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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 26 February 2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed 23 January 2026 and the IDS filed on 26 February 2026 that necessitated reopening of prosecution. As directed by the amendment claims 4, 24 and 25 have been amended. Claims 1-30 are presently pending in this application.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of many of the prior-filed applications (see filing receipt mailed on 08/07/2024) fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, all many of the prior-filed applications fail to provide adequate written description support for:
an applicator comprising a casing; a device for directing a fluid cooling media into the casing; an upper side; a handle; a lower side; and an inlet as required by claim 1;
an applicator comprising casing; gap; inlet; outlet; device for directing air into the casing as required by claim 9;
an applicator comprising a casing having an upper side and lower side; an outlet configured to direct air away from the lower side; and a device for directing air into the casing such that the air removes heat from the magnetic field generating coil as required by claim 16.
Therefore, the effective filing date of claims 1-23 is 12 January 2017, which corresponds to prior filed application no. 15/404,384.
Additionally, the disclosure of all the prior-filed applications (see filing receipt mailed on 08/07/2024) fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, all the prior-filed applications fail to provide adequate written description support for “applying at least the motor-threshold magnetic flux density to a prefrontal cortex of the patient” as required by claim 24. Therefore, the effective filing date of claims 24-30 is 24 July 2024.
Claim Objections
Claims 9, 11 and 25 are objected to because of the following informalities:
claim 9, line 8 “an outlet distant from the inlet” should be amended along the lines of --an outlet separated by a distance from the inlet--;
claim 11, line 2 “tube configured” should be amended to recite --tube is configured--;
claim 25, line 2 it appears “impulses into a trapezoidal” should be amended to recite --impulses of the time-varying magnetic field into a trapezoidal--.
Appropriate correction is required.
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, 3-5, 9, 11-13 and 15-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4, 7 and 27 of copending Application No. 19/023,044. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application clearly anticipates the claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 10-11 and 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “an inlet proximate to a connecting tube, wherein the connecting tube is configured to be coupled to the applicator” renders the claim indefinite because it is unclear whether the connecting tube is part of the claimed treatment device or merely an external/environmental structure. The claim does not positively recite a connecting tube as a component of the treatment device.
Regarding claim 2, the limitation “are between wires is eliminated” renders the claim indefinite because it is unclear the degree of elimination. The claim suggests complete removal of air without specifying an objective standard such that one of ordinary skill in the art would be reasonably apprised the metes and bounds of the claim.
Regarding claim 4, the limitation “the fluid cooling media is directed between the patient and the magnetic field generating coil” renders the claim indefinite because the patient is not part of the claimed device, therefore it is unclear whether the claim requires a structural airflow passage in the applicator or actual airflow through a space between the patient and the coil. It appears the claim should be amended along the lines of --the fluid cooling media is directed between the lower side and the magnetic field generating coil--.
Regarding claim 4, 10 and 20, the limitation “coil is flat” renders the claim indefinite because it is unclear if the coil being flat is referring the wire forming the coil (i.e., flat ribbon wire), the shape of the coil when formed (i.e., planar surface shape of the coil), or if the limitation is referring to the plane of coil with respect to the casing.
Claims 3, 5-8, 11 and 21-23 are rejected due to their dependency on a rejected claim.
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 1, 3-5, 9, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al. (US 2016/0015995 A1) (Leung) in view of Jacobs (US Patent No. 3,251,085).
Referring to claim 1: Leung teaches a treatment device (see figure 1) for treatment of a patient (see paragraph [0028], [0030], [0033] and [0044]), the treatment device comprising: an applicator (see figure 1, #102; paragraph [0032]-[0038]) comprising: a casing (see figure 2, #112); a magnetic field generating coil (see figure 3, #120) enclosed by the casing; and a device for directing a fluid cooling media into the casing, wherein the fluid cooling media removes heat from the magnetic field generating coil (see paragraph [0047]); an upper side (see figure 3B, #112A) configured to be placed away from the patient (see figure1); a handle (see figure 2, #114) coupled to the casing, wherein the handle and the casing form an opening (see paragraph [0047]; wherein it is clear that the handle and the casing form an opening for allowing forced-air from the blower through the casing); a lower side (see figure 3B, #112B) fully capable of being placed on the patient; an inlet (see paragraph [0047]; wherein the device includes a forced-air cooling system and wherein it is clear the device includes an air inlet for taking air into the forced-air cooling system); a connecting tube (see figure 1, wherein a connecting tube couples the applicator, #102, to the control module, #104), wherein the connecting tube is configured to be coupled to the applicator (see figure 1); and a switching device (see figure 6; reproduced below from US 2016/0015995 corresponding patent no. US 10,369,373 for readability) configured to be switched to discharge a capacitor (see figure 6; paragraph [0047]) to the magnetic field generating coil to generate an impulse of a time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla and with a repetition rate in a range of 1 Hz to 300 Hz (see paragraph [0028], [0033] and [0044]), and wherein the time-varying magnetic field is fully capable of being applied to a brain of the patient (see paragraphs [0010] and [0012]-[0015]). Leung does not explicitly teach the inlet being proximate to the connecting tube.
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Jacobs, which is reasonably pertinent to the cooling problem faced by applicant, teaches a device comprising an inlet (see figure 2, #32) configured to enable flow of the fluid into the device (see column 3, lines 19-38); an outlet (see figure 2, #34/35/36) configured to enable the fluid to be removed unimpeded from the applicator (see column 3, lines 19-38); a handle (see figure 2, #12) configured to be used to position the device; a connecting tube configured to be connected to the device (see figure 2; wherein a connecting tube is positioned proximate the inlet, #32), wherein the handle is positioned less proximate to the connecting tube than to the inlet and the outlet is positioned less proximate to the connecting tube than the handle (see figure 2; column 3, lines 19-38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify arrangement of the device of Leung with handle, inlet, outlet and connecting tube arrangement like taught by Jacobs since arranging the position the of the inlet and outlet would be an obvious matter of design choice that would not modify the operation of the device and would aid in cooling of the entire device including the handle while maintaining cooling of the coils (see MPEP 2144.04(VI) and Jacobs column 3, lines 19-38).
Referring to claim 3: Leung, as modified by Jacobs as applied to claim 1 above, teaches the applicator further comprises an outlet less proximate to the connecting tube than the inlet (see Jacobs figure 2). Leung, as modified by Jacobs as applied to claim 1 above, does not explicitly teach the device for directing the fluid cooling media is within the casing, however, Jacobs further teaches a device (see figure 2, #38) for directing the fluid cooling media is within a casing (see figure 2, #16) of the applicator. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the blower of Leung, as modified by Jacobs, within the casing of the applicator like further taught by Jacobs in order to yield predictable results in pulling the cooling air into the casing through the inlets for forcing the air over the coil (see Jacobs column 3, lines 19-38).
Referring to claim 4: Leung further teaches the magnetic field generating coil is flat (see figure 3A), and wherein the fluid cooling media flows in a direction parallel to the magnetic field generating coil such that the fluid cooling media is directed between the patient and the magnetic field generating coil (see figures 1 and 3A; wherein with the first magnetic field generating device, #120A, tilted a gap is formed between the lower portion of the casing and at least a portion of the first field generating device that would be fully capable of allowing fluid flow parallel along the lower side of the magnetic field generating coil).
Referring to claim 5: Leung further teaches the applicator comprises an input element (see figures 1 and 4, #104) fully capable of adjusting the magnetic flux density (see paragraphs [0043]-[0045]).
Referring to claim 9: Leung teaches a treatment device (see figure 1) for treatment of a patient (see paragraph [0028], [0030], [0033] and [0044]) comprising: an applicator (see figure 1, #102; paragraph [0032]-[0038]) comprising: a casing (see figure 2, #112); a magnetic field generating coil (see figure 3, #120) within the casing, wherein the magnetic field generating coil is spaced apart from the casing by a gap (see figure 3A; wherein with the first magnetic field generating device, #120A, tilted a gap is formed between the lower portion of the casing and at least a portion of the first field generating device); an inlet (see paragraph [0047]; wherein the device includes a forced-air cooling system and wherein it is clear the device includes an air inlet for taking air into the forced-air cooling system); a device (see paragraph [0047]) for directing air into the casing such that the air flows from the inlet in a direction parallel to the magnetic field generating coil to remove heat from the magnetic field generating coil (see figures 1 and 3A; wherein with the first magnetic field generating device, #120A, tilted a gap is formed between the lower portion of the casing and at least a portion of the first field generating device that would be fully capable of allowing fluid flow parallel along the lower side of the magnetic field generating coil), wherein the device for directing the air is within the applicator (see paragraph [0047]; wherein it is clear the blower is located within the applicator for providing forced-air over the coils); and a switching device (see figure 6; reproduced above from US 2016/0015995 corresponding patent no. US 10,369,373 for readability) configured to be switched to discharge a capacitor (see figure 6; paragraph [0047]) to the magnetic field generating coil to generate an impulse of a time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla and with a repetition rate in a range of 1 Hz to 300 Hz (see paragraph [0028], [0033] and [0044]), wherein the time-varying magnetic field is fully capable of being applied to a brain of the patient (see paragraphs [0010] and [0012]-[0015]). Leung does not explicitly teach an outlet distant from the inlet.
Jacobs, which is reasonably pertinent to the cooling problem faced by applicant, teaches a device comprising an inlet (see figure 2, #32) configured to enable flow of the fluid into the device (see column 3, lines 19-38); an outlet (see figure 2, #34/35/36) configured to enable the fluid to be removed unimpeded from the applicator (see column 3, lines 19-38); a handle (see figure 2, #12) configured to be used to position the device; a connecting tube configured to be connected to the device (see figure 2; wherein a connecting tube is positioned proximate the inlet, #32), wherein the handle is positioned less proximate to the connecting tube than to the inlet and the outlet is positioned less proximate to the connecting tube than the handle (see figure 2; column 3, lines 19-38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify arrangement of the device of Leung with handle, inlet, outlet and connecting tube arrangement like taught by Jacobs since arranging the position the of the inlet and outlet would be an obvious matter of design choice that would not modify the operation of the device and would aid in cooling of the entire device including the handle while maintaining cooling of the coils (see MPEP 2144.04(VI) and Jacobs column 3, lines 19-38).
Referring to claim 13: Leung further teaches the applicator is hand-held (see paragraph [0034]), and wherein the applicator comprises an input element (see figures 1 and 4, #104) fully capable of adjusting the magnetic flux density (see paragraphs [0043]-[0045]).
Referring to claim 15: Leung further teaches the applicator comprises an upper side (see figure 3B, #112A) and a lower side (see figure 3B, #112B) opposite the upper side, wherein the lower side is configured to be closer to the patient than the upper side (see figure 1), and wherein the lower side comprises a concavity configured to contact the patient (see figures 3A-B).
Claims 2 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Jacobs, further in view of Riehl (US 2005/0261542 A1).
Referring to claim 2: With regards to claim 1 above, Leung, as modified by Jacobs, is silent to the magnetic field generating coil comprises a litz-wire, and wherein the magnetic field generating coil is impregnated such that air between wires is eliminated. Riehl teaches an applicator for providing electromagnetic therapy (see abstract), the applicator comprising a magnetic field generating device fabricated by spooling a ribbon litz-wire (see paragraph [0065]) coated with an insulator and epoxy dipped, coated or impregnated (see paragraph [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing date to construct the magnetic field generating device of Leung, as modified by Jacobs, impregnated litz-wire coil like taught by Riehl in order to make the coil more efficient (see Riehl [0065]) and mechanically bond the windings of the magnetic field generating device into place (see Riehl paragraph [0067]).
Referring to claim 10: With regards to claim 9 above, Leung further teaches the air being fully capable of flowing over an upper side and a lower side of the magnetic field generating coil (see figure 3A). Leung, as modified by Jacobs is silent to the magnetic field generating coil is flat and impregnated. Riehl teaches an applicator for providing electromagnetic therapy (see abstract), the applicator comprising a magnetic field generating device fabricated by spooling a ribbon litz-wire ribbon (see paragraph [0065]) coated with an insulator and epoxy dipped, coated or impregnated (see paragraph [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing date to construct the magnetic field generating device of Leung, as modified by Jacobs, impregnated litz-wire coil like taught by Riehl in order to make the coil more efficient (see Riehl [0065]) and mechanically bond the windings of the magnetic field generating device into place (see Riehl paragraph [0067]).
Referring to claim 11: Leung, as modified by Jacobs, further teaches a connecting tube (see Leung figure 1, wherein a connecting tube couples the applicator, #102, to the control module, #104) configured to be coupled to the applicator; wherein the applicator comprises a first side and a second side opposite the first side, wherein the first side is proximate to the connecting tube (see Leung figure 1) and wherein the first side comprises the inlet (see Jacobs figure 2), and wherein the second side is less proximate to the connecting tube than the first side and wherein the second side comprises the outlet (see Jacobs figure 2).
Referring to claim 12: With regards to claim 9 above, Leung, as modified by Jacobs as applied to claim 1 above, does not explicitly teach the device for directing the air into the casing is enclosed by casing, however, Jacobs further teaches a device (see figure 2, #38) for directing the fluid cooling media is within a casing (see figure 2, #16) of the applicator. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the blower of Leung, as modified by Jacobs, within the casing of the applicator like further taught by Jacobs in order to yield predictable results in pulling the cooling air into the casing through the inlets for forcing the air over the coil (see Jacobs column 3, lines 19-38). Additionally, Leung, as modified by Jacobs, is silent to the magnetic field generating coil comprises a litz-wire. Riehl teaches an applicator for providing electromagnetic therapy (see abstract), the applicator comprising a magnetic field generating device fabricated by spooling a ribbon litz-wire ribbon (see paragraph [0065]) coated with an insulator and epoxy dipped, coated or impregnated (see paragraph [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing date to construct the magnetic field generating device of Leung, as modified by Jacobs, litz-wire coil like taught by Riehl in order to make the coil more efficient (see Riehl [0065]).
Claims 16 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Aho (US 2008/0058581 A1) in view of Jacobs in view of Riehl.
Referring to claim 16: Leung teaches a treatment device (see figure 1) for treatment of a patient (see paragraph [0028], [0030], [0033] and [0044])comprising: an applicator (see figure 1, #102; paragraph [0032]-[0038]) comprising: a casing (see figure 2, #112) comprising an upper side (see figure 3B, #112A) and a lower side (see figure 3B, #112B); a handle (see figure 2, #114) coupled to the casing; and a magnetic field generating coil (see figure 3, #120) enclosed by the casing, wherein the upper side is configured to be placed away from the patient, wherein the lower side is fully capable of being placed on the patient (see figure 1), a device for directing the air into the casing such that the air removes heat from the magnetic field generating coil (see paragraph [0047]); and a switching device (see figure 6; reproduced above from US 2016/0015995 corresponding patent no. US 10,369,373 for readability) configured to be switched to discharge a capacitor (see figure 6; paragraph [0047]) to the magnetic field generating coil to generate an impulse of a time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla and with a repetition rate in a range of 1 Hz to 300 Hz (see paragraph [0028], [0033] and [0044]); wherein the time-varying magnetic field is configured to be applied to a brain of the patient (see paragraphs [0010] and [0012]-[0015]). Leung is silent to the magnetic field generating coil comprising a litz-wire; wherein the upper side comprises the handle and an outlet, wherein the outlet is in a plane between the lower side and the handle such that the outlet is configured to direct air away from the lower side.
Aho teaches an applicator for providing magnetic therapy (see figure 1, #10; paragraph [0031]), the applicator comprising: a casing (see figure 1, #14) comprising an upper side (see figure 1, #125; paragraph [0049]) and an a lower side (see figure 1, #122; paragraph [0049]), wherein the upper side comprises a handle (see figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the arrangement of the handle of Leung to an arrangement on the upper side of the casing like taught by Aho since rearranging the position the of handle would be an obvious matter of design choice that would not modify the operation of the device and would still aid in the positioning of the device with respect to the patient (see MPEP 2144.04(VI)). Leung, as modified by Aho, is silent to the magnetic field generating coil comprising a litz-wire; and an outlet, wherein the outlet is in a plane between the lower side and the handle such that the outlet is configured to direct air away from the lower side.
Jacobs, which is reasonably pertinent to the cooling problem faced by applicant, teaches a device comprising an inlet (see figure 2, #32) configured to enable flow of the fluid into the device (see column 3, lines 19-38); an outlet (see figure 2, #34/35/36) configured to enable the fluid to be removed unimpeded from the applicator (see column 3, lines 19-38); a handle (see figure 2, #12) configured to be used to position the device; a connecting tube configured to be connected to the device (see figure 2; wherein a connecting tube is positioned proximate the inlet, #32), wherein the handle is positioned less proximate to the connecting tube than to the inlet and the outlet is positioned less proximate to the connecting tube than the handle (see figure 2; column 3, lines 19-38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify arrangement of the device of Leung, as modified by Aho, with an inlet and outlet arrangement like taught by Jacobs since arranging the position the of the inlet and outlet would be an obvious matter of design choice that would not modify the operation of the device and would aid in cooling of the entire device including the handle while maintaining cooling of the coils (see MPEP 2144.04(VI) and Jacobs column 3, lines 19-38). The modification of Leung, as modified by Aho and Jacobs, teaches an arrangement of the inlet and outlet such that the outlet is in a plane between the lower side and the handle and the outlet is configured to direct air away from the lower side of the casing (see Aho figure 1; Jacobs figure 2). Leung, as modified by Aho and Jacobs, is silent to the magnetic field generating coil comprising a litz-wire.
Riehl teaches an applicator for providing electromagnetic therapy (see abstract), the applicator comprising a magnetic field generating device fabricated by spooling a ribbon litz-wire ribbon (see paragraph [0065]) coated with an insulator and epoxy dipped, coated or impregnated (see paragraph [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing date to construct the magnetic field generating device of Leung, as modified by Aho and Jacobs, litz-wire coil like taught by Riehl in order to make the coil more efficient (see Riehl [0065]).
Referring to claim 20: Leung further teaches the magnetic field generating coil is flat (see figure 3A).
Referring to claim 21: Leung, as modified by Aho, Jacobs and Riehl, further teaches the air being fully capable of being directed over an upper side and a lower side of the magnetic field generating coil (see Leung figure 3A).
Referring to claim 22: Leung further teaches the magnetic field generating coil is circular (see figures 3A and 3G), wherein the magnetic field generating coil has an inner radius and an outer radius (see figure 3G). Leung, as modified by Aho, Jacobs and Riehl, does not explicitly teach the inner radius is in a range of 3% to 80% of the outer radius. There is no evidence of record that establishes that changing relative dimensions of the inner radius to the outer radius would result in a difference in the functioning of the Leung device and it appears the device would function as intended being given the claimed relative dimensions. Further, a person having ordinary skill in the art, being faced with modifying the relative dimensions of the inner radius to the outer radius of Leung would have a reasonable expectation of success in making such a modification. Lastly, applicant has not disclosed that the claimed range provides an advantage, is done for a particular purpose, or solves a stated problem, indicating that the relative dimensions of the inner radius to the outer radius “may” or “preferably” be within the claimed range, and offering other acceptable ranges that may be used for achieving a convenient shape of the generated magnetic field (see specification as originally filed paragraph [0138]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the radius of curvature of Leung, as modified by Aho, Jacobs and Riehl, to an inner radius in a range of 3% to 80% of the outer radius as a matter of obvious design choice within the skill in the art.
Referring to claim 23: Leung further teaches the magnetic field generating coil comprises a winding area (see figures 3A and 3G). Leung, as modified by Aho, Jacobs and Riehl, does not explicitly teach the winding area being in a range of 15 cm2 to 975 cm2. There is no evidence of record that establishes that changing winding area would result in a difference in the functioning of the Leung device and it appears the device would function as intended being given the claimed dimension of the winding area. Further, a person having ordinary skill in the art, being faced with modifying the winding area of Leung would have a reasonable expectation of success in making such a modification. Lastly, applicant has not disclosed that the claimed range provides an advantage, is done for a particular purpose, or solves a stated problem, indicating that the winding area “may” or “preferably” be within the claimed range, and offering other acceptable ranges (see specification as originally filed paragraph [0140]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the winding area of Leung, as modified by Aho, Jacobs and Riehl, to a winding area in a range of 15 cm2 to 975 cm2 as a matter of obvious design choice within the skill in the art.
Claims 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz et al. (US 2017/0001026 A1) (Schwarz) in view Leung in view of Aho in view of Jacobs in view of Riehl.
Referring to claim 24: Schwarz teaches further teaches a method of applying a time-varying magnetic field to a brain of a patient (see paragraphs [0084] and [0098]) comprising: positioning an applicator proximate to the patient (see paragraph [0098]); generating an impulse of the time-varying magnetic field , wherein the time-varying magnetic field comprises a magnetic flux density in a range of 0.1 Tesla to 7 Tesla, and a repetition rate in a range of 1 Hz to 300 Hz (see paragraphs [0084]-[0085], [0088] and [0108]-[0111]); determining a motor-threshold magnetic flux density by incrementally increasing the magnetic flux density until a muscle contraction occurs (see figure 3a; paragraphs [0084]-[0085], [0088]-[0089] and [0108]-[0111]); and applying at least the motor-threshold magnetic flux density to a prefrontal cortex of the patient (see paragraph [0163]). Schwarz is silent the applicator comprises: a casing; a magnetic field generating coil enclosed by the casing and comprising a litz-wire; a handle on an upper side, wherein the upper side is opposite a lower side, wherein the lower side is configured to be positioned proximate to the patient and wherein the upper side is configured to be positioned less proximate to the patient than the lower side, a device configured to direct air; directing, via the device, the air into the casing; directing, via the device, the air to the magnetic field generating coil to remove heat generated by the magnetic field generating coil such that the air flows out of the applicator through an outlet away from the patient, wherein the outlet is between the patient and the handle; switching a switching device to discharge a capacitor to the magnetic field generating coil.
Leung further a device for applying a time-varying magnetic field to a patient (see paragraphs [0010], [0012]-[0015] and [0056]) comprising: positioning an applicator (see figure 1, #100; paragraphs [0030]-[0038]) proximate to the patient (see figure 1; paragraph [0056]), wherein the applicator comprises: a casing (see figure 2, #112); a magnetic field generating coil (see figure 3, #120) enclosed by the casing; a handle (see figure 2, #114; paragraph [0034]); an upper side (see figure 3B, #112A) opposite a lower side (see figure 3B, #112B), wherein the lower side is configured to be positioned proximate to the patient and wherein the upper side is configured to be positioned less proximate to the patient than the lower side (see figure 1), a device configured to direct air (see paragraph [0047]); directing, via the device, the air into the casing; directing, via the device, the air to the magnetic field generating coil to remove heat generated by the magnetic field generating coil (see paragraph [0047]); switching a switching device (see figure 6; reproduced above from US 2016/0015995 corresponding patent no. US 10,369,373 for readability) to discharge a capacitor (see figure 6; paragraph [0047]) to the magnetic field generating coil; generating an impulse of the time-varying magnetic field, wherein the time-varying magnetic field comprises a magnetic flux density in a range of 0.1 Tesla to 7 Tesla, and a repetition rate in a range of 1 Hz to 300 Hz (see paragraph [0028], [0030], [0033] and [0044]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a simple substitution of the applicator of Schwarz with the applicator of Leung since both devices are configured to generate the same time-varying magnetic field comprising a magnetic flux density in 0.1 Tesla to 7 Tesla, and a repetition rate in a range of 1 Hz to 300 Hz and therefore would yield predictable results in applying a time-varying magnetic field to a brain of the patient. Schwarz, as modified by Leung, is silent to the magnetic field generating coil specifically comprising a litz-wire; the handle being on an upper side; the air flows out of the applicator through an outlet away from the patient, wherein the outlet is between the patient and the handle.
Aho teaches an applicator for providing magnetic therapy (see figure 1, #10; paragraph [0031]), the applicator comprising: a casing (see figure 1, #14) comprising an upper side (see figure 1, #125; paragraph [0049]) and an a lower side (see figure 1, #122; paragraph [0049]), wherein the upper side comprises a handle (see figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the arrangement of the handle of Schwarz, as modified by Leung, to an arrangement on the upper side of the casing like taught by Aho since rearranging the position the of handle would be an obvious matter of design choice that would not modify the operation of the device and would still aid in the positioning of the device with respect to the patient (see MPEP 2144.04(VI)). Schwarz, as modified by Leung and Aho, is silent to the magnetic field generating coil comprising a litz-wire; and an outlet, wherein the outlet is in a plane between the lower side and the handle such that the outlet is configured to direct air away from the lower side.
Jacobs, which is reasonably pertinent to the cooling problem faced by applicant, teaches a device comprising an inlet (see figure 2, #32) configured to enable flow of the fluid into the device (see column 3, lines 19-38); an outlet (see figure 2, #34/35/36) configured to enable the fluid to be removed unimpeded from the applicator (see column 3, lines 19-38); a handle (see figure 2, #12) configured to be used to position the device; a connecting tube configured to be connected to the device (see figure 2; wherein a connecting tube is positioned proximate the inlet, #32), wherein the handle is positioned less proximate to the connecting tube than to the inlet and the outlet is positioned less proximate to the connecting tube than the handle (see figure 2; column 3, lines 19-38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify arrangement of the device of Schwarz, as modified by Leung and Aho, with an inlet and outlet arrangement like taught by Jacobs since arranging the position the of the inlet and outlet would be an obvious matter of design choice that would not modify the operation of the device and would aid in cooling of the entire device including the handle while maintaining cooling of the coils (see MPEP 2144.04(VI) and Jacobs column 3, lines 19-38). The modification of Schwarz, as modified by Leung, Aho and Jacobs, teaches an arrangement of the inlet and outlet such that the outlet is in a plane between the lower side and the handle and the outlet is configured to direct air away from the lower side of the casing (see Aho figure 1; Jacobs figure 2). Schwarz, as modified by Leung, Aho and Jacobs, is silent to the magnetic field generating coil comprising a litz-wire.
Riehl teaches an applicator for providing electromagnetic therapy (see abstract), the applicator comprising a magnetic field generating device fabricated by spooling a ribbon litz-wire ribbon (see paragraph [0065]) coated with an insulator and epoxy dipped, coated or impregnated (see paragraph [0067]). It would have been obvious to one of ordinary skill in the art before the effective filing date to construct the magnetic field generating device of Schwarz, as modified by Leung, Aho and Jacobs, litz-wire coil like taught by Riehl in order to make the coil more efficient (see Riehl [0065]).
Referring to claim 25: Schwarz, as modified by Leung, Aho, Jacobs and Riehl, teaches the time-varying magnetic field induces a current within the tissue (see Schwarz paragraphs [0088] and [0090]) but does not explicitly state the time-varying magnetic field has a maximal value of a magnetic flux density derivative in a range of 300 T/s to 800 kT/s. There is no evidence of record that establishes that changing maximal value of a magnetic flux density derivative would result in a difference in the functioning of the Schwarz device and it appears the device would function as intended being given the claimed range of the maximal value of a magnetic flux density derivative. Further, a person having ordinary skill in the art, being faced with modifying the winding area of Schwarz would have a reasonable expectation of success in making such a modification. Lastly, applicant has not disclosed that the claimed range provides an advantage, is done for a particular purpose, or solves a stated problem, indicating that the winding area “may” or “preferably” be within the claimed range, and offering other acceptable ranges (see specification as originally filed paragraph [0227]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the maximal value of a magnetic flux density derivative of Schwarz, as modified by Leung, Aho, Jacobs and Riehl, to a range of 300 T/s to 800 kT/s as a matter of obvious design choice within the skill in the art.
Referring to claim 26: Schwarz further teaches assembling subsequent impulses into a trapezoidal envelope (see paragraph [0088]).
Referring to claims 27 and 28: Schwarz, as modified by Leung, Aho, Jacobs and Riehl, further teaches the air flows over an upper side of the magnetic field generating coil and a lower side of the magnetic field generating coil, between the casing and the magnetic field generating coil (see Leung figure 3A).
Referring to claim 29: Schwarz, as modified by Leung, Aho, Jacobs and Riehl, further teaches the applicator comprises an inlet and an outlet (see Jacobs figure 2), and wherein the air flows from the inlet to the outlet in a direction parallel to the magnetic field generating coil (see Leung figure 3A; wherein it is clear that when air is flowing through the casing #112 air will be flowing parallel to the magnetic field generating coil).
Referring to claim 30: Leung further teaches the applicator (see figure 1, #100) further comprises a human machine interface (see figure 1, #104), the method further comprising adjusting at least one treatment parameter via the human machine interface, wherein the at least one treatment parameter comprises the magnetic flux density (see paragraphs [0030] [0044]-[0045]).
Allowable Subject Matter
Claims 6-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: Leung further teaches a positioning arm (see figure 1). However, the prior art of record does not teach or reasonably suggest, in combination with the additional limitation of the base claim and any intervening claims the positioning arm comprising a first end coupled to a main body of the treatment device and a second end, wherein the second end comprises a sleeve, wherein the sleeve comprises a gap, and wherein the applicator comprises a latching member configured to be inserted into the gap in the sleeve to lock the applicator to the positioning arm. Claims 7-8 would be allowable based on their dependency on claim 6.
Claim 14 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 a statement of reasons for the indication of allowable subject matter: Leung further teaches a positioning arm (see figure 1). However, the prior art of record does not teach or reasonably suggest, in combination with the additional limitation of the base claim and any intervening claims the positioning arm comprising a first end coupled to a main body of the treatment device and a second end comprising a sleeve, wherein the sleeve comprises a gap, wherein the applicator comprises a latching member configured to be inserted into the gap in the sleeve to lock the applicator to the positioning arm, wherein the connecting tube is configured to be coupled to the applicator proximate to the second end of the positioning arm.
Claims 17-19 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 and to overcome the above provisional double patenting rejection. The following is a statement of reasons for the indication of allowable subject matter: Leung further teaches an applicator having an upper side configured to be placed away from the patient and comprising a handle; and a lower side configured to be placed on the patient. However, the prior art of record does not teach or reasonably suggest, in combination with the additional limitation of the base claim and any intervening claims the upper side forming a concavity (claim 17), an orifice (claim 18) or comprising a marker configured to correspond with the magnetic field generating coil (claim 19).
Conclusion
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/KAYLEE R WILSON/Primary Examiner, Art Unit 3700
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