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 .
Response to Amendment
This office action is in response to the amendment filed on 6/2/2026. Currently claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see pg. 7, filed 6/2/2026, with respect to the previous objection of claims 6 and 13 have been fully considered and are persuasive. The previous objections of claims 6 and 13 have been withdrawn.
Applicant’s arguments, see pgs. 7-8, filed 6/2/2026, with respect to previous rejections of claims 6-8 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejections of claims 6-8 under 35 USC 112(b) has been withdrawn.
Applicant's arguments filed 6/2/2026 with respect to the rejections of claims 1-20 under 35 USC 101 have been fully considered but they are not persuasive.
The crux of applicant’s arguments with respect to the 101 rejection is that the claims are integrated into a practical application because they are tied to treatment through the control and application of the first and second electronic fields by an implantable medical device. In particular applicant uses claim 1 as an example for all the claims. As applicant argues:
“Claim 1 recites, inter alia, processing circuitry configured to "control an implantable medical device implanted within the patient to deliver the first electric field from the first electrode combination of the implanted electrodes according to the therapy parameter values" and "control the implantable medical device to deliver, alternating with the first electric field, the second electric field from the second electrode combination of the implanted electrodes according to the therapy parameter values." As discussed above, examples of treatment include types of therapy. The delivery of the first electric field and the second electric field as recited by claim 1 is thus a treatment that integrates the alleged abstract idea to "determine therapy parameter values" into a practical application.” [see pg. 9 of applicant’s arguments received on 6/2/2026]
This argument is not persuasive. MPEP 2106.05(f) states the following with respect to determining if the claim simply recites a judicial exception with the words “apply it” or its equivalent:
“For claim limitations that do not amount to more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners should explain why they do not meaningfully limit the claim in an eligibility rejection. For example, an examiner could explain that implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. For more information on formulating a subject matter eligibility rejection. See MPEP § 2106.07(a).
When determining whether a claim simply recites a judicial exception with the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners may consider the following:
(1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it". See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015). In contrast, claiming a particular solution to a problem or a particular way to achieve a desired outcome may integrate the judicial exception into a practical application or provide significantly more. See Electric Power, 830 F.3d at 1356, 119 USPQ2d at 1743.
By way of example, in Intellectual Ventures I v. Capital One Fin. Corp., 850 F.3d 1332, 121 USPQ2d 1940 (Fed. Cir. 2017), the steps in the claims described "the creation of a dynamic document based upon ‘management record types’ and ‘primary record types.’" 850 F.3d at 1339-40; 121 USPQ2d at 1945-46. The claims were found to be directed to the abstract idea of "collecting, displaying, and manipulating data." 850 F.3d at 1340; 121 USPQ2d at 1946. In addition to the abstract idea, the claims also recited the additional element of modifying the underlying XML document in response to modifications made in the dynamic document. 850 F.3d at 1342; 121 USPQ2d at 1947-48. Although the claims purported to modify the underlying XML document in response to modifications made in the dynamic document, nothing in the claims indicated what specific steps were undertaken other than merely using the abstract idea in the context of XML documents. The court thus held the claims ineligible, because the additional limitations provided only a result-oriented solution and lacked details as to how the computer performed the modifications, which was equivalent to the words "apply it". 850 F.3d at 1341-42; 121 USPQ2d at 1947-48 (citing Electric Power Group., 830 F.3d at 1356, 1356, USPQ2d at 1743-44 (cautioning against claims "so result focused, so functional, as to effectively cover any solution to an identified problem")).”
While the claims do tie the determined parameter values (i.e. the result of the judicial exception) to the application of electric fields by an implantable device, the resulting electric fields appear to be the mere result of applying judicial exception as they are only the idea of a solution or outcome and thus the claim simply recites a judicial exception with the words “apply it” or its equivalent as described in MPEP 2106.05(f). Additionally, generic processing circuitry (i.e. a generic processor or generic computer) and generic implantable device are essentially doing the application. Thus, claim 1 appears to be merely having the generic processing circuitry and implantable device apply the judicial exception. As ruled by Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) in MPEP 2106.05(f) such mere instructions to apply the judicial exception does not integrate the judicial exception into a practical application. Thus, while the rejection has been updated to account for the amendments to the language, the rejection is maintained.
Applicant’s arguments, see pgs. 10-13, filed 6/2/2026, with respect to the rejection(s) of:
claim(s) 1, 9, 15-16 and 19-20 rejected under 35 USC 102(a)(2) as being anticipated by Lok
claim(s) 2-8 and 17-18 rejected under 35 USC 103 as being unpatentable over Lok in view of Phillips
claim(s) 10-11 and 13-14 rejected under 35 USC 103 as being unpatentable over Lok in view of Romero
claim 12 rejected under 35 USC 103 as being unpatentable over Lok in view of Romero in view of Robinson
have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the additional reference of Carlson et al (WO 2021102120) as outlined below.
Claim Rejections - 35 USC § 101
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (specifically a mental process) without significantly more.
Independent claims:
The claim(s) 1 recite(s):
“receive a request to deliver localized electric field therapy within a cranium of a patient;”
“determine therapy parameter values that define the electric field therapy, wherein the electric field therapy comprises alternating delivery of a first electric field from a first electrode combination of implanted electrodes within the cranium of the patient and a second electric field from a second electrode combination of the implanted electrodes different from the first electrode combination;”
This is a mental process because the human mind is fully capable of observing (i.e. receiving) and determining the broadly claimed parameter values. This judicial exception is not integrated into a practical application because the additional limitations amount to mere instructions to apply an exception and automated analysis that is insignificant extra-solution activity. In this case, the additional limitations are directed to controlling electrodes to produce specific electric fields based the determined parameter values. And, as ruled by Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) in MPEP 2106.05(f) such mere instructions to apply the judicial exception does not integrate the judicial exception into a practical application and, as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim only positively recites processing circuitry (understood to be generic circuitry or generic processor) and a generic implanted device in form of generic implantable electrodes. These elements are well known and conventional as evidenced by disclosure in Lok et al (WO-2018057953 cited in applicant’s IDS) [see para 20 for processing circuitry and see Fig. 1 element 130 (one or more transducer arrays and para 41 for implanted electrodes] and Yoo et al (US 20190001135) [see para 218] Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 1 is rejected under 101.
The claim(s) 16 recite(s):
“receiving, by processing circuitry, a request to deliver localized electric field therapy within a cranium of a patient;”
“determining, by the processing circuitry, therapy parameter values that define the electric field therapy, wherein the electric field therapy comprises alternating delivery of a first electric field from a first electrode combination of implanted electrodes within the cranium of the patient and a second electric field from a second electrode combination of the implanted electrodes different from the first electrode combination;”
This is a mental process because the human mind is fully capable of observing (i.e. receiving) and determining the broadly claimed parameter values. This judicial exception is not integrated into a practical application because the additional limitations amount to mere instructions to apply an exception and automated analysis that is insignificant extra-solution activity. In this case, the additional limitations are directed to controlling electrodes to produce specific electric fields based the determined parameter values. And, as ruled by Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) in MPEP 2106.05(f) such mere instructions to apply the judicial exception does not integrate the judicial exception into a practical application and, as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim only positively recites processing circuitry (understood to be generic circuitry or generic processor) and a generic implanted device in form of generic implantable electrodes. These elements are well known and conventional as evidenced by disclosure in Lok et al (WO-2018057953) [see para 20 for processing circuitry and see Fig. 1 element 130 (one or more transducer arrays and para 41 for implanted electrodes] and Yoo et al (US 20190001135) [see para 218] Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 16 is rejected under 101.
The claim(s) 20 recite(s):
“receive a request to deliver localized electric field therapy within a cranium of a patient;”
“determine therapy parameter values that define the electric field therapy, wherein the
electric field therapy comprises alternating delivery of a first electric field from a first electrode combination of implanted electrodes within the cranium of the patient and a second electric field from a second electrode combination of the implanted electrodes different from the first electrode combination”
This is a mental process because the human mind is fully capable of observing (i.e. receiving) and determining the broadly claimed parameter values. This judicial exception is not integrated into a practical application because the additional limitations amount to mere instructions to apply an exception and automated analysis that is insignificant extra-solution activity. In this case, the additional limitations are directed to controlling electrodes to produce specific electric fields based the determined parameter values. And, as ruled by Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) in MPEP 2106.05(f) such mere instructions to apply the judicial exception does not integrate the judicial exception into a practical application and, as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim only positively recites processing circuitry (understood to be generic circuitry or generic processor), computer-readable storage medium (understood to be generic non-transitory medium or memory) and a generic implanted device in form of generic implantable electrodes. These elements are well known and conventional as evidenced by disclosure in Lok et al (WO-2018057953) [see para 20 for processing circuitry and see Fig. 1 element 130 (one or more transducer arrays), para 41 for implanted electrodes and para 95 for computer-readable storage medium] and Yoo et al (US 20190001135) [see para 218] Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 20 is rejected under 101.
Dependent claims
Regarding dependent claims 2-8, these claims only further describe the generic electrodes with generic features and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 2-8 are rejected under 35 USC 101 for similar reasons as claim 1.
Regarding dependent claim 9 and 15, these claims only further describe the mental process and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 9 and 15 are rejected under 35 USC 101 for similar reasons as claim 1.
Regarding dependent claims 10-14, further recite the structures of a guide layer and adhesive to secure the electrodes. However, as described in Pianaca et al (US 20180021569) [see para 66] use of guide layers / connectors (i.e. like adhesives) in the form of introducers are conventional and well known to be used to help in the placement of implantable leads (i.e. electrodes). Thus, claims 10-14 do not amount to significantly more than the judicial exception for similar reasons as claim 1.
Regarding dependent claims 17-18 these claims only further describe the generic electrodes with generic features and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 17-18 are rejected under 35 USC 101 for similar reasons as claim 16.
Regarding dependent claim 19, this claim only further describes the mental process and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claim 19 is rejected under 35 USC 101 for similar reasons as claim 16.
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, 9, 15-16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lok et al (WO-2018057953, cited on applicant’s IDS received 3/19/2024 as foreign document 1 as Beth Israel Deaconess Medical Center and copy provided by applicant) hereafter known as Lok in view of Carlson et al (WO 2021102120) hereafter known as Carlson.
Independent claim:
Regarding claim 1
Lok discloses
A system [see abstract… “System and methods for determining placement of a transducer array relative to a subject's head, which may be used in treating cancer in the subject, are provided.”] comprising:
processing circuitry [see para 20… “The system further includes circuitry configured to construct, based on at least one image, a representation of a subject's head that includes information for a plurality of structures including at least one tumor positioned within the subject's brain.”] configured to:
receive a request to deliver electric field therapy [see para 40… “identifying a transducer arrangement may include selecting a transducer arrangement from among multiple different transducer arrangements as having the highest amount of energy absorption and/or highest amount of electric field at the tumor. Such a process may allow for identification of a transducer arrangement that allows for targeted and personalized delivery of electric fields and/or electric energy to the tumor, which can be used in treatment.”];
determine therapy parameter values that define the electric field therapy [see para 41… “modeling electric field propagation for a particular transducer arrangement may allow for identification of one or more parameters (e.g., electric field magnitude, frequency, duration) used to operate one or more transducers in order to provide a particular amount of electric field and/or rate of energy absorption at a particular region, such as a tumor inside a person's head.”],
wherein the electric field therapy comprises alternating delivery of a first electric field from a first electrode combination of implanted electrodes within the cranium of the patient and a second electric field from a second electrode combination of the implanted electrodes different from the first electrode combination [see para 41… “During operation, the one or more transducers may be controlled to emit an alternating electric field having one of the identified frequencies.”];
control an implantable medical device implanted within the patient to deliver the first electric field from the first electrode combination of the implanted electrodes according to the therapy parameter values [see Fig. 1 element 130 (one or more transducer arrays (i.e. a first electrode) and para 41… “used to operate one or more transducers in order to provide a particular amount of electric field and/or rate of energy absorption at a particular region, such as a tumor inside a person's head.” an array of transducers is at least a first electrode]; and
control the implantable medical device to deliver, alternating with the first electric field, the second electric field from the second electrode combination of the implanted electrodes according to the therapy parameter values [see Fig. 1 element 130 (one or more transducer arrays (i.e. a second electrode) and paras 48-49… “array operation analyzer 122 may generate different electric field distributions and/or rate of energy absorption distributions for multiple arrangements of one or more transducer arrays.” an array of transducers is at least a second electrode]
However, while Lok discloses the processing circuitry as receiving a request to deliver electric field therapy, Lok fails to fully disclose “receive a request to deliver localized electric field therapy within a cranium of a patient” as claimed.
Carlson discloses in the analogous art of implantable electrode stimulation [see para 2… “This application relates generally to apparatuses and methods for providing tumor treating fields and, in particular, to apparatuses and methods for implanting electrodes within a patient for providing tumor treating fields.”] that positioning and configuring electrodes within a body to create localized electric fields provides treatment benefits in treating tumors [see para 32… “the present disclosure recognizes that there are benefits to positioning electrodes within the body of the patient to provide localized electric fields at the site of a tumor.”]
Since Lok is directed to treating tumors in the brain [see abstract…. “System and methods for determining placement of a transducer array relative to a subject's head, which may be used in treating cancer in the subject, are provided. These techniques may include constructing, based on one or more images, a representation of the subject's head that includes information for a plurality of structures including one or more tumors positioned within the subject's brain.” and paras 2-3…. “The present application relates to techniques for operating one or more transducer arrays to apply an alternating electric field to treat cancer in a patient.”] and Carlson discloses configuring electrodes to create localized electric fields will provide benefits in treatment, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Lok by configuring the processing circuitry and electrodes to deliver localized electric fields in the body part (i.e. specifically the brain) similarly to that disclosed by Carlson (i.e. thereby fully reciting “receive a request to deliver localized electric field therapy within a cranium of a patient”) to achieve these benefits in treatment.
Independent claim:
Regarding claim 16:
A method [see abstract… “System and methods for determining placement of a transducer array relative to a subject's head, which may be used in treating cancer in the subject, are provided.”] comprising:
receiving, by processing circuitry, a request to deliver electric field therapy [see para 20… “The system further includes circuitry configured to construct, based on at least one image, a representation of a subject's head that includes information for a plurality of structures including at least one tumor positioned within the subject's brain.” And see para 40… “identifying a transducer arrangement may include selecting a transducer arrangement from among multiple different transducer arrangements as having the highest amount of energy absorption and/or highest amount of electric field at the tumor. Such a process may allow for identification of a transducer arrangement that allows for targeted and personalized delivery of electric fields and/or electric energy to the tumor, which can be used in treatment.”];
determining, by the processing circuitry, therapy parameter values that define the electric field therapy [see para 41… “modeling electric field propagation for a particular transducer arrangement may allow for identification of one or more parameters (e.g., electric field magnitude, frequency, duration) used to operate one or more transducers in order to provide a particular amount of electric field and/or rate of energy absorption at a particular region, such as a tumor inside a person's head.”],
wherein the electric field therapy comprises alternating delivery of a first electric field from a first electrode combination of implanted electrodes within the cranium of the patient and a second electric field from a second electrode combination of the implanted electrodes different from the first electrode combination [see para 41… “During operation, the one or more transducers may be controlled to emit an alternating electric field having one of the identified frequencies.”];
controlling, by the processing circuitry, an implantable medical device implanted within the patient to deliver the first electric field from the first electrode combination of the implanted electrodes according to the therapy parameter values [see Fig. 1 element 130 (one or more transducer arrays (i.e. a first electrode) and para 41… “used to operate one or more transducers in order to provide a particular amount of electric field and/or rate of energy absorption at a particular region, such as a tumor inside a person's head.”]; and
controlling, by the processing circuitry, the implantable medical device to deliver, alternating with the first electric field, the second electric field from the second electrode combination of the implanted electrodes according to the therapy parameter values [see Fig. 1 element 130 (one or more transducer arrays (i.e. a second electrode) and paras 48-49… “array operation analyzer 122 may generate different electric field distributions and/or rate of energy absorption distributions for multiple arrangements of one or more transducer arrays.” an array of transducers is at least a second electrode].
However, while Lok discloses the processing circuitry as receiving a request to deliver electric field therapy, Lok fails to fully disclose “receiving, by processing circuitry, a request to deliver localized electric field therapy within a cranium of a patient” as claimed.
Carlson discloses in the analogous art of implantable electrode stimulation [see para 2… “This application relates generally to apparatuses and methods for providing tumor treating fields and, in particular, to apparatuses and methods for implanting electrodes within a patient for providing tumor treating fields.”] that positioning and configuring electrodes within a body to create localized electric fields provides treatment benefits in treating tumors [see para 32… “the present disclosure recognizes that there are benefits to positioning electrodes within the body of the patient to provide localized electric fields at the site of a tumor.”]
Since Lok is directed to treating tumors in the brain [see abstract…. “System and methods for determining placement of a transducer array relative to a subject's head, which may be used in treating cancer in the subject, are provided. These techniques may include constructing, based on one or more images, a representation of the subject's head that includes information for a plurality of structures including one or more tumors positioned within the subject's brain.” and paras 2-3…. “The present application relates to techniques for operating one or more transducer arrays to apply an alternating electric field to treat cancer in a patient.”] and Carlson discloses configuring electrodes to create localized electric fields will provide benefits in treatment, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Lok by configuring the processing circuitry and electrodes to deliver localized electric fields in the body part (i.e. specifically the brain) similarly to that disclosed by Carlson (i.e. thereby fully reciting “receiving, by processing circuitry, a request to deliver localized electric field therapy within a cranium of a patient”) to achieve these benefits in treatment.
Independent claim:
Regarding claim 20:
A computer-readable storage medium [see abstract… “System and methods for determining placement of a transducer array relative to a subject's head, which may be used in treating cancer in the subject, are provided.” And Fig. 12 element 1230 and para 95… “a system memory 1230”] comprising instructions that, when executed, cause processing circuitry [see Fig. 12 element 1220 and para 95… “a processing unit 1220, a system memory 1230, and a system bus 1221 that couples various system components including the system memory to the processing unit 1220.” A processing unit is interpreted as processing circuitry] to:
receive a request to deliver electric field therapy [see para 40… “identifying a transducer arrangement may include selecting a transducer arrangement from among multiple different transducer arrangements as having the highest amount of energy absorption and/or highest amount of electric field at the tumor. Such a process may allow for identification of a transducer arrangement that allows for targeted and personalized delivery of electric fields and/or electric energy to the tumor, which can be used in treatment.”];
determine therapy parameter values that define the electric field therapy [see para 41… “modeling electric field propagation for a particular transducer arrangement may allow for identification of one or more parameters (e.g., electric field magnitude, frequency, duration) used to operate one or more transducers in order to provide a particular amount of electric field and/or rate of energy absorption at a particular region, such as a tumor inside a person's head.”],
wherein the electric field therapy comprises alternating delivery of a first electric field from a first electrode combination of implanted electrodes within the cranium of the patient and a second electric field from a second electrode combination of the implanted electrodes different from the first electrode combination [see para 41… “During operation, the one or more transducers may be controlled to emit an alternating electric field having one of the identified frequencies.”];
control an implantable medical device implanted within the patient to deliver the first electric field from the first electrode combination of the implanted electrodes according to the therapy parameter values [see Fig. 1 element 130 (one or more transducer arrays (i.e. a first electrode) and para 41… “used to operate one or more transducers in order to provide a particular amount of electric field and/or rate of energy absorption at a particular region, such as a tumor inside a person's head.”]; and
control the implantable medical device to deliver, alternating with the first electric field, the second electric field from the second electrode combination of the implanted electrodes according to the therapy parameter values [see Fig. 1 element 130 (one or more transducer arrays (i.e. a second electrode) and paras 48-49… “array operation analyzer 122 may generate different electric field distributions and/or rate of energy absorption distributions for multiple arrangements of one or more transducer arrays.” an array of transducers is at least a second electrode].
However, while Lok discloses the instructions and processing circuitry as receiving a request to deliver electric field therapy, Lok fails to fully disclose “receive a request to deliver localized electric field therapy within a cranium of a patient” as claimed.
Carlson discloses in the analogous art of implantable electrode stimulation [see para 2… “This application relates generally to apparatuses and methods for providing tumor treating fields and, in particular, to apparatuses and methods for implanting electrodes within a patient for providing tumor treating fields.”] that positioning and configuring electrodes within a body to create localized electric fields provides treatment benefits in treating tumors [see para 32… “the present disclosure recognizes that there are benefits to positioning electrodes within the body of the patient to provide localized electric fields at the site of a tumor.”]
Since Lok is directed to treating tumors in the brain [see abstract…. “System and methods for determining placement of a transducer array relative to a subject's head, which may be used in treating cancer in the subject, are provided. These techniques may include constructing, based on one or more images, a representation of the subject's head that includes information for a plurality of structures including one or more tumors positioned within the subject's brain.” and paras 2-3…. “The present application relates to techniques for operating one or more transducer arrays to apply an alternating electric field to treat cancer in a patient.”] and Carlson discloses configuring electrodes to create localized electric fields will provide benefits in treatment, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Lok by configuring the instructions, processing circuitry and electrodes to deliver localized electric fields in the body part (i.e. specifically the brain) similarly to that disclosed by Carlson (i.e. thereby fully reciting “receive a request to deliver localized electric field therapy within a cranium of a patient”) to achieve these benefits in treatment.
Dependent claims:
Regarding claims 9:
wherein the processing circuitry is configured to:
estimate propagation of the first electric field and the second electric field through tissue; [see abstract of Lok… “The representation of the subject's head may be used to calculate electric field propagation for one or more arrangements of a transducer array on a surface of the subject's head. These techniques may further include determining one or more rate of energy absorption distributions and/or one or more electric field distributions using the calculated electric field propagation for multiple arrangements of the transducer array.”]
cycle, based on the estimate, the first electric field and the second electric field on and off [See Para 36 of Lok… “The one or more transducers may be placed on a surface of the subject proximate to the location of the tumor and may emit alternating electric fields. In embodiments where the one or more transducer arrays are used to treat a brain tumor, the one or more transducer arrays may be placed on the subject's head (e.g. , on the subject's scalp).”]
Regarding claim 15, para 5 of Lok [see “In some embodiments, the at least one structure includes an artificial structure introduced into the subject's head. In some embodiments, the artificial structure includes an implantable electrode configured to emit an electric field.”] discloses an implantable medical device in the form of electrodes, para 20 of Lok [see “The system further includes circuitry configured to construct, based on at least one image, a representation of a subject's head that includes information for a plurality of structures including at least one tumor positioned within the subject's brain.”] discloses processing circuitry as claimed and paras 41 and 95 of Lok [see “During operation, the one or more transducers may be controlled to emit an alternating electric field having one of the identified frequencies. As another example, modeling how electric field propagation varies over a range of electric field magnitude” and “an exemplary system for implementing the invention includes a general purpose computing device in the form of a computer 1210. Components of computer 1210 may include, but are not limited to, a processing unit 1220”] disclose stimulation circuitry in the form of a processor.
Regarding claim 19:
estimating, by the processing circuitry, propagation of the first electric field and the second electric field through tissue [see abstract of Lok … “The representation of the subject's head may be used to calculate electric field propagation for one or more arrangements of a transducer array on a surface of the subject's head. These techniques may further include determining one or more rate of energy absorption distributions and/or one or more electric field distributions using the calculated electric field propagation for multiple arrangements of the transducer array.”]; and
cycling, by the processing circuitry and based on the estimated propagation, the first electric field and the second electric field on and off [See Para 36 of Lok … “The one or more transducers may be placed on a surface of the subject proximate to the location of the tumor and may emit alternating electric fields. In embodiments where the one or more transducer arrays are used to treat a brain tumor, the one or more transducer arrays may be placed on the subject's head (e.g. , on the subject's scalp).”]
Claim(s) 2-8 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lok in view of Carlson as applied to claims 1 and 16 above, and further in view of Phillips et al (US 20180289311).
Regarding claims 2-4, 6-7 and 17-18:
Lok in view of Carlson discloses the invention substantially as claimed including all the limitations of claims 1 and 16.
However, while Lok in view of Carlson discloses implantable electrodes in head [see para 5 of Lok… “the at least one structure includes an intracranial structure. In some embodiments, the at least one structure includes an artificial structure introduced into the subject's head. In some embodiments, the artificial structure includes an implantable electrode configured to emit an electric field.”], Lok in view of Carlson is silent to all the details of exactly how the electrodes are configured to be placed in the head. Therefore Lok in view of Carlson fails to disclose “wherein the implanted electrodes are carried on one or more medical leads, each medical lead of the one or more medical leads comprising: a non-conductive cap, a post coupled to the non-conductive cap and configured to carry one or more electrodes at respective axial positions along the post, and wherein a cross-sectional area of the post is smaller than a cross-sectional area of the non-conductive cap.” as recited by claims 2 and 17, “wherein the one or more medical leads comprise a plurality of medical leads, and wherein each medical lead of the plurality of leads comprises two or more electrodes disposed at different axial positions along the post”, “wherein the post is configured to be inserted into tissue to a depth limited by a length of the post extending from a distal surface of the non-conductive cap.” as recited by claims 3-4 and/or 18, “wherein each medical lead of the one or more medical leads comprises a respective conductor extending from the respective non-conductive cap” as recited by claim 6 or “wherein each electrode of the implanted electrodes is associated with the respective conductor” as recited by claim 7.
Phillips discloses in the analogous art of intracranial electrode devices [see para 7… “the present invention is a device, which is fully implantable in a person, and records the EEG of a person, and comprises an energy storage module, control logic, memory, an EEG amplifier, a subcranial electrode, an extracranial electrode, and an intercranial portion, the intercranial portion passing through an opening in the skull and comprising a seal”] that a known structure used to place of electrodes at the brain include two leads [see Figs-1-2 element 101, 106 and para 32… “each with a subcranial probe (101, 106) inserted through a burr-hole (102, 105) in the skull (108) and proceeding into the brain (109),”] each with a non-conductive cap [see Fig. 1-2 element 203 and para 33… “A seal (203) is included in the intracranial portion to prevent fluid ingress or egress from the burr-hole, thereby providing electrical insulation”] a post [see Fig. 2 element 205 and para 33… “a subcranial probe (205) contains 9 electrodes (204) evenly spaced,”] that carries multiple electrodes at different axial positions with the post configured to be inserted into tissue to a depth limited by length of post and distal surface of non-conductive cap [see Fig.1-2 and para 32… “In this, two devices are implanted in a person, each with a subcranial probe (101, 106) inserted through a burr-hole (102, 105) in the skull (108) and proceeding into the brain (109)” and para 33… “a subcranial probe (205) contains 9 electrodes (204) evenly spaced”] and the post having a smaller cross-section than the non-conductive cap [see Fig. 2 which shows element 203 (i.e. cap) surrounding element 205 (i.e. post) and with the probe coupled to the non-conductive cap [see Figs. 1-2]. Phillips further discloses the series of electrodes [see Fig. 1-2 element 204] are grounded to a conductive case [see Fig. 2 element 202] between which the cap sits [see Fig. 2] (i.e. implying a respective conductor extending form the non-conductive cap and each electrode associated with the respective conductor) [see para 33… “a subcranial probe (205) contains 9 electrodes (204) evenly spaced, allowing EEG recording at one or more locations along the probe's length. A battery (201) lies flat at the top of the device and conductive case (202) is beneath. The conductive case acts as an extracranial electrode. The case contains an EEG amplifier, processor, and memory, allowing for EEG recording between any two of the subcranial electrodes with the extracranial electrode acting as a ground reference, or between a subcranial electrode and the extracranial electrode. A seal (203) is included in the intracranial portion to prevent fluid ingress or egress from the burr-hole, thereby providing electrical insulation between the intracranial electrodes and the extracranial electrode”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Lok in view of Carlson by placing the electrodes on leads similar to that disclosed by Phillips (i.e. thereby reciting the limitations of claims 2-4, 6-7 and 17-18) because Lok in view of Carlson is silent as to all the structures used with which to place the electrodes at the brain and Phillips discloses a known structure for the placement of electrodes at the brain, therefore this is a known structure to perform a known function.
Regarding claim 5:
Lok in view of Carlson in view of Phillips discloses the invention substantially as claimed including all the limitations of claim 1-2 as outlined above.
However, Lok in view of Carlson in view of Phillips fails to disclose: “wherein the one or more medical leads comprises a first medical lead comprising a first post having a first length and a second medical lead comprising a second post having a second length different than the first length.” as recited by claim 5
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Lok in view of Carlson in view of Phillips’s post to recite the limitation of wherein the one or more medical leads comprises a first medical lead comprising a first post having a first length and a second medical lead comprising a second post having a second length different than the first length as recited by claim 5 because there are only two limited choices on length of the two posts relative to each other (i.e. posts are the same length, the posts have a different length) and the posts have a different length is one of those limited number of choices.
Regarding claim 8:
Lok in view of Carlson discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Lok in view of Carlson fails to disclose “one or more medical leads and wherein the one or more medical leads are configured to position the plurality of electrodes within tissue with respect to a tissue resection region” as recited by claim 8.
Lok further discloses the target of interest include resection cavities [see para 37… “In embodiments where the one or more transducer arrays are used to treat brain cancer, intracranial structures (e.g. , necrotic core, resection cavity, white matter, grey matter, brain matter) and/or extracranial structures (e.g. , an implantable electrode, modulator) may be considered.” And para 52… “The representation may be of the subject' s head and may include information for multiple structures, such as intracranial and extracranial structures, including one or more tumors positioned within the subject's brain. In some embodiments, the representation of the subject' s head may include one or more structures (e.g. , intracranial structure, artificial structure) proximate to the one or more tumors. Examples of structures that may be included in a representation include a necrotic core of a tumor, resection cavity, cerebrospinal fluid, white matter, grey matter, brain matter, and scalp.”]
Phillips discloses in the analogous art of intracranial electrode devices [see para 7… “the present invention is a device, which is fully implantable in a person, and records the EEG of a person, and comprises an energy storage module, control logic, memory, an EEG amplifier, a subcranial electrode, an extracranial electrode, and an intercranial portion, the intercranial portion passing through an opening in the skull and comprising a seal”] that a known structure used to place of electrodes at the brain include two leads [see Figs-1-2 element 101, 106 and para 32… “each with a subcranial probe (101, 106) inserted through a burr-hole (102, 105) in the skull (108) and proceeding into the brain (109),”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Lok in view of Carlson by placing the electrodes on leads similar to that disclosed by Phillips because Lok in view of Carlson is silent as to all the structures used with which to place the electrodes at the brain and Phillips discloses a known structure for the placement of electrodes at the brain, therefore this is a known structure to perform a known function.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Lok in view of Carlson in view of Phillips to achieve the claimed feature of “wherein the one or more medical leads are configured to position the plurality of electrodes within tissue with respect to a tissue resection region” because as explained previously, Lok the primary reference of the combined Lok in view of Carlson in view of Phillips is directed to analyzing resection cavities with the device; therefore, absent unpredictable results, one or ordinary skill would expect to achieve the claimed combination through routine experimentation through the application of placing the device near (i.e. including inside) the tissue structure being studied (i.e. resection cavity).
Claim(s) 10-11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lok in view of Carlson as applied to claims 1 above, and further in view of Romero et al (US 20140180370) hereafter known as Romero
Regarding claims 10 and 13-14:
Lok in view of Carlson discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, while Lok in view of Carlson discloses implantable electrodes in head [see para 5 of Lok… “the at least one structure includes an intracranial structure. In some embodiments, the at least one structure includes an artificial structure introduced into the subject's head. In some embodiments, the artificial structure includes an implantable electrode configured to emit an electric field.”], Lok in view of Carlson is silent to all the details of exactly how the electrodes are configured to be placed in the head. Therefore, Lok in view of Carlson fails to disclose: “an implantation guide layer configured to accept the implanted electrodes through respective positions of the implantation guide layer.” as recited by claim 10, “wherein the implantation guide layer bioresorbable” as recited by claim 13, or “comprising an adhesive layer configured to secure the implanted electrodes within the implantation guide layer.” as recited by claim 14.
Romero discloses in the analogous art of implantable electric stimulation systems [see para 2… “The present invention is directed to the area of implantable electrical stimulation systems”] a known way to apply stimulation to the desired tissue is via a paddle on which electrodes are placed [see para 55… “electrical current is emitted by the electrodes 134 on the paddle or lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system.”]. Romero further discloses a paddle design that includes a carrier [see Fig. 3A-3D element 350 and see para 37… “A carrier 350 has perforations 352 and optionally includes holes 354 through the carrier, as illustrated in FIG. 3A.”] (i.e. implantation guide layer) with holes [see Fig. 3A-3D element 354 and see para 37… “A carrier 350 has perforations 352 and optionally includes holes 354 through the carrier, as illustrated in FIG. 3A.”] in these holes are placed electrodes [see para 40… “The holes 354 are optional and can pass entirely through the body of the carrier. In at least some embodiments, there is a hole for each electrode. “] (i.e. implantation guide layer configured to accept the implanted electrodes through respective positions of the implantation guide layer) and that the electrodes are connected to the carrier by adhesive binding (i.e. an adhesive layer configured to secure the implanted electrodes within the implantation guide layer) and that the carrier is made from ceramic (i.e. wherein the implantation guide layer bioresorbable) [see para 37… “The carrier can be made of, for example, plastic, ceramic, or a non-conductive composite material, or any combination thereof.”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Lok in view of Carlson by placing the electrodes on leads similar to that disclosed by Romero (i.e. thereby reciting the limitations of claims 10 and 13-14) because Lok in view of Carlson is silent as to all the structures used with which to place the electrodes at the brain and Romero discloses a known structure for the placement of electrodes at the brain, therefore this is a known structure to perform a known function.
Regarding claim 11:
Lok in view of Carlson in view of Romero discloses the invention substantially as claimed including all the limitations of claims 1 and 10 as outlined above.
However, Lok in view of Carlson in view of Romero fails to disclose: “wherein the implantation guide layer comprises a plurality of removable portions defined by respective perforations, and wherein the plurality of removable portions are configured to be removed from the implantation guide layer by separation along the respective perforations, and wherein the implantation guide layer is configured to accept respective electrodes of the implanted electrodes through respective passages formed by removal of the removable portions” as recited by claim 11.
Romero further discloses in the analogous art of implantable electric stimulation systems [see para 2… “The present invention is directed to the area of implantable electrical stimulation systems”] discloses the paddle design also includes perforations in circle shapes and/or that form slots through which other structural elements such as conductors can pass [see para 38… “The perforations 352 in the carrier 350 can take any suitable form. For example, the perforations 352 can take the form of multiple holes passing completely through the carrier 350 along one or more lines. In other embodiments, the perforations 352 can be one or more extended slots passing through the carrier along the one or more lines.” And para 39… “The perforations 352 can be arranged along one or more horizontal lines, as illustrated in FIG. 3A.” and “It will be understood that any other suitable arrangement of the perforations, including linear (e.g., only vertical lines or diagonal lines) or non-linear (e.g., concentric circles) arrangements, can be used. Moreover, the perforations may separate individual rows or columns of electrodes, but it will be understood that perforations can be formed between every second row or column, or every third row or column, or in any other regular or irregular pattern.” And para 43… “conductors 320 may pass over the surface of the carrier for attachment to the electrodes or may pass through the perforations for attachment to the electrodes”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Lok in view of Carlson in view of Romero to achieve the claimed feature “wherein the implantation guide layer comprises a plurality of removable portions defined by respective perforations, and wherein the plurality of removable portions are configured to be removed from the implantation guide layer by separation along the respective perforations, and wherein the implantation guide layer is configured to accept respective electrodes of the implanted electrodes through respective passages formed by removal of the removable portions” as recited by claim 11 because as explained previously Romero recognizes using perforated circles and /or slots can be used to move objections through the guide layer; therefore, absent unpredictable results, one or ordinary skill would expect to achieve the claimed combination through routine experimentation through the application of placing the different objects (i.e. electrodes) through the resulting slots/circles from torn perforations with removed portions.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lok in view of Carlson in view Romero as applied to claims 1 and 10 above, and further in view of Robinson et al (US 20210038896) hereafter known as Robinson.
Lok in view of Carlson in view of Romero discloses the invention substantially as claimed including all the limitations of claims 1 and 10 as outlined above.
However, Lok in view of Carlson in view of Romero uses an adhesive to connect the electrodes to the guide layer (as discussed in the rejection to claims 10-11 and 13-14 above) and thus fails to disclose “wherein the implantation guide layer comprises a mesh of fibers configured to accept the implanted electrodes at respective locations within the implantation guide layer”.
Robinson discloses in the analogous art of implantable stimulation devices [see para 2… “The present disclosure relates to electrical stimulators for neuromodulation, delivery systems for implanting electrical stimulators”] that a known way to attach electrodes to another structure includes using a porous substrate that surrounds and enmeshes the electrode (i.e. interpreted as reciting the implantation guide layer comprises a mesh of fibers configured to accept the implanted electrodes at respective locations within the implantation guide layer) [see para 167… “The porous substrate (160) will surround and enmesh or embed the supported electrode structure and will, ideally, adhere to the supported electrode structure as well as filling the voids that were punched in the supported electrode structure in step 2”]
Since Lok in view of Carlson in view of Romero discloses one way to connect the electrode to the guide layer (i.e. using an adhesive) and Robin discloses another way to connect the electrode to the guide layer (i.e. using a mesh of fibers as recited by claim 11), it would have been obvious to having ordinary skill in the art at the time the invention was filed to modify Lok in view of Carlson in view of Romero by including a mesh of fibers to also connect the electrodes to the guide layer similarly to that disclosed by Robinson because one of ordinary skill would expect the use of two independent ways to attach the electrode to the guide layer to improve the structural connection (and if not at least provide the same level of connection) than one independent way alone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hendricks et al (WO-2020018662) hereafter known as Hendricks. Hendricks discloses a system and method that includes implanted electrodes in the brain that employ alternating electric field generation [see abstract and para 12].
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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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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