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 .
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 .
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/068,389 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Application No. 19/068,398 has been found to anticipate each and every element of the present invention, for instance both provide:
19/068,538 (claim 1)
19/068,389 (claim 1)
rehabilitating a patient comprising the steps of: providing a gait trainer
a gait training device comprising:
with an operably connected leg brace;
a leg brace;
sensing movement and position in space of a compromised limb of the patient via one or more sensors attached to the leg brace
at least one sensor connected to the leg brace that generates limb position data based upon a position of a user's limb, wherein the at least one sensor is configured to detect a position of the leg brace in space;
and generating limb data;
at least one sensor is configured to detect a position of the leg brace in space;
analyzing the limb data;
a neuromodulation controller configured to process the limb position data from the at least one sensor,
and signaling one or more neuromodulators to activate based at least in part upon analysis of the limb data, wherein the signaling is timed to assist gait motion of the compromised limb.
and to transmit a signal to the at least one neuromodulator that causes the at least one neuromodulator to deliver an electrical impulse that is configured to activate a specific muscle of the user's limb to accomplish a desired motion of the user's limb.
As set forth above, the present invention is not viewed to be patentably distinct from Application No. 19/068,389.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-8 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larson et al. (US 4,697,808).
As to claim 1, Larson et al. discloses rehabilitating a patient (Abstract) comprising the steps of: providing a gait trainer (Figure 1) with an operably connected leg brace (Figure 1-2); sensing movement and position in space of a compromised limb of the patient (“computer monitors the flexion angles for both knees, as provided by feedback sensors which may be simple potentiometers positioned at knee joints 30. 32 Alternatively, the flexion angle sensors may be strain gauge devices as hereinafter described with reference to FIG. 17. Stimulated extension of both knees proceeds under full closed loop control until the feedback sensors indicate that the knees are near a locked position”(col. 5, lines 44-64); Therefore the sensors detect a position of the leg brace in [a] space as it relates to a person’s posture) via one or more sensors (feedback sensors, depicted as 30 and 32 in Figures 1-2 and 17) attached to the leg brace and generating limb data (col. 5, lines 44-64); analyzing the limb data (col. 7, lines 10-31); and signaling one or more neuromodulators (electrodes, depicted as 172, 174 and 176 in Figures 13-14) to activate based at least in part upon analysis of the limb data (Figures 4-5), wherein the signaling is timed to assist gait motion of the compromised limb (col. 9, lines 15-59; Abstract).
As to claim 2, Larson et al. discloses the signaling step includes delivering an electrical impulse to a muscle of the compromised limb via the one or more neuromodulators (col. 9, lines 15-59; Abstract).
As to claim 4, Larson et al. discloses at least one of the one or more sensors is a tilt sensor (flexion sensor, depicted as 144 in Figure 17; col. 5, lines 44-64), and wherein a swing linkage (hip joints, depicted as 34, 36 in Figures 1-2, 8 and 15) connects the leg brace to the gait trainer proximate to a knee of a compromised limb of the patient (Figures 1-3D, 7-8 and 17).
As to claim 5, Larson et al. discloses accessing a gait trainer having a frame (depicted as 58 and 60 in Figure 7; col. 5, lines 18-20), a leg brace (Figure 1-2), a sensor (feedback sensors, depicted as 30 and 32 in Figures 1-2 and 17) connected to the leg brace (Figures 1-2 and 17) and a neuromodulator (electrodes, depicted as 172, 174 and 176 in Figures 13-14) connected to the leg brace, wherein a compromised limb of a patient is received in the leg brace (see claim 1 in cols. 9-10; col. 9, lines 52-59); sensing movement and position in space of the compromised limb of the patient via the sensor (Figures 4-5); generating and analyzing limb data (col. 7, lines 10-31); and causing a neuromodulator to activate based at least in part upon the analysis of the limb data, wherein the activation of the neuromodulator is timed to assist gait motion of the compromised limb (col. 9, lines 15-59; Abstract).
As to claim 6, Larson et al. discloses causing an electrical impulse to stimulate a muscle of the compromised limb (col. 9, lines 15-59; Abstract).
As to claim 7, Larson et al. discloses a leg brace (Figure 1-2), at least one sensor (feedback sensors, depicted as 30 and 32 in Figures 1-2 and 17) connected to the leg brace (Figures 1-2 and 17) and a neuromodulator (electrodes, depicted as 172, 174 and 176 in Figures 13-14) connected to the leg brace, wherein a user's limb is received in the leg brace(see claim 1 in cols. 9-10; col. 9, lines 52-59); detecting a position of at least part of the leg brace in space via the sensor ((“computer monitors the flexion angles for both knees, as provided by feedback sensors which may be simple potentiometers positioned at knee joints 30. 32 Alternatively, the flexion angle sensors may be strain gauge devices as hereinafter described with reference to FIG. 17. Stimulated extension of both knees proceeds under full closed loop control until the feedback sensors indicate that the knees are near a locked position”(col. 5, lines 44-64); Therefore the sensors detect a position of the leg brace in [a] space as it relates to a person’s posture); and processing position data from the sensor (col. 5, lines 44-64), and responsively transmitting a signal to the neuromodulator that causes the neuromodulator to deliver an electrical impulse to a portion of the user's limb (col. 9, lines 15-59; Abstract).
As to claim 8, Larson et al. discloses a controller (microprocessor; e.g., col. 7, lines 10-31) that is operatively coupled to the sensor and the neuromodulator, wherein the controller carries out the processing and transmitting step (col. 5, lines 44-64), and wherein the delivery of the electrical impulse is timed to assist gait motion of the user's limb (e.g., col. 9, lines 15-59; also see Abstract).
As to claim 18, Larson et al. discloses including an unweighting mechanism (medical walker, depicted as 58 and 60 in Figure 7; col. 5, lines 18-20), directly or indirectly connected to the leg brace (Figures 3B-3C; Since control buttons to the leg brace system are located on the medical walker (depicted as 58,60 in Figure 7), the medical walker is directly or indirectly connected to leg brace), wherein the unweighting mechanism is configured to relieve the user of at least a portion of a user's weight (col. 2, lines 22-36).
As to claim 19, Larson et al. discloses the sensor is at least one of a spatial sensor, or a pressure sensor, or a tilt sensor (col. 5, lines 44-64).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al. (US 4,697,808) in view of Dixon et al. (US Patent Publication 2016/0310731 A1). Larson et al. discloses a gait training device which determining when the foot strikes the ground (e.g., col. 6, lines 47-65) and employs sensors but does not explicitly disclose utilizing a pressure sensor to detect pressure at the bottom of the user’s foot. Dixon et al. discloses a gait training device that incorporates a “pressure sensor may, for example, measure pressure applied by a body part (e.g., a foot) on a surface (e.g., the ground)”(e.g., paragraph 19). It would have been obvious to include a pressure sensor as disclosed by Dixon et al. into the system of Larson et al. in order to provide the predictable results of confirming the foot strikes the surface prior to administering treatment.
Claims 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al. (US 4,697,808) in view of Popovic et al. (US 2010/0170546 A1).
As to claim 9, Larson et al. discloses the invention substantially as claimed with the leg brace is connected to a frame (Figures 3S-3C) but does not explicitly disclose the frame having a plurality of wheels to enable the frame to roll across a surface. Popovic et al. discloses a frame having wheels (Figures 5-6) and that “Standard walkers: a standard walker may include wheels and glide-type brakes. A wheeled walker is one with 2, 3 or 4 wheels. The wheels may be fixed or swivel. It may be fixed height or adjustable height”([0005]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the frame or walker of Larson et al. to be modified by a standard wheeled walker as disclosed by Popovic et al. in order to provide the predictable results of optimizing the treatment device to meet specific patient therapeutic needs and requirements.
As to claim 10, the modified Larson et al. discloses the leg brace is removably connected to the frame (Lason et al., Figures 3A-3D), wherein the frame is adjustable to adjust a height of the frame (Popovic et al., [0005]), wherein the leg brace is configured to receive a thigh and a calf of a user's limb therein, wherein the leg brace includes a knee joint, and wherein the leg brace is not configured to receive part of the user's torso therein (Lason et al., Figures 1-2).
As to claim 11, the modified Larson et al. discloses a swing linkage (hip joints, depicted as 34, 36 in Figures 1-2, 8 and 15) including a pair of arms that are pivotally connected together (Figures 1-2, 8 and 15), wherein the swing linkage is connected to the leg brace at one end, and is connected to the frame at another end thereof (Larson et al., Figure 3B-3C).
As to claim 12, the modified Larson et al. discloses each arm is adjustable in effective length to enable the device to adjust to a length of stride of the user (Larson et al., Figures 1-2, 7-8 and 15).
As to claim 13, the modified Larson et al. discloses the swing linkage includes a hard stop that limits rearward rotation of at least one of the arms, and wherein the swing linkage prevents or limits lateral motion of the leg brace (Larson et al., col. 4, line 63 - col. 5, line 10).
As to claim 14, the modified Larson et al. discloses the swing linkage swing linkage (hip joints, depicted as 34, 36 in Figures 1-2, 8 and 15) is connected to a yoke (pelvic band, depicted as 48 in Figure 1) which is in turn connected to the leg brace (Larson et al., Figures 1-2 and 7-8).
As to claim 15, the modified Larson et al. discloses the gait system connector is adjustable to adjust a height thereof relative to the frame (Popovic et al., [0005]).
As to claim 16, the modified Larson et al. discloses the swing linkage within the brace that enables forward motion in the user to stimulate gait (Larson et al., col. 4, lines 5-19). Thus, the modified Larson et al. limits abduction and adduction of the leg brace.
As to claim 17, the modified Larson et al. discloses the swing linkage is attached to the leg brace at a location between a knee and a thigh of the brace (Larson et al., Figures 1-3D, 7-8 and 17).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached on (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3792
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