DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed February 9, 2026. Currently, claims 51-70 are pending. Claims 51-56, 67-70 have been withdrawn as drawn to non-elected subject matter.
It is noted there is no Power of Attorney in the file. A filing of a paper does not show authorization to conduct an interview (see MPEP 405). Thus, the examiner was unable to contact Applicant to interview or discuss the case. Applicant may wish to file a POA so the examiner may contact Applicant to discuss the merits of the case in the future.
Election/Restrictions
Applicant's election with traverse of Group II, Claims 57-66 in the paper filed February 9, 2026 is acknowledged.
The response argues that all the groups share a common technical feature. This argument has been reviewed but is not persuasive. The common technical feature is not a contribution over the art. Thus, there is no special technical feature linking the inventions.
Claims 51-56, 67-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
This application contains claims 51-56, 67-70 drawn to an invention nonelected with traverse in the paper filed February 9, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Priority
This application is a 371 of PCT/IL2021/050834, filed July 7, 2021 and claims priority to Israel 275926, filed July 8, 2020.
Drawings
The drawings are acceptable.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The specification contains a listing of references on page 1.
Claim Objections
Claims 58, and 60 are objected to because the claim contains more than one period (see 609.01(m)). There are two periods at the end of the claim. This objection may be overcome by deleting one of the periods (see MPEP 608.01(m)).
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 57-58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Question 1
The claimed invention is directed to a process that involves a natural principle and a judicial exception.
Question 2A Prong I
The claims are taken to be directed to an abstract idea, a law of nature and a natural phenomenon.
Claims 57-58 are directed to “a method of sex determination in a Mugilidae fish before appearance of a sex phenotype”.
Claims 57-58 are directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of” specific nucleotide difference when compared to a corresponding sequence” and “the presence of said SD marker being indicative that the fish is a male Mugilidae fish”) and a law of nature/natural phenomenon (i.e. the natural correlation between the presence of a marker and the sex of a Mugilidae fish).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Herein, claims 57-58 involve the patent-ineligible concept of an abstract process. Claim 57 requires wherein presence of said SD marker being indicative that the fish is a male Mugilidae fish. Neither the specification nor the claims set forth a limiting definition for indicating the fish is male and the claims do not set forth how this is accomplished. As broadly recited the wherein clause may be accomplished mentally by thinking about a subject’s marker and assessing whether the subject is a male fish. Thus, the wherein step constitutes an abstract process idea.
Claim 57 further recites a comparison between the nucleotide and a FSHR gene of a female fish that is deemed an abstract idea (see MPEP 2106.04(a)(2)(III)(A); • claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014)).
A correlation that preexists in the human is an unpatentable phenomenon. The association between presence of a marker and the fish is a male Mugilidae fish is a law of nature/natural phenomenon. The wherein clause which tells users of the process to predict male fish in the sample, amounts to no more than an "instruction to apply the natural law". This wherein clause is no more than a mental step. Even if the clause requires something more such as to verbalize the discovery of the natural law, this mere verbalization is not an application of the law of nature to a new and useful end. The wherein clause does not require the process user to do anything in light of the correlation. The wherein clause fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself.”
Question 2A Prong II
The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. While the claim recites determining presence of a sex determination marker, this is not an integration of the exception into a practical application. Instead, these elements are data gathering required to perform the method. Thus, the claim is “directed to” the exception.
Accordingly, the claims are directed to judicial exceptions.
Question 2B
The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons:
The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope.
The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. The determining the presence of a marker is a mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the biomarkers of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The determining step essentially tells users to determine the markers through whatever known processes they wish to use.
The step of determining the presence of a SD marker was well known in the art at the time the invention was made. The prior art teaches at markers may be performed by sequencing or PCR analysis. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any nucleic acid detection method to determine the presence of a marker. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed.
Additionally, the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements were well known.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112-Description
The following is a quotation 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.
Claims 57-66 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to methods which comprise identifying any structurally undefined variant or polymorphism in the gene encoding FSHR of the Mugilidae fish which possess the functionality of being associated with sex determination, i.e. male specific nucleotide difference.
In the case of the instant claims, the functionality of identifying polymorphisms or variants diagnostic of sex determination is a critical feature of the claimed methods.
The specification teaches identifying several variants and polymorphisms in the FSHR gene. However, it is not clear that all of these polymorphisms are associated with sex determination, i.e. male specific nucleotide difference. The specification provides several variants in the FSHR gene but its not clear each of these variants are sex determination variants. The specification teaches several of the SNPs did not fit the expected XY/XX SD model (page 22, lines 1-2). The specification teaches several variants that result in coding changes in the FSHR protein, however the specification does not teach how these variants or polymorphisms affect the FSHR protein or how they are functionally associated with sex determination.
The post filing date art teaches additional mutations, not described in the instant specification that are within the FSHR gene that are sex-specific genetic markers.
Ferraresso et al. (iSicence, Vol. 24, No. 101886, January 22, 2021) teaches fshr is a fish sex determining locus with variable incomplete penetrance. Ferraresso teaches mutations MuCe179, MuCe206 and MuCe322 (see page 4, para 1). MuCe179 and MuCe206 correspond to Val557Met and Phe566Val identified in the instant specification. MuCe322 is a synonymous variant. Table 1 illustrates the frequence of the variants one sex or the other. MuCe322 was found in males and females.
Anderson et al. (Aquaculture Reports, Vol. 33, No. 101858, December 2023) teaches FSHR 1834 G>T as a new sex-specific genetic marker for flathead grey mullet Mugil cephalus. Figure 2 illustrates 6 different variants, including the two described in the instant specification. It is clear that The specification does not describe a representative number of variants within the scope of the claims.
Given the guidance in the specification and what was taught in the art prior to the invention, the skilled artisan would be unable to predictably correlate structural changes in the gene encoding FSHR and sex determination, simply based on their existence.
In analyzing whether the written description requirement is met for a genus claim, it is first determined whether a representative number of species have been described by their complete structure. There is substantial variability among the species of markers encompassed within the scope of the claims. Applicants have not adequately disclosed the relevant identifying characteristics of a representative number of species within the claimed genus.
With respect to claims which encompass variants, no common structural attributes identify the members of the genus. The current claims encompass a large genus of nucleic acids which comprise variants in any region of FSHR nucleic acid. The genus includes an enormous number of variants, polymorphisms and mutations for which no written description is provided in the specification. This large genus is represented in the specification by only the particularly named 2 polymorphisms for which data is provided. The genus includes a large number of polymorphisms and mutations for which no written description is provided in the specification. This large genus is represented in the specification by two mutations identified as sex determination markers, however this disclosure does not provide for a predictable association with any polymorphism or variant in the FSHR gene as is broadly claimed. Here, no common element or attributes of the sequences are disclosed which would permit selection of sequences as polymorphisms. No structural limitations or requirements which provide guidance on the identification of sequences which meet the functional limitations of sex determination is provided. The specification provides no correlation between the structure of the recited polymorphisms and the claimed function of such polymorphisms. Therefore, the polymorphisms are not representative of the genus of any polymorphism associated with sex determination in Mugilidae fish because it is not clear which polymorphisms or mutations within the coding or non-coding region of the FSHR gene would have the same affect. Therefore the specification fails to teach how to distinguish members of the claimed genus of polymorphisms and variants which possess the claimed functionality from non members.
Thus considering the breadth of the markers required by the claimed methods, their specific required functionalities, and the teachings of the instant specification, it is the conclusion that the specification does not provide an adequate written description of the broadly claimed subject matter.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Claims 57-58 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.
A) The claims are indefinite. It is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of Claim 57 is directed to a method of sex determination in a Mugilidae fish before appearance of a sex phenotype. However, the claim only provides for determining presence of a sex determination marker of a male Mugilidae fish. Thus it is not clear if applicant intends to cover any method for determining presence of a sex determination marker of a male Mugilidae fish, or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If the claim requires something more, it is unclear what additional active process step the method requires and it appears that the claims are incomplete. The claims fail to provide any active steps that clearly accomplish the goal set for the by the preamble of the claims. Claim 58 is similarly indefinite
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dor et al. Animcal Genetics, Immunogenetics, Molecular Genetics and Functional Genomics, doi:10.1111/age.12486, 2016). Dor teaches identifying the sex-determining region in flathead grey mullet (Mugil cephalus). Dor maps the SD region to include FSHR/GTH-R1. Dor does not teach a specific nucleotide difference, i.e. a single nucleotide polymorphism.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
March 18, 2026