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 .
Priority
This application claims benefit to U.S. Provisional Application Serial Number 63/414,670, filed 10/10/2022. Claims 1-20 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement submitted on 10/5/2023 has been considered by the examiner. All NPL citations are lined through because no document for any of the NPL citations has been received; thus, none of the NPL citations have been considered.
Drawings
The drawings are objected to for the informalities detailed below.
37 C.F.R. 1.84(u)(1) drawn to the numbering of views states:
“The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear”. Figures 1A, 1B and 1C are properly identified; however, the additional text of “Fig. 1A - 1C” on the first sheet and “Figure 1A - 1C (continued)” on the second sheet is unnecessary and confusing and needs to be removed.
37 C.F.R. 1.84(t) drawn to the numbering of sheets of drawings states:
“Numbering of sheets of drawings. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in paragraph (g) of this section. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking.” The sheets of drawings received 10/5/2023 are not numbered with two Arabic numerals placed on either side of an oblique line, i.e., 1/3 through 3/3.
Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 3-4, 8-9, 13 and 15-16 are objected to because of the following informalities:
Claim 3 recites “The method of Claim 2 where one or more of the materials is mixed...” which should be “The method of Claim 2, where one or more of the materials is mixed...”, i.e., with a comma after “The method of Claim 2”, to be grammatically correct and to match the form of the other claims.
Claim 4 recites “The method of Claim 1 where the non-biological material contains...” which should be “The method of Claim 1 where the non-biological material contains...”, i.e., with a comma after “The method of Claim 1”, to be grammatically correct and to match the form of the other claims.
Claim 8 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 8 has not been further treated on the merits.
Claim 9 is objected to under 37 CFR 1.75(c) as being in improper form because it depends from claim 8 which is a multiple dependent claim which does not refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 9 has not been further treated on the merits.
Claim 13 is objected to because claim 13 recites “A kit that includes the material described in claims 1” which should be “A kit that includes the material described in claim 1”.
Claim 15 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 15 has not been further treated on the merits.
Claim 16 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 16 has not been further treated on the merits.
Appropriate correction of the above informalities 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 and 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-12 and 17-19 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 and 17-19 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 and 17-19 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Claims 1-9 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 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 and 17-19, 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 and 17-19 do not recite additional elements that amount to significantly more than the judicial exception.
Regarding claims 1-12 and 17-19, 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 and 17-19 do not amount to significantly more than the judicial exceptions and are not patent eligible.
Thus, claims 1-12 and 17-19 are rejected under U.S.C. 101 as not being drawn to patent eligible subject matter.
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 1-20 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 and 6-20 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 3-4. 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 migration distance" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a migration distance; hence, the limitation is without antecedent basis.
Claim 1 recites the limitation "the synthetic test material" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a synthetic test material; hence, the limitation is without antecedent basis.
Claim 1 recites the limitation "the measured value" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a measured value; hence, the limitation is without antecedent basis.
Claim 1 recites the limitation "the extent" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite an extent; hence, the limitation is without antecedent basis.
Claims 2-9 and 13-17 depend from claim 1, directly or indirectly, and none of claims 2-9 and 13-17 resolve the indefiniteness described above; hence, claims 2-9 and 13-17 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 2 recites the limitation "the non-biological test material" 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 non-biological test material; hence, the limitation is without antecedent basis.
Claim 6 recites the limitation "the distance migrated" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends from claim 1 and neither claim 1 nor claim 6 recites a distance migrated; hence, the limitation is without antecedent basis.
Claim 7 recites the limitation "the distance migrated" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 7 depends from claim 1 and neither claim 1 nor claim 7 recites a distance migrated; hence, the limitation is without antecedent basis.
Claim 8 recites the limitation "the migration corrected value" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claims 1 and 2; neither claim 1 nor claim 2 nor claim 8 recites a migration corrected value; hence, the limitation is without antecedent basis.
Claim 9 recites the limitation "the first toxicity test" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 8 which depends from claims 1 and 2; none of claims 1-2 or 8-9 disclose a first toxicity test; hence, the limitation is without antecedent basis.
Claim 10 recites the limitation "the migration distance" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 10 does not disclose a migration distance; hence, the limitation is without antecedent basis.
Claim 10 recites the limitation "the measured distance" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 10 does not disclose a measured distance; hence, the limitation is without antecedent basis.
Claim 10 recites the limitation "the categorization or prediction" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Claim 10 does not disclose a categorization or prediction; hence, the limitation is without antecedent basis.
Claim 10 recites the limitation " the migration distance measurement and correction" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Claim 10 does not disclose a migration distance measurement and correction; hence, the limitation is without antecedent basis.
Claim 11 recites the limitation "the established ocular irritancy classes" in line 1. 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 line 1. 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 13 recites the limitation "the material described in claims 1" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 13 depends from claim 1 and neither claim 1 nor claim 13 discloses material described in claims 1; hence, the limitation is without antecedent basis.
Claim 14 recites the limitation "the material described in Claim 1" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from claim 1 and neither claim 1 nor claim 14 discloses material described in claim 1; hence, the limitation is without antecedent basis.
Claim 14 recites the limitation " the ocular irritancy, damage, or toxicity prediction" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from claim 1 and neither claim 1 nor claim 14 discloses an ocular irritancy, damage, or toxicity prediction; hence, the limitation is without antecedent basis.
Claim 15 recites the limitation "the material described in Claims 1 and 2" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends from claims 1 and 2 and neither claim 1, claim 2 nor claim 15 discloses material described in Claims 1 and 2; hence, the limitation is without antecedent basis.
Claim 15 recites the limitation "the ocular irritancy, damage or toxicity prediction" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends from claims 1 and 2 and neither claim 1, claim 2 nor claim 15 discloses an ocular irritancy, damage, or toxicity prediction; hence, the limitation is without antecedent basis.
Claim 16 recites the limitation “the materials described in Claims 1-3” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from claims 1-3 and neither claim 1, claim 2, claim 3 nor claim 16 discloses materials described in Claims 1-3; hence, the limitation is without antecedent basis.
Claim 16 recites the limitation "the ocular toxicity" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from claims 1-3 and neither claim 1, claim 2, claim 3 nor claim 16 discloses an ocular toxicity; hence, the limitation is without antecedent basis
Claim 16 recites the limitation "the eye" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from claims 1-3 and neither claim 1, claim 2, claim 3 nor claim 16 discloses an eye; hence, the limitation is without antecedent basis.
Claim 17 recites the limitation "the prediction of acute toxicity after oral ingestion" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from claim 1 and neither claim 1 nor claim 17 discloses a prediction of acute toxicity after oral ingestion; hence, the limitation is without antecedent basis.
Claim 17 recites the limitation "the depth measurement of Claim 1" in line 2 and lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from claim 1 and neither claim 1 nor claim 17 discloses a depth measurement of Claim 1 nor any depth measurement; hence, the limitation is without antecedent basis.
Claim 18 recites the limitation "the prediction of acute toxicity after oral ingestion" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 18 depends from claim 2 and neither claim 2 nor claim 18 discloses a prediction of acute toxicity after oral ingestion; hence, the limitation is without antecedent basis.
Claim 18 recites the limitation "the depth measurement of Claim 2" in line 2 and lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Claim 18 depends from claim 2 and neither claim 2 nor claim 18 discloses a depth measurement of Claim 2; hence, the limitation is without antecedent basis.
Claim 18 recites the limitation "the addition" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 18 depends from claim 2 and neither claim 2 nor claim 18 discloses an addition; hence, the limitation is without antecedent basis.
Claim 19 recites the limitation "the extent of measured macromolecular damage" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 19 does not recite an extent of measured macromolecular damage; hence, the limitation is without antecedent basis.
Claim 20 recites the limitation "the prediction of acute toxicity after oral ingestion" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 20 dose not disclose a prediction of acute toxicity after oral ingestion; hence, the limitation is without antecedent basis.
Claim 20 recites the limitation "the depth measurement of Claim 1" in line 2 and lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Claim 20 does not disclose a depth measurement of Claim 1 nor does claim 1 disclose a depth measurement; hence, the limitation is without antecedent basis.
Claim 20 recites the limitation "the addition" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 20 does not disclose an addition; hence, the limitation is without antecedent basis.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “polyvinyl chloride”, and the claim also recites “(CASRN 9002-86-2)” which is the narrower statement of the range/limitation.
Likewise, claim 2 also recites the broad recitations of “polypropylene”, “polystyrene”, “acrylate”, “polyethylene”, “ethylene vinyl acetate”, “polyesters” and “polyurethanes”, and the claim also recites “(CASRN 9003-07-0)”, “(CASRN 9003-53-6)”, “(CASRN 25133-97-5)”, “(CASRN 9002-88-4)”, “(CASRN 24937-78-8)”, “(CASRN 113669-97-9)” and “(CASRN 9009-54-5)”, respectively, which are the narrower statements of the range/limitation.
Claim 4 recites the broad recitation “polyvinyl chloride”, and the claim also recites “(CASRN 9002-86-2)” which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 recites “the solid support selected from cardboard, paper, plastic, glass, or similar” which renders the claim indefinite because the metes and bounds of “similar” is not disclosed in the original disclosure.
Claim 10 recites “Bovine Corneal Opacity and Permeability (BCOP), EpiOcular™ Eye Irritation Test, Hen's Egg Test - Chorioallantoic Membrane (HET-CAM), Isolated Chicken Eye (ICE), Ocular Irritection®, OptiSafe Eye Irritation Test™, Short Time Exposure (STE), or similar” which renders the claim indefinite because the metes and bounds of “similar” is not disclosed in the original disclosure.
Claim 10 contains the trademark/trade names EpiOcular™ Eye Irritation Test, Ocular Irritection®, and OptiSafe Eye Irritation Test™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe toxicology tests and, accordingly, the identification/description is indefinite.
Claim 19 recites “or in combination with Claim 1 disclosure” which renders the claim indefinite because claim 1 is drawn to a method and it is unclear how the method of claim 1 is incorporated into the method of claim 19 by the phrase “or in combination with Claim 1 disclosure”.
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 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 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 are anticipated by public use and sale of the OptiSafe EIT kit as documented by Choksi.
Conclusion
No claims are allowed.
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.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651