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
This Office Action is in response to the Applicant’s reply received 6/9/20. Claims 1-10 are pending and considered on the merits.
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.
Claims 1-10 are rejected under 35 U.S.C. 112, first paragraph, as containing 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 a specific strain of Cellvibrio sp. KY-GH-1 to obtain the gene to express the α-neoagarobiose hydrolase (α-NABH) enzyme. It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted in paragraphs 00100-00103 of the specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
35 U.S.C. 101 REJECTION BASED ON JUDICIAL EXCEPTIONS
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1-4 is/are directed to a natural product (e.g. natural phenomenon). The enzyme GH117A α-neoagarobiose hydrolase (α-NABH) appears to be a naturally occurring enzyme which is made by the naturally occurring bacteria Cellvibrio sp. KY-GH-1 as supported by the Specification (0001 and 0007) and Kwon 2019 (pg. 2, col 2, bottom). This enzyme is expressed from GH117A (Specification 0007) which appears to correspond to the gene α-CvNabh117A of Kwon 2019 since it appears to encode the same enzyme from the same bacteria. Neither reference appears to show that the enzyme claimed is any different than that produced naturally by Cellvibrio sp. KY-GH-1.
Claim Interpretation
Claims 2-4 are compositions comprising GH117A α-neoagarobiose hydrolase (α-NABH) but contain product-by-process limitations on how this enzyme is produced (e.g. cloned, transformed etc). M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”. In this case it appears the enzyme has the same structure no matter how it is produced. Therefore art reading on this enzyme will also read on these claims.
Claim Rejections - 35 USC § 102/103
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.
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) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) or under 35 U.S.C. 103 as being anticipated by or obvious over Kwon 2019 (Biotechnology Reports, 2019, in IDS 5/1/24).
As detailed below, Kwon 2019. teach a product that appears substantially identical in structure to the claimed enzyme but not SEQ ID NO. 1. They both teach the same enzyme (GH117A α-neoagarobiose hydrolase ) from the same bacteria (Cellvibrio sp. KY-GH-1) with the same gene. The gene encoding SEQ ID NO. 1 is GH117A (Specification 0007), which appears to correspond to the gene α-CvNabh117A of Kwon 2019. Since a gene inherently has the same sequence, it appears that the enzyme of Kwon 2019 is either inherently the same or very close to the SEQ ID No. 1. Therefore a dual rejection under 102/103 is made since the composition of Kwon 2019 either inherently meets the claims (M.P.E.P 2112 III and V) or is prima facie obvious since the compositions are structurally similar and share a similar utility and therefore are expected to have similar properties (MPEP 2144.09).
Kwon 2019 teach GH117 α-NABH produced by Cellvibrio sp. KY-GH-1 which appears to be identical to the SEQ ID No. 1 claimed by the Applicant. Kwon 2019 teach in Fig. 4, that Cellvibrio sp. KY-GH-1 converts agarose to neoagarobiose (NA2). In turn the bacteria uses GH117 α-NABH to degrade NA2 into 3,6-anhydro-L-galactose (L-AHG) and galactose (Fig 4, see last two steps).
Therefore the invention as a whole would have either been anticipated or prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) or under 35 U.S.C. 103 as being anticipated by or obvious over Jang 2020 (KMB 2020 47th annual meeting, in IDS 5/1/24).
As detailed below, Jang 2020 teach a product that appears substantially identical in structure to the claimed enzyme but not SEQ ID NO. 1. They both teach the same enzyme (GH117A α-neoagarobiose hydrolase ) from the same bacteria (Cellvibrio sp. KY-GH-1) with the same gene. The gene encoding SEQ ID NO. 1 is GH117A (Specification 0007), which appears to correspond to the gene GH117A of Jang 2020 (see F-15, 1st line). Since a gene inherently has the same sequence, it appears that the enzyme of Jang 2020 is either inherently the same or very close to the SEQ ID No. 1. Therefore a dual rejection under 102/103 is made since the composition of Jane 2020 either inherently meets the claims (M.P.E.P 2112 III and V) or is prima facie obvious since the compositions are structurally similar and share a similar utility and therefore are expected to have similar properties (MPEP 2144.09).
Jang 2020 teach GH117 α-NABH produced by Cellvibrio sp. KY-GH-1 which appears to be identical to the SEQ ID No. 1 claimed by the Applicant (Jang, F-15 1st lines). Jang 2020 teach GH117 α-NABH converts neoagarobiose (NA2) into 3,6-anhydro-L-galactose (L-AHG) and galactose at a pH of 7.5 and a temperature of 35°C (Jang, F-15).
Therefore the invention as a whole would have either been anticipated or prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kwon 2019 (Biotechnology Reports, 2019, in IDS 5/1/24) as applied to claims 1-5 above, and further in view of Lin et al. (CN 106467901, published 2017). Lin e al. is in Chinese. An English translation is provided. All citations will be to this translation for convenience.
Kwon 2019 teach a method of feeding agarose to Cellvibrio sp. KY-GH-1 which in turn converts the agarose to NA2 which is digested to L-AHG using GH117 α-NABH (Kwon Fig 4). What they do not teach is conditions listed in the claims. However this would be obvious in view of Lin et al. who teach Cellvibrio is culture in media that comprises agarose and MnCl2 at a pH of 7 and a temperature of 30 °C (Lin, pg. 2, middle). Therefore it would be obvious to use this culture medium to grow Cellvibrio sp. KY-GH-1 and produce L-AHG, since this media is know to cultivate Cellvibrio and this bacteria converts agarose to NA2 which is then converted to L-AHG. One of ordinary skill would recognize this as simply using known conditions and materials to cultivate one Cellvibrio for another of the same genus (MPEP 2141 III (B-D)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Free of the Art
It appears claim 10 is free of the art. The closest prior art that teaches either Cellvibrio or GH117 α-NABH in combination with the reducing agent TCEP is Kwon 2020 (published Nov. 5, 2020, in IDS 5/1/24) and Jang 2021 (Applied Microbiology and Biotechnology, published May 31, 2021, in IDS 5/1/24). Both of these articles are disqualified as prior art by exception 102(b)(1)(A) since they are less than 1 year from the effectively field date of this Application which is Nov, 2, 2021. Both articles list Young Ho Kim (the inventor) as the primary author.
The closest qualified prior art is Kotaro et al. (JP 2013247884 A, in IDS 5/1/2024). However the α-neoagarobiose hydrolase disclosed in JP’884 does not match the SEQ ID NO. 1.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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