DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 14/412875, filed on 5 January 2015.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract contains the legal phraseology “means”.
Claim Interpretation
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.
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.
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: “retaining element” in claim 58.
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
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 51-64 and 66 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.
Claim 51 at line 9 recites the limitation "the outlet". There is insufficient antecedent basis for this limitation in the claim.
In claim 58, limitation “retaining element” 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.
At line 1 of claim 66, it is unclear if “fan” is the same as or different than “the fan” recited in claim 65. A suggested amendment to claim 66 is –the fan--.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 51 is rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 51 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 51 at line 9 recites “the outlet is positioned farther from the patient than the inlet opening” which is a recitation of human subject matter. A suggested amendment is to insert “configured to” language to obviate a rejection under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 51-59, 61-66 and 68-70 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ishikawa (U.S Patent No. 5,984,854).
Regarding claim 51, Ishikawa teaches a treatment device for generating a time-varying magnetic field (see Abstract and Fig. 1; col. 4, lines 61-63; and col. 6, lines 13-26), the treatment device comprising:
a stimulation coil encapsulated in a plastic housing (col. 4, lines 64-67 – col. 5, line 1; and Figs. 2A-2B),
wherein the stimulation coil is configured for an electric current in a range of 500 A to 6000 A (col. 5, lines 23-30), and wherein the plastic housing comprises:
an inlet opening (pipe 4a/c) configured to provide air to the stimulation coil (Figs. 1-2B and col. 5, lines 1-7 and col. 6, lines 27-32); and
an outlet opening (discharge pipe 4b/d) configured to direct the air away from a patient (Figs. 1-2B and col. 5, lines 1-7 and col. 6, lines 27-32),
wherein the outlet (discharge pipe 4b/d) is positioned farther from the patient than the inlet opening (pipe 4a/c) as shown in Fig. 1;
a pulse capacitor configured to be discharged to the stimulation coil such that the stimulation coil generates the time-varying magnetic field (col. 5, lines 13-30);
a thyristor configured to be switched (col. 5, lines 13-21); and
a fan/cooling apparatus 4 configured to aspirate air towards the stimulation coil through the inlet opening such that the stimulation coil is cooled (col. 9, lines 21-23 and col. 5, lines 1-7 and col. 6, lines 27-32),
wherein the cooling apparatus 4 is positioned between the inlet opening (pipe 4a/c) and the outlet opening (discharge pipe 4b/d) as shown in Fig. 1, and
wherein the cooling apparatus 4 is configured to direct the air from the inlet opening to the outlet opening (col. 5, lines 1-7).
While Ishikawa does teach that the disclosed cooling apparatus may be a fan, Ishikawa fails to disclose explicitly that the fan itself is positioned between the inlet opening and the outlet opening, and the fan itself is configured to direct the air from the inlet opening to the outlet opening. However, since Ishikawa does disclose that the cooling apparatus 4 is positioned between the inlet opening (pipe 4a/c) and the outlet opening (discharge pipe 4b/d) as shown in Fig. 1, and the cooling apparatus 4 is configured to direct the air from the inlet opening to the outlet opening (col. 5, lines 1-7), and that a fan may be used instead of the disclosed cooling element/apparatus, it would have been obvious to one of ordinary skill in the art in light of such a substitution that the fan (instead of the cooling apparatus) would be positioned between the inlet and outlet openings, and direct air from the inlet opening to the outlet opening. Substituting the fan for the cooling element would have arrived at the same purpose of cooling the coil (col. 9, lines 21-23).
Regarding claim 52, the treatment device is configured to apply the time-varying magnetic field to a body region of the patient, the body region comprising at least one of an abdomen, a buttock, or a thigh (Figs. 1, 5A-5C and 7A).
Regarding claim 53, the treatment device is capable of generating a time-varying magnetic field comprising diphase impulses with a stimulation frequency in a range of 10 Hz to 30 Hz (as shown in Fig. 4 and disclosed at col. 5, lines 60-67 – col. 6, lines 1-12; and due to thyristors 16,16a - col. 5, lines 13-23).
Regarding claim 54, the inlet opening (pipe 4a/c) is positioned on a perimeter of the plastic housing (Figs. 2A-2B).
Regarding claim 55, the plastic housing is replaceable (due to various connections between the components – col. 4, lines 64-67 – col. 5, lines 1-11).
Regarding claim 56, the plastic housing comprises a first side configured to be oriented towards the patient and a second side configured to be oriented away from the patient (Figs. 1-2B and 5A-5B), and wherein the fan/cooling apparatus 4 is proximate to the second side (bottom of coil as oriented in Fig. 1) such that a distance between the fan/cooling apparatus 4 and the second side is less than a distance between the fan and the first side (the position of the coils can be changed during treatment (col. 8, lines 25-29).
Regarding claim 57, the fan/cooling apparatus 4 is configured to direct the air from the stimulation coil in a direction perpendicular to the stimulation coil (discharge pipe 4b is perpendicular to the stimulation coil in 19 as shown in Fig. 1).
Regarding claim 58, Ishikawa teaches a treatment device for generating a time-varying magnetic field (see Abstract and Fig. 1; col. 4, lines 61-63; and col. 6, lines 13-26), the treatment device comprising:
a stimulation coil encapsulated in a plastic housing (col. 4, lines 64-67 – col. 5, line 1; and Figs. 2A-2B) comprising an inlet opening (pipe 4a/c) and an outlet opening (discharge pipe 4b/d) (Figs. 1-2B and col. 5, lines 1-7 and col. 6, lines 27-32);
wherein the housing comprises a first side and a second side, wherein the first side is configured to be positioned facing towards a patient (Figs. 1, 5A and 8A-8B, wherein the second side is opposite to the first side (Figs. 1-2B and 5A-5B), and
wherein the inlet opening is positioned on a side of the housing between the first side and the second side (Figs. 1 and 2A-2B);
a retaining element (synthetic resin which tightly covers each coil) disposed between the stimulation coil and the housing such that the stimulation coil is spaced from the housing (col. 4, lines 66-67 – col. 5, line 1);
a thyristor configured to enable a pulse capacitor to discharge a current pulse in a range of 500 A to 6000 A to the stimulation coil such that the stimulation coil generates the time-varying magnetic field (col. 5, lines 13-30); and
a fan/cooling apparatus 4 configured to aspirate air into the housing through the inlet opening to cool the stimulation coil (col. 9, lines 21-23 and col. 5, lines 1-7 and col. 6, lines 27-32),
wherein the cooling apparatus 4 is configured to direct the air through the housing from the inlet opening to the outlet opening (col. 5, lines 1-7).
While Ishikawa does teach that the disclosed cooling apparatus may be a fan, Ishikawa fails to disclose explicitly that the fan itself is configured to direct the air through the housing from the inlet opening to the outlet opening. However, since Ishikawa does disclose that the cooling apparatus 4 is configured to direct the air through the housing from the inlet opening to the outlet opening (col. 5, lines 1-7), and that a fan may be used instead of the disclosed cooling element/apparatus, it would have been obvious to one of ordinary skill in the art in light of such a substitution that the fan (instead of the cooling apparatus) would be configured to direct air through the housing from the inlet opening to the outlet opening. Substituting the fan for the cooling element would have arrived at the same purpose of cooling the coil (col. 9, lines 21-23).
Regarding claim 59, the stimulation coil is configured to be replaced by another stimulation coil (col. 7, lines 65-67; and due to various connections between the components – col. 4, lines 64-67 – col. 5, lines 1-11).
Regarding claim 61, the inlet opening (pipe 4a/c) is positioned on a perimeter of the plastic housing (Figs. 2A-2B).
Regarding claim 62, the housing is replaceable (due to various connections between the components – col. 4, lines 64-67 – col. 5, lines 1-11).
Regarding claim 63, the coil is between the first side of the housing and the fan (Figs. 1-2B and 5A-5B),
wherein the fan/cooling apparatus 4 is disposed farther from the first side of the housing than from the coil (the position of the coils can be changed during treatment (col. 8, lines 25-29) and thus placement of the coil as shown in Fig. 9 would position the fan/cooling apparatus 4 farther from the first side of the housing than from the coil as the first side of the housing could be facing away from the patient and the fan/cooling apparatus behind the patient), and
wherein the fan/cooling apparatus 4 is configured to direct the air in a direction away from the patient (due to discharge pipe 4b/d).
Regarding claim 64, the fan/cooling apparatus 4 is configured to direct the air from the stimulation coil in a direction perpendicular to the stimulation coil (discharge pipe 4b is perpendicular to the stimulation coil in 19 as shown in Fig. 1).
Regarding claim 65, Ishikawa teaches a treatment device for generating a time-varying magnetic field (see Abstract and Fig. 1; col. 4, lines 61-63; and col. 6, lines 13-26), the treatment device comprising:
a stimulation coil encapsulated in a plastic housing (col. 4, lines 64-67 – col. 5, line 1; and Figs. 2A-2B), wherein the plastic housing is removably coupled to the treatment device (due to various connections between the components – col. 4, lines 64-67 – col. 5, lines 1-11);
a pulse capacitor configured to be discharged to the stimulation coil such that the stimulation coil generates the time-varying magnetic field (col. 5, lines 13-30); and
a fan/cooling apparatus 4 configured to aspirate air into the plastic housing through an inlet opening (4a/c) to cool the stimulation coil (col. 9, lines 21-23 and col. 5, lines 1-7 and col. 6, lines 27-32),
wherein the fan/cooling apparatus 4 is configured to direct the air through the plastic housing from the inlet opening to an outlet opening (4b/d) such that the air flows out of the plastic housing in a direction away from a patient (col. 5, lines 1-7), and
wherein the fan/cooling apparatus 4 is configured to direct air from the stimulation coil in a direction perpendicular to the stimulation coil (discharge pipe 4b is perpendicular to the stimulation coil in 19 as shown in Fig. 1).
While Ishikawa does teach that the disclosed cooling apparatus may be a fan, Ishikawa fails to disclose explicitly that the fan itself is configured to direct the air from the inlet opening to the outlet opening, and in a direction perpendicular to the stimulation coil. However, since Ishikawa does disclose that the cooling apparatus 4 is configured to direct the air from the inlet opening to the outlet opening (col. 5, lines 1-7), and in a direction perpendicular to the stimulation coil (discharge pipe 4b is perpendicular to the stimulation coil in 19 as shown in Fig. 1), and that a fan may be used instead of the disclosed cooling element/apparatus, it would have been obvious to one of ordinary skill in the art in light of such a substitution that the fan (instead of the cooling apparatus) would be positioned to direct air from the inlet opening to the outlet opening, and in a direction perpendicular to the stimulation coil. Substituting the fan for the cooling element would have arrived at the same purpose of cooling the coil (col. 9, lines 21-23).
Regarding claim 66, while Ishikawa does teach that the disclosed cooling apparatus may be a fan, Ishikawa fails to disclose explicitly that the fan itself is positioned between the inlet opening and the outlet opening. However, since Ishikawa does disclose that the cooling apparatus 4 is positioned between the inlet opening (pipe 4a/c) and the outlet opening (discharge pipe 4b/d) as shown in Fig. 1, and that a fan may be used instead of the disclosed cooling element/apparatus, it would have been obvious to one of ordinary skill in the art in light of such a substitution that the fan (instead of the cooling apparatus) would be positioned between the inlet and outlet openings. Substituting the fan for the cooling element would have arrived at the same purpose of cooling the coil (col. 9, lines 21-23).
Regarding claim 68, the stimulation coil comprises a plurality of wires 5a,b (col. 5, lines 1-11).
Regarding claim 69, the plastic housing comprises a concave curvature (Fig. 7C).
Regarding claim 70, the inlet opening (pipe 4a/c) is positioned on a perimeter of the plastic housing (Figs. 2A-2B).
Claim 60 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ishikawa (U.S Patent No. 5,984,854) in view of Mo (U.S. Pub. No. 2006/0187607). Regarding claim 60, Ishikawa discloses the invention as claimed, see rejection supra; however Ishikawa fails to disclose that the treatment device further comprises a source of light. Mo teaches an apparatus for creating a time-varying, pulsed magnetic field for the stimulation of biological tissue (see Abstract and [0002]), as likewise disclosed by Ishikawa, wherein the apparatus for creating pulse magnetic stimulation comprises a voltage supplying section, an input switch, a pulse capacitor and a magnet coil [0081] (as likewise disclosed by Ishikawa), wherein the control unit for controlling the components of the generation of the magnetic field includes peripherals such as a monitor, keyboard and memory unit [0092]. A monitor is a known source of light. At the time of the invention, it would have been obvious to one of ordinary skill in the art to incorporate a monitor as taught by Mo, into an apparatus for generating a pulsed magnetic field as taught by Ishikawa, as Ishikawa recognizes the use of electrical control circuitry to generate such a pulsed magnetic field (Figs. 1, 3 and col. 5, lines 12-30 and 60-67) and Mo discloses use of a conventional control unit/computer with a display to control the magnetic stimulation apparatus [0083]; a display of which is well-known to emit light.
Allowable Subject Matter
18. Claim 67 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 67, while the prior art teaches a treatment device for generating a time-varying magnetic field, the treatment device comprising: a stimulation coil encapsulated in a plastic housing, wherein the plastic housing is removably coupled to the treatment device; a pulse capacitor configured to be discharged to the stimulation coil such that the stimulation coil generates the time-varying magnetic field; and a fan configured to aspirate air into the plastic housing through an inlet opening to cool the stimulation coil, wherein the fan is configured to direct the air through the plastic housing from the inlet opening to an outlet opening such that the air flows out of the plastic housing in a direction away from a patient, and wherein the fan is configured to direct air from the stimulation coil in a direction perpendicular to the stimulation coil, the prior art of record does not teach or fairly suggest a treatment device for generating a time-varying field as claimed by Applicant, wherein the plastic housing comprises a first side configured to be positioned proximate to the patient and a second side configured to be positioned farther from the patient than the first side, wherein the stimulation coil is positioned closer to the first side than the second side, and wherein the fan is positioned closer to the second side than the first side.
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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