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 Aug. 28, 2026 has been entered. Claims 1-3, 7-23, and 27 remain pending in the application. Applicant’s amendments to the claims have overcome the 102 rejections previously set forth in the Non-Final Office Action mailed June 5, 2026.
Response to Arguments
Applicant’s arguments, see pg. 7, filed Aug. 28, 2026, with respect to Malekkhosravi have overcome the previous 35 USC 102 rejections from the June 5, 2026 Office Action. A new 35 USC 103 rejection below is being applied using Malekkhosravi in light of the amendments to the claim. Examiner agrees that Malekkhosravi does not teach the amended limitation of the cavity being formed by lateral edge surfaces of at least some of the plurality of padding mesas and by the surface of the at least one pad.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 7-9, 10-13, 15, 22-23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Malekkhosravi et al. (US 20180289969 A1, published Oct. 11, 2018, hereinafter referred to as “Malekkhosravi”) in view of Vito et al. (US 20140338104 A1, published Nov. 20, 2014, hereinafter referred to as “Vito”).
Regarding claims 1 and 23, Malekkhosravi teaches a method of wearing a neural implant head-piece, and a wearable holding device (Fig.’s 4A & 7-8B “wearable medical device 100” ¶[0089] (also referred to as “recharging device” and element “101”); Fig.’s 10-31 “wearable medical device 2400, which may be substantially similar to recharging device 100, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100, 2200, and 2300” ¶[0170]) for a neural implant (“FIG. 1D is a conceptual diagram illustrating an example patient with two IMDs 14A and 14B (hereinafter “IMDs 14”) disposed on a cranium of a patient and a recharging device 40 configured to recharge the power sources of the IMDs 14. IMDs 14 may be coupled to respective electrical stimulation leads 15A and 15B” ¶[0059]) head-piece (“FIG. 1D, recharging device 40” ¶[0060]; Fig. 4A “Recharging device 103 may be similar to recharging device 40 of FIG. 1D. Power source compartment 116 may be coupled to one or more recharge coil containers 118A, 118B (collectively, “recharge coil containers 118”)… Recharge coil containers 118 may be similar to recharge coils 42A and 42B of FIG. 1D, and power source compartment 116 may be similar to power unit 42 of FIG. 1D.” ¶[0085]), the wearable holding device comprising: at least one pad surrounding at least part of the neural implant head-piece (Fig. 4A “Recharge coil containers 118 may be configured to be secured to flexible body 110… second main surface 128 is configured to contact scalp 16 once securing member 102 is secured to head 12. In this example, recharge coil containers 118 may be configured to be secured to second main surface 128 of flexible body 110.” ¶[0088]), the at least part of the neural implant head-piece being configured to be mounted to an exterior of a head (Fig. 4A “such that recharge coil containers 118 contact scalp 16.” ¶[0088]), the at least one pad forming a cavity configured to receive and cover the at least part of the neural implant head-piece and to maintain stability of the neural implant head-piece relative to the head (“second main surface 128 is configured to contact scalp 16 once securing member 102 is secured to head 12. In this example, recharge coil containers 118 may be configured to be secured to second main surface 128 of flexible body 110.” ¶[0088]; or “FIG. 10A-10C further illustrates wearable medical device 300 including a plurality of holding features 304 attached to flexible body 310, wherein each holding feature 304 is configured to hold one of recharging coil container 318. Recharging coil container 318 may be substantially similar to recharging coil container 118.” ¶[0117]); and a holding textile configured to hold the at least one pad forming the cavity to the head (Fig. 4A “securing member 102” ¶[0088]; “securing member 102 may be made of a fabric such as a micro-polyester and/or spandex material, or materials such as poly propylene, polyethylene, silicone, polycarbonate, acrylic, acrylonitrile butadiene styrene, polystyrene, styrene acrylonitrile, whether alone or in a combination with each other, or other similar materials.” ¶[0082]); wherein the at least one pad comprises a plurality of padding mesas extending to a height from a surface of the at least one pad, the plurality of padding mesas being separated from each other by padding gaps configured to permit the plurality of padding mesas to be moved closer to each other or further away from each other as the at least one pad is deformed by pressure on the head (Fig. 3 “Holding features 304, 306 may be pockets formed between an inner layer 313A and an outer layer 313B of flexible body 310. Holding features 304, 306 may be configured to be accessible from inner layer 313B. Alternatively, holding features 304, 306 may be configured to be accessible from outer layer 313A. In some examples, the holding features of any of the examples herein may alternatively or further comprise loop-and-hook features such as VELCRO brand hook-and-loop features, snaps, hooks, elastic or other stretchable bands, buttons, zippers, or any other type of holding features. Wearable medical device 300 may be formed from a polyester/Spandex blend, and/or Lycra, and/or cotton, so that securing member 302 and flexible body 310 are configured conform to the exterior side of scalp 16 of the patient to maintain a stable position of recharge coil container 318.” ¶[0118]; there are gaps separating the pockets), and the at least one pad is configured to deform in shape to follow a topography of the head (Fig. 4A “Flexible body 110 may be configured to conform to contour of at least some of each of the left anterior quadrant, the left posterior quadrant, the right posterior quadrant, and the right anterior quadrant of scalp 16 of the patient when securing member 102 is stably mounted to head 12.” ¶[0084]).
Regarding the limitation of padding gaps configured to permit the plurality of padding mesas to be moved closer to each other or further away from each other as the at least one pad is deformed by pressure on the head, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Malekkhosravi contains all of the structural components of the claim and is made from a material that can structurally conform to the to the shape of the head and therefore permits the padding mesas to move closer or further away from each other during deformation; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Malekkhosravi does not disclose the cavity being formed by lateral edge surfaces of at least some of the plurality of padding mesas and by the surface of the at least one pad.
Vito’s invention relates to the field of protective headgear, and more particularly, to impact-resistant padding for protective headgear and shares the common goal of comfortably wearing on a head. As shown in FIG. 4, spacing pad 130 may comprise an array of raised portions 131 formed on a surface thereof. Raised portions 131 may have a rectangular shape, as shown in FIG. 4. However, one of ordinary skill in the art will understand that other shapes may be chosen. For example, raised portions 131 may have a square shape or a diamond shape. Raised portions 130 desirably enable air circulation across spacing pad 130 and concentrate the load from an impact on spacing pad 130. An array of raised portions 131 having a diamond shape may be particularly desirable, as these raised portions 131 may enable greater flexibility of spacing pad 130 (¶[0028]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to form the cavities with the plurality of mesas surrounding the cavities as taught by Vito in the method and wearable holding device of Malekkhosravi in order to provide comfort and increase flexibility of the headgear.
Regarding claim 2, Malekkhosravi teaches wherein the at least part of the neural implant head-piece is configured to communicate at least one of power and data to or from at least one of a power source and a data source (“FIG. 3A depicts a conceptual diagram illustrating a variety of shapes for relatively compact recharging coil components 80A-80F (collectively, “coil components 80”), which may be employed by wearable medical devices discussed and depicted herein.”¶[0077]; Fig. 5 “coil 80 housed within charging coil container 118… Power source compartment 116 of FIG. 5 may include a housing that houses processing circuitry 150 that controls delivery of energy from rechargeable power source 158 by sending control signals to components such as power management circuitry 162 and modulating circuitry 164.” ¶[0095]; and “power source compartment 116 including a telemetry circuitry 156. Telemetry circuitry 156 may support wireless communication between IMD 14 and recharging device 100 under the control of processing circuitry 150… telemetry circuitry 156 may receive a signal from one or more IMDs 14 that indicates that a temperature of a respective IMD 14 exceeds a threshold as a result of an induced current, and in response to which recharging device 103 may reduce the power of the electromagnetic field for the respective IMD 14 to reduce current inducted in IMD 14” ¶[0095]).
Regarding claim 3, Malekkhosravi teaches wherein the at least part of the neural implant head-piece comprises a battery (Fig. 1D “power unit 44” ¶[0060] which could be a battery for portability and rechargability; Fig. 2 “Power source 58 may include one or more capacitors, batteries, or other energy storage devices. Power source 58 may then deliver operating power to the components of IMD 14.” ¶[0069]).
Regarding claim 7, Malekkhosravi teaches wherein the at least part of the neural implant head-piece is configured to communicate at least one of power and data to or from at least one of a power source and a data source (see claim 2 USC 102 rejection above), and wherein the at least one pad forms a cord opening for at least one cord (cable 120 in Fig. 5 and ¶[0085]: a cable extends from the charging coil/mesa to the I/O port of device 116 and in Fig. 10A, element 318 fits into a pocket; the wire extends from pocket to device 316 which is in pocket 306) carrying the at least one of power and data to or from the at least one of the power source and the data source (Fig. 4A “cables 120A, 120B (collectively, “cables 120”)” ¶[0085]).
Regarding claim 8, Malekkhosravi teaches further comprising a plurality of padding mesas separated from each other by padding gaps (Fig. 3 “Holding features 304, 306 may be pockets formed between an inner layer 313A and an outer layer 313B of flexible body 310. Holding features 304, 306 may be configured to be accessible from inner layer 313B. Alternatively, holding features 304, 306 may be configured to be accessible from outer layer 313A.” ¶[0118]; there are gaps between the holding features) and wherein the cord opening is formed by at least some of the plurality of padding mesas (cable 120 in Fig. 5 and ¶[0085]: a cable extends from the charging coil/mesa to the I/O port of device 116 and in Fig. 10A, element 318 fits into a pocket; the wire extends from pocket to device 316 which is in pocket 306).
Regarding claims 9, 15 and 27, Malekkhosravi does not disclose wherein the at least one pad and the holding textile each forms an opening for an ear of the head.
Vito teaches, as shown in FIG. 16, the cap body may include an opening 820 in the area of the user's ear. The opening may be desirable in order to promote aeration within the cap, and to provide the user better hearing (¶[0076]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to form openings for the ear of the wearer as taught by vito in the method and wearable holding device in order to promote aeration within the cap and provide better hearing.
Regarding claim 10, Malekkhosravi teaches wherein the cavity configured to receive and cover the at least a part of the neural implant head-piece is formed to be positioned over at least one of a parietal bone of the head, a temporal bone of the head, a mastoid process of a head, and an occipital bone of the head, when the holding textile holds the at least one pad forming the cavity to the head (Fig. 4B “securing member 102 may be secured to head 12 along relatively flat plane 104 that extends from forehead 106 of head 12 to anterior middle 108 of the back of head 12. In some examples, securing member 102 may be configured to secure to head 12 substantially only along plane 104, such that it may be difficult or impossible or otherwise uncomfortable for securing member 102 to be secured to head 12 along a plane other than plane 104. However, plane 104 upon which securing member 102 is secured to head 12 may be modifiable, such that recharging device 100 may be configured in different ways to identify or select different plane 104.” ¶[0079]; and “Flexible body 110 may be configured to conform to contour of at least some of each of the left anterior quadrant, the left posterior quadrant, the right posterior quadrant, and the right anterior quadrant of scalp 16 of the patient when securing member 102 is stably mounted to head 12… flexible body 110 may be configured to substantially cover most or all of scalp 16” ¶[0084]).
Regarding claim 11, Malekkhosravi teaches wherein the at least one pad forms at least one textile opening (“FIGS. 17A-17H depict conceptual diagrams illustrating various views of wearable medical device 1000, which may be substantially similar to wearable medical device 100, 300, 400, 500, 600, 700, 800, and 900” ¶[0135] and “bracket 1012 of FIG. 17H” ¶[0137]) configured to permit attaching of the holding textile to the at least one pad (Fig. 17H “Brackets may be configured to enable holding features 1004 to securely receive charge units 1082.” ¶[0137] and “FIGS. 17A-17H further illustrates multiple holding features 1004 of wearable medical device 1000 formed by flexible rails, which have opposing, left and right ends attached to respective securing members 1002A, 1002B. Holding features 1004 may extend in an arc superior to respective securing members 1002A, 1002B to span left and right quadrants of scalp 16 when the respective securing member 1002A, 1002B is mounted to head 12.” ¶[0136]).
Regarding claim 12, Malekkhosravi teaches wherein the holding textile comprises at least one of: a neck strap (“FIGS. 30A-30D depict conceptual diagrams illustrating various views of wearable medical device 2300, which may be substantially similar to wearable medical device 100, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100, and 2200” and “Wearable medical device 2300 may include collar member 2304 secured to securing member 2302. Collar member 2304 may be attached to a posterior inferior edge of securing member 2302.” ¶[0168]) a strap configured to extend over a top portion of the head, a forehead strap, and a strap for a back of the head (“Securing member 102 may be a band that is configured to extend substantially fully around an outer perimeter of scalp 16 along one relatively flat plane.” ¶[0079]; “in FIG. 7A, portion 202 of securing member 102A may extend out from flexible body 110. Further, flexible body 110 may extend out distance 204 from portion 202 of securing member 102A, therein enabling securing member 102A to increase or reduce a circumferential length of securing member 102A” ¶[0105]; and “Wearable medical device 300 may include securing member 302 that is substantially similar to securing member 102 with exception to any differences described herein. Securing member 302 may extend around head 12 in a generally horizontal plane (that is, across forehead 106 of patient, alongside both ears, and across the posterior portion of scalp 16 adjacent the neck of the patient—as illustrated in FIGS. 10A-10C).” ¶[0117]).
Regarding claim 13, Malekkhosravi teaches wherein the holding textile (Fig. 4A “securing member 102” ¶[0088]) comprises the neck strap, the strap configured to extend over the top portion of the head, the forehead strap, and the strap for a back of the head (see claim 12 USC 102 rejection above).
Regarding claim 22, Malekkhosravi teaches wherein the holding textile comprises a webbing material (“securing member 102 may be made of a fabric such as… poly propylene…” ¶[0082]).
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Malekkhosravi in view of Vito, as applied to claims 1 and 13 above, and in even further view of Pukish (US 3327316 A, published June 27, 1967, hereinafter referred to as “Pukish”).
Regarding claim 14, Malekkhosravi and Vito teach the wearable holding device of claim 13.
Malekkhosravi and Vito do not teach wherein the at least one pad comprises at least one elongated arm configured to permit attachment to at least one of the neck strap, the strap configured to extend over the top portion of the head, the forehead strap, and the strap for the back of the head.
Pukish, concerned with the common problem of securing an article to the head of a user, discloses protective headgear, and more particularly to an improved protective headgear adapted to be worn by wrestlers or other athletes (Col. 1, ln. 9-11). Referring to FIGS. 1 and 2, this improved headgear comprises a pair of padded ear pieces 10 configured to cover each of the side or ear regions of the wearer and connected together by head straps 11, 12, 13, and 14 which extend laterally across the head of the wearer as shown in FIGS. 1 and 2. Preferably, these head straps 11 through 14 are formed of elastic material and are connected to tab projections (elongated arms) on the respective padded ear pieces 10 (pads) in any suitable manner, for example by sewing, as indicated in the drawings by the box stitching at 11a-14a. In a similar manner, a pair of elastic chin straps 16 are connected to the lower tap portions of the respective ear pieces 10, to support a padded chain piece 17 over the chin region of the wearer (Col. 2, ln. 23-36).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have at least one elongated arm for attachment to one of the claimed straps as taught by Pukish in the wearable holding device of Malekkhosravi and Vito in order to provide a ledge for attachment of the strap such as a base for sewing of the strap to the padding.
Regarding claim 19, Malekkhosravi and Vito teach the wearable holding device of claim 1.
Although Vito discloses foam, Malekkhosravi and Vito do not teach wherein the at least one pad comprises a breathable foam.
Pukish teaches the inside surface of pad 19 bearing against the ear of the wearer can be covered with a moisture-absorbing pad 30, as shown in FIG. 4, and which can be formed of a soft felt padding or an open-cell polyurethane foam pad preferably from 1/3" to 1/4" in thickness. Such pads are desirable for absorbing perspiration from the wearer's head to prevent the ear pieces from becoming wet and slippery and more easily moved out of place. (Col. 3, ln. 33-41).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the pad made of breathable foam such as open-cell polyurethane foam as taught by Pukish in the wearable holding device of Malekkhosravi and Vito in order to prevent the device from moving out of place and absorb any perspiration.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Malekkhosravi in view of Vito.
Regarding claims 16 and 18, Malekkhosravi and Vito teach the wearable holding device of claim 1.
Malekkhosravi also teaches in a separate embodiment wherein the neural implant head-piece is configured to be magnetically mounted to the exterior of the head (“as depicted in FIGS. 33A-33C, securing member 2502D may include a magnetic element configured to magnetically hold one of charging modules 2504C to a location adjacent the power source and power management circuit housing of securing member 2502D. Charging modules 2504 may work substantially similar to recharging device 103 described herein, such that charging modules 2504 may be used to recharge power sources of IMDs 14 as depicted in FIG. 33” ¶[0172]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to magnetically mount the implant head-piece on the exterior of the head in order to hold the charging module close to the power source to recharge the IMDs.
Malekkhosravi and Vito do not disclose wherein the cavity configured to receive and cover the at least a part of the neural implant head-piece is formed to comprise a surrounding clearance between the at least one pad and the neural implant headpiece that is no larger than a distance of magnetic misalignment of the neural implant headpiece, wherein the surrounding clearance comprises 12 mm or less of height clearance between a top portion of the neural implant headpiece and the at least one pad.
The specification discloses the appropriate ranges that apply to the claimed invention in ¶[0027] as no larger than a distance of magnetic misalignment of the neural implant headpiece such as 12 mm or less of height clearance. However, the specification does not disclose that the specifically claimed range(s) of 12 mm or less is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Malekkhosravi teaches the wearable cavity as shown in claim 1 above and provides device stability and conformability for the retention of the neural implant headpiece, the prior art therefore provides teaching that the surrounding clearance is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Since Applicants fail to disclose that the claimed range(s) of 12 mm or less provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that the wearable device holds the implant device in place absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of 12mm or less by normal optimization procedures known in the wearable arts.
Regarding claim 17, Malekkhosravi and Vito do not disclose wherein a surrounding clearance between the at least one pad and the neural implant headpiece comprises 5mm or less of clearance between the at least one pad and a side perimeter of the neural implant headpiece.
The specification discloses the appropriate ranges that apply to the claimed invention in ¶[0027] as 5 mm or less. However, the specification does not disclose that the specifically claimed range(s) of 5 mm or less is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Malekkhosravi teaches the wearable cavity as shown in claim 1 above and provides device stability and conformability for the retention of the neural implant headpiece, the prior art therefore provides teaching that the surrounding clearance is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Since Applicants fail to disclose that the claimed range(s) of 5 mm or less provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that the wearable device holds the implant device in place absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of 5 mm or less by normal optimization procedures known in the wearable arts.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Malekkhosravi in view of Vito, as applied to claim 1 above, and in even further view of Larkin (US 20130256345 A1 , published Oct. 3, 2013, hereinafter referred to as “Larkin”).
Regarding claims 20-21, Malekkhosravi and Vito teach the wearable holding device of claim 1. Vito also teaches wherein the at least one pad comprises a closed cell foam (“Suitable materials for use in forming absorption pads 150 include, for example, conventional closed or open-cell foams” ¶[0031]).
Malekkhosravi and Vito do not disclose wherein the closed cell foam comprises at least one of an ethylene-vinyl acetate (EVA) and a polyurethane foam.
Larkin’s inventions relates to a wearable neckpiece for tethering a cable, such as a cable used in conjunction with an electronic device (¶[0002]). The neckpiece 10C and/or band 43 of Fig.’s 9-10 may be made of a molded plastic or foam, such as a closed-cell polyurethane foam to provide a lightweight and comfortable neckpiece 10C (¶[0089]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to construct the pad with a closed cell foam including polyurethane foam as taught by Larkin in the wearable holding device of Malekkhosravi and Vito in order to provide a lightweight and comfortable device.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET.
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/E.N.C./ Patent Examiner, Art Unit 3792
/ALLEN PORTER/ Primary Examiner, Art Unit 3796
