DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 31 December 2025 has been entered. Claims 1, 8, 13-14, 19-20, 27, and 32-33 are currently amended. Claims 5-6 and 40 are canceled, with 33-39 previously withdrawn. Claims 1-4 and 7-39 are pending in the application. Applicant’s amendments to the drawings, claims, and specification have overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 02 July 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations recited in claims 2-3 have been incorporated into amended independent claim 1 but have not been canceled or amended, such that claims 2-3 no longer further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-4, 7-24, 26-29, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US PGPub No. 2014/0288577), hereinafter Robinson, in view of Plachta et al. (US PGPub No. 2017/0304630), hereinafter Plachta, and further in view of Feng et al. (CN 108837305, see machine translation), hereinafter Feng.
Regarding claims 1-3, Robinson teaches a medical device, comprising: a flexible electrode array; wherein the flexible electrode array is configured to undergo a change in configuration (Figs. 7a-7b and par. 0077: “Electrodes (not shown) are formed on each wing, and optionally on the supporting member 702, to form a paddle electrode assembly. When wings 712 and 714 are furled as shown in FIG. 7b, the paddle wings 712, 714 are brought close to and lie against the supporting member 702 so that the electrode assembly 700 presents a smaller cross section so as to fit within a Tuohy needle or the like”);
further wherein: the device has a removable support element which provides rigidity to the device in one or more directions (Figs. 7a-7b: supporting member 702; par. 0078: “the support member is hollow to allow for the introduction of a removable stylet to stiffen the assembly during placement”);
the device has a proximal section and a distal section, the flexible electrode array being arranged in the distal section (Fig. 2b), and further wherein the distal section has a bend radius of no more than about 2 mm in a first direction (Figs. 7b-7c: wings 712 and 714, supporting member diameter 728; pars. 0077-0078: “When wings 712 and 714 are furled as shown in FIG. 7b, the paddle wings 712, 714 are brought close to and lie against the supporting member 702 so that the electrode assembly 700 presents a smaller cross section so as to fit within a Tuohy needle or the like […] A diameter 728 of the support member may be in the range of 800-1200 µm”),
the distal section has a bend radius in a second direction which is orthogonal to said first direction which is more than the bend radius in the first direction, and when the removable support element is removed, the distal section has a decreased bend radius in the second direction (par. 0038: “the electrode assembly may have reduced longitudinal rigidity, with implantation being effected by insertion of a stylet into the hollow support member during implantation, so that once the electrode assembly is implanted and the stylet and introducer withdrawn the assembly is of reduced longitudinal rigidity” and par. 0078: “the support member is hollow to allow for the introduction of a removable stylet to stiffen the assembly during placement”).
Robinson teaches wherein the flexible electrode array changes configuration by resiliently unfurling the paddle wings after releasing a deformation force (par. 0021: “the paddle wing being configured to resiliently unfurl away from the support member upon release of the deformation force, the paddle wing bearing at least one electrode”), and does not teach wherein the actuation mechanism for unfurling the flexible electrode array is a fluidically actuatable fluidic component. However, in a related implantable device art, Plachta teaches using a fluidically actuatable fluidic component to control furling and unfurling of a flexible electrode array (Fig. 9 and par. 0122: “Within the support substrate 1 is a fluid channel system 32 which is completely surrounded by the support substrate 1. The fluid channel system 32 essentially extends in the region of the support substrate region 1B which, because of inherent pretensioning of the material, takes on the shape of a right cylinder by rolling itself up. If, on the other hand, the fluid channel system 32 is filled with a fluid, preferably water, then the water pressure applied along the fluid channel system flattens out the support substrate region 1b against the inherent rollup force of the material”). To provide the device of Robinson with a fluidically actuatable fluidic component to control furling and unfurling, as taught by Plachta, would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the following reasons:
Robinson teaches a prior art flexible electrode array upon which the claimed invention (having a controllable actuation for changing configuration, via a fluidic component) can be seen as an “improvement” (Robinson teaches a change in configuration that is only controllable by release of a deformation force). Plachta teaches a prior art comparable device (flexible electrode array) having a fluidically actuatable fluidic component for controlling the change in configuration. Thus, the manner of enhancing a particular device (flexible electrode array) was made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in Plachta. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art flexible electrode array of Robinson, and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have readily recognized that a fluidically actuatable fluidic component would allow the furling and unfurling of the flexible array to occur in a controlled manner.
Robinson is silent with respect to the distal section’s degree of flexibility in the second direction after the removable support is removed and does not explicitly teach wherein the bend radius of the distal section in the second direction is no more than about 2 mm. However, in a related implantable device art, Feng teaches a bending radius of 2 mm for an implantable device (par. 0056: “The bending stiffness of the flexible packaging material 1 is similar to that of human tissue, and its minimum bending radius can reach 2 mm”) in order to fit well with surrounding tissue (par. 0057). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the paddle lead of the combined reference to have a bend radius of no more than about 2 mm in the second direction when the removable support element is removed, as suggested by Feng, since this bend radius is similar to human tissue and would allow the implant to fit well with surrounding tissue, as taught by Feng.
Regarding claim 4, the combination teaches the device of claim 3 as described previously. Robinson further teaches wherein the medical device is elongate and the first direction is substantially perpendicular to the longitudinal axis of the device (Fig. 7b: wings 712 and 714 furling perpendicularly around the longitudinal axis of the device).
Regarding claim 7, the combination teaches the device of claim 1 as described previously. Robinson and Plachta further teach wherein the flexible electrode array and the fluidic component are arranged such that a change in configuration of the fluidic component causes the flexible electrode array to transition between a compressed configuration and an expanded configuration having a greater projected surface area than the compressed configuration (see Robinson at Figs. 7a-7b and par. 0027: “an electrode assembly which can be implanted via introducer when furled but which is a paddle electrode assembly having greater lateral dimension than the introducer internal diameter when unfurled;” and Plachta at Fig. 2a and 9: expanded configuration with greater surface area; Fig. 2b: compressed configuration with smaller surface area).
Regarding claims 8-9, the combination teaches the device of claim 7 as described previously. Robinson further teaches wherein, in the compressed configuration, the flexible electrode array is rolled and substantially cylindrical (Fig. 7b: rolled and cylindrical configuration when wings 712-714 are furled).
Regarding claims 10-11, the combination teaches the device of claim 7 as described previously. Robinson further teaches wherein the transition between the compressed configuration and the expanded configuration includes unrolling of the flexible electrode array, and further wherein the unrolling is about an axis substantially perpendicular to the first direction (par. 0077: “When wings 712 and 714 are unfurled as shown in FIG. 7a, the paddle wings reside in a common nominal plane”).
Regarding claim 12, the combination teaches the device of claim 7 as described previously. Robinson further teaches wherein in the expanded configuration, the flexible electrode array is substantially planar (Fig. 7a: substantially planar unfurled paddle electrode).
Regarding claim 13, the combination teaches the device of claim 7 as described previously. Robinson further teaches wherein, in the expanded configuration, the medical device has a thickness of no more than 5mm (par. 0078: “the paddle thickness 722 may comprise a single layer of stitches or multiple layers of stitches, or a single layer or multilayer substrate, and could for example be in the range of 100-2000 µm”).
Regarding claims 14-15, the combination teaches the device of claim 7 as described previously. Plachta further teaches wherein the medical device is arranged to limit expansion in a thickness of the device during changes in configuration, including a constraining layer arranged substantially parallel to the fluidic component that includes one or more portions of inelastic material (par. 0009: “a flexible, biocompatible support substrate 1 which in the embodiment shown is a polyimide film;” examiner notes that polyimide is inelastic; see also annotated Fig. 9).
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Annotated Figure 9
Plachta teaches that this arrangement of the fluidic component forces the substrate to extend as required (par. 0122: “the fluid channel system 32 is provided with fluid channel branches 33 running in the circumferential direction of the sleeve surface of the self-shaping right cylinder. When filled, they force the support substrate region 1B to extend as required”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrange the fluidic component of the combined device in the arrangement taught by Plachta, with portions of inelastic material between, so that the substrate can extend as required when the fluidic component is filled, as taught by Plachta.
Regarding claims 16-17, the combination teaches the device of claim 14 as described previously. Plachta further teaches wherein the medical device further comprises a constraining layer which is arranged substantially parallel to the fluidic component (as outlined previously in the rejection of claim 15) and includes a plurality of strips of stiff material which are arranged substantially parallel to each other and wherein the parts of the constraining layer between said strips are more flexible than said strips, wherein the portions of stiff material are arranged so as not to impede the change of configuration in directions other than the thickness direction (Figs. 8a and 9: cuff M partly surrounding support substrate 1; par. 0119: “the cuff M is produced from a stable plastic material and for example from parylene”), which improves handling of the flexible electrode array (par. 0117: “The cuff M acts first of all to improve handling of the implantable cuff electrode CE which, because of its very small support substrate thickness and also the very fine wired electrode assemblies positioned on the support substrate surface, demands very careful handling by the operator”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with a plurality of stiff strips, as taught by Plachta, in order to improve the handling of the flexible electrode array, as taught by Plachta.
Regarding claim 18, the combination teaches the device of claim 14 as described previously. Plachta further teaches wherein the fluidic component comprises a fluidic channel extending within the fluidic component (Fig. 9: fluid channel system 32) and the fluidic component further comprises at least one tie which joins opposing sides of the fluidic channel so as to prevent or limit expansion of the fluidic channel in the thickness direction of the device during changes in configuration (Fig. 9: portions of substrate 1 between fluid channel branches 33; wherein the inelastic substrate portions between fluid channel branches are performing the same function as the tie which joins opposing sides of the fluidic channel, such that they are functional equivalents).
Regarding claim 19, the combination teaches the device of claim 14 as described previously. Plachta further teaches wherein the fluidic component includes a plurality of independently inflatable chambers wherein the chambers are sized so as to prevent or limit expansion of the fluidic channel in a thickness direction of the device during changes in configuration (Fig. 9: channel openings 34; par. 0123: “At least two channel openings 34 within the support substrate 1 are provided in order to fill the fluid channel system 32. Their sizes and configurations are determined such that they open in a fluid-tight manner at entry and exit openings within the fluid supply or removal lines 35 and 36 running inside the cuff M;” examiner notes that fluid chambers in the disclosed arrangement limit expansion of the fluidic channel system in a thickness direction of the device, as broadly as claimed).
Regarding claim 20, the combination teaches the device of claim 19 as described previously. Plachta further teaches electrically actuatable fluid valves arranged fluidically between first and second independently inflatable chambers (Fig. 9: channel openings 34; par. 0123: “At least two channel openings 34 within the support substrate 1 are provided in order to fill the fluid channel system 32. Their sizes and configurations are determined such that they open in a fluid-tight manner at entry and exit openings” and par. 0125: “the channel openings 34 are provided with metallic contacts via which an electrical voltage can be applied along the supply lines 35 and 36 to unfold the implantable electrode assembly”) but does not explicitly teach wherein the valves include a pressure valve. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include a pressure valve for at least one of the valves in the device of the combined reference, since there are a finite number of identified, predictable solutions (i.e. types of valves) for controlling fluid flow, and a person of ordinary skill in the art could have selected a pressure valve for fluid control with a reasonable expectation of success.
Regarding claim 21, the combination teaches the device of claim 2 as described previously. Plachta further teaches further comprising: a fluidic connector in fluid communication with the fluidic component (Fig. 9: fluid supply or removal lines 35 and 36; par. 0123: “supply or removal lines 35 and 36 running inside the cuff M are connected fluidically with a fluid control system 37”) and an electrical connector in electrical contact with the electrode array (Fig. 2a: connection structures V and electrical lines L), said connectors being provided in the proximal section of the device for connection of the fluidic component and the electrode array to external devices (Fig. 2a: connection structures V can be connected proximally to generator 6; Fig. 9: fluid control system 37).
Regarding claim 22, the combination teaches the device of claim 21 as described previously. Robinson further teaches wherein the distal section of the device is more flexible than the proximal section (Figs. 1 and 2c: implantable device proximal to distal flexible paddle electrode).
Regarding claim 23, the combination teaches the device of claim 21 as described previously. The combination does not explicitly teach wherein the distal section comprises at least 90% of the volume of the device. However, it would have been an obvious matter of design choice to configure the distal section of the device to comprise at least 90% of the volume of the device, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 24, the combination teaches the device of claim 21 as described previously. Robinson further teaches further comprising a conductive connector connecting the electrode array to the electrical connector and a first sheath which surrounds the conductive connector (par. 0078: “a shaft may be provided within the support member to provide desired resilience to the electrode assembly and/or to carry conductive wires to the electrodes”).
Regarding claims 26 and 28, the combination teaches the device of claim 24 as described previously. Robinson further teaches further comprising a second, removable sheath surrounding the flexible electrode array, the fluidic component, and the first sheath, wherein the internal diameter of the second sheath is 1 cm or less (0037: “The introducer may be a hypodermic needle such as a Tuohy needle”).
Regarding claim 27, the combination teaches the device of claim 26 as described previously. Robinson further teaches herein the flexible electrode array and the fluidic component are arranged in a compressed configuration within the second sheath, and the device is arranged such that actuation of the fluidic component after removal of the second sheath causes the fluidic component and the flexible electrode array to change to an expanded configuration having a greater projected surface area than the compressed configuration (par. 0027: “an electrode assembly which can be implanted via introducer when furled but which is a paddle electrode assembly having greater lateral dimension than the introducer internal diameter when unfurled”).
Regarding claim 29, the combination teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the fluidic component and the flexible electrode array are separate or separable. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the fluidic component and flexible electrode array separable, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 31, the combination teaches the device of claim 1 as described previously. Robinson further teaches wherein the flexible electrode array comprises electrodes provided on a flexible substrate (par. 0077: “Electrodes (not shown) are formed on each wing, and optionally on the supporting member 702, to form a paddle electrode assembly”).
Regarding claim 32, the combination teaches the device of claim 1 as described previously. The combination is silent with respect to the maximum uninflated width dimension of a fluidic channel in the fluidic component, but Plachta teaches 4 fluid channel branches running in the circumferential direction of the flexible electrode array (Fig. 9: fluid channel branches 33; par. 0122) and also teaches a maximum axial length of 4 cm (par. 0034: “the implantable electrode assembly should not exceed an axial length of 4 cm”), which corresponds to a maximum width of about 4.5 mm per fluid channel, if the fluid channels run in the circumferential direction. It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose a width for the fluid channel branches of 5 mm or less, as suggested by Plachta, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Plachta and Feng and further in view of Gerber (US PGPub No. 2007/0027514).
Robinson in view of Plachta and Feng teaches the device of claim 24 as described previously but does not explicitly teach further comprising a fluid channel connecting the fluidic component to the fluidic connector, wherein the first sheath also surrounds the fluid channel. However, in an analogous art, Gerber teaches an electrode array with a fluidically inflatable component wherein a first sheath surrounds a conductive connector that connects the electrode array to the electrical connector (par. 0033: “Lead body 16 carries a plurality of electrical conductors. […] Each of the electrodes 24 is coupled to one or more of the electrical conductors within lead body 16. The conductors electrically couple the electrodes to stimulation pulse generation circuitry within stimulator 12”) and a fluid channel that connects the fluidic component to the fluidic connector (Figs. 14-15 and par. 0073: “Lead body 16 defines an inner lumen that serves as an inflation channel for transmission of an inflation fluid into the inflatable chamber of distal end 18”).
To provide the device of the combined reference with a sheath surrounding a conductive connector and a fluid channel, as taught by Gerber, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention because it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Gerber (supplying conductive and fluid connectors within a single sheath/lead) to the device of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system that had a single connecting lead rather than two separate connectors.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Plachta and Feng and further in view of De La Rama et al. (US PGPub No. 2016/0310725), hereinafter De La Rama.
Robinson in view of Plachta and Feng teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the medical device includes one or more components which are imageable by X-ray. However, in an analogous art, De La Rama teaches a medical device including one or more components which are imageable by X-ray (par. 0046: “at least a portion of the sheath 114 is loaded with BaSO4 or similar substance for radiopacity, and the distal tip of the sheath 114 may include a platinum iridium marker band for additional visualization”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the medical device of the combined reference with BaSO4 or a platinum iridium marker band for radiopacity, as taught by De La Rama, in order to allow for visualization, as taught by De La Rama.
Response to Arguments
Applicant’s arguments, filed 31 December 2025, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Robinson. As described previously, Robinson teaches a removable support element which provides rigidity to the device in one or more directions.
Applicant’s arguments with respect to De La Rama have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794
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