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 .
Claim Status
1. Claims 14-16 and 18 are pending and under examination to the extent of the elected species of a carbon dot and polyethyleneimine (PEI).
Claims 1-13 are canceled.
Claims 17 and 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 24, 2025.
Information Disclosure Statement
2. The information disclosure statement filed February 06, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the IDS was filed after the time periods specified in 37 C.F.R. 1.97(b) and the IDS is not accompanied by the statement specified in paragraph (e) of 37 C.F.R. 1.97 and the fee set forth in § 1.17(p).
The IDS has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Response to Arguments – Objections to the Specification
3. Applicant’s arguments and amendments filed February 06, 2026 have overcome the objections of record.
Response to Arguments – Drawings
4. Applicant’s arguments February 06, 2026 have overcome the objections of record.
Response to Arguments – Claim Rejections - 35 USC § 112(b)
5. Applicant’s arguments and amendments filed February 06, 2026 have overcome the rejections of record.
Claims 3, 5-7, and 10 are cancelled; therefore, any rejections to these claims have been rendered moot.
Response to Arguments – Claim Rejections - 35 USC § 103
6. Applicant’s arguments and amendments filed February 06, 2026 have overcome the rejections of record. However, said amendments have necessitated new grounds of rejection under 35 U.S.C. 103.
Claims 2-9 are cancelled; therefore, any rejections to these claims have been rendered moot.
Claim Rejections - 35 USC § 103
7. 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.
8. Claims 14-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Giraldo Gomez et al. (US-11186845-B1, published 11/30/2021 (previously cited)) in view of Thagun et al. (Advanced Science. 2019; 6(23):1902064 (previously cited)) and further in view of Chen et al. (Advanced Drug Delivery Reviews. 2013; 65:1357–1369 (previously cited)).
Regarding claim 14, Giraldo Gomez et al. (US-11186845-B1, published 11/30/2021 (previously cited)) teaches a conjugate comprising one or more polypeptides (col. 1, lns. 53-59), one or more nucleic acids (col. 2, lns. 52-64), and a functionalized nanoparticle (col. 2, lns. 39-60), wherein the polypeptide comprises the chloroplast-targeting amino acid sequence obtained from the rubisco bisphosphate carboxylase small chain A (RBCSIA) protein (i.e., MASSMLSSATMV) and a polypeptide linker amino acid sequence GGC (col. 2, lns. 12-24; col. 9, lns. 21-37; Giraldo Gomez SEQ ID NO:1), wherein the one or more nucleic acids are electrostatically bound to the functionalized nanoparticle, and wherein the functionalized nanoparticle is a carbon dot (col. 2, lns. 39-51).
Giraldo Gomez does not teach the entirety of SEQ ID NO:4 and is silent as to whether the recited chloroplast-targeting polypeptide is capable of electrostatically binding to a nucleic acid molecule. However, Applicant’s disclosure notes that SEQ ID NO:4 is comprised of three distinct polypeptide domains: amino acid residues 1-12 (i.e., MASSMLSSATMV; SEQ ID NO:1) were obtained from the rubisco bisphosphate carboxylase small chain A (RBCSIA) protein (see Applicant’s specification dated 06/22/2023, p. 09, lns. 3-10); amino acid residues 13-18 comprises a flexible glycine-rich polypeptide linker (see Applicant’s specification dated 06/22/2023, p. 12, lns. 1-14; SEQ ID NO:3); and amino acid residues 19-30 comprise a repetitive positively charged region capable of electrostatically binding to nucleic acid molecules (see Applicant’s specification dated 06/22/2023; p. 11, lns. 1-13; SEQ ID NO:2). Therefore, Giraldo Gomez teaches the chloroplast targeting domain and function of the instant SEQ ID NO:4 and a flexible glycine-rich linker.
Thagun teaches a polypeptide that comprises a chloroplast-targeting amino acid sequence linked to an amino acid sequence comprising instant SEQ ID NO:2 that is capable of electrostatically binding to a nucleic acid molecule and the formation of complexes comprising DNA electrostatically bound to the polypeptide (pp. 2-3, “2… Formulation of a Plasmid DNA/CTP/CPP Complex for Chloroplast Transformation”, first paragraph).
Chen teaches importance of fusion protein linkers in creating stable, bioactive fusion proteins (Abstract), indicates that use of linkers is so routine in the art that linkers can be categorized into three broad categories (i.e., flexible, rigid, and in vivo cleavable linkers); Abstract), and teaches the use of the GGGGGG polypeptide sequence as a flexible linker that increases protein stability and folding (p. 1360, Table 3).
The combination of Giraldo Gomez, Thagun, and Chen teaches a conjugate comprising one or more polypeptides, one or more nucleic acids, and a functionalized nanoparticle, wherein the polypeptide comprises the chloroplast-targeting amino acid sequence obtained from the rubisco bisphosphate carboxylase small chain A (RBCSIA) protein (i.e., MASSMLSSATMV), a flexible polypeptide linker (i.e., GGGGGG), and an amino acid sequence that is capable of electrostatically binding to a nucleic acid molecule (i.e., KHKHKHKHKH), wherein the one or more nucleic acids are electrostatically bound to the functionalized nanoparticle, and wherein the functionalized nanoparticle is a carbon dot.
The level of ordinary skill in the plant biotechnology art is high as evidenced by both Giraldo Gomez and Thagun. It would have been prima facie obvious to one of ordinary skill in the art to substitute the chloroplast-targeting polypeptide taught by Gomez for the chloroplast-targeting polypeptide taught by Thagun. One of ordinary skill in the art would have been motivated to do so because the targeting polypeptide taught by Gomez is obtained from a rubisco subunit and therefore localizes efficiently to the plastids. One of ordinary skill in the art would have a reasonable expectation of success that combining the chloroplast-targeting delivery system taught by Giraldo with the DNA-binding domain taught by Thagun would enhance the ability of both polypeptides to delivery nucleic acids to the plastids. One would have been motivated to connect the domains taught by Giraldo Gomez and Thagun with a flexible GGGGGG linker to improve to the stability of the fusion protein because the use of protein linkers is routine in the art when designing fusions proteins as demonstrated by the extensive review article published by Chen. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention without any surprising or unexpected results.
Regarding claim 15, in addition to the teachings discussed above, Giraldo Gomez teaches a conjugate wherein the nucleic acid is DNA (col. 2, lns. 52-56).
Regarding claim 16, in addition to the teachings discussed above, Giraldo Gomez teaches a conjugate wherein the functionalized nanoparticle is coated with PEI (col. 2, lns. 57-60).
Regarding claim 18, Giraldo Gomez teaches a composition comprising the recited conjugate and a carrier (i.e., cyclodextrin; col. 1, lns 66-67).
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention without any surprising or unexpected results.
Examiner’s Contact Information
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS JAVON SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663