DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 07/14/2026 has been entered.
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 Status
Claims 1, 3, 9, 11, and 12 are pending.
Claims 1, 3, 9, 11, and 12 are examined.
Applicant’s Response
Applicant’s response, filed 07/14/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 12 are 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 Specification provides support for discarding of triploid embryos from an in vitro fertilization cycle (page 17, line 16), transferring only unaffected embryos (page 1, line 31), and a commercially available kit for preparation of a library (page 6, line 31). However, the Specification does not provide support for a kit comprising at least one electronic device with a processor or processors and a memory, and a computer readable medium with instructions discarding an embryo. Thus, it is unclear how the kit and computer readable medium are able to discard the embryo. This is a new ground of rejection.
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.
Claims 1, 3, 9, 11, and 12 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. This is a new ground of rejection.
With respect to claims 1 and 12, in step (i) the claims recite the limitation of “the matrix M is output as the input to the second SNP selection process”. The claims are indefinite because there is no antecedent basis for “the second SNP selection process”. The claims later describe a second SNP selection process, however, as currently amended, it is unclear what process the matrix is the input for.
With further respect to claims 1 and 12, in step (v), the claims recite the limitation of “wherein all the SNP combinations of the matrix M are evaluated”. The claims are indefinite because there is no antecedent basis for “the SNP combinations”. Thus, it is unclear which SNPs are evaluated.
With further respect to claims 1 and 12, in step (vi), the claims recite the limitation of “the SNPs of the matrix M of the block-region”. The claims are indefinite because there is no antecedent basis for “the block-region”. Thus, it is unclear which SNPs are organized in groups of high correlation.
The remaining claims are rejected due to their dependence on indefinite claims without remedying the indefiniteness.
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, 3, 9, 11 and 12 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to an abstract idea of mental steps, mathematic concepts, or a natural law without significantly more. Any newly recited portion is necessitated by claim amendment.
The MPEP at MPEP 2106.03 sets forth steps for identifying eligible subject matter:
(1) Are the claims directed to a process, machine, manufacture or composition of
matter?
(2A)(1) Are the claims directed to a judicially recognized exception, i.e. a law of nature,
a natural phenomenon, or an abstract idea?
(2A)(2) If the claims are directed to a judicial exception under Prong One, then is the
judicial exception integrated into a practical application?
(2B) If the claims are directed to a judicial exception and do not integrate the judicial
exception, do the claims provide an inventive concept?
With respect to step (1): Yes, the claims recite a method, a kit, and a computer-readable medium.
With respect to step (2A)(1): The claims recite an abstract idea of mental processes and mathematic concepts. “Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection” (MPEP 2106.04). Abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (procedures for observing, evaluating, analyzing/judging and organizing information (MPEP 2106.04(a)(2)). Laws of nature or natural phenomena include naturally occurring principles/relations that are naturally occurring or that do not have markedly different characteristics compares to what occurs in nature (MPEP 2106(b).
Mental processes recited in claim 1:
a first SNP selection process wherein:
the allele frequency values of some n candidate SNPs (t1…tk) of each subject x, wherein the subject is the family or relatives of the embryo, in a chromosomal region of interest and specifically extracted for a study population, are taken as an input; and wherein this process is configured to maximise the situation in which one of the parts has the allele frequency value of an SNP in a heterozygous state, while the other parent has the allele frequency value of an SNP in a homozygous state, and to obtain a panel of z optimised SNPs for both maximised allele frequency values in the form of matrix M whose columns correspond to the subjects of the population and the rows to the allele frequency values of each SNP for each subject, wherein the matrix M is output as the input to the second SNP selection process
the process comprises the selection of those SNPs that are biallelic, wherein subjects are represented as length haplotypes m formed by binary string {1,0}, wherein 1|0 and 0|1 are the allele frequency values for heterozygous SNPs and 0|0 and 1|1 are the allele frequency values for the homozygous SNPs; wherein this selection is made throughout the chromosomal region of interest
the process comprises a stage of analysing the n candidate SNPs in the region and excluding the SNPs that meet any of the following conditions: SNPs with more than one alternative allele (non-biallelic SNPs); SNPs whose alleles are different from the change of a single nucleotide; SNPs that are homozygous in at least 99% of the population of interest; and uncommon SNPs, wherein the minor allele frequency is less than 1%
a second SNP selection process wherein:
the matrix M obtained in the first SNP selection process is received as input, wherein all the SNP combinations of the matrix are evaluated to obtain a minimum set of tagSNPs constituting a candidate tagSNP panel
the process comprises, firstly, that the SNPs of the matrix M of the block-region are organised in groups of high correlation based on the pairwise r2 criterion
wherein the selection of tagSNPs within each group is made based on the linkage disequilibrium (LD) criterion, starting with k = 1 SNPs and studying all possible k-combinations, organising the SNPs within each group
providing a diagnosis of a genetic disease of the embryo by comparing the validated tagSNP panel with the polymorphism pattern of the embryo derived from the biopsy
Mathematical concepts recited in claim 1
the process comprises a stage of maximising the situation in which one of the parents has the allele frequency value of a SNP in a heterozygous state, while the other parent has the allele frequency value of the SNP in a homozygous state, wherein the value of a SNP is informative and this is achieved through the maximization of the allele frequency value of two functions above a certain threshold value: MaxP:p-(3p2) + (4p3) – (2p4), HET rate: 2pq wherein p and q are, respectively, the allele frequencies of the reference and alternative alleles for each SNP
wherein the pairwise r2 criterion is calculated from the allele frequency calculated for the matrix M
wherein the SNPs of different groups will present low correlation, wherein two SNPs will belong to the same group only when the pairwise r2 therebetween exceeds a certain threshold value set by the user
a third process configured to validate the candidate tagSNP panel obtained in the second SNP selection process, wherein a genomic database is used in which subjects are randomly chosen to perform 300 in silico crosses, wherein, for each cross, the number of tagSNPs of said candidate tagSNP panel that are informative for that cross is counted, and the average number of informative tagSNPs of said candidate tagSNP panel over the 300 crosses is computed as a measure of the informative power of said candidate tagSNP panel, thereby providing a validated tagSNP panel
Dependent 3, 9, and 12 claims recite additional steps that either are directed to abstract ideas or further limit the judicial exceptions in independent claim 1 and as such, are further directed to abstract ideas. Hence, the claims explicitly recite numerous elements that individually, and in combination constitute abstract ideas.
Claims 3, 9, and 12 include abstract steps:
Claim 3: “the chromosomal region of interest is defined as any position that is located in a region ranging from two megabases above and two megabases below the gene or mutation under study”
Claim 9: “if a SNP does not exceed the r2 criterion or LD it will be considered in one group only and taken as tagSNP by itself”
Claim 12: “a first SNP selection process […]; a second SNP selection process […]; a third process […]”
The abstract recited in the claims are evaluated under Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance in the mind and by mathematical concepts because the steps involve nothing more than selecting SNPs based on calculated criteria.
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I; MPEP2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
Claim 1 recites the following additional elements:
a biopsy and obtaining a polymorphism pattern of the embryo derived from said biopsy
discarding the embryo when the comparison indicates the presence of the genetic disease
The step of a biopsy does not integrate the judicial exceptions into a practical application as it gathers the data on which the judicial exceptions are performed. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application (MPEP 2106.05(g)). The step of discarding the embryo does not integrate the judicial exceptions into a practical application because the discarding step is conditional on the comparison indicating the presence of a genetic disease, and thus does not necessarily have to occur within the metes and bounds of the claim.
Claims 11 and 12 are directed to generic computer parts that perform or carry out the abstract ideas. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc. ... are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(f)).
None of these dependent claims recite additional elements, alone or in combination, which would integrate a judicial exception into a practical application.
With respect to step (2B): Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims lack a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements do not rise to the level of significantly more than the judicial exception. As set forth in the MPEP at 2106.05(d)(I), determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to claim 1: The additional elements of a biopsy of an embryo and obtaining a polymorphism pattern of the embryo derived from said biopsy and discarding the embryo when the comparison indicates the presence of the genetic disease do not rise to the level of significantly more than the judicial exception. The Specification discloses that triploid embryos should always be discarded from any in vitro fertilization cycle (page 17, line 16). Furthermore, the step of discarding the embryo is not actually required by the claims if the embryo does not have a genetic disease. The prior art to Treff et al. (“Advances in Preimplantation Genetic Testing for Monogenic Disease and Aneuploidy”, IDS reference) discloses that the field has shifted from polar body or blastomere biopsy toward trophectoderm biopsy as the new standard. As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
With respect to claim 11: The additional elements of at least one electronic device with a processor or processors and a memory, wherein the memory stores instructions that when executed by the processor or processor cause the electronic device to execute the method do not rise to the level of significantly more than the judicial exception. With respect to the processor and memory, as exemplified in the MPEP at 2106.05(f) with reference to Alice Corp. 573 US at 223, 110 USPQ2d at 1983 “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”. Therefore, the programmed computer constitutes no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2105(b)I-III).
With respect to claim 12: The additional elements of a computer readable medium with instructions configured to be executed by one or more processors that make the electronic device of the kit of claim 11 perform a method do not rise to the level of significantly more than the judicial exception. With respect to the computer-readable medium and processor, as exemplified in the MPEP at 2106.05(f) with reference to Alice Corp. 573 US at 223, 110 USPQ2d at 1983 “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”. Therefore, the programmed computer constitutes no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2105(b)I-III).
In combination, the computer elements that implement the judicial exceptions fail to rise to the level of significantly more. No non-routine element has clearly been identified.
The claims have all been examined to identify the presence of one or more judicial exceptions. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. Individually, the limitations of the claims and the claims as a whole have been found to not meet the eligibility requirements.
Response to Arguments
Applicant states that “The Applicant has amended claim 1 to address [the] concerns by establishing an explicit and continuous link between the first, second, and third processes, and the practical application of discarding the embryo with a genetic disease. […] Accordingly, claim 1 as amended integrates each of the alleged judicial exceptions into a practical application because the first process produces the matrix M, which is used as input to the second process; the second process produces the candidate tagSNP panel, which is validated by the third process; and the validated tagSNP panel is compared with the embryo’s polymorphism pattern to provide a diagnosis and discard embryos with a genetic disease. This chain of processes imposes meaningful limits of the alleged judicial exceptions because each step is necessary for and contributes to the ultimate practical result of identifying and discarding embryos carrying genetic diseases in preimplantation genetic diagnosis”.
It is respectfully submitted that this is not persuasive. While it is appreciated that Applicant amended the claims to connect each SNP selection process stage, the claims are not integrated into a practical application by the discarding of the embryo. The step of discarding the embryo is conditional on the comparison indicating a presence of a genetic disease, and thus does not have to occur if the comparison does not indicate the presence of a genetic disease. Therefore, the claim simply recites data gathering and performing abstract ideas on gathered data and does not recite a practical application. Thus, the rejection under 35 USC 101 is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emilie A Smith whose telephone number is (571)272-7543. The examiner can normally be reached 9am - 5pm.
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/E.A.S./Examiner, Art Unit 1686
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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