DETAILED ACTION
This action is pursuant to the claims filed on July 12, 2026. Claims 61-111 are pending. Claims 1-60 is/are canceled. Claims 100-103 is/are withdrawn. A final action on the merits of claims 61-100 and 104-111 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.
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, 80-90 and 93-99 are rejected under 35 U.S.C. 103 as being unpatentable over Schouenborg (hereinafter ‘Schouenborg ‘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 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 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), the casing further comprising a first structural component (pg. 21, ln. 15-20: the bulged container 715 is filed with porous, water insoluble material 716, for instance silica), in which the conductive element can slide in the 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 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 at least one opening is positioned laterally with respect to the casing of the distal chamber (opening 713 is positioned laterally with respect to the longitudinal axis ‘N’ of the bulged container 715 of the proto electrode 701),
wherein the casing and the first structural components are not fixedly attached to the electrically conductive element such that the entire casing and the electrically conductive element are capable of independent axial movement relative to each other such (although Fig. 10b does not show the proximal end of the proto electrode 701, Fig. 3 shows that the proximal end of the conductive body 202 and the proximal end of the second coat 204 are coupled via a solder 211; the instant application discloses that both the casing 13 and the conductive element 18 are attached to a cover 7 as shown in instant specification Fig. 19a and Applicant is advised to claim this feature to distinguish from the solder 211 of the Schounberg reference. The examiner notes that the distal portion of the second coat 204 [casing] and the distal portion of the body 202 are not fixedly attached which translates to the distal end of the body 702 being capable of independent axial movement relative to the container 715 when a compressive force is applied),
wherein the first structural component is slidably engaged with the first structural component (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).
PNG
media_image1.png
835
844
media_image1.png
Greyscale
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. The examiner notes that the modified electrically insulated portion of the conductive element (modified insulated 702) would therefore be configured to slidably engage with the first structural component (715).
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, exhibiting an annular form, constituting the first structural component (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; note that the container 715 is annular shaped). 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/slidable marginally in the axial direction.
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, the material being selected from the group consisting of polyurethanes, polyethylenes, polymers with a backbone comprising benzene, polymers based on the polymerization of tetrafluoroethylene, and flexible inorganic materials (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).
In regards of claim 105, Schouenborg ‘612 further discloses wherein the lumen provided between the first structural component and the electrically insulated portion of the conductive element restricts radial movements of the conductive element with respect to the distal casing (the porous water insoluble material 716 occupies the casing 715 to restrict extreme radial movement of the electrically conductive element 702 within the casing 715 as shown in annotated Fig. 10b).
In regards to claim 106, Schouenborg ‘612 further discloses wherein the electrical impedance between the non-insulated portion of the conductive element and the soft tissue adjacent to the at least one opening is lower than the electrical impedance between the non-insulated portion of the conductive element and the tissue surrounding the proximal part of the proximal compartment (the impedance between the distal tip of the elongated conductive element 702 and tissue adjacent to the lateral opening 714 is lower than the distal tip of the elongated conductive element and tissue surrounding the proximal part of the 718 since there is a casing 717 in between the distal tip 702 and the proximal part 718 as shown in the annotated figure above).
In regards to claim 107, Schouenborg ‘612 further discloses wherein the microelectrode comprises a flexible filament securely attached to the microelectrode at a location facilitating the removal of the microelectrode from the soft tissue (given that the claim limitation is broad, any structural element that can be configured for pulling, for example, the insulator conductor 10 as shown in Fig. 1, that when pulled, can assist in removal of the microelectrode).
In regards to claim 108, Schouenborg ‘612 further discloses the casing and the conductive element are configured relative to each other to limit the range of axial movement of the casing relative to the conductive element such that the distal tip of the non-insulated portion of the conductive element does not contact or puncture the casing (due to the connection of the proximal end of the casing 717 and the proximal part of the conductive tip 702 as shown in exemplary Fig. 3, it would further limit axial movement between the distal portion of the tip 702 and the distal portion of the casing 704 to prevent any puncture of the casing 704 from the tip 702 ).
In regards to claim 109, Schouenborg ‘612 further discloses the material of the electrically conductive element is selected from platinum, iridium, gold, wolfram, stainless steel, and alloys thereof, and conductive polymers, carbon-containing materials, graphene, graphite and carbon nanotubes (pg. 30, ln. 30-pg. 31, ln. 2: the electrode body is preferably of a noble metal or an alloy of noble metals or comprising noble metals such as gold, silver, platinum, iridium, but other biologically acceptable metals such as stainless steel and tantalum can also be used as well as gold plated copper.).
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).
Allowable Subject Matter
Claim 79 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to claim 79, Schouenborg ‘165 fails to disclose a void/lumen between the first structural component (716) and the outermost layer of the proximal electrically insulated portion of the conductive element (proximal portion of the elongated electrically conductive element 702). While pharmacologically active compounds fill the first structural component (pg. 21, ln. 19-21), there is no motivation to modify the outermost layer of the proximal electrically insulated portion of the conductive element and incorporate a composition facilitating the movement of the first structural element with respect to the outermost layer, wherein the composition comprises any one of lipids, hyaluronic acid, silicones, a polymer of monosaccharides and combinations thereof.
Response to Arguments
Applicant’s Remarks filed on July 12, 2026 is fully acknowledged.
Applicant’s amendment of claims 61, 62, 64, 65, 72 and 88 obviates the claim objections.
Applicant’s argument directed towards the 112(f) interpretation of “a first structural component”, as recited in independent claim 61, is persuasive and the interpretation has been withdrawn.
Applicant’s amendment of claims 67, 71, 74, 79, 80, 82, 84, 85, 86, 88 and 90 overcomes the 112b rejection.
Applicant’s argument directed to independent claim 61 rejected under 35 U.S.C. 103 as being unpatentable over Schouenborg ‘612 (WO 2013191612) has been fully considered.
Applicant’s argument that Schouenborg ‘612 fails to disclose “axial movement of the entire casing with respect to the electrically conductive element” is unpersuasive. The instant application discloses that both the casing (13) and the conductive element (18) are attached to a cover (7) as shown in the instant specification Fig. 19a to provide for the axial movement of ‘the distal end’ of the entire casing with respect to ‘the distal end’ of the electrically conductive element. In essence, an axial independence or axial movement described throughout the specification is coupling of the proximal ends of the casing and the conductive element to an intermediate member while the distal ends of the casing and the conductive element are floating and uncoupled. Similar to Applicant’s disclosed invention, Schouenborg ‘612 discloses only the proximal portions of the conductive body (702 in Fig. 10b) and casing (715 in Fig. 10b) are coupled via a solder (solder 211 at proximal end of the microelectrode is shown in exemplary Fig. 3) while the distal end of the conductive body is floating with the casing (the floating arrangement shown in Fig. 10b). As such, a compressive force applied at the floating distal tip of the body (702) is capable of independent axial movement and axial independence relative to the entire container (715) and vice versa.
Applicant’s argument that Schouenborg’s opening is near the distal tip of the outer coat 704 and oriented more in the axial direction and therefore does not disclose a lateral opening is unpersuasive. As long as the opening is oriented away from the axial direction in any manner, it meets the claim limitation.
With respect to claim 65, Applicant is encouraged to provide a specific material of the electrically insulated portion that is configured to reduce friction since it is the Examiner’s position that as long as the material is electrically insulated, it meets the claim limitation.
With respect to claim 66, Applicant is encouraged to provide specific structural features of the second structural component (e.g. material and/or dimension) to overcome providing additional water insoluble material of Schouenborg ‘612.
With respect to claim 79, in view of the claim amendment, Applicant’s argument is persuasive and the rejection has been withdrawn.
With respect to claims 72-78, Applicant argues that supplying microfiber net to provide cell ingrowth and inter-electrode positional stability does not provide a casing capable of axial movement. However, it is the examiner’s position even with the microfiber net, a compressive force applied on at the distal tip of the casing or only applied at the electrode body of Schouenborg ‘612 still allow for marginal independent axial movement due to the floating arrangement of the electrode body within the casing.
With respect to claims 74-76, Applicant argues that the microfiber net of Schouenborg ’65 are permanent or slowly-degrading inter-electrode connection for long-term positional stability and are therefore opposite to the claimed degradable engagement element. However, even if it is a slowly-degrading inter-electrode connection, the microfiber of Schouenborg ’165 is capable of degrading. Therefore, this argument is unpersuasive and Applicant is encouraged to recite structural differences, including specific materials or dimensional features to differentiate from the microfiber of Schouenborg ‘165.
With respect to claims 91-92, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). 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
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH STOKLOSA can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EUN HWA KIM/Primary Examiner, Art Unit 3794 8/10/2026
Prosecution Insights