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 1-20 are pending in this application.
Priority
It is acknowledged that the instant application claims benefit of 63322558 filed on 03/22/2022.
Election
Applicant's election with traverse of Group I, Claims 1-12 in the response filed on 04/27/26, is acknowledged.
Applicants argue that there is no search and/or examination burden to search and examine Group I together with Group III because there would be significant overlap in search terms and searching location.
Applicants’ arguments have been fully considered and are deemed persuasive. Therefore, the previous restriction requirement between Group I and III is withdrawn, and claims 1-12 and 18-20 will be examined on the merits.
Claims 13-17 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention.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 03/29/2023 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
This application contains sequence disclosures, i.e., the amino acid sequence X1X2X3X4X5X6X7X8X9, that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2) ST.25 and 37 C.F.R. § 1.831(b) ST.26. However, this application fails to fully comply with the requirements of 37 C.F.R. § 1.821 through 1.825 ST.25 and 1.831-1.839 ST.26.
The following sections of the specification contain said amino acid sequence that contain four or more specifically defined amino acids without any corresponding SEQ ID NO: and/or no reference to any SEQ ID NO: in the Brief Description of the Drawings.
In Figure 1, amino acid sequences are disclosed without SEQ ID NO: identification.
Numerous recitations of the amino acid sequence X1X2X3X4X5X6X7X8X9 throughout the specification, i.e. para [0008], [0028], [0030], [0031]….
* If the noted sequences are in the sequence listing as filed, Applicants must amend the specification to identify the sequences appropriately by SEQ ID NO:. If the noted sequences are not in the sequence listing as filed, Applicants must provide (1) an updated copy of the sequence listing containing the requisite sequences in computer readable form (.txt or .xml), (2) an amendment directing its entry into the specification, (3) a statement that no new matter has been added and (4) an amendment to the specification to identify the identified sequences by SEQ ID NO:, which can be in the Brief Description of the Drawings section of the specification (For Figures only) and (5) an updated incorporation by reference statement with the new date of creation, sequence file name and size. – See also MPEP 2422.
Appropriate correction is required.
Claim Objections
Claims 9 and 20 are objected to because of the following informalities:
Claims 9 and 20 are objected to because the recitation of “the amino acid sequence X1X2X3X4X5X6X7X8X9” needs to be labeled with a corresponding SEQ ID NO.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
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 1-12 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 genus of methods of recovering a metal product, comprising: providing a sample including a metal component; contacting the sample with any polypeptide including at least a portion of a repeats-in-toxin (RTX) domain; and binding an amount of the metal component to the polypeptide to form a metal-peptide complex, wherein the metal component includes rare earth elements (REEs), REE- containing compounds, or combinations thereof.
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.
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 few representative species of a beta-roll peptides shown in Figure 1, which can be used in the claimed method for binding different metals. However, these disclosed peptides fail to provide adequate written description for a methods of recovering a metal product, comprising: providing a sample including a metal component; contacting the sample with any polypeptide including at least a portion of a repeats-in-toxin (RTX) domain; and binding an amount of the metal component to the polypeptide to form a metal-peptide complex, wherein the metal component includes rare earth elements (REEs), REE- containing compounds, or combinations thereof. The genus of any polypeptides used in the claimed methods are so broad as to encompass any polypeptide having any structure as long as it has “a portion” of a RTX domain which can be as small as an atom or a single amino acid.
In this case, the specification fails to describe any identification of structural characteristics or properties of any polypeptide having any structure as long as it has “a portion” of a RTX domain which can be as small as an atom or a single amino acid. In addition, the specification fails to describe how such a broad genus of polypeptides can be used in the claimed method for binding different metals. It is also noted by the Examiner that none of the dependent claims remedy the deficiency of claim 1 with regard to the ‘written description’ requirement. Taken together, the genus of claimed methods using “any polypeptide having any structure as long as it has “a portion” of a RTX domain encompasses widely variant species, having essentially any structure, and Applicants have failed to describe that they have possession of the broad genus of claimed methods as noted above.
While M.P.E.P. section 2163 acknowledges that a single species can describe a genus, it also acknowledges that for a genus that encompasses widely variant species, disclosure of a single species within the genus fails to adequately describe all members of the genus. 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.
Given the lack of additional representative species of the genus of claimed methods as noted 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 § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shur et al. (A designed, phase changing RTX-based peptide for efficient bioseparations, BioTechniques 54:197-206, April 2013) in view of Bulutoglu et al. (Block V RTX Domain of Adenylate Cyclase from Bordetella pertussis: A Conformationally Dynamic Scaffold for Protein Engineering Applications, Toxins, 2017, 9, 289, pages 1-13) and Cotruvo et al. (Lanmodulin: A Highly Selective Lanthanide-Binding Protein from a Lanthanide-Utilizing Bacterium, J. Am. Chem. Soc. 2018, 140, 15056−15061).
The instant claims are drawn to a method of recovering a metal product, comprising: providing a sample including a metal component; contacting the sample with a polypeptide including at least a portion of a repeats-in-toxin (RTX) domain; and binding an amount of the metal component to the polypeptide to form a metal-peptide complex, wherein the metal component includes rare earth elements (REEs), REE- containing compounds, or combinations thereof; and a method of recovering rare earth elements (REEs), comprising: providing a solution including a concentration of REEs, REE-containing compounds, or combinations thereof; contacting the solution with a disordered polypeptide including at least a portion of a repeats-in-toxin (RTX) domain; binding an amount of the REEs, REE-containing compounds, or combinations thereof to the polypeptide to form a metal-peptide complex having a beta-roll secondary structure; and isolating a product including a concentration of metal-peptide complexes from the solution.
Shur et al. teach a method of recovering a metal product, comprising: providing a sample or solution including a metal component; contacting the sample with a RTX-based peptides having bet-roll structure, i.e., GGAGNDTLY and other beta-roll peptides shown in Figure 1; and binding an amount of a metal, i.e., calcium to the polypeptide to form a metal-peptide complex, which in turn fold into a beta-roll structure, and precipitate (see Abstract, entire reference including Figures 1-3), thereby isolating a product including a concentration of metal-peptide complexes. Said method is used for bioseparation/purification which is a non-chromatographic isolation, and GGAGNDTLY satisfies the amino acid sequence of X1X2X3X4X5X6X7X8X9 recited in claims 9 and 20. Shur et al. further teach tandem repeats, i.e., 5, 9, 13 or 17 repeats of the beta-roll peptides, are explicitly taught (see under “Cloning” on page 198).
Shur et al. do not teach rare earth metal.
Bulutoglu et al. teach the isolation of the Block V RTX domain of adenylate cyclase (CyaA) from Bordetella pertussis, which is intrinsically disordered without metal, and reversibly folds into beta-roll structure upon calcium binding. Bulutoglu et al. emphasizes this utility for protein engineering application.
Cotruvo et al. teach a method of recovering a REE product, comprising: providing a sample or solution including a metal component; contacting the sample with lanmodulin (LanM), a naturally disordered protein that undergoes a conformational change upon binding lanthanides (Ln which is a REE) with high affinity, far superior to calcium (see abstract), thereby achieving REE separation and recovery (see entire reference including Figures 1-4). Cotruvo et al. further teach that Ln salts are found in mining, coal waste (see Introduction and cited reference 5 of Erickson et al.)
It would have been obvious to a person of ordinary skill in the art (POSITA) prior to the effective filing date of the instant application to practice the method taught by Shur et al. with beta-roll peptides from RTX domain of adenylate cyclase (CyaA) from Bordetella pertussis has taught by Bulutoglu et al. especially for Ln bioseparation as taught by Cotruvo et al. A POSITA would have been motivated to practice such methods composition because [1] Shur et al. and Bulutoglu et al. provide ready to use RTX polypeptides, i.e., GGAGNDTLY repeats or native B. pertussis Block V, which has already been known to bind metals, which fold from disordered state into beta-roll upon binding for easy isolation/separation/precipitation; [2] Cotruvo et al. demonstrated that analogous disordered proteins can be used for selective binding of REE such as Ln; [3] acidic conditions (low pH) are routine in REE leaching from e-wastes/mining wastes.
Claims 7 and 8 are included in this rejection because the use of lower pH range as recited therein falls under optimization of ranges through routine experimentation according to MPEP 2144.05 II(A) which has been copied/pasted below.
II. OPTIMIZATION OF RANGES
A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such
concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.).
A POSITA would have had a reasonable expectation of success to practice such method because all of the required biochemical reagents and techniques were readily available and rampantly used as evidenced by Shur et al., Bulutoglu et al. and Cotruvo et al. prior to the filing of the instant application.
For the reasons provided herein, the invention as claimed is prima facie obvious over the combined teachings of the prior art.
Conclusion
Claims 1-12 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
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