DETAILED ACTION
Preliminary Amendment
The preliminary amendment filed on June 17, 2025 has been entered. The claims pending in this application are claims 21-40. Claims 21-40 will be examined.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. For example, see page 19. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because of the following informality: since cases 17/519,350, 17/353,756, and 16/098,620 have been patented, applicant is required to update these information in the first paragraph of the specification
Appropriate correction is required.
Claim Objections
Claim 26 or 31 is objected to because of the following informality: “said processing” should be “said processing one or more nucleic acid molecules derived from said nucleic acid sample”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
A newly added independent claim 21 contains a limitation “wherein said one or more cell-free nucleic acid molecules comprise one or more methylated nucleic acid molecules, under conditions sufficient to enrich said one or more methylated nucleic acid molecules at a specificity of at least 60%”, a newly added dependent claim 22 contains a limitation “said one or more methylated nucleic acid molecules are enriched at a specificity of at least 90%”, a newly added dependent claim 23 contains a limitation “said one or more methylated nucleic acid molecules are enriched at a specificity of at least 60% to 99%”, and a newly added dependent claim 25 contains a limitation “said one or more nucleic acid molecules derived from said nucleic acid sample of said subject are present at an amount of less than or equal to 10 nanograms (ng)”, However, pages 9-11, page 20, lines 4-12, and FIG. 3B of the specification suggested by applicant do not describes above limitations recited in claims 21-23 and 25 because nowhere in the specification describes that said one or more methylated nucleic acid molecules are enriched to a specificity of 60% or 90% or 99% and one or more nucleic acid molecules comprising one or more cell-free nucleic acid molecules derived from said nucleic acid sample of said subject are present at an amount of less than or equal to 10 nanograms (ng).
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 or 28 or 29 recites the limitation “said plurality of filler nucleic acid molecules” in the claim. There is insufficient antecedent basis for this limitation in the claim because there is no phrase “a plurality of filler nucleic acid molecules” in claims 21 and 25 and claim 27 or 28 or 29 appears to be dependent on clam 26. Please clarify.
Claim 30 recites the limitation “said mixture” in the claim. There is insufficient antecedent basis for this limitation in the claim because there is no phrase “a mixture” in claims 21 and 25 and claim 30 appears to be dependent on clam 26. Please clarify.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-25 and 31-33 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Wielscher et al., (BMC Clinical Pathology, 11, 11, 2011).
Regarding claims 21-25 and 31-33, Wielscher et al., teach a method for processing a nucleic acid sample of a subject, comprising: processing one or more nucleic acid molecules derived from said nucleic acid sample (ie., cell-free DNAs in blood plasma or serum), wherein said one or more nucleic acid molecules comprise one or more cell-free nucleic acid molecules and wherein said one or more cell-free nucleic acid molecules comprise one or more methylated nucleic acid molecules, under conditions sufficient to enrich said one or more methylated nucleic acid molecules at a specificity of at least 60% (ie., methylated nucleic acid molecules in blood serum have an ability to be enriched to a specificity of at least 60% using methyl CpG binding domain of MeCp2 protein) as recited in claim 21 wherein said one or more methylated nucleic acid molecules are enriched at a specificity of at least 90% (ie., methylated nucleic acid molecules in blood serum have an ability to be enriched to a specificity of at least 90% using methyl CpG binding domain of MeCp2 protein) as recited in claim 22, said one or more methylated nucleic acid molecules are enriched at a specificity of at least 60% to 99% (ie., methylated nucleic acid molecules in blood serum have an ability to be enriched to a specificity of at least 60% to 99% using methyl CpG binding domain of MeCp2 protein) as recited in claim 23, said nucleic acid sample is a cell-free DNA (cfDNA) sample (ie., cell-free DNAs in blood plasma or serum) as recited in claim 24, said one or more nucleic acid molecules derived from said nucleic acid sample of said subject are present at an amount of less than or equal to 10 nanograms (ng) (eg., 12.2±7.9 ng/ml=4.3 or 20.1 ng/ml) as recited in claim 25, said processing comprises capturing said one or more methylated nucleic acid molecules using one or more binders (ie., methyl CpG binding domain of MeCp2 protein) as recited in claim 29, said one or more binders exhibit a reduced level of a non-specific binding to non-methylated nucleic acid molecules of said one or more cell-free nucleic acid molecules (ie., methyl CpG binding domain of MeCp2 protein only binds to methylated DNA) as recited in claim 32, and said one or more binders comprise one or more proteins comprising a methyl-CpG-binding domain as recited in claim 33 (see pages 2-5).
Therefore, Wielscher et al., teach all limitations recited in claims 21-25 and 31-33.
Claims 21-24 and 34-40 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Lo et al., (US 2014/0080715 A1, published on March 20, 2014).
Regarding claims 21-24 and 34-40, Lo et al., teach a method for processing a nucleic acid sample of a subject, comprising: processing one or more nucleic acid molecules derived from said nucleic acid sample (ie., cell-free DNAs in blood plasma), wherein said one or more nucleic acid molecules comprise one or more cell-free nucleic acid molecules and wherein said one or more cell-free nucleic acid molecules comprise one or more methylated nucleic acid molecules, under conditions sufficient to enrich said one or more methylated nucleic acid molecules at a specificity of at least 60% (ie., methylated nucleic acid molecules in blood serum have an ability to be enriched to a specificity of at least 60% using antibodies against methylated cytosine) as recited in claim 21 wherein said one or more methylated nucleic acid molecules are enriched at a specificity of at least 90% (ie., methylated nucleic acid molecules in blood serum have an ability to be enriched to a specificity of at least 90% using antibodies against methylated cytosine) as recited in claim 22, said one or more methylated nucleic acid molecules are enriched at a specificity of at least 60% to 99% (ie., methylated nucleic acid molecules in blood serum have an ability to be enriched to a specificity of at least 60% to 99% using antibodies against methylated cytosine) as recited in claim 23, said nucleic acid sample is a cell-free DNA (cfDNA) sample (ie., cell-free DNAs in blood plasma) as recited in claim 24, said processing comprises immunoprecipitating said one or more methylated nucleic acid molecules using one or more antibodies (ie., antibodies against methylated cytosine) as recited in claim 33, said one or more antibodies comprise a 5-MeC antibody or a 5-hydroxymethyl cytosine antibody as recited in claim 35, sequencing said one or more methylated nucleic acid molecules, thereby generating a methylation profile of said subject as recited in claim 36, processing one or more additional nucleic acid molecules derived from another nucleic acid sample from a healthy subject (ie., the plasma from a health control) as recited in claim 37, said processing of said one or more additional nucleic acid molecules comprises enriching for one or more methylated nucleic acid molecules of said another nucleic acid sample as recited in claim 38, sequencing said one or more methylated nucleic acid molecules of said another nucleic acid sample, thereby generating a methylation profile of said healthy subject as recited in claim 39, and comparing said methylation profile of said subject to said methylation profile of said healthy subject as recited in claim 40 (see paragraphs [0002], [0055], [0139], and [0301]).
Therefore, Lo et al., teach all limitations recited in claims 21-24 and 34-40.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 26, 27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Wielscher et al., as applied to claims 21-25 and 31-33 above, and further in view of Weindel et al., (US 2003/0224366 A1, published on December 4, 2003) and Roberts et al., (US 2008/0102452 A1, published on May 1, 2008).
The teachings of Wielscher et al., have been summarized previously, supra.
Wielscher et al., do not disclose that said processing comprises combining said one or
more nucleic acid molecules derived from said nucleic acid sample with a plurality of filler nucleic acid molecules to generate a mixture as recited in claim 26 wherein said plurality of filler nucleic acid molecules comprises at least about 5% methylated filler nucleic acid molecules as recited in claim 27, an amount of said plurality of filler nucleic acid molecules is from 30 ng to 100 ng as recited in claim 29, and said mixture comprises at least 100 ng of total nucleic acid molecules as recited in claim 30.
Weindel et al., teach that human background DNA (hBG-DNA) is spiked at 0 to 4000 ng/ml to a plasma sample (see paragraph [0429]).
Roberts et al., teach that methylated spike-in control nucleic acids added to a sample of target nucleic acids for the process of isolation and analysis of methylated DNA provide increased confidence in the isolation and detection procedure (see paragraph [0014] and [0144] to [0146]).
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 claims 26, 27, 29, and 30 by combining said one or more nucleic acid molecules derived from said nucleic acid sample taught by Wielscher et al., with a plurality of filler nucleic acid molecules to generate a mixture wherein said plurality of filler nucleic acid molecules comprises at least about 5% methylated filler nucleic acid molecules, an amount of said plurality of filler nucleic acid molecules is from 30 ng to 100 ng and said mixture comprises at least 100 ng of total nucleic acid molecules in view of the prior arts of Wielscher et al., Weindel et al., and Roberts et al.. One having ordinary skill in the art would have been motivated to do so because Weindel et al., teach that human background DNA (hBG-DNA) is spiked at 0 to 4000 ng/ml to a plasma sample (see paragraph [0429]) while Roberts et al., teach that methylated spike-in control nucleic acids added to a sample of target nucleic acids for the process of isolation and analysis of methylated DNA provide increased confidence in the isolation and detection procedure (see paragraph [0014] and [0144] to [0146]). 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 claims 26, 27, 29, and 30 by combining said one or more nucleic acid molecules derived from said nucleic acid sample taught by Wielscher et al., with a plurality of methylated filler nucleic acid molecules to generate a 1 ml mixture such that, in said mixture, said plurality of filler nucleic acid molecules comprises at least about 5% methylated filler nucleic acid molecules and an amount of said plurality of methylated filler nucleic acid molecules is from 30 ng to 100 ng, and said mixture comprises at least 100 ng of total nucleic acid molecules in view of the prior arts of Wielscher et al., Weindel et al., and Roberts et al., in order to increase confidence in the isolation and detection procedure when one having ordinary skill in the art isolates and detects
the methylated nucleic acids using the method recited in claim 21.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al., as applied to claims 21-24 and 34-40 above, and further in view of Roberts et al..
The teachings of Lo et al., have been summarized previously, supra.
Lo et al., do not disclose that said processing comprises combining said one or more nucleic acid molecules derived from said nucleic acid sample with a plurality of filler nucleic acid molecules to generate a mixture as recited in claim 26 wherein said plurality of filler nucleic acid molecules comprises at least about 5% methylated filler nucleic acid molecules as recited in claim 27 and said plurality of filler nucleic acid molecules comprises a length of about 50 base pairs to about 800 base pairs as recited in claim 28. However, Lo et al., teach that plasma DNA molecules are known to exist in circulation in the form of short molecules, with the majority of molecules about 160 bp in length (see paragraph [02228]).
Roberts et al., teach that methylated spike-in control nucleic acids added to a sample of target nucleic acids for the process of isolation and analysis of methylated DNA provide increased confidence in the isolation and detection procedure and the length of a spiking reagent is in the range of about 10% to about 200% of the length of the nucleic acids in the sample being analyzed (see paragraph [0014], [0136], and [0144] to [0146]).
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 claims 26-28 by combining said one or more nucleic acid molecules derived from said nucleic acid sample taught by Lo et al., with a plurality of filler nucleic acid molecules to generate a mixture wherein said plurality of filler nucleic acid molecules comprises at least about 5% methylated filler nucleic acid molecules and said plurality of filler nucleic acid molecules comprises a length of about 50 base pairs to about 800 base pairs in view of the prior arts of Lo et al., and Roberts et al.. One having ordinary skill in the art would have been motivated to do so because Lo et al., teach that plasma DNA molecules are known to exist in circulation in the form of short molecules, with the majority of molecules about 160 bp in length (see paragraph [02228]) while Roberts et al., teach that methylated spike-in control nucleic acids added to a sample of target nucleic acids for the process of isolation and analysis of methylated DNA provide increased confidence in the isolation and detection procedure and the length of a spiking reagent is in the range of about 10% to about 200% of the length of the nucleic acids in the sample being analyzed (see paragraph [0014], [0136], and [0144] to [0146]). 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 claims 26-28 by combining said one or more nucleic acid molecules derived from said nucleic acid sample taught by Lo et al., with a plurality of methylated filler nucleic acid molecules with defined lengths (ie., about 200% of the length of the nucleic acids in the sample equals to 320 bp) to generate a mixture such that, in said mixture, said plurality of filler nucleic acid molecules comprises at least about 5% methylated filler nucleic acid molecules and said plurality of filler nucleic acid molecules comprises a length of about 50 base pairs to about 800 base pairs in view of the prior arts of Lo et al., and Roberts et al., in order to increase confidence in the isolation and detection procedure of the methylated nucleic acids when one having ordinary skill in the art isolates and detects the methylated nucleic acids using the method recited in claim 21.
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.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No.11,078,475 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over, the reference claims. See 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); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Although claims 21-40 in this instant application are not identical to claims 1-22 of U.S. Patent No.11,078,475 B2, since the content of U.S. Patent No.11,078,475 B2 teaches comparing cfDNA sequences in the nucleic acid sample with cfDNA sequences of a normal cfDNA and the methylation profile of cfDNA sequences in the nucleic acid sample with the methylation profile of cfDNA sequences of the normal cfDNA (eg., see columns 6 and 17) and the phrase “less than 100 ng” in claim 1 of U.S. Patent No.11,078,475 B2 has no bottom limit, claims 1-22 of U.S. Patent No.11,078,475 B2 are directed to the same subject matter and fall entirely within the scope of claims 21-40 in this instant application. In other words, claims in this instant application are anticipated by claims 1-22 of U.S. Patent No.11,078,475 B2.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No.11,560,558 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over, the reference claims. See 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); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Although claims 21-40 in this instant application are not identical to claims 1-24 of U.S. Patent No.11,560,558 B2, since the content of U.S. Patent No.11,560,558 B2 teaches comparing cfDNA sequences in the nucleic acid sample with cfDNA sequences of a normal cfDNA and the methylation profile of cfDNA sequences in the nucleic acid sample with the methylation profile of cfDNA sequences of the normal cfDNA (eg., see columns 6 and 17) and the phrase “at least about 50 nanograms (ng)” in claim 10 of U.S. Patent No.11,078,475 B2 has no top limit and can be 100 ng, claims 1-24 of U.S. Patent No. 11,560,558 B2 are directed to the same subject matter and fall entirely within the scope of claims 21-40 in this instant application. In other words, claims in this instant application are anticipated by claims 1-24 of U.S. Patent No.11,560,558 B2.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No12,031,184 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over, the reference claims. See 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); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Although claims 21-40 in this instant application are not identical to claims 1-22 of U.S. Patent No.12,031,184 B2, since the content of U.S. Patent No.12,031,184 B2 teaches sequencing the captured cell-free methylated DNA, comparing the sequences of the captured cell-free methylated DNA to control cell-free methylated DNAs sequences from healthy and cancerous individuals and from individuals with distinct cancer types and subtypes, and identifying the presence of DNA from cancer cells if there is a statistically significant similarity between one or more sequences of the captured cell-free methylated DNA and cell-free methylated DNAs sequences from cancerous individuals,
“the filler DNA is 50 bp to 800 bp long, preferably 100 bp to 600 bp long, and more preferably 200 bp to 600 bp long” and that a binder selective for methylated polynucleotides is a protein comprising a Methyl-CpG-binding domain or 5-MeC antibody for immunoprecipitating the cell-free methylated DNA (see abstract and columns 1, 7 and 8), claims 1-22 of U.S. Patent No. 12,031,184 B2 are directed to the same subject matter and fall entirely within the scope of claims 21-40 in this instant application. In other words, claims in this instant application are anticipated by 1-22 of U.S. Patent No.12,031,184 B2.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No.12,227,737 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over, the reference claims. See 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); and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). Although claims 21-40 in this instant application are not identical to claims 1-27 of U.S. Patent No.12,227,737 B2, since the content of U.S. Patent No.12,227,737 B2 teaches sequencing the captured cell-free methylated DNA, comparing the sequences of the captured cell-free methylated DNA to control cell-free methylated DNAs sequences from healthy and cancerous individuals and from individuals with distinct cancer types and subtypes, and identifying the presence of DNA from cancer cells if there is a statistically significant similarity between one or more sequences of the captured cell-free methylated DNA and cell-free methylated DNAs sequences from cancerous individuals and that a binder selective for methylated polynucleotides is a protein comprising a Methyl-CpG-binding domain or 5-MeC antibody for immunoprecipitating the cell-free methylated DNA (see columns 2, 7 and 8), claims 1-27 of U.S. Patent No.12,227,737 B2 are directed to the same subject matter and fall entirely within the scope of claims 21-40 in this instant application. In other words, claims in this instant application are anticipated by 1-27 of U.S. Patent No. 12,227,737 B2,
Conclusion
Note that: (1) since claims 21-40 in this instant case is very broad, based on applicant’s amendment in response to this office action, US Patent No. 12,592,321 may be used to nonstatutory double patenting reject claims 21-40; and (2) case 17/353,756 has been allowed recently and has not have a Patent Number yet. Claims 21-40 of this instant case can be used to double patenting reject claims 21-40.
No claim is allowed.
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 Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/Primary Examiner, Art Unit 1683 May 15, 2026
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