DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed on 23 Jun 2026. As directed by the amendment: claims 1-5, 8-9, 12-14, and 19-20 have been amended, claims 6-7, 10-11, and 16-18 have been canceled, and claims 21-26 have been added. Thus, claims 1-5, 8-9, 12-15, and 19-26 are presently pending in this application.
Response to Arguments
Claim Objection
Applicant’s arguments, see Remarks, filed 23 Jun 2026, with respect to the objection to claim 13 have been fully considered and are persuasive in light of the claim amendments. The objection to claim 13 has been withdrawn.
However, new claim objections are made below.
§ 112(b) Rejections
Applicant’s arguments, see Remarks, filed 23 Jun 2026, with respect to the rejections of claims 3, 14, and 20 under 35 U.S.C. 112 have been fully considered and are persuasive in light of the claim amendments. The rejections of claims 3, 14, and 20 under 35 U.S.C. 112 have been withdrawn.
However, claim 19 remains rejected, as explained in further detail below, and new rejections are made as necessitated by the claim amendments.
§ 102 Rejections
Applicant’s arguments, see Remarks, filed 23 Jun 2026, with respect to the rejection(s) of claim(s) 1 and 19 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 in view of de Graff et al. (US 20110034912 A1, previously cited), hereinafter de Graff, in view of Anikeeva et al. (US 20140371564 A1), hereinafter Anikeeva.
Applicant's arguments filed 23 Jun 2026 regarding the rejection of claim 12 under 35 U.S.C. 102 have been fully considered but they are not persuasive.
Applicant argues that “Nowhere does de Graff teach or suggest a plurality of openings ... in continuous fluidic communication with the drug delivery lumen and an external area adjacent to the tubular body as claimed” (Remarks, page 9). Examiner respectfully disagrees. De Graff discloses a plurality of openings in continuous fluidic communication with the drug delivery lumen and an external area adjacent to the tubular body as claimed (Fig. 49, valves 218, paragraph [0300], “At the end of the channels 216N are valves 218N which in embodiments are MEMS valves … The release of a drug can be controlled by means of the MEMS valve 218N”).
Therefore, the rejection of claim 12 under 35 U.S.C. 102 is maintained below.
Claim Objections
Claims 1, 5, 8, 12-13, 19, 21, and 26 are objected to because of the following informalities:
Claim 1 recites “an elongate tubular electrode body” in line 2. Claim 1 further recites “the electrode body” in line 4, “the elongate tubular body” in line 7, and “the tubular electrode body” in lines 9-10. Claim 5 recites “the tubular body” in line 3. Claim 8 recites “the tubular body” in line 2. These terms will be interpreted as being the same elongate tubular electrode body in line 2 of claim 1, but should be revised to be consistent throughout the claims.
Claim 12 recites “an elongate tubular body” in line 2. Claim 12 further recites “the tubular body” in lines 8 and 10-11. Claim 13 recites “the tubular body” in line 2. These terms will be interpreted as being the same elongate tubular electrode body in line 2 of claim 12, but should be revised to be consistent throughout the claims.
Claim 21 recites “an elongate tubular body” in line 2. Claim 21 further recites “the tubular body” in lines 8 and 10-11. Claim 26 recites “the tubular body” in line 2. These terms will be interpreted as being the same elongate tubular electrode body in line 2 of claim 21, but should be revised to be consistent throughout the claims.
Claim 1 recites “a drug delivery lumen” in line 5. Claim 1 further recites “the lumen” in line 6. Claims 2 and 8 recite “the drug delivery lumen”. “The lumen” in claim 1 should be revised to read “the drug delivery lumen” for consistency throughout the claims.
Claim 12 recites “a drug delivery lumen” in line 5. Claim 12 further recites “the lumen” in line 6. Claim 13 recites “the drug delivery lumen”. “The lumen” in claim 12 should be revised to read “the drug delivery lumen” for consistency throughout the claims.
Claim 19 recites “a drug delivery lumen” in line 8. Claim 19 further recites “the lumen” in line 9. “The lumen” in claim 19 should be revised to read “the drug delivery lumen” for consistency throughout the claims.
Claim 21 recites “a drug delivery lumen” in line 5. Claim 21 further recites “the lumen” in line 6. Claims 22 and 26 recite “the drug delivery lumen”. “The lumen” in claim 21 should be revised to read “the drug delivery lumen” for consistency throughout the claims.
Claim 19 recites “an intracranial depth electrode device” in lines 1-2. Claim 19 further recites “the intracranial electrode device” in line 5, and “the depth electrode device” in line 14. These terms will be interpreted as being the same intracranial depth electrode device in lines 1-2 of claim 19, but should be revised to be consistent throughout the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 19, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claims 1, 19, and 21 recite “a drug delivery lumen defined through a length of the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the along an entire length of the elongate tubular body”. The specification discloses that “the drug delivery lumen is defined within the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the elongate tubular body” (paragraph [0014]), but does not disclose that the lumen is coaxial with the longitudinal axis along an entire length of the elongate tubular body.
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 19-20 and 23 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 19 recites the limitation "the target intracranial position" on page 4, line 12. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation will be interpreted as “a target intracranial position”.
Claim 20 is also rejected because it is dependent on claim 19.
Claim 23 recites the limitation "the inflammation of brain tissue" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation will be interpreted as “inflammation of brain tissue”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 22 recites “wherein the drug delivery lumen is constructed and arranged to deliver at least one treatment agent to a target area of a patient’s brain”. This limitation is already recited in lines 12-14 of parent claim 21. Therefore, claim 22 does not further limit the subject matter of claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Graff et al. (US 20110034912 A1, previously cited), hereinafter de Graff.
Regarding claim 12, de Graff discloses a neural depth electrode device (Fig. 1, paragraphs [0080], [0297], deep brain stimulation) comprising:
(a) an elongate tubular body (Fig. 49, paragraph [0300], substrate 200N; paragraph [0085], "Substrate 200 may also be three-dimensional. ... the three-dimensional substrate may be pliable, flexible and stretchable while still comprising homogeneous or substantially homogenous material throughout its form, such as a foam or a flexible/stretchable polymeric sphere, ovoid, cylinder, disc, or other three-dimensional object.");
(b) at least one thin film electrode array disposed on an outer surface of the elongate tubular body (Fig. 49, paragraph [0300], circuitry 1000N comprising electrodes 1022N; Figs. 36-37, paragraph [0214]);
(c) a drug delivery lumen defined through a length of the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the elongate tubular body (Fig. 49, paragraph [0300], reservoir 204, channels 216, refill line 219); and
(d) a plurality of openings defined in the outer surface of the tubular body, wherein the plurality of openings are in continuous fluidic communication with the drug delivery lumen and an external area adjacent to the tubular body and are disposed adjacent to the at least one thin film electrode array (Fig. 49, paragraph [0300], valves 218),
wherein the drug delivery lumen is constructed and arranged to deliver at least one treatment agent through the plurality of openings to a target area of a patient's brain (paragraph [0297], deep brain stimulation, surface of the brain; paragraph [0303], "sheets that comprise stretchable and/or flexible electronics may deliver stimulation to the brain").
Regarding claim 13, de Graff discloses the neural depth electrode device of claim 12, as explained above. De Graff further discloses a drug delivery opening defined at a distal end of the tubular body (paragraph [0300], valve 218, see annotated Fig. 49 below),
wherein the distal end opening is in fluidic communication with the drug delivery lumen (paragraph [0300], "At the end of the channels 216N are valves 218N which in embodiments are MEMS valves ... The release of a drug can be controlled by means of the MEMS valve 218N"), and
wherein the drug delivery opening is in fluidic communication with the drug delivery lumen (paragraph [0300], "One benefit of such a capability is to deliver drugs to reduce rejection or scar formation at the interface between the tissue and the apparatus. The release of a drug can be controlled by means of the MEMS valve 218N").
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Regarding claim 14, de Graff discloses the neural depth electrode device of claim 12, as explained above. De Graff further discloses that the at least one treatment agent reduces the inflammation of brain tissue (paragraph [0140], "circuitry can comprise heat or light activated drug-delivery polymers that when activated could release chemical agents, such as anti-inflammatory drugs, to local sites in the body").
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 8-9, 21-23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over de Graff et al. (US 20110034912 A1, previously cited), hereinafter de Graff, in view of Anikeeva et al. (US 20140371564 A1), hereinafter Anikeeva.
Regarding claim 1, de Graff discloses a neural electrode device (Fig. 1, paragraph [0080]), comprising:
(a) an elongate tubular electrode body (Fig. 49, paragraph [0300], substrate 200N);
(b) at least one electrode array disposed on an outer surface of the electrode body (Fig. 49, paragraph [0300], electrodes 1022N); and
(c) a drug delivery lumen defined in the elongate tubular electrode body (Fig. 49, paragraph [0300], reservoir 204, channels 216, refill line 219).
(d) a drug delivery opening defined at a distal end of the tubular electrode body (paragraph [0300], valve 218, see annotated Fig. 49 below), wherein the drug delivery opening is in fluidic communication with the drug delivery lumen (paragraph [0300], "At the end of the channels 216N are valves 218N which in embodiments are MEMS valves ... The release of a drug can be controlled by means of the MEMS valve 218N").
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De Graff does not explicitly disclose that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body.
However, Anikeeva teaches a neural probe (Abstract) wherein the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body (Fig. 3D, paragraph [0074], "The inner circle rings a hollow core (lumen) 314 that extends along the neural probe's longitudinal axis for drug delivery, fluid removal, etc.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de Graff with the teachings of Anikeeva so that the drug delivery lumen is defined in the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body, because doing so enables a smaller tip diameter, allowing deeper insertion into neural tissue (Anikeeva, paragraph [0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the device so that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body, for the purpose of reducing the spatial requirements of the device, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 2, the neural depth electrode device of claim 1 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses that the drug delivery lumen is constructed and arranged to deliver at least one treatment agent to a target area of a patient's brain (paragraph [0297], deep brain stimulation, surface of the brain; paragraph [0303], "sheets that comprise stretchable and/or flexible electronics may deliver stimulation to the brain").
Regarding claim 3, the neural depth electrode device of claim 2 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses that the at least one treatment agent reduces the inflammation of brain tissue (paragraph [0140], "circuitry can comprise heat or light activated drug-delivery polymers that when activated could release chemical agents, such as anti-inflammatory drugs, to local sites in the body").
Regarding claim 5, the neural depth electrode device of claim 1 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses that the at least one electrode array is a thin film electrode array disposed on an outer surface of the tubular body (Fig. 49, paragraph [0300], circuitry 1000N comprising electrodes 1022N; Figs. 36-37, paragraph [0214]).
Regarding claim 8, the neural depth electrode device of claim 1 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses a plurality of openings defined in the outer surface of the tubular body (Fig. 49, paragraph [0300], valves 218), wherein the plurality of openings are in fluidic communication with the drug delivery lumen (paragraph [0300], "At the end of the channels 216N are valves 218N which in embodiments are MEMS valves ... The release of a drug can be controlled by means of the MEMS valve 218N").
Regarding claim 9, the neural depth electrode device of claim 8 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses that the plurality of openings are disposed adjacent to the at least one electrode array (Fig. 49, paragraph [0300], electrodes 1022N are adjacent to valves 218).
Regarding claim 21, de Graff discloses a neural depth electrode device (Fig. 1, paragraphs [0080], [0297], deep brain stimulation),
(a) an elongate tubular body (Fig. 49, paragraph [0300], substrate 200N; paragraph [0085], "Substrate 200 may also be three-dimensional. ... the three-dimensional substrate may be pliable, flexible and stretchable while still comprising homogeneous or substantially homogenous material throughout its form, such as a foam or a flexible/stretchable polymeric sphere, ovoid, cylinder, disc, or other three-dimensional object.");
(b) at least one thin film electrode array disposed on an outer surface of the elongate tubular body (Fig. 49, paragraph [0300], circuitry 1000N comprising electrodes 1022N; Figs. 36-37, paragraph [0214]);
(c) a drug delivery lumen defined through a length of the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the elongate tubular body (Fig. 49, paragraph [0300], reservoir 204, channels 216, refill line 219); and
(d) a plurality of openings defined in the outer surface of the tubular body, wherein the plurality of openings are in continuous fluidic communication with the drug delivery lumen and an external area adjacent to the tubular body and are disposed adjacent to the at least one thin film electrode array (Fig. 49, paragraph [0300], valves 218),
wherein the drug delivery lumen is constructed and arranged to deliver at least one treatment agent through the plurality of openings to a target area of a patient's brain (paragraph [0297], deep brain stimulation, surface of the brain; paragraph [0303], "sheets that comprise stretchable and/or flexible electronics may deliver stimulation to the brain").
De Graff does not explicitly disclose that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body.
However, Anikeeva teaches a neural probe (Abstract) wherein the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body (Fig. 3D, paragraph [0074], "The inner circle rings a hollow core (lumen) 314 that extends along the neural probe's longitudinal axis for drug delivery, fluid removal, etc.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Foster with the teachings of Anikeeva so that the drug delivery lumen is defined in the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body, because doing so enables a smaller tip diameter, allowing deeper insertion into neural tissue (Anikeeva, paragraph [0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the device so that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body, for the purpose of reducing the spatial requirements of the device, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 22, the neural depth electrode device of claim 21 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses that the drug delivery lumen is constructed and arranged to deliver at least one treatment agent to a target area of a patient's brain (paragraph [0297], deep brain stimulation, surface of the brain; paragraph [0303], "sheets that comprise stretchable and/or flexible electronics may deliver stimulation to the brain").
Regarding claim 23, the neural depth electrode device of claim 22 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses that the at least one treatment agent reduces the inflammation of brain tissue (paragraph [0140], "circuitry can comprise heat or light activated drug-delivery polymers that when activated could release chemical agents, such as anti-inflammatory drugs, to local sites in the body").
Regarding claim 26, the neural depth electrode device of claim 21 is obvious over de Graff and Anikeeva, as explained above. De Graff further discloses a drug delivery opening defined at a distal end of the tubular body (paragraph [0300], valve 218, see annotated Fig. 49 below),
wherein the distal end opening is in fluidic communication with the drug delivery lumen (paragraph [0300], "At the end of the channels 216N are valves 218N which in embodiments are MEMS valves ... The release of a drug can be controlled by means of the MEMS valve 218N"), and
wherein the drug delivery opening is in fluidic communication with the drug delivery lumen (paragraph [0300], "One benefit of such a capability is to deliver drugs to reduce rejection or scar formation at the interface between the tissue and the apparatus. The release of a drug can be controlled by means of the MEMS valve 218N").
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Claims 4 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over de Graff et al. (US 20110034912 A1, previously cited), hereinafter de Graff, in view of Anikeeva et al. (US 20140371564 A1), hereinafter Anikeeva, and further in view of Sartorius et al. (Rapid termination of intraoperative stimulation-evoked seizures with application of cold Ringer's lactate to the cortex, 1998, previously cited), hereinafter Sartorius.
Regarding claim 4, the neural depth electrode device of claim 2 is obvious over de Graff and Anikeeva, as explained above. Although de Graff further discloses that the at least one treatment agent comprises a coolant (paragraph [0302]), De Graff does not explicitly disclose that the at least one treatment agent comprises a seizure treatment agent comprising a cannabinoid or cold saline.
However, Sartorius teaches (Abstract), wherein cold saline is delivered to a target area of a patient's brain as a seizure treatment (Intraoperative Technique, second paragraph, "if the seizure activity or after-discharge potentials measured by electrocorticography did not terminate within a few seconds after removal of stimulus, or if the seizures began to spread, cold Ringer’s solution (4°C) was immediately poured over the surface of the stimulated cortex and its adjacent margins").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de Graff and Anikeeva with the teachings of Sartorius so that the at least one treatment agent comprises a seizure treatment agent comprising cold saline, because doing so stops seizure activity without interfering with electrocorticography or stimulation mapping (Sartorius, Conclusions).
Regarding claim 25, the neural depth electrode device of claim 22 is obvious over de Graff and Anikeeva, as explained above. Although de Graff further discloses that the at least one treatment agent comprises a coolant (paragraph [0302]), De Graff does not explicitly disclose that the at least one treatment agent comprises a seizure treatment agent.
However, Sartorius teaches (Abstract), wherein cold saline is delivered to a target area of a patient's brain as a seizure treatment (Intraoperative Technique, second paragraph, "if the seizure activity or after-discharge potentials measured by electrocorticography did not terminate within a few seconds after removal of stimulus, or if the seizures began to spread, cold Ringer’s solution (4°C) was immediately poured over the surface of the stimulated cortex and its adjacent margins").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de Graff and Anikeeva with the teachings of Sartorius so that the at least one treatment agent comprises a seizure treatment agent comprising cold saline, because doing so stops seizure activity without interfering with electrocorticography or stimulation mapping (Sartorius, Conclusions).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over de Graff et al. (US 20110034912 A1, previously cited), hereinafter de Graff, in view of Sartorius et al. (Rapid termination of intraoperative stimulation-evoked seizures with application of cold Ringer's lactate to the cortex, 1998, previously cited), hereinafter Sartorius.
Regarding claim 15, de Graff discloses the neural depth electrode device of claim 12, as explained above. Although de Graff further discloses that the at least one treatment agent comprises a coolant (paragraph [0302]), De Graff does not explicitly disclose that the at least one treatment agent comprises a seizure treatment agent.
However, Sartorius teaches (Abstract), wherein cold saline is delivered to a target area of a patient's brain as a seizure treatment (Intraoperative Technique, second paragraph, "if the seizure activity or after-discharge potentials measured by electrocorticography did not terminate within a few seconds after removal of stimulus, or if the seizures began to spread, cold Ringer’s solution (4°C) was immediately poured over the surface of the stimulated cortex and its adjacent margins").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de Graff with the teachings of Sartorius so that the at least one treatment agent comprises a seizure treatment agent comprising cold saline, because doing so stops seizure activity without interfering with electrocorticography or stimulation mapping (Sartorius, Conclusions).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Foster et al. (US 20060178709 A1, previously cited), hereinafter Foster, in view of Anikeeva et al. (US 20140371564 A1), hereinafter Anikeeva.
Regarding claim 19, Foster discloses a method of implanting an intracranial electrode device (Fig. 2, paragraph [0040], stimulator 140), the method comprising:
forming at least one hole in a skull of a patient (Fig. 7, paragraph [0090], hole 170 in skull 141);
urging the intracranial electrode device through the at least one hole (Fig. 7, paragraph [0090], stimulator 140 implanted into hole 170), wherein the intracranial electrode device comprises a drug delivery lumen defined through a portion of the intracranial electrode device (Fig. 7, paragraph [0091], catheter 143; Fig. 4, paragraph [0068]);
wherein the intracranial electrode device comprises:
(a) an elongate tubular body (Fig. 2, paragraph [0041], lead 141);
(b) at least one electrode disposed on the elongate tubular body (Fig. 2, paragraph [0041], electrodes 142); and
(c) a drug delivery lumen (Fig. 2, paragraph [0054], infusion outlet 149).
positioning the intracranial electrode device at a target intracranial position (Fig. 7, paragraph [0090], "The stimulator (140) is placed within the lumen of the hole (170) and coupled to the walls of the hole (170) and/or the top surface of the stimulation site"; paragraph [0091], "a lead (141) may be coupled to the stimulator (140) with the distal end of the lead (141) being routed to a particular location within the cerebral cortex (35) or other stimulation site in the brain ... A catheter (143) may additionally or alternatively be coupled to the stimulator (140) and routed to the stimulation site so as to deliver one or more drugs at the stimulation site.");
actuating the intracranial electrode device to stimulate tissue at the target intracranial position (paragraph [0091], "The distal end of the lead (141) may include one or more electrodes (142) configured to deliver an electrical stimulation current to the stimulation site"); and
delivering at least one treatment agent to the target intracranial position through the drug delivery lumen (paragraph [0091], "A catheter (143) may additionally or alternatively be coupled to the stimulator (140) and routed to the stimulation site so as to deliver one or more drugs at the stimulation site").
Foster does not explicitly disclose that the drug delivery lumen is defined in the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body.
However, Anikeeva teaches a neural probe (Abstract) wherein the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body (Fig. 3D, paragraph [0074], "The inner circle rings a hollow core (lumen) 314 that extends along the neural probe's longitudinal axis for drug delivery, fluid removal, etc.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Foster with the teachings of Anikeeva so that the drug delivery lumen is defined in the elongate tubular body such that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body, because doing so enables a smaller tip diameter, allowing deeper insertion into neural tissue (Anikeeva, paragraph [0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the device so that the lumen is coaxial with a longitudinal axis of the elongate tubular body along an entire length of the elongate tubular body, for the purpose of reducing the spatial requirements of the device, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Foster et al. (US 20060178709 A1, previously cited), hereinafter Foster, in view of Anikeeva et al. (US 20140371564 A1), hereinafter Anikeeva, and further in view of de Graff et al. (US 20110034912 A1, previously cited), hereinafter de Graff.
Regarding claim 20, the method of claim 19 is obvious over Foster and Anikeeva, as explained above. Foster does not explicitly disclose that the at least one treatment agent reduces the inflammation of brain tissue or minimizes or eliminates a seizure.
However, de Graff teaches a device for delivery of electrical stimulation and at least one treatment agent (paragraph [0130]), wherein the at least one treatment agent reduces the inflammation of brain tissue (paragraph [0140], "circuitry can comprise heat or light activated drug-delivery polymers that when activated could release chemical agents, such as anti-inflammatory drugs, to local sites in the body").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Foster and Anikeeva with the teachings of de Graff so that the at least one treatment agent reduces the inflammation of brain tissue, because doing so enables controlled release of the treatment agent to areas where the treatment agent is effective, and when the treatment agent is desired (de Graff, paragraph [0300]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over de Graff et al. (US 20110034912 A1, previously cited), hereinafter de Graff, in view of Anikeeva et al. (US 20140371564 A1), hereinafter Anikeeva, and further in view of Foster et al. (US 20060178709 A1, previously cited), hereinafter Foster.
Regarding claim 24, the neural depth electrode device of claim 22 is obvious over de Graff and Anikeeva, as explained above. De Graff does not explicitly disclose that the at least one treatment agent comprises a seizure treatment agent comprising a cannabinoid.
However, Foster teaches a neural stimulator (Fig. 2, paragraph [0040], stimulator 140) wherein the at least one treatment agent comprises a seizure treatment agent comprising a cannabinoid (paragraph [0059], "drugs that may be applied to a stimulation site to promote neural remodeling include...cannabinoids (e.g., .DELTA..sup.9-tetrahydrocannabinol)"; paragraphs [0083], [0096], [0102]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de Graff and Anikeeva with the teachings of Foster so that the at least one treatment agent comprises a seizure treatment agent comprising a cannabinoid, because doing so promotes neural remodeling at a specific location (Foster, paragraph [0096]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
