DETAILED ACTION
This action is pursuant to the claims filed on January 3, 2023. Claims 61-103 are pending. Claims 1-60 is/are canceled. Claims 100-103 is/are withdrawn. A first action on the merits of claims 61-99 is as follows.
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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on November 13, 2025 is acknowledged.
Claim Objections
Claims 61-62, 64-65, 72, 79, 84 and 88 are objected to because of the following informalities:
Claim 61, ln. 14 recite “slide in an axial direction”. Claim 61, ln. 8 recites the same limitation and “an axial direction” should be changed to –the axial direction--.
Claim 72, ln. 2 recites “higher that the friction…”. However, “that” should be changed to –than--.
The following claim limitations are written in the alternative language. The examiner advises to choose one specific term or use “and/or”.
Claim 61, ln. 5: “the casing (envelope)”
Claim 61, ln. 7: “encapsulated (surrounded)”
Claim 61, ln. 9: “providing (after implantation)”
Claim 62, ln. 2: “the casing (envelope)”
Claim 64, ln. 1-2: “a lumen/void (enabling axial movements)”
Claim 65, ln. 3: “the element is/are (each) selected…”
Claim 79, ln. 5: “silicones (such as silicone oil or silicone grease)”
Claim 84, ln. 4-5: “benzene (e.g. parylenes such as Parylene C and Parylene M)”
Claim 84, ln. 5-6: “flexible inorganic materials (such as glass or glass-like materials)”
Claim 88, ln. 1-2; “the electrically conductive element extending (in proximal direction)”
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:
“a first structural component” in claim 61, ln. 12-13.
“means for increasing friction between the casing and the adjacent soft tissue” in claim 77, ln. 1-2.
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.
“a first structural component” is being interpreted to cover the corresponding structure described in the specification [0207].
“The first structural element features a recess (30 [in Fig. 5a]) which may reach around the whole circumference of the first structural element. The recess secures the attachment of the casing (31) to the first structural element. The void/lumen (annular channel) (29a) between the proximal insulated portion of the conductive element and the first structural element is sufficient for the proximal insulated portion of the element to slide with respect to the first structural element.”
“means for increasing friction” is being interpreted to cover the corresponding structure described in the specification [0071]: “the casing comprises means for increasing friction between the casing and the adjacent soft tissue. Preferably, the means for increasing friction is selected from micro- or nano-fibers attached to the outermost surface of the casing.”
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.
Claims 67, 71, 74, 79, 80, 82, 84-86, and 88 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 pre-AIA the applicant regards as the invention.
The following claims 67, 71, 74, 82, 84-86, 88 and 90 recite “optionally”, “preferably”, “such as”, or “in particular”.
Claim 67, ln. 4: “optionally the perpendicular distance not changing more than 20%”;
Claim 71, ln. 2: “preferably exhibiting an annular form forming the first structural component”;
Claim 74, ln. 2: “such as a needle”;
Claim 79, ln. 4: “particularly a composition”
Claim 79, ln. 5: “silicones (such as silicone oil or silicone grease)”;
Claim 80, ln. 2: “suitably cylindrical shape”;
Claim 82, ln. 1: “optionally the proximal compartment comprises at least one biologically active substance such as a pharmaceutically active substance”;
Claim 84, ln. 4-5: “benzene (e.g. parylenes such as Parylene C and Parylene M)”;
Claim 84, ln. 5-6: “flexible inorganic materials (such as glass or glass-like materials)”;
Claim 85, ln. 2: “optionally the proximal compartment, comprises a biocompatible material dissolvable or degradable in aqueous body fluids and providing structural support to the microelectrode when dry”;
Claim 86, ln 2: “optionally the proximal compartment, comprise(s) a biocompatible material providing structural support to the probe when dry for insertion into soft tissue”; and
Claim 88, ln. 3: “in particular osseous or connective tissue”.
However, these phrases render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 90 recites “the biocompatible matrix-materials”. There is insufficient antecedent basis for said limitation.
Appropriate corrections are required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 61-71, 79-90 and 93-99 are rejected under 35 U.S.C. 103 as being unpatentable over Schouenborg ‘612 (hereinafter ‘Schouenborg ‘612 ‘612’ WO 2013/191612).
In regards to independent claim 61, Schouenborg ‘612 discloses a microelectrode (proto electrode 701 in Fig.10b, pg. 21, ln. 10-30) configured to be at least partially embedded into or at least partially placed adjacent to soft tissue, in particular nervous, endocrine and muscle tissue, comprising an elongated electrically conductive element (pg. 3, ln. 30-31: “[t]he microelectrode of the invention is formed upon insertion of a corresponding proto microelectrode into soft tissue and equilibration with aqueous body fluid in the tissue”), comprising an elongated electrically conductive element (metallic electrode body 702, see annotated Fig. 10 below, pg. 21, ln. 10-30), the elongated electrically conductive element comprising proximal (proximal portion of the metallic body 702 extending rearwards from the bulged container 715, see annotated Fig. 10b) and distal portions (front portion of the metallic body 702 including the bulged container 715, see annotated Fig. 10b), at least part of the conductive element being disposed in a casing (envelope) of electrically insulating non-degradable material (second coat 704 of polymer, water insoluble material disposed radially distant from and enveloping the body 702 so as to provide a tubular space/void 708, see annotated Fig. 10b), wherein the distal portion of the element is encapsulated (surrounded) by the casing forming a distal chamber (distal chamber including the tubular space/void 708 formed by the distal tip of the second coating 704 and the bulged container 715 as annotated in Fig. 10b), in which the conductive element can slide in an axial direction (given that the distal end of the body 702 is floating within the void 708, a compressive force applied against the proto electrode is capable of causing the body 702 to marginally extend or shrink along a longitudinal direction so as to conform to and follow the movements of the surrounding tissue), the casing of the distal chamber having at least one opening providing (after implantation) a fluidic electrically conductive bridge between the non-insulated portion of the conductive element and the soft tissue enabling an exchange of ions between the distal chamber and the tissue (col. 21, ln. 22-24: aqueous body fluid enters through openings 713 so that the tubular space 708 is filled with body fluid; the examiner notes that body fluid is conductive in nature and is capable of electrically connecting the conductive body 702 with the surrounding soft tissue), wherein the at least one opening is useful for recording and stimulation of electrically excitable cells (pg. 12, ln. 11-17: “the microelectrode for providing electrical stimulation to structures of soft tissue such as neurons, for recording electrical signals emanating form such structures”), wherein the casing comprises a first structural component in which the electrically insulated portion of the conductive element can slide in an axial direction (pg. 21, ln. 15-20: the bulged container 715 is filed with porous, water insoluble material 716, for instance silica; the free floating conductive body 702 is capable of marginally extending or compressing in a longitudinal direction so as to conform to and follow the movements of the surrounding tissue and therefore the conductive body 702 is capable of sliding along the bulged container 715).
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However, Schouenborg ‘612 does not disclose wherein the elongated electrically conductive element comprises a proximally electrically insulated portion since the entire length of the electrically conductive element is not insulated.
In an alternate embodiment of Fig. 7, Schouenborg ‘612 discloses providing a thin insulative polymer coating (505* in Figs. 6-7) throughout the entirety of the conductive element (502* in Fig. 6) except along the distal portion (the portion of the conductive body 502* exposed from the coating 505* in Figs. 6-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the conductive element in the embodiment of Fig.10b, and provide an insulative polymer coating along the entirety of the conductive element except for the distal portion thereof, as incorporating insulative coating along the proximal portion of the conductive element only expose the distal end thereof involves routine skilled in the art and a predictable result of electrically coupling the distal end portion of the conductive element with soft tissue would ensue.
In regards to claim 62, Schouenborg ‘612 further discloses wherein the first structural component partitions the casing into a distal chamber and a proximal compartment (bulge 715 partitions from portion 704 and 717 as shown in annotated Fig. 10b above).
In regards to claim 63, Schouenborg ‘612 further discloses wherein at least a part of the electrically insulated portion is localized within the distal chamber (Fig. 7 illustrates that the thin insulative polymer coating 505* extends proximally towards the distal tip of the conductive element 502*; therefore, the conductive body 702 comprising the thin insulative polymer coating would be localized within the distal chamber except towards the distal-most end of the body 702).
In regards to claim 64, Schouenborg ‘612 further discloses wherein a lumen is provided between the first structural component and the electrically insulated portion of the conductive element (given that the porous water insoluble material 716 is not necessarily adhered onto the conductive element 702, the conductive body 702 is capable of moving axially during the compression of the body 702 with respect to the material 716).
In regards to claim 65, Schouenborg ‘612 further discloses wherein the innermost material(s) of the casing and/or the first structural components and/or the outermost material of the proximal electrically insulated potion of the element is/are (each) selected to reduce friction (given that the claim does not require any specific material for the innermost material of the casing or in comparison with another material; therefore, the examiner notes that any material will generally reduce friction).
In regards of claim 66, Schouenborg ‘612 discloses substantially all the limitations of the claim(s) except for a second structural component configured to reduced radial movement of the non-insulated portion of the conductive element relative to the distal casing, while also being configured to enable an axial movement of the non-isolated conductive element with respect to the second structural component. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide an additional structural component distal to the first structural component (porous, water insoluble material 716 in Fig. 10c) 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. Doing so enables additional member to hold a pharmacologically active compound, such as dopamine, to release additional pharmacological active compound to the soft tissue adjacent to the microelectrode (col. 21, ln. 19-24).
In regards of claim 67, Schouenborg ‘612 discloses wherein the perpendicular distance between the non-insulated portion of the conductive element and the at least one opening in the casing of the distal chamber remains essentially the same during axial movements of the casing relative to the conductive element (the examiner notes that the void between the floating electrode body 702 and the coating 704 is essentially the same because the proximal end of the coating body 702 is fixedly connected to the body 702, and therefore, even if there is a marginal movement between the distal tip of the conductive element and the distal portion of the casing, generally, the perpendicular distance or radial distance between the two will be marginal or constant as the coating and the body generally move in sync according to the movement of the soft tissue).
In regards to claim 68, Schouenborg ‘612 further discloses that the dimension of the microelectrode can be from 5 microns to 30 microns (pg. 25, ln. 24-27). However, Schouenborg ‘612 does not disclose that the at least one opening has an area of at least about 1 um2. Given that the diameter of the microelectrode is at least 5 um, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide the at least one opening that is substantially smaller than the diameter of the microelectrode, having an area of at least about 1 um2. Providing small lateral openings/holes along an insulative elongate body such as the casing and optimizing the size of the opening for body fluid to flow into the distal chamber involves routine skill in the art.
In regards to claim 69, Schouenborg ‘612 further discloses wherein the distal chamber comprises a plurality of openings in the distal casing (pg. 21, ln. 28-30: the openings 713, 714 in Fig. 10b).
In regards to claim 70, Schouenborg ‘612 further discloses wherein the distal portion of the casing of the distal chamber has a three-dimensional shape narrowing in distal direction (Fig. 10b illustrates the tapering distal tip wherein the openings 713 and 714 are present).
In regards to claim 71, Schouenborg ‘612 further discloses wherein a proximal portion of the distal chamber narrows down (the container 715 which is the proximal portion of the distal chamber comprises a narrowing portion (e.g. from the maximum diameter of the container 715 to the second coat 704 in Fig. 10b). As explained in claim 61, the entire conductive element (702) is insulated except for the tip portion as shown in Figs. 6-7, therefore, the conductive element (702) disposed axially within the material (715) is electrically insulated portion and with sufficient compressive force against the tip of the microelectrode, the conductive element (702) is movable marginally in the axial direction.
In regards to claim 79, Schouenborg ‘612 further discloses wherein a void/lumen between the first structural element (a porous water insoluble material 716 in Fig. 10b) and the outermost layer of the proximal electrically insulated portion of the conductive element (thin polymer first layer 551* as shown in exemplary Fig. 7, see rejection of claim 61) comprises a composition facilitating the movement of the first structural element with respect to the outermost layer (pg. 21, ln. 19-24: the mixture of pharmacologically active compound and the aqueous body fluid inherently provide lubrication between conductive body 702 and the porous water insoluble material 716 such that the pharmacologically active compound is released through the lumen 708 and to the soft tissue; note that since the body 702 is floating within the lumen 708, 716, and 718, there is a marginal movement between the material 716 and the outermost layer/polymer first layer of the conductive body 702).
In regards to claim 80, Schouenborg ‘612 further discloses wherein the casing has a rotationally symmetric shape (pg. 5, ln. 13-15: “[t]he proto electrode of the invention is preferably rotationally symmetric in respect of its central axis extending from its front end to its rear end”; the cylindrical shape of the casing 704, 717 and 715 is symmetrical as shown in Fig. 10b).
In regards to claim 81, Schouenborg ‘612 further discloses in an alternative embodiment, the diameter of the proximal compartment widening in a proximal direction (microelectrode 1101 in Figs. 15-16; proximal portion shown best in Fig. 16). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the proximal portion of the microelectrode to have a diameter greater than the distal portion, as increased diameter of the proximal portion of a microelectrode for better handling involves routine skill in the art and a predictable result would ensue.
In regards to claim 82, Schouenborg ‘612 further discloses wherein the distal chamber comprises at least one biologically active substance such a pharmaceutically active substance (pg. 21, ln. 15-20: the bulged container 715 of polymer material is filed with porous, water insoluble material 716, for instance silica. A pharmacologically active compound, such as dopamine, is absorbed on the porous material 716).
In regards to claim 83, Schouenborg ‘612 further discloses wherein the conductive element extending proximally of the proximal compartment is of a material or of materials different from that or those of the conductive element disposed in the proximal and distal compartment (Fig. 3 illustrates that the conductive element extending proximally from the proximal compartment is different from the body 202 connected by a solder 211).
In regards to claim 84, Schouenborg ‘612 further discloses wherein the electrically insulating material of the casing is a biocompatible, non-degradable flexible polymeric material (pg 7, ln. 1-11: “[t]he second coat [704] must be biocompatible and sufficiently flexible… insulating polymer material of the second coat is a Parylene, such as Parylene C”).
In regards to claim 85, Schouenborg ‘612 further discloses wherein the distal chamber comprises a biocompatible material dissolvable or degradable in aqueous body fluids and providing structural support to the microelectrode when dry (pg. 4, ln. 24-30: “[electrically conductive material having a front (distal) end and a rear (proximal) end… a first coat of water soluble and/or swellable and/or degradable material on the electrode extending along the electrode body…”; The material of the first coat can be one which is readily soluble in aqueous body fluid, such as glucose, or one which is not readily soluble in aqueous body fluid, such as glucose acetate, or one of intermediate solubility, such as partially acetylated glucose. A material of the first coat of a desired dissolution rate can also be obtained by combining materials of different solubility and/or dissolution properties, such as a combination of a low molecular carbohydrate and a peptide or protein, for instance the combination of glucose and gelatin.; pg. 24, ln. 15-24: dry sucrose coat; these various water soluble material in its dried state provide structural support to the proto electrode prior to degradation or dissolving).
In regards to claim 86, Schouenborg ‘612 further discloses wherein the distal chamber comprises a biocompatible material providing structural support to the probe when dry for insertion into soft tissue, wherein the biocompatible material is dissolvable or degradable in aqueous body fluids (pg. 4, ln. 24-30: “[e]lectrically conductive material having a front (distal) end and a rear (proximal) end… a first coat of water soluble and/or swellable and/or degradable material on the electrode extending along the electrode body…”; these various water soluble material in its dried state provide structural support to the proto electrode prior to degradation or dissolving).
In regards to claim 87, Schouenborg ‘612 further discloses wherein the microelectrode or microelectrode probe is embedded in an embedding matrix of biocompatible material providing sufficient rigidity to the probe when dry for insertion into soft tissue and dissolvable or degradable in aqueous body fluid (pg. 10, ln. 16-21: “[a]ccording to an advantageous aspect of the invention the proto microelectrode can comprise a third coat on its second coat. The material of the third coat is soluble in body fluid. It is preferred for the third coat to extend from the rear end of the proto microelectrode to the front end thereof, and to fully cover the front end. The aim with providing a third coat is to reinforce the proto electrode to avoid breaking it during insertion into soft tissue”).
In regards to claim 88, Schouenborg ‘612 further discloses an element holder (Fig. 3 illustrates the conductive body 202 which is equivalent to the conductive body 702 extending through the solder 211), the electrically conductive element extending (in proximal direction) through the element holder (pg. 18, ln. 19-20: Fig. 3 illustrates the conductive body 202 which is equivalent to the conductive body 702 extending through the solder 211), the holder configured to be secured to a tissue different from the soft tissue (the solder 211 is capable of being secured to a tissue area when it is implanted along within a soft tissue).
In regards to claim 89, Schouenborg ‘612 further discloses wherein the electrically conductive element is in electrical engagement with an apparatus for registration of biological signals and stimulation of soft tissue (pg. 19, ln. 1-4: the proto electrode 301’ in Fig. 4 which is equivalent to the proto electrode 701 in Fig. 10b is electrically connected to a control unit for recording and/or transmitting electric signals received from the body 302 in Fig. 4 or body 702).
In regards to claim 90, Schouenborg ‘612 further discloses wherein the biocompatible matrix-materials are selected from carbohydrate-based materials, protein-based materials, and non-natural polymeric materials, and mixtures thereof (pg. 4, ln. 24-30: “[e]lectrically conductive material having a front (distal) end and a rear (proximal) end… a first coat of water soluble and/or swellable and/or degradable material on the electrode extending along the electrode body…”; these various water soluble material in its dried state provide structural support to the proto electrode prior to degradation or dissolving).
In regards to claim 93, Schouenborg ‘612 further discloses a second array of microelectrodes (Fig. 11a-11c discloses an electrode array comprising four proto electrodes 802a-802d), wherein the microelectrodes are partially or entirely embedded in an array matrix of biocompatible material providing sufficient rigidity to the array when dry for insertion into soft tissue and dissolvable or degradable in aqueous body fluid (pg. 11, ln. 25-30: “To facilitate insertion into soft tissue, the proto electrode bundle of the invention is incorporated into a shell 880 of a water soluble material”).
In regards to claim 94, Schouenborg ‘612 further discloses wherein the biocompatible dissolvable or degradable materials are selected from carbohydrate-based materials, protein-based materials, and non-natural polymeric materials and mixtures thereof (pg. 31, ln. 15-25: [p]referred first coat materials are water soluble carbohydrates and proteins as well as mixtures thereof. However, it is also possible to use water insoluble polymer materials swellable in water and/or degradable in body fluid).
In regards to claim 95, Schouenborg ‘612 further discloses an array cover (base 820 in Fig. 11A serves as a partial cover of proximal end of the array 800’).
In regards to claim 96, Schouenborg ‘612 further discloses the array matrix extends to the distal face of the array cover (Fig. 12a illustrates the shell 880 extends to the distal face of the base 820).
In regards to claim 97, Schouenborg ‘612 further discloses an array casing (base 820 in Fig. 11A serves as a partial cover of proximal end of the array 800’) of a flexible, non-degradable material embracing a part of the array matrix (pg. 23, ln. 12-13: “the base is preferably of a biocompatible polymer material like polypropylene which exhibit flexibility).
In regards to claim 98, Schouenborg ‘612 further discloses an outer array matrix of a biocompatible material which is solid when dry and dissolvable or degradable in aqueous body fluids (pg. 23, ln. 1-3: the proto electrode bundle/array comprises multi layers of dissolution material or water soluble material, including its shell; therefore, an additional layer other than the shell reads on the outer array matrix).
In regards to claim 99, Schouenborg ‘612 further discloses wherein the biocompatible materials are selected from carbohydrate-based materials, protein-based materials, and non-natural polymeric materials, and mixtures (pg. 31, ln. 15-25: [p]referred first coat materials are water soluble carbohydrates and proteins as well as mixtures thereof. However, it is also possible to use water insoluble polymer materials swellable in water and/or degradable in body fluid).
Claims 72-78 and 91-92 are rejected under 35 U.S.C. 103 as being unpatentable over Schouenborg ‘612 as applied to claim 61, and further in view of Schouenborg (hereinafter ‘Schouenborg ‘165’, WO 2018/106165).
In regards to claim 72-78, Schouenborg ‘612 discloses the invention substantially as claimed in claim 61 and discussed above. Schouenborg ‘612 does not specifically disclose the friction between the casing and the adjacent soft tissue is higher than the friction between the innermost material of the casing and/or the first structural component and/or the outermost material of the proximal electrically insulated portion of the element.
Schouenborg ‘165 teaches providing a net-like structure along a distal portion of an outer surface of a microelectrode (self-assembling fibrin net 17 as shown in Figs. 7a-7c) which comprises openings of sufficient size to allow cell ingrowth (pg. 5, ln. 39-pg. 6, ln. 2). The net-like structure is formed from microfibers comprising of a material selected from polyester, polylactide, polyglycolide or mixtures or copolymers thereof, electrospun albumin, electrospun gelatin, electrospun fibrin, electrospun mucus material rich in glucoprotein (pg. 5, ln. 24-30). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal portion of the distal chamber of the casing of Schouenborg ‘612 and incorporate a net-like structure comprising microfibers formed from dissolvable/degradable material in body fluid so that the net-like structure along the outer surface of the microelectrode comprising openings of sufficient size to allow cell ingrowth (pg. 6, ln. 1-2). The examiner notes that the net-like structure formed from microfibers provide increased friction against the soft tissue since it provides a roughened surface of the microelectrode. In addition, the examiner notes that the openings read on the limitation, an engagement element, of the net-like structure which is capable of engaging with rigid pins. The examiner notes that the pin is not part of the microelectrode since the claim recites that the pin is being configured to insert the microelectrode into the soft tissue.
In regards to independent claim 91-92, Schouenborg ‘612 discloses microelectrode (proto electrode 701 in Fig.10b, pg. 21, ln. 10-30, see the rejection of claim 61 above).
Schouenborg ‘612 does not disclose arranging the microelectrode into an array arrangement and the microelectrodes adhesively attached to micro or nanofibers, wherein the micro or nanofibers are degradable.
Schouenborg ‘165 teaches providing a net-like structure along a distal portion of an outer surface of a microelectrode (self-assembling fibrin net 17 as shown in Figs. 7a-7c) which for coupling to other microelectrodes and further comprising openings of sufficient size to allow cell ingrowth (pg. 5, ln. 39-pg. 6, ln. 2). The net-like structure is formed from microfibers comprising of a material selected from polyester, polylactide, polyglycolide or mixtures or copolymers thereof, electrospun albumin, electrospun gelatin, electrospun fibrin, electrospun mucus material rich in glucoprotein (pg. 5, ln. 24-30). Note that some of the materials are degradable in body fluid (pg. 7, ln. 17-24: “It is preferred for the glue to be dissolved and/or degraded within a period of time that is shorter or substantially shorter than the time required for degradation of biodegradable fibres”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal portion of the distal chamber of the casing of Schouenborg ‘612 and incorporate a net-like structure comprising microfibers formed from dissolvable/degradable material in body fluid as taught by Schouenborg ‘165 so that the net-like structure along the outer surface of the microelectrode adhesively couple adjacent microelectrodes to provide an electrode array arrangement and openings sufficiently sized to allow cell ingrowth (pg. 6, ln. 1-2).
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 1/9/2026