CTNF 18/479,837 CTNF 77364 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 is a CON of PCT/CN2021/130299 filed 11/12/2021. Information Disclosure Statement 06-52 The information disclosure statements (IDS) submitted on 10/3/2023, 12/20/2023 and 6/17/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Drawings 06-37 AIA The drawings were received on 10/3/2023 . These drawings are found acceptable by the examiner . Specification 07-29 AIA The disclosure is objected to because of the following informalities: (a) The disclosure is objected to at page 12 because the disclosure comprises of sequences of <10 nucleotides in the Table 1 at paragraph [0076] that are not represented by a proper sequence identifier (SEQ ID NO:) as discussed at MPEP 2417 and supported in the RAW sequence listing and CRF filed in the instant invention. (b) The use of the term “Rapid Taq PCR Master mix” at paragraphs [0020], [0021], [0047], [0048], [0064], [0079]-[0081], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-7 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. (a) Claim 1 is indefinite at the recitation of “related to chicken body size traits” because it is unclear the metes and bounds of what is meant by “related” in context to the “chicken body size traits” with regards to IGF2BP1 gene. Clarification is required. (b) Claims 2-3 are indefinite because the claims do not recite any active steps signifying an application of the molecular marker of claim 1 or any genetic improvement on the chicken body size traits. MPEP 2173.05q states “While minute details are not required in method claims, at least the basic steps must be recited in a positive, active fashion” (see ex parte Erlich , 3 UsPQ2d1011, p.1011 (Bd. Pat, Applicant. Int.1986). (c) Claims 4-7 are indefinite at the recitation of “a genetic improvement” because the claims do not provide a clear nexus between the steps of extracting chicken DNA, designing a primer based on a marker gene, performing PCR and selecting homozygous chicken and the recitation of “a genetic improvement”. It cannot be determined how one is to draw a conclusion of a genetic improvement” give the claims as broadly recited. A clear interpretation cannot be ascertained. (d) Claim 5 is indefinite because a clear interpretation of Applicant’s intent cannot be ascertained. Specifically, the claim is very narrative in form with no active method steps but rather conclusory statements. The claim appears to recite properties of the components intended to be use in the claimed improvement method. Additionally, the limitation “there are six genotypes: WW genotype shows a band of 2344 bp; L2W genotype shows two bands of 2344 bp and 790 bp; L1W genotype shows two bands of 2344 bp and 290 bp; L2L2 genotype shows a band of 790 bp; L1L2 genotype shows two bands of 290 bp and 790 bp; and L1L1 genotype shows a band of 290 bp” is unclear because it cannot be determined how the limitation further defines or limit the method as there are no specific active steps recited. MPEP 2173.05q states “While minute details are not required in method claims, at least the basic steps must be recited in a positive, active fashion” (see ex parte Erlich , 3 UsPQ2d1011, p.1011 (Bd. Pat, Applicant. Int.1986). Clarification is required. 07-35-01 (e) Claim 6 contains the trademark/trade name “2xRapid Taq PCR Master Mix”. 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 a product used for rapid PCR reactions and, accordingly, the identification/description is indefinite. (f) Claim 6 is indefinite at the recitation of “ASP-F and ASP-R” because it is unclear what these abbreviations are intended to represent, abbreviations often have more than one meaning in the art and accordingly, the metes and bounds of the limitations cannot be ascertained. Clarification is required. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 9. 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. 10. Claims 1 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to non-statutory subject matter. (a) The claim 1 recite(s) a molecular marker of IGF2BP1 gene related to chicken body size traits, comprising an insertion or deletion of a nucleotide sequence shown in SEQ ID NO: 2 or an insertion or deletion of a nucleotide sequence shown in SEQ ID NO: 3. The specification teaches at paragraph [0037] teaches that “the inventors discovered from the first time that two deletion genotypes at upstream of the IGF2BP gene”. The specification further states at paragraph [0037] that “the molecular marker of IGF2BP1 gene related to chicken body size traits is the insertion or deletion of the nucleotide sequence of the chicken at position chr27: 6082202-6085435 or the insertion or deletion of the nucleotide sequence of the chicken at position chr27: 6083984-6085538.” The claim 1 is directed to the judicial exception of a natural phenomenon or law of nature. The claims recite the correlation between a IGF2BP1 having an insertion or deletion and naturally occurring chicken traits. Note that the unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). As in Mayo Collaborative Services v. Prometheus , the recited relationship is a natural phenomenon that exists apart from any human action. See also Cleveland Clinic Foundation v. True Health Diagnostic, LLC , 2018-1218 (Fed Cir. 2019) which states that “The re-phrasing of the claims does not make them less directed to a natural law.” In Mayo , the Court further noted that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." 566 U.S. at 77. Additionally, “‘conventional or obvious’ ‘[pre]-solution activity’ is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.” Id. at 79 (quoting Flook , 437 U.S. at 590); see also Bilski , 561 U.S. at 593 (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’”) (quoting Diehr , 450 U.S. at 191–192). Accordingly, the claim is deemed to be patent ineligible. 11. Claims 2-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. (a) The claims 2-3 are directed to application of the molecular marker as clamed in claim 1 in genetic improvement on the chicken body size trains and determining an insertion or deletion of the nucleotide sequences as shown in shown in SEQ ID NO: 2 or SEQ ID NO: 3 and selecting homozygous chicken individuals with the deletion of the nucleotide sequence shown in SEQ ID NO: 3 for breeding. The claims recite a “use” of the molecular marker of claim 1 without setting forth any steps involved in the process. MPEP 2173.05(q) states that "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101 . In re Moreton , 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101 : "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid." Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater , 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus , 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. The claims also recite the abstract idea of “determining an insertion or deletion…” and “selecting homozygous chicken…”. The steps are not active steps and can be interpreted as steps encompassing mental analyses and/or reading data on paper or on a general computer screen. Based on the 2019 updates: Subject Matter Eligibility, claims recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations evaluations, judgments and opinions or claims encompassing a human performing the steps(s) mentally with the aid of a pen and paper. Examples of claims that recite mental processes include: a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.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 Corp .; a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC ; and a claim to identifying head shape and applying hair designs, which is a process that can be practically performed in the human mind, In re Brown. Accordingly, the claims are deemed to be patent ineligible. 12. Claims 4-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. (a) The claims are directed to a genetic improvement method for chicken body size traits, comprising the following steps: i) extracting chicken DNA to be tested, designing a primer according to the molecular marker as claimed in claim 1 and utilizing the designed primer to carry out PCR amplification and selecting homozygous chicken individuals with the deletion of the nucleotide sequence shown in SEQ ID NO: 2 according to PCR amplification resulting for breeding. The claim 5-7 recites properties, intended results intended method steps and general data gathering/analyses steps. These claims recite the judicial exception of a natural correlation in the recitation of the correlation between identifying insertion or deletion of the molecular marker of a IGF2BP1 gene and the identification of chicken body size traits. The claims also recite the abstract ideas of selecting homozygous chicken, identifying band sizes and genotype identification which under the broadest reasons interpretation covers performance of the limitations in the mind as well as mathematical calculations and statistical modeling which could be interpreted as performing calculations mentally or by hand on paper which falls within the “Mental Processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application because the claim only describes the natural correlation, i.e., the association between pathogens and bovine respiratory disease and adds well-understood, routine and convention steps to use it. This is analogous to the ineligible diagnostic method in Mayo Collaborative Services v, Prometheus Laboratories . In Mayo , the Court found that “[i]f a law of nature is not patentable, the neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." 566 U.S. at 77. Additionally, “‘conventional or obvious’ ‘[pre]-solution activity’ is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.” Id. at 79 (quoting Flook , 437 U.S. at 590); see also Bilski , 561 U.S. at 593 (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’”) (quoting Diehr , 450 U.S. at 191–192). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of extracting DNA, designing primers, PCR amplification and electrophoresis are all steps that are considered conventional and routine in the technological field. General and conventional steps of extracting DNA, designing primers to a molecular marker of IGF2BP1 gene, performing PCR, genotyping and electrophoresis are exemplified by Lan et al (CN110468218, translated document, November 19, 2019) which teaches IGF2BP1 gene insertion/deletion method of a marker, extraction DNA, designing primer, performing amplification and electrophoresis to perform genotype identification (see translated document). 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. Closest prior art 07-96 AIA 13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhao et al (citation #2 made of record on IDS filed 12/20/2023) teach research progress of IGF2 gene expression regulation and its genetic variation in animal growth and development (abstract) . Conclusion 14. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible. 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, GARY BENZION can be reached at 571-272-0782. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CYNTHIA B WILDER/Primary Examiner, Art Unit 1681 Application/Control Number: 18/479,837 Page 2 Art Unit: 1681 Application/Control Number: 18/479,837 Page 3 Art Unit: 1681 Application/Control Number: 18/479,837 Page 4 Art Unit: 1681 Application/Control Number: 18/479,837 Page 5 Art Unit: 1681 Application/Control Number: 18/479,837 Page 6 Art Unit: 1681 Application/Control Number: 18/479,837 Page 7 Art Unit: 1681 Application/Control Number: 18/479,837 Page 8 Art Unit: 1681 Application/Control Number: 18/479,837 Page 9 Art Unit: 1681 Application/Control Number: 18/479,837 Page 10 Art Unit: 1681 Application/Control Number: 18/479,837 Page 11 Art Unit: 1681 Application/Control Number: 18/479,837 Page 12 Art Unit: 1681