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
Status of the Claims
Claims 1, 4, 6-9, 20, 22, 41-43, 48, 50-51, 67, 89, 93 and 99 are pending. Claims 1, 4, 6-9 and 20 are the subject of this FINAL Office Action. Claims 22, 41-43, 48, 50-51, 67, 89, 93 and 99 are withdrawn.
Large IDS With Multiple Irrelevant References
Applicants filed over 30 pages of IDSs with 200-plus listed references. First, it is impossible to search in detail through all 200-plus references in any reasonable amount of time. To this end, after a random examination of the references within the time allotted to the Examiner, the Examiner determines that many of the references are irrelevant to the claimed subject matter, having nothing to do with spores containing barcodes and germination genes made inoperable (e.g. 8-page IDS 05/22/2023, ref # 14, 20, 32, 361, 43; 26-page IDS 05/22/2023, ref # 1, 16, 29, 38, 51, 62, 66, 81). Which leads to the larger problem: which references are relevant, and why were these seemingly irrelevant references filed? Before filing an IDS, Applicants have a duty to examine the references themselves and determine which references are reasonably pertinent to the claimed invention. If any particular preference(s) is/are directly pertinent to the claimed invention, then Applicants are encouraged to point this out in the form of a new IDS.
Priority
The claims receive a priority date of 06/01/2020 because the priority document (PCT/US2020/035619) filed on that date is the first priority document to include written description support for spore “genome modified to render inoperable two more genes that are needed for spore germination,” much less the specific genes required (e.g. sleB, cwlD, etc.). In addition, none of the other priority documents provide any detail about “biological barcodes” in or on a spore, much less their specific sequences or sequence requirements.
Claim Interpretations
Applicants’ claims are too broad to warrant allowance. The claims are directed to a spore with (a) “biological barcode” and (b) modified genome “render inoperable two or more genes that are needed for spore germination.” The specification fails to define “biological barcode” or “genes that are needed for spore germination.” Thus, any sequence can be a “barcode” (as DNA sequences are in fact barcodes of life); and any gene with any effect on germination can be a “gene[] that [is] needed for spore germination.”
Oddly, claim 20 recites characteristics of the spores in intended use form (e.g. “degradation of the isolated spores is less than 5% after storing for 3, 6, 12, or 24 months under storage conditions comprising standard ambient temperature and pressure and humidity less than 50%”), which fails to further limit the spores. In other words, the broad-claimed spores, with “biological barcodes” and two inoperable spore germination effecting genes, do not contain anything that makes them less susceptible to degradation. Nor does the specification indicate any physical and/or compositional features (claimed or unclaimed) of the claimed spores that yield this result. Thus, any spore with the minimal physical and/or compositional features of claim 1 will necessarily meet the results of claim 20 because a thing cannot be separated from its characteristics.
New Grounds of 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.
Claim(s) 1, 4, 6-9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPRINGER (US20230348895, effective filing 01/08/2020), in view of KIM (US 20040171065).
The prior art as a whole demonstrates that it would have been obvious to a skilled artisan at the time of filing to apply familiar germination gene deactivations to prevent Bacillus spores from pathogenicity with a reasonable expectation of success.
As to claims 1, 4-9 and 20, SPRINGER teaches Bacillus spores with 20-40bp unique molecular barcodes (Claims 5-6 & 14, paras. 0024, 0101 & 0127, Fig. 1) and with two germination genes inoperable including GerA, GerD, sleB and cwlJ (claims 26-27, Fig. 1, paras. 0155ff). SPRINGER teaches Bacillus subtilis, or Bacillus thuringiensis (para. 0014, for example).
As to barcode “incorporated into the genome so that it is not expressed by the spore,” the specification states “[f]or example, the biological barcode integrated into the organism, genome or otherwise, does not comprise a promoter” (para. 0033). SPRINGER teaches “[i]n some embodiments of any of the aspects, the genetic barcode element comprises: (a) a first primer binding sequence; (b) at least one barcode region; (c) a transcription initiation site; and (d) a second primer binding sequence” (para. 0017; see also claim 8). This is in contrast to options with “transcription initiation site” or promotor (e.g. Fig. 7; claim 8). Thus, SPRINGER teaches iterations in which the barcode does not have a promotor.
SPRINGER does not explicitly teach inactivated cwlD.
However, cwlD was commonly inactivated in Bacillus spores in order to prevent pathogenicity just like in SPRINGER. For example, KIM teaches
It is considerable that the organisms genetically engineered is likely to be regulated under laws and rules; hence non-reproductive spore is preferable. For example, Bacillus subtilis lack of cwlD gene is preferably used due to being non-reproductive
(para. 0063). Thus, a skilled artisan would have expected that including cwlD inactivation would yield similarly non-pathogenic Bacillus spores as in SPRINGER to achieve the non-pathogenicity suggested in both SPRINGER and KIM.
Therefore, the claims are obvious.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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/AARON A PRIEST/ Primary Examiner, Art Unit 1681
1 Especially egregious as evidence by its title alone: “Composition, system and method for treating stains and odors.”