second interconnect interface of the ECM to add to the integrated device (para. 0014; Fig. 1A, 45 electronic leads provide a connection between 40 activation chip first interconnect interface of ECM and 30 electrode interconnect interface of second right side PDCM; Fig. 2A, electronic leads 245 provide a connection between activation chip 240 third interconnect interface of ECM and electrode 230 interconnect interface of second right side PDCM); and
integrating the ECM and the PDCM at least partially within a body of an ophthalmic device (para. 0033-0055, ophthalmic device 100; para. 0059-0074, ophthalmic device 200).
Kim differs from the instantly claimed invention in that Kim fails to explicitly disclose wherein the first and second PDCM comprise a drug and at least one other drug.
Gutierrez teaches the use of the same or different drugs within the reservoirs of the PDCM (para. 0022; para. 0049).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the drugs contained in the PDCMs of Kim to comprise first and second drugs as taught by Gutierrez, because Gutierrez teaches that the therapeutic agents of their invention may be any of a single or a combination of therapeutic agents as desired by a user (para. 0049) and that the large area of the outer surface of the eye allows for delivery of neuroprotective agents, antioxidants, angiostatic agents, and anti-vascular endothelial growth factors for treatment benefit of many different diseases (para. 0054).
Further, Kim differs from the instantly claimed method in that Kim fails to explicitly disclose creating an integrated device after securing the at least one drug in the at least one reservoir.
Kim seems to suggest the timing of creating an integrated device after securing the drug in the reservoir, as Kim discloses that the electrode (30/230) may be installed in the reservoir/substrate (20/220) to load the drugs from the reservoir/substrate (20/220) to the eye seemingly indicating that the drugs are already loaded in the electrode before installation to create the PDCM (para. 0038-0039; para. 0064-0065) and that the electrode (30/230) is electrically connected through wire (45/245) to the activation chip (40/240) to activate iontophoresis by creating the integrated device of the ECM and the PDCM (para. 0048; para. 0073; para. 0033-0055, ophthalmic device 100; para. 0059-0074, ophthalmic device 200).
Further still, Kim differs from the instantly claimed invention in that Kim fails to explicitly disclose encapsulating the integrated device within a body of an ophthalmic device.
Gutierrez teaches an integrated ophthalmic device comprising electronic components and drug reservoirs encapsulated entirely within an ophthalmic device to provide polymeric passive transport as an adjunct to iontophoresis to provide controlled release mechanisms (Fig. 7D showing integrated electronic components power source 760, capacitor 762, WiFi antenna 765, and electronics module 767 and drug reservoir components 725 filled with therapeutic agents 730 covered by thin film electrode 780 encapsulated within body of overmold polymer layer 775; para. 0061).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the integrated device of Kim to further be encapsulated entirely within a similar ophthalmic device as taught by Gutierrez, because Gutierrez teaches the use of a polymeric passive transport ophthalmic device as an adjunct to iontophoresis (which Kim uses for drug delivery) to provide controlled release in constant doses over long periods, cyclic dosage, and tunable release (para. 0061).
Regarding claim 18, the cited prior art suggests the method of claim 17; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein choosing the first PDCM and the at least the second PDCM further comprises choosing at least two drugs that interact for improved efficacy of treatment of the disorder of the eye.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to utilize drugs that interact positively since there are only a finite number of predictable solutions (i.e. do not interact, interact net positively, interact net negatively). Kim discloses that their invention is focused on creating safer and more efficient drug delivery technology (para. 0004) and Gutierrez teaches the use of single or a combination of therapeutic agents for treatment benefit of many different diseases (para. 0049). Thus, utilizing drugs that interact positively would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 19, the cited prior art suggests the method of claim 17. Kim further discloses: treating the disorder of the eye with the ophthalmic device (para. 0004-0012); however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the at least one drug is actively dispensed to the eye using the ECM and the first PDCM and the at least one other drug is dispensed to the eye using the ECM and the at least the second PDCM.
Gutierrez teaches the use of the same or different drugs within the reservoirs of the PDCM as desired by a user (para. 0022; para. 0049).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the drugs contained in the PDCMs of Kim to comprise and actively dispense first and second drugs as taught by Gutierrez, because Gutierrez teaches that the therapeutic agents of their invention may be any of single or a combination of therapeutic agents as desired by a user (para. 0049) and that the large area of the outer surface of the eye allows for delivery of neuroprotective agents, antioxidants, angiostatic agents, and anti-vascular endothelial growth factors for treatment benefit of many different diseases (para. 0054).
Regarding claim 20, the cited prior art suggests the method of claim 19; however, the current combination of the prior art differs from the instantly claimed invention in that the current combination fails to suggest: wherein treating the disorder of the eye with the ophthalmic device further comprises choosing a schedule of delivery of the at least one drug and the at least one other drug
Gutierrez teaches a method of treating a disorder of the eye with an ophthalmic device that comprises choosing a schedule of delivery of the at least one drug and the at least one other drug to allow for customized delivery (para. 0071-0072; para. 0094, therapeutic agents can be released from individual reservoirs at programmed times).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of the current combination of Kim and Gutierrez to further comprise choosing a delivery schedule as taught by Gutierrez, because Gutierrez discloses that this allows for fully customized delivery profiles (para. 0071-0072).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Gutierrez as applied above, and further in view of US/2003/0199807 A1 to Dent and US/2024/0050644 A1 to Kulik.
Regarding claim 2, the cited prior art suggests the method of claim 1. Kim suggests that the PDCM and ECM components are manufactured separately and stored at least briefly (para. 0059-0074, components of integrated device structures 200 constructed separately and installed within and on platform 210); however the prior art differs from the instantly claimed invention in that the prior art fails to suggest manufacturing and storing the ECM and the PDCM in different environments.
Dent teaches problems faced when manufacturing, loading, and storing electronic and drug reservoir components together (para. 0014-0015).
Kulik teaches a drug delivery system comprising active ingredient means and an electronic means (Fig. 1, active ingredient means 10 and electronic means 12) and manufacturing and storing, at least briefly, the electronic and active ingredient components separately to avoid damage to the electronic components (para. 0012).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kim and Gutierrez to comprise manufacturing and storing the ECM and PDCM in different environments as taught by Dent and Kulik, because Dent teaches that manufacturing and storing electronic and drug reservoir components together runs the risk of the electronic components being corroded or otherwise degraded by moisture penetrating or leaking through the housing during manufacture and storage (para. 0014-0015), and Kulik teaches that manufacturing and storing electronic and drug reservoir components separately provides the advantage that the drug reservoir components may be sterilized in a manner that may damage the electronic components in a combined manufacture and that separation allows for production in a continuous process that may simplify the manufacture (para. 0012).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Gutierrez as applied above, further in view of EP/2891501 B1 to Pang, and as evidenced by NPL U to Modula.
Regarding claim 3, the cited prior art suggests the method of claim 1. Kim further discloses: manufacturing the ECM, comprising: fabricating a flexible substrate (para. 0035, platform 10; para. 0036); bonding at least one component electrical chip and at least one interconnect interface to the flexible substrate to form the ECM (para. 0034; para. 0037).
The prior art differs from the instantly claimed invention in that the prior art fail to suggest sterilizing the ECM using an electronic-safe technique.
Pang teaches a drug delivery device (Fig. 1-3) and sterilizing a drug delivery device comprising sterilizing the drug delivery module of a drug delivery device separately from an electronic module to avoid damaging the electronics (para. 0109).
Pang is considered to be analogous to the instantly claimed invention in that Pang discloses a drug delivery device. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kim and Gutierrez to comprise sterilizing the electronic module of the drug delivery system separately from the drug module as taught by Pang, because Pang discloses that vulnerable electronics may be subject to damage during exposure to gamma radiation (para. 0109).
Further, Kim suggests that the PDCM and ECM components are manufactured separately and stored at least briefly (para. 0059-0074, components of integrated device structures 200 constructed separately and installed within and on platform 210); however, the prior art differs from the instantly claimed invention in that the combination of the prior art fails to explicitly suggest storing the ECM in an electronic safe packaging and environment.
Modula teaches that proper storage of electronic components ensures that electronic components are safe and slows deterioration (Electronic Components Storage; Why is an Environment-Controlled Warehouse Vital for Electronic Components?).
However, it would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kim and Gutierrez to comprise storing the ECM in an electronic safe packaging and environment, because NPL U to Modula shows that proper storage of electronic components helps ensure that every part is kept safe from dirt, dust, temperature changes, and mechanical stress (Electronic Components Storage). NPL U to Modula further shows that electronics are prone to deterioration over time and that improper environment can speed up this process (Why is an Environment-Controlled Warehouse Vital for Electronic Components?).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Gutierrez as applied above, further in view of EP/2891501 B1 to Pang, and as evidenced by NPL V to Médecins Sans Frontières (hereinafter referred to as “MSF”).
Regarding claim 4, the cited prior art suggests the method of claim 1. Kim further discloses: manufacturing the PDCM, comprising: fabricating at least one reservoir in a substrate (para. 0039-0047; Fig. 1C, substrate 20 comprising support surface 23 and supply surface 27 with drug receiving reservoir 21 disposed between), wherein each of the at least one reservoir comprises a storage volume (Fig. 1C showing storage volume of drug receiving reservoir 21); filling the storage volume of each of the at least one reservoir with at least one drug (para. 0044; Fig. 1C showing drug receiving reservoir 21 filled with drugs); and attaching the passive interconnect interface (para. 0039, electrode 30 comprises passive interconnect interface).
The prior art differs from the instantly claimed invention in that the current combination of the prior art fails to explicitly disclose covering an opening of each of the at least one reservoir with an electrode to secure the at least one drug in each of the at least one reservoir; sealing the PDCM to keep the at least one drug under hermetic or near hermetic storage conditions.
Gutierrez teaches covering an opening of each of the at least one reservoir with an electrode to secure the at least one drug in each of the at least one reservoir; and sealing the PDCM to keep the at least one drug under hermetic or near hermetic storage conditions to provide controlled release in accordance with on-demand signals (para. 0066-0067; Fig. 7D showing thin film electrode 780 covering opening of reservoir 725).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of making the PDCM of the current combination of Kim and Gutierrez to further comprise covering and sealing the opening with an electrode to secure the drug in the reservoir and keep the drug at hermetic conditions as taught by Gutierrez, because Gutierrez teaches that providing an electrode in contact with the interconnect interface and securing the drug in the reservoir as an adjunct to iontophoresis (which Kim uses for drug delivery) provides controlled release in constant doses over long periods, in accordance with first-order constant release profiles and in accordance with on-demand pulsatile signals/commands (para. 0066).
Further, the prior art differs from the instantly claimed invention in that the prior art fail to disclose sterilizing the at least one reservoir using at least one of gamma radiation, ETO, autoclave, or e-beam.
Pang teaches sterilizing a drug delivery device comprising sterilizing the drug delivery module of a drug delivery device with gamma radiation separately from an electronic module to allow for sterilization of a closed drug chamber (para. 0109).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kim and Gutierrez to comprise sterilizing the drug delivery reservoir with gamma radiation as taught by Pang, because Pang discloses that a closed drug chamber may be impervious to ethylene oxide gas, but amenable to sterilization with gamma radiation (para. 0109).
Further still, Kim suggests that the PDCM and ECM components are manufactured separately (para. 0059-0074, components of integrated device structures 200 constructed separately and installed within and on platform 210); however, the prior art differs from the instantly claimed invention in that the combination of the prior art fails to explicitly disclose storing the PDCM in sterile packaging and according to storage instructions for the at least one drug.
MSF teaches that drug quality is dependent upon correct storage (Deterioration; Drug Quality and Storage; Storage Conditions).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kim and Gutierrez to comprise storing the drugs sterilely and according to storage instructions for the at least one drug, because NPL V to MSF shows that the deterioration of drugs leads to a reduction of therapeutic activity and possibly an increase in toxicity (Deterioration). Further, NPL V to MSF shows that drug quality depends on correct manufacturing and storage and that stability of drugs depends on both environmental factors and drug-related factors; therefore, it is necessary to respect storage instructions (Drug Quality and Storage; Storage Conditions).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Gutierrez as applied above, and as evidenced by NPL V to MSF.
Regarding claim 6, the cited prior art suggests the method of claim 5.
The prior art differs from the instantly claimed invention in that the current combination of the prior art fails to suggest the PDCM and the other PDCM storing one drug and at least one other drug, respectively.
Gutierrez teaches the use of the same or different drugs within the reservoirs of the PDCM (para. 0022; para. 0049).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the drugs contained in the PDCMs of Kim to comprise first and second drugs as taught by Gutierrez, because Gutierrez teaches that the therapeutic agents of their invention may be any of single or a combination of therapeutic agents as desired by a user (para. 0049) and that the large area of the outer surface of the eye allows for delivery of neuroprotective agents, antioxidants, angiostatic agents, and anti-vascular endothelial growth factors for treatment benefit of many different diseases (para. 0054).
Further, Kim suggests that the PDCM and ECM components are manufactured separately (para. 0059-0074, components of integrated device structures 200 constructed separately and installed within and on platform 210); however, the prior art differs from the instantly claimed invention in that the combination of the prior art fails to explicitly disclose storing the PDCMs separately based on different storage instructions for one drug and at least one other drug.
MSF teaches that drug quality is dependent upon correct storage (Deterioration; Drug Quality and Storage; Storage Conditions).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Kim and Gutierrez to comprise storing the PDCMs separately according to storage instructions for one drug and an at least one other drug, because NPL V to MSF shows that the deterioration of drugs leads to a reduction of therapeutic activity and possibly an increase in toxicity (Deterioration). Further, NPL V to MSF shows that drug quality depends on correct manufacturing and storage and that stability of drugs depends on both environmental factors and drug-related factors; therefore, it is necessary to respect storage instructions (Drug Quality and Storage; Storage Conditions).
Claims 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over US/2020/0214887 A1 to Gutierrez.
Regarding claim 7, Gutierrez discloses an ophthalmic device (Fig. 2B, ophthalmic device 200; Fig. 5D, ophthalmic device 200 further comprising polymeric overmold layer 290; para. 0055) comprising:
a modular electronic control module (ECM) comprising a first interconnect interface (para. 0058, integrated electronic components power source 250, capacitor 255, WiFi antenna 265, electronics module 270 may be formed on top surface of substrate 205, within a housing integrated with substrate 205, on a separate polymeric substrate, or within a housing integrated with a separate polymeric substrate; para. 0059; para. 0064; Fig. 2B, electronic leads 275 provide a connection between capacitor 255 interconnect interface of ECM and valve/thin film electrode 280/295 interconnect interface of PDCM);
a modular primary drug container module (PDCM) comprising a passive second interconnect interface (Fig. 2B showing substrate 205 comprising multiple release regions 210 comprising reservoirs 215; Fig. 2D showing holding chambers 235 of reservoirs 215 filled with therapeutic agents 240 covered at egress 245 by valve/thin film electrode 280/295; para. 0059; para. 0064; Fig. 2B, electronic leads 275 provide a connection between capacitor 255 interconnect interface of ECM and valve/thin film electrode 280/295 interconnect interface of PDCM),
wherein the passive interconnect interface of the PDCM is mated with the interconnect interface of the ECM (para. 0059; para. 0064; Fig. 2B, electronic leads 275 provide a connection between capacitor 255 interconnect interface of ECM and valve/thin film electrode 280/295 interconnect interface of PDCM), wherein the PDCM is passive (para. 0064-0065; para. 0067; para. 0070; without connection of PDCM components to ECM, PDCM components may not receive a stimulus to undergo dissolution and are therefore dependent upon the active provision of stimulus from the ECM) and the ECM is active (para. 0059; para. 0067; para. 0070; components of ECM generate electronic activated stimulus to PDCM); and
a body comprising a biocompatible material safe for ocular wear and configured to encapsulate the PDCM (para. 0058, biocompatible materials comprise polymers; para. 0070, polymeric overmold layer 290 fully encapsulating polymeric substrate 205 which comprises PDCM components; Fig. 2D showing 200 ophthalmic device comprising polymeric overmold layer 290 in contact with scleral surface 230 of eye).
Gutierrez differs from the instantly claimed invention in that Gutierrez fails to explicitly disclose the body configured to encapsulate the ECM and the PDCM when the ECM is provided on a separate substrate from the substrate of the PDCM.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the body so that it encapsulated the ECM and the PDCM when the ECM is provided on a separate substrate from the PDCM since this claimed position of the body does not change the ECM’s ability to provide electrical stimulation to the PDCM as is clearly seen when the ECM and PDCM are on the same substrate (Fig. 2C-D). Since applicant has not given any criticality to why the position of the body as encapsulating both the ECM and the PDCM disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 8, Gutierrez suggests the invention of claim 7. Gutierrez further discloses: wherein the ECM comprises active electronics of the ophthalmic device (para. 0058, integrated electronic components power source 250, capacitor 255, WiFi antenna 265, electronics module 270 may be formed on top surface of substrate 205, within a housing integrated with substrate 205, on a separate polymeric substrate, or within a housing integrated with a separate polymeric substrate; para. 0059; para. 0064; Fig. 2B, electronic leads 275 provide a connection between capacitor 255 interconnect interface of ECM and valve/thin film electrode 280/295 interconnect interface of PDCM; para. 0067; para. 0070; components of ECM generate electronic activated stimulus to PDCM).
Regarding claim 9, Gutierrez suggests the invention of claim 7. Gutierrez further discloses: wherein the PDCM comprises no active electronics, components, chips, and/or semiconductor-based materials (Fig. 2B showing substrate 205 comprising release regions 210 comprising reservoirs 215; Fig. 2D showing holding chambers 235 of reservoirs 215 filled with therapeutic agents 240 covered at egress 245 by valve/thin film electrode 280/295; para. 0059; Fig. 2B, electronic leads 275 provide a connection between capacitor 255 interconnect interface of ECM and valve/thin film electrode 280/295 interconnect interface of PDCM; para. 0064-0065; para. 0067; para. 0070; without connection of PDCM components to ECM, PDCM components may not receive a stimulus to undergo dissolution and are therefore dependent upon the active provision of stimulus from the ECM).
Regarding claim 10, Gutierrez suggests the invention of claim 7. Gutierrez further discloses: wherein the PDCM comprises at least one reservoir configured to store at least one drug and an electrode covering an opening of each of the at least one reservoir, wherein the electrode is configured to electrodissolve to release the at least one drug when a signal is delivered from the ECM (Fig. 2B showing substrate 205 comprising release regions 210 comprising reservoirs 215; Fig. 2D showing holding chambers 235 of reservoirs 215 filled with therapeutic agents 240 covered at egress 245 by valve/thin film electrode 280/295; para. 0059; Fig. 2B, electronic leads 275 provide a connection between capacitor 255 interconnect interface of ECM and valve/thin film electrode 280/295 interconnect interface of PDCM; para. 0064-0065; para. 0067; para. 0070; without connection of PDCM components to ECM, PDCM components may not receive a stimulus to undergo dissolution and are therefore dependent upon the active provision of stimulus from the ECM).
Regarding claim 11, Gutierrez suggests the invention of claim 7. Gutierrez further discloses: wherein the PDCM further comprises a plurality of reservoirs configured to store one or more drugs (Fig. 2B showing substrate 205 comprising release regions 210 comprising reservoirs 215; Fig. 2D showing holding chambers 235 of reservoirs 215 filled with therapeutic agents 240 covered at egress 245 by valve/thin film electrode 280/295; para. 0057).
Regarding claim 12, Gutierrez suggests the invention of claim 11. Gutierrez further discloses: wherein the one or more drugs are the same at least one drug per reservoir or different at least one drug per reservoir (Fig. 2B showing substrate 205 comprising release regions 210 comprising reservoirs 215; Fig. 2D showing holding chambers 235 of reservoirs 215 filled with therapeutic agents 240 covered at egress 245 by valve/thin film electrode 280/295; para. 0022; para. 0054, scleral tissue provides abundant space for release of neuroprotective agents, antioxidants, angiostatic agents, and antivascular endothelial growth factor treatments; para. 0057).
Regarding claim 13, Gutierrez suggests the invention of claim 11. Gutierrez further discloses: wherein each of the plurality of reservoirs is uniquely addressable via an electronic lead formed by the mating of the passive second interconnect interface of the PDCM and the first interconnect interface of the ECM (para. 0060, valve/ thin film electrode 280/295 may be provided over each reservoir 215; para. 0064, one or more electronic leads 275 may be used to mate the PDCM and ECM; Fig. 2B showing embodiment wherein each electronic lead 275 comprises bifurcated sections leading to each reservoir 215).
Regarding claim 14, Gutierrez suggests the invention of claim 7, Gutierrez further discloses: wherein the ECM comprises electronic components disposed on a polymer substrate (para. 0058, integrated electronic components power source 250, capacitor 255, WiFi antenna 265, electronics module 270 may be formed on top surface of substrate 205, within a housing integrated with substrate 205, on a separate polymeric substrate, or within a housing integrated with a separate polymeric substrate), where the electronic components comprise an application specific integrated circuit (ASIC), an oscillator, a battery, a capacitor, and/or an antenna (para. 0015, battery; para. 0058, capacitor 255, WiFi antenna 265).
Regarding claim 15, Gutierrez suggests the invention of claim 7. Gutierrez further discloses: wherein the ECM comprises a plurality of interconnect interfaces for mating with any number of interconnect interfaces of the PDCM (para. 0060, 280/295 valve/ thin film electrode may be provided over each 215 reservoir; para. 0064, one or more electronic leads 275 may be used to mate the PDCM and ECM); however, Gutierrez fails to disclose at least one other PDCM comprising another passive interconnect interface.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have duplicated the PDCM to include another PDCM connected to the ECM since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.
Regarding claim 16, Gutierrez suggests the invention of claim 15. Gutierrez further suggests wherein each of the PDCM and the second PDCM comprise one or more reservoirs providing a stand-alone, sealed, and sterile storage environment for one or more drugs (per the duplication of parts above: Fig. 2B showing 205 substrate comprising 210 release regions comprising 215 reservoirs; Fig. 2D showing 235 holding chambers of 215 reservoirs filled with 240 therapeutic agents covered at 245 egress by 280/295 valve/thin film electrode; para. 0057; para. 0059; para. 0064; Fig. 2B, 275 electronic leads provide a connection between 255 capacitor interconnect interface of ECM and 280 electrode valves interconnect interface of PDCM; para. 0067).
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.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
9 February 2026