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 .
Status of the Claims
Applicant’s amendment was filed 11/10/2025.
Response to Amendments
In view of amendments,
Objections:
The Specification Objection regarding the hyperlink is withdrawn.
The Drawing Objection is withdrawn.
35 USC § 112(b):
The rejections regarding the “probe…..particularly at both ends” is withdrawn.
The rejections regarding the second use of “a primer…” in claim 1 is withdrawn.
The rejection regarding “the primer sequence” in claim 8 is withdrawn.
35 USC § 112(d):
The rejections regarding “the additional barcode” is withdrawn.
Response to Remarks:
It is noted that all Remarks relate to withdrawn rejections.
Claim Rejections - 35 USC § 112(b)
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, 3-11, 13-17 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 1, recites a method comprising RT-MLPA wherein the step is carried out using at least one probe selected from the probes:
the probes SEQ ID NO: 1 to 13, and/or 866 to 938, and/or SEQ ID NO: 940 to 1104, and/or SEQ ID NO: 1211 to 1312, and/or
the probes SEQ ID NO: 96 to 99, and/or SEQ ID NO: 1105 to 1107 and/or SEQ ID NO: 939, and/or
- the probes SEQ ID NO: 1108 to 1123,
each of the probes being fused, at one end, with a primer sequence,
at least one of the probes of said pair comprising a molecular barcode sequence, and wherein the probes SEQ ID NO: 14 to 91 are also used for the RT-MLPA step.
The claim is indefinite in the recitation of “ and wherein the probes SEQ ID NO: 14 to 91 are also used for the RT-MLPA step, since it is unclear how these probes are also used for the RT-MLPA step since, as phrased, it is unclear whether or not these probes are intended to comprise a barcode/be fused with a primer. Claims 3-11, 13-17 depend from claim 1 and are indefinite in, and rejected for, the same reason.
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.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more, and there is not integration into a practical application by doing more such as applying a particular treatment. Regarding laws of nature, their unpatentability was confirmed by the US Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “Laws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U.S. 175, 185 (1981); see also Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010).
101 Analysis, Step 1 shows that the claims are directed to a method, a valid statutory category.
Step 2A, Prong One: The claim is directed to a natural phenomenon, specifically a correlation between the presence of an 5’-3’ imbalance in a subject and the presence of cancers. The claim accomplishes this by detecting the abundance of 5’, 3’ nucleic acids using RT-MLPA, which is a known method in the art (e.g. Yong Mar 2018 J Exp Clin Canc Res 3(1):68).
Step 2A, Prong Two: The additional elements do not integrate the judicial exception into a practical application of the judicial exception (see MPEP 2106.04(d)) The method of diagnosing comprises an RT-MLPA step on a natural sample using a probe that is selected from SEQID NO: 1108-1123. No further elements are recited.
RT-MLPA is a routine laboratory technique using known probe hybridization (e.g. Yong, Mar 2018 J Exp Clin Canc Res 3(1):68), Kvastad 2015 Sci Reports 5:16519). In the instant case, the probe set of SEQIDNO from which at least one is selected, are known fragments of nature.
SEQID 1108 is a fragment of nature:
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271
665
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Greyscale
SEQIDNO: 1109 is a fragment of nature
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302
1157
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Step 2B: There are not additional elements that allow the claim to amount to significantly more than the judicial exceptions. Thus, the claim is patent ineligible.
Conclusion
Claims 1, 3-17 are rejected. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Horth whose telephone number is (703)756-4557. The examiner can normally be reached Monday-Friday 8-4 EST.
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/LISA HORTH/Examiner, Art Unit 1681 /GARY BENZION/Supervisory Patent Examiner, Art Unit 1681
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