Prosecution Insights
Last updated: April 19, 2026
Application No. 18/152,042

METHODS OF DETECTING GENOMIC REARRANGEMENTS USING CELL FREE NUCLEIC ACIDS

Final Rejection §101§103
Filed
Jan 09, 2023
Examiner
GRAY, JESSICA
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Guardant Health Inc.
OA Round
2 (Final)
0%
Grant Probability
At Risk
3-4
OA Rounds
3y 2m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 5 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
47 currently pending
Career history
52
Total Applications
across all art units

Statute-Specific Performance

§101
13.8%
-26.2% vs TC avg
§103
29.7%
-10.3% vs TC avg
§102
15.4%
-24.6% vs TC avg
§112
22.9%
-17.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 5 resolved cases

Office Action

§101 §103
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 . Priority This application 18/152,042 filed on 01/09/2023 is a Continuation of PCT No. PCT/US2021/041148 filed on 07/09/2021 and claims the benefit of priority of US Provisional Patent Application No. 63/050,373, filed on 07/10/2020. The priority date of claim 1 and its dependent claims is determined to be 07/10/2020, the filing date of provisional U.S. Patent Application No. 63/050,373. Status of Claims Applicant’s amendments to claims filed 12/09/2025 in response to the Non-Final Rejection mailed 09/09/2025 are acknowledged. Claims 1, 3, 20, 43, and 61 are amended. Claims 1-3,10,14,20,28,37,40,43,50,55-56,59,61,65,67,71,74 and 76 are pending and under examination. Response to Remarks filed 12/09/2025 The amendments and arguments presented in the papers filed 12/09/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 09/09/2025 listed below have been reconsidered as indicated. a) The objections to the specification regarding the use of trade names or marks are withdrawn in view of the amendments to the specification. b) The objections to claims 3 and 43 because of informalities are withdrawn in view of the amendments to the claims. c) The 35 USC 112(b) indefiniteness rejections of claims 1 and 61 have been withdrawn in view of the amendments to the claims. Maintained grounds of rejection are detailed below and this action is made FINAL. Claim Rejections - 35 USC § 101 - maintained 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 43 and 67 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. 35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II. Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility. Step 1 The claimed invention is directed to the statutory category of a process. Step 2A, Prong One The claim is (claims are) taken to be directed to an abstract idea, a judicial exception. Claim 43, step (e) is directed to a method further comprising “determining a likelihood that the subject has a cancer”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, the comparing step encompasses the mental step of making a mental judgment. Claim 67, step (a) is directed to a method further comprising “determining whether DNA molecules corresponding to the sequence-variable target region set comprise cancer-associated mutations”. As written, the comparing step encompasses the mental step of making a mental judgment. Step 2A, Prong Two The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. While claim 1, which claims 43 and 67 depend from, recites a method comprising steps “dividing a sample…”; “isolating a plurality of tagged DNA molecule…”; “linearly amplifying at least a portion of the tagged DNA molecules …”; “capturing the first population of processed DNA…”; “amplifying and/or eluting the first population of processed DNA…”; “enriching the second aliquot…”; “sequencing at least a portion…”; and “detecting the presence or absence of a plurality of genomic rearrangements…”, this is not an integration of the exception into a practical application. Instead, this element is data gathering and analysis required to perform the method. (See MPEP 2106.04(a)(2)(III); claims to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739,1741-42 (Fed. Cir. 2016). Step 2B The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not add a specific limitation other than what is well-understood, routine, and conventional in the field. Steps directed to “tagging and isolating DNA, amplifying DNA with primers, capturing and sequencing processed DNA, and detecting genomic rearrangements” are techniques that are routine, conventional, and well-known in the art as demonstrated in the 103 rejection documented below. Furthermore, the courts have recognized the following laboratory techniques as well-understood, routine, conventional activities in the life science arts when they are claimed in a merely generic manner or as insignificant extra-solution activity: 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) 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) For these reasons, the claims are rejected under section 101 as being directed to non-statutory subject matter. Response to Arguments against Claim Rejection - 35 U.S. C § 101 The response asserts the rejection merely considers various claim elements individually and a proper analysis of eligibility must consider whether the claim as a whole sets forth an unconventional combination of elements (p. 12-13). The response further asserts the claims recite unconventional activity, citing in particular the limitations of claim 1 (“dividing a sample of tagged molecules---and detecting the presence or absence of a plurality of genomic rearrangements”). The response asserts that there is no evidence that these combinations of elements were widely prevalent in the field at the relevant time, The response asserts that the claims are eligible under 35 U.S.C § 101 for at least the reason that they recite an unconventional combination of elements, and therefore contain an inventive concept apart from the alleged judicial exceptions (p. 13-14). The response further asserts that it was unconventional to perform the method, including the combination of elements cited in the Remarks (p. 14). Applicant's arguments have been fully considered but are not persuasive. The rejection is maintained but has been rearranged for clarity. The Examiner maintains that the cited active steps were routine, well-known and conventional in the art and that each of the claimed active steps entails a data-gathering step in the method. The development of assays incorporating multiple well-known active steps (here: “dividing a sample of tagged DNA molecules--; isolating a plurality of tagged DNA molecules--; linearly amplifying at least a portion of the tagged DNA molecules--; capturing the first population of processed DNA--; amplifying and/or eluting ---; enriching [an] aliquot ---; sequencing ---; and detecting the presence or absence of a plurality of genomic rearrangements---“) is standard and routine in the field. One of skill in the art would have considered it conventional to combine and reorder routine and well-known steps in the design of a new protocol. Claims 43 and 67 remain drawn to steps indicated above that can be performed as a purely mental process. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claims 1-3, 10, 14, 20, 28, 37, 40, 43, 50, 55, 56, 59, 61, and 65 remain rejected under 35 U.S.C. 103 as being unpatentable over Woodhouse et al. (US PGPub 20190241974) in view of Corioni et al. (US PGPub 20190017113). This maintained rejection has been modified to correct minor annotation errors in the office action dated 09/09/2025. Regarding claim 1, Woodhouse teaches methods for detecting and targeting genomic rearrangements in DNA molecules of interest (DMOIs), the method comprising determining the sequence of tagged and enriched DMOI (para 210), splitting a patient sample into two or more test samples (prior to or after processing of the patient sample) and the methods are carried out on the two or more test samples (i.e. dividing the sample into at least first and second aliquots) (para 412), isolating the DNA molecules of interest (para 30), linearly amplifying the template (para 505) using primers comprising sequences specific for regions of interest (rearrangement detection barcodes) (para 14), and sequencing adapters (para 122). Woodhouse further teaches sequencing amplification products (para 22) and determining the presence or absence of the genomic rearrangement (para 51). Woodhouse further teaches enriching the DNA molecules of interest (para 30). The teaching by Woodhouse of carrying out methods on all test samples (para 412) satisfies the requirement for enriching and sequencing the second sample (or aliquot). Woodhouse teaches the method may further comprise immobilizing the DMOIs to a solid substrate (surface) (para 212) Woodhouse does not teach primers that comprise a non-nucleotide binding partner; using binding to the non-nucleotide binding agent to immobilize on the solid support; or amplifying and/or eluting the first population of processed DNA as recited in instant claim 1. Corioni teaches sequencing methods for detection of genomic rearrangements, the method comprising using a biotinylated primer that can allow for capture of the amplified products by forming a complex with reciprocal binding partners on a solid support (para 62). Corioni further teaches amplifying the DNA attached to the solid surface (para 3). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Woodhouse and Corioni to arrive at the instantly claimed invention. The modification would have improved combining the methods of Woodhouse and Corioni by adding the biotin binding moiety to the primer of Woodhouse and using the binding moiety as a target to capture and immobilize molecules before amplification. One would have been motivated to do so for the advantage of removing undesired species or for the benefits of selective amplification of a subset of molecules. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art. Regarding claim 2, Woodhouse teaches methods are carried out on the two or more test samples (i.e. dividing the sample into at least first and second aliquots) (para 412). Woodhouse further teaches the method comprises matching sequenced products to a reference sequence (para 262) and detecting genetic alterations such as mutations (paras 233 and 234). Regarding claim 3, Woodhouse teaches cfDNA as a DMOI (DNA molecule of interest) (para 418), wherein DMOIs can be tagged (para 210), which reads on the limitation recited in (a) of claim 3. Regarding claim 10, Woodhouse does not teach any of the recited limitations. Corioni teaches washing of the polynucleotides to remove any undesired species, which reads on the limitation recited in (c) of claim 10. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Woodhouse and Corioni to arrive at the instantly claimed invention. The modification would have improved adding the wash step of Corioni after tagging molecules and before the amplification of Woodhouse. One would have been motivated to do so for the advantage of removing undesired species before amplification. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art. Regarding claim 14, Woodhouse teaches genomic rearrangements comprise gene fusions (para 2), which reads on the limitation recited in (a) of claim 14. Regarding claim 20, Woodhouse teaches primers that tile genes of interest (para 67, Fig. 7), which reads on the limitation recited in (a) of claim 20. Regarding claim 28, Woodhouse teaches the method may comprise incorporation of universal primer binding sites into the amplification product by primers comprising universal primer binding sites, thus tagging the amplification product of a first reaction (i.e., producing a sample of tagged DNA molecules that are amplified tagged DNA molecules) that can be targeted again with a further pair of primers that are specific for the UPS (para 122), which reads on the limitation recited in (e) of claim 28. Regarding claim 37, Woodhouse does not teach any of the recited limitations. Corioni teaches a primer with a binding partner comprising a biotin moiety and a solid support comprising a biotin-binding moiety such as avidin or streptavidin (para 62), which reads on the limitation recited in (a) of claim 37. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Woodhouse and Corioni to arrive at the instantly claimed invention. The modification would have improved combining the methods of Woodhouse and Corioni by adding the biotin binding moiety to the primer of Woodhouse and using the binding moiety as a capture tag to immobilize the targeted population of molecules. One would have been motivated to do so for the advantage of removing undesired species or for the benefits of selective amplification of a subset of molecules. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art. Regarding claim 40, Woodhouse teaches the method comprises incorporation of universal primer binding sites into the amplification product by primers comprising universal primer binding sites, thus tagging the amplification product of a first reaction and producing tagged DNA molecules that can be targeted again with a further pair of primers that are specific for the UPS (para 122), which reads on the limitation recited in (b) of claim 40. Regarding claim 43, Woodhouse teaches a subject that has received treatment for cancer (para 49), which reads on the limitation recited in (c) [Note: corrected from “(c)(b)” in Office Action dated 09/09/2025] of claim 43. Regarding claim 50, Woodhouse teaches detecting residual disease following treatment for cancer; i.e. an incomplete response (para 439), which reads on the limitation recited in (a) of claim 50. Regarding claim 55, Woodhouse teaches determining the presence or absence of a gene fusion event that is known, or is suspect to be, associated with cancer (para 119). Regarding claim 56, Woodhouse teaches recommending the patient for treatment based on the presence or absence of the genomic rearrangement event (para 425) and selecting a treatment regimen for the patient according to the presence or absence of a genomic rearrangement (para 38), which reads on the limitation recited in (b) of claim 56. Regarding claim 59, Woodhouse teaches the cancer may be any cancer, but of particular interest is lung cancer (para 419). Regarding claim 61, Woodhouse teaches the sequencing comprises high-throughput sequencing (para 97), which reads on the limitation recited in (a) of claim 61. Regarding claim 65, Woodhouse teaches pooling samples together into a single reaction tube (para 499), which reads on the limitation recited in (a) of claim 65. Claims 67 and 71 remain rejected under 35 U.S.C. 103 as being unpatentable over Woodhouse et al. (US PGPub 20190241974) in view of Corioni et al. (US PGPub 20190017113) as applied to claims 1-3, 10, 14, 20, 28, 37, 40, 43, 50, 55, 56, 59, 61, and 65, and further in view of Yegnasubramanian et al. (US PGPub 20140274767). Regarding claims 67 and 71, neither Woodhouse nor Corioni teach the limitations of claims 67 or 71. Yegnasubramanian teaches methods for genome scale analysis of methylation in prostate cancer comprising methods amplifying desired target sequences (para 67). Yegnasubramanian teaches assaying epigenetic alterations (epigenetic target region sets) in metastatic prostate cancer (para 44), which reads on the limitation recited in (b) of claim 67. Yegnasubramanian further teaches DNA hypermethylation alterations as targets (para 7), which reads on the limitation recited in (a) of claim 71. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Woodhouse and Corioni with Yegnasubramanian to arrive at the instantly claimed invention. The combination would have entailed using the epigenetic and hypermethylated region targets of Yegnasubramanian as the targets used in performing the method of Woodhouse and Corioni. One would have been motivated to do so because epigenetic hypermethylation changes “are a hallmark of human cancers” (Yegnasubramanian para 5) and both Woodhouse and Corioni desired to identify genomic variations that contributed to cancer. It would have been prima facie obvious to add an additional target set to expand the number of rearrangements in a sample. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art. Claims 74 and 76 remain rejected under 35 U.S.C. 103 as being unpatentable over Woodhouse et al. (US PGPub 20190241974) in view of Corioni et al. (US PGPub 20190017113) as applied to claims 1-3, 10, 14, 20, 28, 37, 40, 43, 50, 55, 56, 59, 61, and 65, and further in view of Boutros et al. (WO 2017/132748). Regarding claims 74 and 76, Neither Woodhouse nor Corioni teach the limitations of the claims. Boutros teaches methods of characterizing prostate cancer including genomic rearrangements and determining biomarkers. Boutros teaches a method comprising determining prostate cancer patient biomarkers (Abstract), which reads on the limitations recited in claims 74 and 76. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Woodhouse and Corioni with Boutros to arrive at the instantly claimed invention. The combination would have entailed adding the additional step of assaying for cancer biomarkers as taught by Boutros to the method of Woodhouse and Corioni. One would have been motivated to do so for the advantage of improving the ability to prognose and predict cancer progression and response to treatment as sought by Woodhouse. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art. Response to Arguments against Claim Rejection - 35 U.S. C § 103 The response notes that paragraph 514 of Woodhouse (cited in support of an alleged linear amplification of Woodhouse) does not exist (p. 15). The Examiner thank the Applicant for bringing this annotation error to their attention. The response asserts that the linear amplification described in paragraph [0505] of Woodhouse et al. (i) does not use a primer that comprises a rearrangement detection barcode (among other things) and (ii) describes a sequential amplification that requires the use of a forward and then a reverse primer (p. 15). Applicant's arguments have been fully considered but are not persuasive. Regarding assertion (i), Woodhouse teaches that primers comprise sequences specific for regions of interest (para 14). It is noted that a barcode is broadly interpreted as any sequence specific to a rearrangement. The region of interest in this case, as taught by Woodhouse, is genomic rearrangements. Thus any sequence in primers specific for regions of interest is encompassed by a rearrangement detection barcode. Regarding assertion (ii), the claim as written requires (i) linearly amplifying at least a portion of the tagged DNA molecules isolated from the first aliquot with a set of primers that target a first plurality of loci of interest and further that the primers (ii) comprise a rearrangement detection barcode, a sequencing adapter, and a non-nucleotide binding partner. Woodhouse satisfies this requirement in the teaching of “Linear amplification of the template was performed on two of the replicates using only the ROSI forward primer panel” (para 505). The teaching of an additional amplification by a reverse primer (following PCR cleanup and elution), does not negate the teachings of Woodhouse relevant to the claim limitation. Further the claims as written do not exclude the use of additional primers in subsequent steps. The response asserts that Woodhouse states the methods “do not require a further enrichment step, such as enrichment comprising hybridisation to a probe” (Woodhouse para 12) and further that “selective enrichment steps (beyond the selective PCR step) are not necessary in the methods disclosed herein, for example using hybridisation probes, since a step of enrichment is inherently incorporated into the selective PCR. Therefore, in preferred embodiments, the methods do not comprise enrichment (for example enrichment of any sample, DNA or amplicon) by hybridisation, for example enrichment using hybridisation probes.(Woodhouse para 250). One of ordinary skill would therefore not look to Corioni et al. to do what Woodhouse says is unnecessary (p. 16). Applicant's arguments have been fully considered but are not persuasive. It is noted that Applicant cited paragraph 250 of Woodhouse recites “preferred embodiments” and is not limiting in that regard. Further, while paragraphs 12 and 30 (cited in the Office Action dated 09/09/2025) of Woodhouse, teach that “the methods disclosed herein do not require a further enrichment step, such as enrichment comprising hybridisation to a probe” (para 12, cited in Remarks dated 12/09/2025) and “enrichment of the sample for the DMOI is not required” (para 30), they do not limit the methods of Woodhouse to the single embodiment. In particular paragraph 30 of Woodhouse teaches “The method may comprise extracting, isolating or enriching for the DMOI from the patient sample prior to determining the presence or absence of a genomic rearrangement”. Thus, Woodhouse is encompassed by claim limitations that require capturing the first population of processed DNA on a solid support using binding to a non-nucleotide binding partner. The response asserts that Woodhouse et al. does not teach capturing the first population of processed DNA on a solid support using binding to the non-nucleotide binding partner or amplifying and/or eluting the first population of processed DNA, and Corioni et al. does not remedy this deficiency. (p. 16) and further that Corioni et al. does not teach or suggest that a biotinylated primer should be used to linearly amplify DNA or that biotin should be added to a primer that contains a rearrangement detection barcode. Thus, the combination of Corioni et al. and Woodhouse et al. are insufficient to bridge the gap between their disclosure and the present claims. One of ordinary skill would have had no reason or motivation from Woodhouse et al. or Corioni et al., alone or together. (p. 17). The response additionally asserts Corioni et al. also does not teach: 1) linearly amplifying at least a portion of the tagged DNA molecules isolated from the first aliquot with a set of primers that target a first plurality of loci of interest and comprise a rearrangement detection barcode, a sequencing adapter, and a non-nucleotide binding partner (thereby producing a first population of processed DNA); 2) capturing the first population of processed DNA on a solid support using binding to the non-nucleotide binding partner; and 3) amplifying and/or eluting the first population of processed DNA (p. 17). Applicant's arguments have been fully considered but are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The teachings of each of the references and their combination is presented above in the 103 rejection. The response asserts that with the present invention one can obtain information about the location of a first plurality of loci of interest using linear amplification with only a single primer. Woodhouse et al. focuses on "forward primers and reverse primers [that] produce a PCR amplification product when a genomic rearrangement is present" (Abstract of Woodhouse et al.); and Corioni et al. does not remedy this deficiency (p. 18). Applicant's arguments have been fully considered but are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that with the present invention one can obtain information about the location of a first plurality of loci of interest using linear amplification with only a single primer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claims 67 and 71 The response asserts Yegnasubramanian et al. does not remedy the deficiencies of Woodhouse et al. and Corioni et al., as it also does not suggest linearly amplifying at least a portion of tagged DNA molecules isolated from a first aliquot of a sample with a set of primers that target a first plurality of loci of interest and comprise a rearrangement detection barcode, a sequencing adapter, and a nonnucleotide binding partner (thereby producing a first population of processed DNA); capturing the first population of processed DNA on a solid support using binding to the non-nucleotide binding partner; and amplifying and/or eluting the first population of processed DNA (p. 18-19). Applicant's arguments have been fully considered but are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains the rejection of independent claim 1, which claims 67 and 71 depend from, over Woodhouse and Corioni as detailed in the 103 rejection above. Applicant provides no arguments against the use of Yegnasubramanian regarding the limitations of claims 67 and 71. Claims 74 and 76 The response asserts Boutros et al. does not remedy the deficiencies of Woodhouse et al. and Corioni et al., as it also does not suggest linearly amplifying at least a portion of tagged DNA molecules isolated from a first aliquot of a sample with a set of primers that target a first plurality of loci of interest and comprise a rearrangement detection barcode, a sequencing adapter, and a nonnucleotide binding partner (thereby producing a first population of processed DNA); capturing the first population of processed DNA on a solid support using binding to the non-nucleotide binding partner; and amplifying and/or eluting the first population of processed DNA (p. 19). Applicant's arguments have been fully considered but are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains the rejection of independent claim 1, which claims 74 and 76 depend from, over Woodhouse and Corioni as detailed in the 103 rejection above. Applicant provides no arguments against the use of Boutros regarding the limitations of claims 74 and 76. Conclusion 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. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA GRAY whose telephone number is (571)272-0116. The examiner can normally be reached Monday-Friday 8-5 with second Fridays off. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, WINSTON SHEN can be reached at (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JESSICA GRAY/Examiner, Art Unit 1682 /WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Jan 09, 2023
Application Filed
Sep 04, 2025
Non-Final Rejection — §101, §103
Dec 09, 2025
Response Filed
Mar 20, 2026
Final Rejection — §101, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 2m
Median Time to Grant
Moderate
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