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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11771357. Although the claims at issue are not identical, they are not patentably distinct from each other, since they both recite A cortical electrode assembly configured, in use, to sense electrical activity at a surface of a brain, the assembly comprising: a ring-shaped substrate; and a plurality of electrical sensors affixed to the ring-shaped substrate, wherein the plurality of electrical sensors are spaced along the ring-shaped substrate so as to form a ring of electrical sensors that substantially encircle an aperture formed by the ring-shaped substrate and An electrocorticography method, comprising: placing a cortical electrode assembly on a surface of a brain; applying an electrical stimulus to the surface of the brain; and measuring a response to the electrical stimulus based on signals generated by a plurality of electrical sensors of the cortical electrode assembly, wherein the cortical electrode assembly includes: a ring-shaped substrate; and Filed : August 25, 2023 the plurality of electrical sensors affixed to the ring-shaped substrate, wherein the plurality of electrical sensors are spaced along the ring-shaped substrate so as to form a ring of electrical sensors that substantially encircle an aperture formed by the ring-shaped substrate. The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10, 13-16, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120277834 A1 to Mercanzini et al. (hereinafter, Mercanzini’834).
The following rejection is based on one of two illustrated embodiments of the Mercanzini’834 reference, each independently applied and not relied on in combination in order to accommodate possible alternate interpretations of what might constitute a broadest reasonable interpretation of the “ring-shaped substrate” being claimed. Interpretation A (as it will be referred to in citation for clarity) relates generally to that shown in e.g. Fits. 1, 5A, 6A-B. Interpretation B relates generally to that shown in e.g. Figs. 17C-D and 18B. Where the material disclosed in Mercanzini’834 pertains to both or all embodiments, such material will be cited first and without distinction to the specific interpretations.
Regarding Claim 1, Mercanzini’834 discloses a cortical electrode assembly (Mercanzini’834: Abstract; Para. [0005]-[0007])
configured, in use, to sense electrical activity at a surface of a brain (Mercanzini’834: Para. [0161]),
the assembly comprising: a ring-shaped substrate (Mercanzini’834: Interpretation A: microelectrode array film 110 as part of surface probe 101 as seen in Figs. 1 and 5A is reasonably construed as a ring-shaped substrate, as it generally defines a polygonal shape (4-sided polygon) surrounding a central aperture in a loop. | Interpretation B: in Figs. 17C-D and 18B, surface probe 401 defines a round ring shape with a central aperture and comprises microelectrode array film 410.); and
a plurality of electrical sensors affixed to the ring-shaped substrate (Mercanzini’834: Para. [0022]; Interpretation A: microelectrode elements 140 | Interpretation B: microelectrode elements 440),
wherein the plurality of electrical sensors are spaced along the ring-shaped substrate so as to form a ring of electrical sensors that substantially encircle an aperture formed by the ring-shaped substrate (Mercanzini’834: Interpretation A: Para. [0110] microelectrodes 140 of each cortical depth probe 130 encircles the central-most aperture | Interpretation B: the electrodes 440 reasonably form a ring and encircle the aperture at the center of the ring of probe 401).
Regarding Claim 2, Mercanzini’834 discloses the cortical electrode assembly of claim 1, Mercanzini’834 further discloses wherein each of the plurality of electrical sensors comprises an electrically conductive contact configured to contact the surface of the brain in use (Mercanzini’834: Para. [0004], [0007], [0115]).
Regarding Claim 3, Mercanzini’834 discloses the cortical electrode assembly of claim 2, Mercanzini’834 further discloses wherein the electrically conductive contacts of the plurality of electrical sensors are metallic contacts (Mercanzini’834: Para. [0004], [0007], [0115]).
Regarding Claim 4, Mercanzini’834 discloses the cortical electrode assembly of claim 2, Mercanzini’834 further discloses wherein: the electrically conductive contacts of the plurality of electrical sensors are each disc- shaped (Mercanzini’834: Para. [0162] indicates the electrodes can have shapes such as circles, i.e. discs); and
a diameter of each of the electrically conductive contacts is in the range 2 millimeters (mm) through 8 mm (Mercanzini’834: Para. [0103], [0148]).
Regarding Claim 5, Mercanzini’834discloses the cortical electrode assembly of 2, Mercanzini’834 further discloses wherein adjacent electrically conductive contacts for at least a subset of the plurality of electrical sensors are spaced apart on the ring- shaped substrate from their centers by a distance in the range 2 millimeters (mm) through 8 mm (Mercanzini’834: Para. [0103]).
Regarding Claim 6, Mercanzini’834 discloses the cortical electrode assembly of claim 5, Mercanzini’834 further discloses wherein the subset of the plurality of electrical sensors includes at least a majority of the plurality of electrical sensors (Mercanzini’834: Para. [0103], [0243] discloses uniformly spaced electrodes; Interpretation A: Fig. 1 shows the electrodes being uniformly spaced electrodes; Interpretation A: Fig. 1 shows the electrodes uniformly spaced both on their respective depth probes 130, as well as the depth probes being uniformly spaced about the perimeter of the substrate | Interpretation B: Figs. 17C-D and 18B show the electrodes 440 being uniformly distributed on their respective arms, and the arms uniformly distributed about the ring).
Regarding Claim 7, Mercanzini’834 discloses the cortical electrode assembly of claim 5, Mercanzini’834 further discloses wherein the subset of the plurality of electrical sensors includes all of the plurality of electrical sensors (Mercanzini’834: Para. [0103], [0243] discloses uniformly spaced electrodes; Interpretation A: Fig. 1 shows the electrodes uniformly spaced both on their respective depth probes 130, as well as the depth probes being uniformly spaced about the perimeter of the substrate | Interpretation B: Figs. 17C-D and 18B show the electrodes 440 being uniformly distributed on their respective arms, and the arms uniformly distributed about the ring).
Regarding Claim 8, Mercanzini’834 discloses the cortical electrode assembly of claim 2, Mercanzini’834 further discloses wherein a total number of electrical sensors in the plurality of electrical sensors affixed to the ring-shaped substrate is in the range of 10 electrical sensors through 80 electrical sensors (Mercanzini’834: Both Interpretation A & Interpretation B are within the claimed range. Interpretation A: the device is shown as having 36 microelectrodes (Fig. 6A, item 140)| Interpretation B: the device is shown as having 12 microelectrodes (Fig. 17A item 440)).
Regarding Claim 9, Mercanzini’834 discloses the cortical electrode assembly of claim 1, Mercanzini’834 further discloses wherein the ring-shaped substrate comprises an insulating material that is configured to prevent electrical sensors affixed to the substrate from electrically shorting in use (Mercanzini’834: Para. [0115], [0117]).
Regarding Claim 10, Mercanzini’834 discloses the cortical electrode assembly of claim 1, Mercanzini’834 further discloses wherein the ring-shaped substrate is substantially circular (Mercanzini’834: Interpretation B: Figs. 17C-D and 18B clearly show a circular ring-shaped substrate).
Regarding Claim 13, Mercanzini’834 discloses the cortical electrode assembly of claim 1, Mercanzini’834 further discloses further comprising a plurality of leads extending from the plurality of electrical sensors , the plurality of leads configured to transmit electrical signals representative of electrical activity sensed at the surface of the brain to a signal acquisition apparatus (Mercanzini’834: Interpretation A: Para. [0107] discloses that each microelectrode has a respective conductor that is disposed within the film 110, such that it necessarily is routed around the aperture ‘…each of the microelectrode elements 140 is in electrical communication with the control circuitry 160 via a respective electrical conductor disposed in the microelectrode array film 110 and the ribbon cable tether 180.’ | Interpretation B: Para. [0158] ‘On the surface of the circular microelectrode array film 440M are microelectrode array elements 440M which are in communication with the control circuitry 460M through embedded conductive traces’, [0163]).
Regarding Claim 14, Mercanzini’834 discloses the cortical electrode assembly of claim 13, Mercanzini’834 further discloses wherein the plurality of leads are routed around the aperture formed by the ring-shaped substrate so that the aperture is clear of interference that would prevent an operator to access the surface of the brain via the aperture in use (Mercanzini’834: Interpretation A: Para. [0107] discloses that each microelectrode has a respective conductor that is disposed within the film 110, such that it necessarily is routed around the aperture | Interpretation B: Para. [0158], [0163] disclose each microelectrode being controlled through embedded conductive traces, likewise necessarily routing around the aperture).
Regarding Claim 15, Mercanzini’834 discloses the cortical electrode assembly of claim 13, Mercanzini’834 further discloses wherein the plurality of leads includes a respective lead for each of the plurality of electrical sensors (Mercanzini’834: Interpretation A: Para. [0107] discloses that each microelectrode has a respective conductor that is disposed within the film 110, such that it necessarily is routed around the aperture | Interpretation B: Para. [0158], [0163] disclose each microelectrode being controlled through embedded conductive traces, likewise necessarily routing around the aperture).
Regarding Claim 16, Mercanzini’834 discloses the cortical electrode assembly of claim 1, Mercanzini’834 further discloses wherein the ring-shaped substrate is shaped substantially as an oval or an n-sided polygonal ring, wherein n is at least 3 (Mercanzini’834: Interpretation A: Fig. 1, the ring is a 4-side polygonal loop | Interpretation B: the ring is shown to be a circular/oval loop.).
Regarding Claim 18, Mercanzini’834 discloses a cortical electrode assembly configured, in use, to sense electrical activity at a surface of a brain (Mercanzini’834: Para. [0161]), the assembly comprising a plurality of electrical sensors arranged in the shape of a ring (Mercanzini’834: Para. [0022]; Interpretation A: microelectrode elements 140 | Interpretation B: microelectrode elements 440; Interpretation A: microelectrode array film 110 as part of surface probe 101 as seen in Figs. 1 and 5A is reasonably construed as a ring-shaped substrate, as it generally defines a polygonal shape (4-sided polygon) surrounding a central aperture in a loop. | Interpretation B: in Figs. 17C-D and 18B, surface probe 401 defines a round ring shape with a central aperture and comprises microelectrode array film 410.).
Regarding Claim 20, Mercanzini’834 discloses an electrocorticography method (Mercanzini’834: Abstract), comprising: placing a cortical electrode assembly on a surface of a brain (Mercanzini’834: Para. [0005]-[0007]);
applying an electrical stimulus to the surface of the brain; and measuring a response to the electrical stimulus based on signals generated by a plurality of electrical sensors of the cortical electrode assembly (Mercanzini’834: Para. [0015]),
wherein the cortical electrode assembly includes: a ring-shaped substrate (Mercanzini’834: Interpretation A: microelectrode array film 110 as part of surface probe 101 as seen in Figs. 1 and 5A is reasonably construed as a ring-shaped substrate, as it generally defines a polygonal shape (4-sided polygon) surrounding a central aperture in a loop. | Interpretation B: in Figs. 17C-D and 18B, surface probe 401 defines a round ring shape with a central aperture and comprises microelectrode array film 410.); and
the plurality of electrical sensors affixed to the ring-shaped substrate (Mercanzini’834: Para. [0022]; Interpretation A: microelectrode elements 140 | Interpretation B: microelectrode elements 440),
wherein the plurality of electrical sensors are spaced along the ring-shaped substrate so as to form a ring of electrical sensors that substantially encircle an aperture formed by the ring-shaped substrate (Mercanzini’834: Interpretation A: microelectrodes 140 of each cortical depth probe 130 encircles the central-most aperture | Interpretation B: the electrodes 440 reasonably form a ring and encircle the aperture at the center of the ring of probe 401).
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) 11, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mercanzini’834.
Regarding Claim 11, Mercanzini’834 discloses the cortical electrode assembly of claim 1, Mercanzini’834 does not explicitly disclose wherein an outer diameter of the ring- shaped substrate is in the range 3 centimeters (cm) to 10 cm.
It would have been obvious to one having an ordinary skill in the art at the time the invention was filed to modify the system as taught by Mercanzini’834 with an outer diameter of the ring-shaped substrate in the range of 3-10cm, since it has been held that where the general conditions of a claim are disclosed within the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (See MPEP 2144.05).
Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Mercanzini’834 with the claimed dimensions because Applicant has not disclosed that having those particular dimensions of inner and outer diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the sizes as taught by Mercanzini’834, because it allows the device to be sized and shaped for its intended neurological application and since it appears to be an arbitrary design choice which fails to patentably distinguish over Mercanzini’834. Therefore, it would have been an obvious matter of design choice to modify Mercanzini’834 to obtain the invention as specified in the claim.
Regarding Claim 12, Mercanzini’834 discloses the cortical electrode assembly of claim 11, Mercanzini’834 does not explicitly disclose wherein an inner diameter of the ring-shaped substrate is in the range 2 cm to 9 cm.
It would have been obvious to one having an ordinary skill in the art at the time the invention was filed to modify the system as taught by Mercanzini’834 with an inner diameter in the range of 2-9cm, since it has been held that where the general conditions of a claim are disclosed within the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (See MPEP 2144.05).
Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Mercanzini’834 with the claimed dimensions because Applicant has not disclosed that having those particular dimensions of inner and outer diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the sizes as taught by Mercanzini’834, because it allows the device to be sized and shaped for its intended neurological application and since it appears to be an arbitrary design choice which fails to patentably distinguish over Mercanzini’834. Therefore, it would have been an obvious matter of design choice to modify Mercanzini’834 to obtain the invention as specified in the claim.
Regarding Claim 19, Mercanzini’834 discloses the cortical electrode assembly of claim 18, Mercanzini’834 further discloses wherein the microelectrodes are fixed in position relative to each other (Mercanzini’834: Para. [0121], [0140], [0150]); Para. [0109] ‘the cortical neuromodulation device is sized and shaped for its intended neurological application’; ‘the diameter and length may vary depending on the particular anatomical target of varying sizes; the number, shape, orientation, size and spacing of the microelectrode elements can be defined in response to the intended target’). Mercanzini’834 does not explicitly disclose wherein an inner diameter of the ring is in the range 2 centimeters (cm) to 9 cm.
It would have been obvious to one having an ordinary skill in the art at the time the invention was filed to modify the system as taught by Mercanzini’834 with an inner diameter in the range of 2-9cm, since it has been held that where the general conditions of a claim are disclosed within the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (See MPEP 2144.05).
Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Mercanzini’834 with the claimed dimensions because Applicant has not disclosed that having those particular dimensions of inner and outer diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the sizes as taught by Mercanzini’834, because it allows the device to be sized and shaped for its intended neurological application and since it appears to be an arbitrary design choice which fails to patentably distinguish over Mercanzini’834. Therefore, it would have been an obvious matter of design choice to modify Mercanzini’834 to obtain the invention as specified in the claim.
Allowable Subject Matter
Claim 17 would be allowable should Applicant overcome the non-statutory double patenting rejection(s), set forth in this Office action and should the claim be amended to include all of the limitations of the base claim and any intervening claims.
Mercanzini’834 fails to teach or fairly suggest, in combination with the other limitations of the claim, a plurality of ring- shaped substrates in a concentric arrangement, each ring-shaped substrate having a respective plurality of electrical sensors affixed to the ring-shaped substrate so as to form a respective ring of electrical sensors on the respective ring-shaped substrate, wherein the plurality of ring-shaped substrates are spaced apart from each other so as provide a respective gap between each of the ring-shaped substrates through which stimulation electrodes can be inserted to facilitate cortical or subcortical brain mapping.
While certain prior art references cited herewith (e.g. Watanabe et al., US 2017/0347908 A1; Blauer et al., US 2017/0027465 A1; Gliner, US 7221981 B2) teach certain benefits to concentrically arranged circles of electrodes, they fail to disclose or render obvious the use of a plurality of different substrates arranged concentrically and spaced apart so as to facilitate insertion of stimulation electrodes through the provided gaps for subcortical brain mapping.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2017/0347908 A1 to Watanabe et al.; US 2017/0027465 A1 to Blauer et al.; US 7221981 B2 to Gliner.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791