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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/17/2026 has been entered.
Applicant’s amendments and remarks, filed on 02/12/2026, 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 Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.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 and 48-50 are under examination.
Claims 1-29, 46, 47 are cancelled. Claims 48-50 are newly added.
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.
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 modified in view of applicant’s amendments.
Claim 30-45 and 48-50 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:
2) determining, using the computing environment, 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…;
3) further determining, using the computing environment, 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 …;
4) utilizing the determined chromosome bin sequence of step 2) and the determined sequencing depth sequence of step 3), 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…;
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 MPEP §2111, during patent examination, claims must be interpreted in their broadest reasonable manner consistent with the specification. This means that examiners consider the claim language in light of the specification as understood by a person of ordinary skill in the art, ensuring that the claims are not unduly narrowed by implicit limitations not explicitly recited in the claim (37 CFR 1.75(d)(1)).
With regards to said determining, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. MPEP 2106.04, subsection II. In this case, under the BRI, the recited acts of determining set forth or describe observing data and/or manipulating data all of which may be practically performed in the human mind of a scientist. . 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]. As such, these steps encompass a mental process of observing data and/or manipulating data. MPEP 2106.04(a)(2), section III [Step 2A, Prong 1: YES].
Mathematical Concept
Under the BRI, the recited acts of determining require performing various mathematical calculations (e.g. calculating a ratio of a number of nucleic acid bins, calculating sequencing depth, performing a “non-parametric test” to determine an aneuploidy detection result). As such, these steps set forth or describe a mathematical calculation and/or mathematical relationship. This position is further supported by applicant’s own specification, which teaches that “non-parametric tests” include well-known statistical/mathematical tests, e.g. chi-squared, Mann-Whitney, etc. [0064]. As such, these steps recite a mathematical concept. MPEP 2106.04(a)(2) Section I. While no specific equation is being claimed, Applicant is reminded that there is no particular word or set of words that indicates a claim recites a mathematical calculation. See MPEP 2106.04(a)(2) [Step 2A, Prong 1: YES].
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]
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 steps that are not part of the abstract idea are as follows:
using the sequencing environment to determine the sequence of the DNA present in the sample selected from the group consisting of a blood sample, a urine sample, a cell sample, a mucus sample or a tissue sample.
In this case, under the BRI, the claimed “using” step (to determine the sequence of DNA) is recited at a high level of generality and amounts to necessary gathering of data for use by the abstract idea. Therefore, this step amounts to “insignificant extra-solution activity” and do not integrate the judicial exception into a practical application. See MPEP 2106.05(g).
With regards to the claimed “sequencing environment” and “computing environment”, these are recited at a high level of generality and thus can be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment. In addition, “generic computer components such as a computer and database do not satisfy the inventive concept requirement.” See MPEP 2106.05(h). For these reasons, and absent any evidence to the contrary, the examiner maintains that the claims as a whole are directed to an abstract idea and do not integrate the abstract idea into a practical application. [Step 2A, Prong 2: NO]
In summary, the claimed invention does not provide any objective evidence of an improvement to the technology, nor does the specification explain the details of an unconventional technical solution expressed in the claim, or identify technical improvements realized by the claim over the prior art. See MPEP 2106.04(d)(1) and MPEP 2106.05(a). Therefore, even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception 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, 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) for the following reasons:
As discussed above, the above non-abstract steps (including the full limitations and not just the verbs) amount to nothing more than insignificant extra-solution activity. Moreover, the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014);
Therefore, even when viewed as a combination, there is nothing unconventional with regards to the non-abstract steps set forth above. Thus, the independent claim(s) as a whole do not amount to significantly more than the exception itself. For these reasons, the claim(s) is/are not patent eligible. [Step 2B: NO].
Dependent Claims
Dependent claims 31-45 and 48-50 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). Regarding claim(s) 48-50, these claims further limit the nature of the samples and sequencing and therefore are not patent eligible for all the reasons discussed above in the Step 2A (prong 2) and Step 2B analysis. Therefore, the claims as a whole are not patent eligible. For additional guidance, applicant is directed generally to the October 2019 Revised Patent Subject Matter Eligibility Guidance.
Response to Arguments
Applicant’s arguments, filed 02/12/2026, have been fully considered but are not persuasive for the following reasons.
Applicant argues that the claimed invention is not directed to a mental process because the claim requires the use of data derived from physical sequencing measurements and reference genome data. In response, the examiner has explicitly identified the steps that recite the abstract idea and provided sufficient reasoning as to why these steps are abstract (Step 2A, prong 1 analysis, above). In addition, Applicant is again reminded that the data (regardless of whether it is associated with a physical measurement, lifestyle, activity, or behavior) is still abstract for reasons set forth above. Accordingly, but for the recitation of a computer, there is nothing in the claims that foreclose the analysis steps from being performed by the mind of a scientist. Applicant additionally argues that the claimed calculation steps (directed to permutation testing and determining a test statistic) cannot be performed mentally because they require repeated permutations and comparisons. In response, this argument is not persuasive because the Office's eligibility guidance does not set limit on the size of the data or number of calculations that can or cannot be performed mentally. MPEP § 2106.04(a)(2)III. For these reasons, absent any evidence to the contrary, the examiner maintains that the identified steps fall within the “mental processes” grouping of abstract idea. See also MPEP 2106.04 and 2106.05(II). [Step 2A, Prong 1: YES].
Applicant argues that the claimed invention is not “directed to” a pure mathematical concept (but merely uses mathematical operations). In response, a limitation that is merely based on or involves a mathematical concept described in the specification may not be sufficient to fall into this grouping, provided the mathematical concept itself is not recited in the claim. In this case, as set forth above (Step 2A, prong 1 analysis), the instant claims explicitly recite “determining” steps that require mathematical concepts and/or relationships. In addition, MPEP 2106.04(a)(2) provides other examples of mathematical calculations and relationships recited in a claim including:
i. performing a resampled statistical analysis to generate a resampled distribution, SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65, 127 USPQ2d 1597, 1598-1600 (Fed. Cir. 2018), modifying SAP America, Inc. v. InvestPic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed. Cir. 2018);
iii. using a formula to convert geospatial coordinates into natural numbers, Burnett v. Panasonic Corp., 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) (non-precedential);
iv. managing a stable value protected life insurance policy via performing calculations, Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012);
v. using an algorithm for determining the optimal number of visits by a business representative to a client, In re Maucorps, 609 F.2d 481, 482, 203 USPQ 812, 813 (CCPA 1979); and
vi. calculating the difference between local and average data values, In re Abele, 684 F.2d 902, 903, 214 USPQ 682, 683-84 (CCPA 1982).
iv. organizing information and manipulating information through mathematical correlations, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014).
As such, the cited claim limitations explicitly recite a mathematical concept (e.g. calculations or mathematical relationships) and are not merely “based on or involve” a mathematical concept (e.g. a see-saw is inherently based on physical laws of a lever).
Applicant argues that the claimed invention is not directed to a natural correlation because it directed to an analytical method for detecting aneuploidy. In response, the claim results in detecting aneuploidy (i.e. a particular disease/condition) based on the use and manipulation of sequence data obtained from a subject. Therefore, the examiner maintains that the resulting “performing” step requires determining a naturally occurring relationship between a subject’s genomic sequencing data and disease. See MPEP 2106.04(b).
Applicant argues that the claimed invention integrates any alleged abstract idea into a practical application. In response, as discussed in the Step 2A, prong 2 analysis, the claimed step of determining the sequence of DNA is not limited to any particular techniques or devices and generally results in collecting data for use by the abstract idea. Therefore, this step amounts to insignificant extra-solution activity and is not indicative of an integration into a practical application. See MPEP 2106.05(g). With regards to the claimed sequencing and computing environments, these are recited at high level of generality and amount to generic computer components. Accordingly, these features are merely being used as tools to collect data and perform generic computer functions or the abstract idea, and therefore amount to no more than mere instructions to apply the exception using a generic computer for reasons discussed above (Step 2A, prong 2). Therefore, even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application.
Applicant argues that the claimed invention recites “significantly more” than any alleged judicial exception by reciting a specific non-generic ordered combination of elements (e.g. chromosome bin ratios and sequence depth ratio sequences defined by ratios) that provided an improved “technical framework”. In response, applicant’s argument relies directed upon the “determining” steps that have been interpreted as part of the judicial exception (Step 2A, prong 1). Moreover, applicant has failed to provide any evidence that the appended step for “determining” DNA sequence data is unconventional or provides for a new technology (Step 2A, prong 2 or Step 2B). As such, applicant is essentially asserting that the “abstract idea” is providing the improvement to the technology (by providing more accurate data). However, 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, the claims do not integrate the abstract idea into a practical application and do not provide an improvement to the technology (under Step 2A, prong 2, or Step 2B). See MPEP 2106.04(d)(1).
Applicant additionally cites the Liu declaration as evidence that the claimed method provides a technical improvement. In particular, the declaration asserts that the claimed invention provides a technical improvement in sequencing-based aneuploidy detection by improving robustness in the presence of sequencing noise and non-uniform read distribution and, further, by reducing false positive results relative to conventional Z-score based approaches. In response, the MPEP is clear that the word "improvements" in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B. MPEP 2106.04(d)(1). In this case, the declaration does not contend that the claimed invention results in an improvement to the functioning of a computer or that applicant invented any new type sequencing device, i.e. there is nothing unconventional with regards to how the data is being collected for subsequent analysis. Notably, the declaration also relies upon a plurality of different limitations that are not even presently recited in claim 30 (e.g. isolating a complete human DNA from a sample; 93 national reference materials, Youden’s index, karyotyped samples, etc.). It is improper to import such limitations into the claims. See MPEP 2111.01. Therefore, similar to applicant’s arguments above, the totality of the declaration is essentially arguing that the improvement is entirely in the realm of abstract ideas and that abstract idea is providing the improvement (by providing “better data”). However, Applicant is reminded that the claimed invention’s use of the ineligible concept to which it is directed (i.e. the abstract idea) cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.” BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018). 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). As such, the claims do not recite an improvement to computer functionality and, unlike Ex Parte Desjardins, do not delineate steps through which machine learning technology achieves an improvement. For example, "Ex parte Desjardins had claims drawn to the use of a machine learning model, trained on one task with a first set of data, and set parameter weights, then trained again using differing data on a different task, adjusting parameters and weights, while protecting performance of the first task. Further, in Desjardins, the retraining of the particular ML changed the structure of that ML in a way that provided "'[a]n improvement in the functioning of a computer, or an improvement to other technology or technical field,' as discussed in MPEP §§ 2106.04(d)(l) and 2106.05(a). Moreover, the independent claim in Ex parte Desjardins contained specific limitations as to how at least some aspects of the asserted improvements are achieved: "When evaluating the claim as a whole, we discern at least the following limitation of independent claim 1 that reflects the improvement: "adjust the first values of the plurality of parameters to optimize performance of the machine learning model on the second machine learning task while protecting performance of the machine learning model on the first machine learning task." We are persuaded that constitutes an improvement to how the machine learning model itself operates, and not, for example, the identified mathematical calculation." Ex parte Desjardins, p9. As such, unlike Desjardins, the instant claims do not clearly set forth the link between the data gathered, training of models, the structure of the models, and how training affects the structure to obtain the desired results or asserted improvement. In summary, the claimed invention does not result in improvements to the functioning of a particular machine or add a specific limitation other than what is well-understood, routine, conventional activity in the field, e.g., a non-conventional and non-generic arrangement of various computer components. The claimed invention is directed to obtaining data, analyzing data, and generating a result (aneuploidy detection result) and merely invokes generic computer elements for performing the claimed steps rather than a specific method that improves the relevant technology. The Federal Circuit has held that claims involving data collection, analysis, and output often are directed to abstract ideas. Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016). Therefore, when read in light of applicant’s own specification and the declaration, the examiner maintains that the asserted improvement is to the method of data processing techniques. As such, the improvement is integral to the abstract idea of mathematical concepts and therefore is not to the “non-abstract application realm.” SAP, 898 F.3d at 1168. Accordingly, the declaration is not sufficient to overcome the rejection under 35 USC 101. For these reasons (and those set forth above), the examiner maintains that the claims as a whole are directed to an abstract idea and do not integrate the abstract idea into a practical application.
Claim rejections - 35 USC § 112, 2nd Paragraph
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.
The following rejections are necessitated by amendment.
Claim 30-45 and 48-50 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 30 are also rejected due to said dependency.
Claim 30 recites (in the preamble) “A method that uses a sample collection process, a sequencing environment and a computing environment for detecting rare chromosomal aneuploidies.” In this case, it is unclear as to the metes and bounds of the terms “sequencing environment” and “computing environment” such that the artisan would know what structural limitations are intended. A review of the specification does not provide any limiting definitions that would serve to clarify the scope. In addition, it is also unclear as to the metes and bounds of the “sample collection process”. A review of the specification does not provide any limiting definition that would serve to clarify the scope, nor does the body of the claim recite any steps directed to collecting samples. Applicant is reminded that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone [See MPEP 2111.02]. Clarification is requested via amendment.
Claim 30 recites “using the sequencing environment to determine the sequence of the DNA…”. In this case, the above limitation is problematic because the claim does not set forth any boundaries on the structure of the “sequencing environment” nor does it set forth any steps involved in the method/process of use. As such, it is unclear in what way is the claimed “sequencing environment” is used to achieve the claimed function. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP § 2173.05(q). Clarification is again requested via amendment. The examiner suggests replacing intended use language with a positive process limitation, e.g. determining the sequence of DNA present in a sample.
Claim 30 recites “determining, using a computing environment, a chromosome bin sequence…wherein the chromosome bin sequence a) comprises at least one bin number ratio…, and b) provides a proportional function model of nucleic acid bins”. In this case, the artisan would recognize that a sequence (e.g. a1, a2, a3,…) and a mathematical model (generally expressed using equations, variables, and/or logical rules) are entirely different mathematical representations. Therefore, after careful consideration, it is unclear in what way the claimed chromosome bin sequence “comprises at least one bin number ratio” and simultaneously “provides a proportional function model”. A review of the specification does not provide any limiting definition of the claimed “proportional function model” or any equation relating the different claimed elements that would serve to clarify the issue. Clarification is requested via amendment.
Cited Prior Art
The following prior art made of record and not presently relied upon is considered pertinent to applicant' s disclosure. Applicant is reminded that prior art rejections under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be applied in the next Office action in light of applicant's amendments, and that the next Office action can properly be made "Final" if these rejections are necessitated by amendment. See MPEP 706.07.
Fiorentino et al. (Prenatal Diagnosis 2016, 36, 304–311) teaches an experimental method and model for analyzing the limits of non-invasive prenatal testing methods, involving determining the actual limit of detection (LOD) of a massively parallel sequencing-based NIPT method and evaluating its performance in testing samples with low FF.
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PABLO S WHALEY/Primary Examiner, Art Unit 3619
Prosecution Insights