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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Barus “Genotypic Characterization of Rhizopus species from Tempeh and Usar: Traditional Inoculum of Tempeh in Indonesia”, Microbiology Indonesia, Vol.14, No.3, September 2020, p 101-107.
Regarding claim 1, 5, 6 and 10, Barus teaches that soybean tempeh is a traditional fermented food from Indonesia made through fermentation of soybean with microorganisms such as, inter alia, Rhizopus microsporus. (pg. 101) In studying the microorganisms responsible for fermentation in tempeh production, Barus isolated, purified and identified Rhizopus microsporus strain TB55. (pg. 103, Fig. 2)
Para. 20 of applicant’s specification states that the Rhizopus strain with a deposit number of DSM 34400 as recited in claim 1 “has been identified as Rhizopus microsporus TB55 strain”. Fig. 2 of applicant’s specification demonstrates that TB55 has 100% identity with SEQ ID NO: 1 and therefor TB55 has the same nucleotide sequence as SEQ ID NO: 1. As such, TB55 reads on the Rhizopus microsporus strain with a deposit number of DSM 34400 and a nucleotide sequence as shown in SEQ ID NO: 1 recited in claim 1.
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Given the disclosure of Barus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to use the isolated and purified Rhizopus microsporus strain TB55 disclosed by Barus to inoculate a soybean substrate for solid or liquid state fermentation to produce tempeh since strain TB55 was identified by Barus as part of an inoculum already being used in tempeh production. Therefore, Barus renders obvious the limitations of claims 1, 5, 6 and 10.
Regarding claim 7, Barus discloses that the growth temperature of TB55 is 33°C. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have fermented the soybeans to make tempeh with TB55 at 33°C since this was known to be a suitable grown temperature for the microorganism.
Claims 2-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Barus “Genotypic Characterization of Rhizopus species from Tempeh and Usar: Traditional Inoculum of Tempeh in Indonesia”, Microbiology Indonesia, Vol.14, No.3, September 2020, p 101-107 as applied to claim 1 above, in further view of Li CN113025500.
Regarding claims 2-4, Barus teaches what has been recited above but is silent regarding the substrate for tempeh production comprising soybean dregs.
Li teaches producing tempeh from soybean dregs as an effective way to achieve high added value by the transformation of soybean byproduct. [0010,0028,0003]
Both Barus and Li are directed to tempeh production. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have used soybean dregs as disclosed by Li as the substrate for tempeh production with strain TB55 in order to produce a high added value product from a soybean processing by-product. Therefore, claims 2-4 are rendered obvious by the modification of Barus with Li.
Regarding claims 6 and 9, Li teaches inoculating a liquid fermentation medium comprising bean dregs with a bacterial broth. [0037-39] It would have been obvious to one of ordinary skill in the art at the time the application was filed to have used this fermentation procedure in the modification of Barus with Li since it was known at the invention was filed to be a suitable fermentation method for bean dregs. Therefore, the modification of Barus with Li renders obvious claims 6 and 9.
Regarding claims 7 and 8, Li teaches performing fermentation of the bean dregs at 26-32°C for 48-96 hours. [0014] It would have been obvious to one of ordinary skill in the art at the time the application was filed to have used these fermentation conditions in the modification of Barus with Li since they were known to be suitable conditions for fermenting bean dregs. These ranges overlap with the ranges for the fermentation conditions recited in claims 7 and 8. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Barus “Genotypic Characterization of Rhizopus species from Tempeh and Usar: Traditional Inoculum of Tempeh in Indonesia”, Microbiology Indonesia, Vol.14, No.3, September 2020, p 101-107 as applied to claim 1 above in further view of de Haan USPN 7045160.
Regarding claim 11, Barus teaches what has been recited above but is silent regarding making an extruded product.
de Haan teaches processing the fermentation products of fungal cells to form an edible substance. (Col. 2, lines 1-18) Suitable fungal cells include Rhizopus oligosporus (synonymous with Rhizopus microsporus). (Col. 3, lines 9-13) de Haan teaches extrusion as a suitable means for forming the edible substance. (Col. 5, lines 1-19) The extrusion texturization processing method of de Haan provides alignment of the fungal proteins into fibers and yields meat like products. (Col. 11, lines 5-14)
Both Barus and de Haan are directed towards using Rhizopus microsporus to produce edible products. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have employed the method of processing of fungal products disclosed by de Haan including extrusion in the method of making tempeh disclosed by Barus in order to form a product having meat-like texture. The alignment disclosed by de Haan demonstrates that the extrusion processing of de Haan is at least uniaxial extrusion. Moisture would be present in the extrusion and therefore it is interpreted to be wet extrusion. Therefore, the modification of Barus with de Haan renders obvious the invention of claim 11.
Response to Arguments
Applicant's arguments filed 15 September 2025 have been fully considered but they are not persuasive.
Applicant asserts on pages 6 and 7 of the remarks that there are differences between the nucleotide sequence of TB55 and SEQ ID NO: 1 because the sequencing read length of TB55 is 695 bp, 660 bp of the sequence being the same as SEQ ID NO:1. This does not negate the fact that TB55 has the same 660 bp sequence as shown in SEQ ID NO: 1 and required by the claims. The presence of absence of 35 bp in TB55 is immaterial to the instantly pending claims which only address the 660 bp of SEQ ID NO:1. Given that TB55 has a sequence with 100% identity to SEQ ID NO: 1, the instant rejection clearly reads on the claims.
Applicant’s assertions regarding Li and de Haan failing to teach SEQ ID NO: 1 are not germane as these references were not relied on to read on this element of the claims.
Applicant asserts on page 8 of the remarks that the Rhizopus microsporus strain of the invention provides advantageous efficacy compared to the cited references. This assertion is not persuasive as the strain of the prior art reads on the claims.
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 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 Michele L Jacobson whose telephone number is (571)272-8905. The examiner can normally be reached Monday through Friday from 10-6.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793