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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Reference to the inactive reference electrode being placed on a skin area of a subject is impermissible. Any reference to structure placed on the body must be made in a functional manner (e.g., adapted to be placed on a skin area of the subject).
Claim Rejections - 35 USC § 102/103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 4-6 is/are rejected under 35 U.S.C. 102(a)(1)) as anticipated by, or in the alternative, under 35 U.S.C. 103 as obvious over Sieving et al. (Sieving: Pub. No. 2021/0290433).
Regarding claim 1, Sieving discloses a transcorneal electrical stimulation (TES) apparatus for treating a disease, comprising: an eye contacting interface comprising at least one active electrode, wherein the eye contacting interface allows the at least one active electrode to contact a corneal surface of a subject's eye (par. 0077); an inactive reference electrode (par. 0077: common/grounding electrode), wherein the inactive reference electrode is placed anywhere on the body of the subject (par. 0077); and a current source (pars. 0005, 0017, etc.); wherein the at least one active electrode and the inactive reference electrode are connected to the current source (par. 0079: current established between electrodes).
Sieving discloses that the reference electrode may include a sub-dermal electrode placed on the forehead above the eyelid (par. 0087). Such a region is considered to constitute a skin area of the subject, since the dermal layer of skin is the middle layer, with sub-dermal placement including placement on the hypodermal layer of skin. The applicant further teaches that TES in practice involves an inactive electrode positioned underneath the skin in close proximity to the eye (par. 0049). Thus, Sieving is considered to include inactive electrode placement on a skin area of the subject.
In any event, while the term “skin” is not explicitly referred to, those of ordinary skill in the art desiring a common grounding electrode would have considered the placement of such an electrode on a skin area to be obvious. Sieving teaches that the goal of electrode placement is to get current to flow through the entire eye, extending outward towards the reference electrode and activating the retina and structures representative of retinofugal pathways (pars. 0008, 0010 and 0077), thus an electrode placed on a skin area (whether it include an epidermal, dermal, or hypodermal layer), would effectively allow for the requisite current flow. The exact location would have been application dependent and subject to routine experimentation to determine the most effective placement for the conditions at hand.
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 4, the various different selectable current levels, application times, current waveforms, etc., provided for by the disclosed reference invention would necessarily require a programmable current provider/source to allow for selection of such treatment customization. Clearly the intent is to provide a device capable of producing customized treatment, thus enhancing the usability, desirability and effectiveness of the product. In the very least, such programmability would have been considered a matter of obvious design in any medical device in order to allow the physician, under whose care the patient resides, the ability to control stimulation in a way that best fits the patient’s needs and in accordance with currently acceptable medical practice. Programmable medical stimulators are further well-known in the art for the same reasons.
Regarding claim 5, note the comment above regarding the insignificance of the preamble.
Regarding claim 6, the current may be pulsed as disclosed in par. 0017, thus inherently requiring a pulse generator.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sieving et al. ‘433.
Regarding claim 2, see pars. 0009 and 0017 where the current may be variable –the current necessarily being controlled by a control unit to allow for the various current parameter options discussed therein. While Sieving does not explicitly refer to a control unit with the ability to adjust current in real-time, such an ability would have been considered obvious by those of ordinary skill in the art. There is clearly an art-recognized need to allow for real-time adjustment of medical stimulator output. Such a need stems from the desire to allow for any necessary adjustments during the initial fitting, and to account for any changes in condition during treatment, thus enabling one to maximize treatment effectiveness and prevent patient discomfort and/or ill-effects resulting from inappropriate settings that may potentially cause harm –critical aspects in any medical treatment device. To provide the clinician with the ability to adjust treatment parameters in real-time to optimize treatment, account for changing conditions, and fit the device to the individual, would have therefore been considered a matter of obvious design.
Regarding claim 3, a control unit must inherently be connected to the current source in order to allow the disclosed control of current.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sieving et al. ‘433 in view of Chow (Pub. No. 2005/0004625).
Regarding claim 7, while Sieving discloses that one or more electrodes may be placed on the cornea (par. 0077), it is not explicitly disclosed that a contact lens is used to place the electrode. Such a means, however, is old and well-known in the art to allow for placement of electrodes about the cornea. Chow, for example, discloses in a related stimulator device that one or more electrodes may be placed on the cornea through the use of a contact lens (see par. 0064 and contact lens element 265). Such a means offers a convenient, less invasive and familiar way in which to place structures on the eye. Those of ordinary skill in the art looking to capitalize on these advantages would have therefore considered placement of one or more electrodes on a contact lens as a matter of obvious design.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sieving and Chow as applied to claim 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 was taken that it was 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 was noted that the term “enhances” is a relative term subject to broad interpretation. Additionally, the applicant did 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 invention defined by Sieving and Chow to form the contact lens would have thus been considered a matter of obvious design to those of ordinary skill in the art. Lacking adequate traversal, this feature is now considered admitted prior art.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, as the examiner is now relying upon Sieving to provide the feature of contention. See the rejection above for a detailed discussion of Sieving and its application to the currently amended claim set.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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
August 13, 2026
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