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 appears filed 1/22/2026.
Claims 119, 123, 125-127, 129-134, 136-137, 149-153 are pending. Claims 1-118, 120-122, 124, 128, 135, 138-148 are cancelled.
The following rejections are maintained. Response to arguetmsn follows.
This action is FINAL.
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) 119, 123, 125-127, 129-134, 136-137, 149-153 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (US Patent Application Publication 2015/0004598 January 1, 2015) in view of Schwartz et al (WO 2012/071428 May 2012 cited on IDS).
With regard to claim 119 and 123, Gao et al. teaches a composition comprising an antibody conjugated to a nucleic acid and a detectable moiety (para 19, 126, and 255). As the first and second cellular component binding reagent can encompass antibodies and Gao et al. teaches compositions of a first and second antibody-nucleic acid complex (para 11), Gao et al teaches these structures. Further Gao et al. teaches luminescent moiety on the oligonucleotides structure (para 17 and 191). The claims are drawn to a first cellular component binding reagent is attached to a cellular component binding reagent specific oligonucleotide and a second cellular component binding reagent attached to a cellular component binding reagent attached to a cellular component biding reagent specific oligonucleotide that is not associated with a luminescent moiety, Gao et al. does not teach therefore disclose a cellular comprising binding reagent that is not associated with a luminescent. Gao et al teaches that the nucleic acids comprise a sequence complementary to another identifier sequences (para 267-269). Gao et al. teaches an excess of antibodies (para 475 and 477).
With regard to claim 125, Gao et al. teaches a structure of a detectable moiety that is a fluorescent moiety (para 283).
With regard to claim 126-127, Gao et a. teaches multiple antibodies-DNA constructs that would be considered cellular component binding reagent and therefore would include at least one more additional reagents and labeled nucleic acids (para 126).
With regard to claim 129 and 134, Gao et al. teaches a compositing comprising multiple antibody conjugated to a nucleic acid and a detectable moiety attached to a sample , and as such teaches the required structures of the claims (para 19, 126, and 255).
Claims 130, Gao et al. teaches a reagent specific oligonucleotide that comprises a detectable moiety (para 255).
With regard to claim 131-132, Gao et al teaches the nucleic acids comprise a sequence hybridized and complementary to another identifier sequences (para 267-269).
With regard to claim 133, Gao et al. teaches a structure of a detectable moiety that is a fluorescent moiety (para 283).
With regard to claim 136, Gao et al. teaches a structure of a detectable moiety that is a fluorescent moiety (para 283).
With regard to claim 137 , Gao et a. teaches multiple antibodies-DNA constructs that would be considered cellular component binding reagent and therefore would include at least one more additional reagents and labeled nucleic acids (para 126). Further Gao et al. teaches reagents (antibodies) that do not conjugate (not associated) (para 126-128).
With regard to claim 149-150, Gao et al. teaches a compositing comprising an antibody conjugated to a nucleic acid and a detectable moiety (para 19, 126, and 255). As the first and second cellular component binding reagent can encompass antibodies and Gao et al. teaches compositions of a first and second antibody-nucleic acid complex (para 11), Gao et al teaches these structures. Further Gao et al. teaches luminescent moiety on the oligonucleotides structure (para 17 and 191). Therefore Gao et al. teaches the structural components of the kit.
With regard to claim 151, Gao et al. teaches a structure of a detectable moiety that is a fluorescent moiety (para 283).
With regard to claims 152-153, Gao et al. teaches that the luminescent oligonucleotides can further include affinity molecules (para 125). This would be considered an additional cellular component binding reagent.
The claims are drawn to a first cellular component binding reagent is attached to a cellular component binding reagent specific oligonucleotide and a second cellular component binding reagent attached to a cellular component binding reagent attached to a cellular component biding reagent specific oligonucleotide that is not associated with a luminescent moiety, Gao et al. does not teach therefore disclose a cellular comprising binding reagent that is not associated with a luminescent.
With regard to claims 119, 123, 149-150, Schwartz et al detection assays for detecting a target using binding moieties. Schwartz et al teaches that the oligonucleotide-signal generating moiety hybrids can be stabilized with unconjugated oligonucleotides or duplex stabilizers which would not have a luminescent moiety (para 97, 99, 284).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of filing to modify Gao to include a second cellular component binding reagent attached to a cellular component biding reagent specific oligonucleotide that is not associated with a luminescent moiety in order to include a stabilizer of unconjugated oligonucleotides or duplex stabilizers of Schwartz et al. to stabilize the detecting binding moieties (see para 284 of Schwartz). The ordinary artisan would be motivated to modify the method and product of Gao et al. to further include a stabilizer for the targets.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is set forth below with response to arguments following. The reply provides two embodiments presented in the figures (figure 9 and 12) (p. 7). However, it is noted that the structures recited in the drawings are not the same as the structure claimed in the art disclosed. As such the arguments appear to be directed to the structure in the specificaoin and not the structure claimed. The reply asserts that the kit is used in the method of figure 12 (p. 8), however, the claims are drawn to structures and not method. Furthermore, it is noted that the structure of the figure is not the same scope as is claimed.
The reply asserts that the methods of Gao and Schwartz involve detectably labeling all antibodies labeling cells and not a subset (p. 9). The reply asserts that therefore the references do not suggest “each different analyte is bound to a different label moiety such that each different analyte has a detectable signal” (p. 9). The reply asserts that Gao fails to teach or suggest having an excess of cellular component binding not associated with label nucleic acids relative to cellular reagents as the recitation in paragraph 475 is based upon secondary antibodies not associated with oligonucleotides (p. 9-10).
This argument has been reviewed but have not been found persuasive.
It is noted that the claims are not limited to antibody labeling cells. With regard to subset, the claim indications that the plurality of label nucleic acids are complementary to only a subset of reagent specific oligonucleotides. Although Gao et al. does not teach this structure, the combination with Schwartz suggests multiple binding reagents and therefore suggests subsets thereof. Further it is noted that the kit itself comprises plurality of cellular component binding reagents and plurality of label nucleic acids. This structure does not preclude having multiple other reagents in the kit (such as subsets).
The reply asserts that Schwartz states that the allow detection of the binding of each antibody independently in a single experiment indicates that the method of Schwartz is intended to couple every signal generator to every antibody oligonucleotide conjugate (p. 10). The reply asserts that Schwartz does not suggest a cellular component binding reagent because the only section in which a complementary oligonucleotide is used as a duplex stabilizer is within the universal oligonucleotide section (p. 10-11).
This argument has been reviewed but have not been found persuasive.
Schwartz et al detection assays for detecting a target using binding moieties. Schwartz et al teaches that the oligonucleotide-signal generating moiety hybrids can be stabilized with unconjugated oligonucleotides or duplex stabilizers which would not have a luminescent moiety (para 97, 99, 284). As such the newly applied combination teaches the recited limitation of the reagent that is “not associated with a luminescent”. The reply asserts that the Schwartz only teaches a duplex stabilizer within the universal oligonucleotide section, however, the kit does not particularly limit the type of cellular binding reagents, nucleic acids or specific oligonucleotides, and as such are encompassed by the structures provided in the combination.
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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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
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