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 .
DETAILED ACTION
Status of Claims
Claims 1,10-15,17-22,24 and 26-32 are pending in the instant application. Claims 13-15, 17-19, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1,10-12,20-22,24,26-29, and 31-32 is contained herein.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 2/6/2026 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 5/6/2026.
New Rejections
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 1,10-12,20-22,24,26-29, and 31-32 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 pre-AIA the applicant regards as the invention.
At the end of claim 1, Applicant recites “the ocular tissue shape as measured by scleral area analysis”. The language “scleral area analysis” is unclear with respect to the preamble of claim 1 wherein the claim mentions more than one ocular tissue being other than “the sclera” (e.g. cornea). Thus if the tissue is anything other than the sclera how does this language relate to those tissues? Are Applicants implying that the tissue is limited to the sclera perhaps or something else? Thus the claim and claims dependent on it which do not rectify the issue are considered indefinite. The examiner will use the most reasonable broadest interpretation with respect to the language.
Additionally the claim recites “the mechanical and/or chemical property of an ocular tissue”. Now is the latter limited to the prior recited ocular tissues in the preamble or any ocular tissue while the later recited language regarding strengthening and stabilization is applicable to the ocular tissues in the preamble since the claim could be interpreted several ways? Thus the scope is indefinite. In terms of prior art regarding the aforementioned language, the examiner will assume that any tissue is intended in regard to the phrase “an ocular tissue” within the claim scope until the issue is addressed. Correction is required.
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 of this title, 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.
Claims 1,10,11,20-22,26-29 and 31-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 2003/0167033.
The instant claims may be drawn to a method of altering a chemical/mechanical property of an ocular tissue comprising irradiation of indocyanine green (ICG) after administration to a portion of a sclera in a patient by injection. Claims state that ICG (the photoactive agent) is adjacent to or permeated (diffused through) the ocular tissue such as the sclera.
US 2003/0167033 suggests a method of photodynamic therapy using singlet oxygen on an eye using a photoactive agent such as ICG absorbing into the patient’s retina after administration through the sclera (see [0010], [0084] for ICG, and FIG. 12 below):
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The method may be used for either diagnostic purposes or a therapeutic effect such as change in cells or tissues (see [0037]). Various irradiation wavelengths may be employed in addition to formulating compositions thereof (see [0053] and [0214]-[0244]). Thus based on the teachings in the publication, one skilled in the art would have readily arrived at the claimed method using a photoactive agent such as ICG. Changes to the ocular tissue would have been an inherent consequence upon employing the suggested method disclosed in the art that would be verified using routine methods. Note that any differences in solvents, additives, etc. do not tip the scales towards patentability as this would be considered routine optimization by one skilled in the art.
Generally, these differences will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed.
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 BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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