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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 January 2025 has been entered.
Status of Claims
This office action is responsive to the amendment filed 03 November 2025. As directed by the amendment claims 1-3, 11 and 28 have been amended, claims 33-57 have been added, and claims 4-10, 12-27 and 29-32 have been cancelled. Thus, claims 1-3, 11, 28 and 33-57 are presently pending in this application.
Claim Objections
Claims 28, 38, 48, 51, 53 and 55 are objected to because of the following informalities:
claim 28, line 8 “an applicator” should be amended to recite --the applicator-- since an applicator is recited in line 7;
claim 38, line 2 “the applicator to the patient” should be amended to recite --the applicator adjacent to the patient--;
claim 48, line 5 “positioned to the patient” should be amended to recite --positioned adjacent to the patient--;
claim 51, line 4 “control switching device” should be amended to recite --control a switching device--;
claims 53 and 55, “maintained to the patient” should be amended to recite --maintained adjacent to the patient--.
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.
Due to the very large patent family, a double patenting analysis is only provided based on the independent claims.
At least claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 9 of U.S. Patent No. 11,794,029 in view of Leung et al. (US 2016/0015995 A1) (Leung). U.S. Patent No. 11,794,029 teaches a device as claimed but does not teach first and second magnetic field generating devices mutually tilted with respect to each other. Leung teaches two magnetic field generating devices (see figure 3A, #120A/B) mutually tilted by element #122. It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the tilting mechanism of Leung with the device of U.S. Patent No. 11,794,029 to gain the advantage of being able to direct the magnetic field to a focal point as set forth in paragraph [0033] of Leung.
At least claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 10 of U.S. Patent No. 11,266,852 in view of Leung. U.S. Patent No. 11,266,852 teaches a device as claimed but does not teach a blower configured to enable a fluid to flow into the applicator; and a first and second magnetic field generating devices mutually tilted with respect to each other. Leung teaches two magnetic field generating devices (see figure 3A, #120A/B) mutually tilted by element #122 and a blower configured to enable a fluid to flow into the applicator (see paragraph [0047]). It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the tilting mechanism of Leung with the device of U.S. Patent No. 11,794,029 to gain the advantage of being able to direct the magnetic field to a focal point as set forth in paragraph [0033] of Leung. Additionally, it would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the blower of Leung with the device of U.S. Patent No. 11,794,029 to gain the advantage of being able cool the coils as set forth in paragraph [0047] of Leung.
At least claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 15 of U.S. Patent No. 10,632,321 in view of Leung. U.S. Patent No. 10,632,321 teaches a device as claimed but does not teach a first and second magnetic field generating devices mutually tilted with respect to each other. Leung teaches two magnetic field generating devices (see figure 3A, #120A/B) mutually tilted by element #122. It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the tilting mechanism of Leung with the device of U.S. Patent No. 10,632,321 to gain the advantage of being able to direct the magnetic field to a focal point as set forth in paragraph [0033] of Leung.
At least claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 19 of U.S. Patent No. 10,695,576 in view of Leung. U.S. Patent No. 10,695,576 teaches a device as claimed but does not teach first and second magnetic field generating devices mutually tilted with respect to each other. Leung teaches two magnetic field generating devices (see figure 3A, #120A/B) mutually tilted by element #122. It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the tilting mechanism of Leung with the device of U.S. Patent No. 10,695,576 to gain the advantage of being able to direct the magnetic field to a focal point as set forth in paragraph [0033] of Leung.
At least claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 11 and 18 of U.S. Patent No. 10,709,895 in view of Leung. U.S. Patent No. 10,709,895 teaches a device as claimed but does not teach first and second magnetic field generating devices mutually tilted with respect to each other. Leung teaches two magnetic field generating devices (see figure 3A, #120A/B) mutually tilted by element #122. It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the tilting mechanism of Leung with the device of U.S. Patent No. 10,709,895 to gain the advantage of being able to direct the magnetic field to a focal point as set forth in paragraph [0033] of Leung.
At least claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 29 of U.S. Patent No. 11,464,994 in view of Leung. U.S. Patent No. 11,464,994 teaches a device as claimed but does not teach a blower configured to enable a fluid to flow into the applicator; and a first and second magnetic field generating devices mutually tilted with respect to each other. Leung teaches two magnetic field generating devices (see figure 3A, #120A/B) mutually tilted by element #122 and a blower configured to enable a fluid to flow into the applicator (see paragraph [0047]). It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the tilting mechanism of Leung with the device of U.S. Patent No. 11,464,994 to gain the advantage of being able to direct the magnetic field to a focal point as set forth in paragraph [0033] of Leung. Additionally, it would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to include the blower of Leung with the device of U.S. Patent No. 11,794,029 to gain the advantage of being able cool the coils as set forth in paragraph [0047] of Leung.
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 1-3, 11, 33-43 and 51-57 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.
Referring to claim 1, the limitation “the second magnetic field generating device is configured to be cooled by air” renders the claim indefinite because it unclear if the air is intended to be the fluid recited in line 3 or an additional fluid within the device.
Claim 11 recites the limitation "the handle body" in 23. There is insufficient antecedent basis for this limitation in the claim because the claim only previous a handle and a casing.
Referring to claim 37, the limitation “a marker above the first magnetic field generating device” renders the claim indefinite because the term “above” is a relative spatial term that does not specify the reference orientation, e.g., above relative to gravity, the patient-facing side, the applicator casing, the upper side/lower side, or normal operating position.
Referring to claim 43, the limitation “each of the first time-varying magnetic field and the second time-varying magnetic field is generated in a first train having a first repetition rate and a second train having a second repetition rate” renders the claim indefinite because the limitation is unclear as to whether both the first and second magnetic fields are generated in both trains, whether each magnetic field has its own first and second trains, or whether the first field corresponds to the first train and the second field corresponds to the second train.
Referring to claim 43, the limitation “wherein each train is followed by a period with no time-varying magnetic field applied to the patient” renders the claim indefinite because the limitation is unclear because it does not specify whether “no time-varying magnetic field” means no field generated by the claimed device, no field from the first and second magnetic field generating devices, or absolutely no time-varying magnetic field from any source. It appears the claim should be amended to recite “wherein each train is followed by a period during which the first and second magnetic field generating devices do not apply a time-varying magnetic field to the patient.”
Referring to claims 40 and 51, the limitation “a concave shape forming an open-ended region” renders the claim indefinite because it is unclear whether the concave shape itself defines an open recess, a through-channel, a cavity, a grove, etc. or merely a curved surface region. The specification as originally filed does not recite explicitly recite “an open-ended region” to aid one of ordinary skill in the art in determining the metes and bounds of the claim.
Claims 2-3, 33-36, 38-39, 41-42 and 52-57 are rejected due to their dependency on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 51 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Leung et al. (US 2016/0015995 A1) (Leung).
Referring to claim 51: Leung teaches a treatment device (see figure 1) for applying time-varying magnetic fields to a patient (see paragraph [0028], [0030], [0033] and [0044]), comprising: an energy source (see figure 1; paragraphs [0028]-[0030]; wherein it is clear that the device includes an energy source for powering the stimulator, #102) configured to charge a capacitor (see figure 6; paragraph [0047]); a control unit (see figure 1, #104; see paragraphs [0044]-[0045]) configured to control a switching device (see figure 6; reproduced above from US 2016/0015995 corresponding patent no. US 10,369,373 for readability) to enable discharging energy to a first magnetic field generating device (see figures 3A-G, #120A; paragraph [0035]-[0038]) to generate a first time-varying magnetic field (see paragraph [0028], [0033] and [0044]); a connecting tube (see figure 1, wherein a connecting tube couples the applicator, #102, to the control module, #104) configured to be connected to an applicator (see figure 1, #102; paragraph [0032]-[0038]); the applicator comprising: a front side, a rear side, wherein the connecting tube is configured to be connected to the rear side (see figure 1); an upper side (see figure 3B, #112A) configured to be positioned less proximate to the patient than to a lower side (see figure 3B, #112B); the lower side configured to face the patient (see figure 1), wherein the lower side comprises a concave shape forming an open-ended region (see figures 3A-B), wherein the open-ended region is positioned less proximate to the connecting tube than to the front side (see figure 1); the first magnetic field generating device positioned in a first plane (see figure 3A), and a second magnetic field generating device positioned in a second plane (see figure 3A), wherein the second magnetic field generating device is configured to receive electric current to generate a second time-varying magnetic field (see paragraph [0028], [0033] and [0044]), and wherein the first plane and the second plane are mutually tilted with respect to each other (see figure 3A); wherein the first time-varying magnetic field is configured to be applied to the patient to induce a first electric current in the patient; and wherein the second time-varying magnetic field is configured to be applied to the patient to induce a second electric current in the patient (see paragraph [0032]).
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, 11, 28, 33-37, 39-43 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Jacobs (US Patent No. 3,251,085).
Referring to claims 1-3: Leung teaches a treatment device (see figure 1) for treating a body of a patient (see paragraph [0030]), comprising: an applicator (see figure 1, #102; paragraph [0032]-[0038]), the applicator comprising: an inlet configured to enable flow of a fluid into the applicator (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 handle (see figure 2, #114; paragraph [0034]) configured to be used to position the applicator to the patient; a first magnetic field generating device (see figures 3A-G, #120A; paragraph [0035]-[0038]) and a second magnetic field generating device (see figures 3A-G, #120B; paragraph [0035]-[0038]), wherein each of the first magnetic field generating device and the second magnetic field generating device is configured to be cooled by air (see paragraph [0047]); a connecting tube (see figure 1, wherein a connecting tube couples the applicator, #102, to the control module, #104) configured to be connected to the applicator; a capacitor (see figure 6; reproduced below from US 2016/0015995 corresponding patent no. US 10,369,373 for readability; paragraph [0047]) configured to be discharged to the first magnetic field generating device such that the first magnetic field generating device generates a first time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla (see paragraph [0028], [0033] and [0044]), wherein the first time-varying magnetic field comprises biphasic impulses (see paragraph [0033]), wherein the second magnetic field generating device is configured to receive electric current to generate a second time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla (see paragraph [0028], [0033] and [0044]), and wherein the second time-varying magnetic field comprises biphasic impulses (see paragraph [0033]); wherein the first magnetic field generating device is configured to be positioned in a first plane (see figure 3A); wherein the second magnetic field generating device is configured to be positioned in a second plane (see figure 3A), and wherein the first plane and the second plane are mutually tilted with respect to each other (see figure 3A); wherein the first time-varying magnetic field is configured to be applied to the body of the patient to induce a first electric current in the body of the patient; and wherein the second time-varying magnetic field is configured to be applied to the body of the patient to induce a second electric current in the body of the patient (see paragraph [0032]). Leung does not explicitly teach an outlet configured to enable the fluid to be removed unimpeded from the applicator, 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.
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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 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 11: Leung teaches a treatment device (see figure 1) for applying time-varying magnetic fields to a patient (see paragraph [0028], [0030], [0033] and [0044]), comprising: an energy source (see figure 1; paragraphs [0028]-[0030]; wherein it is clear that the device includes an energy source for powering the stimulator, #102) configured to charge a capacitor (see figure 6; paragraph [0047]); a switching device (see figure 6; reproduced above from US 2016/0015995 corresponding patent no. US 10,369,373 for readability) configured to enable discharging of the capacitor to a first magnetic field generating device (see figures 3A-G, #120A; paragraph [0035]-[0038]) to generate the first time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla (see paragraph [0028], [0033] and [0044]); an applicator (see figure 1, #102; paragraph [0032]-[0038]) comprising: a casing (see figure 2, #112); an upper side (see figure 3B, #112A) configured to be placed positioned less proximate to the patient than to a lower side (see figure 3B, #112B); the first magnetic field generating device (see figures 3A-G, #120A; paragraph [0035]-[0038]) and a second magnetic field generating device (see figures 3A-G, #120B; paragraph [0035]-[0038]), wherein the second magnetic field generating device is configured to receive electric current to generate a second time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla (see paragraph [0028], [0033] and [0044]); an inlet configured to enable air to flow into the casing to remove heat from the first magnetic field generating device such that the air flows between the casing and the first magnetic field generating device (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 handle (see figure 2, #114; paragraph [0034]) configured to be used to position the applicator to the patient; wherein the first magnetic field generating device is configured to be positioned in a first plane (see figure 3A); wherein the second magnetic field generating device is configured to be positioned in a second plane (see figure 3A), and wherein the first plane and the second plane are mutually tilted with respect to each other (see figure 3A); wherein the first time-varying magnetic field is configured to be applied to the patient to induce a first electric current in the patient; and wherein the second time-varying magnetic field is configured to be applied to the patient to induce a second electric current in the patient (see paragraph [0032]). Leung does not explicitly teach an outlet configured to enable directing the air out of the casing; wherein the handle is positioned such that a closed-loop opening is formed through the handle body.
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 air into the device (see column 3, lines 19-38); an outlet (see figure 2, #34/35/36) configured to enable air 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) and wherein the handle is positioned such that a closed-loop opening is formed through the handle body to allow the air to flow through the entire casing including the handle body (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 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 28: Leung teaches a treatment device (see figure 1) for applying time-varying magnetic fields to a patient (see paragraph [0028], [0030], [0033] and [0044]), comprising: an energy source (see figure 1; paragraphs [0028]-[0030]; wherein it is clear that the device includes an energy source for powering the stimulator, #102) configured to charge a capacitor (see figure 6; paragraph [0047]); a control unit (see figure 1, #104; see paragraphs [0044]-[0045]) configured to control a switching device (see figure 6; reproduced above from US 2016/0015995 corresponding patent no. US 10,369,373 for readability) to enable discharging energy to a first magnetic field generating device (see figures 3A-G, #120A; paragraph [0035]-[0038]) to generate a first time-varying magnetic field with a repetition rate in a range of 1 Hz to 300 Hz (see paragraph [0028], [0033] and [0044]); a positioning arm (see figure 1 and 5C; paragraph [0046]) configured to be connected to an applicator (see figure 1, #102; paragraph [0032]-[0038]); the applicator comprising: a lower side (see figure 3B, #112B) configured to be positioned proximate to the patient (see figure 1; paragraph [0035]); an upper side (see figure 3B, #112A) configured to be positioned less proximate to the patient than to the lower side (see figure 1); an inlet configured to enable fluid flow into the applicator (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 blower (see paragraph [0047]) configured to enable a fluid to flow into the applicator through the inlet to remove heat from the first magnetic field generating device; a handle (see figure 2, #114; paragraph [0034]) configured to be used to position the applicator to the patient (see figure 1); the first magnetic field generating device positioned in a first plane and a second magnetic field generating device (see figures 3A-G, #120B; paragraph [0035]-[0038]) positioned in a second plane (see figure 3A), wherein the first plane and the second plane are mutually tilted with respect to each other (see figure 3A), and wherein the second magnetic field generating device is configured to receive electric current to generate a second time-varying magnetic field with a repetition rate in a range of 1 Hz to 300 Hz (see paragraph [0028], [0033] and [0044]); wherein the first time-varying magnetic field is configured to be applied to the patient to induce a first electric current in the patient; and wherein the second time-varying magnetic field is configured to be applied to the body of the patient to induce a second electric current in the patient (see paragraph [0032]). Leung does not explicitly teach the inlet being positioned proximate to the positioning arm such that the positioning arm is less proximate to the patient than to the inlet; and an outlet positioned less proximate to the connecting tube than to the inlet, wherein the fluid is directed out of the applicator, wherein the handle is positioned less proximate to the patient than to the outlet.
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 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 33: With regards to claim 3 above, Leung further teaches wherein the first magnetic field generating device is planar, and wherein the first magnetic field generating device is positioned within the applicator such that the first magnetic field generating device is spaced from a casing (see figure 3A, #112; paragraph [0035]) of the applicator 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).
Referring to claim 34: Leung further teaches wherein the gap is between the first magnetic field generating device and the patient (see figures 1 and 3A-3C; paragraph [0035).
Referring to claim 35: Leung, as modified by Jacobs, further teaches the applicator further comprises a blower configured to direct the air in a direction from the inlet to the outlet such that the air flows through the gap to remove heat from the first magnetic field generating device (see Leung paragraph [0047]).
Referring to claim 36: With regards to claim 2 above, Leung, as modified by Jacobs, further teaches a positioning arm (see Leung figure 1 and 5C; paragraph [0046]) fully capable of being connected to the applicator such that the outlet is positioned less proximate to the positioning arm than to the handle (see Leung figure 1).
Referring to claim 37: With regards to claim 2 above, Leung, as modified by Jacobs, further teaches the applicator comprises a marker above the first magnetic field generating device, wherein the marker is positioned less proximate to the connecting tube than to the inlet (see paragraph [0039]).
Referring to claim 39: With regard to claim 11 above, Leung, as modified by Jacobs, further teaches the handle is configured to be positioned less proximate to the patient than to the outlet (see Leung figure 1; Jacobs figure 2).
Referring to claim 40: With regards to claim 11 above, Leung, as modified by Jacobs, further comprising a connecting tube (see Leung figure 1, wherein a connecting tube couples the applicator, #102, to the control module, #104) configured to be connected to the applicator, wherein the outlet is positioned less proximate to the connecting tube than to the inlet (see Leung figure 1; Jacobs figure 2).
Referring to claim 41: With regards to claim 11 above, Leung further teaches the applicator comprises a blower configured to direct the air into the casing (see paragraph [0047]).
Referring to claim 42: With regards to claim 11 above, Leung further teaches the first time-varying magnetic field and the second time-varying magnetic field are generated within a single treatment (see paragraph [0035]; wherein it is clear the first and second time-varying magnetic field are generated within a single treatment since the angle of the coils are adjusted to adjust a focal point of treatment).
Referring to claim 43: With regards to claim 11 above, Leung further teaches each of the first time-varying magnetic field and the second time-varying magnetic field is generated in a first train having a first repetition rate and a second train having a second repetition rate, wherein the first repetition rate is different from the second repetition rate, wherein each train is followed by a period with no time-varying magnetic field applied to the patient (see paragraphs 0035], [0069], and [0071]).
Referring to claim 49: With regards to claim 28 above, Leung further teaches the lower side comprises a concave shape forming an open-ended region (see figures 3A-B).
Referring to claim 50: With regards to claim 28 above, Leung further teaches a main body (see figure 1), wherein the control unit (see figure 1, #104), the energy source, the capacitor and the switching device are within the main body (see figure 6; paragraph [0047]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Jacobs, as applied to claim 11 above, in further view of Culhane (US Patent No. 7,465,269).
Referring to claim 38: Leung, as modified by Jacobs, further teaches a positioning arm (see figure 1) for positioning the device adjacent to the patient but is silent to a belt configured to maintain the applicator adjacent to the patient. Culhane teaches an applicator (see figure 2, #12) for providing electromagnetic treatment to a body region (see abstract; column 3, lines 4-17), wherein the applicator comprises a flexible belt (see figure 5, #62; column 5, lines 19-45). 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 positioning arm of Leung, as modified by Jacobs, with a belt like taught by Culhane in order to yield predictable results in maintaining the device adjacent to the user while ensuring proper placement and focusing of the magnetic fields are maintained during use.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Jacobs, as applied to claim 28 above, in further view of Ross (US Patent No. 6,434,423).
Referring to claim 44: Leung, as modified by Jacobs, is silent to the positioning arm comprises at least one joint configured to be locked by a screw mechanism. Ross teaches an applicator for providing electromagnetic therapy (see abstract; figure 1, #7); and a positioning arm for positioning the applicator proximate to a patient, the positioning arm comprising at least one joint configured to be locked by a screw mechanism (see figure 1, #10; column 2, lines 20-28). 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 positioning arm of Leung, as modified by Jacobs, with at least one joint and screw mechanism like taught by Ross in order to increase the degree of adjustability and maintain secure position of the applicator proximate to the patient.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Leung in view of Jacobs, as applied to claim 28 above, in further view of Riehl (US 2005/0261542 A1).
Referring to claim 48: Leung, as modified by Jacobs, further teaches that the first magnetic field generating device and the second magnetic field generating device are insulated (see paragraphs [0013], [0032]; claim 1), and wherein the fluid is fully capable of flowing along at least a lower side of the first magnetic field generating device, wherein the lower side of the first magnetic field generating device is configured to be positioned to the patient (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 that would be fully capable of allowing fluid flow along the lower side of the first magnetic field generating device). Leung, as modified by Jacobs, is silent to the first magnetic field generating device and the second magnetic field generating device being impregnated. Riehl teaches an applicator for providing electromagnetic therapy (see abstract), the applicator comprising a magnetic field generating device fabricated by spooling a ribbon of ferromagnetic substrate 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 modify the first and second magnetic field generating devices of Leung, as modified by Jacobs, to being impregnated like taught by Riehl in order to mechanically bond the windings of the magnetic field generating device into place (see Riehl paragraph [0067]).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Leung, as applied to claim 51 above, in further view of Riehl.
Referring to claim 52: Leung further teaches that the first magnetic field generating device and the second magnetic field generating device are insulated planar coils (see figure 3A; paragraphs [0013], [0032] and [0035]; claim 1) cooled by a fluid (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), and wherein the fluid is directed along the first magnetic field generating device in a direction parallel to a lower side of the first magnetic field generating device, wherein the lower side of the first magnetic field generating device is configured to be positioned to the patient and the upper side of the first magnetic field generating device is configured to be positioned away from the patient (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 first magnetic field generating device). Leung is silent to the first magnetic field generating device and the second magnetic field generating device being impregnated. Riehl teaches an applicator for providing electromagnetic therapy (see abstract), the applicator comprising a magnetic field generating device fabricated by spooling a ribbon of ferromagnetic substrate 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 modify the first and second magnetic field generating devices of Leung to being impregnated like taught by Riehl in order to mechanically bond the windings of the magnetic field generating device into place (see Riehl paragraph [0067]).
Claims 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Leung, as applied to claim 51 above, in further view of Culhane.
Referring to claim 53: Leung further teaches a positioning arm (see figure 1) for positioning the device adjacent to the patient but is silent to a belt configured to maintain the applicator adjacent to the patient. Culhane teaches an applicator (see figure 2, #12) for providing electromagnetic treatment to a body region (see abstract; column 3, lines 4-17), wherein the applicator comprises a flexible belt (see figure 5, #62; column 5, lines 19-45). 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 positioning arm of Leung with a belt like taught by Culhane in order to yield predictable results in maintaining the device adjacent to the user while ensuring proper placement and focusing of the magnetic fields are maintained during use.
Referring to claims 54 and 55: Leung is silent to the applicator comprising a cutout positioned less proximate to the connecting tube than to the concave shape; and a belt, wherein the cutout is configured to fix the belt to the applicator, and wherein the applicator is configured to be maintained to the patient by the belt. Culhane teaches an applicator (see figure 2, #12) for providing electromagnetic treatment to a body region (see abstract; column 3, lines 4-17), wherein the applicator comprises a cutout (see figure 2, #58); and a flexible belt (see figure 5, #62; column 5, lines 19-45), wherein the cutout is configured to fix the belt to the applicator (see figure 2; column 5, liens 19-45). 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 applicator of Leung with cutouts and belt like taught by Culhane in order to yield predictable results in maintaining the device adjacent to the user while ensuring proper placement and focusing of the magnetic fields are maintained during use. Leung, as modified by Culhane, clearly teaches the cutouts position less proximate to the connecting tube than to the concave shape of the lower surface.
Claims 56 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Leung, as applied to claim 51 above.
Referring to claim 56: Leung teaches the concave shape comprise a curvature with a radius, however, Leung does not explicitly teach the radius being in a range of 10 mm to 750 mm. There is no evidence of record that establishes that changing the radius of curvature 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 radius of curvatures. Further, a person having ordinary skill in the art, being faced with modifying the radius of curvature 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 radius of curvature “may” or “preferably” be within the claimed range, and offering other acceptable ranges (see specification as originally filed paragraph [0106]) 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 to have a radius in a range of 10 mm to 750 mm as a matter of obvious design choice within the skill in the art.
Referring to claim 57: Leung teaches the concave shape is a section of a curvature defined by an angle; however, Leung does not explicitly teach the angle being in a range of 10° to 270°. There is no evidence of record that establishes that changing the angle of curvature 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 angle of curvatures. Further, a person having ordinary skill in the art, being faced with modifying the angle of curvature 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 radius of curvature “may” or “preferably” be within the claimed range, and offering other acceptable ranges (see specification as originally filed paragraph [0106]) 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 angle curvature of Leung to have a radius in a range of 10° to 270° as a matter of obvious design choice within the skill in the art.
Allowable Subject Matter
Claims 45-47 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 of record does not teach or reasonably suggest, in combination with the additional limitation of the base claim and any intervening claims, the applicator being configured to be connected to the positioning arm by a locking mechanism comprising a latching member, wherein the latching member is configured to fit into a gap to lock the applicator to the positioning arm.
Claims 46-47 would be allowable based on their dependency on claim 45.
Response to Arguments
Applicant’s arguments with respect the presently pending claims as amended have been considered but are moot because the new ground of rejection does not rely on any of the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/KAYLEE R WILSON/Primary Examiner, Art Unit 3700
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