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 .
CONTINUING DATA
This application is a 371 of PCT/CN2021/125262 10/21/2021
FOREIGN APPLICATIONS
CHINA 202011134947.3 10/21/2020
This office action is in response to Applicant’s amendment submitted January 26, 2026.
Claims 1, 4-5, 8, 11-14, 16-17, and 20-29 are pending.
Claims 8, and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 13, 2025.
The rejection of claims 1, 3, 5, 13-14, and 16-18 under 35 U.S.C. 112(b) for broad ranges together with narrow limitations is withdrawn in view of the amendments to the claims.
The rejection of claims 1, 3-5, 13-14, and 16-18 on the basis that it contains an improper Markush grouping of alternatives is withdrawn because R is narrowed in the amended claims.
The rejection of claim(s) 1, 3, 5, and 13-14 under 35 U.S.C. 102(a)(1) as being anticipated by Shafiee is withdrawn because Shafiee’s compound does not meet the limitations of R5 and R9.
The rejection of claim(s) 1, 3, and 13 under 35 U.S.C. 102(a)(1) as being anticipated by Hiatt is withdrawn because Hiatt’s compound does not meet the limitations of R5 and R9.
The following new rejections were necessitated by Applicant’s amendment.
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 24-25 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 24 recites “if Base is different, the detectable label varies”. This limitation is unclear because the claims do not state what Base might be different from or what the detectable label varies from, or whether certain detectable labels are specific to certain bases, or some other meaning of the claim. Claim 25 depends from claim 24 and incorporates the same limitation by reference.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 depends from claim 5 and recites a number of compounds. Claim 5 requires that the compound carries a detectable label, but the compounds in claim 16 do not contain a detectable label. Detectable labels are required by claim 5 and are not present in the compounds recited in claim 16, so claim 16 fails to include all the limitations of the claims upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 13, and 20-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yagodkin (Nucleosides, Nucleotides, and Nucleic Acids, cited on IDS).
Yagodkin teaches the following compounds 10a-d. See Scheme 4.
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Compounds 10a-d are compounds of formula (A) wherein R’ is H. X is O. R is the first group listed in claim 1. R5 or R9 is the moiety illustrated in the definition of R5 or R9 wherein m2 is 0, one of R10a-R10c is N3, and the rest are H. R5 or R9 is H, and R6-R8 are all H. The compounds are useful for producing oligonucleotide libraries.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-5, 13-14, 16-17, and 20-23, 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canard (US 5,798,210, 1998) in view of Wada (Tetrahedron Letters 42 (2001) 1069-1072).
Canard teaches the following compound (see Figure 1 and description of Figure 1):
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The compounds are used for nucleic acid sequencing (see title). Base can be A, T, C, or G. See first paragraph. The compounds may also bear an individual label. Column 3, lines 14-19. The label is fluorescent (column 1, lines 40-44). Canard also discloses a kit containing a primer and/or a solid phase, and/or a nucleic acid polymerase. Column 5, lines 15-20.
The Canard compounds differ from formula (A) and the first four compounds in claim 4 or 16-17, because claimed R5 or R9 are NH2 or NHMe and not the moiety claimed for R5 or R9.
Wada teaches the 2-(azidomethyl)benzoyl (AZMB) group as a protecting group for deoxyribonucleosides (page 1070, first full paragraph). The structure of the protecting group and how it is reversed is shown in Scheme 1:
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The AZMB group can be introduced into primary and secondary hydroxy groups and removal is easily carried out. Page 1071, last paragraph.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to substitute the AZMB protecting group for the anthranilate esters taught by Canard. Both protecting groups are benzoyl protecting groups, and both protecting groups are used for nucleic acid protection. Simple substitution of one protecting group for the other would result in the claimed invention, and the results would have been predictable because both protecting groups are benzoyl protecting groups and both are used for protecting the 3’-O position in deoxynucleotides. Substitution of the AZMB protecting group for the protecting group used by Canard would result in compounds such as those shown in current claims 4 and 16-17.
The compound which would result is a compound of Formula (A). R’ is a triphosphate. R is the first group listed in claim 1. R5 or R9 is the moiety illustrated in the definition of R5 or R9 wherein m2 is 0, one of R10a-R10c is N3, and the rest are H. Base is any of the four different bases taught by Canard.
It would have been obvious to one of ordinary skill in the art to include a label because Canard teaches that the compounds should be labeled for detection.
It would have been obvious to one of ordinary skill in the art to include the compound or multiple compounds in a kit along with a reagent for pretreating the nucleic acid molecules, a support for linking nucleic acid molecule to be sequenced, a reagent for linking the nucleic acid molecule to the support, a polymerase for carrying out the nucleotide polymerization reaction, a buffer, or a washing solution because Canard’s compounds are used for nucleic acid sequencing and are disclosed as kits.
Claim(s) 24-26 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canard (US 5,798,210, 1998) in view of Wada (Tetrahedron Letters 42 (2001) 1069-1072) and further in view of Graham (Tetrahedron Letters 43 (2002) 4785-4788).
Canard and Wada teach as set forth above, and Canard teaches that fluorescent labels may be used.
Canard and Wada do not teach the particular labels recited in claims 24-26 and 29.
Graham teaches that one fluorescent label for labelling oligonucleotides is Alexa Fluor 532 (page 4787).
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It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare the compounds suggested by Canard in view of Wada and to label the compound using Alexa Fluor 532 because Canard teaches that the compounds may contain a fluorescent label and Alexa Fluor 532 is a known fluorescent label for oligonucleotides.
Claim(s) 5, 16-17, 24-26 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yagodkin in view of Canard and Graham (Tetrahedron Letters 43 (2002) 4785-4788).
Yagodkin teaches as set forth above, compounds of oligonucleotide libraries.
Yagodkin does not teach that the oligonucleotides contain a label.
Canard teaches that compounds used for sequencing may also bear an individual label. Column 3, lines 14-19. The label is fluorescent (column 1, lines 40-44).
Graham teaches as set forth above, that Alexa Fluor 532 is used for labeling oligonucleotides.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepared labeled analogs of Yagodkin’s compounds because compounds in sequencing libraries may bear a fluorescent label. The skilled artisan would have utilized Alexa Fluor 532 in particular because it has been successfully used to label oligonucleotides.
Response to Arguments
Applicant argues that the claimed reversible blocking groups can be removed at a fast rate, and that Wada teaches that the removal takes longer. This argument is not persuasive because the blocking group used by Wada is the same blocking group used in the current specification. Only the method of removing it appears to be different in the current specification, not the structure of the group itself. In order for evidence of secondary considerations to be accorded substantial weight, there must be a nexus between the evidence and the claimed invention. In this instance, the fast removal rate is due to the method of removing the group and not the structure of the group itself because the prior art group has the same structure as the group used in the current specification.
Applicant argues that the skilled artisan would not have chosen Wada’s blocking group because removal is slower than Canard’s removal. This argument is not persuasive because Canard does not require that the blocking group is removed quickly and Wada teaches that removal is easy. MPEP states that an exemplary rationale to support a conclusion of obviousness is simple substitution of one known element for another to obtain predictable results. The rationale only requires that the results are predictable. Wada teaches that removal is easy, so the results would have been predictable.
Conclusion
No claims are allowed.
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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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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