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).
Specification
The use of the term FAM, HEX, ROX, VIC, CY5, 5-TAMRA, TET, CY3 and JOE, which is/are a trade name or a mark or names/marks used in commerce, noted in this application at, at least: Page 3, para 1 and 2. The term(s) should be accompanied by the generic terminology; furthermore the term(s) should be capitalized if not, wherever it/they appear(s) or, where appropriate, include a proper symbol(s) 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.
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 3-6, 8-9, 16 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 and 4 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 5 recites the limitation “wherein a dosage of the primer” in line 1. There is insufficient antecedent basis for this limitation in the claim. Since there is more than one primer referenced in claim 1, please articulate to which primer(s) “the primer” refers, and if the claim is amended, please ensure that the reference to dosage is clear with respect to whether it references one or more primer(s). Claim 6 has the same issue, though here regarding “the probe”. Claim 16 has the same, “a dosage of the primer” issue as in claim 5.
Claim 8 is indefinite in the recitation of “the two nucleic acid compositions combined are respectively present in a separate package”. It is not clear how combined and in “a separate package” is separate from. Perhaps the intent is that the compositions are combined and presented in a single package (not different packages as are found in claim 7), or this may be an incorrect interpretation, so further clarification is required.
Claim 9 is indefinite in the recitation of “an internal standard upstream primer,…downstream primer..” and “…for monitoring”. It is not clear whether the upstream and downstream primer are a forward and reverse pair of primers, or something different. Also, the claim ends with “for monitoring” but does not articulate what is being monitored (where reference to successful sample amplification, or something similar, may clarify this reference.
If this is the intent and does not invoke new matter or antecedent basis issues, structuring the claim to the effect of “internal control forward primer, internal control reverse primer and internal control probe OR internal control primer pair, consisting of a forward and reverse primer, and an internal control probe, that detect amplification of an internal control sequence, OR something similar clarifying whether the primers are a pair and what the “for monitoring” references, might clarify the 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 basepairs 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.
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 5-6, 8-9, 16 are rejected. Claims 1, 2, 3,4,7,10,11-15,17 are allowable.
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/LISA HORTH/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681