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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS document(s) have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is invited to point out any particular references in the submitted IDS documents which they believe may be of particular relevance to the instant claimed invention in response to this Office action.
The information disclosure statements filed 26 January 2024 and 8 April 2024 fail to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because each non-patent literature reference has not been provided a publication date. It has been placed in the application file, but the lined-through information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
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 Objections
Claims 36, 37, and 45 are objected to because of the following informalities:
Claim 36: “the positioning arm” should read --the positioning arm.-- to add a period at the end of the claim.
Claim 37: “sleeve..” should read --sleeve.--.
Claim 45: “to contact the patient” should read --to contact the patient.--.
Appropriate correction is required.
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:
“device for directing a fluid cooling media” first appearing in claim 31 (corresponding structure disclosed in applicant’s specification as a blower, pump, fan, or a hose with a nozzle and/or jet ([0089]; [00665])
“switching device” first appearing in claim 31 (corresponding structure disclosed in applicant’s specification as a switch 30 element including a diode, MOSFET, JFET, IGBT, BJT, or thyristor [00127])
“latching member” first appearing in claim 36 (corresponding structure disclosed in applicant’s specification as element 22, [00118])
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 31-38 and 55 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 31 recites the limitation “an inlet proximate to a connecting tube, wherein the connecting tube is configured to be coupled to the applicator”. As written, it is unclear whether the connecting tube is intended to be part of the applicator or some external component.
Claim 55 recites a magnetic flux density in units of T/s while parent claim 54 recites the magnetic flux density in units of Teslas. It is unclear how applicant intends to characterize the magnetic flux density claimed.
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 31 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0015995 (Leung et al.) in view of U.S. Patent No. 3,251,085 (Jacobs).
Regarding claim 31, Leung teaches a treatment device for treatment of a patient (abstract; [0030]; Figure 1), the treatment device comprising: an applicator (102) comprising: a casing (112); a magnetic field generating coil (coil, [0034]) enclosed by the casing; and a device for directing a fluid cooling media into the casing, wherein the fluid cooling media removes heat from the magnetic field generating coil (“forced-air cooling systems”, [0047]); a lower side configured to be placed on the patient (Figure 1); an upper side configured to face away from the patient, wherein the upper side is positioned opposite to the lower side (Figure 1); a handle (114); and a switching device configured to be switched to discharge a capacitor to the magnetic field generating coil to generate an impulse of at time-varying magnetic field with a magnetic flux density in a range of 0.1 Tesla to 7 Tesla and with a repetition rage in a range of 1 Hz to 300 Hz ([0033]; “switching device” construed as thyristors, [0047]; 3T at 1Hz, [0044]; Figure 6), and wherein the time-varying magnetic field is configured to be applied to a brain of the patient (The limitation “to be applied to a brain of the patient” is intended use. Since the magnetic stimulator 102 is handheld and capable of being placed “over a portion of a human body” [0030], the stimulator 102 is capable of being placed to apply stimulation to the patient’s brain.). Leung does not teach the handle forms an opening, wherein the opening is proximate to the upper side and an inlet proximate to a connecting tube, wherein the connecting tube is configured to be coupled to the applicator.
However, Jacobs teaches a handheld device (Figure 1) comprising a casing (15); a handle (11) forming an opening, wherein the opening is proximate to an upper side of the device; and a cooling system comprising an inlet (32) proximate to a connecting tube, wherein the connecting tube is configured to be coupled to the device (“cooling system”, col. 3, lines 19-38; “connecting tube” extends through an “opening” in the handle, see annotated Figure 2 below). 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 device of Leung such that the handle includes an opening proximate the upper side of the device and a connecting tube as taught by Jacobs in order to provide an opening for wiring inputs to extend through the handle to the interior of the device located away from the treatment region of the device. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the applicator of Leung as modified to include an inlet proximate the connecting tube as taught by Jacobs in order to allow the intake of air to be passed over the heat-generating components of the interior of the device for cooling (Jacobs: col. 3, lines 19-39), as desired by Leung ([0047]).
Regarding claim 33, Leung in view of Jacobs teaches all the limitations of claim 31. Leung as modified does not specify the applicator further comprises an outlet farther from the connecting tube than the inlet.
However, Jacobs further teaches the device includes an outlet (36) farther from the connecting tube than the inlet (32) (col. 3, lines 19-39; Figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Leung as modified to include an outlet farther from the connecting tube than the inlet as taught by Jacobs in order to provide an exhaust for the air blown over the heated interior components (Jacobs: col. 3, lines 19-39).
Regarding claim 34, Leung in view of Jacobs teaches all the limitations of claim 33. Leung as modified teaches the magnetic field generating coil is flat, and wherein the fluid cooling media flows in a direction parallel to the magnetic field generating coil (flat coil, Figures 1 and 3C; air blown over flat coils flows in a direction reasonably parallel to the flat coil, see Figures 1 and 3C; cooling, [0047]).
Regarding claim 35, Leung in view of Jacobs teaches all the limitations of claim 31. Leung as modified teaches the applicator further comprises an input element configured to adjust the magnetic flux density (“one or more control knobs 106 to adjust the tMS stimulator settings”, [0044]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0015995 (Leung et al.) in view of U.S. Patent No. 3,251,085 (Jacobs) as applied to claim 31 above, and further in view of U.S. Patent No. 6,149,577 (Bouldin et al.).
Regarding claim 32, Leung in view of Jacobs teaches all the limitations of claim 31. Leung as modified does not specify the magnetic field generating coil comprises an insulated wire.
However, Bouldin teaches a magnetic stimulation device (abstract), comprising a magnetic field generating coil comprising an insulated wire (col. 4, lines 14-19). 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 coil of Leung as modified to comprise an insulated wire as taught by Bouldin “because of the heat generated in the coil due to the inherent resistance of the wire to carry a current” (Bouldin: col. 4, lines 14-19).
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 31-37, 39-52, and 54-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18/783,229 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 31 of the instant application is merely broader in scope than all that is recited in claim 1 of the ‘229 application. That is, claim 31 is anticipated by claim 1 of the ‘229 patent. Similarly, instant claim 39 is anticipated by claim 9 of the ‘229 patent, instant claim 46 is anticipated by claim 16 of the ‘229 patent, and instant claim 54 is anticipated by claim 24. Once applicant has received a patent for a species or a more specific embodiment, applicant is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)). Claims 32-37, 40-45, 47-52, and 55-60 of the instant application are anticipated by claims 1-30 of the ‘229 application, by the same reasoning.
Allowable Subject Matter
Claim 38 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.
Claim 53 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
No prior art of record teach and/or fairly suggest the treatment device of claim 38 wherein the applicator is configured to be maintained to the patient by a belt, within the context of all the limitations of parent claims 31 and 36.
No prior art of record teach and/or fairly suggest the treatment device of claim 53, wherein the treatment device further comprises a positioning arm configured to maintain the applicator proximate to the patient, and wherein the applicator is maintained to the patient by a belt, within the context of all the limitations of claims 46 and 50-52.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
