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 .
Priority
This application was filed July 17, 2025, and is a continuation of the 371 application of PCT/US24/42648 filed on August 16, 2024, which claims benefit to the provisional application 63/520,597 filed on August 18, 2023.
Response to Traversal: Applicant asserts that the provisional filing date is August 18, 2023. Applicants’ comments on priority are acknowledged, and the Examiner appreciates the clarification, the appropriate priority date has been cited above.
Claim Status
In the response filed on the 22nd of May 2026, Applicant has amended claims 53-55, 57-61, 70, 75, 80, cancelled claims 1-52, 56, 67, and 71-74, and filed new claims 82 and 83.
Applicant’s election without traverse of Group I: claims 53-74, 79, and 80, Species election: Adenine nucleobase, promoter proximal sequence length of at least 5 nucleotides, SEQ ID NO: 6, and T7 promoter species in the reply filed on Dec. 22, 2025, is acknowledged.
Claims 54, 65-66, and 75-81, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 Dec. 2025.
Currently, claims 53, 55, 57-64, 68-70, and 82-83 are under examination in this application.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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 82 and 83 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.
This rejection is a new rejection necessitated by amendments to the claims.
Claims 82 and 83, which ultimately depend from claim 53, wherein the polynucleotide sequence comprises a promoter proximal sequence with four or more consecutive nucleotides (see claim 53, lines 1-5). However, claim 82 recites SEQ ID NO: 7 and claim 83 recites SEQ ID NO: 71, which contains three adenine nucleobase and does not contain four or more consecutive nucleotides having an adenine nucleobase (see e.g. specification page 32, and table 1). Therefore, claim 82 (i.e. SEQ ID NO: 7) and claim 83 (i.e. SEQ ID NO: 71) fails to include all the limitations of the claim upon which it depends because it does not contain four or more consecutive nucleotides having an adenine nucleobase. 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. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 53, 57-64, 68-70, and 82-83 are rejected under 35 U.S.C. 103 as being unpatentable over Erosherko et al., (WO2019/060631A1, published 2019; hereinafter as “Erosherko”), Liu Quanjun et al., (CN110982877, published April 2020; hereinafter as “Liu”), Akeson et al., (US2002/0142344A1, published 2002, hereinafter as “Akeson”), and Guo et al., (US20230203555A1, published June 29, 2023, hereinafter as “Guo”).
This rejection is a new rejection necessitated by amendments to the claims, and any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
Applicant has elected the species of four consecutive adenine nucleobase, and the specifications states that Table 1: Exemplary promoter proximal sequence with T7 promoter (i.e. SEQ ID NO: 9) (see Spec. e.g. Table 1, page 32). Furthermore, the specification recites that the recombinant polynucleotide of any one of the preceding embodiments (i.e. embodiment 53, SEQ ID NO: 9), wherein the sequence encoding the target is situated 3' of the promoter proximal sequence (see Spec. para, 364-372, pages 60-61).
Regarding claim 53, 57-64, 68-70, and 82, Erosherko discloses a recombinant polynucleotide sequence comprising: (i) a promoter sequence comprising a 5' end and a 3' end (i.e. from bacteriophage T7)(see e.g. para. 86-89, 92, 347-403, Example 7, fig. 4-7)(see sequence results below for SEQ ID NO:6 Result 1, file: Published Applications NA Main, us-19-272-607a-6.align450.rnpbm; Database (Dd) SEQ ID NO: 57 is 100% match to Applicant’s SEQ ID NO: 6) and (iii) a sequence encoding a target, wherein the sequence encoding the target is operably linked to a 3' end of the promoter proximal sequence (e.g. oligonucleotide)(see e.g. para. 3-8, 13, 45, 86, 92-95, 149-156, 185, 397; Example 7, fig. 4-7).
[AltContent: textbox ([img-media_image1.png]
[img-media_image1.png]See Result 1 for SEQ ID NO: 6 )]Erosherko does not explicitly disclose a (ii) a promoter proximal sequence adjacent to the 3' end of the promoter sequence, wherein the promoter proximal sequence comprises four or more consecutive nucleotides having an adenine nucleobase.
However, the prior art of Liu discloses (ii) a promoter proximal sequence adjacent to the 3' end of the promoter sequence, wherein the promoter proximal sequence comprises ten consecutive nucleotides having an adenine nucleobase (i.e. see sequence results below for SEQ ID NO: 9, Result 25, file: N Geneseq, us-19-272-607a-6.align450.rng, Database (Dd) SEQ ID NO: 2 is 82.2% and Query match and 96.9% best local similarity match to Applicant’s SEQ ID NO: 9). Further, Liu discloses that connecting a promoter sequence to the tail end of a DNA sequence allows for storing information (see claims 1-4).
[AltContent: textbox ([img-media_image2.png]
[img-media_image3.png]
See Result 25 for SEQ ID NO: 9)]Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have combined the recombinant polynucleotide sequence, as taught by Erosherko, to incorporate the T7 promoter proximal sequence comprises ten consecutive nucleotides having an adenine nucleobase, as taught by Liu, with a reasonable expectation of success because one of ordinary skill in the art would know adding the consecutive adenine bases would avoid damage of the traditional PCR reading method to the high-temperature denaturation of the nucleic acid sequence, and the sequence would be able have infinite repeated information reading, as well as mass information copying without damaging the original sequence (see Liu, disclosure of the invention section). Further, Liu discloses a method for repeatedly reading nucleic acid information based on RNA transcription can avoid the damage of high temperature denaturation of nucleic acid sequences by traditional PCR reading methods (see e.g. abstract). Moreover, an artisan of ordinary skill in the art of (i.e. recombinant polynucleotide technology) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007). In the instant case, both Erosherko and Liu disclose methods utilizing the T7 promoter (see e.g. Example 7 of Erosherko and Example 1 of Liu). Therefore, it would have been obvious for a person of ordinary skill in the art to have combine known prior art elements (i.e. T7 promoter sequences) to yield predictable results with a reasonable expectation of success.
Regarding claim 60, Erosherko and Liu do not explicitly disclose a sequence wherein the promoter proximal sequence comprises twelve or more consecutive nucleotides having an adenine nucleobase.
However, the prior art of Akeson disclose a sequence wherein the promoter proximal sequence comprises twelve or more consecutive nucleotides having an adenine nucleobase (see sequence results below for SEQ ID NO:10, Results 5, file Published Applications NA Main, us-19-272-607a-10.rnpbm, Database (Dd) SEQ ID NO: 57 is 100% match to Applicant’s SEQ ID NO: 10), which create specific polymeric blocks of interest (i.e. polyA block), which can be an easily distinguishable pattern (see e.g. 43-46, 57, 68, 105 and 124, claim 1, and fig. 7).
[AltContent: textbox ([img-media_image4.png]
See Result 5 for SEQ ID NO: 10)]Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have combined the recombinant polynucleotide sequence, as taught by Erosherko, to incorporate the T7 promoter proximal sequence comprises twelve consecutive adenine nucleotides having an adenine nucleobase, as taught by Akeson, with a reasonable expectation of success because one of ordinary skill in the art would know that the addition of twelve consecutive adenine nucleotides would create a specific signal (e.g. ionic current), which would allow for detection of the consecutive adenine sequences(i.e. polyA block)(see e.g. paras. 105 and fig. 7). Further, Akeson discloses that targeted blocks of consecutive adenine nucleotides allows for a variety of different applications to detect the targeted sequence of interest (see e.g. abstract). Moreover, an artisan of ordinary skill in the art of (i.e. recombinant polynucleotide technology) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007). In the instant case, both Erosherko and Akeson disclose methods utilizing the T7 promoter (see e.g. Example 7 of Erosherko and section 2 of Akeson). Therefore, it would have been obvious for a person of ordinary skill in the art to have combine known prior art elements (i.e. T7 promoter sequences) to yield predictable results with a reasonable expectation of success.
Regarding new claim 83, Erosherko, Liu, and Akeson do not explicitly disclose a polynucleotide sequence comprising SEQ ID NO: 72.
[AltContent: textbox ([img-media_image5.png]
See Result 1 for SEQ ID NO: 72)]However, the prior art of Guo discloses a polynucleotide comprising the sequence of SEQ ID NO:72, which has four or more (i.e. six) consecutive nucleotides having an adenine nucleobase (see sequence results below for SEQ ID NO: 72, Result 1, file Published Applications NA Main, us-19-272-607a-72.rnpbm, Database (Dd) SEQ ID NO: 43 is 91% match to Applicant’s SEQ ID NO: 72). Further, Guo discloses that the use of the nucleic acid construct in a yeast-based in vitro biosynthesis system (such as a yeast-based in vitro protein synthesis system) can significantly improve protein synthesis efficiency using specific primers (see e.g. abstract, table 2).
Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have combined the recombinant polynucleotide sequence (i.e. SEQ ID NO: 6), as taught by Erosherko, to incorporate the polynucleotide comprising the sequence of SEQ ID NO:72, as taught by Guo, with a reasonable expectation of success because one of ordinary skill in the art would know that the use of the nucleic acid construct in a yeast-based in vitro biosynthesis system can significantly improve protein synthesis efficiency (as taught by Guo, see e.g. abstract, table 2). Moreover, an artisan of ordinary skill in the art of (i.e. recombinant polynucleotide technology) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007). In the instant case, both Erosherko and Guo disclose methods utilizing the T7 promoter (see e.g. Example 7 of Erosherko and Table 2 of Guo). Therefore, it would have been obvious for a person of ordinary skill in the art to have combined the known prior art elements (i.e. T7 promoter sequences) to yield predictable results with a reasonable expectation of success.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues that the claims are unobvious over Getts et al., (US2008/0160581A1, published 2008), in view of Felletti, et al. (Elife 10: e71611, published 2021), and Collins et al., (WO2010/075441A1, published 2010, hereinafter as “Collins”).
Applicant arguments are acknowledged, have been fully considered, and have been deemed partially persuasive. Thus, Applicant’s arguments with respect to the previous rejection of the claims over Getts et al., in view of Felletti, et al., and Collins et al. have been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Erosherko et al., (WO2019/060631A1, published 2019; hereinafter as “Erosherko”), Liu Quanjun et al., (CN110982877, published April 2020; hereinafter as “Liu”), Akeson et al., (US2002/0142344A1, published 2002, hereinafter as “Akeson”), and Guo et al., (US20230203555A1, published June 29, 2023, hereinafter as “Guo”).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Erosherko et al., (WO2019/060631A1, published 2019; hereinafter as “Erosherko”), Liu Quanjun et al., (CN110982877, published April 2020; hereinafter as “Liu”), Akeson et al., (US2002/0142344A1, published 2002, hereinafter as “Akeson”), and Guo et al., (US20230203555A1, published June 29, 2023, hereinafter as “Guo”), as applied to claims 53, 57-64, 68-70, and 82-83 above, and further in view Imburgio, Diane, et al. (Biochemistry 39.34: 10419-10430, published 2000, hereinafter as “Imburgio”; prior art of record), and Sorge, Joseph (WO2002/031200 A1, published 2002, hereinafter as “Sorge”; prior art of record).
This rejection is a new rejection necessitated by amendments to the claims, and any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection.
The teachings of Erosherko et al. apply here as indicated above.
Regarding claim 55, as discussed above, Erosherko et al. discloses a recombinant polynucleotide sequence. Additionally, the prior art of Liu discloses that adding the consecutive adenine bases would avoid damage of the traditional PCR reading method to the high-temperature denaturation of the nucleic acid sequence, and the sequence would be able have infinite repeated information reading, as well as mass information copying without damaging the original sequence (see Liu, disclosure of the invention section). Further, Liu discloses a method for repeatedly reading nucleic acid information based on RNA transcription can avoid the damage of high temperature denaturation of nucleic acid sequences by traditional PCR reading methods (see e.g. abstract).
Erosherko et al. does not explicitly disclose that when paired with a complementary sequence of nucleotides, the promoter proximal sequence has a lower melting temperature than a comparable reference promoter proximal sequence, wherein the comparable reference promoter proximal sequence comprises a lesser number of consecutive nucleotides comprising an adenine nucleobase as compared to the promoter proximal sequence.
Nevertheless, the prior art of Imburgio discloses various upstream binding regions with T7 promoter variants (see e.g. page 1-2). Further, the prior art of Sorge discloses that GC base pairs are more stable than AT pairs because their bases are held together by three hydrogen bonds rather than by two, thus the AT-rich regions of DNA are the first to melt (see e.g. Section “A. Melting Temperature Assay”).
Accordingly, prior to the effective filing date of the instant claimed invention, it would have been prima facie to obvious for a person of ordinary skill in the art to have had the recombinant polynucleotide, as taught by Erosherko et al.,, with a lower melting temperature than that of a comparable reference promoter proximal sequence with a reasonable expectation of success because one of ordinary skill in the art would know that any promoter proximal sequence that comprises a lesser number of consecutive nucleotides comprising an adenine nucleobase as compared to the promoter proximal sequence with more would naturally have a higher melting temperature as taught by Sorge because the comparable sequence would have more GC base pairs that have a higher melting temperature. Further, one of ordinary skill in the art would have predictable results with a reasonable expectation of success because the prior art of Imburgio discloses that one of ordinary skill in the art would be able to design the sequences, and thus optimize the melting temperature of the comparable sequence through routine optimization.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant argues that the claims are unobvious over Getts et al., (US2008/0160581A1, published 2008), in view of Felletti, et al. (Elife 10: e71611, published 2021), and Collins et al., (WO2010/075441A1, published 2010, hereinafter as “Collins”), and further in view of Eroshenko and Namdev.
Applicant arguments are acknowledged, have been fully considered, and have been deemed partially persuasive. Thus, Applicant’s arguments with respect to the previous rejection of the claims over Getts et al., in view of Felletti, et al., Collins et al., and further in view of Eroshenko and Namdev. have been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Erosherko et al., (WO2019/060631A1, published 2019; hereinafter as “Erosherko”), Liu Quanjun et al., (CN110982877, published April 2020; hereinafter as “Liu”), Akeson et al., (US2002/0142344A1, published 2002, hereinafter as “Akeson”), and Guo et al., (US20230203555A1, published June 29, 2023, hereinafter as “Guo”). In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claim is allowed.
Applicants’ 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPHINE GONZALES whose telephone number is (571)272-1794. The examiner can normally be reached M-Th: 10AM - 5:00PM (EST).
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Josephine Gonzales PhD
Examiner
Art Unit 1638
/JOSEPHINE GONZALES/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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