DETAILED ACTION
This action is pursuant to RCE filed on 11/24/2025. Claims 1-19 are pending. A non-final action on the merits of claims 1-19 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/2025 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-9, and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et a. (hereinafter ‘Rapoport’, US 20180078767 A1) in view of Imran et al. (hereinafter ‘Imran’, US 9314618 B2)
Regarding independent claim 1, Rapoport discloses a neural interface device (device shown in Figs. 2A-C) comprising:
a thin-film microelectrode array (electrode array 200 in Fig. 2C; [0057]: the electrode array 200 contains the flexible circuit 207, electrodes 208, traces 205, and lead wires 206; [0059]: the electrodes range in diameter from 5µm to 500 µm) configured to record from a target area ([0062]: the array can be used for recording electrical brain signals), the thin film microelectrode array comprising a plurality of wings and a central region (central region and two wings highlighted in Fig. 2 below), wherein a plurality of electrodes are disposed on the plurality of wings (electrodes 208 are disposed on the wings as seen in Fig. 2C and 2D; the claim does not limit that the electrodes are only disposed on the wings) and microelectronics are disposed on the central region (flexible circuit 207 shown in Fig. 2D covering the central region and wings; [0063]: the conductive traces are embedded in the flexible circuit, thus forming the microelectronics; [0062]: the electrodes are supported on the flexible circuit, making them part of the same film; the claim does not limit that the microelectronics are only disposed on the central region); and
a stent-mesh (skeleton member 201 in Fig. 2A) configured to attach to the thin-film microelectrode array ([0058]: the flexible circuit 207 can be mounted on top of skeleton member 201),
wherein the thin-film microelectrode array and stent-mesh form an assembly (assembly shown in Figs. 2C-D) configured to be selectively moved between a rolled-up state (rolled assembly shown in Figs. 3A-B; [0066]: folded configuration to accommodate cannulation prior to deployment) and a deployed state ([0076]: unfolded assembly shown in Figs. 2A-D),
wherein in the deployed state, the assembly forms a geometry ([0076]: expanded/deployed state as seen in Figs. 2A-D) that conforms to a cortical surface ([0052]: the expanded, deployed configuration conforms to the inner shape of the intracranial ventricular department; the electrode array is a flexible conformal array [0027]; if the flexible, conformal array were to be placed on a cortical surface of the brain, it would simply flex and conform to that surface as it does to the various ventricular locations; it is even discussed how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration [0086]).
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Rapoport further discloses that the skeleton member can form an array of loops that can be nine loops wide or more ([0051]). Furthermore, Rapoport discloses that the array is flexible ([0047]).
However, Rapoport is silent to and the rolled-up state having a substantially flat geometry in the central region with the wings forming a spiral geometry about the central region. Additionally, while it is the examiner’s opinion that Rapoport discloses the array deploying into a shape that conforms to a cortical region of the brain, this limitation is not specifically stated in Rapoport.
Imran teaches a flexible, implantable circuit comprising an array of conductors ([Abstract]). Imran further teaches that the flexible circuit has a rolled-up state as seen in Fig. 16A where the center is substantially flat and the wings form a spiral shape around it. The use “substantially flat” allows for a degree of bend in the center, thus Imran meets the claim language. Imran further teaches that the electrode array deploys to a flat configuration as shown in Fig. 16C for placement on the target tissue, similar to the deployed state of Rapoport ([Col 11, lines 28-45]). Because Rapoport discloses utilizing a flexible array which imparts the ability to be flattened and conform to uneven surfaces, it would be an obvious design choice to combine with a shape that would substantially conform to different surfaces, such as a flat deployment state, to allow for variations in placement. Choice in placement is directed towards intended use and the device of Rapoport is capable of being inserted and placed on different types of tissue. Rapoport even discusses how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration ([0086]). Furthermore, because Rapoport discloses utilizing more loops to create a wider array, there are multiple configurations in which to form the unexpanded state, such as folding or rolling into a spiral configuration. It would be an obvious design choice for one of ordinary skill in the art to choose an unexpanded state in which the center is substantially flat and the wings form a spiral shape as evidenced by Imran since utilizing such an unexpanded state is merely one of several choices for one of ordinary skill in the art as the applicant has not provided criticality to the spiral configuration. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the unexpanded and deployed shapes of Imran with the device of Rapoport such that in the unexpanded state the center is substantially flat with spiral wings and in the fully deployed and unrestricted state the array is relatively flat for placement on additional tissue surfaces.
Regarding claim 2, the Rapoport/Imran combination discloses the neural interface of claim 1, wherein the thin-film microelectrode array comprises:
a connector (package 703 in Fig. 7);
a thin-film flexible cable (cable 206 in Fig. 7) in electrical communication with the connector ([0092]: the cable 206 bundles the electrode leads which then connect to the package 703); and
two lateral wings (side panels 202 in Fig. 2B and 3A) distal of the thin-film flexible cable (the electrode array is distal to the cable as seen in Fig. 7).
Regarding claim 3, the Rapoport/Imran combination discloses the neural interface of claim 2, wherein the two lateral wings are flexible ([0054]: the side panels are deformable; [0056]: the side panels do not have stiffeners and can wrap upwards to conform to the anatomy).
Regarding claim 5, the Rapoport/Imran combination discloses the neural interface of claim 1, wherein the thin-film microelectrode array comprises active electronics ([0090]: the active electronic components are contained in the package).
Regarding claim 6, the Rapoport/Imran combination discloses the neural interface of claim 5, further comprising an application-specific integrated circuit (circuit 207 in Fig. 2C) bonded to the thin-film microelectrode array and encapsulated thereon (flexible circuit 207 is bonded to the electrode as seen in Fig. 2C and encapsulated between the skeleton and the electrodes as seen in Fig. 2D).
Regarding claim 7, the Rapoport/Imran combination discloses the neural interface of claim 5, further comprising an integrated circuit fabricated monolithically along the thin-film microelectrode array ([0060]: the flexible circuit 207 can be a continuous sheet, imparting a monolithic fabrication) using thin-film semiconductors ([0058]: the flexible circuit can be a polymer substrate which are known in the art to be used for semiconductor fabrication).
Regarding claim 8, the Rapoport/Imran combination discloses the neural interface of claim 1, wherein the stent-mesh comprises a shape memory alloy ([0051]: the skeleton member 201 can be made from a shape memory alloy).
Regarding claim 9, the Rapoport/Imran combination discloses the neural interface of claim 1, wherein at least one of the thin-film microelectrode array and the stent-mesh comprises one or more retrieval features ([0067]: a retraction force is applied to cable 206 and the cylindrical channel compresses the electrode array) configured to enable re-rolling of at least one of the thin-film microelectrode array and the stent-mesh into a delivery cannula upon retraction ([0067]: a retraction force is applied to cable 206 and the cylindrical channel compresses the electrode array and the compression causes folding of the array which allows it to be removed from the implantation site).
Regarding claim 11, the Rapoport/Imran combination discloses the neural interface of claim 1, wherein the neural interface is configured to be inserted through an angled cranial incision ([0030]: the electrodes can be inserted via a cannula or catheter; the incision is angular as seen in Figs. 10A-C) in the rolled-up state and conform to brain tissue in the deployed state ([0067]: the conformal electrode array assumes a folded axial configuration inside the cylindrical channel which is then deployed into the desired site, which the deployed state is the expanded state as discussed above).
Regarding independent claim 12, Rapoport discloses a neural interface comprising:
a self-expanding thin-film microelectrode array (electrode array 200 in Fig. 2C; can be expanded as shown in Fig. 2C or rolled as in Figs. 3A-B) configured to record from a target area ([0062]: the array can be used for recording electrical brain signals), wherein the self-expanding thin-film microelectrode array is configured to be selectively moved between a rolled-up state (rolled assembly shown in Figs. 3A-B; [0066]: folded configuration to accommodate cannulation prior to deployment) and a deployed state ([0076]: unfolded assembly shown in Figs. 2A-D), the thin film microelectrode array comprising a plurality of wings and a central region (central region and two wings highlighted in Fig. 2 above), wherein a plurality of electrodes are disposed on the plurality of wings (electrodes 208 are disposed on the wings as seen in Fig. 2C and 2D; the claim does not limit that the electrodes are only disposed on the wings) and microelectronics are disposed on the central region (flexible circuit 207 shown in Fig. 2D covering the central region and wings; [0063]: the conductive traces are embedded in the flexible circuit, thus forming the microelectronics; [0062]: the electrodes are supported on the flexible circuit, making them part of the same film; the claim does not limit that the microelectronics are only disposed on the central region),
wherein the self-expanding thin-film microelectrode array comprises at least one deployment feature (skeleton member 201) configured to facilitate movement of the self-expanding thin-film microelectrode array from the rolled-up state to the deployed state upon deployment from a delivery device ([0051]: the skeleton member can provide the capability of folding and unfolding of the conformable electrode array), and at least one retrieval feature ([cable 206 in Fig. 7) configured to facilitate movement of the self- expanding thin-film microelectrode array from the deployed state to the rolled-up state for retraction into the delivery device ([0067]: during the reverse transition, a retraction force is applied to the cable 206, the opening of the cylindrical channel compresses the electrode array to cause folding into the axial configuration),
wherein in the deployed state, the self-expanding thin-film microelectrode array forms a geometry ([0076]: expanded/deployed state as seen in Figs. 2A-D) that conforms to a cortical surface ([0052]: the expanded, deployed configuration conforms to the inner shape of the intracranial ventricular department; the electrode array is a flexible conformal array [0027]; if the flexible, conformal array were to be placed on a cortical surface of the brain, it would simply flex and conform to that surface as it does to the various ventricular locations; it is even discussed how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration [0086]).
Rapoport further discloses that the skeleton member can form an array of loops that can be nine loops wide or more ([0051]). Furthermore, Rapoport discloses that the array is flexible ([0047]).
However, Rapoport is silent to the rolled-up state having a substantially flat geometry in the central region with the wings forming a spiral geometry about the central region. Additionally, while it is the examiner’s opinion that Rapoport discloses the array deploying into a shape that conforms to a cortical region of the brain, this limitation is not specifically stated in Rapoport.
Imran teaches a flexible, implantable circuit comprising an array of conductors ([Abstract]). Imran further teaches that the flexible circuit has a rolled-up state as seen in Fig. 16A where the center is substantially flat and the wings form a spiral shape around it. The use “substantially flat” allows for a degree of bend in the center, thus Imran meets the claim language. Imran further teaches that the electrode array deploys to a flat configuration as shown in Fig. 16C for placement on the target tissue, similar to the deployed state of Rapoport ([Col 11, lines 28-45]). Because Rapoport discloses utilizing a flexible array which imparts the ability to be flattened and conform to uneven surfaces, it would be an obvious design choice to combine with a shape that would substantially conform to different surfaces, such as a flat deployment state, to allow for variations in placement, such as on a cortical surface. Choice in placement is directed towards intended use and the device of Rapoport is capable of being inserted and placed on different types of tissue. Rapoport even discusses how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration ([0086]). Furthermore, because Rapoport discloses utilizing more loops to create a wider array, there are multiple configurations in which to form the unexpanded state, such as folding or rolling into a spiral configuration. It would be an obvious design choice for one of ordinary skill in the art to choose an unexpanded state in which the center is substantially flat and the wings form a spiral shape as evidenced by Imran since utilizing such an unexpanded state is merely one of several choices for one of ordinary skill in the art as the applicant has not provided criticality to the spiral configuration. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the unexpanded and deployed shapes of Imran with the device of Rapoport such that in the unexpanded state the center is substantially flat with spiral wings and in the fully deployed and unrestricted state the array is flat for placement on additional tissue surfaces.
Regarding claim 13, the Rapoport/Imran combination discloses the neural interface of claim 12, wherein one or more of the at least one deployment feature and the at least one retrieval feature comprises a taper (the cable 206 comprises a taper shown in Fig. 7).
Regarding claim 14, the Rapoport/Imran combination discloses the neural interface of claim 12, wherein the self-expanding thin-film microelectrode comprises a modulus of elasticity and flexural rigidity to expand the self-expanding thin-film microelectrode array when in an unconfined state via a spring restoring force ([0076]: the electrode array may be made from a shape memory allow which assists in unfolding the array once deployed which in turn discloses a modulus of elasticity and flexural rigidity that allows for the array to be compressed and expanded into its restored shape).
Regarding claim 15, the Rapoport/Imran combination discloses the neural interface of claim 12, further comprising an application-specific integrated circuit (circuit 207 in Fig. 2C) bonded to the self-expanding thin-film microelectrode array and encapsulated thereon (flexible circuit 207 is bonded to the electrode as seen in Fig. 2C and encapsulated between the skeleton and the electrodes as seen in Fig. 2D).
Regarding claim 16, the Rapoport/Imran combination discloses the neural interface of claim 12, further comprising an integrated circuit fabricated monolithically ([0060]: the flexible circuit 207 can be a continuous sheet, imparting a monolithic fabrication) along the self-expanding thin-film microelectrode array using thin-film semiconductors ([0058]: the flexible circuit can be a polymer substrate which are known in the art to be used for semiconductor fabrication).
Regarding claim 17, the Rapoport/Imran combination discloses the neural interface of claim 12, wherein the neural interface is configured to be inserted through an angled cranial incision ([0030]: the electrodes can be inserted via a cannula or catheter; the incision is angular as seen in Figs. 10A-C) in the rolled-up state and conform to brain tissue in the expanded state ([0067]: the conformal electrode array assumes a folded axial configuration inside the cylindrical channel which is then deployed into the desired site, which the deployed state is the expanded state as discussed above).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over The Rapoport/Imran combination as applied to claim 1 and described above, in view of Wentai et al. (hereinafter ‘Wentai’, US 20170246452 A1).
Regarding claim 4, the Rapoport/Imran combination discloses the invention substantially in claim 1 and described above. Rapoport further discloses the stent-mesh comprises an eyelet (loop at the end of the skeleton in Fig. 2A)
However, the Rapoport/Imran combination does not teach the thin-film microelectrode array comprising an eyelet and sutures configured to attach the electrode array to the stent-mesh.
Wentai teaches an electrode array to provide electrical stimulation to the brain or spinal cord ([Abstract]). Wentai further teaches utilizing suture holes in the electrode array to fasten the array to biological tissue ([0219]). It would be routine for one skilled in the art to include suture holes in the electrode array of The Rapoport/Imran combination such that the stent and array can be not only fastened to each other but also to the target biological tissue. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the electrode array eyelets of Wentai with the electrode array of the Rapoport/Imran combination such that the stent and array can be connected to each other and the target tissue.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the Rapoport/Imran combination as applied to claim 1 and described above, in further view of Rapoport.
Regarding claim 10, the Rapaport/Imran discloses the invention substantially in claim 9/1 and described above. Rapaport further discloses the retrieval feature comprises a taper positioned on the distal end of a thin-film flexible cable of the neural interface (taper from electrode to cable shown on the distal end of the cable shown in Fig. 7).
However, Rapoport does not disclose the taper is positioned on a proximal end of the retrieval feature.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to move the taper from the distal end to the proximal end, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over the Rapoport/Imran combination in view of Cadwell (US 11185684 B2).
Regarding independent claim 18, Rapoport discloses a method comprising:
attaching a thin-film microelectrode array to a stent to form a stent-microelectrode assembly ([0058]: the flexible circuit 207 of the electrode array 200 can be mounted onto the skeleton member 201), the thin-film microelectrode array comprising a plurality of wings and a central region (central region and two wings highlighted in Fig. 2 above), wherein a plurality of electrodes are disposed on the plurality of wings (electrodes 208 are disposed on the wings as seen in Fig. 2C and 2D; the claim does not limit that the electrodes are only disposed on the wings) and microelectronics are disposed on the central region (flexible circuit 207 shown in Fig. 2D covering the central region and wings; [0063]: the conductive traces are embedded in the flexible circuit, thus forming the microelectronics; [0062]: the electrodes are supported on the flexible circuit, making them part of the same film; the claim does not limit that the microelectronics are only disposed on the central region);
rolling the wings of the thin-film microelectrode array towards a central region of the thin- film microelectrode array to provide a rolled-up state of the stent-microelectrode assembly ([0060]: side panels are folded of the electrode array; [0066]: the folded configuration allows for the electrode array to accommodate cannulation prior to deployment);
loading the stent-microelectrode assembly into a delivery catheter in the rolled-up state ([0066]: the folded configuration allows for the electrode array to accommodate cannulation prior to deployment; [0030]: the electrodes are inserted via a catheter);
advancing the delivery catheter to a target region ([0075]: cannulate along a trajectory suitable for deployment of the array);
delivering the stent-microelectrode assembly at the target region in the rolled-up state ([0075]: the array is deployed; [0066]: the folded configuration is the state of the array moving through the cannula);
expanding the stent-microelectrode assembly from the rolled-up state to a deployed state ([0076]: following deployment, the conformal electrode array changes from a collapsed state to an unfolded configuration) comprising a surface (expanded configuration is planar as seen in Figs. 2A-D) that conforms to a cortical surface of the target region ([0052]: the expanded, deployed configuration conforms to the inner shape of the intracranial ventricular department; the electrode array is a flexible conformal array [0027]; if the flexible, conformal array were to be placed on a cortical surface of the brain, it would simply flex and conform to that surface as it does to the various ventricular locations; it is even discussed how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration [0086]); and
positioning the stent-microelectrode assembly adjacent to the target region in the deployed state ([0076]: the electrode array is deployed to maintain contact with the ventricular surface).
Rapoport further discloses that the skeleton member can form an array of loops that can be nine loops wide or more ([0051]). Furthermore, Rapoport discloses that the array is flexible ([0047]).
However, Rapoport is silent to the rolled-up state having a substantially flat geometry in the central region with the wings forming a spiral geometry about the central region. Additionally, while it is the examiner’s opinion that Rapoport discloses the array deploying into a shape that conforms to a cortical region of the brain, this limitation is not specifically stated in Rapoport.
Imran teaches a flexible, implantable circuit comprising an array of conductors ([Abstract]). Imran further teaches that the flexible circuit has a rolled-up state as seen in Fig. 16A where the center is substantially flat and the wings form a spiral shape around it. The use “substantially flat” allows for a degree of bend in the center, thus Imran meets the claim language. Imran further teaches that the electrode array deploys to a flat configuration as shown in Fig. 16C for placement on the target tissue, similar to the deployed state of Rapoport ([Col 11, lines 28-45]). Because Rapoport discloses utilizing a flexible array which imparts the ability to be flattened and conform to uneven surfaces, it would be an obvious design choice to combine with a shape that would substantially conform to different surfaces, such as a flat deployment state, to allow for variations in placement. The device of Rapoport is capable of being inserted and placed on different types of tissue. Rapoport even discusses how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration ([0086]). Furthermore, because Rapoport discloses utilizing more loops to create a wider array, there are multiple configurations in which to form the unexpanded state, such as folding or rolling into a spiral configuration. It would be an obvious design choice for one of ordinary skill in the art to choose an unexpanded state in which the center is substantially flat and the wings form a spiral shape as evidenced by Imran since utilizing such an unexpanded state is merely one of several choices for one of ordinary skill in the art as the applicant has not provided criticality to the spiral configuration. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the unexpanded and deployed shapes of Imran with the device of Rapoport such that in the unexpanded state the center is substantially flat with spiral wings and in the fully deployed and unrestricted state the array is relatively flat for placement on additional target tissues.
However, the Rapoport/Imran combination does not specifically disclose deploying the electrode to a cortical surface of the brain or detaching the stent from the electrode array.
Cadwell teaches an electrode array that is deployed with an inserter to a target location on the brain ([Abstract]). The electrode array is deployed to a cortical surface as shown in Fig. 8 for the evaluation of a patient’s condition prior to epileptic treatment (Col 1, lines 25-31). Cadwell further teaches the use of an inserter 201 in Fig. 2C which allows for the expansion of the electrode array upon deployment, similar to the stent of Rapoport (Col 2, lines 16-30). The electrode array of Cadwell can be folded like an accordion as shown in the figures prior to deployment, or utilize a rolled configuration, similar to that of the Rapoport/Imran combination ([Col 8, lines 45-54]). Upon placement of the electrodes at the target location, Cadwell teaches removing the inserter through the original hole while leaving the electrode array in the desired location for data collection (Col 10, lines 29-41). Utilizing an inserter in this manner reduces the risk, costs, and discomfort associated with removing a skull flap for both implantation and removal (Col 1, lines 32-44). Rapoport is capable of being inserted and placed on different types of tissue. Rapoport even discusses how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration ([0086]). Thus, it is an obvious combination to combine the device of the Rapoport/Imran combination with that of Cadwell as it would maintain operability and not lead to any unexpected outcomes. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the inserter and placement location steps of Cadwell with the method of the Rapoport/Imran combination such that the electrode array could be placed and the inserter removed in a way that reduces risk, cost, and discomfort while still imparting the ability to collect epileptic data prior to treatment.
Regarding claim 19, the Rapoport/Imran/Cadwell combination discloses the method of claim 18 and describe above. The combination further teaches retracting the stent within the deliver catheter, wherein the stent assumes a rolled-up state (Cadwell [Col 10, lines 29-41]: the inserter can be hydraulically actuated and during removal the pressure is released which causes the inserter to go back to its original state); and removing the delivery catheter from the target region to extract the stent (Cadwell [Col 10, lines 42-57]: after deployment, the inserter and the cannula are removed through the burr hole).
Response to Arguments
Applicant's arguments filed 10/22/2025 have been fully considered but they are not persuasive.
Regarding claims 1, 12, and 18, even though during the interview the examiner stated that the proposed amendments appeared to overcome the rejection of record, upon further consideration the claim amendments do not overcome the rejection of record. The claim amendment does not explicitly state the structure, configuration, or shape that allows for the array to conform to a cortical surface. While the amendment does remove some of the functional language, the shape of the deployed state remains undefined and it is for that reason that Rapoport still meets the claim language. Rapoport can conform to different types of tissue. The electrode array of Rapoport is a flexible conformal array ([0027]). If the flexible, conformal array of Rapoport were to be placed on a cortical surface of the brain, it would simply flex and conform to that surface as it does to the various ventricular locations. Rapoport does not teach away from being able to conform to a cortical surface. In fact, Rapoport even discusses how the electrodes disclosed are analogous to cortical surface electrodes as they are conformable electrode arrays that are simply placed on the brain tissue without requiring penetration ([0086]). Furthermore, the instant application states that the invention described “assumes the shape of a curved surfaces of the brain including but not limited to the outer cortical surfaces, the inner ventricular surfaces, and the inner surfaces of blood vessels within the brain” (paragraph [0051] of the instant application). Thus, by admission of the applicant, if the deployed state conforms to a ventricular surface, it also conforms to a cortical surface. Therefore, the rejections are maintained because the specific geometry, structure, or configuration which allows for the instant application to conform to a cortical is not claimed and it is the opinion of the examiner that the invention of Rapoport conforms to the cortical surface if it is placed on the cortical surface because it is a flexible, conformal array and there is no teaching in Rapoport that would teach away from being able to assume the shape of the cortical surface.
Additionally, while it is the examiner’s opinion that Rapoport discloses the amended limitation, the combinations with Imran address changing the shape of the deployed state to assume a flatter geometry which would conform to various surfaces. Modifying the shape of the array in the deployed configuration is of routine skill in the art and the instant application discusses utilizing a substantially planar shape which would conform to both cortical and ventricular surfaces. Rapoport both alone and in combination with Imran would form flexible, substantially flat geometries that would conform to the target tissue on which they are placed. Therefore, the rejections are maintained.
The rejections to the dependent claims are maintained because the rejections of the independent claims are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./ Examiner, Art Unit 3794