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 4/08/2026.
Applicant’s election without traverse of Group I in the reply filed on 8/11/2025 is acknowledged.
Claims 1-3,7-8,13,17,19,51 are pending. Claims 4-6,9-12,14-16,18,20-50 have been cancelled.
Claims 17,19, are withdrawn as being drawn to a nonelected invention.
The following rejections are newly applied as necessitated by amendment.
The following action is FINAL.
Withdrawn Rejections
The 35 USC 112a, 35 USC 112b, 35 USC 103 rejections made in the previous office action is withdrawn based upon amendments to the claims.
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) 1-2,7-8,13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (Genome Medicine 2013 Vol. 5 p. 50).
With regard to claim 1, Shen et al. teaches double stranded probes that are completely complementary (see figure below that starts with P7) (abstract). Shen et al. teaches that this includes a target region, a barcode, a priming section (figure 1, parge 3 and 5) and the complement of each. However, Shen et al. does not teach in the particular order of claimed. It would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to perform a rearrangement of known parts of a structure. The rearrangement of the probe of Shen would be routine optimization of known structures for a polynucleotide probe that comprises the same structural components. These sections would be obvious in view of Shen et al. teaches of the double stranded probes that comprise each of these regions. The rearrangement of the probe structure would allow for the same structural functionality.
With regard to claim 2, Shen et al. teaches a linker sequence blanked by amplification sites (figure 1).
With regard to claim 7, Shen et al. teaches a structures a first and second target polynucleotide sequences (p 2). The regard to the limitation “target polynucleotide sequence is known to have more than one allele” is considered any base pair position.
With regard to claim 8, Shen et al. teaches that the probe can target multiple regions of target loci (para 78). Although Shen et al. does not specifically teach the gap size, “about 2” bp in length, would encompass 1 bp which would be encompassed by two distinct target regions.
With regard to claim 13, Shen et al. teaches a population of probes that comprise DNA (p. 2).
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Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (Genome Medicine 2013 Vol. 5 p. 50)as applied to claims 1-2, 7-8 and 13 in view of Shah et al. (US Patent Application Publication 2020/0165599 May 28, 2020 previously cited).
With regard to claim 1, Shen et al. teaches double stranded probes that are completely complementary (see figure below that starts with P7) (abstract). Shen et al. teaches that this includes a target region, a barcode, a priming section (figure 1, parge 3 and 5) and the complement of each. However, Shen et al. does not teach in the particular order of claimed.
Shen et al. does not teach a spacer sequence..
With regard to claim 3, Shah et al. teaches that probes can include spacer regions between primer regions (para 94-98). Shah et al. teaches that these can include non-nucleotide spacers and therefore would be considered non-human polynucleotide sequences (para 94-98).
Therefore it would be prima facie obvious to the ordinary artisan at the time of the effective filing date to modify Shen et al. to include the spacer of Shah et al in the probe structure. It would be obvious as spacers a known structures within probes that can be used to space out primer target areas for efficiency (para 94-98). Therefore it would be routine to modify the probe of Shen et al. with known structures of probes with the intended outcome of a probe that can be used for detection.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (Genome Medicine 2013 Vol. 5 p. 50) as applied to claims 1-2, 7-8 and 13 in view of LaBaer et al (US Patent Application Publication 2019/0366237 December 5, 2019 previously cited)
With regard to claim 1, Shen et al. teaches double stranded probes that are completely complementary (see figure below that starts with P7) (abstract). Shen et al. teaches that this includes a target region, a barcode, a priming section (figure 1, parge 3 and 5) and the complement of each. However, Shen et al. does not teach in the particular order of claimed.
Shen et al. does not teach a tag..
With regard to claim 51, Labear et al. teaches a Halo fusion tag between the barcode and the target of interests (para 23). Labear et al. teaches a florescent tag (para 30) and as such these can be detected digitally.
Therefore it would be prima facie obvious to the ordinary artisan at the time of the effective filing date to modify Shen et al. to include the tag of Labear in the probe structure. It would be obvious as tags are known structures within probes that can be used to label areas of the probe for detection (para 30, 45). Therefore it would be routine to modify the probe of Shen et al. with known tag structures of probes with the intended outcome of a probe that can be used for detection.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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