DETAILED ACTION
Reassignment of the Application
1. Please note that this application has been reassigned to Examiner Kaijiang Zhang, in Art Unit 1684. In order to expedite accurate processing of the application papers, all future correspondence with the Office should reflect this change.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
3. Applicant’s election of Group I (claims 1-9) in the reply filed on 12/4/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
4. Claims 1-19 and 21 are pending in the application. Claims 10-19 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-9 are currently under examination.
Claim Objections
5. Claim 3 is objected to because of the following informalities: 1) “according to claim 1 claim1” in line 1 should be changed to “according to claim 1modified inosine, 7-aza- or 7-deaza-8-aza-modified N6-methyladenosine, 7-aza- or 7-deaza-8-aza-modified xanthosine” should be changed to “7-deaza- or 7-deaza-8-aza-modified inosine, 7-deaza- or 7-deaza-8-aza-modified N6-methyladenosine, 7-deaza- or 7-deaza-8-aza-modified xanthosine” to correct the typographical error(s) because “7-aza” would not constitute an modification (i.e., non-modified inosine, N6-methyladenosine and xanthosine has “7-aza”, whereas “7-deaza” would constitute an modification). Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-9 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.
In the preliminary amendment filed on 9/22/2022, the 2nd wherein clause in claim 1 was changed from “wherein the nucleic acid moiety comprises or consists of 7-deazapurines and/or 7-deaza-8-azapurines, and optionally modified and/or unmodified pyrimidine nucleotides” to “wherein the nucleic acid moiety comprises or consists of a first nucleic acid selected from 7-deazapurines, and combinations thereof, and optionally modified pyrimidine nucleotides and/or unmodified pyrimidine nucleotides”. However, the changed wherein clause has caused confusion because, with respect to the optional “modified pyrimidine nucleotides and/or unmodified pyrimidine nucleotides”, there can be two different interpretations: i) wherein the “nucleic acid moiety” comprises or consists of, optionally, modified and/or unmodified pyrimidine nucleotides (which are in addition to the “first nucleic acid” comprised in the “nucleic acid moiety”); ii) the recited “modified and/or unmodified pyrimidine nucleotides” are optional parts of the list from which the “first nucleic acid” is selected). Since there are multiple ways to interpret the 2nd wherein clause, claim 1 is 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 (see MPEP 2173.02.I: “…For example, if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate.”).
Claims 2-9, each of which depends from claim 1, are also rejected for the same reason.
Claim Rejections - 35 USC § 102
8. 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 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.
9. 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.
10. Claims 1, 4-5 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terrett et al. (WO 2016/109808 A1).
Regarding claim 1
Terrett et al. teach, throughout the whole document, a compound library comprising a plurality of conjugate molecules (e.g., small molecules conjugated to DNA oligonucleotides) (see paragraphs [00137] and [00142]), wherein each conjugate molecule comprises a small organic molecule (e.g., small organic compound. See paragraph [0028]) covalently coupled to a nucleic acid moiety (see paragraphs [00137] and [00142]), wherein the nucleic acid moiety comprises or consists of a first nucleic acid selected from 7-deazapurines (e.g., 7-deazaadenosine and/or 7-deazaguanosine), and/or 7-deaza-8-azapurines, and combinations thereof, and optionally modified pyrimidine nucleotides and/or unmodified pyrimidine nucleotides (see paragraph [0025]).
Regarding claim 4
The compound library according to Terrett et al., wherein the plurality of conjugate molecules comprises at least ten conjugate molecules (see paragraphs [0058] and [00145]).
Regarding claim 5
The compound library according to Terrett et al., wherein the nucleic acid moiety comprises at least 2 nucleotides (see paragraph [0015]).
Regarding claim 8
The compound library according to Terrett et al., wherein the nucleic acid moiety is DNA (see paragraphs [00137] and [00142]).
Regarding claim 9
The compound library according to Terrett et al., wherein: a) the conjugate molecules further comprise a linker between the nucleic acid moiety and the organic molecule (see paragraphs [0015] and [0065]); b) the conjugate molecules differ from each other by comprising different nucleic acid moieties (see paragraphs [0058], [00135] and [00137]); c) the organic molecule consists of 2 or more carbon atoms; and/or d) the organic molecule has a molecular weight of at most 900 daltons (e.g., about 300 Daltons) (see paragraph [0028]).
Claim Rejections - 35 USC § 103
11. 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 of this title, 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.
12. 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.
13. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Terrett et al. (WO 2016/109808 A1) as applied to claim 1 above, and further in view of Hara et al. (J. Org. Chem. 2017, 82:25-36).
Terrett et al. teach the compound library of claim 1 as discussed above. Terrett et al. do not teach 7-deaza-8-azaadenosine or 7-deaza-8-azaguanosine.
However, Hara et al. teach 7-deaza-8-azaadenosine (i.e., 8-aza-7-deazaadenosine) and 7-deaza-8-azaguanosine (i.e., 8-aza-7-deazaguanosine) (see the whole document, e.g., page 25, paragraph spanning columns 1-2). Hara et al. further teach that such nucleoside/nucleotide analogs can help increase the stability of DNA duplexes (see page 25, paragraph spanning columns 1-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alternatively use 7-deaza-8-azaadenosine and/or 7-deaza-8-azaguanosine, as taught by Hara et al., as the nucleoside/nucleotide analog(s) used in the compound library of Terrett et al. thus arriving at the instantly claimed invention, because: 1) both 7-deaza-8-azaadenosine and 7-deaza-8-azaguanosine were art-recognized nucleoside/nucleotide analogs used for nucleic acid modifications; 2) using 7-deaza-8-azaadenosine and/or 7-deaza-8-azaguanosine would provide the benefit of increasing the stability of DNA duplexes (see Hara et al., page 25, paragraph spanning columns 1-2). Given the teachings of the prior art and the level of the ordinary skilled artisan at the effective filing date of the claimed invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
14. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Terrett et al. (WO 2016/109808 A1) as applied to claim 1 above, and further in view of Blain et al. (WO 2019/236644 A1).
Terrett et al. teach the compound library of claim 1 as discussed above. Terrett et al. do not teach the nucleoside modifications as listed in claim 3.
However, Blain et al. teach nucleoside modifications such as 7-deaza-modified xanthosine (e.g., 7-Deaza-2’-deoxyxanthosine) (see paragraph [00110]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alternatively use 7-deaza-modified xanthosine, as taught by Blain et al., as the nucleoside modification used in the compound library of Terrett et al. thus arriving at the instantly claimed invention, because 7-deaza-modified xanthosine was an art-recognized nucleoside modification suitable for such purpose. In addition, combining prior art elements according to known methods to yield predictable results is considered prima facie obvious (see MPEP 2143.I.A). Given the teachings of the prior art and the level of the ordinary skilled artisan at the effective filing date of the claimed invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
15. Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Terrett et al. (WO 2016/109808 A1).
Terrett et al. teach the compound library of claim 1 as discussed above. Terrett et al. further teach the following: 1) wherein the nucleic acid moiety comprises a sequence element of 3 to 18 nucleotides in length on its 5’ or 3’ end (see paragraph [0015]); 2) wherein each conjugate has the structure Org-SNS-(INS)-TNS, wherein “Org” represents the small organic molecule, “SNS” represents a first nucleic acid identifier sequence, “INS” represents an optional second nucleic acid identifier sequence, and “TNS” represents a terminal nucleic acid identifier sequence, wherein each of SNS and TNS is 3 to 18 nucleotides in length and INS is 3 to 50 nucleotides in length (see paragraph [0015]; Figure 1).
Although Terrett et al. do not specifically disclose exactly what nucleotides are comprised in each of nucleic acid sequence segment as recited in instant claims 6-7, Terrett et al. do teach that such nucleic acid sequence segment may include, without limitation, any natural nucleosides or nucleoside analogs as listed in paragraph [0025], including 7-deazapurines (e.g.,7-deazaadenosine and 7-deazaguanosine), modified pyrimidine nucleotides and unmodified pyrimidine nucleotides. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose any combination of the listed natural nucleosides or nucleoside analogs for each of the nucleic acid sequence segment thus arriving at the instantly claimed invention, because Terrett et al. expressly suggested so. Given the teachings of the prior art and the level of the ordinary skilled artisan at the effective filing date of the claimed invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Conclusion
16. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684