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 .
Applicant’s arguments and amendments have been thoroughly reviewed and considered. Claims 152-170 remain withdrawn. Claims 1-15, 33-39, and 171 are pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/13/2025, 1/5/2026, 4/16/2026, and 6/11/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Applicant’s Amendments
35 USC 101 Rejections
Claims 1-15, 33-39, and 171 were rejected under 35 U.S.C. 101 for being directed to judicial exceptions without significantly more. These rejections have been maintained. See “Response to Applicant’s Arguments” below.
35 USC 103 Rejections
Claims 1-2, 11-12, 33-34, 38-39, and 171 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Cancer Discovery, 2020).
Claims 3-6 and 36-37 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Cancer Discovery, 2020), and in view of Drew et al. (Cell, 1984) and Golonka et al. (JNCI Cancer Spectrum, 2019).
Claims 7-9 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Cancer Discovery, 2020) in view of Kincaid et al. (WO 2019/140201 A1).
Claim 10 was rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Cancer Discovery, 2020) in view of Serpas et al. (PNAS, 2019).
Claim 13 was rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Cancer Discovery, 2020) in view of Maida et al. (World J Gastroenterol, 2014).
Claims 14-15 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Cancer Discovery, 2020) in view of Al-Mayouf et al. (Nature Genetics, 2011).
Claim 35 was rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Cancer Discovery, 2020), in view of Widlak et al. (The Journal of Biological Chemistry, 2000), as evidenced by PhosphoSitePlus (2016) and Lu et al. (World J Gasteroenterol, 2004).
In light of the exclusion of Jiang as prior art (see “Response to Applicant’s Declaration” below), these rejections have been withdrawn. See “Free of the Prior Art” below.
Response to Applicant’s Declaration
Applicant has provided a declaration to exclude the primary reference used in the 35 USC 103 Rejections, Jiang et al. (Cancer Discovery, 2020), as prior art under the 35 USC 102(b)(1)(A) exception, as the prior art was filed within the one year grace period of the effective filing date of the claimed application.
This declaration is sufficient to invoke this exception, and so Jiang is no longer considered prior art.
Response to Applicant’s Arguments
Regarding the 35 USC 101 Rejections, Applicant argues that the analyzing and second identifying steps of the method of claim 1 are not directed to mental processes, as they cannot be performed practically in the human mind (Remarks, pages 12-13). Applicant also argues that the instant claims merely involve a judicial exception and do not recite said exception, and so the claim would not be directed to a law of nature (Remarks, page 13). Applicant goes on to state that any alleged judicial exception is integrated into practical application because the claim, in its determining a classification of the level of abnormality in a tissue type, provides an alleged improvement to a technical field. This improvement was discussed in previous Remarks and responses, and Applicant adds that it is not required to provide data for every embodiment to show such an improvement (Remarks, pages 14-15). Regarding the conventionality of the claims, Applicant argues that the Examiner has not provided an adequate factual determination of conventionality (Remarks, page 16).
Regarding mental processes, MPEP 2106.04(a)(2)(III) states that mental processes that require a human to use a physical aid are still considered judicial exceptions, including those that are performed on a computer. Section C in this portion of the MPEP further discusses this, and states that this is true when the claimed process can be carried out with existing computers, with no new machinery being necessary. The second identifying elements of claim 1 noted by Applicant above can incorporate a computer as a tool to perform a mental process. The identifying step amounts to noting particular sequence reads, which is a mental process. Though there are at least 10,000 sequence reads, the process of identifying each individual read is not changed, and could be done in the human mind or with pen and paper. A computer may be used for the analysis of the reads and storage of information related to them, as well as to sort reads based on end sequences, but this does not change the mental aspect of the identifying step. Though the analysis step of the claim involves the obtaining of sequence reads, which generally involves sequencing and so would not amount to a mental process, the presence of a step within the larger claim that is not drawn to a mental process does not alone indicate that the claim amounts to more than the claimed judicial exception(s).
Regarding natural laws, the Examiner stated in previous actions that this law “is the relationship between the expression of the nuclease and the presence of an abnormality in the one or more tissue types.” This law is clearly stated in claim 1 in the first identifying step and the final determining step, where the first identifying step establishes that a nuclease is differentially expressed in abnormal tissues and the final determining step classifies the abnormality in the tissues of the sample. Though the first identifying step does not specifically require the expression level of the nuclease to be measured, such expression is also not specifically measured in the natural law. Both rely on the correlation between the expression level and the abnormality. Such a correlation is shown in a similar example in MPEP 2106.04(b) I to be a law of nature or natural phenomena (“a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk”).
Regarding conventionality, Applicant cites MPEP 2106.05(d)(I). It is noted that the conventionality determination only applies to the additional elements of the claim, which would apply to the analyzing step of claim 1. This step simply involves obtaining sequence reads with a high level of generality, and the wherein clauses of the step simply describe the amount and type of sequences that may be sampled. MPEP 2106.05(d)(II) specifically states that the sequencing of nucleic acid sequences is well-understood, routine, conventional activity when recited at a high level of generality, which is the case in the instant claims. Applicant has not noted any aspects of the claimed sequencing that would render it unconventional. Regarding the alleged improvements to a field of technology, these improvements seem to be related to the use of a cutting-signature ratio as opposed to a motif diversity score, which results in increased accuracy (para. 183 of the instant specification and page 14, para. 2 of Applicant’s Remarks). Though Applicant states that it is not required to include data for every embodiment in their specification, the Examiner argues that the proposed improvement is not recited even generally in the instant claims. Claim 1 requires the analysis of a single nuclease, and thus no cutting-signature ratio is required. Claims 3 and 5, though they require a second nuclease, also do not require such a cutting-signature ratio, nor do any of the other instant claims. In order for an alleged improvement to a technological field to be considered in overcoming a 35 USC 101 Rejection, that improvement must be achieved by the claimed invention.
Further regarding conventionality, though the Jiang reference is no longer considered prior art, it is noted that this does not change the finding that the additional elements of the claims are drawn to well-understood, routine, and conventional activity. Thus, Applicant’s argument are not considered persuasive, and the 35 USC 101 Rejections have been maintained.
It is noted that to overcome the 35 USC 101 Rejections, a clear, active treatment step may be recited. Applicant has support for such a treatment step in paras. 415-420 of the instant specification. Applicant is reminded that such a treatment step must apply to every subject examined in the method of claim 1 in order to be used to overcome the 35 USC 101 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 1-15, 33-39, and 171 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a natural law and abstract ideas.
Claims 1 and 3 are directed to a method of classifying a level of abnormality in a subject involving the use of a nuclease that preferentially cuts DNA (or two nucleases, in the case of claim 3). The abstract ideas recited are the determining steps and second identifying step of the method, as these encompass mental processes (see the “Response to Applicant’s Arguments” section above). As written, these steps are recited at a high level of generality without any specific techniques that would render them unable to practically be done in the human mind or by a human with a physical aid, including the use of a computer. See MPEP 2106.04(a). The law of nature recited is the relationship between the expression of the nuclease and the presence of an abnormality in the one or more tissue types. These judicial exceptions are not integrated into a practical application because there is not a required treatment step or anything else that would integrate the method into a practical application. See MPEP 2106.04(d)(2). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not require any additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art. These additional elements amount to the analyzing step, which encompasses sequencing a particular type of sample with a high level of generality. Such a step is noted to be conventional in MPEP 2106.05(d)(II). Thus, claims 1 and 3 are directed to judicial exceptions without significantly more.
Claim 2 depends on claim 1 and further specifies how the determination of the level of abnormality in the sample is made. This limitation is an extension of the abstract ideas recited in claim 1, and does not provide any specific techniques that would render the determination unable to practically be done in the human mind. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claim 4 depends on claim 3 and discusses how the nucleases used may be differentially expressed in abnormal cells (i.e. upregulated or downregulated). This claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art, as measuring nuclease expression is known. For example, Coy (US 2008/0234393 A1) teaches useful DNase nucleic acids from the detection and treatment of carcinomas and their precursor lesions (Abstract). Para. 32 describes several DNase molecules that may be examined, including DNASE1, DNASE1L1 (also called DNASE X), and DNASEIL2. Example 1 of the reference details a finding of overexpression of DNASE X in cancer tissue samples (paras. 255-265). The reference notes that the detection of DNase nucleic acids can be done by any suitable technique known in the art (paras. 148 and 170). Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 3.
Claim 5 depends on claim 1 and is similar to claim 3 in that a second nuclease is required. The main difference between claims 5 and 3 is in how the count of the second sequence reads is used. In claim 5, it is used to aid in determining the first parameter described in claim 1. This limitation is still an extension of the abstract idea recited in claim 1, and does not provide any specific techniques that would render the determination unable to practically be done in the human mind. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claim 6 depends on claim 5 and discusses how the nucleases used may be differentially expressed in abnormal cells (i.e. upregulated or downregulated), similar to the manner recited in claim 4. This claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Coy as described above, as this claim is also mainly drawn to evaluating nuclease activity. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 5.
Claim 7 depends on claim 1 and requires that fetal tissue be examined. This claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Zhang et al. (Journal of Histochemistry & Cytochemistry, 2008). This reference teaches taking samples of fetal tissue, placing them on microarrays, and performing staining (“Materials and Methods”). This involved standard procedures and commercially available kits and reagents. This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claims 8 and 9 depend on claim 1 and require that the subject be a pregnant female, placental tissue in maternal plasma be examined, and that the abnormality examined be preeclampsia, preterm birth, fetal chromosomal aneuploidies, or fetal genetic disorders. These claims do not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Lo et al. (Nature Medicine, 2007). This reference teaches measuring placental mRNA in maternal plasma in order to diagnose fetal aneuploidy (trisomy 21; Abstract). This involved methods of processing, assaying, and amplifying that included commercially available reagents, kits, microarrays, software, equipment, and primers and probes (see Lo Supplementary Methods). This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, these claims are also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claim 10 depends on claim 1 and requires additional analyzing and determining steps related to a second biological subject. These limitations are similar to the abstract ideas recited in claim 1, and do not provide any specific techniques that would render the determination unable to practically be done in the human mind. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claims 11-13 depend on claim 1 and require that the abnormality examined be a pathology, specifically cancer in the case of claim 12, and specifically a pathology with multiple stages in the case of claim 13. These claims thus also only further define the judicial exceptions of claim 1 in that the abnormality analyzed in the method is further specified. Additionally, these claims do not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Elston et al. (Histopathology, 1991). This reference teaches methods of tissue preparation and tumor grading using histology, cell nuclei, and mitotic and tubule structures (pages 404-405, “Materials and methods”). Staining techniques were routine (page 404, “Tissue Preparation”), and analysis of samples was conducted with a commercially available microscope (page 405, “Mitotic counts”). This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, these claims are also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claims 14-15 depend on claim 11 and require that the abnormality be an auto-immune disorder, specifically systemic lupus erythematosus (SLE) in the case of claim 15. These claims thus also only further define the judicial exceptions of claims 1 and 11 in that the abnormality analyzed in the method is further specified. Additionally, these claims do not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Hanly et al. (Journal of Immunological Methods, 2010). This reference teaches using assays to detect autoantibodies to diagnose and assess patients with SLE (Abstract). These measurements occurred with commercially available screening tools, kits, and equipment, as well as standard procedures (page 76, “2.4 Measurement of autoantibodies”). This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, these claims are also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 11.
Claims 33 and 37 provide a list of nucleases that may be used in claims 1 and 3 respectively. These claims thus also only further define the judicial exceptions of claims 1 and 3 in that the differentially regulated nuclease(s) in abnormal cells that is/are analyzed in the method is further specified. Additionally, these claims do not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Coy as described above, as these claims are also mainly drawn to evaluating nuclease activity. Thus, these claims are also directed to a judicial exception without significantly more for the reasons set forth above with respect to claims 1 and 3.
Claim 34 depends on claim 33 and further specifies that the nuclease DNASEIL3 must be used, and that this nuclease must produce a particular end signature. This claim thus also only further defines the judicial exception of claim 33 in that the differentially regulated nuclease in abnormal cells that is analyzed in the method is further specified. Additionally, this claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Serpas et al. (PNAS, 2019). Serpas teaches DNASE1L3, and notes that this nuclease preferentially creates particular end motifs in nucleic acid fragments, including the end motif CCCA (Abstract and Table 1). This was examined in a previously described mouse model, and the nucleic acid analysis involved the use of commercially available kits, reagents, and equipment (page 648, column 1). This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 33.
Claim 35 depends on claim 33 and further specifies that the nuclease DFFB must be used, and that this nuclease must produce a particular end signature. This claim thus also only further defines the judicial exception of claim 33 in that the differentially regulated nuclease in abnormal cells that is analyzed in the method is further specified. Additionally, this claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Widlak et al. (The Journal of Biological Chemistry, 2000), as evidenced by PhosphoSitePlus (2016). Widlak teaches the cleavage preferences of DFF40 (an alternative name for DFFB, see PhosphoSitePlus; Title). Widlak found that after cleavage with DFFB, the frequencies for the end signature were as follows: R (72%), R (74%), R (66%), Y (61%; page 8228, column 1, para. 1). This encompasses the sequence AAAT, which is one of the end signatures specified in claim 35. The methods of this study involved using previously recorded procedures and commercially available reagents (page 8227, “Assay for Endonuclease Activity” and “Analysis of Cleavage Sites”). This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 33.
Claim 36 depends on claim 33 and further specifies that the nuclease DNase I must be used, and that this nuclease must produce a particular end signature. This claim thus also only further defines the judicial exception of claim 33 in that the differentially regulated nuclease in abnormal cells that is analyzed in the method is further specified. Additionally, this claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Drew et al. (Cell, 1984). Drew teaches methods related to the cleavage patterns of DNase I, DNase II, and copper-phenanthroline (Abstract). This reference teaches that DNase I preferentially cleaves sites, and can leave a TAAT end sequence (see Figure 1b, which shows increased activity for DNase I around nucleotides 12-15, which are shown in Figure 1a to be a TAAT, as well as Figure 2a-b, which both show the probability that DNase I can cleave after the TAAT sequence). These methods involved commercially available reagents with known equipment (pages 500-501, “Experimental Procedures”). This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 33.
Claim 38 depends on claim 1 and further specifics that the analyzing step must be conducted with sequencing. This claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of Serpas, as this reference teaches sequencing DNA libraries using a commercially available platform and software (page 648, “DNA Sequencing Using the Illumina Platform”). This reference does not discuss any modifications to the commercial and standard aspects of these methods, providing evidence to the routineness of these methodologies. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claim 39 depends on claim 1 and further specifies the first parameter used. This limitation is still an extension of the abstract idea recited in claim 1, and does not provide any specific techniques that would render the determination unable to practically be done in the human mind. Thus, this claim is also directed to a judicial exception without significantly more for the reasons set forth above with respect to claim 1.
Claim 171 depends on claim 1 and requires that the first sequence end signature comprise more than one base. This claim does not further specify a treatment or other integrating step or involve additional elements that are not well-understood, routine, or conventional to those of ordinary skill in the art in view of at least Serpas, which teaches end signatures with four nucleotides, as described above.
Free of the Prior Art
Lo et al. (US 2021/0189494 A1; note that the teachings cited here appear in either provisional application 62/958,651 and/or provisional application 62/949,867, from which this application claims priority) teaches methods for detecting a genetic disorder in a gene associated with a nuclease and for monitoring an activity of a nuclease (Abstract). Figure 37 shows the expression of DNASE1 in different tissues, though this does not show expression in abnormal tissues (para. 45). The reference also shows the analysis of end motifs (Figure 1 and para. 10), and notes that analysis of end motifs can relate to nuclease activity and disorders affecting nucleases (para. 72). Para. 252 discusses monitoring the activity of a nuclease such as DNASE1, and Figure 33 shows end fragments produced with different doses of DNASE1, and the reference notes that this can be an indication of DNASE1 activity (paras. 255-258). However, the reference does not explicitly show that DNASE1, or any other nuclease, is differentially regulated in abnormal tissues, as claimed, and so does not clearly link the presence, absence, or amount of particular end motifs present in a sample with said differential regulation.
Echevarria (US 2021/0318324 A1; note that the teachings cited here appear in provisional application 62/694,323, from which this application claims priority) teaches the measurement of the expression of EXO1 in relation to cancer in a subject (Abstract). Expression level of EXO1 was shown to be higher in both localized and metastatic prostate cancer compared to controls (para. 21 and Figure 13D), as well as in localized and castration resistant prostate cancer compared to controls (para. 26 and Figure 14C). However, the expression level of EXO1 is used as merely a biomarker for disease (see for example paras. 77-78), with no indication that this data could or would be used in conjunction with end motif data for EXO1.
Coy (US 2008/0234393 A1) teaches useful DNase nucleic acids from the detection and treatment of carcinomas and their precursor lesions (Abstract). Para. 32 describes several DNase molecules that may be examined, including DNASE1, DNASE1L1 (also called DNASE X), and DNASEIL2. Example 1 of the reference details a finding of overexpression of DNASE X in cancer tissue samples (paras. 255-265). However, this reference uses the DNase nucleic acids as molecular markers (para. 8), and does not provide any indication that this data could or would be used in conjunction with end motif data.
Similar prior art to that of Echevarria and Coy was found that generally discusses particular nuclease biomarkers in relation to abnormalities, but none which link these abnormalities to an analysis of end motif data. Wang et al. (Aging, 2020) found a decrease in DNASE1L3 expression with hepatocellular carcinoma (Abstract and Figure 1) and notes that DNASE1L3 generally has influence over particularly generated end-motif frequencies (page 1172, column 1, para. 3), but does not expand on combining these two concepts, and mentions end motifs merely in a general discussion of the function of the nuclease. Lu et al. (World J Gastroenterol, 2004) notes that DFF40 (also known as DFFB) expression increases when liver ischemia is present (Abstract and page 2132, column 1, para. 3), but end sequences are not mentioned.
Thus, claims 1-15, 33-39, and 171 are considered to be free of the prior art, as no prior art could be found that would anticipate or render obvious the use of nuclease expression data with end motif data for that nuclease to arrive at the method of instant claim 1.
Conclusion
No claims are currently allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/F.F.G./Examiner, Art Unit 1681
/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681
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