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/Restrictions
Applicant's election with traverse of Group I (claims 1-8) in the reply filed on March 17, 2026 is acknowledged. The traversal is on the ground(s) that the search for both sets of claims substantially overlaps and that issues regarding patentability are the same for both sets. This is not found persuasive because the apparatus is not limited to treating brain diseases. The preamble in claim 1 recites intentional use and does not breathe life and meaning into the claim. The body of the claim does not contain any restriction on the type of therapy employed. The apparatus, for example, could be found in any system that applies stimulation to the eye, including systems aimed at treating glaucoma, enhancing ocular blood flow, stimulating phosphenes, preventing degenerative eye diseases, iontophoresis, electrocautery, etc.. Treatments for dementia and/or depression are recognized to have vastly different mechanisms than any of the treatment examples listed above. The inventions therefore contain divergent subject matter and require a different field of search employing different searching strategies.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2 and 3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 2, the relationship between data related to brain activity and the adjustment of current parameters is unknown. The claim limitation has a wide breadth. It is unclear what constitutes “data related to brain activity” (e.g, detected chemical imbalances, EEG activity, metabolic activity, magnetic field activity, changes in blood oxygenation and flow, the subjective mood of the individual under treatment, etc.). The relationship between transcorneal current parameters and brain activity is further unclear. It is, for example, not known what effect changing current frequency, or pulse duration or repetition periods, etc., of transcorneal stimulation has on brain activity and the treatment of brain disease. The term “brain disease” is expansive and may cover a multitude of different and highly complex diseases that have proven particularly difficult to treat (e.g., Alzheimer’s, dementia, depression, etc.), that may require a wide variety of specialized pulse parameters in various combinations. The nature of the invention and state of the art is such that there is a high level of unpredictability. The reference “Transcorneal electrical stimulation enhances cognitive functions in aged and 5XFAD mouse models,” authored by several of the inventors of the invention, states that to the best of their knowledge, it is the first study to investigate the effect of TES on cognitive functions in animal models (page 14, second last paragraph of col. 1). The applicants provide no direction to assist artisans, and no working examples of this relationship. As such, it is believed that the quantity of experimentation needed to make or use the invention based on the content of the disclosure would be excessive.
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.
Claim(s) 1 and 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chow (Pub. No. 2005/0004625).
Regarding claim 1, Chow shows a transcorneal electrical stimulation (TES) apparatus, comprising: an eye contacting interface (see Figs. 10 and 11, interfaces 265, 270) comprising at least one active electrode (par. 0064); an inactive reference electrode (par. 0064, return electrode); and a current source (pars. 0060, 0064); wherein the at least one active electrode and the inactive reference electrode are connected to the current source (inherently required for stimulation; see also Figs. 6 or 7).
Regarding the recitation of brain disease treatment in the claim preamble, as stated in MPEP 2112.02, II.:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997)
Lacking any limitations in the body of the claim restricting the system to the treatment of a brain disease, the preamble is considered a statement of intended use, and thus of no significance.
Regarding claim 5, note the comment above regarding the insignificance of the preamble.
Regarding claim 6, see par. 0060.
Regarding claim 7, see Fig. 10, par. 0064.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pascual-Leone (Pascual: EP 2 114 517 B1).
Regarding claim 1, Pascual discloses a transcorneal electrical stimulation (TES) apparatus (par. 0025), comprising: an eye contacting interface (par. 0025, electrode applied to orbit of the eye which is considered a part of the eye) comprising at least one active electrode (par. 0025, annular electrode); an inactive reference electrode (par. 0025, reference electrode); and a current source (Fig. 1, par. 0020); wherein the at least one active electrode and the inactive reference electrode are connected to the current source (inherently required for stimulation).
Regarding the preamble recitation involving treatment of a brain disease, note the comments above.
Regarding claim 2, see par. 0039.
Regarding claims 3 and 4, see par. 0028 where the current source is controllable and programmable. Connection of the control unit to the current source would inherently be required to allow such control.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chow.
Regarding claim 4, while Chow does not explicitly disclose that the current provider is programmable, the examiner takes Official Notice that programmable electrical stimulators are well-known in the medical art. Such a feature allows one to specifically tailor stimulation to suit the needs of the individual patient rather than simply applying a “one size fits all” generic treatment regimen to all patients.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chow as applied to claims 1 and 5-7 above, and further in view of Pugh et al. (Pub. No. 2014/0005514).
Regarding claim 8, while it is not explicitly disclosed that the contact lens embodiment of Chow comprises a material that enhances electrode-skin contact and patient comfort, those of ordinary skill in the art would have considered such a feature to be an obvious design consideration. Pugh discloses a contact lens for providing stimulation, wherein the lens itself is made of silicone elastomers or hydrogels to form a soft lens (par. 0059). Such materials are widely recognized for their biocompatibility and flexibility, enhancing wearer comfort and conformance to the eye. Furthermore, Official Notice is taken that it is old and well-known to include highly conductive materials in the formation of electrodes, (e.g., gold, silver, conductive polymers, etc.) to enhance conductivity across the electrode-skin interface. It is noted that the term “enhances” is a relative term subject to broad interpretation. Additionally, the applicant does not disclose any particular materials, further establishing that such materials are common and well-known. Clearly establishing an effective interface between the electrode and tissue is highly desired and necessary for proper and consistent application of the electrical stimulation current. To employ such materials in the contact lens of Chow would have thus been considered a matter of obvious design to those of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Morimoto ‘784 discloses a contact lens electrode employing stimulation currents of 20 to 300 microamperes. Fisher ‘438 teaches that various brain disorders such as ADD and dyslexia can be caused by eye muscle dysfunction. Paul ‘834 discloses the use of microcurrent stimulation from 100 to 1,000 microamperes using electrodes in contact with the user’s eyes. Newsome ‘389 discloses the use of conductive soft contact lens structure. Wang ‘340 discloses treatments for brain diseases such as dementia and Alzheimer’s that involves electrical or light stimulation of the eye.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
March 26, 2026
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