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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/17/2026 was filed after the mailing date of the Non-final Rejection on 05/18/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of claims / Response to Amendment
This office action is in response to an amendment filed on August 17, 2026.
Claims 26-33, 35-37, 40-55 and 57 were previously pending. Applicant amended claim 26.
Claims 26-33, 35-37, 40-55 and 57 are currently pending, with claims 51-52 and 54 withdrawn. Claims 26-33, 35-37, 40-50, 53, 55 and 57 are under examination.
All of the previously presented rejections have been withdrawn as being obviated by the amendment of the claims, which introduces new combinations of elements that were not previously considered in the prior rejection (e.g., the amended claim 26 now requires the oligonucleotides of the first solvent are insufficient to amplify and detect both the first AND second forms of the analyte, which was not presented in prior claims and not considered in the prior office action.)
Thus, the scope of the claims has been changed in a manner that were not considered in the previous rejections.
Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
This office action contains new grounds for rejection necessitated by amendment.
Priority
The priority date of the instant claims 26-33, 35-37, 40-50, 53, 55 and 57 is August 17, 2026, the date on which the claims were amended with additional limitations, not disclosed by prior-filed applications.
Applicant’s claim for the benefit of prior-filed applications under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
When claims are amended to include subject matter not originally disclosed in the specification, the effective filling date for those amended claims becomes to the date of amendment. This is because per MPEP 211.01, claims are entitled to the benefit of the filling date of the application only if the disclosure of the application supports the claims under 35 U.S.C. 112(a).
Further, MPEP 211.05 states:
“Under 35 U.S.C. 119(e), the written description and drawing(s) (if any) of the provisional application must adequately support and enable the subject matter claimed in the nonprovisional application that claims the benefit of the provisional application. In New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294, 63 USPQ2d 1843, 1846 (Fed. Cir. 2002), the court held that for a nonprovisional application to be afforded the benefit date of the provisional application, "the specification of the provisional must ‘contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms,’ 35 U.S.C. 112¶1, to enable an ordinarily skilled artisan to practice the invention claimed in the nonprovisional application."
“Under 35 U.S.C. 120, a claim in a U.S. application is entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) except for the best mode requirement, in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). “
In this case, the specifications of the instant application, as well as earlier filed provisional and nonprovisional applications do not adequately support the amended claims. Specifically, there is no written description support for any oligonucleotide in the first solvent that can meet the claimed limitation of being insufficient to amplify and detect the first AND the second form of the analyte, as required by amended claim 26.
Therefore these claims cannot receive the benefit of the earlier filling date and are instead accorded the filling date on which the amendment was made.
If the applicant disagrees with the examiner's determination of the priority date, the burden shifts to the applicant to provide evidence demonstrating that the claims are supported by the disclosure in the earlier application. Such as providing specific references (e.g. paragraphs, figures, examples, etc.) in the prior application that correspond to the elements of each disputed claim. Additionally, the applicant should explain how these references are sufficient in complying with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
Claim 26 recites the term "analyzer" in "providing a sample to an analyzer." The application's disclosure does not expressly define "analyzer" with any structural features.
Thus, the term "analyzer" is interpreted under BRI as any entity capable of performing any analyzing function in a process, encompassing analytical devices such as a spectrophotometer that analyzes absorbance of a sample, or a lab technician who performs analytical tests.
Claim 26 recites "analyte specific reagent (ASR)," which is defined in the specification as follows:
“Analyte-specific reagents” or “ASRs” refer to reagents that interact specifically with a single analyte or substance generated in the presence of an analyte. For example, in a PCR assay, primers and probes for a single analyte would be considered ASRs. In an ELISA assay, a primary antibody that recognizes a single analyte would be considered an ASR. " ([00126])
Claim 26 recites "in vitro diagnostic (IVD)," which is defined in the specification as follows:
"An “in vitro diagnostic” or “IVD” is a product used to perform an assay on a biological sample in isolation from the source of the sample. Where the source is a multicellular organism, a sample is generally obtained from the organism and then subjected to analytical procedures (e.g., amplification and/or binding reactions) in an artificial environment, e.g., a reaction vessel." ([00127])
New Grounds of Rejections - 35 USC § 112(b)
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.
Claims 26-33, 35-37, 40-50, 53, 55 and 57 are rejected under 35 U.S.C. 112(b), 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.
Regarding claim 26, the claim recites a first solvent "that contains one or more oligonucleotides which, in combination with the oligonucleotides of the amplification reagent, are sufficient to amplify and detect a second region of a second form of the analyte." The claim further recites that the oligonucleotides of the first solvent are insufficient to amplify and detect both the first and second forms of the analyte:
"wherein the one or more oligonucleotides of the first solvent are insufficient to amplify and detect the first form of the analyte,
wherein the one or more oligonucleotides of the first solvent are insufficient to amplify and detect the second form of the analyte."
These limitations are indefinite because neither the claim nor the specification describe any oligonucleotide structure or composition in the first solvent that directly support or relates to the recited functional language, specifically, oligonucleotides of the first solvent that are insufficient to amplify and detect both the first and second forms of the analyte.
Therefore, it is unclear what structural or compositional features the oligonucleotides must have to be sufficient, in combination with the amplification reagent, to amplify and detect the second form of the analyte, while also being insufficient to amplify and detect both the first and second forms of the analyte.
It is also unclear whether the recitations merely mean that the first solvent comprising the oligonucleotides lacks other reagent components necessary for amplification, such as DNA polymerase, and therefore must be combined with the amplification reagent to carry out amplification; or whether the limitations require specific oligonucleotide structures that satisfy the recited functional requirements.
Claims 27-33, 35-37, 40-50, 53, 55 and 57 are rejected for depending from claim 26 and not remedying the indefiniteness.
New Grounds of Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 26-33, 35-37, 40-50, 53, 55 and 57 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 26, the claim recites a first solvent "that contains one or more oligonucleotides which, in combination with the oligonucleotides of the amplification reagent, are sufficient to amplify and detect a second region of a second form of the analyte." The claim further recites that the oligonucleotides of the first solvent are insufficient to amplify and detect both the first and second forms of the analyte:
"wherein the one or more oligonucleotides of the first solvent are insufficient to amplify and detect the first form of the analyte,
wherein the one or more oligonucleotides of the first solvent are insufficient to amplify and detect the second form of the analyte."
These limitations lack written description support because the specification does not describe any oligonucleotide structure or composition in the first solvent that are insufficient to amplify and detect both the first AND second forms of the analyte.
Although the specification discloses oligonucleotides of the first solvent that are insufficient to amplify and detect the first OR the second form of the analyte ([0049]; [0052]; [0056]; [00327]; [000328]; [00329]), it does not provide written description support for any oligonucleotide in the first solvent that can meet the claimed limitation of being insufficient to amplify and detect the first AND the second form of the analyte, as required by the claim.
Therefore, the application's disclosure does not meet the written description requirement under 35 U.S.C. 112(a), for there is insufficient disclosure that convey to a person skilled in the art that the inventor was in possession of the full breadth of the claim at the time of filling.
Claims 27-33, 35-37, 40-50, 53, 55 and 57 are rejected because they depend from claim 26 and inherit the deficiencies of the base claim.
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.
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/TIAN NMN YU/Examiner , Art Unit 1681 /AARON A PRIEST/Primary Examiner, Art Unit 1681
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