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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/23/2025 has been entered.
Claim Status
As of the Final Office Action mailed 5/8/2025, claims 1, 3, 6-9, 11-14, 18-22, and 33-36 were pending.
In Applicant's Response filed on 10/23/2025, claims 1, 6, 8, 11-12, 14, and 19-21 were amended, claims 3, 7, 9, 13, 22, and 34 were canceled, and claim 37 has been newly added.
As such, claims 1, 6, 8, 11-12, 14, 18-21, 33 and 35-37 are pending and have been examined herein.
Withdrawn Objections/Rejections
The rejection of record of claim 1, 3, 6-9, 11-14, 18-22, and 33-36 under 35 USC § 112(a) have been withdrawn in view of Applicant’s amendments. Rejections of claims 3, 7, 9, 13, 22, and 34 are moot.
The rejection of record of claim 7-8 and 19 under 35 USC § 112(b) have been withdrawn in view of Applicant’s amendment to claim 8 and 19. Rejection of claim 7 is moot in view of its cancelation.
The rejection of record of claims 1, 3, 11-13, 18-19, 21-22, 34, and 36 under 35 USC § 102(a)(1) and (a)(2) as being anticipated by Robl et al (US 8,551,705 B2, 28 Jan 2011) has been withdrawn in view of Applicant’s amendments to claim 1.
The rejection of record of claims 6-9 under 35 USC § 103 as being unpatentable over Robl et al as applied to claims 1-3, 11, 13, 18-19, and 22 and further in view of Lagutina et al (Biol Repro, 1 Feb 2004; 70(2):400-405) have been withdrawn in view of Applicant’s amendments. Rejection of claims 7 and 9 are moot in view of their cancelation.
The rejection of record of claim 14 under 35 USC § 103 as being unpatentable over Robl et al as applied to claims 1, 3, 11-13, 18, 22, and 34 above, and further in view of American-International Charolais Association (Referenced herein as AICA; “Genomic Enhanced EPD” 23 Dec 2014; Retrieved from the Internet 26 Apr 2025 from https://charolaisusa.com/pdf/2015/GEPD_4c_hr.pdf) have been withdrawn in view of Applicant’s amendments.
The rejection of record of claims 33 under 35 USC § 103 as being unpatentable over Robl et al as applied to claims 1-3, 11, 13, 18-19, and 22 and further in view of Prather (US 4,994,384 A, 27 Oct 1987) have been withdrawn in view of Applicant’s amendments.
The rejection of record of claims 20 and 35 under 35 USC § 103 as being unpatentable over Robl et al (US 8,551,705 B2, 28 January 2011) in view of Lagutina et al (Biol Repro, 1 Feb 2004; 70(2):400-405) as applied to claims 6-9, and further in view of Paffoni et al (Fertil Steril. 30 Oct 2006; 87(1):77-82; previously cited).
New Grounds of Rejections
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 1, 6, 8, 11-12, 14, 18-21, 33 and 35-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions (natural correlation and abstract idea) without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. Here, the claims recite, inter alia, a method of generating bovine diploid embryos and/or offspring comprising the steps of: a) obtaining a bovine androgenetic embryonic haploid cell isolated from a preimplantation bovine androgenetic haploid embryo at the cleavage stage up to and including the blastocyst stage, b) deriving haploid outgrowth from the embryonic haploid cell of step (a), c) characterizing a genome of the haploid cells of step (a) or (b), d) selecting one or more sister cells of the characterized haploid cell of step (c); and e) deriving ungulate bovine diploid embryos and/or offspring from the selected haploid cells of step (d), wherein the bovine androgenetic haploid embryo has been prepared by a method comprising removing a bovine oocyte’s genome either before or after fertilization of the oocyte by intracytoplasmic sperm injection (ICSI) of a single sperm. This is a method/process; therefore, the claims fall within a statutory category. [Step 1: YES]
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. A claim “recites” a judicial exception when the exception is “set forth” or “described” in the claim (see MPEP 2106.04(II)). The claims recite judicial exceptions. provides a description of the natural correlation between particular genomic characteristics of a bovine haploid cell and their “commercially valuable traits.” The recitation of “characterizing a genome of the haploid cells of step (a) or (b), d) selecting one or more sister cells of the characterized haploid cell of step” as in instant claim 1 because the characterizing step and selection step provides a description of the natural correlation between particular genomic characteristics of a bovine haploid cell and their “commercial value” and the selection step requires a mental step because it requires drawing a conclusion from the comparison of genomic traits during data gathering. Claim 14 recites that the characterizing comprises “screening and scoring the genome of the haploid cells to identify the presence or absence of polymorphisms indicative of commercially valuable traits”. The instant specification describes “characterizing” as performing haploid genomic scoring of the haploid cell (see para 20). It defines “scoring” and “screening” as “scoring may include (i) scoring the genomic screening the haploid embryonic-derived cell or (ii) selecting the haploid embryonic-derived cells for the preferred haploid genomic score or selection index. The score may comprise including a weighted combination of one or more single nucleotide polymorphisms” and “"Screening" typically refers to detecting (preferably through genotyping) the presence or absence of certain commercially valuable traits. "Scoring" typically refers to screening for multiple traits at once, then creating a score that is made up of a series of traits that are equally or differentially weighted according to their relative value. Selection then refers to identifying a subpopulation of animals in the population with the highest scores. "Selection" can also refer to a genomic value made up of hundreds or thousands of genomic markers that span the entire genome and constitute a genomic prediction of the breeding value or transmitting ability of an individual. A subpopulation of animals is then selected on the basis of their genomic breeding values or genomic transmitting ability.” (see para 20 and 85). The screening and scoring steps of claim 14 requires a mental step (an abstract idea) because these steps require drawing a conclusion from the comparison of traits detected during data gathering, applying a relative value to the traits, and adding them up to create a total score (also a mental step) to select a particular embryo. Thus, the claims recite a judicial exception, a natural correlation and an abstract idea. [Step 2A, Prong 1: YES]
Therefore, the analysis proceeds to Step 2A Prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application. In addition to the judicial exceptions, independent claim 1 also recites a step of “deriving ungulate bovine diploid embryos and/or offspring from the selected haploid cells of step (d).” This step is recited in generic terms such that the claim does not appear to be directed to making embryos or offsprings with any particular characteristics and is merely instructions to apply the judicial exception. One consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984 (warning against a § 101 analysis that turns on "the draftsman’s art").
Some applicable considerations to whether the limitation amounts to more than instructions to merely “apply” include (see MPEP 2106.05(f)):
Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished: The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application because this type of recitation is equivalent to the words "apply it". Here, in the generic recitation of “deriving ungulate bovine diploid embryos and/or offspring from the selected haploid cells of step (d)”, the claim provides no restriction on how the result (diploid embryo and/or offspring) is accomplished nor does it indicate any particular trait of the derived embryo/offspring based on the previous steps claimed (i.e., the claims do not require that the derived embryo/offspring to have the same characteristics selected for). This is substantiated by p. 12-13 of the instant specification which indicates that the derivation could include removal of chromosomes. This implies that other modifications could also be included in the derivation process, made both to retain the selected characteristics, to make additional modifications, or dispose of traits/chromosomes not related to selected characteristics (regardless of the impact on the characteristic retention).
The particularity or generality of the application of the judicial exception: Again, the derivation step recited in the claim is recited at a high level of generality as stated above. While dependent claims 18 states that deriving the embryo or offspring “comprises introducing the genome of the one or more selected haploid cell of (d) into one or more oocytes,” claim 19 recites “comprising introducing the genome of the one or more selected haploid cell of (d) into one or more fertilized and enucleated oocytes before paternal pronuclear formation,” claim 20 recites “introducing the genome of the selected haploid cell of (d) into a parthenogenetically activated oocyte before maternal pronuclear formation,” and claim 21 recites “wherein deriving diploid embryos and/or offspring comprises introducing the genome of the selected haploid cell of (d) and the genome of a second haploid cell into an oocyte, wherein the second haploid cell is derived from an in vitro cultured ungulate parthenogenetic haploid embryo of the same species as the first,” these limitation are still recited with a high level of generality (and, as discussed below, well-known, routine, and conventional in the art).
Here, given that step (e) of claim 1 is recited in such generic terms, it does not amount to more than a recitation of the words "apply it" (or an equivalent). [STEP 2A, Prong 2: NO]
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP 2106.05). This is based on an additional consideration of whether the elements in addition to the judicial exception add beyond what was well-understood, routine, and conventional to the claims. The additional claim limitation of instant claim 1 (as well as dependent claims 18-21) are routine, well-understood, and conventional in the art.
Vichera et al (Reprod Fertil Dev. July 2011; 23(6):769-79) teaches the developmental ability of bovine androgenetic haploid embryos constructed by different methods, namely IVF and intracytoplasmic sperm injection (ICSI) before and after oocyte enucleation (abstract). Androgenetic haploid embryos were produced using four different strategies: (1) IVF before oocyte enucleation; (2) IVF after enucleation; (3) ICSI before oocyte enucleation; and (4) ICSI after enucleation. Once obtained, the blastomeres of these androgenetic haploid embryos were used as male genome donors to reconstruct biparental embryos by fusion with matured oocytes. To verify the cytoplasmic contribution of androgenetic haploid blastomeres, we used spermatozoa incubated previously with exogenous DNA that coded for a green fluorescent protein gene (pCX-EGFP) and the enhanced green fluorescent protein (EGFP)-positive androgenetic haploid blastomeres generated were fused with mature oocytes. Of the reconstructed embryos reaching the cleavage and blastocyst stages, 85.1% and 9.0%, respectively, expressed EGFP (P > 0.05). EGFP expression was observed in 100% of reconstructed embryos, with 91.2% exhibiting homogenic expression. To confirm sperm genome incorporation, androgenetic haploid blastomeres generated by ICSI prior to enucleation and using Y chromosome sexed spermatozoa were used for biparental embryo reconstruction. Incorporation of the Y chromosome was confirmed by polymerase chain reaction and fluorescence in situ hybridization analysis.
AICA (“Genomic Enhanced EPD” 23 Dec 2014; Retrieved from the Internet 26 Apr 2025 from https://charolaisusa.com/pdf/2015/GEPD_4c_hr.pdf; previously cited) teaches that genetic evaluations can be sued to enhance selection and characterize genetics for animals for traits that impact profitability (p. 1, para 1). Genetic evaluations and genomic results are incorporated as a correlated trait (p. 1, para 2). Genetic correlation is calculated between the values obtained from the genomic testing results and phenotypic data. The stronger the genetic correlation, the more the genetic value will impact the EPD and accuracy for a trait. These traits include calving ease direct, birth weight, weaning weight, yearling weight, maternal milk, ribeye area, marbling, and scrotal circumference (p. 1, para 3). The test used to determine these traits examines 78,000 SNPs as well as proprietary SNPS for traits such as Horned/Poll, coat color, and genetic defects can be tested simultaneously as the data is produced (p. 2, “What is the merit” para 1).
The art demonstrates that generating bovine haploid androgenetic cells and subsequent embryos are routine and conventional in the art. Given that the claims recites the characterization, selection, and scoring steps are claimed at a high level of generality, Applicant is relying on the conventional and well-understood use of these steps as instantly claimed to directly inform the judicial exception, and therefore are not evidence of additional features over the judicial exception itself. [STEP 2B: NO]
The claims fail to recite additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the claims do not qualify as eligible subject matter under 35 USC 101.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 6, 8, 11-12, 14, 18-19, 21, and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robl et al (US 8,551,705 B2, 28 Jan 2011; previously cited) as evidenced by IVF Glossary (Ovation Fertility, Retrieved from the Internet 26 April 2025; previously cited) in view of Vichera et al (Reprod Fertil Dev. July 2011; 23(6):769-79).
Robl teaches a method for producing an animal embryo having a desired genetic makeup, the method comprising: (i) producing an animal embryo comprising a haploid genome of male or female origin (i.e., androgenetic or parthenogenetic), (ii) culturing said embryo to produce a multi-celled embryo comprising a haploid genome of male or female origin; (iii) isolating one or more cells from said multi-celled embryo and screening said one or more cells for a desired genetic makeup (“obtaining an . . . embryonic haploid cell” as in instant claim 1 in part); (iv) selecting said one or more cells determined to comprise the desired genetic makeup; and (v) transferring the nucleus of said one or more cells selected in step (iv) into an oocyte and activating said oocyte to produce an embryo comprising said desired genetic makeup, where the embryo comprising the desired genetic makeup is diploid (see claim 2 and 16 of Robl) (“characterizing a genome of the haploid cells of step (a) . . . selecting one or more sister cells of the characterized haploid cell of step (c) and d) deriving . . . diploid embryos from the selected haploid cells of step (d) ” as in instant claim 1 in-part; “wherein deriving diploid embryos comprises introducing the genome of the one or more selected haploid cells of (d) into one or more oocyte” as in instant claim 18). The reference teaches that the male- or female-derived haploid cells (“androgenetic haploid cell” as in instant claim 1 in-part) are cultured to produce “propagating haploid cells” (Summary and Objects of the Invention” para 4) (“deriving haploid outgrowth from the embryonic haploid cell of step (a) as in instant claim 1 in-part; “wherein deriving haploid outgrowth comprises cellular multiplication to produce a larger number of haploid cells, the method comprising in vitro culturing as in instant claim 11). The oocyte is an enucleated or haploid oocyte (see claim 3 of Robl). The reference teaches that suitable mammalian sources for oocytes include sheep, bovine, pigs, mice, human, etc. and will be obtained from primate or ungulates (col 10, lines 4-10) (“bovine” as in instant claim 1 in-part; “haploid cell is derived from an bovine . . . embryo” as in instant claim 6 in-part). The invention relates to the production and multiplication (“multiplication” as in instant claim 11) of cells containing haploid chromosome content and the use of these cells to produce an embryo with diploid content of DNA (col 4, lines 12-17). The animal embryo is produced by transfer of the nucleus of a parthenogenetic cell into an enucleated oocyte (see claim 11 of Robl). The reference teaches introduction of a selected male (i.e., androgenetic) or female haploid genome into an enucleated oocyte to produce a diploid cell (col 9, lines 40-47) and that the animal embryo is produced by fertilization of an oocyte that has removal of a male pronucleus therefrom (see claim 8 of Robl) (“introducing the genome of the one or more selected haploid cell of (d) into one or more fertilized and enucleated oocytes before paternal pronuclear formation” as in instant claim 19 in-part). Robl teaches that the selected haploid cells of male or female origin have their genomes introduced into a haploid oocyte and that the diploid nuclear transfer will be obtained wherein both the male and female DNA has been selected based on its genetic makeup (col 9, lines 40-50) (“wherein deriving diploid embryos comprises introducing the genome of the selected haploid cell of (d) and the genome of a second haploid cell into an oocyte, wherein the second haploid cell is derived from an in vitro cultured bovine parthenogenetic haploid embryo of the same species as the first” as in instant claim 21; “wherein the genome of the second haploid cell comprises a pre-characterized genome” as in instant claim 36).
Evidentiary reference IVF Glossary defines “multi-cell embryo” as a cleavage stage embryo and states that an embryo is at the multi-cell stage from day 2 until day 4 when it develops into a morula (“Multi-cell Embryo” top of p. 3). Thus, absent evidence to the contrary, the multi-celled embryo of Robl is a pre-implantation embryo between cleavage and morula (>32 cells) stage (see also para 0025 of instant specification) and overlaps with “isolated from a preimplantation embryo up to and including the blastocyst stage” as in instant claim 1 in-part and “wherein the bovine embryonic haploid cell is isolated from a preimplantation embryo at cleavage, four cells, eight cells, or sixteen cells” as in instant claim 12.
The difference between Robl and the instant invention is that it does not teach that the bovine androgenetic haploid embryo has been prepared by a method comprising removing a bovine oocyte’s genome either before or after fertilization of the oocyte by intracytoplasmic sperm injection of a single sperm (instant claim 1 in-part and instant claim 37).
Vichera teaches comparison of the developmental ability of bovine androgenetic haploid embryos constructed by different methods, namely IVF and intracytoplasmic sperm injection (ICSI) before and after oocyte enucleation (abstract) (“bovine androgenetic haploid embryo has been prepared by a method comprising removing a bovine oocyte’s genome either before or after fertilization of the oocyte by intracytoplasmic sperm injection of a single sperm” as in instant claim 1 in-part; “bovine androgenetic haploid embryo has been prepared by a method comprising removing a bovine oocyte’s genome after fertilization of the oocyte by intracytoplasmic sperm injection of a single sperm” as in instant claim 37). Androgenetic haploid embryos were produced using four different strategies: (1) IVF before oocyte enucleation; (2) IVF after enucleation; (3) ICSI before oocyte enucleation; and (4) ICSI after enucleation. Once obtained, the blastomeres of these androgenetic haploid embryos were used as male genome donors to reconstruct biparental embryos by fusion with matured oocytes. To verify the cytoplasmic contribution of androgenetic haploid blastomeres, we used spermatozoa incubated previously with exogenous DNA that coded for a green fluorescent protein gene (pCX-EGFP) and the enhanced green fluorescent protein (EGFP)-positive androgenetic haploid blastomeres generated were fused with mature oocytes (“introducing the genome of the one or more selected haploid cell of (d) into one or more oocytes” as in instant claim 18). Of the reconstructed embryos reaching the cleavage and blastocyst stages, 85.1% and 9.0%, respectively, expressed EGFP (P > 0.05). EGFP expression was observed in 100% of reconstructed embryos, with 91.2% exhibiting homogenic expression. To confirm sperm genome incorporation, androgenetic haploid blastomeres generated by ICSI prior to enucleation and using Y chromosome sexed spermatozoa were used for biparental embryo reconstruction. Incorporation of the Y chromosome was confirmed by polymerase chain reaction and fluorescence in situ hybridization analysis.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create diploid bovine embryos from embryonic haploid cells using the method as taught by Robl, where the bovine androgenetic haploid embryo is prepared by removing the oocyte genome before or after ICSI as taught by Vichera, to arrive at the instantly claimed invention. Vichera shows that haploid bovine embryos can be developed by ICSI (androgenetic). One of ordinary skill would have been motivated to apply the method as taught in Vichera in the method as taught by Robl to obtain the predictable result of having androgenetic haploid embryos that can be successfully used to develop diploid embryos as taught by the prior art.
Regarding instant claim 8, Vichera is silent to how many hours before or after fertilization the oocyte genome is removed. However, it would have been a matter of routine optimization using standard laboratory techniques available at the time of filing to determine the appropriate before or after fertilization to remove the genome of the oocyte as instantly claimed to create a androgenetic haploid embryo as taught by Vichera with a reasonable expectation of success. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). It might be good to include the optimization case law.
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection does not rely on the Lagutina reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. While Applicant correctly argues that the previously and currently cited Robl reference does not teach androgenetically derived embryo, newly cited reference Vichera teaches that androgenetically derived embryos can be derived before or after oocyte genome removal in bovines and had confirmed sperm genome incorporation (see 103 rejection above).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robl et al in view of Vichera et al as applied to claims 1, 6, 8, 11-12, 14, 18-19, 21, and 36-37 above, and further in view of American-International Charolais Association (Referenced herein as AICA; “Genomic Enhanced EPD” 23 Dec 2014; Retrieved from the Internet 26 Apr 2025 from https://charolaisusa.com/pdf/2015/GEPD_4c_hr.pdf; previously cited).
The teachings of Robl and Vichera were recited in the above 35 U.S.C. 103 rejection as applied to claim 1 of which claim 14 depends. The teachings will not be repeated here.
Regarding claim 14, Robl teaches that the haploid genome can be analyzed to detect the presence or absence of a specific DNA associated with a phenotype and that the screening for a desired genetic makeup (i.e., multiple traits) can be done by restriction fragment length polymorphisms analysis or single-strand conformational polymorphism analysis (see claims 19-20 of Robl) (“wherein characterizing the genome of the ungulate embryonic haploid cell of (a) comprises screening . . . the genome of the haploid cell to identify the presence or absence of polymorphisms . . .” as in instant claim 14 in-part).
AICA teaches that genetic evaluations can be sued to enhance selection and characterize genetics for animals for traits that impact profitability (p. 1, para 1). Genetic evaluations and genomic results are incorporated as a correlated trait (p. 1, para 2). Genetic correlation is calculated between the values obtained from the genomic testing results and phenotypic data. The stronger the genetic correlation, the more the genetic value will impact the EPD and accuracy for a trait. These traits include calving ease direct, birth weight, weaning weight, yearling weight, maternal milk, ribeye area, marbling, and scrotal circumference (p. 1, para 3). The test used to determine these traits examines 78,000 SNPs as well as proprietary SNPS for traits such as Horned/Poll, coat color, and genetic defects can be tested simultaneously as the data is produced (p. 2, “What is the merit” para 1). This shows that genetic traits in bovines can be scored through screening SNPs and renders obvious “scoring the genome . . . to identify the presence or absence of polymorphisms indicative of commercially valuable traits” as in instant claim 14.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to produce a diploid bovine embryo as taught by Robl and Vichera in combination, where the genome is scored based off of polymorphisms that indicate commercially valuable traits as taught by AICA, to arrive at the instantly claimed invention. As AICA shows that genetic evaluations can be performed on the genome of cows, one of ordinary skill would have been motivated to modify the method of Robl and Vichera in combination to include genome scoring as taught by AICA with a reasonable expectation of advantageously accurately selecting for traits such as birth weight, maternal milk, and marbling as taught by the prior art.
Response to Arguments
Applicant has not provided any arguments challenging the teachings of cited reference AICA nor has Applicant attempted to distinguish the teachings of AICA and the instantly claimed invention.
Claim(s) 20 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robl et al in view of Vichera et al as applied to claims 1, 6, 8, 11-12, 14, 18-19, 21, and 36-37 above, and further in view of Paffoni et al (Fertil Steril. 30 Oct 2006; 87(1):77-82; previously cited).
The teachings of Robl and Vichera in combination were recited in the above 35 U.S.C. 103 rejection as applied to claim 6 of which claim 20 depends. The teachings will not be repeated here.
Regarding instant claim 20 in-part, Robl teaches the introduction of the genome of the selected cell of (d) into an oocyte (see col 9 lines 40-55). It also teaches that preimplantation genetic diagnosis can be performed on oocytes to diagnose single gene disorders by first polar body analysis and to identify oocytes that contain maternal unaffected genes (Background, para 4) (“oocyte comprises a pre-characterized genome” as in instant claim 35).
The difference between the combined teachings and the invention as instantly claimed is that it does not teach that the oocyte is parthenogenetically activated before maternal pronuclear formation (instant claim 20 in-part).
Paffoni teaches the in vitro development of human oocytes after parthenogenetic activation (title). The reference teaches that oocytes were sequentially exposed to 5 uM ionomycin in IVF medium and after 18-20 hours, were evaluated for signs of activation (p. 78, para 7). Oocytes showing one enlarged pronucleus and no extrusion of the second polar body were considered activated (same para). This reference shows that oocytes can be parthenogenetically activated before pronuclear formation (as in instant specification working examples) and reads on instant clam 20 in-part. 70 of the embryos were then allocated to the ICSI procedure for fertilization (p. 79, Results, para 3). The treatment with ionomycin resulted not only in efficient oocyte activation, but also in parthenote development to the blastocyst stage (p. 80, Discussion, para 2).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create diploid bovine embryos from embryonic haploid cells using the method as taught by Robl and Vichera in combination, where the oocyte is parthenogenetically activated before pronuclear formation as taught by Paffoni, to arrive at the instantly claimed invention. Paffoni shows the successful parthenogenetic activation of human oocyte using ionomycin. One of ordinary skill would have been motivated to modify the method of Robl and Vichera to include parthenogenetic activation of the oocyte using ionomycin prior to introduction of the embryonic haploid cell into the oocyte as taught by Paffoni with the reasonably expectation of advantageously creating efficient oocyte activation and parthenote development to the blastocyst stage as taught by the prior art.
Response to Arguments
Applicant has not provided any arguments challenging the teachings of cited reference Paffoni nor has Applicant attempted to distinguish the teachings of Paffoni and the instantly claimed invention.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robl et al in view of Vichera et al as applied to claims 1, 6, 8, 11-12, 14, 18-19, 21, and 36-37 above, and further in view of Prather (US 4,994,384 A, 27 Oct 1987; previously cited).
The teachings of Robl and Vichera were recited in the above 35 U.S.C. 103 rejection as applied to claim 1 of which claim 33 depends. The teachings will not be repeated here.
The difference between the combined teachings and the invention as instantly claimed is that it does not teach that the diploid embryo is cloned or multiplied to make multiple copies of the embryo.
Prather teaches a method for multiplying bovine embryos by enucleating a recipient oocyte, transferring the donor embryo nucleus into the enucleated recipient oocyte and fusing via dielectrophoresis to allow the generation of multiplied genetically identical cattle (abstract). The overall procedure may be described as cloning or as a multiplication of embryos for the production of multiple genetically identical embryos, and ultimately, animals (col 3, lines 48-52) (“the diploid embryo is cloned or multiplied to make multiple copies of the embryo” as in instant claim 33). The reference teaches that nuclear transplantation from a multi-cell embryo to a plurality of embryonic single cells offers the potential to overcome non—viability after two to four bisections and enable the production of large numbers of multiplied identical animals.
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create diploid bovine embryos from embryonic haploid cells using the method as taught by Robl and Vichera in combination, where the diploid embryo is cloned or multiplied as taught by Prather, to arrive at the instantly claimed invention. Prather shows that bovine diploid embryos are capable of being multiplied or cloned by transferring the embryo nucleus into enucleated recipient oocytes. One of ordinary skill in the art would have been motivated to clone/multiply the resulting diploid embryos of Robl and Vichera in combination using a similar manner to the teachings of Prather with a reasonable expectation of advantageously creating multiple genetically identical embryos as well as use the clones in the production of large numbers of multiplied identical animals such as cattle as taught by the prior art.
Response to Arguments
Applicant has not provided any arguments challenging the teachings of cited reference Prather nor has Applicant attempted to distinguish the teachings of Prather and the instantly claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached T-F 7-3.
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, Peter Paras Jr can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.R./Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632