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 Status
The amended claim set filed 10 Sep 2026 is acknowledged. Claims 1, 3-7, and 9 are currently pending. Of those, claims 1 and 3-6 are currently amended, and no claims are new. Claims 3, 9, 11, and 14-15 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3 Nov 2025. Claims 2, 8, and 10-15 are cancelled. Claims 1 and 4-7 were initially examined on the merits, after rejoinder claims 1, 3-7 and 9 were examined on the merits.
Response to Arguments
The Applicants’ arguments filed 10 Sep 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 17 June 2026 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The sequence deficiency is resolved by the amended specification filed 10 Sep 2026 and statement that the substitute specification contains no new matter.
The rejection of claims 1 and 4-7 under 35 U.S.C. 101 is withdrawn in view of the claim amendments to include non-natural elements and the arguments pointing out the non-natural elements.
Election/Restrictions
Claims 1 and 4-7 are allowable. Claims 3 and 9, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions 1-3, as set forth in the Office action mailed on 4 Sep 2025, is hereby withdrawn and claims 3 and 9 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The following is a statement of reasons for the indication of allowable subject matter: The bacteria Bacillus subtilis FNFH_BS06, with a preservation number of CGMCC No. 24836, is novel at the time of filing and it would not have been obvious to obtain the exact strain by isolation from the same natural source or by modifying another B. subtilis strain due to the low expectation of success in obtaining the exact same strain. The claimed bacterial agent is also not drawn to a natural product due to its formulation in synthetic medium.
New Rejection(s)
Claim Rejections - 35 USC § 112(a)
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.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of degrading glycinin and/or β-conglycinin using a product comprising the bacterial agent of claim 1, does not reasonably provide enablement for a method of degrading glycinin and/or β-conglycinin using the full scope of fermented products of claim 3, which are not required to comprise the bacterial agent of claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01. Although all factors were considered, the Wands factors that were most relevant for this decision are discussed in detail below.
The breadth of the claims: Claim 9 is a method with the step of applying the fermented product of claim 3 to a substrate comprising glycinin and/or β-conglycinin, with the effect of degrading the glycinin and/or β-conglycinin at least partially. The fermentation product of claim 3 is a product-by-process claim that is obtained by fermenting soybean meal with the bacterial agent of claim 1, which is a bacterial agent, comprising a medium; and a Bacillus subtilis FNFH_BS06, with a preservation number of CGMCC No. 24836, wherein the medium is a LB medium comprising 10 g/L peptone, 5 g/L yeast extract, and 5 g/L sodium chloride; or a GYP medium comprising 10 g/L glucose, 8 g/L yeast extract, and 2 g/L soy peptone.
The instant specification does not define the term “fermentation product”. MPEP 2113 states: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
The broadest reasonable interpretation of “fermentation product” is that it includes any chemical or mixture that is produced by the claimed fermentation process. Therefore, the fermentation products of claim 3 are broad and include products that do not comprise live bacteria or functional enzymes. Nevertheless, claim 9 requires that the full scope claimed be capable of the effect of degrading the glycinin and/or β-conglycinin at least partially.
The amount of direction provided by the inventor and the existence of working examples: The examples show that B. subtilis FNFH_BS06 degrades glycinin and/or β-conglycinin [Table 1, 0036], including when used to ferment soybean meal [0057-0058, Table 2]. The examples also teach other properties of the strain [0039-0040]. The specification teaches that the examples “proves that the Bacillus subtilis FNFH_BS06 has a very good degradation effect on the antigen proteins in the soybean meal, and can degrade macromolecular insoluble proteins in the soybean meal into micromolecular soluble proteins and peptides within 24 hours, thereby improving the protein bioavailability.” [0059].
The specification does not provide direction about what enzymes or other properties of the Bacillus subtilis FNFH_BS06 are used for degrading glycinin and/or β-conglycinin.
The state of the prior art and the level of predictability in the art: Ramos et al. (2000, “Fermentative metabolism…”; hereafter Ramos; PTO-892) teaches “Bacillus subtilis grows in the absence of oxygen using nitrate ammonification and various fermentation processes. Lactate, acetate, and 2,3-butanediol were identified in the growth medium as the major anaerobic fermentation products” (Abstract). Ramos teaches the fermentation products lactate, acetate, and 2,3-butanediol obtained by fermenting B. subtilis. These products have defined chemical structures, so they are the same product as the lactate, acetate, and 2,3-butanediol obtained by fermenting soybean meal using the specific bacterial agent comprising B. subtilis FNFH_BS06 and a medium that is LB or GYP medium. The art does not provide any way for lactate, acetate, and/or 2,3-butanediol to achieve the claimed function of degrading glycinin and/or β-conglycinin.
Yang et al. (2020, “Improvement of the protein…”; PTO-892) teaches fermenting soybean meal using B. subtilis to decrease the levels of β-conglycinin and glycinin (Abstract), but teaches that “the reaction was stopped by autoclaving at 121 °C for 15 min.” (pg. 2 Section 2.2). Yang also teaches additional processing of the fermented product by protein extraction (pg. 2 Section 2.4). Therefore, Yang teaches the live bacteria is required for the function and that the reaction can be stopped by autoclaving to kill the bacteria. The fermentation product, after processing by autoclave, is not capable of decreasing the levels of β-conglycinin and glycinin.
The quantity of experimentation needed to make or use the invention: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success and without undue experimentation. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution.
No quantity of experimentation will change the properties of a product to make it capable of something that it is not capable of. The specification and art both teach that the function of “decreasing the levels of β-conglycinin and glycinin” in the substrate requires the presence of live B. subtilis. The fermentation products claimed are broader and include products that do not comprise live B. subtilis FNFH_BS06. So the amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully decreasing the levels of β-conglycinin and glycinin in the substrate. Therefore, claim 9 is rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement.
Claim 9 is 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.
MPEP 2163 states:
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
Claim 9 is a method with the step of applying the fermented product of claim 3 to a substrate comprising glycinin and/or β-conglycinin, with the effect of degrading the glycinin and/or β-conglycinin at least partially. The fermentation product of claim 3 is a product-by-process claim that is obtained by fermenting soybean meal with the bacterial agent of claim 1, which is a bacterial agent, comprising a medium; and a Bacillus subtilis FNFH_BS06, with a preservation number of CGMCC No. 24836, wherein the medium is a LB medium comprising 10 g/L peptone, 5 g/L yeast extract, and 5 g/L sodium chloride; or a GYP medium comprising 10 g/L glucose, 8 g/L yeast extract, and 2 g/L soy peptone.
The instant specification does not define the term “fermentation product”. MPEP 2113 states: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
The broadest reasonable interpretation of “fermentation product” is that it includes any chemical or mixture that is produced by the claimed fermentation process. Therefore, the fermentation products of claim 3 are broad and include products that do not comprise live bacteria or functional enzymes. Nevertheless, claim 9 requires that the full scope claimed be capable of the effect of degrading the glycinin and/or β-conglycinin at least partially.
The examples show that B. subtilis FNFH_BS06 degrades glycinin and/or β-conglycinin [Table 1, 0036], including when used to ferment soybean meal [0057-0058, Table 2]. The examples also teach other properties of the strain [0039-0040]. The specification teaches that the examples “proves that the Bacillus subtilis FNFH_BS06 has a very good degradation effect on the antigen proteins in the soybean meal, and can degrade macromolecular insoluble proteins in the soybean meal into micromolecular soluble proteins and peptides within 24 hours, thereby improving the protein bioavailability.” [0059]. The specification does not provide direction about what enzymes or other properties of the Bacillus subtilis FNFH_BS06 are used for degrading glycinin and/or β-conglycinin.
Ramos et al. (2000, “Fermentative metabolism…”; hereafter Ramos; PTO-892) teaches “Bacillus subtilis grows in the absence of oxygen using nitrate ammonification and various fermentation processes. Lactate, acetate, and 2,3-butanediol were identified in the growth medium as the major anaerobic fermentation products” (Abstract). Ramos teaches the fermentation products lactate, acetate, and 2,3-butanediol obtained by fermenting B. subtilis. These products have defined chemical structures, so they are the same product as the lactate, acetate, and 2,3-butanediol obtained by fermenting soybean meal using the specific bacterial agent comprising B. subtilis FNFH_BS06 and a medium that is LB or GYP medium. The art does not provide any way for lactate, acetate, and/or 2,3-butanediol to achieve the claimed function of degrading glycinin and/or β-conglycinin.
Yang et al. (2020, “Improvement of the protein…”; PTO-892) teaches fermenting soybean meal using B. subtilis to decrease the levels of β-conglycinin and glycinin (Abstract), but teaches that “the reaction was stopped by autoclaving at 121 °C for 15 min.” (pg. 2 Section 2.2). Yang also teaches additional processing of the fermented product by protein extraction (pg. 2 Section 2.4). Therefore, Yang teaches the live bacteria is required for the function and that the reaction can be stopped by autoclaving to kill the bacteria. The fermentation product, after processing by autoclave, is not capable of decreasing the levels of β-conglycinin and glycinin.
The specification, when read in view of the art, teaches that the structure correlated with the function of “degrading the glycinin and/or β-conglycinin” is the live bacteria Bacillus subtilis FNFH_BS06. This structure is not required by claim 9, so the specification does not demonstrate possession of the method’s function by describing a structure correlated with the claimed invention.
The specification also describes using the method with a single product, live Bacillus subtilis FNFH_BS06; this is not a representative number of species relative to the broad genus of “fermentation products” that include chemicals such as lactate, acetate, and 2,3-butanediol and complex mixtures of chemicals such as the autoclaved soybean fermentation and the purified proteins thereof. So, the specification does not demonstrate possession of the method’s function by describing a representative number of species of the method.
Therefore, claim 9 is rejected because one of ordinary skill in the art would not have believed that the specification demonstrates possession of the method as broadly claimed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramos et al. (2000, “Fermentative metabolism…”; hereafter Ramos; PTO-892).
Ramos teaches “Bacillus subtilis grows in the absence of oxygen using nitrate ammonification and various fermentation processes. Lactate, acetate, and 2,3-butanediol were identified in the growth medium as the major anaerobic fermentation products” (Abstract). Ramos does not teach that lactate, acetate, and 2,3-butanediol can be “obtained by fermenting soybean meal with the bacterial agent of claim 1” as in claim 3.
MPEP 2113 states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). … "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). … As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
The instant specification does not define the term “fermentation product”. The broadest reasonable interpretation is that it includes any chemical or mixture that is produced by the claimed fermentation process. In this case, Ramos teaches the fermentation products lactate, acetate, and 2,3-butanediol obtained by fermenting B. subtilis. These products have defined chemical structures, so they are the same product as the lactate, acetate, and 2,3-butanediol obtained by fermenting soybean meal using the specific bacterial agent comprising B. subtilis FNFH_BS06 and a medium that is LB or GYP medium. The burden shifts to the applicant to demonstrate that lactate, acetate, and 2,3-butanediol are not fermentation products that are obtained from the claimed method.
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 3 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-7 of copending Application No. 18/555,540 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. This copending application has been allowed and this rejection will convert to a non-provisional rejection when the other application issues.
‘540 claims 4-7 each teach a product created by a method of adding B. subtilis FNFH_BS08 to soybean meal, and ‘540 claim 6 teaches fermenting the soybean meal. ’540 claims 4-5 teach that the product has degraded antigens that can be glycinin and β-conglycinin. ‘540 does not teach the use of a bacterial agent, comprising a medium; and a Bacillus subtilis FNFH_BS06, with a preservation number of CGMCC No. 24836, wherein the medium is a LB medium comprising 10 g/L peptone, 5 g/L yeast extract, and 5 g/L sodium chloride; or a GYP medium comprising 10 g/L glucose, 8 g/L yeast extract, and 2 g/L soy peptone.
MPEP 2113 states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). … "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). … As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
The instant specification does not define the term “fermentation product”. The broadest reasonable interpretation is that it includes any chemical or mixture that is produced by the claimed fermentation process. In this case, the claims of ‘540 teaches fermentation products obtained by fermenting B. subtilis. These products are made from the same fermenting process with the same bacterial species and have the same degrading glycinin and β-conglycinin property, so they appear to be the same product as obtained by fermenting soybean meal using the specific bacterial agent comprising B. subtilis FNFH_BS06 and a medium that is LB or GYP medium. The burden shifts to the applicant to establish a nonobvious difference between the claimed product and the product of the ’540 claims.
Claims 3 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 19/805,756 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
‘756 claims 1-7 teach a method for creating a product by co-fermenting soybean meal using B. subtilis FNFH_BS08 and S. cerevisiae. ‘756 claims 8-13 teach the fermented soybean meal produced by the method. ‘756 claims 4-5 teaches a bacterial agent comprising Bacillus subtilis FNFH_BS08 and GYP medium, which is contacted with the soybean meal. The claims do not teach sterilizing the fermented product, so the product comprises live B. subtilis. The claims of ‘756 does not teach the use of a bacterial agent comprising Bacillus subtilis FNFH_BS06, with a preservation number of CGMCC No. 24836.
MPEP 2113 states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). … "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). … As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
The instant specification does not define the term “fermentation product”. The broadest reasonable interpretation is that it includes any chemical or mixture that is produced by the claimed fermentation process. In this case, the claims of ‘756 teaches fermentation products obtained by fermenting B. subtilis (as well as the not claimed yeast S. cerevisiae). These products are made from the same fermenting process with the same bacterial species. The fermentation products also have live B. subtilis, so they are presumed capable of the function of degradation in glycinin and β-conglycinin, absent evidence to the contrary. So, the product of ‘756 appears to be the same product as obtained by fermenting soybean meal using the specific bacterial agent comprising B. subtilis FNFH_BS06. The burden shifts to the applicant to establish a nonobvious difference between the claimed product and the product of the ’756 claims.
Conclusion
Claims 1 and 4-6 are allowed, rejoined claims 3 and 9 are not. See MPEP 706.07(a): “If rejoinder occurs after a first Office action on the merits and if any of the rejoined claims are unpatentable (e.g., a rejection under 35 U.S.C. 112(a) is made), the next Office action may be made final if the rejection of the rejoined claims was necessitated by applicant’s amendment.”
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 AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
