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 May 18, 2026. Currently, claims 1-5, 8-22 are pending. Claims 1-5, 10-12 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election without traverse of the particular SNPs in the paper filed May 18, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
PNG
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636
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Greyscale
It is noted that a translation of the foreign document has not been received.
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.
Page 2 of the specification includes a list of references.
Requirement for Information
Applicant and the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
Applicants have a second application, namely 18/224,725 that is directed to genotyping a very large number of SNPs. The examiner requires further information in order to make further determinations about the patentability of the instant claims. In response to this requirement, please provide answers to each of the following interrogatories eliciting factual information:
Are the elected SNPs disclosed in 18/224,725, if so which SNPs? Please also identify which SNPs are not disclosed in 18/224,725.
Applicants note in their specification the use of the Illumina array (para 49 and 59). The examiner requires further information in order to make further determinations about the patentability of the instant claims. In response to this requirement, please provide answers to each of the following interrogatories eliciting factual information:
Are the elected SNPs disclosed on the Illumina platform array, if so which SNPs? Please also identify those SNPs not disclosed on the Illumina platform array.
The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
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 13-22 are rejected under 35 U.S.C. 101 because the claimed invention fails to recite a claim within one of the statutory classes and is thus directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because Claims 13-22 provides for the use of the SNP molecular marker combination of Claims 13-22, but fails to provide any recited steps. . The claim scope is so broad so as to encompass reviewing data about mutations that may be present in the SNP of the panel, and so “the use” of the SNP panel encompasses mental processes. In this way, the claim additionally sets forth an abstract idea. Claims 13-22 do not include any further steps that integrate the judicial exceptions, as they include nothing other than the judicial exceptions. MPEP 2173.05(q) provides that “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 101 because a “use” is not among the categories of patentable inventions specified in 101.
Claims 8-9 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 8-9 are directed to “a method for genetic relationship identification of a Huaxi cattle” by identifying a genotype of the SNP molecular marker combination using a genomic DNA of a Huaxi cattle to be identified, calculating a LOD score and identifying a genetic relationship. Claim 9 recites “when the LOD value is greater than 0 a candidate parent has a possibility of being a true parent and when the LOD value is less than 0 the candidate parent does not have the possibility of being a true parent.
Claims 8-9 are directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of “identifying a genotype”, “calculating a LOD value” and “identifying a genetic relationship”) and a law of nature/natural phenomenon (i.e. the natural correlation between the genotypes and paternity index).
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, claim 8 involves the patent-ineligible concept of an abstract process. Claim 8 requires performing the step of “identifying a genotype of the SNP molecular marker combination”. Neither the specification nor the claims set forth a limiting definition for "identifying" and the claims do not set forth how “identifying” is accomplished. As broadly recited the identifying step may be accomplished mentally looking at SNP data, taking data from a database, for example. These limitations encompass abstract ideas.
The step of calculating a LOD value is a mathematical concept. This step requires a mathematical calculation and so falls into the mathematical concepts grouping of abstract ideas.
Claim 9 further recites a comparison between the LOD score and the value 0 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)).
Further correlation that preexists in the human is an unpatentable phenomenon. The association between SNP molecular markers and paternity index is a law of nature/natural phenomenon. The "identifying a genetic relationship of the Huaxi cattle to be identified based on the LOD value" step which tells users of the process to predict parents of a cattle, amounts to no more than an "instruction to apply the natural law". This assessing step is no more than a mental step. Even if the step 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 "identifying" step does not require the process user to do anything in light of the correlation. The "identifying" step 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. 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. If the identifying a genotype of the SNP moelculear marker combination is taken to require more than mental process, it is 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 SNP molecular markers was well known in the art at the time the invention was made. The prior art teaches that SNPs may be analyzed using commercially available biochips and arrays that comprise the claimed SNPs. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any analysis to determine the SNPs status. 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. Specifically, the specification teaches using the Illumina Platform (see para 49 and 59)
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- 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 8-9, 13-22 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 pre-AIA the applicant regards as the invention.
Claims 8-9, 13-22 are indefinite because it is unclear what the position and chromosome position is relative to. The Bos-taurus has numerous different versions and each versions have different relative positions. Position 10000 in one version differs from position 10000 in another version. Thus, the position numbers provided in the claims are relative and without a particular reference genome, the marker positions are meaningless.
Claims 13-22 are indefinite because they attempt to claim a process without setting forth any steps involved in the process. See MPEP 2173.05(q). Claim 13 is drawn to a method for genetic relationship identification of a Huaxi cattle using SNP molecular marker combination. The method sets forth “the use” of SNP molecular marker combination. The claim further sets forth “the use” of a SNP molecular marker combination with no further limitation on how the panel is used.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-9, 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (Animals, Vol. 11, No. 3469, pages 1-16, December 6, 2021) in view of Zhang et al. (CN107586856, January 1, 2018).
Ma teaches assessing the genetic background and selection signature of Huaxi cattle using high-density SNP arrays. Ma teaches unique genetic features and phylogenetic relationship of Huaxi cattle for further breeding improvements of Huaxi cattle. Ma teaches using the Illumina BovineHD SNP array to genotype nine populations (page 3, para 3). Ma teaches analyzing genetic diversity, average minor allele frequency and observed heterozygosity (page 4). Moreover, LD scores were analyzed and square correlation coefficients were analyzed.
Ma does not teach paternity testing using SNPs.
However, Zhang teaches paternity tests and individual identification may be performed on SNP sites. Zhang teaches SNP marker combinations may be analyzed using software to detect maximum likelihood for paternity test, calculating the LOD value of the parent-child index and when the LOD value is more than 0, the candidate parent may be the real parent and when the LOD value is less than 0 the candidate parent is impossible to be the real parent.
Therefore, it would have been prima facie obvious prior to the invention to have used the data from Ma to further analyze the cattle to assess parentage as taught by Zhang. Zhang teaches how to determine parents using LOD scores. Ma teaches the importance of knowing and understanding beef cattle lines and parental inbreeding. Therefore, the ordinary artisan would have been motivated to have used the paternity testing method of Zhang to assess and determine the genetic relationship of Huaxi cattle for the expected benefits taught by Ma. There would have been a reasonable expectation of success the ordinary artisan could use the SNP marker panels, as taught by Ma to determining and calculated the LOD value and determine the parent of each cattle.
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al. (US 2024/0043912, filed July 21, 2023, foreign priority June 27, 2022). Chen is Applicant’s own work and provides 112,177 SNPs for breeding chop of Huaxi cattle.
Gao et al (US 12,426,578, September 30, 2025, foreign filing July 9, 2024) teaches methods for Huaxi cattle based on whole genome SNP information. Gao does not teach the instant SNPs.
Chen et al. (“Developing a liquid capture chip to accelerate the genetic progress of cattle, Vol. 2, pages 204-216, 2024). Chen teaches using the Cattle 110K liquid chip and Illumina Bovine HD Beadchip.
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.
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, 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
June 30, 2026
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