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 .
Claim Objections
Claims 1, 7, and 12 are objected to because of the following informalities:
In claim 1, line 11, “on or” should read “on, or”
In claim 7, line 8, “form of or saw-tooth pulses” should read “form of saw-tooth pulses”
In claim 7, line 11, “1,5 to 3 Hz” should read “1.5 to 3 Hz”
In claim 12, line 2, “impedance of or 4 to 16” should read “impedance of 4 to 16”
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:
“sender/receiver unit” in claim 9; no equivalent structure recited in the specification.
“memory unit” in claim 9, equivalent structure disclosed on page 16, lines 20-21. Therefore, the interpretation of “memory unit” is best understood as a USB stick, SD card, and equivalents thereof.
“data processing device” in claim 9; no equivalent structure recited in the specification.
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 1-14 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.
Regarding claim 1, the phrase "particularly brain tissues" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For examination purposes, the claim will be read as though the electromagnetic device may stimulate various bodily tissues, including, but not limited to, brain tissues. See MPEP § 2173.05(d).
Claim 6 recites the phrase “configured to one or more of:” in line 2 which renders the claim indefinite. It is unclear whether the claim requires one of the subsequent options listed, as suggested by “to one or more of”, or all of the options, as suggested by the use of “and” in line 5. It is suggested to change “and” to “or”. For the purposes of examination, the claim is treated as requiring only one of the options listed. See MPEP § 2173.05(d).
Regarding claim 9, the phrase "particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For examination purposes, the claim will be read as though the amplifier may conceivably be a class d amplifier but it’s not required to be. See MPEP § 2173.05(d).
Claim limitation "sender/receiver unit" in claim 9, line 6 and “data processing device” in claim 9, line 9 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. The specification does not recite sufficient structure to perform the claimed 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.
The dependent claims not specifically addressed above are rejected under 35 U.S.C. 112(b) as
indefinite due to their dependence from indefinite claims.
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 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.
Claim(s) 1-4 and 6-10 as best understood in light of the rejection under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Butinar et al. (WO 2015155605) in view of Savage (WO 2008/051790).
Regarding claim 1, Butinar et al. teaches an electromagnetic device adapted for stimulating tissues, particularly brain tissues (Abstract), of a subject with pulsed electromagnetic fields (PEMF) (page 5, lines 22-25) with the aim of treating psychiatric disorders, depression disorders or sleep disorders (page 12, lines 27-30), the electromagnetic device comprising:
a band-shaped body structure (Fig. 3, headband 4), a plurality of coils (Fig. 3, inductive coils 3.1, 3.2, 3.3; page 12, lines 6-10) and drive electronics (Fig. 2, GSM device 1; page 1, lines 16-25; page 11, lines 9-24),
the drive electronics being configured for driving the plurality of coils by providing current, electrical pulses to the plurality of coils (page 11, line 28-29; page 3, lines 1-3 & 15-22),
the plurality of coils being configured for, in operation and in reaction to the pulses received from the drive electronics, providing a stimulus in the form of PEMFs to the tissue of a subject (page 5, lines 23-25), wherein
the plurality of coils is provided in (Abstract, “inductive coil that is installed in the headband”; page 12, lines 6-7) or
on, or
both in and on the band-shaped body structure distributed along a length (L) of the band-shaped body structure such that when the band-shaped body structure is mounted on the head of a subject in a head-band-like manner, coils are arranged along all of the circumference of the head of the subject, and such that at least one coil of the plurality of coils is arranged adjacent to the frontal region of the brain of the subject such as to enable, when the coils are in operation, stimulating the frontal region of the brain of the subject, and that other coils plurality of coils are arranged adjacent to other regions of the brain such as to enable, when the coils are in operation, stimulating other regions of the brain of the subject.
Butinar et al. fails to specifically disclose alternating current and AC pulses.
Savage teaches an analogous electromagnetic generator wherein the drive electronics being configured for driving the plurality of coils by providing alternating current, AC, pulses to the plurality of coils, and the plurality of coils being configured for, in operation and in reaction to the AC pulses received from the drive electronics (paragraphs 0010, 0030, and 0040; Fig. 3).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the electromagnetic device of Butinar et al. with the plurality of coils being configured for, in operation and in reaction to AC pulses received from the drive electronics of Savage. By implementing an alternating current, a pulsed sinusoidal magnetic field is created; a pulsed sinusoidal magnetic field may emulate Earth’s Schumann Resonance electromagnetic frequency range, thereby promoting a state of relaxation (Savage, paragraphs 0005 and 0030).
Regarding claim 2, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above wherein the coils of the plurality of coils are distributed evenly along the length of the band-shaped body structure (Butinar et al., Fig. 3, headband 4 and inductive coils 3.1-3.3, where coils 3.1, 3.2, and 3.3 are spaced evenly along the length).
Regarding claim 3, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above wherein the coils of the plurality of coils are distributed along the entire length of the band-shaped body structure (Butinar et al., see Modified Fig. 3, where the inductive coils are distributed along the length of the headband).
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Modified Figure 3
Regarding claim 4, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above wherein the band-shaped body structure comprises opposite end sections at longitudinally opposite ends, and wherein no coils are arranged in the end sections (Butinar et al., see Modified Fig. 3, where the end sections of the headband 4 do not have coils).
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Modified Figure 3
Regarding claim 6, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above wherein the drive electronics (Butinar et al., Fig. 2, GSM device 1; page 1, lines 16-25; page 11, lines 9-24) is configured to one or more of:
operate the plurality of coils such that coils, which when the band-shaped body structure is mounted on the head of a subject are arranged on mutually opposite positions of the head of the subject, are operated in mutually opposite phases (Butinar et al., Fig. 3, where inductive coils 3.1 and 3.3 are arranged mutually opposite; page 12, lines 6-11; page 1, line 34 & page 2, lines 1-2), and/or
operate the plurality of coils such that coils which are spaced apart with a distance corresponding to half of a length of the band-shaped body structure are operated in mutually opposite phase.
Regarding claim 7, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above wherein the drive electronics (Butinar et al., Fig. 2, GSM device 1) is configured to:
provide the plurality of coils with AC-pulses in the form of square pulses,
provide the plurality of coils with AC-pulses in the form of square impulses with a period of less than one second and a rise time of less than one second,
provide the plurality of coils with AC-pulses in the form of or saw-tooth pulses,
provide the plurality of coils (Butinar et al., Fig. 3, inductive coils 3.1, 3.2, 3.3; page 12, lines 6-10) with AC pulses (Savage, paragraphs 0010 and 0030) having a frequency of less than 3 Hz (Butinar et al., page 13, lines 18-19),
provide the plurality of coils with AC-pulses having a frequency of 1.5 to 3 Hz,
provide the plurality of coils with AC pulses having a frequency of between 45 and 60 Hz,
provide the plurality of coils with AC-pulses having a frequency of 50 to 60 Hz, or
provide the plurality of coils with AC-pulses having a frequency about 55 Hz.
Regarding claim 8, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above wherein the band-shaped body structure is made of a resilient and heat resistant material (Butinar et al., page 2, lines 29-32).
Regarding claim 9, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above. Butinar et al. further teaches drive electronics (Fig. 2, GSM device 1; page 1, lines 16-25; page 11, lines 9-24) but fails to specifically disclose wherein the drive electronics comprises: a) an amplifier, particularly a class d amplifier, configured to amplify AC pulses, b) a pulse generator configured to generate AC pulses, c) a sender/receiver unit configured to send and/or receive or both send and receive data signals and/or AC pulses, d) a memory unit, e) a data processing device, or f) input and/or output terminals for any one of the above items b) to d).
Savage teaches an analogous electromagnetic generator wherein the drive electronics (Fig. 1) comprises:
an amplifier, particularly a class d amplifier, configured to amplify AC pulses (Fig. 1; para. 0039, “The coil driver 66 may be an amplifier”),
a pulse generator configured to generate AC pulses (Fig. 1, analog converter 64; para. 0029),
a sender/receiver unit configured to send or receive or both send and receive data signals and/or AC pulses (para. 0039, "The coil driver 66 buffers the high impedance output voltage from the digital to analog converter 64”),
a memory unit (para. 0028, "Next, at step 52, the microcontroller 14 adds a fractional constant to the accumulator or buffer and stores the LSB in the sixteen bit phase accumulator"),
a data processing device (para. 0060, "The microcontroller 98 then decodes the incoming data to make a determination at step 142"; para. 0051, “the microcontroller 98 is in electrical communication with a coil driver 102”), or
input and/or output terminals for any one of the above items b) to d).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the electromagnetic device of Butinar et al. in view of Savage with the drive electronics comprising an amplifier, a pulse generator, sender/receiver unit, memory unit, and data processing device of Savage. Modifying the drive electronics to include an amplifier, pulse generator, memory unit and sender/receiver unit creates a complex control system. The additional drive electronic components ensure the effective amount of current is supplied to coil to drive an appropriate waveform. Additionally, a data processing device may supplement the magnetic system via an executable code from a feedback system/loop which safeguards the generated magnetic field (Savage, paragraphs 0029, 0039, and 0050).
Regarding claim 10, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above wherein the band-shaped body structure (Butinar et al., Abstract):
is configured for mounting on the head of a subject, or
is provided as a head-band (Butinar et al., Fig. 1, headband 4; page 2, lines 29-33), or
is incorporated in a pillow.
Claim(s) 5 and 11-13 as best understood in light of the rejection under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Butinar et al. in view of Savage, further in view of Liemohn et al. (US 2019/0224489).
Regarding claim 5, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 1 as stated above. Butinar et al. in view of Savage fails to teach wherein the drive electronics are configured to operate at an impedance of 1 to 16 Ohms.
Liemohn et al. teaches an analogous ultra-low-intensity oscillating magnetic field generator wherein the drive electronics are configured to operate at an impedance of 1 to 16 Ohms (para. 0059).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the electromagnetic device of Butinar et al. in view of Savage with the drive electronics configured to operate at an impedance of 1 to 16 Ohms of Liemohn et al. An optimum impedance is required in an efficient oscillator design; therefore, if the coils are connected in a series, the impedance of each coil reflects a percentage of the total impedance for the circuit. A low impedance permits more current to flow into the coils; the current driven into the coils ultimately generates the stimulating fields (Liemohn et al., paragraphs 0058-0059, 0064).
Regarding claim 11, a modified Butinar et al. in view of Savage, further in view of Liemohn et al. teaches the electromagnetic device according to claim 5 as stated above wherein the drive electronics are configured to operate at an impedance of 2 to 4 Ohms (Liemohn et al., para. 0059).
Regarding claim 12, a modified Butinar et al. in view of Savage, further in view of Liemohn et al. teaches the electromagnetic device according to claim 5 as stated above wherein the drive electronics are configured to operate at an impedance of 4 to 16 Ohms (Liemohn et al., para. 0059).
Regarding claim 13, a modified Butinar et al. in view of Savage, further in view of Liemohn et al. teaches the electromagnetic device according to claim 5 as stated above. Butinar et al., as modified above, fails to teach wherein the drive electronics are configured to operate at a voltage below 25 Volts.
Savage further teaches wherein the drive electronics are configured to operate at a voltage below 25 Volts (Savage, para. 0076).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the electromagnetic device of Butinar et al. in view of Savage, further in view of Liemohn et al. with the drive electronics configured to operate at a voltage below 25 Volts of Savage. Setting a maximum voltage of 25 Volts establishes a low-voltage power supply that provides the necessary current to the coils for the specified, low intensity therapy treatment, thereby preventing the device from producing excessive, hazardous currents (Savage, paragraphs 0021 and 0073).
Claim(s) 14 as best understood in light of the rejection under 35 U.S.C. 112(b) above, is/are rejected under 35 U.S.C. 103 as being unpatentable over Butinar et al. in view of Savage, further in view of O Gyeong Taek (KR 100864146), citing to attached translation.
Regarding claim 14, Butinar et al. in view of Savage teaches the electromagnetic device according to claim 8 as stated above. Butinar et al. in view of Savage fails to teach wherein the plurality of coils is embedded in the resilient material.
O Gyeong Taek teaches an analogous electromagnetic field generator wherein the plurality of coils is embedded in the resilient material (page 8, para. 13, “device 500 is preferably designed with a silicon material”; Fig. 8, electromagnetic wave generator group 520, main body part 510).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the electromagnetic device of Butinar et al. in view of Savage with the resilient material that the coils are embedded in of O Gyeong Taek. Embedding the coils in a silicone material may prevent the likelihood of the coils leaking and burning the user due to overheating (O Gyeong Taek, page 5, para. 11, “possible to prevent safety accidents such as leakage, fire, burn, etc. due to coil damage or overheating”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“ELMAG GmbH” (DE 20021433) discloses a magnetic field therapy device with drive electronics comprising a pulse generator for generating a control voltage that controls the current to the coil. Jiang et al. (2018) discloses a pulse electromagnetic field apparatus that produces a field by driving an alternating current through multi-turn coils. Okano et al. (2017) investigates alternating current electromagnetic fields on human subjects, specifically, the effects of two separate electromagnetic coils, set horizontally inside an EMF exposure device. Mishelevich et al. (US 2007/02601078) teaches a transcranial magnetic stimulation with a plurality of coils disposed on a frame. Mueller (US 6,179,771) discloses a coil arrangement for transcranial magnetic stimulation that targets the frontal region of the brain. The frame, that the coils are arranged on, does not appear to wrap around the circumference of the head. Burnett et al. (US 2003/0158583) discloses a device for electromagnetic stimulation, the device comprises a polarity of coils located on a “body wrap” structure.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791