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
The instant application was filed 06/17/2023 and is a continuation in part of PCT/CN2021/137231 , filed 12/10/2021 and is a continuation in part of PCT/CN2021/086902 , filed 04/13/2021 which claims foreign priority to 202011496184.7, filed 12/17/2020 which claims foreign priority to 202210753404.2, filed 06/28/2022 and claims foreign priority to 202310565785.6, filed 05/19/2023.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/CN2021/137231, PCT/CN2021/086902 , 202011496184.7, 202210753404.2, 202310565785.6, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The filed wrapper does not provide certified translations of any of the priority documents or the PCT from which the instant application is a PCT. Thus support cannot be determined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/23/2024 is being considered by the examiner.
Specification
Thee title has a typographical error and should be amended to recite, “methylation.”
Claim Objections
Claims 13-24 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiply dependent cases. See MPEP § 608.01(n). Accordingly, the claims 13-24 not been further treated on the merits.
Claim Rejections - 35 USC § 112
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 1-12 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.
Claims 1-12 recite, “comprises a continuous fragment of at least 55% of the full length of the sequence of” or “at least one selected from the group consisting of continuous fragments each of at least 55% of the full length of one of the sequences of.” The metes and bounds are unclear what “55% of the full length” requires. It is unclear if it encompasses any nucleic acid sequence that is 55% of the length, 55% identical, or something else.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more as the claims lack any limitation which require the hand of man. The claim(s) recite(s) the SEQ ID NO which encompass naturally occurring nucleic acids. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims provide no limitation which require the hand of man.
Claim analysis
The instant claim 1 is directed towards A molecular marker for identifying DNA methylation and thereby detecting benignity or malignancy of a lung nodule, characterized in that the molecular marker for identifying DNA methylation comprises the sequence of, or the completely complementary sequence to, SEQ ID NO:6 or comprises a continuous fragment of at least 55% of the full length of the sequence of, or the completely complementary sequence to, SEQ ID NO:6..
SEQ ID NO 6 is a naturally occurring nucleic acid from the gene ZSCAN31.
Dependent claims draw the invention to naturally occurring nucleic acids from HOXB4, (SEQ ID NO 1 and 2), PTGER4 (SEQ ID NO 3 and 4) and LHX9 (SEQ ID NO 5).
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a composition.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, natural phenomena or natural composition.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the claims provide no additional limitations.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, the claims provide no limitations which require or demonstrate the hand of man has modified the nucleic acids from the way they occur in nature.
Tai (EP2966183) and Weiss (Journal of Thoracic Oncology (2016) Vol. 12 No. 1: 77-84) Homo sapiens prostaglandin E receptor 4 (subtype EP4), mRNA (cDNA clone MGC:126583 IMAGE:8069040), complete cds BC101534 submitted July 7, 2006), Lin (Lin et al. BMC Genomics 2014, 15:1079 http://www.biomedcentral.com/1471-2164/15/1079), Homo sapiens homeobox B4 (HOXB4), mRNA NM_024015 (https://www.ncbi.nlm.nih.gov/nuccore/1519245986?sat=47&satkey=4895528submitted 11/22/2018), Sakeda( Laboratory Investigation (2013) 93, 408–421), Houng Ly ( Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 3515. doi:10.1158/1538-7445.AM2017-3515) Homo sapiens partial LHX9 gene for LIM-homeobox 9, exon 2 (AJ277916, July 26, 2016, https://www.ncbi.nlm.nih.gov/nucleotide/AJ277916.1?report=genbank&log$=nuclalign&blast_rank=1&RID=GTP785E4016 demonstrate the sequences are naturally occurring.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Tai (EP2966183,).
Tai teaches method of detecting lung cancer including SEQ ID NO 2 which comprises instant SEQ ID NO 6 (nucleotides 1695-1884). Thus it anticipates the claims.
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai (EP2966183) and Weiss (Journal of Thoracic Oncology (2016) Vol. 12 No. 1: 77-84) Homo sapiens prostaglandin E receptor 4 (subtype EP4), mRNA (cDNA clone MGC:126583 IMAGE:8069040), complete cds BC101534 submitted July 7, 2006), Lin (Lin et al. BMC Genomics 2014, 15:1079 http://www.biomedcentral.com/1471-2164/15/1079), Homo sapiens homeobox B4 (HOXB4), mRNA NM_024015 (https://www.ncbi.nlm.nih.gov/nuccore/1519245986?sat=47&satkey=4895528submitted 11/22/2018), Sakeda( Laboratory Investigation (2013) 93, 408–421), Houng Ly ( Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 3515. doi:10.1158/1538-7445.AM2017-3515) Homo sapiens partial LHX9 gene for LIM-homeobox 9, exon 2 (AJ277916, July 26, 2016, https://www.ncbi.nlm.nih.gov/nucleotide/AJ277916.1?report=genbank&log$=nuclalign&blast_rank=1&RID=GTP785E4016
Tai teaches method of detecting lung cancer including SEQ ID NO 2 which comprises instant SEQ ID NO 6 (nucleotides 1695-1884).
Tai does not teach SEQ ID NO 4 (PtGER4), HOXB4 (SEQ ID NO 2), LHX9 (SEQ ID NO 5)
However, Weiss teaches examination of PTGER 4 methylation with lung cancer (title). Homo sapiens prostaglandin E receptor 4 (subtype EP4), mRNA (cDNA clone MGC:126583 IMAGE:8069040), complete cds BC101534 submitted July 7, 2006) nucleotides 764-906 comprise SEQ ID NO 4 and nucleotides 538-711 comprise SEQ ID NO 3)
Lin teaches a study of DNA methylation in non-small cell lung cancer. Lin teaches, “Genes related to the epithelial-to-mesenchymal transition, such as AXL, ESRP1, HoxB4, and SPINT1/2, were among the nearly 20% of the candidate genes that were differentially methylated between epithelial and mesenchymal cells. “ (abs)
Homo sapiens homeobox B4 (HOXB4), mRNA NM_024015 encompasses SEQ ID NO 2, nucleotides 254-74) and SEQ ID NO 1 (nucleotides 406-262).
Houng Ly teaches, “Oncogenic mutations of RAS are detected in approximately 30% of human cancers. KRAS is highly mutated in pancreatic, colorectal and lung cancers.” Houng Ly teaches, “We showed that LHX9 rescued KRAS suppression in multiple cell lines as well as xenograft. LHX9 overexpression substituted for KRAS in KRAS-driven xenograft. Moreover, in activated-MEK-overexpressing HA1E cells, LHX9 formed tumors as robustly as myristoylated AKT. LHX9 rescued KRAS suppression by both restoring KRAS-dependent pathways and activating KRAS-independent pathways.”
Sakeda teaches, “LHX9 were not expressed in the lung cancer cell lines examined.” (page 414, 2nd column, bottom 3rd full paragraph).
Homo sapiens partial LHX9 gene for LIM-homeobox 9, exon 2 comprises SEQ ID NO 5, nucleotides 116-236)
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to combine nucleotide sequences to known genes implicated in lung cancer including HOXB4, PTGER4, LHX( and ZSCAN31. The artisan would be motivated to provide probes to isolate and further examine expression and methylation of the genes. The artisan would have a reasonable expectation of success as all the genes were known and implicated in lung cancer.
Summary
No claims are allowed.
Conclusion
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/Steven Pohnert/Primary Examiner, Art Unit 1683