DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The appeal brief filed September 19, 2025, has been received.
Claims 1-20 are pending. Claims 9-20 are withdrawn.
Claims 1-8 are examined on the merits.
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on September 19, 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651
Response to Arguments
The following rejections under 35 U.S.C. 103 have been withdrawn: the rejection under 35 U.S.C. 103 of claims 1 and 3-8 as being unpatentable over Baltzley; the rejection under 35 U.S.C. 103 of claim 2 as being unpatentable over Baltzley in further view of Svihus. Upon further consideration, there is insufficient evidence to support a conclusion that the B27, 2084, and 22CP1 strains of Baltzley are directed to the claimed NRRL B-50622 and PTA-7547 strains. Therefore, these rejections under 35 U.S.C. 103 have been withdrawn.
The provisional nonstatutory double patenting rejections over claims 1-18 of Application No. 17/769,433 have been rendered moot by the abandonment of Application No. 17/769,433. Therefore, the provisional nonstatutory double patenting rejections have been withdrawn.
However, upon further consideration, a new ground(s) of rejection under 35 U.S.C. 103 is made in view of the newly cited references Millan and Rhine, as well as Frodyma (previously cited in the rejection under 35 U.S.C. 101). The elected species ‘Bacillus subtilis NRRL B-50622’ (elected as the primary species) is allowable over the prior art. However, Frodyma discloses the elected species ‘Bacillus subtilis PTA-7547’ as the secondary species. The search and examination has been extended to the species Bacillus subtilis NRRL B-50136, Bacillus licheniformis NRRL B-50141, and Bacillus amyloliquefaciens NRRL B-50151 as the primary species or the secondary species according to MPEP 803.02(III)(C)(2). Rhine discloses each of these three strains.
Applicant's arguments filed September 19, 2025, have been fully considered but they are not persuasive with respect to the rejections under 35 U.S.C. 112(a) and 35 U.S.C. 101.
Regarding the rejection under 35 U.S.C. 112(a), Applicant asserts that the Examiner has no statutory or regulatory authority to demand the statement set forth in the third paragraph of page 4 and in the first paragraph of page 24 of the last Office Action (the specific strain will be irrevocably and without restriction or condition…) because 37 C.F.R. 1.808 expressly provides an exception to the general rule against restrictions on the availability to the public of deposited biological materials. It is further asserted that Applicant has already confirmed the recited deposits were made under terms that comply with the terms of the Budapest Treaty and 37 C.F.R. 1.801-1.809, including 37 C.F.R. 1.808(a)(2). However, MPEP 2404.01 states, “Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b) ), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990)” (emphasis added). Additionally, MPEP 2410.01 states, “Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent” (emphasis added). Therefore, the rejection under 35 U.S.C. 112(a) has been maintained.
Regarding the rejection under 35 U.S.C. 101, Applicant asserts that the pending claims are clearly directed to a practical, real-world application of the recited Bacillus strains –an animal feed pellet comprising viable spores and/or cells of one or more of the recited Bacillus strains. Examiners determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the flowchart in MPEP 2106(III). The practical application is addressed in Step 2A, Prong Two (see MPEP 2106.04(II)(A)). As explained in the rejection, the judicial exception (product of nature exception) is not integrated into a practical application since the inclusion of the viable spores and/or cells of the claimed Bacillus strain (the PTA-7547 strain) in an animal feed pellet (the ‘additional element’ to the claimed product of nature) does not set forth a practical application of the judicial exception. The inclusion of the claimed product of nature in an animal feed pellet itself is not directed to a practical application of the product of nature since the claims do not require that the viable spores and/or cells undergo a pelleting process to make the animal feed pellet. The claims are broadly drawn to a combination of an animal feed pellet and viable spores and/or cells of one or more of the claimed Bacillus strains.
Applicant also asserts that the pending claims do not seek to tie up the underlying strains themselves, nor do they seek to tie up all uses of the recited strains. However, as indicated in MPEP 2106.04(b)(II), products of nature are considered to be a judicial exception because they tie up the use of naturally occurring things. In this case, since at least the claimed viable spores and/or cells of the PTA-7547 strain is a product of nature (as established through the analysis under Step 2A, Prong One in the rejection which involves markedly different characteristics analysis; see page 9, first paragraph of the last Office Action), then its use is tied up by the instant claims.
With respect to the analysis under Step 2A, Prong 1 in the rejection, Applicant asserts that the animal feed pellet is not a “product of nature” because it exhibits markedly different characteristics from any naturally occurring counterparts. Applicant asserts that those skilled in the art will understand that the processes used to produce pelleted animal feeds (regardless of whether the pellets are formed into spherical balls, rounded tablets or cylindrical tubes) comprise heat, moisture and mechanical pressure that materially alter the structural and nutritional characteristics of the underlying components, thereby creating a non-naturally occurring composition that is unlike anything found in nature. Applicant cites three references, Mavromichalis, Abdollahi, and Landeros (footnotes 7-9). However, those references are not of record (not provided with the IDS filed 3/4/24; no copies filed with the appeal brief or prior responses). Therefore, the passages of these references cited on pages 5-6 of the appeal brief cannot be considered. In any case, the markedly different characteristics analysis under Step 2A, Prong 1 is conducted on the naturally occurring product (viable spores and/or cells of one or more of the claimed Bacillus strains, in particular of the PTA-7547 strain) itself, not on the ‘additional element’ recited in the claim other than the naturally occurring product. As explained on page 6, second paragraph of the last Office Action, the claims do not require that the viable spores and/or cells undergo a pelleting process to make the animal feed pellets, so the claims are broadly drawn to a combination of an animal feed pellet (which is not a product of nature) and the claimed viable spores and/or cells (the naturally occurring product). The pellet itself is an ‘additional element’ to the naturally occurring product (viable spores and/or cells of one or more of the claimed Bacillus strains). Since the claims do not require that the viable spores and/or cells undergo a pelleting process, then any effect of heat, moisture, or mechanical pressure of the pelleting process on the spores and/or cells of the claimed Bacillus strain(s) would not be under consideration to determine whether markedly different characteristics are conferred on the naturally occurring product (viable spores and/or cells of one or more of the claimed Bacillus strains, e.g. the PTA-7547 strain).
Applicant asserts that even if a claim recites a “product of nature” exception, it must nevertheless be found patent-eligible at Step 2A, Prong 2 if it incorporates that exception into a practical application, i.e., if it relies upon or uses the exception in a manner that imposes meaningful limits on Applicant’s claim to use of the exception. Applicant cites MPEP 2106.04(d). Applicant asserts that claim 1 recites a practical application that imposes meaningful limits on Applicant’s claim to use of the recited Bacillus strains – an animal feed pellet. The Examiner respectfully disagrees, maintaining that the inclusion of the viable spores and/or cells in an animal feed pellet does not set forth a practical application of the viable spores and/or cells (the product of nature). The claims are broadly drawn to a combination of an animal feed pellet and the viable spores and/or cells, and do not require that the viable spores and/or cells undergo a pelleting process. Therefore, the rejections under 35 U.S.C. 101 are maintained.
Claim Rejections - 35 USC § 112
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.
Claims 1-8 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The organisms, Bacillus subtilis NRRL B-50622 strain (elected species), as well as the strains NRRL B-50016, NRRL B-50151, NRRL B-50304, NRRL B-50605, NRRL B-50606, NRRL B-50607, and NRRL B-50622 (non-elected species), are recited in the claims, and thus are essential to the claimed invention. Since the microorganisms are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganisms are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the microorganisms, and it is not apparent if the biological materials are readily available to the public.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
NOTE: The claims are enabled for the following strains which are recited in the claims of U.S. Patent Nos. 8,383,097; 9,809,477; 10,207,943; and 9,234,251: strain PTA-7547 (elected species), as well as strains NRRL B-50017, NRRL B-50136, NRRL B-50141, and NRRL B-50349 (non-elected species).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. The claims are directed to a statutory category, i.e. a composition of matter (Step 1: YES).
Claims 1 and 3: Claim 1 recites an animal feed pellet comprising viable spores and/or cells of one of more of the recited Bacillus strains. Claim 3 limits the scope to viable spores of one or more of the recited Bacillus strains. The Bacillus subtilis strain PTA-7547 recited in claim 1 is a naturally occurring microorganism, as evidenced by Frodyma (WO 2008/021761. Listed on IDS filed 3/4/24). See page 1, lines 23-24; page 3, lines 19-28; and page 4, lines 14-15 of Frodyma. Therefore, viable spores and/or cells of the PTA-7547 strain is a product of nature. As such, claims 1 and 3 are each a nature-based composition since they each comprise a product of nature (at least the viable spores and/or cells of the PTA-7547 strain).
Under Step 2A, Prong One of the analysis, the claimed nature-based composition is compared to its naturally occurring counterpart to identify markedly different characteristics based on structure, function, and/or other properties. The ‘additional element’ recited in claims 1 and 3 other than the judicial exception is an animal feed pellet that comprises the viable spores and/or cells. The claims do not require that the viable spores and/or cells undergo a pelleting process to make the animal feed pellet, so the claims are broadly drawn to a combination of an animal feed pellet and viable spores and/or cells of one or more of the claimed Bacillus strains. An animal feed pellet does not appear to have an effect on Bacillus strains, and thus does not appear to have an effect on the PTA-7547 strain. Combining an animal feed pellet with the product of nature (at least the viable spores and/or cells of the PTA-7547 strain) does not appear to markedly change any characteristic of the PTA-7547 strain, absent a showing of evidence by Applicant. As such, the claimed viable spores and/or cells of the PTA-7547 strain do not have any markedly different characteristics from what occurs in nature and is a ‘product of nature’ exception. Accordingly, claim 1 and 3 each recite a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. The animal feed pellet is the ‘additional element’ other than the judicial exception (the product of nature). The inclusion of the viable spores and/or cells of the PTA-7547 strain in an animal feed pellet does not set forth a practical application of the judicial exception. As such, there is no integration of the product of nature into a practical application (Step 2A, Prong Two: NO), so claims 1 and 3 are each directed to a judicial exception (Step 2A: YES).
Claims 1 and 3 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As pointed out above, the ‘additional element’ other the judicial exception is the animal feed pellet. As evidenced by Behnke (Feed Tech. 2001. 5(4): 19-22. Previously cited), the additional element of animal feed pellet is well-understood, routine and conventional activity in the field of animal feed prior to Applicant’s invention. Specifically, Behnke indicates that pelleting was introduced to the U.S. feed industry in the late 1920’s and its popularity has grown steadily until about 80% of all feed in the U.S. are currently pelleted (page 19, first paragraph). The supplementation of animal diets with Bacillus subtilis, including their spores, has been well known in the art of animal feed, as it was known decades prior to Applicant’s invention to include Bacillus subtilis as a probiotic administered to animals, including as a direct fed microbial feed additive; see page 1968, right column, first three paragraphs of Jenny (J. Dairy Sci. 1991. 74: 1968-1973. Previously cited) and page 588, first paragraph of Jorgensen (Journal of Microbiological Methods. 2007. 68: 588-595. Previously cited). Since animal feed pellets are the predominant animal feed form, then the combination of Bacillus subtilis (its viable spores or cells) and an animal feed pellet is well-understood, routine and conventional activity prior to Applicant’s invention. Since the additional element of claims 1 and 3 is a well-understood, routine and conventional activity prior to Applicant’s invention, then the additional element does not amount to significantly more than the claimed judicial exception (Step 2B: NO). As such, claims 1 and 3 are not eligible subject matter under 35 U.S.C. 101.
Claim 2: Claim 2 recites an animal feed pellet comprising (1) viable spores and/or cells of one of more of the recited Bacillus strains, and (2) one or more enzymes. As discussed above, viable spores and/or cells of the Bacillus subtilis strain PTA-7547 recited in claims 1 and 3 is a product of nature. Additionally, the Examiner takes official notice that enzymes are products of nature (for example, they naturally exist in saliva). As such, claim 2 is a nature-based composition since it comprises two products of nature.
Under Step 2A, Prong One of the analysis, the claimed nature-based composition is compared to its naturally occurring counterpart to identify markedly different characteristics based on structure, function, and/or other properties. One ‘additional element’ recited in claim 2 other than the judicial exceptions (two products of nature) is an animal feed pellet that comprises the viable spores and/or cells and the one or more enzymes. The claim does not require that the viable spores and/or cells and the one or more enzymes undergo a pelleting process to make the animal feed pellet, so the claim is broadly drawn to a combination of an animal feed pellet, viable spores and/or cells of one or more of the claimed Bacillus strains, and one or more enzymes. Because the two products of nature (the viable spores and/or cells; the enzyme(s)) do not occur together in nature, then each product of nature is considered an ‘additional element’ to the other product of nature. Combining an animal feed pellet with the viable spores and/or cells of the PTA-7547 strain and the one or more enzymes does not appear to markedly change any characteristic of viable spores and/or cells of the PTA-7547 strain and the enzyme(s) because each product of nature would appear to continue to have the same properties in the combination as it had alone, absent a showing of evidence by Applicant. As such, the claimed viable spores and/or cells of the PTA-7547 strain and the enzyme(s) each do not have any markedly different characteristics from their naturally occurring counterparts, and are each a ‘product of nature’ exception. Accordingly, claim 2 recites ‘product of nature’ exceptions (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. See the preceding paragraph for the ‘additional elements’ other than the judicial exceptions (two products of nature). The combination of the viable spores and/or cells of the PTA-7547 strain, the one or more enzymes, and the animal feed pellet does not set forth a practical application of the judicial exceptions. As such, there is no integration of the products of nature into a practical application (Step 2A, Prong Two: NO), so claim 2 is directed to judicial exceptions (Step 2A: YES).
Claim 2 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. See above for the ‘additional elements’ other than the judicial exceptions (two products of nature). As evidenced by Behnke, Jenny, and Jorgensen, the additional element of an animal feed pellet comprising the claimed viable spores and/or cells is well-understood, routine and conventional activity prior to Applicant’s invention. See the discussion regarding those references in the rejection of claims 1 and 3. Therefore, it is well-understood, routine and conventional activity to include viable spores and/or cells of a Bacillus subtilis strain (thus the claimed PTA-7547 strain) with an animal feed pellet. Additionally, the additional element of one or more enzymes is well-understood, routine and conventional activity in the field of animal feed prior to Applicant’s invention. According to Pariza (Regulatory Toxicology and Pharmacology. 2010. 56: 332-342. Previously cited), feed enzymes are typically added to animal feed to increase nutrient bioavailability by acting on feed components prior to or after consumption (abstract). Since animal feed pellets are the predominant animal feed form (see discussion above regarding Behnke), then the combination of enzyme(s) and an animal feed pellet is well-understood, routine and conventional activity in the field of animal feed prior to Applicant’s invention. Since the additional elements recited in claim 2 are well-understood, routine and conventional activities prior to Applicant’s invention, then the additional elements do not amount to significantly more than the claimed judicial exceptions (Step 2B: NO). As such, claim 2 is not eligible subject matter under 35 U.S.C. 101.
Claims 4 and 7: Claim 4 recites an animal feed pellet comprising viable spores and/or cells of at least two of the recited Bacillus strains. As discussed above, viable spores and/or cells of the Bacillus subtilis strain PTA-7547 recited in the claims is a product of nature. The Bacillus subtilis strain NRRL B-50622 recited in claim 4 appears to be a product of nature since the instant specification and WO 2013/096369 (Listed on the IDS filed 3/4/24), cited in the specification for disclosing the NRRL B-50622 strain (page 3, lines 30-31 of the specification), do not disclose that the strain was obtained through genetic engineering. Claim 7 limits the Bacillus strains to these two strains, so the same analysis applies to claim 7. As such, claims 4 and 7 are each a nature-based composition since they each comprise two products of nature (at least the viable spores and/or cells of the PTA-7547 strain; at least the viable spores and/or cells of the NRRL B-50622 strain).
Under Step 2A, Prong One of the analysis, the claimed nature-based composition is compared to its naturally occurring counterpart to identify markedly different characteristics based on structure, function, and/or other properties. One ‘additional element’ recited in claims 4 and 7 other than the judicial exceptions (two products of nature) is an animal feed pellet that comprises the viable spores and/or cells of the at least two Bacillus strains (the PTA-7547 and NRRL B-50622 strains). Claims 4 and 7 do not require that the viable spores and/or cells undergo a pelleting process to make the animal feed pellet, so the claims are broadly drawn to a combination of an animal feed pellet and viable spores and/or cells of the PTA-7547 and NRRL B-50622 strains. Also, because the two products of nature do not occur together in nature, then each product of nature is considered an ‘additional element’ to the other product of nature. Combining an animal feed pellet with the viable spores and/or cells of the PTA-7547 and NRRL B-50622 strains does not appear to markedly change any characteristic of viable spores and/or cells of the PTA-7547 strain and the viable spores and/or cells of the NRRL B-50622 strain because each product of nature would appear to continue to have the same properties in the combination as it had alone, absent a showing of evidence by Applicant. As such, the claimed viable spores and/or cells of the PTA-7547 strain and the claimed viable spores and/or cells of the NRRL B-50622 strain each do not have any markedly different characteristics from their naturally occurring counterparts, and are each a ‘product of nature’ exception. Accordingly, claim 4 and 7 each recite ‘product of nature’ exceptions (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. See the preceding paragraph for the ‘additional elements’ other than the judicial exceptions (two products of nature). The combination of the viable spores and/or cells of the PTA-7547 strain, the viable spores and/or cells of the NRRL B-50622 strain, and the animal feed pellet does not set forth a practical application of the judicial exceptions. As such, there is no integration of the products of nature into a practical application (Step 2A, Prong Two: NO), so claims 4 and 7 are each directed to judicial exceptions (Step 2A: YES).
Claims 4 and 7 each do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. See above for the ‘additional elements’ other than the judicial exceptions (two products of nature). As evidenced by Behnke, Jenny, and Jorgensen, the additional element of an animal feed pellet comprising viable spores and/or cells of Bacillus subtilis is well-understood, routine and conventional activity prior to Applicant’s invention. See the discussion regarding Behnke, Jenny, and Jorgensen in the rejection of claims 1 and 3. Therefore, it is well-understood, routine and conventional activity to include viable spores and/or cells of Bacillus subtilis strains (thus the claimed PTA-7547 and NRRL B-50622 strains) in an animal feed pellet. Since the additional elements recited in each of claims 4 and 7 are well-understood, routine and conventional activities prior to Applicant’s invention, then the additional elements do not amount to significantly more than the claimed judicial exceptions (Step 2B: NO). As such, claims 4 and 7 are not eligible subject matter under 35 U.S.C. 101.
Claims 5 and 6: Claim 5 recites the further limitation that the animal feed pellet comprises at least 1 x 104 colony-forming units of the one or more Bacillus strains per gram of said animal feed pellet. Claim 6 recites the further limitation that the one or more Bacillus strains comprises about 1 x 106 to about 1 x 1012 colony-forming units of said one or more Bacillus strains per gram of the animal feed pellet. These limitations are considered an ‘additional element’ to the judicial exception (viable spores and/or cells of the PTA-7547 strain). The concentration of the Bacillus strain would not confer any markedly different characteristic on the viable spores and/or cells of the Bacillus strain, thus claims 5 and 6 each recite ‘product of nature’ exceptions (Step 2A, Prong One: YES). Additionally, the concentration of the Bacillus strain does not set forth a practical application of the judicial exception (Step 2A, Prong Two: NO). The inclusion of various concentrations of viable spores and/or cells of a Bacillus subtilis strain is well-understood, routine, and conventional activity prior to Applicant’s invention because the selection of suitable dose of nutritional additives (which the Bacillus subtilis strain is directed to) to an animal was well known. As such, the ‘additional element’ of each of claims 5 and 6 does not amount to significantly more than the judicial exception (Step 2B: NO). Thus claims 5 and 6 are not eligible subject matter under 35 U.S.C. 101.
Claim 8: The analyses applied to claims 4-7 are also applicable to claim 8. For the same reasons set forth with respect to claims 4-7, claim 8 is not eligible subject matter under 35 U.S.C. 101.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
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.
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.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Millan (WO 2012/110778) in view of Rhine (WO 2010/104794. Listed on IDS filed 3/4/24).
Millan discloses a feed additive composition comprising a direct fed microbial (DFM) in combination with a protease, a xylanase, an amylase, and a phytase (abstract). The direct fed microbial (DFM) may be a spore forming bacterium and hence the term DFM may be comprised of or contain spores, e.g. bacterial spores (page 9, lines 5-6). The DFM may be a viable microorganism that may include microbial spores (page 8, line 31; page 9, lines 6-8). In one embodiment, the DFM may be selected from Bacillus subtilis, Bacillus licheniformis, and Bacillus amyloliquefaciens (page 10, lines 4-5). Also, the DFM may be a combination comprising two or more Bacillus strains (page 10, line 7).
Additionally, Millan discloses an embodiment in which the feed is pelleted (page 15, lines 28). Preferably, the feed may be a fodder (page 38, line 12), and the term fodder includes pelleted feeds (page 328, line 21).
Therefore, Millan suggests the embodiment of a pelleted feed (directed to an ‘animal feed pellet’) comprising at least one Bacillus strain (e.g. strain(s) of Bacillus subtilis, Bacillus licheniformis, and Bacillus amyloliquefaciens) which may be in the form of a viable microorganism that includes microbial spores, meeting limitations of the claimed invention.
Millan differs from the claimed invention in that Millan does not expressly disclose that the at least one Bacillus strain comprises one or more of the strains recited in the instant claims.
Rhine discloses a process for increasing the degradability of lignocellulosic fibres (page 1, lines 7-8). The method of Rhine may be used in connection with a microbial or biological process where it is desired to achieve an increased utilization of the material comprising lignocellulosic fibres, wherein said microbial or biological process includes feed for live stocks (page 8, lines 31-34). The method of Rhine comprises incubating the material comprising lignocellulosic fibres with one or more microorganisms (page 2, lines 9-13). Particular preferred microorganism strains include Bacillus subtilis (NRRL B-50136), Bacillus licheniformis (NRRL B-50141), and Bacillus amyloliquefaciens (NRRL B-50151) (page 5, lines 17-23). These strains are amongst the strains recited in instant claims 1, 3, and 4.
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the Bacillus strain(s) of the pelleted feed rendered obvious by Millan with one or more of Bacillus subtilis (NRRL B-50136), Bacillus licheniformis (NRRL B-50141), and Bacillus amyloliquefaciens (NRRL B-50151). It would have been an obvious matter of simple substitution of one Bacillus strain (e.g. Bacillus subtilis, Bacillus licheniformis, and Bacillus amyloliquefaciens as taught by Millan) for another for the predicable result of obtaining a pelleted feed comprising DFM. Moreover, one of ordinary skill in the art would have been motivated to include one or more of those strains of Rhine because they increase the degradability of lignocellulosic fibers, thereby increasing utilization of a material comprising lignocellulosic fibers as feed for livestock. There would have been a reasonable expectation of obtaining the pelleted food as sought by Millan by including at least one of the NRRL B-50136, NRRL B-50141, and NRRL B-50151 strains of Rhine as the at least one Bacillus strain of the Millan invention because Millan discloses that the DFM of their invention may be selected from Bacillus subtilis, Bacillus licheniformis, and Bacillus amyloliquefaciens (page 10, lines 4-5).
Therefore, Millan in view of Rhine renders obvious instant claims 1 (search extended to the species NRRL B-50136, NRRL B-50141, and NRRL B-50151 strains), 2 (the protease, xylanase, amylase, and phytase of the pelleted feed of Millan is directed to ‘one or more enzymes’), 3 (viable spores are taught by Millan), and 4 (when two or more of the three strains).
Regarding claims 5 and 6, Millan discloses that suitable dosages of DFM in the feed can be between about 1 x 103 CFU/g feed to about 1 x 109 CFU/g feed which overlaps with the ranges of instant claims 5 and 6; or between about 1 x 104 CFU/g feed to about 1 x 108 CFU/g feed which falls in the range of instant claim 5 and overlaps with the range of instant claim 6 (page 19, lines 16-17). Therefore, instant claims 5 and 6 are rendered obvious.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Millan and Rhine as applied to claims 1-6 above, and further in view of Frodyma (WO 2008/021761. Listed on IDS filed 3/4/24).
As discussed above, Millan in view of Rhine render obvious claims 1-6 with respect to the following species for which the search and examination has been extended to: Bacillus subtilis NRRL B-50136, Bacillus licheniformis NRRL B-50141, and Bacillus amyloliquefaciens NRRL B-50151. However, Millan in view of Rhine fail to render obvious the claimed invention in which the secondary species is the elected species Bacillus subtilis PTA-7547.
Frodyma discloses Bacillus subtilis PTA-7547 (page 22, line 29).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute a second of the Bacillus strains (in combination with a least one of the NRRL B-50136, NRRL B-50141, and NRRL B-50151 strains) of the pelleted feed rendered obvious by Millan in view of Rhine with Bacillus subtilis PTA-7547. It would have been an obvious matter of simple substitution of one Bacillus strain for another for the predicable result of obtaining a pelleted feed comprising DFM. There would have been a reasonable expectation of obtaining the pelleted food as sought by Millan by including B. subtilis PTA-7547 as a second Bacillus strain because Millan discloses that the DFM of their invention may be a Bacillus subtilis (page 10, lines 4-5).
Conclusion
No claims are allowed.
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/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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