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 .
The Applicants’ Amendment to the Claims filed on March 18, 2026 is entered.
Claims 35-38, 40-55 are cancelled.
Claim 60 is new.
Claims 1-34, 39, and 56-60 are pending.
Claims 4, 7, 25-34, 39, and 57-58 are withdrawn.
Claims 1-3, 5, 6, 8-16, 17-24, 56 and 59-60 are under examination.
Priority
This US17/049,748 filed on 10/22/2020 which is a 371 of PCT/US2019/027970 filed on 04/17/2019 claims US priority benefit of US Provisional 62/662,066 filed on 04/24/2018.
Information Disclosure Statement
The IDS filed on 11/21/2025 has been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-24, and 56) in the reply filed on 02/02/2024 is as previously acknowledged.
The following are the elected species:
Low molecular weight carboxylates (1st agent listed in claim 1);
Claim 2, 1st agent (from among claims 2-4; note that claim 3 is examined to elected species of low molecular weight carboxylates);
Claim 6 (from among claims 6-7: elected 2nd agent species being aluminum ammonium sulfate, aluminum ammonium sulfate dodecahydrate, aluminum chloride, aluminum sulfate, erbium (III) acetate, erbium (III) chloride, holmium chloride, zirconium (IV) chloride, or hafnium (IV) chloride;
Species requirement between claims 15 and 16 is WITHDRAWN;
Low molecular weight carboxylates (as 1st agent listed in claim 25);
Low molecular weight carboxylates (as 1st agent listed in claim 29);
Claim 30 (from among claims 30-31); and
Ammonium acetate (as the type of 1st agent listed in parts A and B).
Response to Amendment
All rejections made in the last office action are withdrawn in view of the Applicants’ Amendment to the Claims filed on March 18, 2026.
Claim interpretation
Claims are being construed to read the term “primarily” as meaning more than 50%. This interpretation is consistent with specification. See page 25, lines 5-12 which recites that the term “primarily” means “more than 50%”.
Claim Objections
Currently amended claim 1 is objected to because of the following informalities: Claim 1 recites the term “potion” in lines 9 and 10 which should be amended to “portion”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – new grounds necessitated by amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Currently amended claims 1-3, 5, 6, 8-16, 17-24, 56 and 59-60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of isolating proteins from a biological sample by contacting the sample with a first agent being ammonium acetate at protein-precipitating concentrations in combination with beta-alanine capable of forming weak water-soluble coordination complexes with aluminum or contacting with ammonium acetate at lower concentration wherein the protein precipitating effects of ammonium acetate are eliminated and aluminum coordination by protein side chains are blocked or reduced, where the second agent is aluminum ammonium sulfate, aluminum ammonium sulfate dodecahydrate, aluminum chloride, aluminum sulfate, erbium (III) acetate, erbium (III) chloride, holmium chloride, zirconium (IV) chloride, or hafnium (IV) chloride, does not reasonably provide enablement for the presently claimed method of separating the solid phase of the mixture of step (a) from the liquid phase of the mixture of step (a), wherein the liquid phase contains the proteins from the sample to be isolated, wherein the one or more first agents are primarily in the liquid phase, and the one or more second agents are primarily in the solid phase, and isolating the proteins of interest from the liquid phase of step (b), where the first and second agents are in any concentration and include any type of low molecular weight carboxylates or sulfates, any carboxylate or sulfonated polymers, and the second agent is any multivalent salt and in the presence of any lytic reagent. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands 858 F.2d 731,8 USPQ2nd 1400 (Fed. Cir, 1988).. They include: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The nature of the invention: As explained in the instant Specification and in the Applicants’ Remarks filed on 03/18/2026, the nature of the present invention is a method to isolate protein present in an environmental or biological sample for further analysis. The nature of the invention is to isolate such proteins from the sample by contacting the sample with a first agent being ammonium acetate at protein-precipitating concentrations in combination with beta-alanine capable of forming weak water-soluble coordination complexes with aluminum or contacting with ammonium acetate at lower concentration wherein the protein precipitating effects of ammonium acetate are eliminated and aluminum coordination by protein side chains are blocked or reduced. The nature of the presently claimed invention is to a method of separating the solid phase of the mixture of step (a) from the liquid phase of the mixture of step (a), wherein the liquid phase contains the proteins of interest from the sample to be isolated, wherein the one or more first agents are primarily in the liquid phase, and the one or more second agents are primarily in the solid phase, and isolating the proteins of interest from the liquid phase of step (b).
Breadth of claims: The claims are broad to where the first and second agents are in any concentration and include any type of low molecular weight carboxylates or sulfates, any carboxylate or sulfonated polymers, and the second agent is any multivalent salt and in the presence of any lytic reagent.
The State of the Art: A review of the patent and non-patent literature indicates that the state of the art is unpredictable for isolating a protein of interest from a biological or environmental sample using any concentration of the first and second agents and include any type of low molecular weight carboxylates or sulfates, any carboxylate or sulfonated polymers, and the second agent is any multivalent salt and in the presence of any lytic reagent. For example, the prior art reference of Vlassov et al (WO-2017/044827; of record) discloses a method for isolating biological components being nucleic acids from a biological or environmental sample. For example, Vlassov et al discloses that the sample is a stool sample (page 8, para 2) or soil sample (page 1, para 2; page 8, para 3) using methods steps that are essentially the same as the instant claims. However, Vlassov et al does not disclose isolating a protein of interest of such sample wherein the liquid phase contains the protein of interest but rather discloses precipitating contaminating proteins using such methods.
The Guidance provided in the instant specification & Working Examples:
The specification discloses a method of isolating proteins from a biological sample by contacting the sample with a first agent being ammonium acetate at protein-precipitating concentrations in combination with beta-alanine capable of forming weak water-soluble coordination complexes with aluminum or contacting with ammonium acetate at lower concentration wherein the protein precipitating effects of ammonium acetate are eliminated and aluminum coordination by protein side chains are blocked or reduced, where the second agent is aluminum ammonium sulfate, aluminum ammonium sulfate dodecahydrate, aluminum chloride, aluminum sulfate, erbium (III) acetate, erbium (III) chloride, holmium chloride, zirconium (IV) chloride, or hafnium (IV) chloride.
The specification shows a prophetic, exemplary example 7 of a method for isolating DNA, RNA and proteins from soil or stool samples.
The specification provides two working examples that relates to the presently claimed invention. Specifically, Example 2 showed effects of titration of ammonium acetate on DNA, RNA and protein isolation from stool samples. Example 2 showed various concentrations of ammonium acetate on DNA, RNA, and protein isolation. Example 6 shows effects of beta-alanine on DNA, RNA and protein isolation from stool samples.
The level of skill in the art: The level of skill in the art was high before the effective filing date of the presently claimed invention.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention. See In re Wands 858 F.2d 731,8 USPQ2nd 1400 (Fed. Cir, 1988).
Conclusion
No claims are allowed.
The following references are relevant and though not applied in this office action may be applied in a future office action if appropriate.
Erandi Prashani Mayadunne Dissertation, Ok State Univ 2013 entitled: “Non Polar And Affinity Monolithic Stationary Phases For HPLC Of Larger And Small Molecules And Their Use In A Multi Column Liquid Phase Separation Platform For the Capturing And Fractionation Of Sialoglycoproteins From Human Serum” (of record).
Zhang Dissertation, The Univ of Western Ontario 2006 entitled: “Sub-Microliter Protein & Peptide Sample Preparation by Capillary Electrophoresis” (of record).
Sadilek Dissertation, 2017; of record.
Soberon-Chavez, (Microbiology Monographs 2011, Vol 20: Biosurfactants; of record).
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 CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
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