DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a device, classified in A61N2/00.
II. Claims 14-19, drawn to device, classified in A61M21/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design or mode of operation. Invention I is directed to a device that uses magnetic fields and light stimulation while Invention II is directed to a device with electrodes that generates stimuli based on an EEG signal, thus Inventions I and II have completely different structures and modes of operation. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Separate classification thereof and
A different field of search.
As noted above, Inventions I and II are classified in different areas and their different structures and functions would require searches in different classification areas.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This application contains claims directed to the following patentably distinct species A-stimulation using permanent magnets (see figure 1) and species B – stimulation with a transcranial magnetic stimulation coil (see figure 2). The species are independent or distinct because the two are completely different magnetic stimulation paradigms that require different structures and control mechanisms. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 7 and 11-13 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The two species fall under different subclasses and would require different fields and queries of search due to their different structures and control operations.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Hal Gibson on 1/21/2025 a provisional election was made without traverse to prosecute the invention of Group II, claims 14-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/13/2023 is being considered by the examiner.
Claim Objections
Claim 14 objected to because of the following informalities:
In claim 14, line 5, “provide a stimulus to subject” should be --provide a stimulus to a subject--.
In claim 14, line 8, “delivered; estimate” should be –delivered; and estimate--.
Appropriate correction is required.
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 14-19 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 14 recites the limitation "the intrinsic frequency" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Claims 15-19 inherit the deficiencies of claim 14.
Claim 15 recites the limitation "the form" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the form" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the form" and “the skin” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0056083 (Jin).
In regards to claim 14, Jin discloses a device and methodology for optimizing stimulation (paragraphs 4-106; figure 3) where the device has the following components:
a controller (309) comprising a processor, an EEG amplifier, and memory (paragraphs 58 and 70; figure 3);
a first electrode (303) configured to detect electrical brain activity and coupled to the controller (paragraphs 36 and 70; figure 3);
a second electrode (306) configured to detect a reference signal and coupled to the controller (paragraphs 36 and 70; figure 3);
wherein the controller is configured to
generate and provide a stimulus to subject through rhythmic stimulation frequencies in or around a desired EEG band (paragraphs 17, 52-54, 58-63, and 69; Administering stimulation requires the generation and providing of a stimulus.);
determine an optimal rhythmic stimulation frequency which optimizes an aspect of an EEG spectrum recorded while the stimulus is being delivered (paragraphs 5, 17, 52-54, 58-63, and 69; Adjustments of stimulation frequency after each pulse train for maximum settling time where maximum settling is correlated to pulse frequency matching resonant frequency); and
estimate the intrinsic frequency of the EEG band based on EEG data received from the subject (paragraphs 17, 52-55, 58-63, and 69).
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.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0056083 (Jin) as applied to claim 14 above, and further in view of US 2008/0269652 (Reiner).
In regards to claims 15-17, Jin discloses the limitations of claim 14 but does not state that the stimulus is generated by lights, speakers, or pressure applied to skin. In a related area, Reiner discloses a multimodal therapeutic system which uses massage, pulses of light, and pulses of sound (title and abstract; paragraphs 9-36). Reiner discloses the use of a controller (30) that controls speakers (26) to deliver sound to the subject (paragraphs 6, 17, 25 and 33), light to deliver visible signals (paragraphs 6, 10, 11, 16, 17, 21, and 24-36; bulbs, light emitting diodes or other light producing material emit the light), and a massage system that exerts pressure on the skin (paragraphs 15, 22, 23, 34, and 35). Reiner states that the combination of stimulation techniques provides stimulation that exceeds the expected results from single or paired techniques (paragraph 9). Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of Jin to provide light, sound, and pressure stimuli as taught by Reiner in order to provide better stimulation results than individual or paired stimulation and provide better relaxation.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0056083 (Jin) as applied to claim 14 above, and further in view US 2018/0055402 (Izvarina).
In regards to claim 19, Jin discloses the limitations of claim 14 but does not state that the electrodes are part of a headband. In a related area, Izvarina discloses methods and system for therapeutic neuromodulation (title and abstract). Of note is paragraph 72, which describes the electrodes used in the device and the use of headbands or caps to hold the electrodes in place. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Jin to make the electrodes as part of an EEG cap or headband in order to hold the electrodes in place.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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, Charles Marmor 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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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791