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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Dec. 12, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
Claims 1-15 are currently pending and under consideration.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: on pg. 12 ln. 27, “As shown in Figures 5A-5C, the releasable connection 10 is provided”; there is no element 10 in these figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Objections
Claims 14-15 are objected to because of the following informalities: an --a-- should be added between “generating” and “sensed” in claim 14 line 4. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: insert element… to simultaneously move the shuttle elements… in claim 12 as this can be an element for insert and does not provide enough structure in the claim.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. For “insert element”, the specification discloses element 9 in Fig. 3 and any equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim limitation “insert element… to simultaneously move the shuttle elements…” in claim 12 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While “element” 9 is in Fig. 3 and on p. 13 of the spec., there is no description of what this “element” actually is. The description is a nonce term without any clear and definite structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-15 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.
The term “high density” in claims 1-15 is a relative term which renders the claim indefinite. The term “high density” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, “high density brain electrode assembly” will be interpreted as “brain electrode assembly”.
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 1-4, 6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pellinen et al. (US 20150112360 A1, published Apr. 23, 2015, hereinafter referred to as “Pellinen”).
Regarding claim 1, Pellinen teaches a high density brain electrode assembly (“Fig. 1 is a perspective view of a neural intervention system 10” ¶[0012]), comprising an elongated main shaft (Fig. 1 “guide tube 12” ¶[0033]) comprising a plurality of guiding lumens (Fig. 1 “plurality of deployment channels 14” ¶[0033]), extending to a distal end of the main shaft (FIG. 3A is a perspective view of the distal portion of the guide tube 12 including the deployment channels 14 shown in FIG. 2 ¶[0018]), a plurality of elongated electrode shanks (Fig. 1 “number of neural probes 16” ¶[0033]), each comprising a plurality of electrical contacts (Fig.’s 4- 5B “The neural probe 16 comprises opposed first and second electrodes 36 and 38 comprising an electrode array supported by a tape-spring-type carrier 40” ¶[0043]), wherein each electrode shank extends through one of the plurality of guiding lumens (Fig. 1 “guide tube 12 supporting a plurality of deployment channels 14 that are configured to direct the delivery of a number of neural probes 16 into body tissue 18” ¶[0033]), and wherein each electrode shank is movable from a retracted position in which the electrode shank is retracted within the main shaft to an extended position in which the electrode shank extends distally from the distal end of the main shaft (Fig.’s 4-5B “The tape spring-type shape of the carrier 40 provides the neural probe 16 with a degree of linear rigidity along the trajectory of the distal channel portion 14B and outwardly therefrom” ¶[0043]), a plurality of shuttle elements (Fig.’s 4-5B “tape spring-type shape of the carrier 40” ¶[0043]), wherein each shuttle element extends through one of the plurality of guiding lumens, and wherein each shuttle element is movable between a retracted position in which the shuttle element is retracted within the distal end of the main shaft and an extended position in which the shuttle element extends distally from the distal end of the main shaft (Fig.’s 4-5B “tape spring-type carrier 40 flexes … as the probe moves along a bend in the lumen 22 of exemplary deployment channel 14. The tape spring-type shape of the carrier 40 provides the neural probe 16 with a degree of linear rigidity along the trajectory of the distal channel portion 14B and outwardly therefrom” ¶[0043]), wherein the electrode shanks are more flexible than the shuttle elements (Fig.’s 4-5B “The tape spring-type shape of the carrier 40 provides the neural probe 16 with a degree of linear rigidity along the trajectory of the distal channel portion 14B” ¶[0043]), wherein each shuttle element is connected with an electrode shank of the plurality of electrode shanks to move the respective electrode shank from the retracted position to the extended position (Fig.’s 4-5B “The neural probe 16 comprises opposed first and second electrodes 36 and 38 comprising an electrode array supported by a tape-spring-type carrier 40” ¶[0043]), and wherein the high density brain electrode assembly is arranged to distribute distal ends of the electrode shanks over a surface area in a plane perpendicular to a longitudinal axis of the main shaft which is larger than a largest cross section of the distal end of the main shaft perpendicular to the longitudinal axis of the main shaft (“The exemplary deployment channels 14, 26, 32 and 34 can be angled in many different orientations. That is for the purpose of introducing a plurality of neural probes 16 into a target body tissue at any one of a number of trajectories off axis from axis A-A of the guide tube 12. This greatly improves the footprint of deployed electrodes so that multiple spatially separate stimulation and recording channels radiate outwardly from the distal portion 12B of the guide tube” ¶[0041]).
Regarding claim 2, Pellinen teaches wherein one or more of the plurality of guiding lumens have a non-zero exit angle with respect to a longitudinal axis of the main shaft such that the electrode shanks, in the extended position, extending from the one or more guiding lumens diverge away from the longitudinal axis (deployment channels 14, 26, 32 and 34 can be angled in many different orientations. That is for the purpose of introducing a plurality of neural probes 16 into a target body tissue at any one of a number of trajectories off axis from axis A-A of the guide tube 12. This greatly improves the footprint of deployed electrodes so that multiple spatially separate stimulation and recording channels radiate outwardly from the distal portion 12B of the guide tube. ¶[0041] According to the present invention, the trajectory of the distal channel portion defining the distal open end 22B, 32B and 34B ranges from about 10 degrees to 180 degrees with respect to axis A-A. ¶[0040]).
Regarding claim 3, Pellinen teaches wherein the guiding lumens are at least partially formed by guiding tubes or tunnels extending through the main shaft (FIGS. 3B and 3C are schematic views of deployment tubes 14. ¶[0019]).
Regarding claim 4, Pellinen teaches wherein proximal ends of the electrode shanks are connected to each other by an electrical lead element (“A thin-film ribbon cable 19 in Fig. 6, which connects from the manifolds 48 to an electronic subsystem (not shown), serves as an interface to any one of a number of external devices, such as implantable pulse generator (IPG) 17 (FIGS. 1 and 7)” ¶[0053]).
Regarding claim 6, Pellinen teaches wherein each guiding lumen guides one electrode shank and one shuttle element (Fig. 6: each of the element 16 shuttle elements which correspond to one electrode shank is associated with one guiding lumen 14. The respective proximal open channel ends are arranged in concentric circles, the outer circle 50 corresponding to the first manifold/neural probe assembly 44 and the inner circle 52 corresponding to the second manifold/neural probe assembly 46. The respective distal ends of the probes 16 are received in the proximal open ends of the channels 14. ¶[0050]).
Regarding claim 12, Pellinen teaches wherein the electrode assembly comprises an insert element that is connected to proximal ends of the shuttle elements to simultaneously move the shuttle elements between the retracted position and the extended position (Fig. 6: perspective view of a neural intervention system 10A similar to that shown in FIG. 2 but with the plurality of neural probes 16 directly connected to a plunger 48 and push rod 50 as an actuation mechanism. ¶[0026]. The opposite face of the plunger 48 supports a push rod 50. The push rod extends to the proximal end 12C of the guide tube and has a length that is sufficient for a user to grasp and manipulate to move the plurality of probes 16 through their respective deployment channels and out the open ends thereof. ¶[0051]).
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.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rezai et al. (US 7181288 B1, published Feb. 20, 2007, previously cited on Dec. 12, 2024 IDS, hereinafter referred to as “Rezai”) in view of Pellinen.
Regarding claim 1, Rezai teaches a high density brain electrode assembly (Fig.’s 1-8D “neurostimulation device 10” Col. 1, ln. 47), comprising an elongated main shaft (Fig. 1 “cannula 15” Col. 2, ln. 11), a plurality of elongated electrode shanks, each comprising a plurality of electrical contacts (Fig. 3A “Each lead 20 includes a support for or substrate 40 having a plurality of electrodes bands 45, 50, 55, 60, 65.” Col. 2, ln. 52-54), and wherein each electrode shank is movable from a retracted position in which the electrode shank is retracted within the main shaft to an extended position in which the electrode shank extends distally from the distal end of the main shaft (Fig. 1-2 “The plurality of leads 20 can be movable between a retracted position (as shown in FIG. 1) and an extended position.” Col. 2, ln. 12-14), and wherein the high density brain electrode assembly is arranged to distribute distal ends of the electrode shanks over a surface area in a plane perpendicular to a longitudinal axis of the main shaft which is larger than a largest cross section of the distal end of the main shaft perpendicular to the longitudinal axis of the main shaft (“In operation, the device 10 will be first introduced into the target site as the leads 20 are in the retracted position. Once the device 10 has been implanted, the leads 20 can be moved to the extended position such that the leads 20 are deployed in the desired three-dimensional array.” Col. 3, ln. 16-20; and Fig.’s 2 & 6 Col. 2 ln. 35-50).
Rezai teaches only one lumen and does not disclose the assembly comprising a plurality of guiding lumens, extending to a distal end of the main shaft, wherein each electrode shank extends through one of the plurality of guiding lumens, a plurality of shuttle elements, wherein each shuttle element extends through one of the plurality of guiding lumens, and wherein each shuttle element is movable between a retracted position in which the shuttle element is retracted within the distal end of the main shaft and an extended position in which the shuttle element extends distally from the distal end of the main shaft, wherein the electrode shanks are more flexible than the shuttle elements, wherein each shuttle element is connected with an electrode shank of the plurality of electrode shanks to move the respective electrode shank from the retracted position to the extended position.
Pellinen’s invention relates to a neural probe comprising an electrode array of at least one of a stimulation electrode and a recording electrode. The electrode array is supported on a carrier having a shape and structure similar to a carpenter's tape spring. The tape spring-type carrier provides the electrode array with stiffness along a line of trajectory once deployed into body tissue, but with a degree of flexibility that allows the electrode array to move with the tissue (¶[0003]). FIG. 3A is a perspective view of the distal portion of the guide tube 12 including the deployment channels 14 (guiding lumen) shown in FIG. 2 (¶[0018]). The guide tube 12 is a conduit shaped structure having a side wall 12A extending along a longitudinal axis A-A from a distal portion 12B to a proximal end 12C connectable to a chamber 20 (¶[0034]). FIG. 2A is an enlarged view of the distal end 12D of the guide tube. This view shows that the distal open ends 22B of exemplary deployment channel 14 can reside on the distal guide tube end 12D (¶[0042]). The exemplary deployment channels 14, 26, 32 and 34 can be angled in many different orientations. That is for the purpose of introducing a plurality of neural probes 16 into a target body tissue at any one of a number of trajectories off axis from axis A-A of the guide tube 12. This greatly improves the footprint of deployed electrodes so that multiple spatially separate stimulation and recording channels radiate outwardly from the distal portion 12B of the guide tube. Enhanced deployment of neural probes 16 makes it possible to spontaneously record neuronal activity, movement-related activity, or evoked activity as a result of stimulation from nearby sites (¶[0041]). FIGS. 4, 4A, 4B, 5, 5A and 5B illustrate a novel aspect of a neural probe 16 according to the present invention. The neural probe 16 comprises opposed first and second electrodes 36 and 38 comprising an electrode array supported by a tape-spring-type carrier 40 (shuttle element that is less flexible than the electrode shanks and is connected to electrodes). The carrier 40 is of a metal, preferably selected from tungsten, stainless steel, platinum-iridium, or of a polymeric material, and in an unstressed condition has a shape similar to a carpenter's tape for a tape measure. The tape spring-type carrier 40 flexes to permit the neural probe 16 to readily bend, thereby when in a stressed condition collapsing into a shape having a linear cross-section 40A (FIG. 4A) perpendicular to the length of the carrier as the probe moves along a bend in the lumen 22 of exemplary deployment channel 14. The tape spring-type shape of the carrier 40 provides the neural probe 16 with a degree of linear rigidity along the trajectory of the distal channel portion 14B and outwardly therefrom that is not available with prior art probes (¶[0043]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to provide a plurality of guiding lumens wherein each electrode shank extends through one of the plurality of guiding lumens as taught by Pellinen in the assembly of Rezai in order to greatly improve the footprint of deployed electrodes radially outwardly from the distal portion of the guide tube. Further, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a plurality of shuttle elements moveable from a retracted position to an extended position that is less flexible than the electrode shanks and connected to the electrodes as taught by Pellinen in the assembly of Rezai in order to provide an improved degree of stiffness along a line of trajectory once the probe is deployed into the body tissue while allowing for a degree of flexibility to accommodate movement of the body tissue surrounding the neural probe (Pellinen ¶[0007]).
Regarding claim 7, Rezai teaches “It will be appreciated that any number of outer leads can be positioned within the cannula 515” (Col. 4, ln. 20-22), however, Rezai and Pellinen do not teach wherein the main shaft comprises at least 10 guiding lumens.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include at least 10 guiding lumens instead of just 8 as depicted in Pellinen, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further, as Rezai indicates that any number of leads can be used and Pellinen indicates that the spread of the electrodes allows more reach, increasing the number of guiding lumens and therefore electrode presence, greater increases the spread of area capable of being stimulated and sensed.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pellinen, as applied to claim 4, and in further view of Dittmer et al. (US 20180339149 A1, published Nov. 29, 2018, hereinafter referred to as “Dittmer”).
Regarding claim 5, Pellinen disclose the assembly of claim 4. Pellinen does not disclose wherein the electrode shanks and the electrical lead element are cut integrally from a single sheet of material.
Dittmer’s invention relates to a multi-contact electrode, a method for manufacturing a multi-contact electrode, and a use of such multi-directional multi-contact electrode (¶[0002]). The electrode segments may form very fine leads or channels within the multi-contact electrode. Thereby, the multi-contact electrode allows an internal routing, which means a transfer of signals within the electrode body. Further, the fine leads or channels may form a unitary part with the multi-contact electrode and therefore no assembly of components is necessary (¶[0016]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to cut the electrode shanks and the electrical lead element from a single sheet of material as taught by Dittmer in the assembly of Pellinen in order to minimize assembly of components.
Claims 8, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pellinen, as applied to claim 1, and in further view of Haidarliu et al. (US 20100114272 A1, published May 6, 2010, previously cited on the Dec. 12, 2024 IDS, hereinafter referred to as “Haidarliu”).
Pellinen teaches the assembly of claim 1.
Regarding claims 8 and 13, Pellinen does not explicitly disclose wherein the guiding lumens have an inner diameter of 50 µm to 500 µm and wherein the main shaft has a diameter of 0.2 mm to 10 mm.
Haidarliu’s invention relates to a device and methods for targeting multiple sites of nervous tissue and, more particularly, to a multi-wire electrode device and methods of use thereof (¶[0001]). The device included 8 micro-wire electrodes having wire diameters of 25-33 µm, an outer tube (main shaft) fabricated from a standard hypodermic or thin wall stainless steel tube having a diameter of about 0.6 mm, and an inner tube (guiding lumen) (also fabricated from a standard hypodermic or thin wall stainless steel tube) having a diameter of about 0.4 mm, so that the bent micro-wires would have room to move freely inside the outer guide tube (Haidarliu ¶[0094]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to the guiding lumens have an inner diameter of 50 µm to 500 µm specifically 400 µm and wherein the main shaft has a diameter of 0.2 mm to 10 mm specifically 0.6 mm, as taught by Haidarliu in the assembly of Pellinen in order to provide a system that can be used in the patient’s brain region and allow the micro-wires to have room to move freely inside the guide tube.
Regarding claim 11, Pellinen does not disclose wherein an extendable part of each electrode shank extends in the extended position at least 0.5 mm from the distal end of the main shaft.
The device of Haidarliu’s invention comprises multiple micro-wire electrodes, each of said multiple micro-wire electrodes comprising an attached portion, and a free portion, wherein said free portion is positionable within said outer elongated element body. In another embodiment, the length of the free portion is any suitable length which is necessary to define the neuronal structure and/or activity. In another embodiment, the length of the free portion is between 1-6 mm. In another embodiment, the length of the free portion is between 3-4 mm. In another embodiment, the length of the free portion is between 1-10 mm. In another embodiment, the length of the free portion is between 5-10 mm. In another embodiment, the length of the free portion is between 10-20 mm. In another embodiment, the length of the free portion of some of the multiple micro-wire electrodes differs from the length of the free portion of other micro-wire electrodes. In another embodiment, the length of the free portion depends on the use of the device of this invention. In another embodiment, the use of the device for animal studies requires different length of specific electrodes in the free portion or different total length of free portion for clinical use in humans (¶[0048]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to make the extendable part of each electrode shank extend in the extended position at least 0.5 mm from the distal end of the main shaft as taught by Haidarliu in the assembly of Pellinen in order to properly define the neuronal structure of interest.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pellinen, as applied to claim 1, and in further view of Zhang et al. (Advanced Material Interfaces, 2020, 7, hereinafter referred to as “Zhang”).
Pellinen teaches the assembly of claim 1.
Regarding claim 9, Pellinen does not disclose wherein a distal end of each shuttle element is releasably coupled to a distal end of each associated electrode shank.
Zhang’s study relates to chronically implanted neural probes and the mechanical mismatch between the stiff probe and ultrasoft brain tissue poses acritical challenge for chronic recordings (pg. 1). the low stiffness of flexible neural probe makes it susceptible to bending and buck-ling during insertion into the brain. To deal with this dilemma, several delicate strategies have been developed to guide the insertion such as transient shuttles with dissolvable support materials such as silk, sugars, hydrogel or polyethyleneglycol (PEG) as coatings, metal as rigid backbone layers for insertion, and removable shuttles with SU-8 shanks or microneedles as temporary carriers. To remove the need of additional materials that may displace tissue in shuttle strategies, mechanically adaptive materials that change modulus on exposure to physiological conditions have been utilized as the probe substrates (pg. 1). The implantation is realized by using a temporary engaging mechanism enabled by the micro post engaged into the via hole at the tip of the ultra-flexible neural probe. Figure 1 schematically shows the strategy of implanting an ultraflexible neural probe into brain enabled by a removable insertion shuttle consisting of a steel needle with a dissolvable spheroid micropost close to its tip (pg. 2).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to releasably couple the shuttle element to the distal end of the electrode shank as taught by Zhang in the assembly of Pellinen in order to allow the flexible probe to accurately record soft brain tissue while allowing a stiff member to aid in placement of the flexible probe and be able to remove the stiff member.
Regarding claim 10, Pellinen does not disclose wherein each shuttle element is arranged to lose its stiffness at least partially after implantation.
Zhang’s study relates to chronically implanted neural probes and the mechanical mismatch between the stiff probe and ultrasoft brain tissue poses acritical challenge for chronic recordings (pg. 1). the low stiffness of flexible neural probe makes it susceptible to bending and buck-ling during insertion into the brain. To deal with this dilemma, several delicate strategies have been developed to guide the insertion such as transient shuttles with dissolvable support materials such as silk, sugars, hydrogel or polyethyleneglycol (PEG) as coatings (Stiffness that is lost/dissolved after implantation), metal as rigid backbone layers for insertion, and removable shuttles with SU-8 shanks or microneedles as temporary carriers. To remove the need of additional materials that may displace tissue in shuttle strategies, mechanically adaptive materials that change modulus on exposure to physiological conditions have been utilized as the probe substrates (pg. 1). The implantation is realized by using a temporary engaging mechanism enabled by the micro post engaged into the via hole at the tip of the ultra-flexible neural probe. Figure 1 schematically shows the strategy of implanting an ultraflexible neural probe into brain enabled by a removable insertion shuttle consisting of a steel needle with a dissolvable spheroid micropost close to its tip (pg. 2).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the shuttle element lose its stiffness as taught by Zhang in the assembly of Pellinen in order to allow the flexible probe to accurately record soft brain tissue while allowing a stiff member to aid in placement of the flexible probe.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pezaris et al. (US 20100094382 A1, published Apr. 15, 2010, previously cited on the Dec. 12, 2024 IDS, hereinafter referred to as “Pezaris”) in view of Pellinen.
Regarding claim 14, Pezaris teaches a neuroprosthetic system for substituting a sensory modality of a mammal by electrical stimulation of a non-superficial brain region of said mammal corresponding to said neural modality to be substituted (“invention relates to the field of visual prosthetics and methods of allowing a subject to view visual information from an artificial source, e.g., by stimulating the lateral geniculate nucleus” ¶[0002]), said system comprising: at least one sensor, for use by the mammal, arranged for generating sensed data feed by sensing a neural modality to be substituted (visual sensor may be operatively connected to the visual information translator. For example, a visual sensor or source of visual information may contain a microprocessor or digital signal processor operative to translate the visual information into electrical signals, a visual sensor may also be connected via leads or wirelessly to the visual information translator” ¶[0069]), at least one high density brain electrode assembly (“the electrodes of the visual prosthesis may be in the form of an array or bundle, wherein each electrode of the array or bundle is operative to deliver electrical signals to a lateral geniculate nucleus of a mammal” ¶[0012]), a driving unit (“The prosthesis has a stimulator” ¶[0082]), arranged for electrically driving the electrical contacts of the high density brain electrode assembly for stimulation of said non-superficial brain region (“The stimulator receives information from the visual information translator and drives the electrodes. A stimulator is operatively connected to receive a signal from the visual information translator and to transmit an electrical signal to the electrodes” ¶[0082]), and a processing unit arranged for analyzing the sensed data feed for providing stimulation patterns for electrically driving the electrical contacts of the high density brain electrode assembly corresponding to subsets of locations in said non-superficial brain region, for substituting said sensory modality (“An auxiliary computational device accepts signals from a source of visual information, i.e., the visual sensor, and decodes these signals into appropriate patterns of activation for the electrodes” (¶[0080]).
Although Pezaris teaches an electrode assembly, Pezaris does not disclose at least one high density brain electrode assembly as claimed in claim 1.
Pellinen teaches the high density brain electrode assembly of claim 1 (see above 35 USC 102 rejection).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to swap the electrode assembly of Pezaris with the electrode assembly of Pellinen swapping features that serve the same purpose would yield the same results and would be predictable. Further, the electrode assembly of Pellinen greatly improves the footprint of deployed electrodes radially outwardly from the distal portion of the guide tube and provides sufficient support to the probes for proper placement of the electrodes (¶[0007]).
Regarding claim 15, Pezaris teaches arranged for substituting visual perception in the non-superficial brain region of said mammal (“Pezaris’s invention relates to the field of visual prosthetics and methods of allowing a subject to view visual information from an artificial source, e.g., by stimulating the lateral geniculate nucleus” ¶[0002]), wherein said at least one sensor comprises at least one portable imaging unit arranged for capturing images and generating a captured image data feed (“A visual sensor may be operatively connected to the visual information translator. For example, a visual sensor or source of visual information may contain a microprocessor or digital signal processor operative to translate the visual information into electrical signals, a visual sensor may also be connected via leads or wirelessly to the visual information translator” ¶[0069]).
Regarding the limitation of the imaging unit being portable, the fact that a claimed device is portable or movable is not sufficient by itself to patentably distinguish over an otherwise old device unless there are new or unexpected results. See MPEP 2144.04(V)(A) and In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Baudino et al. (US 6353762 B1) – guiding lumens with larger surface area spread
McIver (US 20070239059 A1) – multielectrode probe
Vetter et al. (US 20090118806 A1) – multielectrode probe with shuttle
Merz et al. (US 20100076536 A1) – multielectrode probe
Mercanzini et al. (US 20130085361 A1) – discusses some sizing of probe and components
Lu et al. (US 20200155857 A1) – appears to be single material construction
Cavuto et al. (US 20210338127 A1) – insertion support element
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/E.N.C./ Patent Examiner, Art Unit 3792
/ALLEN PORTER/ Primary Examiner, Art Unit 3796
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