DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/11/2026 has been entered.
Response to Amendments
Entry of Amendments
Claim(s) 21, 30, 36 have been amended.
Rejections under NSDP
Previous rejections under NSDP still stands as TD filed on 1/2/2025 is in “disapproved” status.
For further details see the rejections/objections for Claim(s) 21-40 herein.
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 Langi, 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 §§ 706.02(1)(1) - 706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-l.jsp.
Claim(s) 21-25, 30, 34, 36-39 of instant application are rejected on the ground of nonstatutory double patenting as being unpatentatble over claim(s) 1-5, 10 and 15-20 of U.S. Patent No. 11,878,181 (reference) in view of Bonmassar et al. (US 20150080637)
Claim(s) 26-29, 31-33, 35 and 40 of instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 10 and 16 of U.S. Patent No. 11,878,181 (reference) in view of Bonmassar and/or Tepper et al. (US 6,261,221).
Although the claims at issue are not identical to anticipated claims 21-25, 30, 34, 36-39, they are not patentably distinct from each other. The reference claims are patentably indistinct to the instant claims because Claims are related by genus (instant) and species (reference) relationship and instant application broadens the scope of subject matter claimed in the reference patent.
Rejected claim(s) 21-25, 30, 34, 36-39 contain, in combination with the features of any claim to which they refer, additional feature(s) that are known and/or obvious in view of Bonmassar and/or Tepper.
As charted below:
US Appl. No. 18/404509 (instant)
US Pat. No. 11,878,181 (reference)
21. A method for inducing a pulsed electromagnetic field (PEMF), the method comprising:
providing a micro-coil surrounding a metallic core having a central axis and operable as a flux guide, coils of the micro-coil being stacked along the central axis and extending around the central axis;
selecting a treatment region of a live subject;
positioning the flux guide proximate the treatment region with the central axis directed into the treatment region; and
pulsing the micro-coil to induce a pulsed electromagnetic field (PEMF) into the treatment region.
1.A method for remediation of erythrocyte aggregation in vivo, the method comprising:
providing a micro-coil surrounding a metallic core having a central axis and operable as a flux guide;
selecting a treatment region of a live subject, containing a blood vessel passing erythrocytes therethrough;
positioning the flux guide proximate the treatment region with the central axis directed into the treatment region; and
pulsing the micro-coil to induce a pulsed electromagnetic field (PEMF) into the treatment region.
22. The method of claim 21, further comprising cycling the electromagnetic field between an on condition and an off condition for a time selected to effect disaggregation of erythrocytes in the treatment region.
2. The method of claim 1, comprising cycling the electromagnetic field between an on condition and an off condition for a time selected to effect disaggregation of erythrocytes in the subject.
23. The method of claim 21, wherein the treatment region comprises a bodily member of a subject.
3. The method of claim 1, wherein the treatment region comprises a bodily member of the subject.
24. The method of claim 21, further comprising: placing the flux guide in a cassette; and placing the cassette against skin of a subject.
4. The method of claim 1, comprising: placing the flux guide in a cassette; and placing the cassette against skin of the subject.
25. The method of claim 24, wherein the cassette is formed of a non-magnetic material and secured to the subject.
5. The method of claim 4, wherein the cassette is formed of a non-magnetic material and secured to the subject.
26. The method of claim 24, wherein the cassette is sealed so as to be water tight.
#11878181 in view of Tepper et al.
27. The method of claim 26, further comprising: recharging a battery by a transformer process that does not require electrical contact.
#11878181 in view of Tepper et al.
28. The method of claim 21, wherein the micro-coil is encased in a cassette free to be positionable by one or more of an article of clothing and a securement mechanism to operate adjacent a bodily member selected from an ankle, leg, wrist, arm, neck, head, and torso, abdomen, and thorax.
#11878181 in view of Tepper et al.
29. The method of claim 21, wherein the flux guide is sized and shaped to appear as one of a watch and a health monitoring device.
#11878181 in view of Tepper et al.
30. An apparatus operable as a therapeutic device, the apparatus comprising:
a first micro-coil constituted by wire wrapped around a first metallic core acting as a first flux guide directing a first magnetic field along a first central axis of the first metallic core in response to electrification of the wire, the first metallic core including a first annulus and a
second annulus mounted to a back, the first annulus and the second annulus forming a track with
the first micro-coil being positioned within the track;
a source of electricity operably connected to selectively pulse electric current through the wire; and
a cassette, sized and shaped to have a length and a width each larger than a thickness thereof, to receive the first micro-coil and the source therein and to orient the central axis into the subject when the cassette is placed with the length and width effectively parallel to and proximate to skin of the subject.
10. An apparatus operable as a therapeutic device effective to dis-aggregate erythrocytes while moving with a subject, the apparatus comprising:
a micro-coil constituted by wire wrapped around a metallic core acting as a flux guide directing a magnetic field along a central axis of the metallic core in response to electrification of the wire;
a source of electricity operably connected to selectively pulse electric current through the wire; and
a cassette, sized and shaped to have a length and a width each larger than a thickness thereof, to receive the micro-coil and the source therein and to orient the central axis into the subject when the cassette is placed with the length and width effectively parallel to and proximate to skin of the subject.
31. The apparatus of claim 30, further comprising: a second micro-coil constituted by wire wrapped around a second metallic core acting as a second flux guide directing a second magnetic field along a second central axis of the second metallic core in response to electrification of the wire, wherein the second micro-coil is operably connected to the source and within the cassette.
#11878181 in view of Tepper et al.
32. The apparatus of claim 31, wherein the first and second micro-coils are stacked in an axial direction.
#11878181 in view of Tepper et al.
33. The apparatus of claim 30, wherein the cassette is sized and shaped to appear as at least one of a watch and a health monitor.
#11878181 in view of Tepper et al.
34. The apparatus of claim 30, wherein the cassette is sized and shaped to position over, and pass a pulsed electromagnetic field (PEMF) through, a targeted blood vessel conducting blood therethrough, thereby remediating erythrocyte aggregation in the blood.
15. The apparatus of claim 10, wherein the cassette is sized and shaped to position over, and pass a pulsed electromagnetic field (PEMF) through, a targeted blood vessel conducting blood therethrough, thereby remediating erythrocyte aggregation in the blood.
35. The apparatus of claim 32, wherein the cassette is sized and shaped to position over, and pass a pulsed electromagnetic field (PEMF) through, a targeted blood vessel conducting blood therethrough, thereby remediating erythrocyte aggregation in the blood.
#11878181 in view of Tepper et al.
36. An apparatus capable of remediating erythrocyte aggregation, the apparatus comprising:
a core of metal, the metal capable of magnetic response, the core having a central axis; a coil of wire wrapped in multiple turns about the core to create a magnetic field in response to current through the wire, the multiple turns being stacked along the central axis ;
the core operable as a flux guide concentrating and urging magnetic flux of the magnetic field in a direction parallel to the central axis;
a cassette sized and shaped to contain the core and coil as an assembly constituting a micro-coil, presenting an effectively planar surface, defined by a longitudinal aspect and a width aspect, both being orthogonal to a thickness aspect thereof, extending parallel to the central axis; and the cassette operable to direct the magnetic flux toward a target region of a subject by placement of the planar surface thereof proximate, and parallel to, the target region.
a source of electrical current operably connected to the coil;
16. An apparatus capable of remediating erythrocyte aggregation, the apparatus comprising:
a core of metal, the metal capable of magnetic response, the core having a central axis; a coil of wire wrapped in multiple turns about the core to create a magnetic field in response to current through the wire;
the core operable as a flux guide concentrating and urging magnetic flux of the magnetic field in a direction parallel to the central axis;
a cassette sized and shaped to contain the core and coil as an assembly constituting a micro-coil, presenting an effectively planar surface, defined by a longitudinal aspect and a width aspect, both being orthogonal to a thickness aspect thereof, extending parallel to the central axis; and the cassette operable to direct the magnetic flux toward a target region of a subject by placement of the planar surface thereof proximate, and parallel to, skin covering the target region.
17. The apparatus of claim 16, comprising a source of electrical current operably connected to the coil.
37. The apparatus of claim 36, wherein the source is enclosed within the cassette.
18. The apparatus of claim 17, wherein the source is enclosed within the cassette.
38. The apparatus of claim 37, wherein: the apparatus comprises a controller operably connected to the coil to generate a pulsed electromagnetic field (PEMF) as the magnetic flux; and the source is a battery.
19. The apparatus of claim 18, wherein: the apparatus comprises a controller operably connected to the coil to generate a pulsed electromagnetic field (PEMF) as the magnetic flux; and the source is a battery.
39. The apparatus of claim 38, wherein: a first aspect ratio of thickness to width is less than one; a second aspect ratio of width to length is less than one; and the apparatus comprises a securement mechanism effective to maintain the planar surface of the cassette positioned to direct the magnetic flux into a blood vessel of the subject.
20. The apparatus of claim 19, wherein: a first aspect ratio of thickness to width is less than one; a second aspect ratio of width to length is less than one; and the apparatus comprises a securement mechanism effective to maintain the planar surface of the cassette positioned to direct the magnetic flux into a blood vessel of the subject as the subject moves about in normal activity.
40. The apparatus of claim 38, wherein the source is rechargeable by a transformer process that does not require electrical contact.
#11878181 in view of Tepper et al.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claim(s) 21 and 23-33 are rejected under 35 U.S.C. 103 as being unpatentable over Tepper et al. (US 6,261,221; hereinafter Tepper) in view of Bonmassar et al. (US 20150080637).
Regarding claim 21, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 a method for inducing a pulsed electromagnetic field (PEMF), the method comprising:
providing a micro-coil (PEMF transducer 20 comprises transducer coil 36; figures 5A, 13) surrounding a metallic core (col. 6 lines 44-50 :- Metglas®, which is a flexible ferrite material which has high permeability, has the ability to store magnetic energy to serve as a core material for the PEMF transducer 20) having a central axis (abs. - transducer energized and de-energized to provide the electromagnetic field),;
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selecting a treatment region (col. 1 line 21 - therapeutic stimulation to a target area of a patient's body) of a live subject (col. 1 line 22 - PEMF therapeutic stimulation to a target area of a patient's body; figure 2) containing a blood vessel;
positioning the flux guide proximate the treatment region (col. 5 lines 36-37 :- PEMF transducer 20 being contoured around the affected body part) with the central axis directed into the treatment region; and
pulsing the micro-coil (20) to induce a pulsed electromagnetic field (PEMF) (para. 7 - exposing the liquid sample to magnetic field created using one or more magnets and an RF pulse sequence) into the treatment region (col. 1 lines 44-47 :- pulsing the transducer coil will produce an applied or driving field that penetrates to the underlying damaged bone or other body tissue; figure 11);
Tepper does not teach explicitly operable as a flux guide, coils of the micro-coil being stacked along the central axis and extending around the central axis.
However, Bonmassar teaches in figure(s) 1-13 operable as a flux guide, coils of the micro-coil being stacked along the central axis and extending around the central axis (para. 33 - magnetic microcoils can be used individually or as a set of multiple microcoil grouped is different spatial configurations to judiciously modify the spatial distribution of the magnetic flux. with two or more coils, along with a simple circular element is the most commonly used coil type in TMS to form a more focused and directed stimulus input under the center of the coil; figs. 2,3,5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tepper by having operable as flux guide as taught by BONMASSAR in order to provide more effective optimal stimulation as evidenced by "maximize current in tissue to excite neurons and to harvest energy drained from microcoil. Judiciously designed microcoil stimulator facilitates spatial selectivity and steerability stimulation while lowering consumption of energy and recovering unused energy stored in the coil. Several different coil array layouts for different stimulation strategies" (abs.).
Regarding claim 23, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the method of claim 21,
wherein the treatment region comprises a bodily member of the subject (col. 2 lines 55-58 :– flexible transducer coil is useful for treating soft tissue. The transducer may be placed in or on a cast or bandage covering the location to be treated; figure 2).
Regarding claim 24, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the method of claim 21,
comprising: placing the flux guide in a cassette (col. 6 lines 41-46 :- PEMF transducer 20. uses a core holder, which is an essentially flat plastic case that is similar to that in which a videocassette may be packaged; figures 5A-B); and placing the cassette against skin of the subject (col. 11 line 35 - a flexible coil 36 could be used with bandaging for a skin wound).
Regarding claim 25, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the method of claim 24,
wherein the cassette is formed of a non-magnetic material (col. 6 lines 41-46 :- PEMF transducer 20. uses a core holder, which is an essentially flat plastic case that is similar to that in which a videocassette may be packaged; figures 5A-B) and secured to the subject (col. 2 lines 55-58 :– The transducer may be placed in or on a cast or bandage covering the location to be treated; figure 2).
Regarding claim 26, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the method of claim 24,
wherein the cassette is sealed so as to be water tight (col. 5 lines 1-15 :- a flat-wound PEMF winding (coil) that may be encapsulated in a shell of a plasticized elastomer material (such as polyurethane) with a selected degree of rigidity. Drive electronics 28 is mounted on a circuit board and encased in a plastic shell 30 that covers the end of PEMF coil 36; figures 5A-B).
Regarding claim 27, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the method of claim 26,
further comprising: recharging a battery by a transformer process that does not require electrical contact (col. 1 lines 50-52 :- rechargeable battery pack).
Regarding claim 28, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the method of claim 21,
wherein the micro-coil is encased in a cassette free to be positionable by one or more of an article of clothing and a securement mechanism (col. 2 lines 55-58 :– flexible transducer coil is useful for treating soft tissue. The transducer may be placed in or on a cast or bandage covering the location to be treated; figure 2) to operate adjacent a bodily member (col. 4 lines 25-28 :- PEMF transducer system that the present invention uses may be formed and anatomically contoured for the shoulder, the wrist, the hip or other areas of the skeletal system) selected from an ankle, leg, wrist, arm, neck, head, and torso, abdomen (col. 11 lines 60-61 :- One of the coils 92 is placed against the patient's back and one against the patient's abdomen), and thorax.
Regarding claim 29, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the method of claim 21,
wherein the flux guide is sized and shaped to appear as one of a watch and a health monitoring device (col. 5 lines 46-60 :- transducer coil may be placed in or on a cast or bandage covering the location to be treated; the PEMF processor maintains treatment data that is available on request to the patient (through a small display), and to a health care professional (via an I/O port) for monitoring and analysis; fig. 2).
Regarding claim 30, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 an apparatus operable as a therapeutic device (col. 1 line 22 - PEMF therapeutic stimulation to a target area of a patient's body; figure 2), the apparatus comprising:
a micro-coil (PEMF transducer 20 comprises transducer coil 36; figures 5A, 13) constituted by wire (col. 5 lines 54-56 :- PEMF transducer 20 includes two parallel PEMF windings of about 7 turns each, 18 gauge wire can be used) wrapped around a metallic core (col. 6 lines 44-50 :- Metglas®, which is a flexible ferrite material which has high permeability, has the ability to store magnetic energy to serve as a core material for the PEMF transducer 20) directing (col. 11 lines 9-11 :- Compact and lightweight devices can be incorporated into casts, bandages, or applied directly to anatomical areas that would be difficult to treat with a bulky and heavy device) a magnetic field along a central axis of the metallic core (col. 1 lines 44-47 :- pulsing the transducer coil will produce an applied or driving field that penetrates to the underlying damaged bone or other body tissue; figs. 2,5A) in response to electrification of the wire (abs. - transducer energized and de-energized to provide the electromagnetic field);
a source of electricity (battery 84 in figure 8) operably connected to selectively pulse electrical current through the wire (col. 8 lines 9-11 :- FET switch 96 is turned on by coil drive amp 80 to present battery voltage across PEMF winding 92 for a period of one-half a normal pulse duration; col. 2 lines 7-10 :- permitting sequencing of the current through the transducer coil in both a first, positive direction and a second, negative direction);
a cassette (col. 6 lines 41-46 :- PEMF transducer 20. uses a core holder, which is an essentially flat plastic case that is similar to that in which a videocassette may be packaged; figures 5A-B), sized and shaped to have a length and a width each larger than a thickness thereof (col. 4 line 41 - size and shape that best suits the patient's wrist or other limb portion), to receive the micro-coil and source therein (clm. 31 - A band type device for applying pulsed electromagnetic field PEMF therapy to tissue); and
to orient the central axis into a subject (col. 5 lines 36-37 :- PEMF transducer 20 being contoured around the affected body part; figs. 2,5A) when the cassette is placed with the length and width effectively parallel to and proximate skin corresponding to of a subject (col. 4 lines 35-37 :- transducer is an integral unit including drive electronics and control electronic that may be held in place by a body strap).
Tepper does not teach explicitly acting as a flux guide. the first metallic core including a first annulus and a second annulus mounted to a back, the first annulus and the second annulus forming a track with the first micro-coil being positioned within the track.
However, Bonmassar teaches in figure(s) 1-13 acting as a flux guide (para. 137 - individual coils or groups of coils from the microcoil array… ability of steering the equivalent or equivalent magnetic dipoles in various directions). the first metallic core (para. 133 - using coil-core materials … metal composite …malleable to micromachining in order to be used in microcoils) including a first annulus and a second annulus mounted to a back, the first annulus and the second annulus forming a track with the first micro-coil being positioned within the track (para. 33 - magnetic microcoils can be used individually or as a set of multiple microcoil grouped is different spatial configurations to judiciously modify the spatial distribution of the magnetic flux. with two or more coils, along with a simple circular element is the most commonly used coil type in TMS to form a more focused and directed stimulus input under the center of the coil; figs. 1, 2,3,5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tepper by having the first metallic core including a first annulus and a second annulus mounted to a back, the first annulus and the second annulus forming a track with the first micro-coil being positioned within the track as taught by BONMASSAR in order to provide effective optimal stimulation as evidenced by "maximize current in tissue to excite neurons and to harvest energy drained from microcoil. Judiciously designed microcoil stimulator facilitates spatial selectivity and steerability stimulation while lowering consumption of energy and recovering unused energy stored in the coil. Several different coil array layouts for different stimulation strategies" (abs.).
Regarding claim 31, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the apparatus of claim 30,
further comprising: a second micro-coil (coils 92; fig. 14) constituted by wire wrapped around a second metallic core acting as a second flux guide directing a second magnetic field along a second central axis of the second metallic core in response to electrification of the wire (col. 11 lines 60-63 :- One of the coils 92 is placed against the patient's back and one against the patient's abdomen. For example, one coil 92 could be centered about the lumbar region and the other about the navel), wherein the second micro-coil is operably connected to the source and within the cassette (col. 5 lines 30-35 :- PEMF transducer shell is sufficiently flexible to permit the patient or a health care professional to adjust the anatomical contour).
Regarding claim 32, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the apparatus of claim 31,
wherein the first and second micro-coils are stacked in an axial direction (col. 2 lines 19-22 :- current through the transducer coil can be sequenced, in much the same way as is done with a full-bridge or half-bridge circuit, to go in both directions).
Regarding claim 33, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the apparatus of claim 30,
wherein the cassette is sized and shaped to appear as at least one of a watch and a health monitor (col. 5 lines 46-60 :- transducer coil may be placed in or on a cast or bandage covering the location to be treated; the PEMF processor maintains treatment data that is available on request to the patient (through a small display), and to a health care professional (via an I/O port) for monitoring and analysis; fig. 2).
Claim(s) 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over Tepper in view of PENNY et al. (US 2009/0248098).
Regarding claim 36, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 an apparatus Capable of remediating (col. 1 line 22 - PEMF therapeutic stimulation to a target area of a patient's body; figure 2), the apparatus comprising:
a core of metal, the metal capable of magnetic response, the core having a central axis (core of 20; col. 6 lines 47-50 :- Metglas.RTM., which is a flexible ferrite material, which has high permeability, has the ability to store magnetic energy. This allows Metglas.RTM. to serve as a core material for the PEMF transducer 20; figs. 2,5A);
a coil of wire wrapped in multiple turns about the core to create a magnetic field in response to current through the wire (PEMF transducer 20 comprises transducer coil 36; figures 5A, 13; col. 5 lines 54-56 :- PEMF transducer 20 includes two parallel PEMF windings of about 7 turns each, 18 gauge wire can be used), the multiple turns being stacked along the central axis (col. 5 line 55 - two parallel PEMF windings of about 7 turns each; fig. 7)
the core concentrating and urging magnetic flux of the magnetic field in a direction parallel to the central axis (axial direction of coil loop 36; col. 11 lines 9-11 :- Compact and lightweight devices can be incorporated into casts, bandages, or applied directly to anatomical areas that would be difficult to treat with a bulky and heavy device; col. 1 lines 44-47 :- pulsing the transducer coil will produce an applied or driving field that penetrates to the underlying damaged bone or other body tissue; figs. 2,5A; abs. - transducer energized and de-energized to provide the electromagnetic field);
a cassette (col. 6 lines 41-46 :- PEMF transducer 20. uses a core holder, which is an essentially flat plastic case that is similar to that in which a videocassette may be packaged; figures 5A-B), sized and shaped to contain the core and coil as an assembly constituting a micro-coil, presenting an effectively planar surface, defined by a longitudinal aspect and a width aspect, both being orthogonal to a thickness aspect thereof, extending parallel to the central axis (col. 4 line 41 - size and shape that best suits the patient's wrist or other limb portion; clm. 31 - A band type device for applying pulsed electromagnetic field PEMF therapy to tissue); and
the cassette operable to direct the central axis toward a target region of a subject by placement of the planar surface thereof proximate, and parallel to (col. 4 lines 35-37 :- transducer is an integral unit including drive electronics and control electronic that may be held in place by a body strap) the target region (col. 5 lines 36-37 :- PEMF transducer 20 being contoured around the affected body part; figs. 2,5A);
a source (battery 84 in figure 8) of electrical current operably connected to the coil (col. 8 lines 9-11 :- FET switch 96 is turned on by coil drive amp 80 to present battery voltage across PEMF winding 92 for a period of one-half a normal pulse duration; col. 2 lines 7-10 :- permitting sequencing of the current through the transducer coil in both a first, positive direction and a second, negative direction).
Tepper does not teach explicitly capable of remediating erythrocyte aggregation.
However, Penny teaches in figure(s) 5, 9 and 14-15 operable as a flux guide (para. 39 - magnetic flux density over a coil arrangement adjusted to the physiological conditions; figs. 6-7); capable of remediating erythrocyte aggregation (para. 26 - aggregation of erythrocytes occurring in the blood-dark field can be dissolved primarily by frequencies ranging from approx. 250 to 1500 Hz; para. 23 - stimulation via a coil arrangement creating a magnetic field; figure 14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tepper by having capable of remediating erythrocyte aggregation as taught by PENNY in order to provide "A device for stimulation via special electric and magnetic fields … between a peripheral area of a human or animal … persons treated with a field having a parasympathetic-frequency 0.2 Hz had a longer reaction time in reference to the sympathetic-frequency 0.1 Hz." (abs.,para. 9).
Regarding claim 37, Tepper in view of PENNY teaches the apparatus of claim 36,
Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 wherein the source is enclosed within the cassette (col. 1 lines 59-63 :- Reducing the battery size and weight will help to reduce the weight and cost of such equipment and improve the patient's comfort; figs. 5A-B).
Regarding claim 38, Tepper in view of PENNY teaches the apparatus of claim 37,
Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 wherein: the apparatus comprises a controller (PEMF microcontroller 62; figure 8) operably connected to the coil to generate a PEMF as the magnetic flux; and the source is a battery (9V battery in fig. 8).
Regarding claim 39, Tepper in view of PENNY teaches the apparatus of claim 38,
Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 wherein: a first aspect ratio of thickness to width is less than one (as seen in fig. 6); a second aspect ratio of width to length is less than one (as seen in fig. 5A); and the apparatus comprises a securement mechanism effective to maintain the planar surface of the cassette positioned to direct the magnetic flux into a blood vessel of the subject (wrist wearable device in fig. 2; col. 6 lines 14-16 :- PEMF transducer 20 and may be secured by a variety of mechanisms, such as by adhesive tape, a clamp, or a clam-shell housing made of plastic or another material; col. 2 lines 62-65 :- PEMF therapy system may be started by the physician and will continue to operate for a predetermined treatment cycle such as four hours per day until the cast has been removed).
Regarding claim 40, Tepper teaches in figure(s) 2, 5A, 5B, 8, 11 and 13 the apparatus of claim 38,
wherein the source is rechargeable by a transformer process that does not require electrical contact (col. 1 lines 50-52 :- rechargeable battery pack).
13. Claim(s) 22 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Tepper in view of Bonmassar, and further in view of PENNY.
Regarding claim 22, Tepper in view of Bonmassar teaches the method of claim 21, comprising cycling the electromagnetic field (abs. of Tepper - PEMF therapy system) between an on condition and an off condition (on/off in figures 5B, 9, 11) for a time selected.
Tepper does not teach explicitly to effect disaggregation of erythrocytes in the subject.
However, Penny teaches in figure(s) 5, 9 and 14-15 to effect disaggregation of erythrocytes in the subject (para. 26 of PENNY - aggregation of erythrocytes occurring in the blood-dark field can be dissolved).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tepper in view of Bonmassar by having to effect disaggregation of erythrocytes in the subject as taught by Penny in order to provide "A device for stimulation via special electric and magnetic fields … between a peripheral area of a human or animal … persons treated with a field having a parasympathetic-frequency 0.2 Hz had a longer reaction time in reference to the sympathetic-frequency 0.1 Hz." (abs.,para. 9).
Regarding claim(s) 34 and 35, Tepper in view of Bonmassar teaches the apparatus of claim 30 and 32, respectively, wherein the cassette is sized and shaped to position over, and pass a PEMF through (col. 5 lines 46-60 :- transducer coil may be placed in or on a cast or bandage covering the location to be treated),
Tepper does not teach explicitly a targeted blood vessel conducting blood therethrough, thereby remediating erythrocyte aggregation in the blood.
However, Penny teaches in figure(s) 5, 9 and 14-15 a targeted blood vessel conducting blood therethrough, thereby remediating erythrocyte aggregation in the blood (para. 26 of Penny - aggregation of erythrocytes occurring in the blood-dark field can be dissolved primarily by frequencies ranging from approx. 250 to 1500 Hz; para. 23 - stimulation via a coil arrangement creating a magnetic field; abs. - control frequency as base oscillation and with application-typical EEG frequencies and higher-frequency sinusoidal oscillations in the range of ca. 250 to 1500 Hz, characteristic stimulation programs can be established in modular configuration; figure 14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tepper in view of Bonmassar by having to effect disaggregation of erythrocytes in the subject as taught by Penny in order to provide "A device for stimulation via special electric and magnetic fields … between a peripheral area of a human or animal … persons treated with a field having a parasympathetic-frequency 0.2 Hz had a longer reaction time in reference to the sympathetic-frequency 0.1 Hz." (abs.,para. 9).
Conclusion
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/AKM ZAKARIA/Primary Examiner, Art Unit 2858