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 .
Election/Restrictions
Applicant elects Group 1 ( claims 1-11,14,15,21-23,28-30,39,59,65, and 99); Species 1 (claims 2,3,5,6,7 and 8) applicant elects Sphingomonas (as recited in claim 5); Species 2 (claims 9,10, and 11) applicant elects genomic addition (as recited in claim 10); Species 3 (claims 28,29,30,39, and 99) applicant elects RNA transcripts (as recited in claim 28); Species 4 (claim 59) applicant elects A. platensis. Claims 3,7, and 8 are withdrawn as they do not read on the elected species of Sphingomonas, from Species 1. Claims 9 and 11 are withdrawn as they do not read on the elected species of addition, from Species 2. Claims 29, 30, 39, and 99 are withdrawn as they do not read on the elected species of RNA transcripts, from Species 3.
Claims 63,64,66, and 98 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06, 2026.
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.
Claims 1,2, 4,10,14,21,22, 28, 59, and 65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dehghani, J et al., Stable transformation of Spirulina (Arthrospira) platensis: a promising microalga for production of edible vaccines. Applied Microbiology and Biotechnology (2018) 102; pp.9267–9278.
Regarding claims 1,2,4, 59, and 65, Dehghani, J. et al., discloses a method of transforming spirulina using co-culturing, in which Agrobacterium tumefaciens (a gram-negative, aerobic bacterium) is co-cultured with A. platensis to (a) induce competence using established culturing conditions, where a specified concentration of log phase S. platensis are plated and transformed by Agrobacterium cells suspended in media and spread on a lawn of S. platensis for a specified incubation period and conditions ,and (b) containing a transforming molecule, pCAMBIA 1304 (page 9268-9269, paragraph 8).
Regarding claims 10,14, and 28, following transformation, RNA extracted from A. platensis was assessed using RT-PCR for expression level of gfp (page 9269, paragraphs 3-4) and PCR analysis was used post transformation to assess the insertion/addition of gfp and hyg’ genes into the genome (page 9271, paragraph 2).
Regarding claims 21 and 22 the transforming molecule comprises the vector pCAMBIA 1304 and consists of T-DNA, a linear polynucleotide sequence of the vector (page 9273, paragraph 1).
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.
Claims 5,6, 15, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Dehghani, J et al., Stable transformation of Spirulina (Arthrospira) platensis: a promising microalga for production of edible vaccines. Applied Microbiology and Biotechnology (2018) 102; pp.9267–9278 as applied to claims 1,2, 4,10,14, 15, 21,22, 28, 59, and 65 above, and further in view of Bendezu, F.O. et al (AU2016370726A1; published 2018-05-10).
The teachings of Dehghani, J et al., are discussed previously.
Dehghani, J et al., teaches co-culturing bacteria that are gram-negative aerobes, with spirulina cells, specifically A. platensis, with the objective of producing vaccines. Further, Deghangi, J et al., teaches the cost-effectiveness and safety of using microalgae to express heavy and light chain recombinant antibodies with effective binding capacity to antigens from hepatitis B (page 9267, paragraph1-2).
Dehghani, J et al., does not teach the bacteria Sphingomonas species (claim 6), or a transformation in which the first insertion is replaced by a second transformation (claim 15), or a transforming molecule containing homology arms (claim 23).
However, regarding claim 6, Bendezu, et al., teaches the use of CRISPR/Cas9 gene editing system used to transform cells, where a Cas9 endonuclease is from Sphingomonas sanxanigenens NX 02 (page 11, paragraph 2) and transformed cells, which include A. platensis in some embodiments (page 54, paragraph 1).
Regarding claim 15, Bendezu, et al., teaches a transformation cassette used to introduce nucleotide sequences that are re-transformed (page 44, paragraph 4).
Regarding claim 23, Bendezu, et al., teaches specific integration of donor DNA with short flanking homology arms (30-50bp) which improve efficiencies over 70% in transformation (page 49, paragraph 3).
Therefore, first, it would have been obvious for one of ordinary skill in the art at the effective date of filing to have modified the methods of co-cultivation by Dehghani, J et al., with Sphingomonas sanxanigenens NX 02 of Bendezu, et al. The simple substitution of Sphingomonas, also a gram-negative aerobic bacterium known to grow in the same natural environments as A. platensis and able to enhance biomass production of A. platensis, in place of Agrobacterium tumefaciens would have resulted in the same genetic transformation of A. platensis genome and addition of desired gene(s). Second, it would have been obvious to an artisan, that incorporating a transformation cassette along with the integration efficiency of flanking homology arms with the sequences of interest, would have enhanced the genomic uptake of donor DNA during the transformation(s), to an already successful method of A. platensis transformation for result effective optimization.
The motivation to combine the methods of Deghani, J et al., with Bendezu et al., are (1) simply, to substitute one bacterial species with known success in transforming A. platensis cells with a similar gram-negative, aerobic bacterium, (2) including the use of transformation cassettes and/or (3) flanking homology arms for transformation efficiency to optimize transformation(s) of gene(s) at the same loci. One would expect success, as the combined prior art teaches co-cultivation of spirulina species with a gram-negative aerobic bacterial species for enhanced genomic transformation of multiple genes, including a history of manufacturing protective antibody, heavy and light chains, along with the transformation efficacy of Sphingomonas species as noted for its Cas9 endonuclease in modifying a DNA target sequence for transformations. Therefore, the combined prior art produces the same outcome as prescribed by the instant application.
Conclusion
No claims are deemed allowable.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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