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
Amended claims 139-145, 147,159-170, filed 9/23/2025, are under examination in this Office action. Claims 146, 148-158 were cancelled.
Priority
This application is a divisional of application 15/965, 796 (7/29/2020), which is a 371 of PCT/US/19/15452 (1/28/19), which has a provisional 62/623,471 (1/29/2018).
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 1/18/2024, 5/27/2025 and 10/1/2025 are in compliance with the provisions of 37 CFR 1.97, except where lined through. Accordingly, the information disclosure statements are being considered by the examiner, except on the IDS of 10/1/2025, NPL Cite 001, Chen et al, and NPL Cite 005 Leaver et al, where at least the volume and year of the submissions differ from the IDS sheet. It is noted that the copending US application 18/860539 (not provided) is cited in the non-patent literature section of the IDS of 10/1/2025.
Drawings
The drawings are objected to because essential printed material shows up as poor-quality font and is not easily readable in FIG 1C (10/6/2023), particularly the Legend at the top of the page identifying the icons.
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.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at paragraph [00115]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Triton-X ([00108] [00123] is a trade name or a mark used in commerce, has been noted in this application. The term 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.
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.
Claim 139-145, 147, 159-170 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 139 is indefinite in the following manners:
Line 6, “wherein the mixture of nucleotides comprises at least one terminator” means that there may be one or more terminators. Next, at line 9, “wherein the at least one terminator is an irreversible terminator” is unclear because if there is more than one terminator, are they all irreversible terminators, or are some reversible terminators? This leads to the final point: in (b) there are a plurality of amplification products wherein a portion of the terminated products comprise at least one terminator, but it is not clear what type of terminator this is. Claims 140-145, 147, 159-161 depend from claim 139 and as such are also indefinite. Claim 162 has the same issue as claim 139. Claims 163-167 depend from claim 162 and as such are also indefinite.
Claim 142 is indefinite in the recitation of: treatment with a nuclease prior to step (a). Since different types of nucleases could have different functions at this step, and would impact the method in different ways, further clarification regarding what type of nuclease is being referenced is required to maintain the clarity of the method.
Claim 160 is indefinite in the recitation of the at least one terminator nucleotides comprise a modification to the alpha group. The use of comprise here could have multiple meanings, one of which could be that there is more than one type of terminator, including a modification to the alpha group, or alternately the meaning could be all terminators comprise a modification to the alpha group. Further clarification is required. Claim 165 has the same issue and thus is indefinite. Claim 166 depends from claim 165 and as such is indefinite.
Claim 166 is confusing in that it references the at least one terminator with modification to the alpha group [are] alpha-thio dideoxynucleotides. Here, the plural “are” could be referencing more than one terminator, or could be intended as “is”.
Claim 168 discloses at least one terminator comprising an alpha-thio dideoxynucleotide, suggestive that there may be other terminator types that are not alpha-thio dideoxynucleotides included in the method. In step (b), the portion of the terminated amplification products comprise the at least one terminator nucleotide which could be interpreted to be the alpha-thio dideoxynucleotide but could also be another terminator type of terminator given the use of “at least one terminator” and the use of “comprise” in the reference. Further clarification is required. Claims 169 and 170 depend from claim 168 and are indefinite as such.
The claims appear to be free of the art. Art not relied upon but of a similar nature includes Shen (WO2013/188582 A1) which may involve multiple displacement amplification, and an isothermal reaction and a long strand length (e.g.P Pg 21), but does not appear to block portions of amplicons in the same way as the instant application.
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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/LISA HORTH/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681