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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I (claims drawn to nucleic acid s and kits comprising the same) in the reply filed on 03/25/2026 is acknowledged.
Applicant’s election, with traverse, of the particular species that are the sequences of SEQ ID NO: 7, 8, and 127 (related to ADHFE1), and SEQ ID NO: 53, 54 and 139 (related to PPP2R5C) and SEQ ID NO: 89, 90, and 101 (related to SDC2) in the reply filed on 03/25/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
Acknowledgment is made of applicant's claim for priority based on application PCT/CN2021/089368 (filed 04/23/2021). It is noted, however, that applicant has not filed a certified copy of the PCT/CN2021/089368.
Additionally, application PCT/CN2021/089368 is filed in a language other than English. An English translation of the non-English language application and a statement that the translation is accurate must be filed. See 37 CFR 1.78. See also MPEP 1895.01.
Applicant cannot rely upon the claim to priority to the PCT/CN2021/089368 application to overcome a prior art rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the priority application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim Objections
Claim 5 is objected to because of the following informalities. The claim recites the phrase “…further comprising at least one selected from…”, where the phrase “…further comprising at least one reagent selected from…” is likely intended.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 and 4-7 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 and 4-7 are unclear over the recitation of “reagents for detecting methylation status of” the various genes, as recited in the preamble of claim 1, in combination with the recitation of the elements as a “reagent for detecting the …gene”. The different between a requirement for detecting “methylation status” and the broader “detecting the ….gene” makes it unclear if the recited reagents are intended to be reagents that in fact detect methylation status.
Claims 1 and 4-7 are unclear over recitation of the singular term “reagent” followed by the recitation of a plurality sequence elements, as recited in claim 1 (from which claims 4-7 depend), and as recited in claim 4. For example, in the limitation “the reagent for detecting the ADHFE1 gene comprises sequences as set forth in SEQ ID NO: 7, SEQ ID NO: 8, and SEQ ID NO: 127”. It is unclear if the reagent (i.e.: a singular reagent) for detecting ADHFE1 is intended to be a single entity (e.g.: one nucleic acid molecule) which comprises all of the recited sequence elements.
The claims may be made more clear in this regard if amended to recite (for example with regard to the ADHFE1-related elements as recited in claim 1):
[[the]] reagents for detecting the methylation status of the ADHFE1 gene comprise[[s sequences as set forth in]] primers that are SEQ ID NO: 7[[,]] and SEQ ID NO: 8, and a probe that is SEQ ID NO: 127
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.
Claim(s) 1 and 4-7 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Li et al ed by Li et al (2023).
Li et al teaches a collection of reagents, which is a kit (relevant to claim 6 and 7), for the analysis of gene methylation associated with colon cancer. Relevant to the rejected claims, Li et al teaches reagents that include primers and probes for the amplification and detection of each of ADHFE1, PPP2R5C and SDC2 (as recite sin claim 1) as well as GAPDH (as recited in claim 4). The reference teaches primers and probes (e.g.: Table 1) that are the same sequences as SEQ ID NO: 7, 8, 127, 53, 54, 139, 89, 90, 101, 1, 2, and 99 as recited in the claims.
Further relevant to the rejection of claims, Li et al teaches reagents including target nucleic acids (relevant to claim 5) and a DNA methylation conversion reagent (relevant to claim 7) (e.g.: p.10243 - DNA isolation, bisulphite treatment and fluorescence-based quantitative methylation-specific polymerase chain reaction (qMSP))
Claim(s) 1 and 4-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al (2012).
Fang et al teaches a collection of reagents, which is a kit (relevant to claim 6 and 7), related to the analysis of DNA methylation in colorectal cancer tissue samples (e.g.: p.1918 - Participants and tissue samples). Fang et al teaches that genomic DNA from colon cancer samples was isolated and treated with bisulphite conversion (relevant to claim 7) (e.g.: p.1918 - DNA isolation and bisulphite conversion), and subjected to whole-genome amplification (relevant to claim 5) (e.g.: p.1918 - Processing of HumanMethylation27 BeadChips).
Relevant to the sequence limitations recited in the claims, the reagents are recited without any length limitations, and thus are directed to only nucleic acids which contain/comprise the recited sequence; the reagents (i.e.: primers and probes) of the claims are not claimed as, for example: the reagents for detecting the methylation status of the ADHFE1 gene comprise a primer consisting of SEQ ID NO: 7, a primer consisting of SEQ ID NO: 8, and a probe consisting of SEQ ID NO: 127.
In the instant case, the whole genome amplification of bisulphite treated genomic DNA from human colon cancer tissue samples would necessarily contain nucleic acids with the required sequences as recited in the claims.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Infinium® HD Assay Methylation Protocol Guide (2015), relevant to the methods of Fang et al, teaches particular methodological steps related to the bisuflite treatment and whole genome amplification of genomic DNA..
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
Prosecution Insights