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 .
Election/Restrictions
Applicant’s election without traverse of Group II, further electing chr2:105459135-105459190 and 5mC modification in the reply filed on 4/6/26 is acknowledged.
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 5-8 and 12-13 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 5 sets forth the preamble of a method, but does not provide any active process steps to define the method. Therefore, it is not clear how any of the tumor screening or prognosis occurs. Further, is unclear what “a method for…diagnostic reagents and drug targets” means or would be.
Claim 5 is further indefinite when it recites “a tumor marker..located on chromosome 1, …and chromosome 21 of the human genome” because it is not clear how “a” marker can be located on all nine recited chromosomes.
Furthermore, in claim 5 the language “comprises one or more CpG sites can be subject to methylation modification” is unclear because it is not clear what is required to comprise one or more CpG sites, and it is not clear what it further means that the sites “can be subject” to methylation modification. There is no clear required method step and so the metes and bounds of the claim is unclear.
In claim 6, “the tumor markers” lacks proper antecedent basis since claim 5 only refers to “a tumor marker.” It is not clear what is “the tumor markers.”
Claims 7 and 8 are both unclear because there is no conjunction joining all of the tumor types, and it is not clear if this is an open or closed group of alternatives. Furthermore, the meaning of the abbreviations is unclear- for example COADREAD is appears in the specification following colon adenocarcinoma, but in the prior art, COAD is used to refer to colon adenocarcinoma, but READ to rectum adenocarcinoma (see Table 1, Vrba USPGPUB). The intended claim terms should be clearly set forth in the claims, rather than using abbreviations that are no universally defined and understood.
Claim 12 is indefinite because “the sequence regions of the tumor markers” lacks antecedent basis, as does “the entire region”. Claim 5 does not recite or imply regions. Furthermore, since claim 5 recites “a tumor marker” it is not clear what is meant when the claim refers to “the tumor markers” according to claim 5. It is not clear what the methylation value must be determined for, since there is no connection in the claim between the obtaining step and any marker or chromosome.
Claim 13 is indefinite because it is not clear if the method is meant to require all four of those techniques or only one of them. Although the plain claim language says “and” the listing appears more as alternatives rather than techniques that are all used together on a single sample.
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 5, 7 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the method claim does not include any positive, active process steps.
Claims 5-8, 12 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and an abstract idea without significantly more. The claim(s) recite(s) the relationship between “tumor” screening, prognosis, diatnostic reagents and drug targets and a methylation marker. This is a law of nature judicial exception since the relationship between methylation and “tumor” exists outside of the hand of man. Furthermore, prognosis, screening and diagnosis all employ mental process abstract ideas. Claims 12 and 13 additionally recite calculating methylation status which is a mathematical process.
This judicial exception is not integrated into a practical application because the claims to not use or apply the judicial exceptions in any way. The only steps in addition to the judicial exceptions are data gathering steps which are considered extrasolution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only steps in addition to the judicial exception were routine data gathering steps at the time of the invention, see for example, Kurdyukov and Bullock which discusses different methylation detection g techniques, including sequencing, probe based, antibody based (ELISA) and mass spectrometry based (see Figure 1, and throughout).
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) 5, 6, 7, 8, 12, and 13 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Vrba and Futcher US 20200255904 A1.
The claims are indefinite; art is being applied as if the claims require using a tumor marker located on chromosome 2 (consonant with the election). This is a reasonable interpretation in light of the specification where analysis of markers relative to cancers occurred on a marker-by-marker basis. See for example, Figure 11 and Example 4.
The recitation “for tumor screening, prognosis, diagnostic reagents and drug targets” is intended use that does not differentiate the method taught in the reference from the instantly claimed method.
The reference teaches using a marker, namely, cg08189989 chr2:105459164-105459165 for the detection of cancer. See at least p. 8, table.
With regard to claim 6, the reference teaches detecting the methylation status of the CpG site, see p. 8.
In the current claim construction, the defining of “the tumor” in claims 7 and 8 further limits the intended use of the claimed method, but does not require any action that is distinct from that carried out in claim 5. Nonetheless, with regard to claims 7 and 8, the reference teaches that the marker was hypermethylated in bladder urothelial carcinoma (i.e. bladder cancer; BLCA), breast invasive carcinoma (i.e. breast cancer; BC), colon adenocarcinoma (i.e. COADREAD), esophageal carcinoma (esophageal carcinoma; ESCA), lung squamous cell carcinoma , rectum adenocarcinoma and uterine corpus endometrial carcinoma, see ¶40 and Table p. 8.
With regard to claims 12 and 13, the reference teaches a method that comprises steps of obtaining a tissue to be tested, extracting DNA of the tissue sample to be tested, and obtaining a methylation value of the sample, and calculating a methylation status of a marker on Chromosome 2, see ¶44. The method used to detect the marker included probe detecting of PCR products, see ¶44, Table 6, noting probe sequences.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
Prosecution Insights