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 .
DETAILED ACTION
Application status
Claims 1-21 are pending in this application.
Priority
It is acknowledged that the instant application claims the benefit of U.S. Provisional Application No. 63337874, filed on 05/03/2022.
Election
Applicant's election with traverse of Group I, Claims 1-20 and species SEQ ID NO: 3, in the response filed on 04/23/07, is acknowledged
Applicants argue that Restriction Requirements are optional in all cases. M.P.E.P. § 803. If the search and examination of an entire application can be made without serious burden, the Examiner must examine it on the merits, even though it arguably may include claims to distinct or independent inventions. M.P.E.P. § 803. Moreover, it is submitted that Applicant should not be required to incur the additional costs associated with the filing of multiple divisional applications in order to obtain protection for the claimed subject matter.
Additionally, Applicants traverse the restriction requirement on the grounds that it would not place an undue burden on the Examiner to search the subject matter of all the claims, Groups I-II together. Furthermore, Applicants submit that a search directed to one Group would likely yield results applicable to other groups. Applicants request reconsideration and withdrawal of the restriction requirement with respect to Groups I-II.
Applicants traverse the requirement for election of a species on the grounds that a search of all the alleged species could be made by the Examiner without an undue burden, and that the results of any such search would likely bear on all of the alleged species. Thus, Applicant respectfully requests reconsideration and withdrawal of the species election requirement.
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. Contrary to Applicants’ arguments, restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required because all of (a)-(e) of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph (italicized for added emphasis).
Claims 14-15, 17 and 21 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention.
For the reasons provided above, this restriction requirement is deemed proper, and therefore, it is made final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/22/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 18, line 14. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825; Applicants’ attention is directed to the final rulemaking notice published at 55 FR 18230 (May 1, 1990), and 1114 OG 29 (May 15, 1990). To be in compliance, Applicants should identify nucleotide sequences of at least 10 nucleotides and amino acid sequences of at least 4 amino acids in the specification by a proper sequence identifier, i.e., “SEQ ID NO:” (see MPEP 2422.01). If these sequences have not been listed in the computer readable form and paper copy of the sequence listing, applicant must provide an initial computer readable form (CRF) copy of the “Sequence Listing”, an initial paper copy of the “Sequence Listing”, as well as an amendment directing its entry into the specification, and a statement that the content of the paper and CRF copies are the same and, where applicable, include no new matter as required by 37 C.F.R. 1.821(e) or 1.821(f) or 1.821(g) or 1.821(b) or 1.825(d). See particularly “VPGXG” in paragraphs [0024], [0028], [0040], [0042] and [0138] of the specification containing amino acid sequences, and therefore, those sequences should be represented by proper sequence identifier numbers.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 is objected to because the recitation of “RRM-RGG” and “HCV” should be in parenthesis and follow the phrase it abbreviates when used for the first time in a claim. The Examiner suggests replacing the noted phrases with ---RNA recognition motif (RRM) and arginine-glycine-glycine (RGG)--- and ---Hepatitis C Virus (HCV)---, respectively.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
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 5-7 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 applicant regards as the invention.
Claims 5-7 recite a phrase “physiologically relevant sample” which is unclear. It is unclear because what criteria is being applied to determine what is a relevant physiological sample from those that are not relevant as a physiological sample. It is noted by the Examiner that the noted phrase is not defined in the specification. In the interest of advancing prosecution, the phrase is interpreted as “any sample”.
Claim 7 recites the limitation "the physiologically relevant sample" in claim 4. There is insufficient antecedent basis for this limitation in the claim. In the interest of advancing prosecution, claim 7 is interpreted to depend from claim 5.
The following is a quotation 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 1-13, 16 and 18-20 are rejected under 35 U.S.C. § 112(a), written description, as failing to comply with the written description requirement. The claim(s) 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(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a method for isolating nucleic acids from a sample comprising nucleic acids, the method comprising: (a) incubating the sample containing the nucleic acids with a population of polymers that bind the nucleic acids and form a coacervate in a liquid-liquid phase separated (LLPS) solution, wherein the incubating is at a temperature above a concentration dependent phase separation transition temperature of the polymers; (b) decanting the coacervate from the LLPS solution; and (c) separating the nucleic acids from the polymers by adding a salt solution, adjusting the pH, or both to the LLPS solution to disrupt an electrostatic interaction between the nucleic acids and the polymers.
To satisfy the written description aspect of 35 U.S.C. § 112(a) for a claimed genus of [compositions or methods], it must be clear that: (1) the identifying characteristics of the claimed [compositions or methods] have been disclosed, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these; and (2) a representative number of species within the genus must be disclosed.
The Court of Appeals for the Federal Circuit has recently held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as be structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical Inc. v. Gen-Probe Inc. (CAFC (2002) 63 USPQ2d 1609).
University of Rochester v. G.D. Searle & Co. (69 USPQ2d 1886 (2004)) specifically points to the applicability of both Lily and Enzo Biochemical to methods of using products, wherein said products lack adequate written description. While in University of Rochester v. G.D. Searle & Co. the methods were held to lack written description because not a single example of the product used in the claimed methods was described, the same analysis applies wherein the product, used in the claimed methods, must have adequate written description as noted from Enzo Biochemical (see above).
The specification discloses only a single representative species of a method for isolating nucleic acids from a sample comprising nucleic acids, the method comprising: (a) incubating the sample containing the nucleic acids with a population of polycationic elastin-like polypeptide (ELP) having the amino acid sequence as set forth in SEQ ID NO: 9 that bind the nucleic acids and form a coacervate in a liquid-liquid phase separated (LLPS) solution, wherein the incubating is at a temperature above 55 °C which allows the nucleic acids to bind the polycationic ELPs; (b) decanting the coacervate from the LLPS solution; and (c) separating the nucleic acids from the polymers by adding a salt solution by adding 100 mM NaCl, adjusting the pH 8, or both to the LLPS solution to disrupt an electrostatic interaction between the nucleic acids and said ELPs. However, this single disclosed species fails to provide adequate written description for a genus of methods for isolating nucleic acids from a sample comprising nucleic acids, the method comprising: (a) incubating the sample containing the nucleic acids with a population of any polymers having any structure that bind the nucleic acids and form a coacervate in a liquid-liquid phase separated (LLPS) solution, wherein the incubating is at any temperature above a concentration dependent phase separation transition temperature of any polymers having any structure; (b) decanting the coacervate from the LLPS solution; and (c) separating the nucleic acids from the polymers by adding any salt solution at any concentration, adjusting the pH to any pH, or both to the LLPS solution to disrupt an electrostatic interaction between the nucleic acids and the polymers (italicized for added emphasis).
In this case, the specification fails to describe any identification of structural characteristics or properties of any polymers having any structure, and how such widely variant genus of polymers having any structure can bind and release nucleic acids by adding any salt and any concentration, adjusting pH to any pH, at any temperature above a concentration dependent phase separation transition temperature of any polymers having any structure, which can be used in claimed genus of methods for isolating nucleic acids. Please refer to the M.P.E.P. section 2163.05 [R-7.2022] under I, B for more details with respect to sufficient number of representative species that should be disclosed to describe a widely variant genus.
It is noted by the Examiner that claim 13 is included in this rejection because the elected species SEQ ID NO: 3 only describes the structure of 5 amino acids, and the instant specification fails to provide a single working example of performing a claimed method using a peptide as set forth in SEQ ID NO: 3. The Examiner further notes that none of the other dependent claims remedy the deficiencies described above regarding the written description requirement.
Given the lack of additional representative species of a genus of methods as explained above, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112(a) published in the Official Gazette and also available at www.uspto.gov.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 8-13, 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perez et al. ("DNA Binding by an Intrinsically Disordered Elastin-like Polypeptide for Assembly of Phase Separated Nucleoprotein Coacervates", Ind Eng Chem Res, published 11/23/2021, 60, 17408 - 17416).
The instant claims are drawn to a method for isolating nucleic acids from a sample comprising nucleic acids, the method comprising: (a) incubating the sample containing the nucleic acids with a population of polymers that bind the nucleic acids and form a coacervate in a liquid-liquid phase separated (LLPS) solution, wherein the incubating is at a temperature above a concentration dependent phase separation transition temperature of the polymers; (b) decanting the coacervate from the LLPS solution; and (c) separating the nucleic acids from the polymers by adding a salt solution, adjusting the pH, or both to the LLPS solution to disrupt an electrostatic interaction between the nucleic acids and the polymers. See above 112(b) rejection for the claim interpretation.
Perez et al. teach a method for isolating nucleic acids from a sample comprising nucleic acids, the method comprising: (a) incubating the sample containing the nucleic acids with a population of polymers that bind the nucleic acids at pH ~6.5 and form a coacervate in a liquid-liquid phase separated (LLPS) solution, wherein the incubating is at a temperature above a concentration dependent phase separation transition temperature of the polymers within the range of ~40-55 °C; (b) decanting the coacervate from the LLPS solution; and (c) separating the nucleic acids from the polymers by adding 100 mM NaCl, adjusting the pH to ~8 release, or both to the LLPS solution to disrupt an electrostatic interaction between the nucleic acids and the polymers, wherein the polymers comprise intrinsically disordered proteins, wherein the intrinsically disordered proteins comprise polycationic elastin-like polypeptides or elastins having the sequence VPGXG, which is identical to Applicants’ SEQ ID NO: 3, further comprising isolating the nucleic acids in the LLPS comprising the separated nucleic acids and polymers by centrifuging the LLPS and removing the supernatant or the coacervate, wherein the supernatant comprises the nucleic acids, further comprising detecting the nucleic acids with a nucleic acid-based diagnostic assay, i.e., UV-vis spectroscopy or fluorescence spectroscopy which is a non-PCR based assay, which identifies and/or quantifies DNA, further comprising separating the nucleic acids from the polycationic elastin-like polypeptide by adjusting the temperature above a transition temperature of the polycationic elastin-like polypeptide (see the entire reference).
Therefore, teachings of Perez et al. anticipate Applicants’ claimed invention.
Conclusion
Claims 1-13, 16 and 18-20 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656