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 .
Status of the Claims
Claim 10 has been cancelled. Claims 1-2, 6-7, 11, 15, and 69 are pending and are examined herein.
Priority
This application, filed 05/08/2023, claims benefit of 63/339,703, filed 05/09/2022. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 05/09/2022.
Information Disclosure Statement
The Information Disclosure Statement filed 11/02/2023 is acknowledged and has been considered.
Withdrawn Rejections/Objections
The rejection of claims 2 and 15 under 35 U.S.C. 112(b) is withdrawn in response to Applicant’s amendment.
The rejection of claims 1, 6, 7, 10, and 11 under 35 U.S.C. 102(a)(1) and (a)(2) is withdrawn in response to Applicant’s amendment.
The rejection of claim 69 under 35 U.S.C. 103 is withdrawn in response to Applicant’s amendment.
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.
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 1, 2, 6, 7, 11, 15, and 69 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/094332 A1, “REAGENTS FOR MASSIVELY PARALLEL NUCLEIC ACID SEQUENCING” (published 05/05/2022, referred to herein as Arslan).
Regarding claims 1, 2, 6, 7, 11, 15, and 69, Arslan teaches a reagent composition, i.e. a nucleic acid hybridization reagent, comprising a reducing agent and a chaotropic agent, i.e. a denaturant (para. 00181, lines 1-5). Arslan teaches that the reducing agent comprises about 12-25mM THPP (para. 00643, lines 1-11) and the chaotropic agent comprises 2-3M guanidine thiocyanate (para. 00647, lines 1-8). Regarding the range of 25-50mM THPP, using THPP’s molecular weight of 208.23 g/mol, Arslan teaches a range of about 5 to 10 mg/ml. Regarding the functional limitations of “wherein the composition removes one or more bound detection agents from a stained biological sample or surface” (instant claim 1) and the recitation of samples and surfaces in claim 2, the composition taught by Arslan is considered capable of performing the claimed functions due to being chemically identical to the claimed composition. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. (See MPEP 2112.01(II) “Composition Claims – If the composition is physically the same, it must have the same properties”).
However, Arslan does not teach the specific combination of THPP and GTC at the specific claimed concentrations in a single reagent composition.
It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to use THPP and GTC as the reducing agent and chaotripic agent, respectively, at the claimed concentrations, which fall within the ranges taught by Arslan, together in a single composition in order to create a nucleic acid hybridization reagent. Doing so is considered to be using the components and concentrations taught by Arslan of the reagent taught by Arslan for the intended purpose taught by Arslan.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 6-7, 11, 15, and 69 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677
September 18, 2026
Prosecution Insights