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 .
Detailed Action
This action is in response to the papers filed August 18, 2026.
Election/Restrictions
Applicant’s reply filed 08/18/2026 to the Requirement for Restriction/Election mailed 05/27/2026 is acknowledged. Applicant elected without traverse Invention I, claim 1, drawn to a method of breeding a Shandong Black cattle comprising using miR-34b to screen an individual with a low miR-34b level as a stud bull.
Claims 2-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim
Claim Listing
The instant claims are the original claims filed on 06/03/2024.
Claims 1-5 are pending.
Claims 2-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim 1 is under examination.
Priority
The instant application 18/732,209 was filed on 06/03/2024. This application claims priority based on Chinese patent application CN202311562773.4 filed 11/22/2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The foreign priority document was originally filed in a non-English language, and a verification of translation was filed on 06/04/2024.
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 § 609.04(a) 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, or by applicant in an information disclosure statement (IDS), they have not been considered.
Sequence Compliance
The instant application was filed on or after 07/01/2022, and therefore the instant application is subject to the requirements of 37 C.F.R. 1.831 through 1.835.
The sequence rules embrace all nucleotide and amino acid sequences defined by:
(1) An unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone; or
(2) An unbranched sequence or linear region of a branched sequence of 10 or more specifically defined nucleotides, wherein adjacent nucleotides are joined by:
(i) A 3' to 5' (or 5' to 3') phosphodiester linkage; or
(ii) Any chemical bond that results in an arrangement of adjacent nucleobases that mimics the arrangement of nucleobases in naturally occurring nucleic acids (i.e., nucleotide analogs).
Disclosed nucleotide or amino acid sequences that do not meet this definition must not be included in the Sequence Listing.
See 37 C.F.R. 1.831, and see guidance of WIPO ST.26 and MPEP 2412-2419.
Appropriate action is required so that the sequences disclosed in the application comply with the sequence rules. Examples found in the application which fail to comply with the sequence rules include:
Figure 7B.
Applicant should carefully review the entire specification to ensure compliance with the sequence rules. Applicant should provide a corresponding sequence identifier (SEQ ID NO) with every appearance of a sequence embraced by the sequence rules. Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier, either in the drawing itself or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawings and their sequence identifiers in the Brief Description is clear. For guidance on amending the Sequence Listing, see MPEP 2414. Appropriate action is required in reply to this Office action. See attached PTO-2301.
For these reasons, both the specification and the drawings are objected to.
Claim Interpretation
Claim 1 recites “the miR-34b has a nucleotide sequence set forth in SEQ ID NO: 11.” Reciting "a" sequence of SEQ ID NO: 11, as claimed, reads on any sequence comprising at least two consecutive nucleotides of SEQ ID NO: 11. To avoid this broadest reasonable interpretation of claim 1, the claim would have to recite "the" nucleotide sequence set forth in SEQ ID NO: 11.
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.
Claim 1 is 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.
Claim 1 recites “screen an individual with a low miR-34b level as a stud bull.” The term “low” in claim 1 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the term. In this case, it is not clear what level or amount of miR-34b should be considered “low” and what level or amount of miR-34b should be considered “not low.” For example, one of ordinary skill in the art, having found the level or amount of miR-34b in an individual or sample thereof, would not be reasonably apprised when to identify the individual as a stud bull based on the results of the screening. For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 is 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.
Claim 1 recites “[a] method of breeding a Shandong Black cattle, wherein a miR-34b is used to screen an individual with a low miR-34b level as a stud bull.” Accordingly, the claim attempts to claim a process of using miR-34b to screen for stud bulls without setting forth any steps involved in the process. In other words, there is no description how miR-34b is “used” to screen for stud bulls or, more generally, how the screening is performed. Therefore, the claim is indefinite because it merely recites using miR-34b without any active, positive steps delimiting how this use is actually practiced. See, MPEP 2173.05(q). Moreover, the method purports to be a method of breading Shandong Black cattle, but there is no description of any breeding step. Accordingly, there is a lack of nexus between the intended result recited in the preamble of the claim and the active, positive steps recited in the body of the claim. Generally, it is unclear if a process of breeding Shandong Black cattle is required or should be considered at least a part of the broadly recited “use” recited by the claim. For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Tscherner et al. (2014) “MicroRNA-34 family expression in bovine gametes and preimplantation embryos” Reproductive Biology and Endocrinology, 12:85, 9 pages.
Tscherner discloses microRNAs (miRNA) are potent effectors of post-transcriptional gene silencing, and the miR-34 family of miRNA are involved in both spermatogenesis and early events of embryogenesis. Tscherner profiled miR-34 expression, including expression of miR-34b, in the gametes of Bos taurus (cattle). In particular, sperm cells were isolated from semen samples of 10 bulls with unknown fertility status, and purified RNA was obtained from gametes and testis tissue. Based on the results, Tscherner suggests that individual variation in sperm miR-34 family abundance may serve as a biomarker of male bovine fertility. See, e.g., Abstract, pages 4-5 and 7, and Figures 1 and 4.
Accordingly, Tscherner is found to teach or fairly suggest a process of screening for male bovine fertility by measuring individual variation in sperm miR-34 family abundance, including miR-34b, among a population of stud bulls.
Tscherner does not teach that the cattle is Shandong Black cattle, as claimed in claim 1. However, prior to the effective filing date of the instantly claimed invention, Shandong Black cattle was a known breed of cattle for beef production. Official Notice taken, if necessary. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to substitute the cattle of Tscherner with Shandong Black cattle, as previously known in the art, with a reasonable expectation of success because breeding and raising Shandong Black cattle is desirable for commercial beef production, and the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim 1 further recites miR-34b has a nucleotide sequence set forth in SEQ ID NO: 11. SEQ ID NO: 11 provides the wild-type sequence of Bos taurus miR-34b (bta-miR-34b), which was known in the art prior to the effective filing date of the instantly claimed invention. Official Notice taken, if necessary. Accordingly, modified Tscherner meets the limitation of miR-34b having a nucleotide sequence set forth in SEQ ID NO: 11.
As explained above under 35 U.S.C. 112(b), claim 1 does not describe how miR-34b is “used” to screen individuals with a low miR-34b level as a stud bull, nor does the claim recite any active, positive steps delimiting how this “use” is actually practiced. Also, there is no standard to ascertain what level or amount of miR-34b is considered “low” rather than “not low.” Therefore, in light of the indefinite scope of claim 1, the screening process of modified Tscherner is found to read on the method set forth in claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James D Schultz can be reached at (571)272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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