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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
In claim 1, line 4: there should apparently be an “and” following the semicolon.
In claim 1, line 9: “average sleep latency” should apparently read --an average sleep latency--.
In claim 1, line 11: “awakening process” should apparently read --an awakening process--.
In claims 2-4, line 1: “Method” should apparently read --The method--.
In claim 3, line 1: “electromagnetic induction” should apparently read --the electromagnetic induction--.
In claim 4, line 4: “rectangular shape” should apparently read --a rectangular shape--.
In claim 5, line 3: “unit” should apparently read --a unit--.
In claim 5, line 4: “memory and control unit” should apparently read --a memory and control unit--.
In claim 5, line 4: “the said unit” should apparently read --the unit-- or --said unit--.
In claim 5, line 5: “time control unit” should apparently read --a time control unit--.
In claims 6-12, line 1: “System” should apparently read --The system--.
In claim 8, line 1: “the said” should apparently read --the-- or --said--.
In claim 9, line 1: “the inductor coil” should apparently read --the flat bifilar inductor coil--.
In claim 10, line 1: “the said” should apparently read --the-- or --said--.
In claim 11, lines 1-2: “the said” should apparently read --the-- or --said--.
In claim 11, lines 3-4: “with periods” should apparently read --with the periods--.
In claim 12, line 2 (two instances): “the said” should apparently read --the-- or --said--.
In claim 12, line 3: “the said” should apparently read --the-- or --said--.
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: “unit for generating short ("spike") pulses of the electric field, “memory and control unit to control…,” and “time control unit to synchronize…” in claim 5; “generation unit” in claims 6 and 7 (taken to be the same as the unit from claim 5), “memory unit” in claims 11 and 12 (taken to be the same as the memory unit from claim 5). The memory unit is taught to be a memory, while the time control unit is taught to be a clock. No structure is disclosed for the other units.
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 1-12 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 1 recites the limitation “generated pulses” in line 5. It is not clear if this is intended to refer to the generated short electric field pulses recited in line 3 or if these are meant to be separate pulses.
Claim 1 also recites the limitations "the sleeping person" in line 5, “the number of transitions” in line 7, “the second stage” in lines 7-8, “the sleep cycle” in line 8, “the first stage” in line 8, “the waking state” in line 8, “the duration” in line 9, “the first 20-30 minutes of sleep” in lines 9-10, “the last 30-60 minutes of sleep” in lines 11-12, “the amount” in line 13, and “the second and third stages” in line 13. There is insufficient antecedent basis for these limitations in the claim.
Claim 1 also recites the limitation “the following algorithms” in lines 5-6. However, the subsequent limitations do not recite algorithms but instead recite intended results and method steps.
Claim 1 also recites the limitation “pulses” in line 9 and again in line 11. It is not clear if these are meant to refer to the electric field pulses recited in line 3, the generated pulses recited in line 5, or to separate pulses.
Claim 2 recites the limitation “the pulses” in line 1. It is not clear if these are meant to refer to the electric field pulses recited in line 3 of claim 1, the generated pulses recited in line 5 of claim 1, or the pulses recited in line 9 or in line 11 of claim 1.
Claim 3 recites the limitations "the rate of change" in line 2, “the value” in line 2, “the magnetic field” in line 2, and “the magnetic field source” in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 4 recites the limitations “the magnetic field value” in line 2, "the rate of rise" in line 3, and “the leading edge” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 4 also recites the limitation “electric pulses” in line 5. It is not clear if this is intended to refer to the electric field pulses recited in line 3 of claim 1, to other pulses recited in claims 1 or 2, or if these are meant to be separate pulses.
Claim 4 also recites the limitation “such pulses” in lines 3-4. It is not clear which pulses are being referred to.
Claim 5 recites the limitations "The system" in line 1, “the electric field” in line 3, and “the periods” in line 5. There is insufficient antecedent basis for these limitations in the claim.
Claim 5 also recites the limitation “short (“spike”) pulses” in line 3. It is not clear if this is intended to refer to the short (“spike”) electric field pulses recited in claim 1 or to separate pulses.
Claim 5 also recites the limitation “memory and control unit” in line 4. It is not clear if this is intended to recite a single unit or two units (i.e., a memory unit and a control unit). Paragraphs 0021-0022 of the published application refer to both a memory unit and a control unit, so these will be taken to be separate units herein.
Claim 5 also recites the limitations “unit for generating” and “control unit to control.” As detailed supra, these claim limitations invoke 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. No structure is taught for these components. 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.
Claim 6 recites the limitation "the generation unit" in line 1. There is insufficient antecedent basis for this limitation in the claim. This limitation is also recited in claim 7, which may need to be amended in kind. This is also taken to be the same as the “unit for generating” recited in claim 5, which (as detailed supra) is indefinite for lack of disclosure of corresponding structure.
Claim 6 also recites the limitation “short (“spike”) pulses” in lines 1-2. It is not clear if this is intended to refer to the short (“spike”) electric field pulses recited in claim 1 or to the short (“spike”) pulses recited in claim 5 or to separate pulses.
Claim 7 recites the limitations "the amplitude" in line 2, “the rate” in line 2, “the leading edge” in lines 2-3, and “the time-varying magnetic field shaper” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 7 also recites the limitation “short (“spike”) pulses” in line 2. It is not clear if this is intended to refer to the short (“spike”) electric field pulses recited in claim 1 or to the short (“spike”) pulses recited in claim 5 or to the short (“spike”) pulses recited in claim 6 or to separate pulses.
Claim 7 also recites the limitation “electric pulses” in line 3. It is not clear if this is intended to refer to the electric field pulses recited in line 3 of claim 1, to other pulses recited in other claims, or if these are meant to be separate pulses.
Claim 8 recites the limitation "the form" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the specified duration parameters" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the converter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the said algorithms” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim; claim 1 only recites “at least one or more … algorithms.”
Claim 11 also recites the limitation “a memory unit” in line 2. It is not clear if this is intended to refer to the memory and control unit recited in claim 5 or to a separate unit.
Claim 11 also recites the limitation “a certain duration” in line 3. It is not clear if this is intended to refer to the previously recited specified duration parameters.
Claim 12 recites the limitation “the said control algorithms” in line 1. There is insufficient antecedent basis for this limitation in the claim
Claim 12 also recites the limitations "the said Bluetooth module" in line 2 and “the said Wi-Fi module” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 also contains the trademarks/trade names Bluetooth and Wi-Fi. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks/trade names are used to identify/describe specific wireless protocols and, accordingly, the identification/description is indefinite.
Claims 2-12 are also rejected by virtue of their dependence upon at least one rejected base claim.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 5, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grossman et al. (U.S. Pub. No. 2019/0143073 A1; hereinafter known as “Grossman”).
Regarding claim 1, Grossman discloses a method for correcting human sleep parameters (Abstract), the method comprising: generating short ("spike") electric field pulses of no less than 20 milliseconds to no more than 1000 milliseconds ([0022]; [0058]; [0060]; [0083]; [0128]; [0141]); using generated pulses near the sleeping person according to at least one of the following algorithms: improving sleep continuity as measured by the number of transitions from the second stage of the sleep cycle to the first stage and to the waking state, reducing average sleep latency by gradually changing the duration of pulses over the first 20-30 minutes of sleep, simplifying awakening process by gradually changing the duration of pulses over the last 30-60 minutes of sleep, increasing the amount of slow sleep in the second and third stages of the sleep cycle ([0024]; e.g., mitigating sleep arousal or reducing sleep fragmentation improves sleep continuity by reducing the number of such transitions to the waking state; [0141]; e.g., enhancing slow-wave rhythms and maintaining deep sleep increases the amount of slow sleep in the second and third sleep cycle stages).
Regarding claim 5, Grossman discloses a system for correcting human sleep parameters to use the method according to claim 1 (Abstract) and comprising the following: unit for generating short ("spike") pulses of the electric field ([0134]; [0283]), memory and control unit to control the said unit for generating pulses ([0271]; [0375]), time control unit to synchronize the generated "spike" pulses with the periods of falling asleep, deep sleep and/or awakening ([0260]-[0261]; [0271]).
Regarding claim 11, Grossman discloses that the said algorithms are stored in a memory unit synchronized with the said time control unit to ensure that the generated "spike" pulses of electric field with a certain duration are aligned in time with periods of falling asleep, deep sleep and awakening ([0014\-[0015]; [0260]-[0261]; [0271]).
Regarding claim 12, Grossman discloses that the said control algorithms can be communicated to the said memory unit through a mobile app using the said Bluetooth module, or by a remote server through the said Wi-Fi module ([0271]; [0378]-[0380]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Grossman as applied to claims 1 and 5 above, and further in view of Wang et al. (CN 110882466 B; hereinafter known as “Wang”).
Regarding claim 2, Grossman discloses that the pulses can be either electric or electromagnetic ([0022]; [0058]; [0060]; [0083]; [0128]; [0283]), but fails to disclose that they are generated by electromagnetic induction. Wang discloses a similar method for correcting human sleep parameters (Abstract) comprising generating electric field pulses by electromagnetic induction in order to conveniently induce the sleep process and allow for sleep promotion or wake functionality. 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 invention of Grossman by generating the pulses by electromagnetic induction, as taught by Wang, in order to conveniently induce the sleep process and allow for sleep promotion or wake functionality.
Regarding claim 3, the combination of Grossman and Wang discloses the invention as claimed, see rejection supra, and Wang further disclose that electromagnetic induction is caused by the rate of change in the value of the magnetic field generated by the magnetic field source (“Further, the magnetic coil 2 of the time-varying magnetic field can coupling into the human body, but human tissue and cannot store the external magnetic field energy, so the effect of the magnetic stimulation is obviously not the effect of the magnetic field direct effect, but still the result of the current effect. according to law of electromagnetic induction law, the magnetic field changing along with time will generate electric field, and the size of the induced electromotive force generated by it is proportional to the change rate of the magnetic flux along with time, according to the law, when a certain time-varying magnetic field is applied to some part of the human body, the human body tissue can be conductor, The electric field is induced in the interior thereof, and the amplitude is only related to the change rate of the magnetic field strength and the geometric shape of the conductor.”).
Regarding claim 6, Grossman discloses that the generating unit produces short (“spike”) pulses that are either electric or electromagnetic ([0022]; [0058]; [0060]; [0083]; [0128]; [0283]), but fails to disclose that they are produced by electromagnetic induction. Wang discloses a similar system for correcting human sleep parameters (Abstract) comprising a generating unit that produces electric field pulses by electromagnetic induction in order to conveniently induce the sleep process and allow for sleep promotion or wake functionality. 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 invention of Grossman by producing the pulses by electromagnetic induction, as taught by Wang, in order to conveniently induce the sleep process and allow for sleep promotion or wake functionality.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Grossman and Wang as applied to claim 6 above, and further in view of Mauger et al. (U.S. Pub. No. 2023/0310862 A1; hereinafter known as “Mauger”). The combination of Grossman and Wang discloses the invention as claimed, see rejection supra, but fails to disclose that the generation unit is designed to change the amplitude of short ("spike") pulses through the rate of rise and amplitude of the leading edge of electric pulses fed to the time-varying magnetic field shaper. Mauger discloses a similar system (Abstract) comprising a generation unit designed to change the amplitude of pulses through the rate of rise and amplitude of the leading edge of electric pulses fed to a time-varying magnetic field shaper in order to control stimulation attributes as desired ([0029]; [0048]). 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 combination of Grossman and Wang by changing the amplitude of short ("spike") pulses through the rate of rise and amplitude of the leading edge of electric pulses fed to the time-varying magnetic field shaper, as taught by Mauger, in order to control stimulation attributes as desired.
Allowable Subject Matter
Claims 4 and 8-10 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.
The following is a statement of reasons for the indication of allowable subject matter: none of the prior art of record teaches or reasonably suggests such a method or system wherein the rate of change in the magnetic field value is controlled by the rate of rise of the leading edge of electric pulses fed to a flat bifilar coil and wherein such pulses have rectangular shape with a fill factor of less than 5%, or wherein the generation unit is designed to change the amplitude of short ("spike") pulses through the rate of rise and amplitude of the leading edge of electric pulses fed to a time-varying magnetic field shaper that is a flat bifilar inductor coil.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THADDEUS B COX/Primary Examiner, Art Unit 3791
Prosecution Insights