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 .
Status of Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 4/22/2026 are acknowledged. Claims 1-7, 9-14 and 16-20 are amended; claims 8 and 15 are canceled; claims 21-22 are new; no claims are withdrawn; claims 1-7, 9-14 and 16-22 are pending and have been examined on the merits.
Drawings
The replacement drawings received 4/22/2026 are accepted.
Claim Objections
The objection to claims 3-4, 8-9, 13 and 15-16, as set forth at pp. 4-5 of the previous Office Action, is moot regarding claims 8 and 15 due to cancelation of the claims and is withdrawn regarding the remaining claims in view of the amendment of the claims.
Claim 9 is objected to because of the following informalities:
Claim 9, line 8 recites “or a Short Time Exposure (STE) test,.” which should be “or a Short Time Exposure (STE) test.”, i.e., with the comma before the period removed. Appropriate correction is required.
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.
Claims 1-12, 17-19 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-12, 17-19 and 22 are drawn to methods comprising a mental step, i.e., a judicial exception.
The first question in the subject matter eligibility determination is “Is the claim to a process, machine, manufacture or composition of matter?” (Step 1)
Yes, claims 1-12, 17-19 and 22 are drawn to methods, i.e., a process.
The second question (Step 2A, prong 1) in the subject matter eligibility determination asks “Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?"
Yes, the claimed methods of claims 1-12, 17-19 and 22 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Claims 1-9 and 22 comprise the mental step of predicting the extent, level or degree of toxicity, irritation or tissue damage of a test substance using the materials of the OptiSafe EIT kit documented as being available for public use or sale by Choksi et al., 2020 (cite U, attached PTO-892; herein “Choksi”); hence, the claimed methods of claims 1-9 and 22 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Claims 10-12 comprise the mental step of improving the categorization or prediction according to established ocular irritancy classes, wherein the false negative rate is reduced compared to predicting the irritancy classification without using the migration distance measurement and correction, using the materials of the OptiSafe EIT kit documented as being available for public use or sale by Choksi et al., 2020 (cite U, attached PTO-892; herein “Choksi”); hence, the claimed methods of claims 10-12 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Claims 17-19 comprise the mental step of improving the prediction of acute toxicity after oral ingestion by the addition, multiplication or otherwise using as a correction factor the depth measurement of Claim 1 using the materials of the OptiSafe EIT kit documented as being available for public use or sale by Choksi et al., 2020 (cite U, attached PTO-892; herein “Choksi”); hence, the claimed methods of claims 10-12 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Step 2A, prong 2 asks “Does the claim recite additional elements that integrate the judicial exception into a practical application?”
Regarding claims 1-12, 17-19 and 22, no, the claims do not integrate the judicial exception into a practical application because the claims do not recite any practical steps to be taken upon making the mental step of predicting the toxicity of a test substance, improving the categorization of a test substance or improving the prediction of acute toxicity.
The final question (Step 2B) in the subject matter eligibility determination to be asked is “Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No, claims 1-12, 17-19 and 22 do not recite additional elements that amount to significantly more than the judicial exception.
Regarding claims 1-12, 17-19 and 22, measuring a distance on the OptiSafe EIT kit Distance Migration Test Card (DMTC250), disclosed as being available for public use or sale by Choksi, is well-understood, routine and conventional because the DMTC250 test card, the dye solution and BB solution of the OptiSafe EIT kit are being used in a well-understood, routine and conventional manner, i.e., spot the sample at the origin, incubate, then read the value from the card.
These well-understood, routine, conventional activities are not part of a specific transformative method, but rather represent generalized method steps which are executed solely for the production of data for the mental step. Accordingly, claims 1-12, 17-19 and 22 do not amount to significantly more than the judicial exceptions and are not patent eligible.
Thus, claims 1-12, 17-19 and 22 are rejected under U.S.C. 101 as not being drawn to patent eligible subject matter.
Response to Arguments
Applicant's arguments filed 4/22/2026 have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on pp. 11-13 regarding the objection to the drawings and claims and rejections under 35 U.S.C. § 112(b) are moot as the rejections have been withdrawn; however, see the new claim objection and claim rejections under 35 U.S.C. § 112(b) necessitated by amendment set forth in this document.
Regarding the rejection of claims 1-12 and 17-19 under 35 U.S.C. §101, Applicant argues (p. 12) that “Applicant respectfully submits that amended independent claims 1 and 10 now recite specific physical steps and are no longer directed to a judicial exception. Accordingly, the claims dependent thereon, namely, claims 2-7, 9, 11-14, and 16-22, are likewise not directed to a judicial exception.”
The claims previously recited specific physical steps. The physical steps are routine, well-understood and conventional whose sole purpose is to generate data for the mental step; hence, Applicant’s argument is unpersuasive and the rejection is maintained with modification for claim amendment.
Claim Rejections - 35 USC § 112
The rejection of claims 1-20 under 35 U.S.C. § 112(b), as set forth at pp. 8-16 of the previous Office Action, is moot regarding claims 8 and 15 due to cancelation of the claims and is withdrawn regarding the remaining claims in view of the amendment of the claims.
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 1-7, 9-14 and 16-22 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.
Claims 1-2 and 10-12 have antecedent basis issues, detailed below, mainly due to limitations in the claims preceded by the word “the” which, in patent claims, indicates that the limitation has been previously set forth, i.e., has an antecedent. Many of the antecedent basis rejections below can be resolved by rewording the claims to avoid the antecedence issue.
Claim 1 recites the limitation "the properties of cell membranes and connective tissues" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite properties of cell membranes and connective tissues; hence, the limitation is without antecedent basis.
Claim 1 recites the limitation "the non-biological, synthetic test material" in lines 16-17. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a non-biological, synthetic test material; hence, the limitation is without antecedent basis.
Claims 2-7, 9, 13-14 and 16-22 depend from claim 1, directly or indirectly, and none of claims 2-7, 9, 13-14 and 16-22 resolve the indefiniteness described above; hence, claims 2-7, 9 and 13-17 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 2 recites the limitation "the false negative rate of the “A” in step (a)" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 2 depends from claim 1 and neither claim 1 nor claim 2 recites a false negative rate of the “A” in step (a); hence, the limitation is without antecedent basis.
New claim 22 depends from claim 2 and does not resolve the indefiniteness; hence, claims 2 and 22 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 10, lines 18-19, recites the limitation “the properties of cell membranes and connective tissues”. There is insufficient antecedent basis for this limitation in the claim. Claim 10 does not recite properties of cell membranes and connective tissues; hence, the limitation is without antecedent basis.
Claim 11 recites the limitation "the established ocular irritancy classes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 depends from claim 10 and neither claim 10 nor claim 11 discloses established ocular irritancy classes; hence, the limitation is without antecedent basis.
Claim 12 recites the limitation "the established ocular irritancy classes" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 12 depends from claim 10 and neither claim 10 nor claim 12 discloses established ocular irritancy classes; hence, the limitation is without antecedent basis.
Claim 1 recites the limitation “a nonanimal toxicity test for the test substance to obtain a single highest assay score "A" for the assay used therein” which renders the claim indefinite because it is unclear if a single nonanimal toxicity test on a test substance is being conducted or multiple nonanimal toxicity tests are conducted on a test substance and highest of multiple assay scores is selected as the highest. Appropriate correction is required. Claims 2-7, 9, 13-14 and 16-22 depend from claim 1; hence, claims 1-7, 9, 13-14 and 16-22 are rejected under 35 U.S.C. 112(b) as being indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-16 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choksi et al., 2021 (cite U, attached PTO-892; herein “Choksi”).
NOTE: Claims 1-16 and 20-21 are drawn to compositions. Intended use recitations in composition claims are met if the compositions could be employed for the intended use regardless of whether the prior art discloses the intended use or not. The intended use recitations are “and the intended use of the kit is to be used alone or in combination with another toxicity test to improve the irritancy, tissue damage, or toxicity prediction” in claim 13, “and the intended use of the kit is to be used alone or in combination with another toxicity test to improve the ocular irritancy, damage, or toxicity prediction” in claim 14, “and the kit is used alone or in combination with another toxicity test to improve the ocular irritancy, damage or toxicity prediction” in claim 15, “used to predict the ocular toxicity or potential to irritate or damage the eye, alone or in combination with another toxicity test” in claim 16 and “to improve the prediction of acute toxicity after oral ingestion, in which the depth measurement of Claim 1 is used as a correction factor for a cell or tissue based in vitro test to identify substance that have acute or chronic toxicity, and the prediction is improved by the addition, multiplication or otherwise using as a correction factor the depth measurement of Claim 1” in claim 20.
Choksi discloses the OptiSafe Eye Irritation Test (EIT) (Title) and discloses that the OptiSafe EIT kit is commercially available (p. 5, “OptiSafe Test Method Protocol”).
Figs. 1A, 2 and 3 of the instant disclosure disclose that the material to practice the claimed method is the DM Test Card from the OptiSafe EIT kit. The specification clearly discloses that the DM Test card along with the platform, dye solution and blank buffer (BB) are components of the OptiSafe EIT kit. Thus, the kits of instant claims 13-16 and 20-21 are anticipated by public use and sale of the OptiSafe EIT kit as documented by Choksi.
Response to Arguments
Regarding the anticipation rejection of the composition claims 13-16 and 20-21 under 35 U.S.C. § 102(a)(1), Applicant argues that the steps for the intended use of the kits of claims 13-16 and 20-21 have been amended in the method claims 1 and 10. The kit disclosed by Choksi could be employed for the intended use; hence, Applicant’s argument is unpersuasive and the rejection is maintained with modification for claim amendment.
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 Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
Prosecution Insights