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 .
RESPONSE TO AMENDMENT
The response amendments filed 4-30-2026 have been entered into the record. Claims 1-7 are pending. Claim 1 is under examination. Claims 2-7 remain withdrawn from consideration.
The text of Title 35 of the U.S. Code not reiterated herein can be found in the previous office action.
Objections/ Rejections Withdrawn
The objection to the disclosure because of informalities is withdrawn in view of the amendment thereto.
The rejection of claim 1 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in view of the translation of the Deposit and the assurances provide at page 7 of the response.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being clearly anticipated by Feng et al (Chemosphere 302:134870, available online May 7, 2022) is withdrawn in view of the properly filed English translation of PCT/CN2021/100071 filed 6-15-2021.
Rejections Maintained
Claim 1 stands rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter for reasons made of record in the Office Action mailed 2-2-2026.
Applicant’s arguments have been carefully considered but are not persuasive. Applicant argues the properties of the bioflocculant and biosurfactant, however these products are naturally produced by the SS15 bacterium. The wherein clause specifically demonstrates that the bacterium was isolated from nature and that no genetic engineering was used to establish the strain and were utilized in the isolation or production of the biosurfactant/bioflocculant. Applicant argues that the BB15 sp. is “induced” by the process recited. It is unclear what “induced” means in this context as naturally endogenous genes can be induced/activated/repressed by culture conditions, expression of genes naturally present in the bacterium does not provide for a markedly difference from the natural bacterium nor provide for a marked difference The BB15 sp. does not appear to be genetically modified for the induction and production of the biosurfactant and bioflocculants. Applicants argue the characteristics of the bioflocculant and biosurfactant produced by the claimed strain, however, the ability to produce these is inherent to the naturally occurring bacterium. The bacterium per se is not markedly different. The characteristics of the Bacillus sp. SS15 bacterium bioflocculant/biosurfactant or biosurfactant have been identified the mere characterization of the natural bacterium’s properties does not provide evidence of markedly different characteristics of the bacterium per se. Induction is not an external genetic process which renders that bacterium markedly different. Applicant argues the screening for suitable strains provided for the instantly claimed SS15. Applicant argues glucose utilization is induced and screened for, however such glucose utilization is not a markedly different characteristic from other Bacillus species that can also utilize glucose (e.g. Bacillus subtilis) which is a well known characteristic in the Bacillus genus. Additionally, the utilization of olive oil is also not unique as Bacillus strains have been shown to do so (see Fancello et al (Microorganisms 2020; see abstract and introduction). The characteristics are necessarily present in the natural Bacillus sp. SS15 isolated from nature. The process of “induction” does not apparently provide for a marked difference in genetic structure, such as that produced by transformation, transduction or genetic engineering. For the foregoing reasons, the rejection is maintained.
New Rejections based on Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim has been amended to insert a process after a wherein clause in a product claim. Therefore, it is unclear what the process is limiting in the product. The claim has not been clearly drafted recite a product by process and as such, the wherein clause is not found to properly limit the product Bacillus sp SS15 claimed. Clarification is requested.
Status of Claims
Claim 1 stands rejected. Claims 2-7 remain withdrawn from consideration.
Conclusion
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 extension fee 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 date of this final action.
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/Patricia Duffy/Primary Examiner, Art Unit 1645