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 .
Application Status
The preliminary amendment filed 7/02/2024 is acknowledged and entered. Claims 1-27 are cancelled. Claims 28-47 are newly added. Claims 28-47 are pending and being examined on the merits.
Priority
The application is a 371 PCT of KR2021/018445 filed 12/07/2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Korea on 07/26/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements filed 1/23/2024, 12/03/2024, 04/11/2025, and 1/30/2026 have been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with 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 - 1.825.
The sequence disclosures are located Table 4.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 28, 30-33, 35, 38-41, 44, and 46-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeong (Jeong et al. SOGANG UNIVERSITY. Ministry of Science and ICT (Research Report), published October 2017).
Regrading claim 28 and 30, Jeong teaches the Coccomyxa subellipsoidea C-169 rbcS2 promoter incorporated into pKA650 for driving expression in Chlorella vulgaris [pg. 25, para 1; Fig. 5].
Regrading claim 31, Jeong teaches that the carbonic anhydrase gene was introduced into the vector [pg. 24, last paragraph – pg. 25, para 3].
Regarding claim 32, Jeong teaches that the pKA650 includes the promoter and terminator derived from the C-169 strain [pg. 25, para 1].
Regarding claim 33, Jeong teaches the carbonic anhydrase gene was operatively linked to the promoter [pg. 25, para 1-3; Fig. 5].
Regarding claim 35, Jeong teaches that pKA650 contained the bleomycin resistance gene sequence (Sh ble) which was obtained from the genomic DNA of Streptomyces verticillus [pg. 25, para 2].
Regarding claim 38-41, 44, and 46-47, Jeong teaches a method for producing a chlorella transformant comprising introducing pKA650 into chlorella vulgaris, where the method is a Gold particle bombardment method and the transformation conditions were OD=0.6, 60 mm diameter, and Target Distance 3 [pg. 25, para 4].
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong (Jeong et al. SOGANG UNIVERSITY. Ministry of Science and ICT (Research Report), published October 2017) in view of Jung (Jung et al. J. Microbiol. Biotechnol. (2006), 16(6), 952–960)
The teachings of Jeong are discussed above as applied to claim 38.
Jeong do not teach wherein the vector further comprises a gene coding for a reporter molecule selected from the group consisting of a growth-promoting protein, a fluorescent protein, and a hydrolase.
Jung teaches transforming chlorella cells with recombinant expression vectors comprising the green fluorescent protein (GPF) coding sequences as a reporter gene to evaluate transformation efficiency and transgene expression [abstract].
It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to incorporate the GFP reporter of Jung into Jeong’s transformation system because GFP was a standard reporter for confirming successful transformation and transgene expression in algal cells. The incorporation represents the predictable use of a known reporter gene in an otherwise conventional transformation system and would have provided immediate visual confirmation of gene expression without altering the fundamental transformation methodology.
Claims 42-43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong (Jeong et al. SOGANG UNIVERSITY. Ministry of Science and ICT (Research Report), published October 2017) in view of Kikkert (Kikkert et al. Humana Press, 2005. 61-78).
The teachings of Jeong are discussed above as applied to claim 38.
Jeong do not teach the claimed cell density, chamber vacuum, or helium pressure for the transformation method.
Kikkert teaches as with any plant transformation method, several parameters need to be optimized for the process to be maximally effective, and the parameters can be grouped as physical, biological, and environmental [pg. 63, last paragraph]. Kikkert teaches that during development of the PDS-1000/He, instrument settings were varied over a wide range and tested with numerous organisms: A vacuum of 28.0 in Hg (94.8 kPa), a helium pressure of about 1100 psi (7584.2 kPa), a gap distance of 6.5–10.0 mm, and a macrocarrier travel distance of 6.0–10.0 mm are near optimal for most plant transformation applications [pg. 64, para 1]. Kikkert teaches that biological parameters include tissue type, cell size, cell culture age, mitotic stage, general cellular health, target tolerance of vacuum, cell density, and cell turgor pressure and that the physiological status of the target influences receptivity to foreign DNA delivery and susceptibility to injury that may adversely affect the outcome of the transformation process [pg. 64, para 2]. Kikkert further teaches how to standardize cell density [pg. 71, para 1], and using a 1300psi helium pressure and a 28-in. Hg as PDS-1000/He settings [pg. 72, section 3.3]. Kikkert teaches that gene gun settings are critical for success and should be checked before each bombardment and that higher particle velocities are obtained with higher helium pressures [pg. 76, para 2]. Kikkert teaches that with intact tissues it may be desirable to increase helium pressure, decrease target cell distance, or bombard each sample multiple times to improve penetration of the particles into the tissues; thereby teaches the need for optimization [pg. 76, para 2].
It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to optimize the cell density, chamber vacuum, and helium pressure employed in Jeong’s transformation method to maximize transformation efficiency while maintaining acceptable cell viability. Such optimization would have involved routine experimentation and therefore would have been obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 28-33 and 35-47 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18291417 (reference application) in view of Jeong (Jeong et al. SOGANG UNIVERSITY. Ministry of Science and ICT (Research Report), published October 2017), Jung (Jung et al. J. Microbiol. Biotechnol. (2006), 16(6), 952–960) and Kikkert (Kikkert et al. Humana Press, 2005. 61-78).
Claim 13 of the reference application anticipates claims 28-30, 38 and 46-47. Regarding claim 31, see claim 14 of the reference application. Regarding claim 33, see claim 18 of the reference application. Regarding claim 39, see claim 19 of the reference application.
To the extent that there are limitations that are not provided for by the referenced claims, the teachings of Jeong, Jung and Kikkert are discussed above. It would have been obvious to have modified the subject matter of the referenced claims with the teaching of Jeong to arrive at the subject matter of the instant claims. The combination of prior art elements according to known methods to yield predictable results supports can support a conclusion of obviousness. See MPEP 2143(I). One of ordinary skill in the art would have a reasonable expectation of success since both Jeong and the referenced claims teach a promoter for Coccomyxa C-169 ribulose-1,5-bisphosphate carboxylase/oxygenase (Rubisco) small subunit 2 (rbcS2) gene used to drive gene expression.
Additionally, it would have been obvious to have modified the subject matter of the referenced claims to arrive at the subject matter of the instant claims for substantially the same reasons as discussed above in view of the teachings of Jung and Kikkert.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Jeong as discussed above. The prior art of record fails to reach or suggest the specific nucleotide sequence of the promoter recited in claim 29 (SEQ ID NO: 2) or the terminator recited in claim 34 (SEQ ID NO: 3). Although Jeong identifies the C-169 rbcS2 promoter and terminator by name and function, it does not disclose their nucleotide sequences. Additionally, GenBank: GW236088.1 (GenBank: GW236088.1. CBPA3103.g1 CBPA Coccomyxa sp. C-169 2kb Coccomyxa subellipsoidea C-169 cDNA cloneCBPA3103 3', mRNA sequence. 12/30/2009) discloses a nucleotide sequence derived from Coccomyxa subellipsoidea C-169 where the sequence corresponding to nucleotides 20-69 are 100% identical to the sequence of applicant’s SEQ ID NO: 2 thereby evidencing that the claimed nucleotide sequence was publicly available prior to the claimed invention; however, GenBank: GW236088.1 does not teach that this sequence contains the rbcS2 gene, rbcS2 promoter, or comprises regions upstream of the rbcS2 gene.
Claim 34 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY NICOLE GROOMS/Examiner, Art Unit 1637
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