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, 6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 of U.S. Patent No. 12,102,838 B2, and claims 1 and 7 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 16 of U.S. Patent No. 11,497,924 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because every feature and elements of the claims in the instant application is recited in claims of the patents. Since the word “comparing” in claims of the instant application does not limit further limitations of the claims of the patents, the claims of the instant application would be obvious in view of the claims of the patents.
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.
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 1, 5, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,004,915 B2 to Saitoh et al (hereinafter ‘Saitoh’) in view of US 8,150,498 B2 to Gielen et al (hereinafter ‘Gielen’).
Regarding claim 1, Saitoh discloses a system for performing transcutaneous magnetic stimulation to treat a subject (column 3, lines 30-32, wherein a compact and economical transcranial magnetic stimulation system that can be operated easily by the patient), the system comprising: a treatment system (Fig. 1 and 3, the control unit 6) the magnetic stimulation system 1a) comprising: a stimulator (Fig. 1, controlling communication with the at least one second processor and configured to generate electric pulses (column 5, lines 1-11, wherein the magnetic stimulation control unit 6, which is designed to control an application of electric current pulses to the stimulation coil 2); and a headpiece (Fig. 3, headpiece 1a) configured to engage a head of the first subject, the headpiece comprising: a magnetic coil in communication with the stimulator and configured to deliver magnetic stimulation to the first subject, the magnetic coil being mounted to a body of the headpiece at a fixed location by a secure locking means (column 4, lines 27-32 and Figs, 1 and 3, wherein as shown in FIG. 1, the transcranial magnetic stimulation system (hereinafter referred to as “magnetic stimulation system”, generally indicated at 1, includes a stimulation coil (magnetic field generating means) 2 and a magnetic stimulation control unit 6, as the processor, electrically connected to the stimulation coil 2 through a cable 4); and an image recording device in communication with the at least one second processor and configured to capture images of the first subject and the headpiece (column 5, line 54 through column 6, line 4, wherein the distal ends 147a and another (not shown) of the arm members 126a and 126b support ultracompact cameras 150a and another (not shown), respectively, with their optical axes directed substantially parallel to the upper and lower surfaces of the coil holder 10a. The optimum coil position is determined for the patient by using a coil holder which is the same as the coil holder 10a in the original diagnosis at the hospital and the cameras 150a and other are positioned to oppose the patient's left and right tragi 24 upon placement of the coil at the optimum coil position. The cameras 150a and other are connected through a communication cable 149 to a display 52 so that image signals are transmitted from the cameras 150a and other into the display where the captured images are shown on the display 52); wherein the at least one second processor is configured to access the at least one second memory and execute the computer-executable instructions (Column 9, lines 52-55, wherein the image sensor automatically recognizes the marking as it moves along the head surface of patient M and thereby positions the coil 2 of the coil holder 10d at the optimum coil position, inherently as instructions) to: receive first stimulation parameter data, the first stimulation parameter data comprising a predetermined position of the headpiece relative to a target anatomy of the first subject (column 4, lines 40-46, wherein he holder fixture 11 includes a standing pole 11a and a base 11b. A part of the standing pole 11a, adjacent the distal end of the holder fixture 11, is made of a metallic flexible tube 11c, allowing the coil 2 to be positioned in an optimal way simply by holding and moving the coil holder 10 onto a predetermined position, inherently as the stimulating position parameter, on of the scalp of the patient M), wherein the fixed location of the magnetic coil corresponds to the predetermined position of the headpiece relative to the target anatomy of the first subject (column 9, lines 49-54, wherein FIG. 3 shows a coil holder 10a which is configured to be capable of being positioned to the patient's tragi 24. As shown, the coil holder 10a has a pair of arm members 126a and 126b made of metal rod and supported at opposite ends thereof on the longitudinal axis extending in parallel to a line connecting the centers of the coils, inherently as coil being in fixed position with respect to rods of the headgear 1a); receive the first image data, the first image data corresponding to one or more first images of at least a portion of the first subject and at least a portion of the headpiece; receive second image data from the image recording device, the second image data corresponding to one or more second images of at least a portion of the first subject and at least a portion of the headpiece (column 5, line 62 through column 6, line 4, wherein the optimum coil position is determined for the patient by using a coil holder which is the same as the coil holder 10a in the original diagnosis at the hospital and the cameras 150a and other are positioned to oppose the patient's left and right tragi 24 upon placement of the coil at the optimum coil position. The cameras 150a and other are connected through a communication cable 149 to a display 52 so that image signals, as the first and second image data by each camera, are transmitted from the cameras 150a and other into the display where the captured images are shown on the display 52); determine, based at least in part on the first image data and the second image data, that the headpiece is at the predetermined position relative to the target anatomy of the first subject (column 5, lines 57-67, wherein the distal ends 147a and another (not shown) of the arm members 126a and 126b support ultracompact cameras 150a and another (not shown), respectively, with their optical axes directed substantially parallel to the upper and lower surfaces of the coil holder 10a. The optimum coil position is determined for the patient by using a coil holder which is the same as the coil holder 10a in the original diagnosis at the hospital and the cameras 150a and other are positioned to oppose the patient's left and right tragi 24 upon placement of the coil at the optimum coil position); and enable operation of the stimulator or the magnetic coil based at least in part on the determination that the headpiece is at the predetermined position relative to the target anatomy of the first subject (column 5, lines 4-16, wherein this allows that the coil holder 10 to be moved smoothly on the head surface 20 of the patient M. . . the magnetic stimulation control unit 6, which is designed to control an application of electric current pulses to the stimulation coil 2, may use any one of conventional units. The control unit 6 is operated by an operator. In the operation, the operator can control various settings such as magnitude and/or waveform of the current pulses determining the intensity of magnetic stimulation and/or the stimulation cycle or interval). Saito does not specifically disclose a prescription system having the first processor. Gielen discloses a prescription system having a first processor with stimulation parameters (column 17, lines 37-44, wherein the navigation processor 224, as the second processor, can include a planning processor, as discussed herein, or a separate planning processor system 226, as the prescription system with first processor, can be included. The planning processor system 226 can also include a display 228 and a user input 230. It will also be understood that the image data is not necessarily first retained in the controller 218, but may be directly transmitted to the workstation 229 or the planning processor system 226), and a prescription system comprising: at least one first memory, the first memory storing first stimulation parameter data and first image data, wherein the first stimulation parameter data and first image data are associated with a first subject; and at least one first processor; (column 15, lines 47-53, wherein the image data, the instructions, and other appropriate portions can be stored on any appropriate memory structure 91 or mechanism such as a hard disk, flash memory, system RAM, or removable storage media. The memory structure can be associated with the planning processor 226, the work station 244, or any appropriate portion). Saitoh and Gielen are combinable because they both disclose brain stimulation. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one oridunary skill in the art to combine the a prescription system having a first processor of Gielen’s system with Saitoh’s so that a user can use the guided procedure 18 to assist in identifying anatomical landmarks, determining an appropriate location of various anatomical targets (column 9, lines 39-43).
Regarding claim 5, in the combination of Saitoh and Gielen, Saitoh discloses wherein the treatment system further comprises a first indicator in communication with the at least one second processor, and wherein the at least one second processor is further configured to access the at least one second memory and execute the second computer-executable instructions to: cause activation of the first indicator based at least in part on the determination that the headpiece is at the predetermined position relative to the target anatomy of the first subject (column 6, line 63 through column 7, line 6, wherein for example, as shown in FIGS. 5A and 5B, if the coil holder 10b is moved away from or toward the optimum coil position, the laser spot 161, as the indicator, from the laser beam oscillators 160a and other take a position lower or higher than the corresponding tragi 24. Then, the patient or the helper moves the coil holder 10b toward or away from the head surface 20 of the patient M so that the laser spots 161 of the laser beam oscillators 160a and other align with the corresponding tragi 24 (See FIG. 5C) while viewing the images on the display 52 captured by the cameras 150a and other).
Regarding claim 13, in the combination of Saitoh and Gielen, Saitoh discloses wherein the treatment system further comprises a user interface configured to control magnetic stimulation provided by the treatment system (column 5, lines 13-15, wherein the operator can control various settings such as magnitude and/or waveform of the current pulses determining the intensity of magnetic stimulation and/or the stimulation cycle or interval).
Regarding claim 16, please refer to corresponding system claim 1 above for further teachings.
Claims 2-4, 10, 11, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Saitoh in view of Gielen and further in view of US 2017/0128737 A1 to Yasumuro et al (hereinafter ‘Yasumuro’).
Regarding claims 2 and 17, Saitoh and Gielen do not specifically disclose determine, based at least in part on one or more object and facial recognition algorithms, that the headpiece is at the predetermined position relative to the target anatomy of the first subject; and enable operation of the stimulator or the magnetic coil based at least in part on the determination that the headpiece is at the predetermined position relative to the target anatomy of the first subject. Yasumuro discloses determine, based at least in part on one or more object and facial recognition algorithms, that the headpiece is at the predetermined position relative to the target anatomy of the first subject; and enable operation of the stimulator or the magnetic coil based at least in part on the determination that the headpiece is at the predetermined position relative to the target anatomy of the first subject (Para [0058], wherein the face shape of the subject 2 is measured with the TOF camera 40 in the state where the subject 2 puts on the helmet 50, which allows the relative relationship between the TOF camera 40 and the face of the subject 2 to be estimated in the position and direction from the measured face shape. The relative relationship in the position and direction represents the mounting posture of the helmet 50 on the subject 2. As described above, the magnetic stimulation coil 30 is fixed to the specific position of the helmet 50, and the relative relationship between the magnetic stimulation coil 30 and the TOF camera 40 is kept constant in the position and direction. Therefore, in the helmet 50, the mounting posture in which the positions and directions of the TOF camera 40 and the face of the subject 2 are obtained when the magnetic stimulation coil 30 stimulates). Saitoh, Gielen and Yasumuro are combinable because they all disclose brain stimulation. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one ordinary skill in the art to combine the determine, based at least in part on one or more object and facial recognition algorithms, that the headpiece is at the predetermined position relative to the target anatomy of the first subject of Yasumuro’s system with Saitoh’s and Gielen’s so that to enhance the accuracy of the deviation calculation (Para [0028]).
Regarding claims 3 and 18, in the combination of Saitoh, Gielen and Yasumuro, Yasumuro discloses determine wherein the one or more object and facial recognition algorithms: determine a position of the headpiece relative to one or more facial features of the first subject using the first image data (Para [0058], wherein the face shape of the subject 2 is measured with the TOF camera 40 in the state where the subject 2 puts on the helmet 50, which allows the relative relationship between the TOF camera 40 and the face of the subject 2 to be estimated in the position and direction from the measured face shape.); and determine the predetermined position of the headpiece relative to the target anatomy of the first subject using the position of the headpiece relative to one or more facial features of the first subject (Para [0064], wherein positioning data based on previously-acquired face shape data in the “correct posture” is readably stored in the teaching information generator 23. The positioning data is described later. The face shape data in the “correct posture” and the positioning data based on the face shape data may be readably stored in a memory device, which is provided in the teaching information controller 23 or outside the device body unit 20).
Regarding claim 4, in the combination of Saitoh, Gielen and Yasumuro, Yasumuro discloses wherein the one or more object and facial recognition algorithms: determine a position of the headpiece relative to one or more facial features of the first subject using the second image data; and compare the position of the headpiece relative to one or more facial features of the first subject using the second image data to the position of the headpiece relative to one or more facial features of the first subject using the first image data (Para [0065], wherein The face shape data in the “current posture” is input to the teaching information generator 23 from the TOF camera 40, and the positioning data is acquired based on the face shape data in the “current posture”. The teaching information generator 23 performs the positioning of the positioning data in the “current posture” with respect to the positioning data in the “correct posture” to calculate the distance between the “correct posture” and the “current posture”.).
Regarding claims 10 and 19, Saitoh and Gielen do not specifically disclose wherein the headpiece comprises one or more headpiece identifiers, the headpiece identifiers comprising at least one of: (i) a barcode, (ii) a radio frequency identification tag, and (iii) a structural pattern, wherein the one or more first images and the one or more second images each comprise at least one headpiece identifier. Yasumuro discloses the headpiece comprises one or more headpiece identifiers, the headpiece identifiers comprising a pattern (para [0123], wherein as illustrated in FIG. 15, polaris markers 68 and 69, as the patterns, are adhered to the subject 2 and the helmet 50, and the guidance accuracy was checked from the relative relationship between the two markers 68 and 69 in the position and direction.). Saitoh, Gielen and Yasumuro are combinable because they all disclose brain stimulation. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one ordinary skill in the art to combine the headpiece comprises one or more headpiece identifiers, the headpiece identifiers comprising a pattern of Yasumuro’s system with Saitoh’s and Gielen’s so that to enhance and the guidance accuracy (Para [0123]).
Regarding claim 11, in the combination of Saitoh, Gielen and Yasumuro, Yasumuro discloses wherein one or more object and facial recognition algorithms: determine that the headpiece is at the predetermined position relative to the target anatomy of the first subject or determine the identity of the first subject based at least in part on the one or more headpiece identifiers (para [0123], wherein as illustrated in FIG. 15, polaris markers 68 and 69 are adhered to the subject 2, on the face, and the helmet 50, and the guidance accuracy was checked from the relative relationship between the two markers 68 and 69 in the position and direction.)
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Saitoh in view of Gielen and further in view of US 2019/0105517 A1 to Tyler.
Regarding claim 15, Saitoh and Gielen do not specifically disclose wherein the system further comprises a remote user device in communication with the treatment system and a data server via a network, wherein the remote user device is configured to remotely monitor use of the treatment system and control the magnetic stimulation provided by the stimulator. Tyler discloses the remote user device is configured to remotely monitor use of the treatment system and control the magnetic stimulation provided by the stimulator (para [0058], wherein the controller may be within the helmet portion, or located at a separate site on the subject's body, or may be located at a separate site on or within the subject's body, such surgically implanted controllers, or carried in a pack or pocket, or may be remote and not attached, to the subject's body. A controller may be built into a transducer. A controller may provide drive voltages and pulse patterns to one or more transducers, or may receive information from a remote or local component and using that information, drive one or more transducers). Saitoh, Gielen and Tyler are combinable because they all disclose brain stimulation. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one ordinary skill in the art to combine the remote user device is configured to remotely monitor use of the treatment system of Tyler’s system with Saitoh’s and Gielen’s so that to monitor and control the system remotely when needed (Para [0006]).
Allowable Subject Matter
Claims 6-9, 12, 14 and 20 are 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 a statement of reasons for the indication of allowable subject matter: the prior art or the prior art of record specifically, Saitoh, Gielen and Yasumuro, does not disclose:
. . . . cause activation of the second indicator based at least in part on the determination that the headpiece is not at the predetermined position, the second indicator indicating a desired direction of movement of the headpiece relative to the head of the first subject toward the predetermined position relative to the target anatomy of the first subject, of claims 6, 7 and 20 combined with other features and elements of the claims;
Claim 8 depend from an allowable base claim and is thus itself allowable;
. . . . determine, based at least in part on one or more object and facial recognition algorithms, the identity of the first subject by comparing the second image data to the first image data; and enable operation of the stimulator or the magnetic coil based at least in part on the determination of the identity of the first subject, of claim 9 combined with other features and elements of the claim;
. . . . wherein the treatment system further comprises a mirror configured to reflect light, and wherein the one or more second images comprises the at least a portion of the first subject and the at least a portion of the headpiece reflected by the mirror, of claim 12 combined with other features and elements of the claim;
. . . . wherein the treatment system further comprises an audio recording device configured to capture verbal commands by the first subject, wherein the at least one second processor is configured to access the at least one second memory and execute the computer-executable instructions to: control the magnetic stimulation provided by the stimulator in response to the verbal commands, of claim 14 combined with other features and elements of the claim.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHERVIN K NAKHJAVAN whose telephone number is (571)272-5731. The examiner can normally be reached Monday-Friday 9:00-12:00 PST.
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/SHERVIN K NAKHJAVAN/Primary Examiner, Art Unit 2672
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