DETAILED ACTION
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 .
Claims 1-10, 17-19 are pending. Claims 1-10 are withdrawn. Claims 17-19 are currently under examination.
This office action is in response to the amendment filed on 11/19/2025.
All previous rejections not reiterated in this office action are withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bangera, in view of Wiles. This rejection is rewritten to address the amendment.
Bangera discloses a method of rapid breeding by using male and female gametes directly from animal stem cells (paragraph [0153], lines 1-4). Bangera discloses embryonic stem cells are initially obtained from bovine embryos (paragraph, [0232], lines 1-5). Bangera discloses DNA sequencing is used to identify ESC clones with preferred chromosomes have desired characteristics (paragraph [0233], 1-6). Bangera discloses selected ESC clones is differentiated to gametes and mating in vitro, wherein the sperm may derive from the same ESC clone differentiated to an oocyte (paragraph [0234] and [0235]). Bangera discloses that the mammal is cattle (paragraph [0231]). Bangera teaches that in vitro fertilization with ESC-derived sperm cells yields embryos which can be used for another round of breeding, or transferred to a foster mother for development to term (paragraph [0236], lines 1-4).
However, Bangera does not teach the first embryo and the second embryo are obtained from inbred lines, wherein the inbred lines are generated using gametes derived from embryos that are full or half sibs, first cousins, or sharing a common ancestor within last 5 generations.
Wiles teach a method of generating genetically stabilized non-human animal inbred strains by 1st establishing a foundation colony, cryopreserved the stock of embryos with pedigree tracking. At appropriate intervals, a pair of brother sister embryos (sibling) derived from a single brother-sister pair are selected from the animals produced and used as a new founder pair to re-establish the foundation stock. Wiles teach practice of this method makes it possible to maintain an inbred strain with limited genetic drift without affecting the inbred status of the strain, wherein the inbred animals that are truly uniform with well-defined genotypes over extended period of time will be available (page , 4th paragraph, and claim 1).
It would have been obvious to an ordinary skilled in the art to choose mating of two inbred lines of mammalian species that are obtained from full or half sibs, first cousins or having common ancestor in the last 5 generation in the rapid breeding method taught by Bangera in view of teaching from Wiles. The ordinary skilled in the art would recognize that inbred lines are generated by mating a brother sister pair, a half sibs, first cousins based on the teaching from Wiles. The ordinary skilled in the art following the teaching by Bangera to perform the rapid breeding method for maintaining genetic stability would have been motivated to use inbred line because inbred lines are selected for specific characteristic. The ordinary skilled in the art would have reasonable expectation of success to obtain an egg and a sperm differentiated from a pair of embryos from two inbred lines; fertilizing them in vitro and transfer to a recipient for producing the animal to obtain an offspring following combined teaching from Bangera and Wiles. Therefore, the claimed invention of claim 17 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bangera and Wiles, as applied to claims 17 above, and further in view of Hayashi et al (IDS). This rejection is rewritten to address the amendment.
The teaching from Bangera and Wiles has been discussed above. Bangera further teaches removing one or more cells from embryo for genetic analysis of desired traits, wherein DNA and RNA may be extracted from said cells and while maintaining the viability of the progeny (page 11, paragraph [0121]-[0123]). Bangera teaches the breeding method may be accomplished using animal stem cells, which includes both ESC and induced pluripotent stem cell from somatic cell (paragraph [0157] and [0166]).
However, neither reference teaches extracting DNA from specific cell type amniocytes or fibroblasts from the first embryo or second embryo while maintaining the viability of the embryo.
Hayashi et al. teach and demonstrate the generation of primordial germ-like cells (PGCLCs) in mice with robust capacity for spermatogenesis from both embryonic stem cell and induced pluripotent stem cells (iPSC) through epiblast-like cells (EPiLCs, precursor of aminocytes) (see abstract, Figure 8 and legend).
It would have been obvious to an ordinary skilled in the art that gametes (eggs and sperms) may be obtained from both ESC and iPSC based on the combined teaching from Bangera and Hayashi. The ordinary skilled in the art intending to determine a predefined genotypic characteristic of an offspring would extracting DNA from cells derived from embryos that would be used to generating gametes prior to the induction of differentiation. The ordinary skilled in the art would be motivated to isolating fibroblast or aminocytes from the embryo for such analysis because fibroblast and aminocytes have been shown in prior art to be able generate iPSC for subsequent differentiation into gametes. Therefore, the claimed invention of claim 18 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bangera and Wiles, as applied to claim 17 above, and further in view of Segelke. This rejection is rewritten to address the amendment.
The teaching from Bangera and Wiles has been discussed above.
However, neither teaches selecting inbred lines using gamete variance as a selection criteria.
Segelke teaches prediction of expected genetic variation within groups of offspring for innovative mating schemes (title). Segelke teaches a method of predicting mean and standard deviation of gamete breeding values (gamete variation) (page 2, 2nd col., 2nd paragraph). Segelke teaches animals with a high mean and a low variability that are relevant for dairy farmers because farmers are more interested in homogenous groups of offspring (page 9, 1st col., 4th paragraph). Segelke teaches animals with a high mean and high standard deviation are interesting for AI companies because selecting these animals will increase the probability of producing animals with extremely positive breeding values in the future (page 9, 1st col., 2nd paragraph). Segelke teaches using gamete variation selection criteria has the advantage of simplifying the selection process for desired trait (page 9, bridging paragraph of 1st and 2nd col).
It would have been obvious to an ordinary skilled in the art performing the rapid breeding of animals method rendered obvious by combined teaching from Bangera and Wiles to use selection criteria such as gamete variance because Segelke teaches aid method has the advantage of being simple and fast. Segelke teaches a software for breeding association including MGBV and SDGBV for a portfolio of bulls of interest and for genotyped cows was already developed (page 9, 2nd col., lines 7-10). The ordinary skilled in the art would thus have reasonable expectation of success to obtain an egg and a sperm differentiated from a pair of embryos from two inbred lines, selected based on gamete variation, fertilizing them in vitro, and transfer back to a foster mother to develop to full term to generate an offspring following combined teaching from Bangera, Wiles and Segelke. Therefore, the claimed invention of claim 19 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Response to Arguments
Applicant argues that the combined teaching from Bangera, in view of Wiles and Segelke cannot establish prima facie obviousness because the combination fails to teach a step “transferring a hybrid embryo into a recipient to produce a production dairy animal” as required by amended claim 17.
This argument is not persuasive because Bangera’s teaching that transferring the IVF embryo to a foster mother to develop the animal to full term in paragraph [0236] as discussed in above rewritten rejection meets the claim limitation of “transferring a hybrid embryo into a recipient to produce a production dairy animal” as required by amended claim 17.
Applicant also submitted a declaration by Dr. Heuer to overcome the present rejections. The declaration under 37 CFR 1.132 filed 11/19/2025 is insufficient to overcome the rejection of claims 17-19 based upon Bangera, Wiles, Segelke as set forth in the last Office action for following reasons.
The declaration first provides a description of the prior art method of producing “production dairy animals” including artificial insemination of the existing production animals using semen purchased from a bull stud. The declaration explains that each bull stud in the dairy industry employs a breeding program that is directed solely to the production of artificial insemination (AI) sires, wherein males and females are evaluated for genetic merit and only the best are selected as parents of prospective AI sires. The declaration states that this prior art method for producing replacement heifers is inferior to the claimed method for at least two reasons: 1) the genetic improvement of production dairy animals is suboptimal because genetic advancement only takes place on the male side; 2) the genetic merit of the replacement heifers on any given dairy farm will be highly variable because 1) the existing production dairy animals are not genomically evaluated and selected as mothers and 2) there will be genetic variance in the specific gametes used to produce each replacement heifer. The declaration states that genetic advancement of production dairy animals with the claimed method is significantly increased compared to the prior art method because both parents of replacement heifers are part of a selective breeding program rather than just the father. The declaration states that since hybrids of two inbred lines are produced by embryo transfer rather than artificial insemination, variability in the genetic merit of replacement heifers on any given dairy farm is significantly reduced compared to prior art method.
The above statements are not persuasive because the so called “prior art breeding program” discussed in the declaration is not based on the teaching from Bangera, Wiles and Selgelke as discussed in the rejection. The rejection does not involve any breeding program based on artificial insemination. The alleged lack of teaching for the amended claim 17 step of “transferring a hybrid embryo into a recipient to produce a production dairy animal” is incorrect because Bangera teaches transferring the hybrid embryo to a foster mother to allow the embryo to develop into full term animal, which meets this limitation. Therefore, for reasons discussed in previous rejection and set forth above, this rejection is still considered proper and thus maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637