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 Arguments
Applicant's arguments filed 7/16/2025 have been fully considered.
Applicant stated that claim 24 was not addressed in the previous Office Action under the art rejection. Claim 24 been withdrawn from the double patenting rejection and is allowable.
Rejected under 35 U.S.C. 103 as obvious over Schroeder et al (2018/0296822).
Applicant amends claim 1 adding a plurality of electrodes “in a three-dimensional configuration”.
First, see par. 0013 of applicant’s specification which teaches only two electrodes are needed to form a three-dimensional configuration.
Second, the liner has a three-dimensional configuration and a plurality of electrodes (two as shown) are not merely flat (in plane 2-2) but have a three-dimensional configuration relative to the residual limb fulfilling the claim language. It is the examiner’s position that the two electrodes are in a three-dimensional configuration relative to the residual limb. If applicant intends “in a three-dimensional configuration” to mean at least three electrodes, the examiner suggests claiming at least three.
Finally, par [0011] of Schroeder et al reads: “FIG. 2 schematically depicts an exploded view of an interface system including a partial cross-sectional view of the conductive human interface of FIG. 1 along line 2-2.” It is inherent that other cross-sections of figure 1 can include additional electrodes not shown in figure 2. Par. 0022 teaches the liner 100 can include one or more compliant electrodes 130 wherein “including one or more” includes three or more. Three or more electrodes inherently form a three-dimensional configuration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 7-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-20 and 33-41 of copending Application No. 18/629,778. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application No. 18/629,778 are directed to a non-transitory computer-readable medium which is considered the subcombination (generic) of the current claims system claims. These subcombination claims are broader and are copied below for convenience; the comparison is self-evident.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19. (Currently amended) A non-transitory computer-readable medium comprising instructions to cause a processor to: store[[ing]] instructions which, when executed by one or more processors of a system, cause the system to: transmit with an electrode controller in electrical communication with an electrode in an apparatus, electrical current with a pulse frequency up to 180 pulses per second and a pulse width of up to 400 microseconds, through a residual limb of an amputee; and stimulate nerve fibers in the residual limb responsive to transmitting electrical current with the electrode; wherein the apparatus comprises: a prosthetic liner made of a first polymer; and a substrate made of a second polymer configured to contact the skin of the residual limb and comprising a plurality of embedded electrodes and a conductor, wherein the first polymer and the second polymer are[[is]] polymer compatible, and wherein the prosthetic liner is bonded to the substrate.
20. (Currently amended) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: detect[[s]] physiological parameters with at least one sensor; measure[[s]] physiological data from the physiological parameters; store[[s] the measured physiological data; process[[es]] the measured physiological data; and provide[[s]] outputs to a user or other computing device responsive to processing the measured physiological data.
Please add the following new claims:
33. (New) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: stimulates muscles in the residual limb responsive to transmitting electrical current with the plurality of electrodes.
34. (New) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: activates the plurality of electrodes by contacting one or more sensors.
35. (New) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: directs the electrode controller to direct a first positive electrode to transmit electrical current to the residual limb and a negative electrode to receive the electrical current in response to a first symptom.
36. (New) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: transmits electrical current to treat one or more symptoms of post-operative pain or post- operative sensation.
37. (New) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: causes the apparatus to: transmit, with an electrode controller in electrical communication with an electrode in the substrate, electrical current through the residual limb responsive to input received from the amputee with a user interface; and stimulate nerve fibers in the residual limb responsive to transmitting electrical current with the electrode.
38. (New) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: causes one or more electrodes to transmit electrical current to the residual limb with a secondary controller in wireless communication with the electrode controller.
39. (New) The non-transitory computer-readable medium of claim 38, wherein: the secondary controller is a computing device and in wireless communication with the electrode controller.
40. (New) The non-transitory computer-readable medium of claim 19, wherein the instructions are further executable by the processor to: controls which electrode in an array of electrodes transmits electrical current through a specific region of the residual limb.
41. (New) The non-transitory computer-readable medium of claim 19, wherein the conductor is a plurality of conductive wires.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-23 are rejected under 35 U.S.C. 103 as obvious over Schroeder et al (2018/0296822).
Evidenced by Laghi et al (2021/0186719), Mulvey et al (Transcutaneous Electrical Nerve Stimulation for Phantom Pain and Stump Pain in Adult Amputees) and Kirn (2015/0142129).
Schroeder et al teaches a system for modulating nerve activation in a residual limb of an amputee, comprising:
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1) prosthetic liner 100 with a first material 110 (see par. 0020, which fails to teach the first material being a polymer); and
2) substrate 120 with a second polymer (par. 0021) comprising a plurality of electrodes 130 in a three-dimensional configuration relative to the residual limb and a conductor 140.
Regarding a “three-dimensional configuration”:
First, see par. 0013 of applicant’s specification which teaches only two electrodes are needed to form a three-dimensional configuration.
Second, the liner has a three-dimensional configuration and a plurality of electrodes (two as shown) are not merely flat (in plane 2-2) but have a three-dimensional configuration relative to the residual limb fulfilling the claim language. It is the examiner’s position that the two electrodes are in a three-dimensional configuration relative to the residual limb. If applicant intends “in a three-dimensional configuration” to mean at least three electrodes, the examiner suggests claiming at least three.
Finally, par [0011] of Schroeder et al reads: “FIG. 2 schematically depicts an exploded view of an interface system including a partial cross-sectional view of the conductive human interface of FIG. 1 along line 2-2.” It is inherent that other cross-sections of figure 1 can include additional electrodes not shown in figure 2. Par. 0022 teaches the liner 100 can include one or more compliant electrodes 130 wherein “including one or more” includes three or more. Three or more electrodes inherently form a three-dimensional configuration.
Wherein the prosthetic liner is attached to an outer surface of the substrate (see figures 2-3),
wherein an inner surface of the substrate is configured to directly contact the residual limb (fully capable of),
wherein the prosthetic liner and the substrate are configured to receive the residual limb such that each electrode in the substrate is in contact with and in electrical communication with the residual limb (fully capable of);
However, Schroeder et al fails to teach the first material 110 (such as a fabric) is a polymer. The examiner provides Laghi et al as evidence that it is well known in the art that a prosthetic liner comprises a polymer such as polyurethane; see fabric layer 30 and par. 0055. It would have been obvious to one having ordinary skill in the art to have made the first material 110 of Schroeder et al from a polymer as evidenced by Laghi et al such that the first polymer is elastic and flexible. The obviousness combination makes the first polymer and the second polymer are polymer compatible (such as capable of being used together or connected together).
The system comprising: 3) an electrode controller (generally 150, see at least par. 0037-0043) in electrical communication with each electrode (see figure 8) to transmit electrical signals to stimulate nerve endings and can include a signal generator 158. The electrical signal can be configured for TENS to manage pain of amputees who experience phantom limb pain; see par. 0041-0042. The examiner takes the position that electrode controller, configured for TENS, inherently fulfills the electrical signals are pulsed electrical current with a pulse frequency up to 180 pulses per second and a pulse width of up to 400 microseconds through the residual limb and stimulate nerve fibers in the residual limb. If not inherent, the examiner evidences Mulvey et al which teaches conventional TENS setting with a pulse frequency of 100 Hz (pulses per second) and a pulse width of up to 80 microseconds (page 2, column 2). It would have been obvious to one having ordinary skill in the art to have used the conventional TENS setting as evidenced by Mulvey et al for the TENS setting so Schroeder et al to manage phantom limb pain.
Claim 2, see par. 0029 teaching the electrical signals can be configured for pain and additionally can be transmitted to muscle or nerves for feedback and par. 0042 for TENS.
Claim 3, phantom limb syndrome (pain) is addressed above.
Claims 4, see at least par. 0040 teaching additional processing device 150 (second controller) can include device communication hardware 156 coupled to one or more processors and can send and receive wireless data (at least Bluetooth). Claims 5 and 8, the examiner evidences Kirn that uses a smart phone 302 as device communication hardware. It would have been obvious to one having ordinary skill in the art to have used a smart phone to see data, enter/adjust data or turn off the system. Claim 12, all electrodes are paired. Kirn provides evidence as having four electrodes in an array in the liner. It would have been obvious to one having ordinary skill in the art to have used at least four electrodes to stimulate specific muscles in a specific area to add additional pressure within a socket. Regarding instructions, memory, processor, see par. 0037-0042 of Schroeder et al.
Claim 6, par. 0013 of applicant’s specification teaches it only takes two electrodes to form a ring.
Claim 7, see the included figure above showing the electrodes extend through an aperture to contact the residual limb.
Claim 9, see the main rejection above teaching liner comprises a polymer such as polyurethane.
Claim 10, see figure 3 of Schroeder et al wherein the liner and substrate are molded as claimed.
Claim 11, the system is fully capable of stimulating myelinated A6 nerve fibers in the residual limb. The claim and specification fail to indicate a specific frequency and pulse width needed.
Claims 13-14, see par. 0039 teaching one or more electrodes with positive and negative contacts wherein the current inherently flows as claimed.
Claims 15-16, see par. 0029 teaching the electrical signals can be configured for pain (TENS) and/or transmitting to muscle or nerves for feedback. The electrodes inherently operate in negative and positive pairs and a secondary controller is responsive to a “first symptom such as pain. See par. 0040 teaching one or more processors which includes a secondary controller.
Claims 17-18, see par. 0021 of Schroeder et al teaching various second polymer materials such as TPE and silicone. Laghi et al teaches various first materials including polyurethane, nylon and silicone. Silicone can be used as the first and second polymer.
Claim 19, see conductive paths 140.
Claim 20, referring to at least claim 1 of Kirn, this is evidence that it is known in the art that the electrode controller controls which electrode in an array (four shown in figure 1) of electrodes (stimulus electrodes) and transmits electrical current through a specific region of the residual limb. It would have been obvious to one having ordinary skill in the art to have used an array to stimulate specific muscles in a specific area to add additional pressure within a socket.
Claim 21, electrode gel is well known and commercially sold and would have been obvious to have used on the embedded electrodes to improve electrical contact with the skin.
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Claims 22-23, referring to Schroeder et al, see at least par. 0037-0042 and figure 8, at least elements 154, 152 (electrode controller/stimulation manager) and executing machine readable instructions. Par. 0039, see subtract electrical noise. Also, see rejected claim 20 above wherein the stimulation of various muscles can be modified, repeated, or omitted based on sensor input (claim 1 of Kirn).
Allowable Subject Matter
Claim 24 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.
The following is an examiner’s statement of reasons for allowance: The prior art of record fails to teach all limitations of claim 1 further comprising: a user interface to receive input from the amputee; an output displayed based on the received input; andinstructions stored in memory in electronic communication with a processor and executable by the processor, to cause the system to: detect physiological parameters with at least one sensor;measure physiological data from the physiological parameters; store the measured physiological data; process the measured physiological data; and provide outputs to a user or other computing device responsive to processing the measured physiological data.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/ Primary Examiner, Art Unit 3774