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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/2025 has been entered.
Applicant’s amendments and remarks, filed on 11/24/2025, are acknowledged. Applicant’s arguments have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.
Status of Claims
Claim 30-45 under examination.
Claims 1-29 are cancelled. Claims 46 and 47 are withdrawn.
Priority
Applicant’s claim for the benefit of foreign priority under 35 U.S.C. 119(a)-(d) to CN 2024/10516920.2, filed 04/28/2024, is acknowledged. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Withdrawn Rejections
The rejection of claims 30-45 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of applicant’s amendments.
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.
The following rejection is maintained.
Claim 30-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Step 1
Regarding claim(s) 30, the invention is directed to a method for detecting chromosomal aneuploidy by performing a process. Thus, the claim is directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. In this case, the claimed steps that are part of the abstract idea are as follows:
1) determining a chromosome bin sequence of a chromosome being tested for aneuploidy according to standard sequences of a human reference genome, wherein the chromosome bin sequence: a) comprises at least one bin number ratio, with each of the at least one bin number ratios being a ratio of the number of nucleic acid bins of the chromosome being tested for aneuploidy in the human reference genome to the number of nucleic acid bins of two or more chromosomes not being tested for aneuploidy of the human reference genome, and b) provides a proportional function model of nucleic acid bins of the chromosome being tested for aneuploidy…;
2) determining a sequencing depth sequence of the chromosome being tested for aneuploidy according to whole genome sequencing data of a nucleic acid sample being tested for aneuploidy, wherein the sequencing depth sequence: a) comprises at least one reference sequencing depth ratio …;
3) utilizing the determined chromosome bin sequence of step 1) and the determined sequencing depth sequence of step 2), which can be determined in either order, to perform a non- parametric test to further determine an aneuploidy detection result of the chromosome being tested for aneuploidy, wherein the non-parametric test is a permutation test, and comprises: a) determining a standard test statistic…; b) according to a preset number of permutations, performing a data exchange operation on the chromosome bin sequence and the sequencing depth sequence to obtain at least one permutation sequence group…; d) determining the aneuploidy detection result of the chromosome being tested for aneuploidy in the nucleic acid sample being tested for aneuploidy by comparing the standard test statistic to the permutation test statistic.
Mental Processes
Under the broadest reasonable interpretation, the above steps require performing algorithmic and/or mathematical processes to analyze nucleic acid data, perform calculations, and determine a result based on said analysis, all of which may be practically performed in the human mind of a scientist. The Office's eligibility guidance does not set limit on the number of calculations that can or cannot be performed mentally. MPEP § 2106.04(a)(2)III. The courts are clear that an invention directed to the “collection, manipulation, and display of data” is an abstract process. See Intellectual Ventures, 850 F.3d at 1340; see generally id. at 1340-41. In addition, the specification provides sufficient evidence that the claims are directed to an abstract idea since the specific descriptions provided for accomplishing these tasks include only data analysis methods [pages 7, 9, 10, 11, 19]. For these reasons, the above steps fall within the “mental processes” grouping of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
Mathematical Concept
Under the broadest reasonable interpretation, the above “determining” steps require performing various algorithmic and/or mathematical calculations (e.g. calculating sequencing depth, calculating a ratio of a number of nucleic acid bins, performing a “non-parametric test” to determine an aneuploidy detection result). While no specific equations are being claimed, Applicant is reminded that there is no particular word or set of words that indicates a claim recites a mathematical calculation. Moreover, the instant specification teaches that “non-parametric tests” include well-known statistical/mathematical tests, e.g. chi-squared, Mann-Whitney, etc. [0064]. Therefore, when read in light of the specification, the above steps reasonably encompass a mathematical concept. See MPEP 2106.04(a)(2), subsection I.C.
Natural Correlation
Under the broadest reasonable interpretation, the above claims also recite a natural correlation. In particular, the instant claims require performing a non-parametric test to determine an aneuploidy detection based on a ratio of sequence depth values (between test and reference genomic data). Therefore, the resulting “performing” step requires determining a naturally occurring relationship between a subject’s genomic sequencing data and disease. See MPEP 2106.04(b). It is noted that even if a claim does recite a law of nature or natural phenomenon, it may still be eligible. For example, claims reciting a naturally occurring relationship between a patient’s genotype and the risk of QTc prolongation (a law of nature) were held eligible as not “directed to” that relationship because they also recited a step of treating the patient with an amount of a particular medication that was tailored to the patient’s genotype. Vanda Pharms., 887 F.3d at 1134-36, 126 USPQ2d at 1279-81. This particular treatment step applied the natural relationship in a manner that integrated it into a practical application. The court’s analysis in Vanda is equivalent to a finding of eligibility at Step 2A Prong Two (Pathway B).
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception.
In this case, the claimed invention does not recite any additional steps/elements appended to the abstract idea (not even a computer processor). Accordingly, the invention as claimed does not recite any additional steps that are indicative of an integration into a practical application. See MPEP 2106.05(g). Consequently, the claimed invention does not integrate the abstract idea into a “practical application.” [Step 2A, Prong 2: NO]
C. Guidance Step 2B:
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. In this case, for reasons discussed above, the claims do not include additional steps and/or elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s). Therefore, based on the two-part analysis, the claims as a whole are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. [Step 2B: NO].
Dependent Claims
Dependent claims 31-45 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claim(s) 31-45, these claims further limit the specificity of the abstract idea set forth above. Accordingly, these claims are still part of the abstract idea and therefore are not patent eligible for reasons discussed above (in the Step 2A, prong 1 analysis). Therefore, based on the two-part analysis, the instantly rejected claims as a whole are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more.
Response to Arguments
Applicant’s arguments, filed 11/24/2025, have been fully considered but are not persuasive for the following reasons.
Applicant argues at length that the claimed invention provides an improvement to the technology by improving the stability and accuracy of the aneuploidy detection result [citing the specification, 0066]. In response, the examiner has carefully considered this argument and reviewed the specification to the extent possible under the examination time constraints. In particular, the specification [0019, 0066] teaches that “According to the technical solutions of the embodiments of the present invention, the chromosome bin sequence built according to the human reference genome is used as a reference sequence of the chromosome under test, and the non-parametric test is performed according to the chromosome bin sequence and the sequencing depth sequence corresponding to the nucleic acid sample under test by using a correlation between a chromosome bin sequence and a sequencing depth sequence”. As best understood, this chromosome bin sequence is being “determined” (or built) entirely according to a particular algorithmic and/or mathematical process (not a physical process). This position is reflected in the examiner’s two-step analysis, which clearly identifies steps 1) through 3) as reciting an abstract idea (Step 2A, prong 1). It is important to note that the judicial exception alone cannot provide the improvement. The improvement can be provided by (1) one or more additional steps/elements appended to the judicial exception; or (2) by the additional steps/elements appended to the judicial exception in combination with the recited judicial exception. See MPEP 2106.05(a). In this case, the problem is that are no additional steps/elements appended to the abstract idea that would serve to “integrate” the abstract idea into a practical application (Step 2A, prong 2). In other words, applicant’s aggregate arguments are essentially asserting that the “abstract idea” is providing the improvement to the technology (by providing more accurate data). As discussed above, the judicial exception alone cannot provide the improvement. See MPEP 2106.05(a). The courts are clear that an invention directed to the “collection, manipulation, and display of data” is an abstract process. See Intellectual Ventures, 850 F.3d at 1340; see generally id. at 1340-41. Similarly, the courts have also instructed that “[t]he different use of a mathematical calculation, even one that yields different or better results, does not render patent eligible subject matter.” Board Of Trustees Of Leland Stanford Junior University, 991 F.3d 1245, 1251 (Fed. Cir. 2021). Therefore, because the claims are entirely directed to an abstract idea and do not recite any steps appended to the JE that (alone or in combination) integrate the abstract idea into a practical application, the examiner maintains that the claims do not provide an improvement to the technology (under Step 2A, prong 2, or Step 2B). See MPEP 2106.04(d)(1).
Applicant additionally asserts that the claimed invention provides more accurate results that various teachings in the prior art for aneuploidy detection (by using chromosomal bin sequence matrices and sequencing depths to compare reference results). In response, this argument has been sufficiently addressed above. In addition, Applicant is reminded that it is improper to conflate 35 USC 101 analysis with prior art analysis under 35 USC 102/103. In other words, it is true that claims can be free of the prior art and yet still rejected under 35 USC 101. Generally, examiners are not expected to make a qualitative judgement on the merits of an asserted improvement. If the examiner concludes the disclosed invention does not improve technology, the burden shifts to applicant to provide persuasive arguments supported by any necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology. Any such evidence submitted under 37 CFR 1.132 must establish what the specification would convey to one of ordinary skill in the art and cannot be used to supplement the specification. See MPEP § 716.09 on 37 CFR 1.132 practice with respect to rejections under 35 U.S.C. 112(a). For at least these reasons, and absent any evidence to the contrary, the rejection is maintained.
Applicant is invited to contact the examiner for an after-final interview to discuss claim amendments that could potentially serve to advance prosecution.
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. The previously applied rejections have been maintained or withdrawn, and no new grounds of rejections have been made. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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