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
Claims 1-2, 4-11, and 13-15 are pending.
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 1, 4-9, 11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over O'Driscoll (US-20130295650, of record in IDS filed on 12/09/2021) in view of Nakamura (Nakamura et al. "Degradation of diclorinated dibenzo-P-dioxin by a cell free extract from Geobacillus midousuji SH2B-J2." (2009)).
Regarding claim 1, O'Driscoll teaches a method for bioremediation of soil, sediment or wastewater containing PCDD and PAHs including benzo[a]pyrene comprising bringing into contact or incubating the soil with live whole cells of thermophilic Geobacillus midousuji SH2B or SH2A (Abstract, [0013], [0014], [0015], [0018], claims 1, 6-7 and 11). O'Driscoll teaches using live cells of Geobacillus midousuji to treat contaminated river mud matrix at 70° C for 24-72 hours (Table 2 Experiment 2, [0083]). O'Driscoll teaches the bioremediation of contaminated soil using Live G. midousuji cell paste and incubated at 62° C in moist conditions ([0120]). O'Driscoll teaches that the method comprises subjecting the soil and/or bacterium to steam (i.e., 100% humidity) to enhance the biodegradation ([0072]). O'Driscoll does not teach wherein the Geobacillus midousuji is activated into log phase growth before administration.
However, Nakamura teaches growing Geobacillus midousuji to log phase, harvesting the cells and using cell free extract with enzymes for bioremediation of environmental contaminants dioxins and PCDD (page 2 para. 1-2). It is understood from Nakamura that Geobacillus midousuji expresses enzymes that degrades PCDDs during log phase growth.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by O'Driscoll by growing Geobacillus midousuji into log phase growth prior to mixing the cells with the soil, as suggested by Nakamura. One of ordinary skill in the art would be motivated to do so in order to express the enzymes responsible for degrading BaP in the cells and thus increase the degradation of BaP. Since O'Driscoll teaches a desire to bioremediate sand containing BaP using Geobacillus midousuji and its BaP degrading enzymes, and since Nakamura teaches Geobacillus midousuji produces enzymes during log phase growth, one of ordinary skill in the art would have a reasonable expectation of success of growing Geobacillus midousuji into log phase and administering the cells to the contaminated soil.
Regarding claims 4-5, the limitations of wherein the BaP concentration in the soil, sediment or wastewater after incubation is less than about 50 PPM, and wherein the BaP concentration in the soil, sediment or wastewater after incubation is less than about 20 PPM are merely stating the result of the active method step. Whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding claims 6-9, O'Driscoll teaches mixing the soil with G. midousuji and teaches an inoculum of 0.1-1.0% w/w ([0113]).
Regarding claim 11, O'Driscoll teaches the soil and SH2B-J2 were incubated with rotation for 24-72 hours ([0083]), and teaches in another example the cells and soil were continually rotated ([0120]).
Regarding claims 13-14, O'Driscoll teaches that the method can be carried out under anaerobic or aerobic conditions ([0048]).
Regarding claim 15, O'Driscoll teaches purifying enzymes from G. midousuji ([0123]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by O'Driscoll by purifying the enzymes from G. midousuji used in the soil after the incubating step. One of ordinary skill in the art would be motivated to do so in order to purify the protein expressed by the strain in the presence of the pollutant. Since O'Driscoll teaches a desire to purify enzymes from G. midousuji involved in the degradation of the pollutant, there is an expectation of success.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over O'Driscoll and Nakamura as applied to claim 1 above, and further in view of Weinstein (US 6,420,165, published 07/16/2002, of record in Office Correspondence mailed on 01/06/2025).
Regarding claim 2, O'Driscoll teaches Geobacillus midousuji SH2B, SH2B-J2, and SH2A([0018], [0081]). O'Driscoll teaches that SH2B-J2 strain is related to Geobacillus sp. (midousuji) isolated in prior art USPN 6,420,165 ([0011]). O'Driscoll does not teach SH2B (American Type Culture Collection (ATCC) No. 55926) or strain SH2A (ATCC No. 202050). However, Weinstein teaches Bacillus midousuji SH2A with accession number ATCC 55926 and Bacillus midousuji SH2B with accession number ATCC 202050 (column 1 line 67 through column 2 line 3). Weinstein teaches that the microorganisms are capable of degrading organic contaminants such as PCB isomers and other organic material contained in a sludge (FIG. 7, claim 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by O'Driscoll by substituting Bacillus midousuji SH2A with accession number ATCC 55926 or Bacillus midousuji SH2B with accession number ATCC 202050 as suggested by Weinstein for the strains taught by O'Driscoll. MPEP 2144.06 II states it is obvious to substitute equivalents know for the same purpose.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over O'Driscoll and Nakamura as applied to claim 1 above, and further in view of Takahashi (Organohalogen Compounds Vol 68 (2006), 2361-2364, of record in IDS) and Liggett (Bacteriological reviews 12.4 (1948): 297-311).
Regarding claim 10, O'Driscoll teaches incubating G. midousuji in trypticase soy broth at 60oC ([0107]). O'Driscoll teaches G. midousuji SH2B-J2 cells were reactivated by thawing frozen cell paste and inoculating a secondary vessel with cell paste and Trypticase Soy Broth media and air ([0111]-[0112]). O'Driscoll does not teach the medium comprising B-complex vitamin and amino-N with trace metals.
However, Takahashi teaches growing Geobacillus midousuji SH2B-J2 in corn steep liquor comprising metallic salts (page 2361 last para.).
Liggett teaches corn steep liquor comprises amino nitrogen (page 301 para. 4) and B-complex vitamin (page 302 para. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by O'Driscoll by adding to the growth medium B-complex vitamin, amino nitrogen and metallic salts as suggested by Takahashi and Liggett. One of ordinary skill in the art would be motivated to do so in order to successfully grow G. midousuji.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-11, and 13-15 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-11 and 13-15 of copending Application No. 18/640659 in view of O'Driscoll.
Regarding instant claim 1, pending claim 1 recites a method for bioremediation of soil, sediment, wastewater, or sorbent materials containing 1,4-dioxane and/or one or more PFAS compounds selected from perfluorohexane sulfonic acid (PFHxS), perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluoropentanoic acid (PFPeA), perfluoroheptane sulfonic acid (PFHpS), perfluoropentane sulfonic acid (PFPeS), 4:2 fluorotelomer sulfonic acid (4:2 FTS), 6:2 fluorotelomer sulfonic acid (6:2 FTS), 8:2 fluorotelomer sulfonic acid (8:2 FTS), perfluorooctane sulfonamide (FOSA), N-ethyl perfluorooctane sulfonamidoacetic acid (NEtFOSAA), N-methyl perfluorooctane sulfonamidoacetic acid (NMeFOSAA), perfluorobutanoic acid (PFBA), perfluorobutane sulfonic acid (PFBS), perfluorodecanoic acid (PFDA), perfluorododecanoic acid (PFDoA), perfluorodecane sulfonic acid (PFDS), perfluoroheptanoic acid (PFHpA), perfluorohexanoic acid (PFHxA), perfluorononanoic acid (PFNA), perfluorononane sulfonic acid (PFNS), perfluorotetradecanoic acid (PFTA), perfluorotridecanoic acid (PFTrDA), and perfluoroundecanoic acid (PFUnA), the method comprising the steps of: administering Geobacillus midousuji, or a mutant derived therefrom, to the soil, sediment, wastewater, or sorbent material to be bioremediated; and incubating the Geobacillus midousuji in the soil, sediment, wastewater, or sorbent material at a temperature ranging from about 40 to about 70°C and a humidity ranging from about 80% to about 100% for a period of time ranging from about 1 hour to about 20 days. Pending claim 10 recites wherein the Geobacillus midousuji is activated into log phase growth before incubation with the soil, sediment, wastewater. Pending claims 1 and 10 do not recite benzo[a]pyrene (BaP). However, O'Driscoll teaches Geobacillus midousuji is used for bioremediation of benzo[a]pyrene (BaP) (Table 2). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method recited in pending claims 1 and 10 by using the method to degrade benzo[a]pyrene (BaP), as suggested by O'Driscoll. One of ordinary skill in the art would be motivated to do so in order to degrade BaP from the soil.
Regarding instant claim 2, pending claim 2 recites wherein the Geobacillus midousuji is strain SH2B (American Type Culture Collection (ATCC) No. 55926), strain SH2A (ATCC No. 202050), or mixtures thereof.
Regarding instant claims 4 and 5, the limitations of wherein the BaP concentration in the soil, sediment or wastewater after incubation is less than about 50 PPM, and wherein the BaP concentration in the soil, sediment or wastewater after incubation is less than about 20 PPM are merely stating the result of the active method step. Whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding instant claim 6, pending claim 6 recites wherein the Geobacillus midousuji to the soil, sediment, wastewater, or sorbent material ratio ranges from about 0.01% to about 1% w/w.
Regarding instant claim 7, pending claim 7 recites wherein the ratio ranges from about 0.01% to about 0.1% w/w.
Regarding instant claim 8, pending claim 8 recites wherein the ratio ranges from about 0.08% w/w to about 0.15% w/w.
Regarding instant claim 9, pending claim 9 recites wherein the ratio is about 0.1% w/w.
Regarding instant claim 10, pending claim 10 recites wherein the Geobacillus midousuji is activated into log phase growth before incubation with the soil, sediment, wastewater, or sorbent material by incubation of the Geobacillus midousuji under an aerobic condition at a temperature ranging from about 600 to about 650 C in a medium comprising B-complex vitamin and amino-N with trace metals.
Regarding instant claim 11, pending claim 11 recites the method further comprising the step of rotating the soil, sediment, wastewater, or sorbent material at least about 1 to about 5 times per day during incubation with the Geobacillus midousuji.
Regarding instant claim 13, pending claim 13 recites wherein the incubation of the Geobacillus midousuji in the soil, sediment, wastewater, or sorbent material is done under aerobic conditions.
Regarding instant claim 14, pending claim 14 recites wherein the incubation of the Geobacillus midousuji in the soil, sediment, wastewater, or sorbent material is done under anaerobic conditions.
Regarding instant claim 15, pending claim 15 recites the method further comprising purifying or harvesting at least one protein product.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 10/07/2025 have been fully considered but they are not persuasive.
Applicant argues that the cited references do not teach the Geobacillus midousuji is activated into log phase growth before administration as claimed.
In response to the argument, O'Driscoll teaches whole cells or enzymes of Geobacillus midousuji can be used to bioremediate soil, sediment or wastewater contaminated with BaP. New reference Nakamura teaches growing Geobacillus midousuji to log phase, harvesting the cells and using cell free extract with enzymes for bioremediation of contaminants (page 2 para. 1-2). It is understood from Nakamura that the enzymes responsible for degrading contaminants are expressed in Geobacillus midousuji during log phase growth. One of ordinary skill in the art would be motivated to grow the bacterium into log phase growth before administration to the soil in order to express the enzymes responsible for degrading BaP in the cells and thus increase the degradation of BaP.
Applicant argues that O'Driscoll only teaches using cell extracts to degrade BaP, not live bacteria as claimed, and argues O'Driscoll's cell-free system with immobilized enzymes greatly enhances the degradation of persistent organic pollutants (POPs) including BaP.
In response to the argument, O'Driscoll teaches that the thermophilic bioremediation process is capable of degradation of aromatics that include some of the most toxic and environmentally persistent compounds, such as PAHs including benzo[a]pyrene ([0013]) and teaches the method can use whole live cells or enzymes (claims 7 and 9-10). Furthermore, the instant claims do not exclude the presence of extracted enzymes. Conclusive proof of efficacy is not required to show a reasonable expectation of success, and obviousness does not require absolute predictability (See MPEP 2143.02(I) and MPEP 2143.02(II)).
Applicant argues that O'Driscoll teaches 10-40% moisture level in the bioreactor, which is much lower than the claimed "from about 80% to about 100%" humidity.
In response to the argument, O'Driscoll teaches that the method comprises using steam to enhance the biodegradation ([0071]). Since steam is water in its gaseous state, meaning the air is completely saturated with moisture, this limitation is understood as 100% humidity.
Applicant argues that there is no motivation to combine O'Driscoll and Zanzotto.
In response to the argument, Zanzotto is not relied upon in this rejection.
Applicant argues the present claims are directed to methods for bioremediation of soil, sediment or wastewater containing benzo[a]pyrene (BaP) whereas the claims of U.S. Application No. 18/640659 are directed to treating different compounds.
In response to the argument, the copending claims recite a method for bioremediation of contaminant in sediment or wastewater using the same steps of administering Geobacillus midousuji activated into log phase growth and incubating the Geobacillus midousuji in the soil or wastewater at a temperature ranging from about 40°C to about 70°C and a humidity ranging from about 80% to about 100% for a period of time ranging from about 1 hour to about 20 days. O'Driscoll teaches that Geobacillus midousuji degrades BaP. One of ordinary skill in the art would be motivated to modify the method recited in pending claims by using the method to degrade benzo[a]pyrene (BaP), as suggested by O'Driscoll. One of ordinary skill in the art would be motivated to do so in order to degrade BaP in the soil, sediment, or wastewater.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699