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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/11/25 has been entered.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 9/11/25, with respect to 112 and 103 rejections have been fully considered and are persuasive. The rejection of claims 1-3 and 5-21 has been withdrawn because of the amendment to claim 1 and 19. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendment to claim 1.
Claim 1 of 11800872 recites: A genetically modified cell expressing a heterologous polynucleotide sequence operably linked to a promoter sequence encoding an RNase III mutant from E. coli or Enterobacter adapted for enhanced generation of small RNA (sRNA) from catalytic cutting of double stranded RNA (dsRNA), wherein said RNase III mutant comprises: an E38A-R107A-R108A RNase III mutant, wherein a glutamic acid is replaced with an alanine at residue 38, and an arginine is replaced with an alanine at residue 107, and an arginine is replaced with an alanine at residue 108, or a homologous RNase III mutant thereof, wherein the homologous RNase III's wild-type sequence includes the conserved residues E38, R107 and R108.
The amended claims are broader than what was recited in the claims of the granted patent ‘872.
Drawings
The drawings were received on 9/11/25. These drawings are acceptable. There are now no color drawings of record.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-7, and 9-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention embraces a genetically modified bacteria engineered to co-express a heterologous bacterial RNase III mutant and a heterologous target dsRNA molecule, wherein the mutant is derived from a wild type RNase Ill from a bacteria selected from the group consisting of: E. coli, Enterobacter sp., Bacillus sp., S. enterica, P. aeruginosa, C. burnetii, R. capsulatus, S. coelicolor, C. jejuni, H. pylori, S. aureus, and L. lactis, wherein the heterologous bacterial RNase III mutant is a triple or quadruple mutant set for in instant claim 1.
Original claim 8 (now cancelled) listed the bacteria set forth in amended claim 1.
Pages 51-52 of the specification provide a definition for the term “RNase III”. The invention includes residues 38, 65, 107 and 108 and their corresponding residues across various homologous RNase III proteins or homologs. The amino acids positions may vary between RNase III enzymes from different sources. For example, E38 in E. coli corresponds to E37 in Aquifex aeolicus.
The specification has written support for E. coli and Enterobacter sp. A search of the prior art does not disclose that the other bacteria listed in the claim would have the same RNase III mutants, E38A, E65A, R107A, R108A.
The claims require the mutation at these specific sites of an amino acid sequence of the bacteria listed in the claims. Thus, if a skilled artisan made these mutations at the same amino acid residues of E. coli or Enterobacter in other the bacteria it might not result in the desired biological activity. Since amino acid positions may vary between RNase III enzymes from the species of bacteria recited in the instant claims (pages 51-52 of the specification). The description of E. coli and Enterbacter does not represent the other species listed in claim 1.
In addition, in view of the variability between RNase III mutants, E. coli and Enterobacter sp do not adequately describe and represent the different species of bacteria listed in claim 1. It would require further experimentation (not undue) to determine if the residues of mutations are actually in the other bacteria or conserved residues that are homologous to the specific mutations claimed.
It is acknowledged that identifying homologs mutants is well within the scope of a skilled artisan and there are several widely-available (and commonly used) tools and databases that can be used to find homologous protein sequences and identify their conserved regions. However, this does not provide written support for instant claim 1 and claims dependent therefrom because adequate written description of RNase mutants set forth instant claim 1 is not based on tools that are routine and conventional in the prior art to determine which amino acids, if any, correspond to the RNase III mutants set forth in S. enterica, P. aeruginosa, C. burnetii, R. capsulatus, S. coelicolor, C. jejuni, H. pylori, S. aureus, and L. lactis. See Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) in MPEP 2163.
For the reasons set forth above, the limited description in the specification does not provide written support for RNase III mutants from Bacillus sp., S. enterica, P. aeruginosa, C. burnetii, R. capsulatus, S. coelicolor, C. jejuni, H. pylori, S. aureus, and L. lactis. In view of the foregoing, it is clear that the specification of the instant disclosure fails to convey to the skilled artisan that the applicant had possession of the claimed genus of RNase III mutants derived a bacteria selected from the group set forth in instant claim 1 and claims dependent therefrom.
Conclusion
See attached PTO-326 for disposition of claims.
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/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636