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
Applicant's election with traverse of Group II in the reply filed on October 13, 2025 is acknowledged. The traversal is on the ground(s) that there is no serious burden to examine all of the claims together. This is not found persuasive because the different inventions require different search queries due to mutually exclusive characteristics at R. Furthermore, this application is a national stage application and the unity of invention standard applies.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 6-12, 15, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
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, 5, 13-14, and 16-18 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.
Regarding claims 1, 3, and 14, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 5 and 16, the limitation "e.g." renders the claim indefinite because e.g. means “for example,” and it is unclear whether the limitation(s) following “e.g.” are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1 and 3, the phrase "particularly such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). There are multiple instances of “such as” in claims 1 and 3.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “R”, and the claim also recites “preferably, R is selected from,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 1, 3, 5, 13, and 16-17 recite “preferably,” “more preferably,” or “most preferably” multiple times (58 times in the entire claim set), so it is not feasible to list every instance of a broad limitation together with a narrow limitation in this rejection. Claim 18 depends from claim 17 and includes all the limitations of claim 17.
Claims 5 and 16 recite “if Base is different, the detectable label (e.g., a fluorescent 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.
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.
Claims 5, 13, and 16 are 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. Claims 5, 13, and 16 depend from claim 1 or claim 4. Claims 5, 13, and 16 each recite that the compound carries an additional detectable label. Detectable labels are not within the scope of formula (A) in claim 1 and are not present in the compounds recited in claim 4, so claims 5, 13, and 16 fail to include all the limitations of the claims upon which they depend. In other words, claims 5, 13, and 16 are broader than the claims upon which they depend. 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.
Claims 1, 3-5, 13-14, and 16-18 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush groupings of claim 1, 3-5, 13-14, and 16-18 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the alternatives defined by the Markush grouping do not share a single structural similarity. The alternatives differ at the variable R, which is disclosed to be a reversible blocking group. Protected compounds include C(=X)-aryl compounds, C(=X)-heteroalkyl groups, C(=X)-heteroaryl, aryl, C-heteroaryl, alkenyl, and alkynyl. A Markush grouping is ordinarily proper if all the members of the group belong to a recognized class and possess one property in common which is mainly responsible for their function in the claimed invention. In this instance, the members of the group do not belong to a recognized class because a large portion of the structure (the R portion) is not shared. The skilled artisan would not expect that all members of the group could be substituted one for the other with the expectation that the same intended result would be achieved because the chemical structures are vastly different. Compounds of similar structures are expected to behave similarly, while compounds of different structures are not expected to behave similarly. For example, a compound containing a heteroaryl group as a blocking group could not be substituted for a compound containing an alkynyl group as a blocking group because the chemical reactivities of the blocking groups are different.
MPEP 2117 also states that the Markush grouping may be considered to be proper where the alternatives share a substantial structural feature that is essential to a common use. In this instance, the members do not share a substantial structural feature because the R compounds have such variability in structure. The skilled artisan would not expect a common use to flow from, for example, a heteroaryl group versus an alkene group because the reactivity of these groups is different.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. The examiner suggests limiting the claims to the elected group wherein R (or A’ in claim 3) is C(=X)-aryl or C(=X)(CH2)m1-aryl.
The search need not be extended to species that fall outside a proper Markush grouping. MPEP 2117.
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, 3, 5, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shafiee (Eur. J. Med. Chem. 34 (1999) 423-431).
Shafiee teaches the following compound on page 424:
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Compound 4 is a compound of formula (A) in claim 1 or formula (III) in claim 3 where Base is cytosine and R (or A’ as in claim 3) is C(=X)-aryl. R’ is H. X is O. R5-R8 are H and R9 is X-CH2-R12 wherein X is NH and R12 is H.
MeNHBz is a fluorophore (page 424, Chemistry), so compound 5 is a compound of claim 5 which carries a detectable label. Compounds 4 and 5 were placed in water (page 424, Chemistry), which reads on a kit containing a washing solution. The compounds were also combined with a buffer (see Figure 2 or Table II), which reads on a kit containing a buffer solution.
Claim(s) 1, 3, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiatt (WO 96/07669, cited on IDS).
Hiatt teaches the compound dATP 3’-O toluate, which is a compound of formula (A) or formula (III). Base is adenine. R’ is a triphosphate. R or A’ is C(=X)-aryl where X is O and R7 is methyl. See page 59. The compound was placed in buffer, which reads on a kit containing a buffer. Page 58, first full paragraph.
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, 3-5, 13-14, and 16-18 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). The compounds may also bear an individual label. Column 3, lines 14-19. 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 the first four compounds on page 21 of the claims, claim 4, because claimed R5-R9 are different.
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 claim 4, top of page 21.
The compound which would result is a compound of Formula (A) or formula (III). R’ is a triphosphate. R or A’ is a C(=X)-aryl group where R9 is X-CH2-R12 where R12 is N3. Base is any of the 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 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.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693