DETAILED ACTION
Applicant’s amendment and remarks filed January 21, 2026 are acknowledged and entered. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claims Summary
Claims 1 and 14 are directed to a method for identifying an indication for testing for tick-borne infection in subject below the age of about 50 years old, or between the age of about 1 year old and about 50 years old (claims 9 and 19). The method comprises:
Screening a subject for peri-papillary ischemia, wherein the subject is presenting a sudden onset of at least one visual symptom associated with tick-borne infection, such as photophobia, among others (claims 2 and 15); the screening comprises at least one optical observation of an optic nerve of the subject (claim 3) selected from at least one of fundus photography, direct and indirect ophthalmoscopy (claim 4);
Recommending the subject undergo further testing for tick-borne infection if peri-papillary ischemia is present; claims 10 and 20 are directed to the step of testing the subject for tick-borne infection, selected from the organisms recited in claims 11, 12, 21 and 22; wherein if the subject has tick-borne infection, the method comprises treating the tick-borne infection (claims 13 and 23).
In claims 5 and 14, the screening step comprises OCT-A, and the steps outlined in claims 6 and 16:
Partitioning an image of a peri-papillary area of the subject into quadrants;
Determining a vessel density for each quadrant;
Determining a total vessel density by calculating a sum of the vessel densities of the quadrants;
Determining a normalized vessel density for a healthy eye with no vessel atrophy; and
Determining a vessel atrophy of the peri-papillary area of the subject based on the total vessel density and the normalized vessel density, wherein if the vessel atrophy is at least about 30%, the subject is determined to have peri-papillary ischemia (claims 7 and 17).
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.
(New Rejection) Claims 1-7, 9, 10, 13-17, 19, 20 and 23 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The claims are directed to a method for identifying an indication for testing for tick-borne infection, testing for tick-borne infection, and treating a tick-borne infection. Prior to the latest claim amendment, the claims were directed to these same embodiments in the context of Lyme-related infection. The specification as a whole is directed to the context of Lyme-related infection and does not support the broader embodiments of tick-borne infections as a whole. While certain tick-borne infections are set forth in the specification, the genus of tick-borne infections is not.
Conclusion
No claim is allowed. Claims 11, 12, 21 and 22 are objected to for being dependent on rejected claims but would otherwise be allowable if rewritten in independent form.
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.
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/STACY B CHEN/Primary Examiner, Art Unit 1672