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 .
Claim Objections
Claims 6 and 13 are objected to because of the following informalities:
Claim 6 recites the limitation:
“wherein each medical lead of the one or more medial leads”
This should be changed to:
“wherein each medical lead of the one or more medical leads”
Claim 13 recites the limitation:
“wherein the implantation guide layer bioresorbable”
This should be changed to:
“wherein the implantation guide layer is bioresorbable”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the one or more medial leads" and “the respective non-conductive cap” in the limitation “wherein each medical lead of the one or more medial leads comprises a respective conductor extending from the respective non-conductive cap”. There is insufficient antecedent basis for these limitations in the claim.
Claim 7 recites the limitation " the respective conductor" in the limitation “wherein
each electrode of the implanted electrodes is associated with the respective conductor”. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the one or more medical leads" in the limitation “further comprising the 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”. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-8 are dependent on claim 1 which do not recite medical leads, a non-conductive cap or a conductor. The limitations “the one or more medial leads” and “the respective non-conductive cap” of claim 6, the limitation “the respective conductor” of claim 7 and the limitation “the one or more medical leads” of claim 8 have no antecedent basis in either claim 1 or the claims themselves which raises questions as to the scope of these claims. For this examination claim 6 will be interpreted as depending from claim 2 (as claim 2 provides antecedent basis for one or more medial (interpreted as medical) leads and non-conductive cap), claim 7 will be interpreted as depending from claim 6 (as claim 6 provides antecedent basis for conductor), and claim 8 will be interpreted as depending from claim 2 (as claim 2 provides antecedent basis for medical leads). Regardless if this is applicant’s intention or not applicant should clarify what is being claimed here.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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 electric field therapy;”
“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 a 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 electric field therapy;”
“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 a 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 electric field therapy;”
“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 a 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 § 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, 9, 15-16 and 19-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by 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
Independent claim:
Regarding claim 1
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 a 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 [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 [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]
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 a 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 [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 [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].
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 a 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 [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 [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].
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… “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… “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… “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… “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 Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-8 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lok in view of Phillips et al (US 20180289311).
Regarding claims 2-4, 6-7 and 17-18:
Lok discloses the invention substantially as claimed including all the limitations of claims 1 and 16.
However, while Lok discloses implantable electrodes in head [see para 5… “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 is silent to all the details of exactly how the electrodes are configured to be placed in the head. Therefore Lok 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 medial 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 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 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 Phillips discloses the invention substantially as claimed including all the limitations of claim 1-2 as outlined above.
However, Lok 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 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 Phillips discloses the invention substantially as claimed including all the limitations of claim 1-2 as outlined above which includes the one or more medical leads as outlined above.
However, Lok in view of Phillips fail to disclose “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.”]
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 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 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 Romero et al (US 20140180370) hereafter known as Romero.
Regarding claims 10 and 13-14:
Lok discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, while Lok discloses implantable electrodes in head [see para 5… “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 is silent to all the details of exactly how the electrodes are configured to be placed in the head. Therefore, Lok 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 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 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 Romero discloses the invention substantially as claimed including all the limitations of claims 1 and 10 as outlined above.
However, Lok 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 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 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 Romero discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Lok 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 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 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
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792