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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-9, in the reply filed on 10/18/24 is acknowledged. Applicant has withdrawn claims 10-13 in their reply of 6/17/26.
Specification
The disclosure is objected to because of the following informalities: Paragraphs 1-4 of the specification should be updated for any issued patent numbers.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/043147 by Strohmeier.
Regarding Claim 1, Strohmeier teaches a method of musculature stimulation mapping (e.g. abstract, 9:1-23, 15:19-32: EMG mapping for stimulation), the method comprising:
disposing a garment on a body part of a user with an array of electrodes of the garment contacting skin of the body part (e.g. abstract, 6:9-22, 10:4-25, Fig. 1: sleeve garment with array of electrodes);
measuring electromyography (EMG) signals using the array of electrodes of the garment disposed on the body part while the user is triggering the EMG signals to perform a movement of the body part (e.g. 6:9-34, 28:34-35, Fig. 1B, Fig. 5: performing gestures, such as wrist extension, and mapping EMG from the sleeve electrodes); and
mapping the measured EMG signals to a musculature anatomy to determine muscles activated by the triggering of the EMG signals (e.g. abstract, 9:1-23, 15:19-32, 7:10-16, 32:20-21, Fig. 4: different gestures produce different EMG signal patterns from the array, the patterns corresponding to the musculature anatomy under the electrode array).
Regarding Claim 7, Strohmeier teaches the method of claim 1, further comprising: based on the mapping of the measured EMG signals to the musculature anatomy, determining electrodes of the array of electrodes for performing functional electrical stimulation (e.g. abstract, 1:11-16: calibrating FES based on EMG patterns from the garment array).
Regarding Claim 8, Strohmeier teaches the method of claim 7, wherein the determined electrodes of the array of electrodes for performing the FES comprises cathode and anode regions of interest (ROI) of the array of electrodes (e.g. 7:18-24: bipolar stimulation).
Regarding Claim 9, Strohmeier teaches the method of claim 7, further comprising: performing FES to evoke the movement of the body part by applying electrical stimulation to the determined electrodes of the array of electrodes (e.g. 4:13-15, 27:6—28:9, 30:26-35: the EMS is used to evoke movement to reproduce the gesture).
Claims 1-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2020/0406035 by Sharma.
The applied reference has a common assignee, and one common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, Sharma teaches a method of musculature stimulation mapping (e.g. ¶ 23: personalized EMG mapping), the method comprising:
disposing a garment on a body part of a user with an array of electrodes of the garment contacting skin of the body part (e.g. ¶20, Fig. 1: sleeve 10 with electrode arrays);
measuring electromyography (EMG) signals using the array of electrodes of the garment disposed on the body part while the user is triggering the EMG signals to perform a movement of the body part (e.g. abstract, ¶14,18-19,45: volitional EMG during intended movement); and
mapping the measured EMG signals to a musculature anatomy to determine muscles activated by the triggering of the EMG signals (e.g. abstract, ¶23, Fig. 6-7: mapping EMG signals to motor units).
Regarding Claim 2, Sharma discloses the method of claim 1, wherein the triggering of the EMG signals does not produce movement of the body part (e.g. ¶14,45: recording intent to move paralyzed muscle).
Regarding Claim 3, Sharma discloses the method of claim 1, wherein the body part of the user is a paralyzed body part of the user (e.g. ¶14,45: recording intent to move paralyzed muscle).
Regarding Claim 4, Sharma discloses the method of claim 1, wherein the user has a spinal cord injury and the body part of the user is a paralyzed body part due to the spinal cord injury (e.g. ¶14: SCI).
Regarding Claim 5, Sharma discloses the method of claim 4, wherein the spinal cord injury is a clinically determined complete spinal cord injury (e.g. ¶2,14: paralysis due to SCI).
Regarding Claim 6, Sharma discloses the method of claim 1, wherein the user has had a stroke and the body part of the user is a paralyzed body part due to the stroke (e.g. ¶2: stroke rehabilitation).
Regarding Claim 7, Sharma discloses the method of claim 1, further comprising: based on the mapping of the measured EMG signals to the musculature anatomy, determining electrodes of the array of electrodes for performing functional electrical stimulation (e.g. abstract, ¶14: FES based on volitional EMG).
Regarding Claim 8, Sharma discloses the method of claim 7, wherein the determined electrodes of the array of electrodes for performing the FES comprises cathode and anode regions of interest (ROI) of the array of electrodes (e.g. ¶22: bipolar stimulation).
Regarding Claim 9, Sharma discloses the method of claim 7, further comprising: performing FES to evoke the movement of the body part by applying electrical stimulation to the determined electrodes of the array of electrodes (e.g. ¶3,22: FES of arm wearing the sleeve to cause contractions).
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.
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Strohmeier, as applied to Claim 1, in view of CN 106693178 A by Li (machine translation) and US 2021/0016079 by Ekelem.
Regarding Claim 2, Strohmeier teaches the method of claim 1, yet does not explicitly disclose wherein the triggering of the EMG signals does not produce movement of the body part. However, Li teaches an analogous FES method of paralyzed limb muscles based on volitional EMG feedback (e.g. page 2, background technology; step A1, collecting the biceps muscle and triceps brachii muscle of the electromyographic signal; page 2-3: collecting volitional EMG signals from the paralyzed muscle, e.g. VEMG2 and VEMG3, “wherein the VEMG is autonomous desire electromyography signal” and stimulating the muscles based on the VEMGs, for example “stimulating elbow joint movement… so that the patient can determine position of the elbow joint motion according to the desire of the user”; page 5: “The invention is mainly used for upper limb rehabilitation training of stroke and spinal cord injury patients. l-NBP in survivors with 30% to 36% of stroke patients with limb dysfunction after the onset for 6 months, when the damaged part is C5 or C6 position for spinal cord injury patients, patients will lose the shoulder, elbow and wrist limb movement function. Elbow joint control of functional electrical stimulation system is designed for rehabilitation training for hemiplegia or paralytic upper limb dysfunction.”). Ekelem also teaches an analogous FES method of paralyzed limb muscles based on intended movement EMG feedback, without requiring limb movement (e.g. ¶¶ 9, 45, 63-64, 68). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to apply the method of FES by Strohmeier in paralyzed muscles via volitional EMG feedback control from paralyzed muscles, as taught by Li and Ekelem, in order to predictably provide FES and thus rehabilitate and maintain muscle strength in patients suffering from paralysis, as suggested by Li (e.g. section background technology; page 5, paragraph 5).
Regarding Claim 3, Strohmeier teaches the method of claim 1, yet does not explicitly disclose wherein the body part of the user is a paralyzed body part of the user. However, Li teaches an analogous FES method of paralyzed limb muscles based on volitional EMG feedback (e.g. page 2, background technology; step A1, collecting the biceps muscle and triceps brachii muscle of the electromyographic signal; page 2-3: collecting volitional EMG signals from the paralyzed muscle, e.g. VEMG2 and VEMG3, “wherein the VEMG is autonomous desire electromyography signal” and stimulating the muscles based on the VEMGs, for example “stimulating elbow joint movement… so that the patient can determine position of the elbow joint motion according to the desire of the user”; page 5: “The invention is mainly used for upper limb rehabilitation training of stroke and spinal cord injury patients. l-NBP in survivors with 30% to 36% of stroke patients with limb dysfunction after the onset for 6 months, when the damaged part is C5 or C6 position for spinal cord injury patients, patients will lose the shoulder, elbow and wrist limb movement function. Elbow joint control of functional electrical stimulation system is designed for rehabilitation training for hemiplegia or paralytic upper limb dysfunction.”). Ekelem also teaches an analogous FES method of paralyzed limb muscles based on intended movement EMG feedback, without requiring limb movement (e.g. ¶¶ 9, 45, 63-64, 68). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to apply the method of FES by Strohmeier in paralyzed muscles via volitional EMG feedback control from paralyzed muscles, as taught by Li and Ekelem, in order to predictably provide FES and thus rehabilitate and maintain muscle strength in patients suffering from paralysis, as suggested by Li (e.g. section background technology; page 5, paragraph 5)
Regarding Claim 4, Strohmeier teaches the method of claim 1, yet does not explicitly disclose wherein the user has a spinal cord injury and the body part of the user is a paralyzed body part due to the spinal cord injury. However, Li teaches an analogous FES method of SCI paralyzed limb muscles based on volitional EMG feedback (e.g. page 2, background technology; step A1, collecting the biceps muscle and triceps brachii muscle of the electromyographic signal; page 2-3: collecting volitional EMG signals from the paralyzed muscle, e.g. VEMG2 and VEMG3, “wherein the VEMG is autonomous desire electromyography signal” and stimulating the muscles based on the VEMGs, for example “stimulating elbow joint movement… so that the patient can determine position of the elbow joint motion according to the desire of the user”; page 5: “The invention is mainly used for upper limb rehabilitation training of stroke and spinal cord injury patients. l-NBP in survivors with 30% to 36% of stroke patients with limb dysfunction after the onset for 6 months, when the damaged part is C5 or C6 position for spinal cord injury patients, patients will lose the shoulder, elbow and wrist limb movement function. Elbow joint control of functional electrical stimulation system is designed for rehabilitation training for hemiplegia or paralytic upper limb dysfunction.”). Ekelem also teaches an analogous FES method of paralyzed limb muscles based on intended movement EMG feedback, without requiring limb movement (e.g. ¶¶ 9, 45, 63-64, 68). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to apply the method of FES by Strohmeier in SCI paralyzed muscles via volitional EMG feedback control from paralyzed muscles, as taught by Li and Ekelem, in order to predictably provide FES and thus rehabilitate and maintain muscle strength in patients suffering from paralysis, as suggested by Li (e.g. section background technology; page 5, paragraph 5)
Regarding Claim 5, Strohmeier teaches the method of claim 4, yet does not explicitly disclose wherein the spinal cord injury is a clinically determined complete spinal cord injury. However, Li teaches an analogous FES method of SCI paralyzed limb muscles based on volitional EMG feedback (e.g. page 2, background technology; step A1, collecting the biceps muscle and triceps brachii muscle of the electromyographic signal; page 2-3: collecting volitional EMG signals from the paralyzed muscle, e.g. VEMG2 and VEMG3, “wherein the VEMG is autonomous desire electromyography signal” and stimulating the muscles based on the VEMGs, for example “stimulating elbow joint movement… so that the patient can determine position of the elbow joint motion according to the desire of the user”; page 5: “The invention is mainly used for upper limb rehabilitation training of stroke and spinal cord injury patients. l-NBP in survivors with 30% to 36% of stroke patients with limb dysfunction after the onset for 6 months, when the damaged part is C5 or C6 position for spinal cord injury patients, patients will lose the shoulder, elbow and wrist limb movement function. Elbow joint control of functional electrical stimulation system is designed for rehabilitation training for hemiplegia or paralytic upper limb dysfunction.”). Ekelem also teaches an analogous FES method of paralyzed limb muscles based on intended movement EMG feedback, without requiring limb movement (e.g. ¶¶ 9, 45, 63-64, 68). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to apply the method of FES by Strohmeier in SCI paralyzed muscles via volitional EMG feedback control from paralyzed muscles, as taught by Li and Ekelem, in order to predictably provide FES and thus rehabilitate and maintain muscle strength in patients suffering from paralysis, as suggested by Li (e.g. section background technology; page 5, paragraph 5)
Regarding Claim 6, Strohmeier teaches the method of claim 1, yet does not explicitly disclose wherein the user has had a stroke and the body part of the user is a paralyzed body part due to the stroke. However, Li teaches an analogous FES method of stroke paralyzed limb muscles based on volitional EMG feedback (e.g. page 2, background technology; step A1, collecting the biceps muscle and triceps brachii muscle of the electromyographic signal; page 2-3: collecting volitional EMG signals from the paralyzed muscle, e.g. VEMG2 and VEMG3, “wherein the VEMG is autonomous desire electromyography signal” and stimulating the muscles based on the VEMGs, for example “stimulating elbow joint movement… so that the patient can determine position of the elbow joint motion according to the desire of the user”; page 5: “The invention is mainly used for upper limb rehabilitation training of stroke and spinal cord injury patients. l-NBP in survivors with 30% to 36% of stroke patients with limb dysfunction after the onset for 6 months, when the damaged part is C5 or C6 position for spinal cord injury patients, patients will lose the shoulder, elbow and wrist limb movement function. Elbow joint control of functional electrical stimulation system is designed for rehabilitation training for hemiplegia or paralytic upper limb dysfunction.”). Ekelem also teaches an analogous FES method of paralyzed limb muscles based on intended movement EMG feedback, without requiring limb movement (e.g. ¶¶ 9, 45, 63-64, 68). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to apply the method of FES by Strohmeier in stroke paralyzed muscles via volitional EMG feedback control from paralyzed muscles, as taught by Li and Ekelem, in order to predictably provide FES and thus rehabilitate and maintain muscle strength in patients suffering from paralysis, as suggested by Li (e.g. section background technology; page 5, paragraph 5)
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 11,266,833 in view of WO 2019/043147 by Strohmeier.
Regarding claim 1, Claim 24 of the issued patent discloses a method of musculature stimulation mapping, the method comprising: disposing on a body part of a user an array of electrodes of the garment contacting skin of the body part; measuring electromyography (EMG) signals using the array of electrodes disposed on the body part while the user is triggering the EMG signals to perform a movement of the body part; and mapping the measured EMG signals to a musculature anatomy to determine muscles activated by the triggering of the EMG signals (e.g. Claim 23: A functional electrical stimulation (FES) system comprising: an FES device configured for connection with an associated body part of a user and including electrodes arranged to apply functional electrical stimulation to the associated body part of the user and to perform electromyography (EMG) measurements of the associated body part of the user; Claim 24: applying an EMG map-to-electrode energization transform to the acquired EMG measurements of the associated body part of the user; wherein the EMG map-to-electrode energization transform includes at least a scaling transform to convert EMG signals of the acquired EMG measurements to FES energization levels.).
Claim 24 of the issued patent does not disclose a garment with the array of electrodes.
However, Strohmeier teaches an analogous FES method of musculature stimulation mapping (e.g. abstract, 9:1-23, 15:19-32: EMG mapping for stimulation), comprising disposing a garment on a body part of a user with an array of electrodes of the garment contacting skin of the body part (e.g. abstract, 6:9-22, 10:4-25, Fig. 1: sleeve garment with array of electrodes). Therefore, it would have been obvious to a person having ordinary skill in the art to include a garment with the array of electrodes in a method as taught by Claim 24 of the issued patent, as taught by Strohmeier, in order to predictably secure the electrodes on the body and acquire reliable EMGs.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 19/215481 in view of WO 2019/043147 by Strohmeier.
Regarding claim 1, Claim 14 of the issued patent discloses a method of musculature stimulation mapping, the method comprising: disposing on a body part of a user an array of electrodes of the garment contacting skin of the body part; measuring electromyography (EMG) signals using the array of electrodes disposed on the body part while the user is triggering the EMG signals to perform a movement of the body part; and mapping the measured EMG signals to a musculature anatomy to determine muscles activated by the triggering of the EMG signals (e.g. Claim 14: performing spatial muscle mapping to determine a sleeve shift and automatically updating NMES stimulation patterns based on the sleeve shift; and delivering neuromuscular electrical stimulation (NMES) to the target muscle or muscle group based on the derived contribution of the spatial muscle activity of the target muscle or muscle group to the measured EMG data).
Claim 14 of the issued patent does not disclose a garment with the array of electrodes.
However, Strohmeier teaches an analogous FES method of musculature stimulation mapping (e.g. abstract, 9:1-23, 15:19-32: EMG mapping for stimulation), comprising disposing a garment on a body part of a user with an array of electrodes of the garment contacting skin of the body part (e.g. abstract, 6:9-22, 10:4-25, Fig. 1: sleeve garment with array of electrodes). Therefore, it would have been obvious to a person having ordinary skill in the art to include a garment with the array of electrodes in a method as taught by Claim 24 of the issued patent, as taught by Strohmeier, in order to predictably secure the electrodes on the body and acquire reliable EMGs.
This is a provisional nonstatutory double patenting rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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