DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 March 2026 has been entered.
Applicant's response has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Any newly recited portions of the below rejections are necessitated by claim amendments herein.
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 .
Claim Status
Claims 1, 5-6, 9-15, 21, 23-24, and 26-31 are currently pending.
Claims 2-4, 7-8, 16-20, 22, 25 have been cancelled.
Claim 15 remains withdrawn.
Claims 1, 5-6, 9-14, 21, 23-24, and 26-31 are examined herein.
Claims 29-31 are newly added.
Specification
All reference to the Specification herein refer to the PG Publication version of the Specification: US20230175058.
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, 5-6, 9-14, 21, 23-24, and 26-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portions are necessitated by claim amendment.
The instant rejection reflects the MPEP at 2106.04, summarized as follows:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): yes, the claims are directed to a method and programmed computer for detecting or treating a cancer in a subject.
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) as follows:
Claim 1: “determine expression profile of one or more genes…quantifying a number…generating a TSS availability profile”; “processing…to detect a differential expression”; “detect differential expression relative to TSS availability profiles”
Claims 6, 11-14, 21, and 23-24, 28-29: recite additional steps that further limit the judicial exceptions in the independent claims 1 and as such, are further directed to abstract ideas. For example, “efficiency” determination (claim 6); “dimensionality reduction” (claims 11/12); “supervised learning” (claims 13/14); “determining a progression (claim 23”; and “determining effectiveness” (claim 24); “determining a start region and a stop region…” (claim 28); “…or Markov blanket filer methods” (claim 29).
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind and/or performance by mathematical operation because the steps involve nothing more than instructions for a user to obtain sequence read data and make determinations for a sequence profile to identify cancer. There are no specifics as to the methodology involved in said operations, thus, under the BRI, one could simply, for example, perform the steps mentally. Alternatively, steps that specifically recite operations such as “processing” and “detecting indicate colorectal cancer” are, under the BRI, performed using mathematical operations or mental operation with the aid of computational generic processing as a tool. The instant Specification, at [0093] as example, teaches software can be utilized to normalize, summarize and analyze data. Said claimed steps are not further defined beyond something that reads on merely looking at data and making a determination or operating a calculation via a computer as a tool. As such, said steps are directed to judicial exceptions.
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following that are considered the additional elements herein:
Claims 1: “obtaining a biological sample from the subject; performing centrifugation on the biological sample to obtain a cell-free deoxyribonucleic acid (cfDNA) sample; enriching the cfDNA a nucleic acid sample obtained or derived from the subject, wherein the cfDNA nucleic acid sample comprises nucleic acid sequences comprising at least a subset of a plurality of transcriptional start sites (TSS), wherein the enriching comprises contacting the cfDNA nucleic acid sample with a probe set comprising hybridization probes having sequence complementarity to the plurality of TSS, wherein the plurality of TSS comprises at least two genomic regions selected from the group listed in TABLE 2, wherein each genomic region of the at least two genomic regions comprises a chromosome start region coordinate and a chromosome stop region coordinate; attaching molecular barcodes to the enriched cfDNA sample; amplifying the barcoded enriched cfDNA sample or derivatives thereof to produce amplification products; sequencing the amplification products or derivatives thereof enriched nucleic acid sample, thereby generating a plurality of sequence reads; aligning the plurality of sequence reads to a reference genome at a set of genomic locations to generate a plurality of aligned sequence reads, wherein the set of genomic locations corresponds to the subset of the plurality of TSS
Claims 5, 9, 10, 21, 23-24, 26-27, and 30-31 recite steps that further limit the recited additional elements in the independent claim 1. With respect to the additional elements in the instant claims, the steps are directed to data gathering, which provide the data to use in the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Claims 1 further include steps reciting: “processing…computer programmed to”. Further steps herein directed to additional non-abstract elements of “processor; computer; etc…” do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
As such, none of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. According to the in the MPEP at 2106, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by one of either (1) a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); (2) a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); (3) a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or (4) a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the additional elements as claimed include, as example, “sequencing” and “aligning” laboratory steps which, as demonstrated by the prior art to Aarthy et al. (previously cited) provide that sequencing in the instant context is directed to routine data gathering elements that are well-understood and conventional in the art. For example, Aarthy et al. provide that next-generation sequencing has been used to analyze cfDNA in many cancer types to identify mutations, but warns of the limitations of this technique due to factors such as false positives, unavailability of source information, cost and others (page 342, col. 1). Aarthy et al. review research with respect to genetic alterations in cfDNA and disclose that certain mutations, microsatellite instabilities, LOH rates, and methylation statuses, have been detected in cf samples and are correlated with same changes in tumors.
Further to the amended claim steps directed to obtaining a biological sample; performing centrifugation on the sample; enriching the cfDNA; attaching molecular barcodes; amplifying the barcoded cfDNA; sequencing the amplification products; and aligning the plurality of sequence reads, recite well-understood, routine and conventional steps in the art of next-generation sequencing detection of mutation ion cell-free DNA. Further prior art example of disclosure include: Hirotsu et al. (Scientific Reports (2020) Vol. 10:10 pages) disclosing molecular barcoding sequencing technologies (abstract). Hirotsu et al. outline various techniques as available to do so including their Non-MB-based (Ion AmpliSeq) and MB-based panel (Ion AmpliSeq HD) for targeting biliary-pancreatic and non-small cell cancers for analysis. See Hirotsu et al. at least at page 2; Figures 2-5.
The Specification indicates that with respect to colorectal cancer, the modified nucleic acid molecule can be sequenced (e.g., using next generation sequencing techniques) to generate sequence reads, which can be used to determine a genetic sequence feature, for example, by measuring gene expression levels or determining an expression profile [0093]… Nucleic acid molecules can be extracted from biological samples by contacting the biological samples with an array of probes under conditions to allow hybridization. The degree of hybridization may be assayed in a quantitative matter using methods known in the art [0098]… Processing a nucleic acid molecule or fragment thereof may comprise performing nucleic acid amplification. For example, any type of nucleic acid amplification reaction can be used to amplify a target nucleic acid molecule or a fragment thereof to generate an amplified product [0106].
As such, activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field; they do not require or set forth a particular machine; they do not effect a transformation of matter; nor do they provide a non-conventional or unconventional step. Rather, the data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 1 the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further exemplified in the MPEP at 2106.05(f) with reference to Alice Corp., 573 US at 223, 110 USPQ2d at 1983 “claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible”. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
Dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception. For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
1. Applicant states that claim 1 has been amended to clarify the claimed subject matter. Applicant further states that, “claim 1 and its dependent claims are patent-eligible, for at least the reason that under the Step 2B analysis of the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), the instant claims as a whole provide an inventive concept that amounts to significantly more than the alleged judicial exception (noting that Applicant does not concede that the instant claims recite any judicial exception). For example, claim 1 recites the following ordered combination of elements which was not well-understood, routine, or conventional as of the effective filing date of the Application:
“obtaining a biological sample from the subject; (b) performing centrifugation on the biological sample to obtain a cell-free deoxyribonucleic acid (cfDNA) sample; (c) enriching the cfDNA sample, wherein the cfDNA sample comprises nucleic acid sequences comprising at least a subset of a plurality of transcriptional start sites (TSS), wherein the enriching comprises contacting the cfDNA sample with a probe set comprising hybridization probes having sequence complementarity to the plurality of TSS, wherein the plurality of TSS comprises at least two genomic regions selected from the group listed in TABLE 2, wherein each genomic region of the at least two genomic regions comprises a chromosome start region coordinate and a chromosome stop region coordinate; attaching molecular barcodes to the enriched cfDNA sample; amplifying the barcoded enriched cfDNA sample or derivatives thereof to produce
amplification products; sequencing the amplification products or derivatives thereof, thereby generating a plurality of sequence reads; aligning the plurality of sequence reads to a reference genome at a set of genomic locations to generate a plurality of aligned sequence reads, wherein the set of genomic locations corresponds to the subset of the plurality of TSS”.
It is respectfully submitted that this is not persuasive. It is maintained that the claim does not specify, for example, which subset of TSS is enriched, beyond recitation of “at least two genomic regions”. The claim does not render any specific region other than what is present in Table 2, of which include a vast laundry list of TSS genomic regions as taken from the human genome, known to encompass the entire TSS representations from the human genome, as indicated in the Specification at least at [0144]. As such, the prior art fully encompasses a routine understanding that genomic regions would be assessed for cancer detections and that subsets of genomic regions would be assessed for such, including regions that encompass transcriptional start sites as available in the entire human genome. As such, the steps are directed only to “getting data” herein even when combined with a step of “sequencing” by next-generation sequencing methods including enrichment and barcoding as claimed, which is also routinely done in the art. All previous responses to this effect are also relied upon herein in answer to the above argument from Applicant.
2. Applicant further points to the MPEP at 2106.05, reciting "[c]onsideration of the elements in combination is particularly important, because even if an additional element does not amount to significantly more on its own, it can still amount to significantly more when considered in combination with the other elements of the claim. See, e.g., Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (process reciting combination of individually well-known freezing and thawing steps was "far from routine and conventional" and thus eligible); BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (inventive concept may be found in the non-conventional and non-generic arrangement of components that are individually well-known and conventional)" (emphases added). Further, M.P.E.P. § 2106.05 also states that "the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) ('the inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art.... [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.')." (Emphases added).
Particularly, Applicant submits that, in the field of colorectal cancer detection using cell- free DNA, it was not well-understood, routine, or conventional as of the effective filing date of the Application for one of ordinary skill in the art to perform the following ordered combination of additional limitations beyond the alleged judicial exception, summarized as follows: (a) obtaining a biological sample; (b) performing centrifugation on the biological sample to obtain a cell-free deoxyribonucleic acid (cfDNA) sample; (c) enriching the cfDNA sample, by contacting the cfDNA sample with a probe set comprising hybridization probes having sequence complementarity to at least two genomic regions selected from the group listed in TABLE 2, (d) attaching molecular barcodes to the enriched cfDNA sample; (e) amplifying the barcoded enriched cfDNA sample or derivatives thereof to produce amplification products; (f) sequencing the amplification products; (g) aligning sequence reads to a reference. (Emphases added).
While the Office has taken the position that certain elements are described in the general field of colorectal cancer detection (which Applicant does NOT concede), Applicant contends that the combination of at least elements (a)-(g) recited in the claims for isolating and treating cell-free DNA was neither conventional nor routine as of the effective filing date of the instant Application. Accordingly, the claimed invention recites additional limitations that amount to significantly more than the alleged judicial exception and therefore provides an inventive concept.
It is respectfully submitted that this is not persuasive. First, Applicant has not shown nor pointed to the Specification showing any recitations of “improvements” with specific respect to colorectal cancer and Table 2. There are no specific probes claimed nor are here any specific indications of how Table 2, for example, is anything other than a laundry list of all TSS in the human genome. There is no showing that enrichment of at least two TSS would, in fact be able to compare to some availability profile to indicate colorectal cancer. The steps by which the cfDNA is obtained, enriched (including barcoding), amplified, sequenced, and aligned are steps routinely practiced, in that very combination by those of skill in the art for analysis of cfDNA. The “data” (TSS Table 2) does not alter the steps by which the processing using routine laboratory steps are practiced.
Further to MPEP2106.05, the court in Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) included that said operation of a second freeze step was what, in combination with routine steps, provided an improvement over conventional techniques and allowed for a new and useful method of preserving hepatocyte cells. The same is not present in the instant claims, i.e., the steps are routinely practiced. Thes instant claims are more akin, in fact to the decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,1373-74 (Fed. Cir. 2015), cert. denied, No. 15-1102, 2016 WL 1117246 (June 27, 2016) wherein, the existence and location of cffDNA is a natural phenomenon; identifying its presence was merely claiming the natural phenomena itself Id. at 1376. Similarly, the claims are linked herein to those found ineligible in In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755, 761-62 (Fed. Cir.2014), wherein it was found that the claims recited methods for screening human germline for an altered BRCA1 gene by comparing the target DNA sequence with wildtype sequence…but comparing two sequences to detect alterations is a patent-ineligible “abstract mental process.” Id. At 763. Other applicable case law directed to 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 (see MPEP 2106.05(d) (II): (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)); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017)); Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546.
In BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016), the decision was directed to improvements to computer technology that included filtering of Internet content in a manner that allowed ISPs to identify individual accounts that communicate with an ISP server and associated a request for Internet content with the specific account. As such, said provided an improvement to the specific problem in computer technology. This is not the same as the argued combination of laboratory steps herein, which are not solving a problem in computer technology nor do they solve a problem in the wet laboratory steps in the biological sciences, as said operations are routinely practiced (as stated above).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 1, 5-6, 9-14, 21, 23-24, 26-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 75, 83, 86, 88-90, 99, 101-110 of copending Application No. 16/937,287 (reference application), in view of Hirotsu et al. (Scientific Reports (2020) Vol. 10:10 pages) disclosing molecular barcoding sequencing technologies and wherein said attachment provides for better detection of rare variants (abstract). As such, additional step for enrichments would have been an obvious variant of the claimed methods in the ’287 application. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 75, 90 and 86 of the reference application recite similar limitations as in claim 1. The claims differ in that claim 1 includes the additional step of processing the TSS availability profile to detect cancer and molecular barcode attachment. Thus, the instant claims encompasses the subject matter of the reference application and are not patentably distinct.
Claims 83 and 99 of the reference application recite similar limitations as claim 14 herein. The claims differ in that claim 14 includes additional mathematical algorithms. Thus, the instant claims encompasses the subject matter of the reference application and are not patentably distinct.
Claim 86 of the reference application recites where the quantifying sequence reads determine the transcriptional availability of the regulatory elements which is recited in claim 1 herein. Thus, the claims are not patentably distinct.
Instant claims 88 and 89 of the reference application recite where the subject is with or without cancer, which is recited in claim 1 of the instant application. Thus, the claims are not patentably distinct
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
1. Applicant states that Applicant states that, “without conceding in the basis of the rejections, and solely to expedite prosecution of the instant Application, Applicant has amended claim 1 to clarify the claimed subject matter. Applicant submits that amended claims 1 and dependent claim 14 are patentably distinct from claims 75, 83, 86, 88-90, and 99 of the '287 Application. Accordingly, Applicant respectfully requests withdrawal of the nonstatutory double patenting rejections”.
It is respectfully submitted that this is not persuasive, as there are no arguments presented beyond stating that the claims have been amended. The claims of the ‘287 application are directed to genomic regions that comprise a chromosomal start region coordinate and chromosomal stop region coordinate and further wherein the TSS comprise at least three genomic regions. The newly amended claims herein include “molecular barcoding” step for enrichment processing. This is step for cfDNA processing is prima facie obvious in view of the well-known application in the prior art as exemplified in the art to Hirotsu et al. Applicant has not pointed to any other specifics herein and as such, the rejection is maintained.
Conclusion
No claims are allowed.
The outstanding rejections under 35 USC 112(b) are withdrawn in view of the claim amendments that clarify that the TSS availability profile is a control by which the expression is compared to indicate presence of colorectal cancer.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/Lori A. Clow/Primary Examiner, Art Unit 1687
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