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 .
Election/Restrictions
Applicant’s election without traverse of Group 1: claims 1-2, 6-7, 10-11, 15, and 69 in the reply filed on 01/22/2026 is acknowledged.
Claims 16-17, 21, 25, 27, 34-35, 38-39, 43, 45-47, 52, 57-59, 62, 65, and 67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/22/2026.
Status of the Claims
Claim 69 has been added by Applicant. Claims 3-5, 8-9, 12-14, 18-20, 22-24, 26, 28-33, 36-37, 40-42, 44, 47, 49-52, 54-56, 60-61, 63-64, 66 and 68 are canceled. Claims 1-2, 6-7, 10-11, 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 1, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. In this case, claim 1 recites “for removing one or more bound detection agent from a stained biological sample or surface”. This is considered an intended use that does not impart any structural difference to the composition to differentiate the claimed composition from the composition in the prior art described herein.
Further, claims 2 and 15 are directed to limit the intended use of the claimed composition and, therefore, fail to meaningfully limit independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 7, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2020/097509 A1, “METHODS AND COMPOSITIONS FOR MESSENGER RNA PURIFICATION” (published 05/14/2020, referred to herein as Abysalh).
Regarding claim 1, as discussed above, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. In this case, claim 1 recites “for removing one or more bound detection agent from a stained biological sample or surface”. This is considered an intended use that does not impart any structural difference to the composition to differentiate the claimed composition from the composition in the prior art described herein.
Regarding claims 1, 6, 7, and 10, Abysalh teaches a buffer composition comprising a denaturing salt and a reducing agent (para. 0005, lines 3-4). Abysalh teaches that the denaturing salt is guanidine thiocyanate (para. 0010, line 1) and the reducing agent is THPP (para. 0012, lines 1-3).
Regarding claim 11, Abysalh teaches GTC at 5 M and THPP at 15 mM. THPP has a molar mass of 208.23 g/mol, which results in a buffer with 3.12 mg/mL THPP.
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.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Abysalh.
Regarding claim 69, Abysalh teaches a composition with a GTC concentration of about 2.5 M (para. 0011, lines 1-2) and a DTT concentration range of between 5 mM and 50 mM.
However, Abysalh does not specifically teach THPP at a concentration range of 5 – 50 mM.
Abysalh does teach that DTT or THPP can be used as the reducing agent in the buffer (para. 0012).
It would have been obvious to one of ordinary skill in the art to modify the buffer with a concentration range of 5-50 mM DTT by substituting DTT with THPP, as taught by Abysalh. Doing so is considered to be a mere simple substitution of one known element for another to obtain predictable results (See MPEP 2143(I)(B)). Abysalh teaches that DTT and THPP are interchangeable as the reducing agent in the buffer composition (para. 0012). THPP has a molar mass of 208.23 g/mol; therefore, a range of 5-50 mM results in a range of about 1-10 mg/mL, which contains the claimed concentration of about 5 mg/mL.
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 March 5, 2026