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 .
Status of claims
Claims 2-5 and 10-12 as filed on 3/27/2026 are under examination in the instant office action.
Claims 1, 6, 8, 9 and 13-16 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 7/02/2025.
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.
Claims 2-5 and 10 remain rejected under 35 U.S.C. 103 as being unpatentable over Campos-Quevedo et al (IDS reference; Plant Cell Tiss Organ Cult, 2013. 113: 217-225) and US 6,620,419 (Lintner).
The cited reference by Campos-Quevedo discloses a method for producing recombinant bioactive proteins in chloroplasts of microalgal culture of Chlamydomonas reinhardtii, wherein the method comprises transformation of the chloroplast genome of microalgae with nucleic acid sequences encoding the recombinant proteins. The cited method comprises steps of introducing the nucleic acid sequence into an expression vector comprising promoters (fig. 2) which is capable of expressing the nucleic acid sequence in microalgae host cell and step of transforming the chloroplast genome of microalgae host cell by the expression vector. For example: see abstract and see page 218, col. 2, at section “materials and methods”. The cited method further comprises step of identifying the transformed microalgae host cell on a medium with an antibiotic as based on the antibiotic resistance of the transformed cells (page 220, col.1, lines 4-6; fig. 2); step for “characterizing” or screening the microalgae host cell for the production of recombinant protein (page 220, col.1, par. 2); steps of extracting the recombinant protein and purifying the recombinant protein from total soluble proteins produced (page 220, paragraph bridging col 1 and col. 2). In the cited method the recombinant protein expression cassette comprises a nucleic acid sequence encoding an epitope Tag peptide such as His tag which is used for separation of bioactive peptide of interest from total proteins produced (see page 220, col. 2, par. 2).
Thus, the cited method of Campos-Quevedo for producing a recombinant bioactive proteins in chloroplasts of microalgal culture of Chlamydomonas reinhardtii comprises the same active steps for producing the recombinant bioactive protein as encompassed by the claimed method. The cited reference by Campos-Quevedo also explicitly recognizes that chloroplasts of microalga are robust expression platforms for production of recombinant bioactive proteins (se abstract, last lines) which allow to overcome problems associated with extraction of peptides from animal sources and with chemical synthesis (see page 210, col. 1, par. 1-2) and also to provide for higher yield of bioactive peptides (see page 210, col. 1, par. 3).
But the cited reference by Campos-Quevedo it is silent about specific claim-recited peptide of SEQ ID NO: 1.
However, the claim-recited peptide of SEQ ID NO: 1 is a peptide Lys Thr Lys Ser (KTTS) which is well known in the prior art as evidenced by US 6,620,419 (Lintner) and which is recognized for its bioactive properties associated with healing, hydrating and all skin treatments (see abstract).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to produce a known bioactive peptide of SEQ ID NO: 1 (peptide Lys Thr Lys Ser or KTTS) by transformation of the chloroplast genome of microalgae by the method of Campos-Quevedo with a reasonable expectation of success because the cited reference by Campos-Quevedo explicitly recognizes that chloroplasts of microalga are robust expression platforms for production of recombinant bioactive proteins that allow to overcome problems associated with extraction of peptides from animal sources and with chemical synthesis and also provide for higher yield of bioactive peptides.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1-5 and 10-12 remain rejected under 35 U.S.C. 103 as being unpatentable over Campos-Quevedo et al (Plant Cell Tiss Organ Cult, 2013. 113: 217-225) and US 6,620,419 (Lintner) as applied to claims 1-5 and 10 above, and further in view of Tissot et al (IDS reference; Plant Biotechnology Journal, 2008, 6, pages 309-320).
The references by Campos-Quevedo et al and US 6,620,419 (Lintner) are relied upon as explained above.
In particular, as applied to claims 11-12, the cited method of Campos-Quevedo et for producing recombinant bioactive proteins in chloroplasts of transformed microalgal culture does not comprise the use of a “signal protein” that will allow the production of recombinant protein in a specific cell compartment.
However, the reference by Tissot teaches that the recombinant proteins of interest produced by transformed chloroplasts of eukaryotic cells are targeted to the specific cellular compartment by signal proteins “SP” (see abstract/summary) and that genetically engineered chloroplasts of eukaryotic cells have high protein synthesis capacity and regarded as bioreactors for production of molecules of therapeutic and industrial interest (page 310, col. 1, par. 2).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to introduce a signal protein into expression cassette for production of recombinant bioactive peptides including a knonw bioactive peptide of SEQ ID NO: 1 with a reasonable expectation of success in producing bioactive peptides including a knonw bioactive peptide of SEQ ID NO: 1 because it is an established practice in recombinant engineering technology as evidenced by Tissot.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed 3/27/2026 have been fully considered but they are not persuasive.
With regard to claim rejected under 35 U.S.C. 103 as being unpatentable over Campos-Quevedo et al (Plant Cell Tiss Organ Cult, 2013. 113: 217-225) and US 6,620,419 (Lintner) applicant argue that the instant specifications and claims are drawn to the use of microalga as a platform for recombinant protein production (response page 5) but primary reference by Campos-Quevedo teaches production of a recombinant protein that is different from the protein of the instant application (response page 8).
This argument is not persuasive because primary reference by Campos-Quevedo explicitly recognizes that chloroplasts of microalga are robust expression platforms for production of recombinant bioactive proteins (see abstract, last lines); thus, it teaches the use of microalga as a platform for recombinant protein production as intended for the insntst application and claims. Moreover, the reference by Campos-Quevedo recognizes that the use of microalga as a platform for recombinant protein production allows to overcome problems associated with extraction of peptides from animal sources and with chemical synthesis (see page 210, col. 1, par. 1-2) and also to provide for higher yield of bioactive peptides (see page 210, col. 1, par. 3).
Although the cited reference by Campos-Quevedo is silent about specific claim-recited peptide of SEQ ID NO: 1, the claim-recited peptide of SEQ ID NO: 1 is a peptide Lys Thr Lys Ser (KTTS) which is well known in the prior art as evidenced by US 6,620,419 (Lintner), which is recognized for its bioactive properties associated with healing, hydrating and all skin treatments (see abstract) and which is produced by fermentation of a microbial strain modified by genetic engineering (col. 3, lines 37-39).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to produce a known bioactive peptide of SEQ ID NO: 1 (peptide Lys Thr Lys Ser or KTTS) by transformation of the chloroplast genome of microalgae by the method of Campos-Quevedo with a reasonable expectation of success because the cited reference by Campos-Quevedo explicitly recognizes that chloroplasts of microalga are robust expression platforms for production of recombinant bioactive proteins that allow to overcome problems associated with extraction of peptides from animal sources and with chemical synthesis and also provide for higher yield of bioactive peptides.
Applicant argues that the protein of the instant application and claims is designed to overcome risk of undesirable recombination and/or large number of repeated amino acids (response page 8, last par.). Yet, the claim 2, line 2, clearly recites peptide of SEQ ID NO: 1, which is well knonw peptide Lys Thr Lys Ser (KTTS) as evidenced by US 6,620,419 (Lintner). Claim 2, line 3, also recites that claimed peptide consists of repeated units of repeated amino acids.
Some of the Applicant’s arguments are drawn to differences and/or to specific manipulations with expression cassettes and purification (response page 9). However, pending claims are generic and they recite generic procedures for expression and purification.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Vera Afremova
June 25, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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