DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on March 3, 2026 has been entered. The claims pending in this application are claims 1-5, 8-19, and 24. The rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on March 3, 2026. Claims 1-5, 8-19, and 24 will be examined.
Specification
The disclosure is objected to because of the following informality: since case 16/815,963 has been patented, applicant is required to update this information in paragraph [0001] of the specification.
Appropriate correction is required.
Double Patenting
Note that the nonstatutory double patenting rejections below have been organized in view of the non-final office action made by the previous examiner.
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.
Claims 1-5 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,626, 449 B2.
Claims 1-13 of U.S. Patent No. 10,626, 449 B2 do not disclose a method recited in claim 1-5 and 8-13 of this instant application. However, the system taught by claims 1-13 of U.S. Patent No. 10,626, 449 B2 has an ability to perform the methods recited in claims 1-5 and 8-13, claims 2-5 and 8-13 in this instant application are identical to claims 2-5 and 8-13 of U.S. Patent No. 10,626,449 B2, and claim 7 of U.S. Patent No. 10,626,449 B2 includes the limitation “there is at least one single nucleotide polymorphism locus located on average every 500kb within each chromosome” in claim 1 of this instant application.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have performed the methods recited in claim 1-5 and 8-13 of this instant application using the system taught by claims 1-13 of U.S. Patent No. 10,626, 449 B2. One having ordinary skill in the art would have been motivated to do so because claims 2-5 and 8-13 in this instant application are identical to claims 2-5 and 8-13 of U.S. Patent No. 10,626,449 B2, claim 7 of U.S. Patent No. 10,626,449 B2 includes the limitation “there is at least one single nucleotide polymorphism locus located on average every 500kb within each chromosome” in claim 1 of this instant application, and the system in claim 1 of U.S. Patent No. 10,626,449 B2 has an ability to (1) extract DNA from a formalin-fixed paraffin-embedded sample comprising at least one tumor cell obtained from a patient to produce at least one solution comprising genomic DNA of the at least one tumor cell, (2) enrich the at least one solution in step (1) for test DNA molecules each comprising at least one locus from the plurality of single nucleotide polymorphism loci, wherein the plurality of single nucleotide polymorphism loci comprises at least 1,000 single nucleotide polymorphism loci, and (3) quantitatively sequence the test DNA molecules to detect the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci as recited in claim 1 of this instant application.
One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to perform the methods recited in claim 1-5 and 8-13 of this instant application using the system taught by claims 1-13 of U.S. Patent No. 10,626, 449 B2.
Claims 1-5 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,279,156 B2.
Since the phrase “at least 5000 single nucleotide polymorphism loci” in claim 1 of U.S. Patent No. 9,279,156 B2 and the limitations “at least 1000 single nucleotide polymorphism loci”,
and “at least 2,500 single nucleotide polymorphism loci” in claims 1 and 2 of this instant case do not have a top limitation, claim 1 of U.S. Patent No. 9,279,156 B2 includes the limitations “at least 1000 single nucleotide polymorphism loci” and “at least 2,500 single nucleotide polymorphism loci” and “at least 5,000 single nucleotide polymorphism loci” in claims 1 and 2 of this instant case, claims 1-18 of U.S. Patent No. 9,279,156 B2 teach all limitations recited in claims 1-5 and 8-13 of this instant case except detecting the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci as recited in claim 1 of this instant case. However, claim 1 of U.S. Patent No. 9,279,156 B2 teaches sequencing the test DNA molecules to determine whether each locus in the plurality of single nucleotide polymorphism loci is homozygous.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have performed the method recited in claim 1 of this instant application by detecting the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci based on determining that each locus in the plurality of single nucleotide polymorphism loci is homozygous or heterozygous and analyzing the plurality of quantitative signals of the plurality of single nucleotide polymorphism loci using the system of claim 10 of U.S. Patent No. 9,279,156 B2 in view of claims 1-18 of U.S. Patent No. 9,279,156 B2. One having ordinary skill in the art would have been motivated to do so because it is known that “[I]n genetics, the definition of homozygous is when you inherit the same DNA sequence for a specific gene from each of your biological parents. If you inherit an identical version (allele) of a gene from both of your parents, you’re homozygous for that gene” and “[H]omozygous means you’ve inherited the same alleles of a gene from each of your parents. In contrast, heterozygous means you’ve inherited different alleles of a gene from each of your parents” (see the definition for “homozygous”). One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to detect the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci by determining that each locus in the plurality of single nucleotide polymorphism loci is homozygous or heterozygous and analyzing the plurality of quantitative signals of the plurality of single nucleotide polymorphism loci using the system of claim 10 in view of claims 1-18 of U.S. Patent No. 9,279,156 B2.
Claims 1-5, 8-19, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 9,574,229 B2.
Claims 1-41 of U.S. Patent No. 9,574,229 B2 teach all limitations of claims 1-5, 8-19, and 24 of this instant case except quantitatively sequencing the test DNA molecules to detect the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci as recited in claim 1 of this instant case and quantitatively sequencing the test DNA molecules to detect the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci as recited in claim 14 of this instant case. However, claims 1 and 22 of U.S. Patent No. 9,574,229 B2 disclose determining the lengths of a plurality of regions of allelic imbalance in the genome of the at least one tumor cell by detecting a plurality of stretches of single nucleotide polymorphism loci in which allelic imbalance is detected in step (3) and performing at least one sequencing reaction on the test DNA molecules to detect the genotype of each locus in the plurality of single nucleotide polymorphism loci to determine whether each locus in the plurality of single nucleotide polymorphism loci has allelic imbalance respectively.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have performed the method of claim 1 of this instant case by quantitatively sequencing the test DNA molecules to detect the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci and have performed the method of 14 of this instant case by quantitatively sequencing the test DNA molecules to detect the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci in view of claims 1-41 of U.S. Patent No. 9,574,229 B2. One having ordinary skill in the art would have been motivated to do so because the content of U.S. Patent No. 9,574,229 B2 teaches that “[A]s used herein, ‘allelic imbalance’ means any instance where the somatic copy number differs from the germline copy number at a genomic locus or region” (see column 2, last paragraph). One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to perform the methods of claims 1 and 14 in this instant case by detecting the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci based on determining allelic imbalance of each locus in the plurality of single polymorphism loci in view of claims 1-41 of U.S. Patent No. 9,574,229 B2.
Claims 1-5 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,225,685 B2.
Since the phrase “at least 2,500 single nucleotide polymorphism loci” in claim 2 has no top limitation, and the phrase “less than 50%” in claim 11, the phrase “less than 25%” in claim 12, and the phrase “less than 10%” in claim 13 have no bottom limit, claims 3 and 17 of U.S. Patent No. 11,225,685 B2 incudes the limitations recited in claims 2 and 11-13 of this instant application respectively and claims 1-20 of U.S. Patent No. 11,225,685 B2 teach all limitations recited in claims 1-5 and 8-13 of this instant case except detecting the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci as recited in claim 1 of this instant case. However, claims 1 and 20 of U.S. Patent No.11,225,685 B2 teaches sequencing the DNA molecules to determine the genotype at each such SNP locus; determining for each homozygous SNP locus whether it is homozygous due to LOH (loss of heterozygosity) and there is at least one single nucleotide polymorphism locus located on average every 500 kb within each chromosome.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have performed the method recited in claim 1 of this instant application by detecting the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci based on determining that each locus in the plurality of single nucleotide polymorphism loci is homozygous or LOH and analyzing the plurality of quantitative signals of the plurality of single nucleotide polymorphism loci using the system of claim 11 of U.S. Patent No. 11,225,685 B2 in view of claims 1-20 of U.S. Patent No.11,225,685 B2. One having ordinary skill in the art would have been motivated to do so because it is known that “[I]n genetics, the definition of homozygous is when you inherit the same DNA sequence for a specific gene from each of your biological parents. If you inherit an identical version (allele) of a gene from both of your parents, you’re homozygous for that gene” and “[H]omozygous means you’ve inherited the same alleles of a gene from each of your parents. In contrast, heterozygous means you’ve inherited different alleles of a gene from each of your parents” (see the definition for “homozygous”), and the content of U.S. Patent No. 11,225,685 B2 teaches that “[A]s used herein, ‘allelic imbalance’ means any instance where the somatic copy number differs from the germline copy number at a genomic locus or region” (see column 2, last paragraph) and “[O]ne example of allelic imbalance is loss of heterozygosity (“LOH”), in which a locus is heterozygous in the germline but homozygous in somatic tissue. In this sense, homozygosity can include homozygous loss (i.e., deletion) of the locus in somatic tissue (see column 3, third paragraph).
One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to detect the copy number of each allele at each such locus in the plurality of single nucleotide polymorphism loci by determining that each locus in the plurality of single nucleotide polymorphism loci is homozygous or LOH and analyzing the plurality of quantitative signals of the plurality of single nucleotide polymorphism loci using the system of claim 11 in view of claims 1-20 of U.S. Patent No. 11,225,685 B2.
Response to Arguments
In page 13, last paragraph bridging to page 16, first paragraph of applicant’s remarks, applicant argues that “the Office Action fails to provide any analysis of any of the reference claims. Instead, the Office Action merely notes-at an extremely high level of generality-that ‘[a]lthough the claims at issue are not identical, they are not patentably distinct from each other.’ See Office Action at p. 6. Thus, the Examiner has established neither anticipation nor obviousness over any claim of the primary references, nor addressed the equitable principles underlying these double patenting rejections. It is NOT the applicant's burden to establish that every new application is patentably distinct from every preceding application naming a common inventor or applicant. Rather, it is the examiner’s burden to analyze all of the claims and make appropriate findings of fact to support an assertion of double patenting. In the absence of such analysis presented in the Office Action, a prima facie case of double patenting cannot stand”.
The above arguments have been fully considered but they are not persuasive toward the withdrawal of the rejections because above nonstatutory double patenting rejections have clearly explained why claims 1-5 and 8-13 should be rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,279,156 B2 or claims 1-13 of U.S. Patent No.10,626, 449 B2 or claims 1-20 of U.S. Patent No.11,225,685 B2 and why claims 1-5, 8-19, and 24 should be rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 9,574,229 B2 (for detail, see above nonstatutory double patenting rejections).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
No claim is allowed.
Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center. The faxing of such papers must conform with 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 CAR § 1.6(d)). The CM Fax Center number is (571)273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph.D., whose telephone number is (571)272-0746. The examiner can normally be reached on Monday-Friday from 9 A.M. to 5 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Dr. Anne Gussow, Ph.D., can be reached on (571)272-6047.
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/FRANK W LU/Primary Examiner, Art Unit 1683
October 2, 2026
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