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 .
Application Status
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in China, CN201811149011.0 (09/29/2018) and CN201811149015 (09/29/2018), which have WIPO certification in the PCTCN2019109036 application. It is noted, however, that applicant has not filed the English translations, as required by 37 CFR 1.55 to obtain the 9/29/2018 priority date. Until these are filed, the priority date is 9/29/2019.
Any objections/rejections not reiterated here are withdrawn in view of amendments.
Specification
The disclosure is objected to because of the following informalities: the use of Keytruda, Agencourt AMPure, and Illumina NovaSeq, and any other trademarked term. Appropriate correction is required.
The use of the terms Keytruda on Pg 3, and Agencourt AMPure, Illumina NovaSeq, at least on Page 17, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
There appears to be one copy of the Specification submitted on 1/6/2025, marked “Substitute Specification - Clean”, however Table 1 is entirely underlined, suggesting this is the marked-up copy. The submission of 1/6/2025 indicates that clean and marked up copies were provided, as is required, though only a “marked up” but labelled clean copy was submitted.
Please submit a proper clean and marked up copy of the Specification.
Claim objections
Claim 16 is objected to because of the following informalities: use of singular vs plural. Appropriate correction is required.
In Claim 16 steps 2 and 3, calculating for each loci and summing score of each loci should reference each locus, not loci.
In Claim 16, the use of mathematical signs in lieu of words, should be replaced with words at: 4) “+ 3 SD” with plus three standard deviations, 5) “sample > the cutoff”, should be replaced with “greater than”; 5) “test plasma sample ≤ the cutoff” should be replaced with “less than or equal to”.
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 3, 16-17,19,31-34,36, 41 and 43 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 3 is indefinite over the recitation of “…wherein the kit comprises a probe set for a biomarker panel, wherein the panel comprises:” bMS-BR1-bMS-BR8, “wherein the probe set is a biotin-labeled probe set”, which can be interpreted in several ways. It is clear that the kit comprises the probe set, however it is unclear as claimed, whether the probe set is intended to include a probe set that could be for any subset of the biomarkers, or whether the probe set is for all of the markers. Additionally, it is unclear whether “set” can reference more than one probe for a particular biomarker (e.g. multiple regions of a biomarker, or a probe for each nucleic acid strand) or whether “set” instead references more than one biomarker.
The claim is also unclear regarding whether the biomarker panel is intended as a component of the kit. This can be remedied by directly stating that the kit also comprises the panel, if that is the intent. Claim 43 depends from claim 3 and is indefinite for the same reason.
Claim 16 is indefinite in the recitation of, …determining length characteristics of loci in MSS samples to construct a baseline, and in the test plasma sample from the cancer patient, using a next-generation sequencing method, wherein the multiple microsatellite loci comprise…” it is unclear exactly what is meant by “and in the test plasma sample, using a next-generation sequencing method”, (and what in the sample) since for example the length characteristics in MSS plasma samples is to construct a baseline for which the test plasma sample would not be included and thus it is unclear how the test plasma sample is part of step 1). Claims 17,19,31-34,36 depend from and are indefinite in the recitation of in the recitation of claim 16. It is also unclear, as written whether the multiple microsatellite loci, which comprise BR1-BR8 are all included in the method, or whether less than all of these may be used to conduct the method.
Claim 31 recites the limitation "the detection marker of microsatellite locus" in the final two lines of the claim. There is insufficient antecedent basis for this limitation in the claim. It is also unclear what exactly “being the detection marker of microsatellite locus” means. Claims 32, 33, 41 depend from and are indefinite in claim 31.
Claim 34 recites the limitation, “under the same NGS test” in line 2, There is insufficient antecedent basis for this limitation (the same NGS test) in the claim. It is also unclear what obtaining detection results form one mor more of 41 genes under the same NGS test means. Claims 36 depends from and is indefinite in claim 34.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, the claims will be given their broadest reasonable interpretation, in view of the specification, and as set forth at MPEP§ 2111. As written claim 3 is interpreted to be a kit with a probe set for a biomarker panel, where the probe set may be for any biomarkers in the panel.
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)(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.
Claims 3 and 43 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shao (US2020/0115708 A1; PCT filed 6/6/2018),
Re: claim 3, kit for detection of MSS comprising a probe set for a biomarker panel where in the panel comprises bMS-BR1-bMS-BR8, wherein the probeset is biotin-labelled, Shao, also interested in microsatellite instability, disclosed a kit with a probe library for hybridization with microsatellite loci, wherein the kit comprised a probe set for a biomarker panel that comprised biomarkers BR1 on chromosome 11, and BR3, on chromosome 2 of the instant application in the instant Table 1, which are recited in claim 1 of Shao as the 7th microsatellite locus (chr 11) and the 2nd microsatellite locus (chr 2) disclosed in the microsatellite listing in Shao claim 1, respectively; the probes are biotin-labelled (Shao, Fig 1, claim 1, 6, 9).
Re; claim 43, wherein the biomarker panel further comprises one or more of the following 41 genes…which includes ATM: Shao’s kit probe library is configured to hybridize to ATM-15 (Shao claims 1, 9, Fig 1).
Conclusion
All claims rejected. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LISA HORTH/ Examiner, Art Unit 1681
/GARY BENZION/ Supervisory Patent Examiner, Art Unit 1681