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 .
This action is in response to papers filed 6/03/2026.
Claims 1, 3-10,12,14-18,20,22-26,28-29,31-35 are pending. Claims 2, 11,13,19,21,27,30,36-70 have been cancelled.
The following rejections are newly applied necessitated by amendment. Response to arguetmsn following.
It is noted that no objections to the drawings have been recited.
This action is FINAL.
Withdrawn Rejections
The 35 USC 112b and 35 USC 102 and 35 USC 103 rejections made in the previous office action are withdrawn based upon amendments to the claims.
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.
Claims 1, 3-10 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Song et al. (US Patent Application Publication 20170298422 October 19, 2017).
The claims have been amended such that the “second polynucleotide” comprise a modified base opposite to the methylcytosine and that codified based capable targeting to a fluorophore. Further the claims is amended to include “first polynucleotide comprises a methylcytosine”.
With regard to claim 1, Song et al. teaches two polynucleotides with one comprising a methylcytosine and a second with a modified base and a fluorophore (solvatochromatic nucleoside) (para 7-9, 59-60).
With regard to claims 3-4, Song et al. teaches detection of a fluorophore that is responsive to excitation inducted by protein (para 7 and 59).
With regard to claim 5, Song et al. teaches the protein is coupled with the protein (para 3).
With regard to claim 6, Song et al. teaches coupling such that the first polynucleotide and second are hybridized (figure 1A).
With regard to claims 7-10, Song et al. teaches that there are first, and second intensities based upon the hybridization (para 109-117).
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) 12, 14-18,20,23,25,28-29,31-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US Patent Application Publication 20170298422 October 19, 2017) in view of Schildkraut et al. (US Application Publication 2018/0195061 July 12, 2018).
Song et al. teaches two polynucleotides with one comprising a methylcytosine and a second with a modified base and a fluorophore (solvatochromatic nucleoside) (para 7-9, 59-60).
However, Song et al. teaches that the targets can be proteins, however, does not teach that the targets comprise epitope and antibody.
With regard to claim 12, Schildkraut et al. teaches a method of using modified guanine or adenine (para 193).
With regard to claims 14 and 20, Schildkraut et al. teaches a method of labeling an oligonucleotide with a SNAP or Clip tag (para 6). Schildkraut et al. teaches that the SNAP or Clip with benzylcytosine (para 199). Schildkraut et al. suggests methods of detecting changes including methylcytosine (para 193).
With regard to claim 15, Schildkraut et al. teaches that the fluorophore is attached to a second protein (para 211).
With regard to claim 16-17, Schildkraut et al. teach multiple proteins that bind to the fluorophore (para 199-204). Schildkraut et al. teaches an epitope finding to an antibody (para 211).
With regard to claim 18, Schildkraut et al. teaches that the first protein can be coupled tot eh second with a linker (para 122).
With regard to claim 23, Schildkraut et al. teaches a method of using biotin and streptavidin (para 10).
With regard to claim 25, Schildkraut et al. teaches FRET labeling (para 211) so that the fluorophore is split between a quencher on one protein and a reporter on another protein.
With regard to claims 28-29, Schildkraut et al. teaches that the polynucleotides can be hybridized prior to coupling and coupling to a substrate (para 101-128 and 146).
With regard to claims 31-32, Schildkraut et al. teaches a substrate (microbead) coupled to multiple oligonucleotides that are coupled to a code (affinity tag) (para 28-29).
With regard to claim 33, Schildkraut et al. teaches that the oligonucleotide of interest can be attached to a bead by an oligonucleotide (para 105-120).
With regard to claim 34, Schildkraut et al. teaches a microbead (para 109).
With regard to claim 35, Schildkraut et al. suggests using suggested methods of detecting changes including methylcytosine (para 193).
Therefore, it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Song et al. to include the affinity tag and microbead of Schildkraut et al. in order to detect methylcytosine in a sample of interest. The ordinary artisan would have a reasonable expectation of success as Schildkraut et al. suggests methods of methylcytosine detection using these tag constraints. It would be obvious to one of ordinary skill in the art to modify Balmforth et al. to use on of the finite methods of label detection including the one taught by Schildkraut et al. in order to detect changes in a target.
Claim(s) 14 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US Patent Application Publication 20170298422 October 19, 2017) in view of Merriman et al. (US Patent Application Publication 2017/0044605 Feb 16, 2017)
Song et al. teaches two polynucleotides with one comprising a methylcytosine and a second with a modified base and a fluorophore (solvatochromatic nucleoside) (para 7-9, 59-60).
However, Song et al. teaches that the targets can be proteins, however, does not teach that the targets are labeled with a Spycatcher or Spytag.
With regard to claim 14 and 22, Merriman et al. teaches detection of methylcytosine targets with SpyCatcher and SpyTag peptide linkers (para 66).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Song et al. to include the affinity tag with Spycatcher or SpyTag as taught by Merriman et al. in order to detect methylcytosine in a sample of interest. The ordinary artisan would have a reasonable expectation of success as Merriman et al. suggests methods of methylcytosine detection using these tag constraints. It would be obvious to one of ordinary skill in the art to modify Song et al. to use on of the finite methods of label detection including the one taught by Merriman et al. in order to detect changes in a target.
Claim(s) 14 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US Patent Application Publication 20170298422 October 19, 2017) in view of Spiegelman et al (US Patent Application 20210063414 effective filing data 2/12/2018).
Song et al. teaches two polynucleotides with one comprising a methylcytosine and a second with a modified base and a fluorophore (solvatochromatic nucleoside) (para 7-9, 59-60).
However, Song et al. teaches that the targets can be proteins, however, does not teach that the targets comprise His-Tag and NTA.
With regard to claims 14 and 24, Spiegelman et al teaches methlycytosine detection by using his-tag and NTA detection combinations (para 28-32).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Song et al. to include the tag of his-tag and NTA of Spiegelman et al in order to detect methylcytosine in a sample of interest. The ordinary artisan would have a reasonable expectation of success as Spiegelman et al suggests methods of methylcytosine detection using these tag constraints. It would be obvious to one of ordinary skill in the art to modify Song et al. to use on of the finite methods of label detection including the one taught by Spiegelman et al in order to detect changes in a target.
Claim(s) 14 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US Patent Application Publication 20170298422 October 19, 2017) in view of He et al. (US Patent Application Publication 2020/0032330 Jan 30, 2020).
Song et al. teaches two polynucleotides with one comprising a methylcytosine and a second with a modified base and a fluorophore (solvatochromatic nucleoside) (para 7-9, 59-60).
However, Song et al. teaches that the targets can be proteins, however, does not teach that the targets comprise Methyl binding protein.
With regard to claims 14 and 26, He et al teaches methylcytosine detection by using Methly binding proteins (para 10, 44).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Song et al. to include the methyl binding proteins of He et al. in order to detect methylcytosine in a sample of interest. The ordinary artisan would have a reasonable expectation of success as He et al. suggests methods of methylcytosine detection using these tag constraints. It would be obvious to one of ordinary skill in the art to modify Song et al. to use on of the finite methods of label detection including the one taught by He et al. in order to detect changes in a target.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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