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
1. The preliminary amendment filed on July 2, 2024 is acknowledged. Claims 1-12 are canceled. Claims 13-21 have been added. Claims 13-21 are currently pending and under examination.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 11, 2025; March 20, 2025; and January 23, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Specification
4. This application fails to comply with the requirements of 37 C.F.R. 1.821-1.825 because it contains sequences that are not identified. For example, Table 4 contain sequences that are not identified. Appropriate sequence identifiers should match the sequence listing and the computer readable form (CFR) submitted with the application. Applicant is required to review the specification for unidentified sequences. Identification of these sequences is required.
Claim Rejections - 35 USC § 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claim 18 recites the limitation "operatively linked to the promoter" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
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.
6. Claim 13-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-31, 33, 38-40 and 46-47 of copending Application No. 2025/0122511 A1 (reference application 18/291,377). Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a biomineralization composition comprising Chlorella in which carbonic anhydrase is introduced. As well as, a biomineralization method, comprising culturing the composition of claim 13.
Meanwhile, the combination of the following co-pending claims are drawn to:
46. A Chlorella transformed with the vector of claim 30.
47. The Chlorella according to claim 46, wherein the Chlorella is Chlorella vulgaris.
A promoter for Coccomyxa C-169 ribulose-1,5-bisphosphate carboxylase/oxygenase (Rubisco) small subunit 2 (rbcS2) gene.
29. The promoter according to claim 28, wherein the promoter comprises the nucleotide sequence of SEQ ID NO: 2.
30. A recombinant vector comprising the promoter of claim 28.
31. The recombinant vector according to claim 30, wherein the vector comprises a target protein-encoding nucleotide sequence.
33. The recombinant vector according to claim 31, wherein target protein-encoding nucleotide sequence is operatively linked to the promoter.
38. A method for producing a Chlorella transformant comprising:
a transformation step of introducing the vector of claim 30 into Chlorella.
39. The method according to claim 38, wherein the transformation step is performed using gold particles bombardment.
40. The method for producing a Chlorella transformant according to claim 38, wherein the cell stage in the transformation step is a log phase.
The ‘target protein’ of the co-pending application is defined by their specification as a carbonic anhydrase, specifically, beta-type (see paragraph 0101 &0114).
The pending claim sets are anticipatory and/or obvious over the other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
7. Claim(s) 13, 15-16 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xia, WO 98/42822, Published: 10/1/98.
Independent claim 13 is drawn to a biomineralization composition comprising Chlorella in which carbonic anhydrase is introduced.
Xia provides promoter sequences isolated from Chlorella virus. The invention includes gene constructs comprising a promoter sequence of the invention operably linked to a DNA sequence of a structural gene. The invention further provides vectors and host cells for expressing a product encoded by the structural gene of a gene construct of the invention, and cells transformed with a heterologous gene operably linked to the promoter. The promoters of the invention include inducible Chlorella promoters (see page 2, lines 22-30; meets claim 13). Xia discloses a gene construct of the invention is introduced into an appropriate host cell for expression of the gene product. Host cells are transformed directly or through a vector. In one embodiment, a suitable vector for a prokaryotic cell such as E. coli strains HB101 or JM109 is the plasmid pKK232-8 (see page 3, lines 11-14; meets claim 15).
Moreover, Xia discloses that the disclosed promoter sequences are operably linked to a structural gene sequence. As used herein, a "heterologous sequence" is a DNA sequence which is different than that to which the promoter sequence is operably linked in the Chlorella virus (see page 5, lines 1-4; meets claims 13 and 18). A structural gene of a gene construct according to the disclosure will typically encode a protein or polypeptide product. Any known or later discovered structural gene which encodes a desired product is operably linked to a promoter sequence of the invention using known methods. Examples of known structural genes suitable for use with the promoters of the invention include nucleic acid sequences encoding carbonic anhydrase (see page 8, lines 17-25; meets claim 13 and 18).
As it pertains to claim 16, claim limitations such as “for Coccomyxa C-169 ribulose-1,5-bisphosphate carboxylase/oxygenase (Rubisco) small subunit 2 (rbcS2) gene” is being viewed as limitations of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 458.
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Furthermore, Xia discloses that the gene construct includes a promoter sequence of the invention operably linked to a structural gene encoding the protein to be produced in the host cell and provides methods for screening and isolating a promoter sequence having strong transcriptional properties, including truncated versions of the Chlorella virus promoters (see page 3, lines 19-25; meets claim 20). As it pertains to claim 21, the Office takes the position that when culturing chlorella, it necessarily forms biominerneralized crystals, absent evidence to the contrary.
Lastly, the methods chosen vary and include chemical transfection methods such as microorganism- mediated gene transfer such as biolistic bombardment (which is known in the art to use a “gene gun” to shoot gold coated DNA into cells) (see page 10, lines 1-5; meets claim 19).
Conclusion
8. No claim is allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 December 20, 2025
/BRIAN GANGLE/Primary Examiner, Art Unit 1645