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 . Applicant’s amendment preliminary amendment filed 6/6/2024 is acknowledged. Claims 1, 3-11, 13-14, 22, 30 and 31 have been amended. Claims 2, 12, 15-21, 23-29 have been amended. Claims 1, 3-11, 13-14, 22, 30-31 are pending and under examination.
Priority
This application is a 371 of PCT/CN2022/142454 filed 12/27/2022.
Drawings
The drawings were received on 6/26/2024. These drawings are objected because the x/y-axis in the drawings are difficult to read and interpret, perhaps due to copy machine artifacts in that the shading makes interpretation difficult.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 3-11, 13-14, 22, 30 and 31 are objected to because of the following informalities:
(a) Claims 1, 3-11, 13-14, 22, 30 and 31 are objected to at “and characterized in that” or/or “characterized in that. It is suggested to amend the claims to recite “comprising of”, “consisting of” or “consisting essentially of” to conformed to US standard. (see MPEP 2111.03). Appropriate correction is required.
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 1, 3-11, 13-14, 22, 30-31 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.
(a) Claim 1, 3-11, 13-14, 22, 30-31 are indefinite because the metes and bounds of the limitations recited therein in the context of the claims are unclear making it difficult to envision the structural components of the primer probe set recited herein. For example, in the claim 1 and subsequence claims the recitation of “paired manner” is confusing because neither the specification nor claims provide a limiting definition of the term in the context of the claims and thus a clear interpretation of the limitations recited therein cannot be ascertained. Additionally, the limitation, “located at 3’ end of the primer signal detection region” is confusing because it is unclear “what region is actually the “primer signal detection region” and it cannot be determined where at the “3’end” applicant is making reference to. It is unclear if applicant is making reference to a “terminal end” of the recited region or somewhere else. Further the structure of the pre-amplification product containing one single-stranded pre-amplification product having the complementary sequence of the primer signal detection region is confusing because the actual structure and binding regions and the act pre-amplification product cannot be envision given the recitation of the primer probe set as recited herein. Likewise, a pre-amplification product would imply that some type of amplification has already occurred so it is also unclear if the pre-amplification product and components recited there are separate entities from the other components of the primer and probe recited in the primer-probe set. The claims are ambiguous as broadly written. Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
(c) Claims 1, 3-11, 13-14, 22, 30-31 is indefinite in the claim 1 at “extends by > 0 bases to form a double-stranded” because it is unclear how the probe extension occurs when 0 base is present. The structural features which allow the function as recited therein in unrecited and therefore the metes and bounds of the claimed limitations is unclear.
(d) Claim 4, 5, 6, 7, 8, 22, and 31 are indefinite at the recitation of “preferably” or “more preferably” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP§ 2173.05(d).
(e) Claims 5-7 are indefinite at the recitation of “primer anchoring region” because the metes and bounds of the limitation cannot be ascertained as the functional features recited therein does not clearly allow one to envision the structural features of the primers in the primer/probe set as instantly clamed. A clear interpretation cannot be ascertained.
(f) Claim 30 is indefinite at the recitation of “judging whether there is a target contained in the sample” because it is unclear what criteria is necessary to accurately performed the claimed function which could be merely be a mental analysis of “thinking” about the method step. Clarification is required.
(g) Claim 31 is indefinite at the recitation of “range of a characteristic Tm values” or “characteristic Tm value” because the metes and bounds of the limitation is unclear as it cannot be determined what is encompassed by the limitation as it relates to Tm values. Clarification is required.
Prior Art
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ji et al (CN109624704A, 10-9-2018) teach the invention claims a primer probe set, the primer probe set used for fluorescent quantitative PCR combined detection of genital tract mycoplasma, Chlamydia trachomatis and gonococcus and the primer probe set comprising: a CT primer pair, CT probe, primer pair, MG MG probe. and NG NG primer probe, wherein the reverse CT primer CT primer pair comprises a forward primer represented by SEQ ID NO.1 and SEQ IDNO.2, the CT probe shown as SEQ ID No. NO.3 and which is labelled with a first fluorescent group; the MG primer pair comprises a forward primer represented by SEQ ID No. NO.4 and reverse primer represented by SEQ ID No. NO.5, the MG probe SEQ ID NO.6 shown and labelled with a second fluorescent group, the reverse primer NG primer pair comprises a forward primer represented by SEQ ID NO.7 and SEQ ID NO.8, and the MG probe shown as SEQ ID No. NO.9 and marked with a third fluorescent group; the first fluorescence radical and the said second fluorescence radical and the third fluorescent group are the same or different from each other.
wherein the first fluorescent group, the second fluorescence radical and the third fluorescent groups can be the same, under this situation, can be accumulated detection of Chlamydia trachomatis and gonococcus and genital mycoplasma detection result is given, namely any one of Chlamydia trachomatis and gonococcus and genital mycoplasma, but not to distinguish the chlamydia trachomatis and neisseria gonorrhoeae and genital mycoplasma.
wherein the first fluorescent group, said second fluorescent group and the third fluorescent group may be different from each other. In this case, it can respectively detect genital tract mycoplasma, Chlamydia trachomatis and gonococcus and given that the detection result of the distinguishing Chlamydia trachomatis and gonococcus and genital mycoplasma.
randomly selecting in real-time quantitative PCR fluorescent group wherein the first fluorescence radical, the specific selection of the second fluorescence radical and the third fluorescent group can be conventionally used in this field, said real-time quantitative PCR fluorescent groups including but not limited to FAM fluorescent group, ROX fluorescent group HEX fluorescent group, CY3 group and CY5 group. Preferably, the first fluorescent group, the second fluorescence radical and the third fluorescent group is FAM fluorescent group, ROX fluorescent group HEX fluorescent group.
wherein, preferably, the primer probe set further comprising internal reference primer pair and internal reference probe. internal reference primer pair and internal reference probe can help the different sample concentrations uniformed. the quantitative result in the different samples is comparable and therefore it is diagnosis, medication instruction and treatment evaluation functions, namely by treating and test result comparison and twice reference result, concluding treatment effect, drug effect and so on.
wherein, more preferably, said internal reference primer pair comprising a reverse primer forward primer represented by SEQ ID NO.10 and SEQ ID NO.11, the reference probe as SEQ ID NO.12 as shown and marked with a fourth fluorescent group; any one of the fourth fluorescent group of the first fluorescence radical, the first fluorescence radical and the third fluorescent group are different, especially preferably, the fourth fluorescent group is a fluorescent group CY5.
wherein, further preferably, the primer probe set by the CT primer pair, the CT probe, primer of said MG, said MG probe, the NG primer pair, the NG probe, the internal reference primer pair and the reference probe; and further preferably, the primer probe set by equal mixing of the CT primer pair, the CT probe, primer of said MG, said MG probe, the NG primer pair, the NG probe, the internal reference primer pair and the reference probe. under the preferred condition of the CT primer in the primer probe set to the CT probe, primer of said MG, said MG probe, the NG primer pair, the NG probe, the internal reference primer pair mutual interference is small and can acquire the more sensitive the detection result and the reference probe.
Specifically, SEQ ID NO.1-12 sequence information in this application as shown in Table 1. (See pages 3-5 of the translated document and claims and Table 1a extracted from the untranslated doc. @ para. [0021]):
PNG
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262
567
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Greyscale
Conclusion
8. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681
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