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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/12/2025 has been entered.
This Office Action is in reply to Applicants’ correspondence of 09/12/2025.
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put this application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is NON-FINAL.
Please Note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 07/27/2022 (CN2022108894331). It is noted, however, that applicant has not filed a certified copy of the application as required by 37 CFR 1.55.
It is noted that the Office’s attempt to electronically retrieve the priority document failed on 12/27/2023.
Withdrawn Claim Objections
The objections to claims as set forth on pages 2-3 of the Office Action of 06/12/2025 are withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 112 – New Matter
The rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (new matter), as set forth on pages 3-4 of the Office Action of 06/12/2025, is withdrawn in light of the amendments to the claims.
Withdrawn Objection to the Drawings
The objection to the drawings as set forth on pages 4-5 of the Office Action of 06/12/2025, is withdrawn in light of the replacement drawings provided with the reply of 09/12/2025.
Withdrawn Claim Rejections - 35 USC § 112 – Indefiniteness
The rejection of claims 11-13 are rejected under 35 U.S.C. 112(b) over tables reciting the same ‘NO.’ with different ‘Position’ designations, as set forth on pages 5-6 of the Office Action of 06/12/2025, is withdrawn in light of the amendments to the claims.
Maintained Claim Rejections - 35 USC § 112 – Indefiniteness
Newly Applied to Newly Presented Claims
Claims 14-16 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.
Claim 14-16 are unclear over the required “sixth marker panel comprising a total of 74,098 markers verified in a Huaxi cattle population from two SNP beadchip used in beef cattle breeding”. The claims thus require a collection of some particular markers, but the source of the markers is not defined, and thus it is unclear what particular markers are required. The sixth panel limitation is further unclear in each claim where the claims recite “a screening method of the sixth marker panel comprises … deleting invalid sites”, where it is unclear what is intended to be required for any site to be “invalid”. The relevant limitations of the claims include “selecting effective information marker sites”, but there does not appear to be any connection between “effective information marker sites” and “invalid sites”. Additionally, it is unclear how the “verified” markers are related to the “effective” markers and the “invalid” sites. The claims are further unclear in this regard where the screening clause of the claims with regard to the sixth marker panel recites “two SNP beadchip used in beef cattle breeding”, which does not specify any particular bead chips, thus making it unclear how the screening is related to any particular marker positions required for the sixth panel.
Response to Remarks
Applicants have traversed the rejection of claims as set forth in the previous Office action and maintained above as applied to the newly presented claims. Applicants’ arguments, relevant to the rejection, have asserted that the claims recite steps related to the use of genotyping results using SNP bead chips with Huaxi cattle population, and that:
"invalid sites" are the complement of effective information marker sites," and the relationship between these terms is unambiguous.
The arguments are not persuasive because there is in fact no teaching in the application as filed which requires that “invalid sites” have some particular relationship with the “effective information marker sites” that are selected in the screening method of the claim. The Examiner maintains that the claims remain unclear in this regard where the screening step is generically drawn to “two SNP beadchip used in beef cattle breeding” (i.e.: not directed to any particular specific combination of polymorphic loci), and as such it is unclear what loci are included in the screening and so it is not clear what loci are particularly included or excluded from the “sixth marker panel”. In this regard it is noted that the method is recited with the open “comprising” transitional term (e.g.: claim 14- …wherein the genome-wide breeding chip of Huaxi cattle comprises a molecular marker combination), where “comprising” is synonymous with "including," "containing," or "characterized by," and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03). Thus it is unlcear when the claims recite “deleting invalid sites in the Huaxi cattle population” how such a “deleting” is intended to change the scope of the claims. Where the methods are “comprising”, the recited limitations appear to set forth what is specially included in the practice of the claimed methods, but it is unclear how a method comprising a molecular marker combination may be expected to exclude any particular element.
Maintained
Improper Incorporation by Reference of Essential Subject Matter
Claim Objection and
Claim Rejection - 35 USC § 112 1st ¶ - Written Description
Newly Applied to Newly Presented Claims
Claims 14, 15 and 16 are each objected to and rejected over recitation of “markers … from chip I and chip N;” and “genome A is used as a reference genome of cattle” as recited in claims 14m 15 and 16 The recitation is an attempt to improperly incorporate essential subject matter by reference. 37 CFR 1.57(c) provides:
“Essential material” may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference.
In making the instant rejection, it is noted that the amendments to the specification of 09/12/2025 include:
The two most commercialized SNP beadchip products used in Chinese beef cattle breeding are Illumina BovineHD 770K (Chip I) and Neogen GGP Bovine 100K (Chip N).
and
The ARS-UCD 1.2/bosTau9 version (genome A) is preferably used as a reference genome of cattle.
As such the recitation in the claims of “markers …. From chip I and chip N” is a reference to the markers that are contained on the commercially available Illumina BovineHD 770K and Neogen GGP Bovine 100K chip sets. And the recitation of “genome A” is a reference to a genomic assembly from a database. In both each case the reference is inappropriate for recitation of a claim limitation. Because the recitation is critical and essential to the practice of the claimed methods, the claims are thus also rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.
Response to Remarks
Applicants have traversed the rejection of claims as set forth in the previous Office action. Applicants’ arguments have asserted that the sequences related to “ARS-UCD 1.2/bosTau9 version” are well-known and commonly used in the field, as set forth at para 13 of the Declaration. This argument is not persuasive. The rejection is not based on the prior use or knowledge in the field of sequences related to of “ARS-UCD 1.2/bosTau9 version”; in the instant case that particular information is required to establish what is being analyzed in the claimed methods, and what features are present on the panel of the claims. Where such information is critical and essential to the claimed subject matter, the information can not be provided by reference to some external source of information.
Claim Rejections - 35 USC § 112 – Written Description
Maintained-in-Part, newly applied to newly presented claims
Claims 16 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed genomic selection (GS) breeding of Huaxi cattle using a genome-wide breeding chip. The claims are directed to the use of a chip that has a plurality of molecular markers (SNPs and Indels) that are associated with seven different panels. The specification further describes the features of the genome-breeding chip as being functionally related to “seven categories of growth, fattening, carcass, meat quality, reproduction, disease, and health” (see for example para 0015). But the specification does not disclose any particular alleles (specific nucleotide content within a precise genomic context) that are present in Huaxi cattle. For example, while the claims encompass a first panel with a site that is NO. 27 Position 1:1073001, the specification does not disclose what allele content (e.g.: minor allele nucleotide and major allele nucleotide) is found at the position in Huaxi cattle. And an analysis of the locus in the ARS-UCD1.2/bosTau9 build does not indicate that the position is a known polymorphism (i.e.: the database indicates the position is a C nucleotide). The mere identification of the locus does not provide the skilled artisan with any knowledge of what other alleles may be in the Huaxi cattle population. And merely finding some alternate allele in a member of the Huaxi cattle population would not inform the skilled artisan as to whether or not such an allele is the same nucleotide content that is functionally relevant as asserted in the specification. As such where the claim recites “estimating GEBV prediction of economic traits including slaughter, meat quality, and body size, and 5 GCBI traits (calving ease, weaning weight, average daily gain during fattening period, carcass weight, and dressing percentage)” the application as original filed does not provide a teaching with regard to which alleles of any polymorphic marker may in fact provide a genomic estimated breeding value prediction of any particular economic trait.
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.
The Application sets forth that the prior art arrays of Illumina BovineHD 770K and Neogen GGP Bovine 100K provide at least a subset of the marker positions of the instant claims.
The Examiner requires additional information in order to make further determinations about the patentability to the instant claims. In response to this
requirement, please provide:
Do the marker panels of the claim which recite particular Bos genome postions (i.e.: the first, second, third, fourth, fifth and seventh marker panels) inlcude positions that are not contained on either the llumina BovineHD 770K or Neogen GGP Bovine 100k sets? If so, please provide an indication of particular genome positions that are novel in the claimed array as compared to each of the the Illumina and Neogen sets.
The fee and certification requirements of 37 CFR 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR 1.105 that are included in the applicant’s first complete communication responding to this requirement.
Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement The fee and certification requirements of 37 CFR 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR 1.105 that are included in the applicant’s first complete communication responding to this requirement.
Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
Prosecution Insights