DETAILED ACTION
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 .
Applicant’s cancellation of claims 6-9, in the paper of 4/8/2025, is acknowledged. Claims 1-11 are still at issue and are present for examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Applicants filing of information disclosure statements on 1/18/2025 are acknowledged and have been considered.
Specification
The disclosure is objected to because of the following informalities:
Applicants drawings are hard to read to the point that they are illegible, especially Figures 1, 3, 7 and 8.
Appropriate correction is required.
Applicants specification is objected to because applicants specification comprises Nucleotide and/or Amino Acids Disclosures Requiring a "Sequence Listing".
Applicants attention is directed to 37 CFR 1.821(a) which presents a definition for "nucleotide and/or amino acid sequences." This definition sets forth limits, in terms of numbers of amino acids and/or numbers of nucleotides, at or above which compliance with the sequence rules is required. Nucleotide and/or amino acid sequences as used in 37 CFR 1.821 through 37 CFR 1.825 are interpreted to mean an unbranched sequence of four or more amino acids or an unbranched sequence of ten or more nucleotides.
Specifically applicants specification at Figure 1, Figure 3, lists nucleotide sequences which require a sequence identifier and are to be included in applicants sequence listing as per 37 CFR 1.821 through 37 CFR 1.825.
Appropriate correction is required.
The use of the terms: Sephadex (paragraph [0027](2X), [0031] ), [0058] ), [0073] ](2X), [0074], [0031] ), [0031] and, [0082]) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim(s) 1, 2, 5-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim(s) 1, 2, 5-11 are directed to all possible methods for producing neoagarotetraose (NA4) and neoagarohexaose (NA6), the method comprisinq enzymatically degrading a substrate by treating the same with a GH16B p-agarase comprising SEQ ID NO: 1. The specification, however, only provides the representative species of methods wherein the substrate is agarose or neoagarooligosaccharides (NAOS), encompassed by these claims. The specification also fails to describe additional representative species of these methods with substrates other than agarose or neoagarooligosaccharides (NAOS), for which no predictability of structure is apparent.
Given this lack of additional representative species of substrates as encompassed by the claims, 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, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel strain Cellvibrio sp. KY-GH-1 strain deposited under accession number KCTC 13629BP. Since the deposited E. coli strain Cellvibrio sp. KY-GH-1 strain is essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. The Cellvibrio sp. KY-GH-1 strain is not fully disclosed, nor have all the sequences required for their construction been shown to be publicly known and freely available. The enablement requirements of 35 U.S.C. ' 112 may be satisfied by a deposit of the Cellvibrio sp. KY-GH-1 strain. The specification does not disclose a repeatable process to obtain the vectors and it is not apparent if the DNA sequences are readily available to the public. Accordingly, it is deemed that a deposit of the Cellvibrio sp. KY-GH-1 strain should have been made in accordance with 37 CFR 1.801-1.809.
If a deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 CFR 1.808, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
1. during the pendency of this application , access to the invention will be afforded to the Commissioner upon request;
2. upon granting of the patent the strain will be available to the public under the conditions specified in 37 CFR 1.808;
3. the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
4. the deposit will be replaced if it should ever become inviable.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR20130030955 and Genbank QEY14910.1(Oct 3, 2019).
KR20130030955 discloses a method for producing neoagarotettraose and neoagarohexose in which agarose or agar, used as a substrate, is reacted with an agarose derived from Streptomyces coelicolor (claim 1). KR20130030955 discloses that DagA of Streptomyces coelicolor is endo-type beta-agarase. KR20130030955 discloses that the production of neoagarotettraose and neoagarohexose with biological functions are useful in the food, cosmetics and pharmaceutical industries. KR20130030955 discloses that the degradation reaction of beta-agarase is performed at 20oC to 90oC and at a pH of 5.0 to 8.0.
KR20130030955 does not teach a GH16B beta-agarase comprising SEQ ID NO:1.
Genbank QEY14910.1(Oct 3, 2019) teaches a GH16 beta agarose comprising the amino acid sequence of SEQ ID NO:1 from Cellvibrio sp KY-GH-1.
One of ordinary skill in the art before the effective filing date would have been motivated to practice the methods of producing neoagarotettraose and neoagarohexose taught by KR20130030955, substituting the GH16 beta agarose comprising the amino acid sequence of SEQ ID NO:1 from Cellvibrio sp KY-GH-1, taught by Genbank QEY14910.1(Oct 3, 2019) as a means of identifying other enzymes for use in producing neoagarotettraose and neoagarohexose. One of ordinary skill in the art would have been further motivated to vary different aspects of the reaction conditions including temperature, pH, buffers, and concentration of components as a means of optimizing the reaction conditions for the Cellvibrio sp KY-GH-1, taught by Genbank QEY14910.1(Oct 3, 2019). The expectation of success is high based upon the high level of recombinant protein expression in the art and the high level of enzymatic reaction design as exemplified by KR20130030955. Further KR20130030955 and Genbank QEY14910.1(Oct 3, 2019) teach all the substrates and methodology required to practice the claimed methods of producing neoagarotettraose and neoagarohexose.
Thus, claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR20130030955 and Genbank QEY14910.1(Oct 3, 2019).
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwon et al. (ACS Omega, Vol 5, pp 29453-29464, Nov 5 2020) and Genbank QEY14910.1(Oct 3, 2019).
Kwon et al. (ACS Omega, Vol 5, pp 29453-29464, Nov 5 2020) discloses the characterization and application of a recombinant exolytic GH50A b-agarase from Cellvibrio sp. KY-GH-1 for the enzymatic production of neoagarobiose from agarose.
Kwon et al. disclose methods to identify exolytic β agarases required for NA2 production from agarose, comprising the GH50A β-agarase gene from agar-degrading Cellvibrio sp. KY-GH-1 which was overexpressed as a recombinant His tagged protein using the Escherichia coli expression system. As a means of characterizing the enzyme activity of the GH50A β-agarase gene from agar-degrading Cellvibrio sp. KY-GH-1, Kwon et al. disclose a method of enzymatically degrading agarose substrate (0.8%) with the GH50 b-agarase in Tris buffer at pH 7.5 at 35oC for 30 minutes. Kwon et al. disclose that the GH50A β-agarase consists of 797 amino acids and was able to produce predominantly NA2 from agarose at an optimal temperature and pH of 35°C and 7.5, respectively. Kwon et al. disclose that the copresence of 5m mM MnSO4 and 10mM tris(2-carboxyethyl) phosphine(TCEP) resulted in a 2.5-fold enhancement of the enzyme activity. Kwon et al. disclose that for NA2 production, neoagaro-oligosaccharides (NAOSs) containing NA4−NA18 were preferred over agarose or agaro-oligosaccharides (AOSs) as substrates.
Kwon et al. does not teach a GH16B beta-agarase comprising SEQ ID NO:1.
Genbank QEY14910.1(Oct 3, 2019) teaches a GH16 beta agarose comprising the amino acid sequence of SEQ ID NO:1 from Cellvibrio sp KY-GH-1.
One of ordinary skill in the art before the effective filing date would have been motivated to practice the methods of identifying/characterizing b-agarase activity comprising degrading agarose taught by Kwon et al, substituting the GH16 beta agarose comprising the amino acid sequence of SEQ ID NO:1 from Cellvibrio sp KY-GH-1, taught by Genbank QEY14910.1(Oct 3, 2019) for the GH50A β-agarase, as a means of identifying other b-agarase enzymes for use in producing agarose degradation products (claims 1-6). One of ordinary skill in the art would have been further motivated to vary different aspects of the reaction including temperature, pH, buffers, and concentration of components such as Mn (MnSO4 and 10mM tris(2-carboxyethyl) phosphine (TCEP) as a means of optimizing the reaction conditions for the Cellvibrio sp KY-GH-1, taught by Genbank QEY14910.1(Oct 3, 2019) (claims 7-11). The expectation of success is high based upon the high level of recombinant protein expression in the art and the high level of enzymatic reaction design as exemplified by KR20130030955. Further Kwon et al. and Genbank QEY14910.1(Oct 3, 2019) teach all the substrates and methodology required to practice the claimed methods of producing neoagarotettraose and neoagarohexose.
Thus, claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwon et al. (ACS Omega, Vol 5, pp 29453-29464, Nov 5 2020) and Genbank QEY14910.1(Oct 3, 2019).
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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rgh
9/4/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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