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 .
Election/Restrictions
Applicant’s election of claims 1-13 and 15-21 in the reply filed on 3 September 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant has elected Invention II, which appears to be directed to claim 1 and its dependents. Accordingly, claims 8-13 and 15-21 are also withdrawn from further consideration as being directed towards a non-elected invention and therefore claims 1-7 will be treated on the merits.
Drawings
3. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “bridge member” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
4. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
5. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
6. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
7. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “bridge member” in claim 3 (which is interpreted for purposes under 35 U.S.C. 112(f) as a member for bridging that is configured to support the first/second ferromagnetic components relative to each other and movably attach to the first/second ferromagnetic components).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-7 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.
10. Claim 1 at lines 4-6 recites that the first ferromagnetic component is “configured to at least partially receive the first stimulation coil,” and the second ferromagnetic component is “configured to at least partially receive the second stimulation coil”. Based on the disclosure, it is unclear what is being defined with respect to the ferromagnetic components “at least partially” receiving the stimulation coils. The figures do not portray what would constitute the ferromagnetic components “at least partially” receiving the stimulation coils, and the specification at least at [0088] and [0111]-[0112], for instance, appear to discuss a scenario of the ferromagnetic components “at least partially” receiving the respective stimulation coil such that the ferromagnetic component “is positioned proximate to a portion of the” respective treatment coil and accordingly, the limitation will be construed as such for purposes of examination.
11. In claim 3, the limitation “bridging member” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
12. Claim 4 at line 4 recites the limitation "the relative position". There is insufficient antecedent basis for this limitation in the claim.
13. Regarding claim 4, given the indefinite nature of “the bridge member” as noted above, it is unclear, in light of the disclosure as a whole, how the first and second portions of the bridge member are configured to slide past each other to adjust the relative position of the first and second coils.
14. Regarding claim 5, and in light of the disclosure (specifically with respect to Figs. 3A-4B), it is unclear how the ferromagnetic cores “at least partially surrounds” portions of the respective stimulation coil give then “surround” would imply enclosing on all sides, so it is unclear how something would partially surround something else and the disclosure does not provide anything specific with respect to that.
15. Claim 6 at line 2 recites the limitation "the first treatment coil". There is insufficient antecedent basis for this limitation in the claim.
16. Claim 6 at line 4 recites the limitation "the second treatment coil". There is insufficient antecedent basis for this limitation in the claim.
17. Claim 7 at line 1 recites the limitation "the first treatment coil". There is insufficient antecedent basis for this limitation in the claim.
18. Claim 7 at line 3 recites the limitation "the second treatment coil". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
19. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
20. 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.
21. Claims 1, 2 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farone (U.S. Pub. No. 2008/0103350). Regarding claim 1, Farone discloses a system for treating or diagnosing a patient (Abstract and [0024]), the system comprising:
a first stimulation coil and a second stimulation coil (522,524), wherein the first and second stimulation coils are circularly shaped (see Figs. 4-9 and [0088]);
a first ferromagnetic component configured to at least partially receive the first stimulation coil, and a second ferromagnetic component configured to at least partially receive the second stimulation coil ([0083]: “…the magnets can all be replaced by electromagnets where the magnetic field is obtained by AC running through wires that are wrapped into a coil…this coil is wrapped on a piece of ferromagnetic material and the most convenient form is a toroid (dough nut shape)…” wherein the wrapping of the coil on the ferromagnetic material is deemed to be the ferromagnetic material being configured to at least partially receive the coil); and
a control circuit in electrical communication with the first and second stimulation coils and configured to provide current to the first and second stimulation coils to generate a magnetic field in a target anatomy of a human subject ([0088]-[0089] and [0092]);
wherein conductive windings of the first stimulation coil 522 ([0083] and Figs. 4 and 7) are centered on a first axis 526, and windings of the second stimulation coil 524 ([0083] and Figs. 4 and 7) are centered on a second axis (Fig. 4), wherein the second axis is angularly offset relative to the first axis (Figs. 4-6); and
wherein, when the first and second stimulation coils are configured adjacent the target anatomy of the human subject, the first and second axes pass through a common point 525 within the target anatomy of the human subject (Fig. 4; [0088] and [0024]).
Regarding claim 2, Farone teaches that the first and second ferromagnetic components can be in the form of a toroid or “dough nut shape” [0083] and a “dough nut shape” is considered to be in the shape of a saucer.
Regarding claim 6, Farone teaches that the first ferromagnetic component defines an central opening that is aligned with a central opening of the first treatment coil, and the second ferromagnetic component defines a central opening that is aligned with a central opening of the second treatment coil ([0083]: “…this coil is wrapped on a piece of ferromagnetic material and the most convenient form is a toroid (dough nut shape)…” wherein a toroid inherently defines a central opening; also as shown in Fig. 7.)
22. Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markoll (U.S. Patent No. 6,447,440). Regarding claim 1, Markoll discloses a system for treating or diagnosing a patient (Abstract and Fig. 1), the system comprising:
a first stimulation coil 18 and a second stimulation coil 18 (as shown in reproduction below), wherein the first and second stimulation coils 18 are circularly shaped (see Figs.1, 2 and 6; col. 6, lines 64-67 – col. 7, lines 1-5; and col. 8, lines 42-48);
a first ferromagnetic component 16 configured to at least partially receive the first stimulation coil 18, and a second ferromagnetic component 16 configured to at least partially receive the second stimulation coil 18 (col. 6, lines 64-67 – col. 7, lines 1-5: the coils 6 each comprise ferrite cores 16, with copper wire windings 18 being wound around the periphery of a particular core, wherein the winding of the wire on the ferrite core is deemed to be the ferrite core being configured to at least partially receive the coil/winding); and
a control circuit in electrical communication with the first and second stimulation coils and configured to provide current to the first and second stimulation coils to generate a magnetic field in a target anatomy of a human subject (col. 5, lines 44-51 and col. 7, lines 6-13);
wherein the conductive copper windings of the first stimulation coil ([0083] and Figs. 4 and 7) are centered on a first axis 22, and the conductive copper windings of the second stimulation coil are centered on a second axis (Fig. 1; reproduction below; col. 7, lines 26-35 and col. 8, lines 42-48), wherein the second axis is angularly offset relative to the first axis 22 (Fig. 1; and reproduction below;); and
wherein, when the first and second stimulation coils are configured adjacent the target anatomy of the human subject, the first and second axes pass through a common point within the target anatomy of the human subject (Fig. 1; col. 7, lines 14-35 and col. 8, lines 42-57).
[AltContent: textbox ([img-media_image1.png])][AltContent: textbox (“first stimulation coil”)]
[AltContent: arrow]
[AltContent: arrow][AltContent: textbox (“second stimulation coil”)]
Regarding claim 3, the system further comprises a bridge member 4/124 that is configured to support the first and second ferromagnetic components relative to each other, wherein the bridge member 4 is movably attached to the first ferromagnetic component or the second ferromagnetic component (Figs. 1, 4 and 6; col. 6, lines 38-63; and col. 8, lines 25-67).
23. Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foreman et al. (U.S. Pub. No. 2006/0142748). Regarding claim 1, Foreman et al. (hereinafter Foreman) discloses a system for treating or diagnosing a patient (Abstract and [0011]), the system comprising:
a first stimulation coil 702 and a second stimulation coil 702, wherein the first and second stimulation coils are circularly shaped (see Fig. 7 and [0076]; coils are circularly shaped by definition);
a first ferromagnetic component 701 configured to at least partially receive the first stimulation coil 702, and a second ferromagnetic component 701 configured to at least partially receive the second stimulation coil 702 (see Fig. 7; [0039] and [0066] also teach: “magnetic circuit” is as referred to as a magnetic core; and Fig. 7 shows two circuits 701)
and a control circuit in electrical communication with the first and second stimulation coils and configured to provide current to the first and second stimulation coils to generate a magnetic field in a target anatomy of a human subject ([0046] and Fig. 1a; [0050]-[0051] and Fig. 3; and [0068]);
wherein conductive windings of the first stimulation coil (top coil 702 in Fig. 7) are centered on a first axis (double-ended arrow “703” in Fig. 7 used to indicate first axis), and windings of the second stimulation coil (bottom coil 702 in Fig. 7) are centered on a second axis (double-ended arrow “703” in Fig. 7 used to indicate second axis as well), wherein the second axis is angularly offset relative to the first axis (the second axis is deemed to be “angularly offset” relative to the first axis as the top coil 702 and bottom coil 702 are not coincident with each other and can be construed as being angled at 180 degrees with respect to each other); and
wherein, when the first and second stimulation coils 702 are configured adjacent the target anatomy of the human subject (placed in the space around “703”), the first and second axes pass through a common point within the target anatomy of the human subject (Figs. 1a-1b and 7; and [0046]-[0048]).
Regarding claim 5, the first ferromagnetic component 701 at least partially surrounds portions of the first stimulation coil 702, and the second ferromagnetic component 701 at least partially surrounds portions of the second stimulation coil 702 (shown in Fig. 7 wherein the magnetic circuit(s) 701 at least partially surround portions of the coils 702).
Claim Rejections - 35 USC § 103
24. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
25. 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.
26. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Markoll (U.S. Patent No. 6,447,440) in view of Ishikawa et al. (U.S. Pub. No. 2001/0031906). Regarding claim 7, Markoll discloses wherein the first treatment coil is attached to the first ferromagnetic component and the second treatment coil is attached to the second ferromagnetic component (col. 6, lines 64-67 – col. 7, lines 1-5: the coils 6 each comprise ferrite cores 16, with copper wire windings 18 being wound around the periphery of a particular core); however Markoll fails to disclose that the first treatment coil is electrically isolated from the first ferromagnetic component, and the second treatment coil is electrically isolated from the second ferromagnetic component.
Ishikawa et al. (hereinafter Ishikawa) teaches a system for treating a patient with magnetic fields, wherein a treatment coil is attached to, and wound around, a ferromagnetic component (Figs. 4-6, [0033]-[0035] and [0091]-[0093]) and as likewise disclosed by Markoll, wherein the copper treatment coil is electrically isolated from the ferromagnetic component due to the insulating layer(s) around the coil ([0039], [0043] and Fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an isolating layer as taught by Ishikawa, around a copper wire for conducting current utilized to generate the treatment field as suggested by Markoll, as Markoll recognizes that a copper wire around a ferrite core enhances a magnetic field utilized to treat the body of a patient (col. 4, lines 65-67 – col. 5, lines 1-22) and Ishikawa teaches that an insulated copper wire ([0039], [0043]) reduces noise caused by contact between coil parts of a copper wire, minimizing noise caused by the coil [0029].
Allowable Subject Matter
27. Claim 4 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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