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
This application claims domestic priority as a CON of PCT/CN2020/120898 (10/14/2020) and claims foreign priority to CHINA 202010358731.9 (4/29/2020). A certified translation of PCT/CN2020/120898 and foreign application 202010358731.9 have not been filed.
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. 120 as follows: The PCT/CN2020/120898 which claims benefit under 35 USC 120 has not been filed in English and applicant is required to provide an English translation of the PCT to receive this date (see MPEP 1895.014).
Response to Remarks: Applicant has indicated that translations have been provided, however, these translations do not appear to be certified, therefore this aspect of the Priority requirements has not yet been met.
Application Status
Amended claims were filed on 6/05/2026, such that claims 1-20 are pending and claims 18-20 are withdrawn.
Any rejection or objection not reiterated herein has been overcome by amendment.
The Specification submission of 6/05/2026 overcomes the Specification objection regarding trademarks in the Specification.
Applicant’s amendments and arguments have been thoroughly reviewed but are not persuasive to place the claims in condition for allowance for reasons that follow.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “fluorescent reporter group”, but depends from claim 2, which indicates that two probes’ reporter groups do not interfere with each other. Therefore, in claim 3, the phrase “group is” should be plural, written as “groups are”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 9 recites a composition comprising an “internal standard control” primer pair, and an “internal control” probe and an “internal control” sequence. The specification does not disclose the term “internal standard control”, or the term “internal control probe”, or the term “internal control sequence” at all, rendering these phrases new matter.
Response to Remarks: The Remarks indicate that no new matter was added, however the phrases recited above as described do constitute new matter. The comments regarding claim 9 indicate the claim was amended, however it is the amendment that adds new matter to the claim.
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, 8 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 3 contain(s) the trademark/trade name(s) FAM, HEX, ROX, VIC, CY5, 5-TAMRA, TET, CY3, JOE. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe fluorescent reporter and, accordingly, the description is indefinite.
Claim 8 is indefinite in the recitation of “each ingredient of the two nucleic acid compositions is present in a mixed form in a single package” It is not clear what is meant by “each ingredient …is present in a mixed form”…this could mean composition 1 is mixed (are the two primers first mixed with the additional reverse primers and probe) and then combined with composition two (which is also first mixed), or it could simply mean that one package comprises a single mix of the two compositions, or it could mean something different, so further clarification is required.
Response to Remarks: Remarks indicate that the trademark/tradenames were removed, however they remain in claim 3. While claim 8 has been amended, obviating past issues, the amendment also has new clarity issues.
Claim interpretation
Claim 13 references sequences “near an 8782-nd site” and near a 28144-th site. It is noted that the Specification further articulates that the positive control includes sequences near these sites and that these sites reference Genbank genome: NC_045512.2 (Specification Pg 6). Further, “near” refers to sequence including the particular sites recited above and includes bases of 100-300 base pairs upstream and downstream thereof (Specification Pg 6). Thus, “near” will be interpreted as the mutation plus or minus up to 300 nucleotides upstream or downstream from the position 8782 or 28144 in NC_045512.2.
Prior Art not relied upon: Art identifies the mutations considered in the instant application (e.g. Table 2: site 8782, and 28144 Pg 670, Wang, C et al. The establishment of reference sequence for SARS-CoV-2 and variation analysis, 10 Mar 2020, Jour Medical Virology 92:667-674; cited on the IDS). However, the primers of claim 1 are not identified in any existing art, rendering the claims free of the art.
Conclusion
Claims 3, 8-9 are rejected, and claim 3 is also objected to. Claims 1, 2, 4-7,10-17 are allowable.
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.
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/LISA HORTH/Examiner, Art Unit 1681
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
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