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 .
Applicant’s amendments and response filed 12 August 2025 have been received and entered into the case.
Claim Status
Claims 2 and 6 have been amended, claims 7, 10, and 18-20 were previously cancelled, claims 8-9, and 11-17 remain withdrawn, and claims 2-6 have been considered on their merits.
Rejection Status
The rejections under 35 U.S.C. § 112(b) have been withdrawn due to Applicants
amendments.
The rejections under 35 U.S.C. § 101 have been maintained.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12 August 2025, with respect to rejection under 35 U.S.C. § 112(b) have been fully considered and are persuasive. The rejection of claims 2-6 has been withdrawn. However, a new rejection is set forth below, which was necessitated by Applicant’s amendments to the claims.
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 2-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and abstract idea without significantly more.
This rejection is repeated with regards to claims 2-6 for the same reasons of record as set forth in the Office action mailed 05 May 2025, additional information has been added which was necessitated by Applicant’s amendments to the claims. A response to Applicant’s traversal follows the reiterated rejection below.
The claim recites a method for testing a compound of interest for potential estrogenic or activity and/or level of estrogenic activity comprising growing a cell in presence of an anti-estrogenic compound and in presence of the compound of interest and determining the adherens junctions morphology of the cell. Thus, the claims as a whole fall within one of four statutory categories, i.e., a process (Step 1: YES).
For Step 2A, prong one, claim 2 and its dependent claims disclose the step of growing a mammalian cell in the presence of anti-estrogenic compound as a control and in the presence of a test compound and determining the cellular morphology in adherens junctions, and the determination of the test compound having an estrogenic activity is based on the formation of discontinuous adherens junctions. Thus, the determination is based on the law of nature, and naturally occurring correlation between the anti-estrogenic activity and discontinuous adherens junctions in cells (MPEP2106.04(b)). The step (b) of determining the adherens junctions morphology of the cell in claims 2 and 6, is an abstract idea specifically, a mental process (see MPEP 2106.04(a)(2)(III)). The step (c) of administering to a subject in need thereof the compound of interest when the compound of interest reduces the formation of discontinuous basolateral adherens junctions in claims 2 and 6, is a conditional limitation. If the compound of interest does not induce the formation of discontinuous basolateral adherens junctions, then the claim would conclude with step (b), an abstract idea. Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations and evaluations. Observing the results of adding a compound to a cell and observing the results does not add a meaningful limitation as it is merely an observational step. Thus, the claims recite judicial exceptions (Step 2A prong one: YES).
For Step 2A, prong two, the additional element of the claims includes the step of growing a mammalian cell in the presence of an anti-estrogenic compound and a test compound for comparison. This step is considered as mere data gathering in conjunction with a law of nature and insignificant extra-solution activity (MPEP 2106.05(h)). This element does not integrate the judicial exception into a practical application because the claim steps are looking at the correlation of the anti-estrogenic compound and the compound of interest have on a cell.
For Step 2B, the above identified additional elements, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims lack extra-solution activity. The addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional (MPEP 2106.05(d)). It is shown in the teachings of Heinrich et al. (of record) examined the effects of the estrogenic and anti-estrogenic compounds on the levels of N-cadherin and β-catenin using electron microscopic examination (figure 3), immunofluorescent confocal microscopy (figure 4), and immunoblot (figure 6). While this is not specifically what Applicant is claiming, this shows this observational activity is known in the art. These are well-understood, routine, conventional laboratory techniques in the life science arts as they are claimed in a merely generic manner (MPEP 2106.05(d)(II)). The wherein clauses in claims 2 and 6 are mere data gathering (MPEP 2106.05(g)). These elements does not integrate the judicial exception into a practical application because the claim steps are observational and looking at the correlation of the anti-estrogenic compound and any compound of interest have on a cell.
Based on the above analysis, the instant claims do not disclose subject matter eligible under 35 U.S.C 101. It is recommended to include an additional step in claims 2 and 6 demonstrating using the abstract idea in a practical application or include an element which is not routine and conventional to include what about the method is specific, uncommon, or unconventional. There is no evidence on the record showing how this is being integrated into a practical application.
Response to Traversal
Applicant's arguments filed 12 August 2025 have been fully considered but they are not persuasive. While the amendments to the claims do recite a further step, step (c) of claims 2 and 6, this amendment does not integrate the claims into a practical application. Additionally, the language of the amendment, when the compound of interest reduces (claim 2) or reduces (claim 6) the formation of discontinuous basolateral adherens junctions, is a conditional limitation. This limitation adds an additional decision point in deciding if the junctions are discontinuous or continuous, yet does not integrate into a practical application. Additionally, if the compound of interest does not reduce the formation of discontinuous basolateral adherens junctions, then the claims end at step (b), which remains mental step and is therefore not incorporated into a practical application.
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 2-6 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.
This is a new rejection, necessitated by applicants amendments to the claims.
Claims 2 and 6 recite the limitation "the formation of discontinuous basolateral adherens junction" in step (c) of claims 2 and 6. There is insufficient antecedent basis for this limitation in the claim. Step (b) of claims 2 and 6 only require determining basolateral adherens junction morphology of the cell. This step does not provide proper antecedent basis for reducing (claim 2) or inducing (claim 6) the formation of discontinuous basolateral adherens junctions. Additionally, the reducing or inducing the formation of discontinuous basolateral adherens junctions would not be an inherent property of the compound of interest because the compound of interest has unknown activity. Therefore, the meaning of the claimed limitation, "the formation of discontinuous basolateral adherens junction", is unclear.
Claims 2-5 are included in the rejection because they depend from claim 2 and do not clarify the issue.
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.
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/N.A.H./Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631