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 .
Status of the Claims
Claims 1-10 and 12-18 are currently pending (claim set as filed on 8/6/2026). Claim 11 is cancelled. Claims 1-6 and 14-18 are withdrawn due to a restriction/election requirement. Claims 7-10 and 12-13 are amended. Claims 7-10 and 12-13 are under examination.
Priority
This application filed on 10/5/2023 claims benefit to a provisional application no. 63/413,412 filed on 10/5/2022. The claim to benefit is acknowledged and therefore the effective filing date of the application is 10/5/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/6/2026 and 8/10/2026 were considered, initialed, and attached hereto. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawal of Objections
Any objections of record not particularly addressed are withdrawn in light of the
amendments and/or applicant’s comments.
Withdrawal of Rejections
Any rejections of record not particularly addressed below are withdrawn in light of the claim
amendments and/or applicant’s comments.
Claim Rejections - 35 USC § 102/103
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 7-10 and 12-13 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sandvang (Pre-Grant Publication No. US 2018/0296475 A1 – date of publication 10/18/2018).
Sandvang’s general disclosure relates to the administering of a pelleted feed composition (see abstract and [0077]) comprising Bacillus coagulans (see [0289]) to an animal to improve upon its health (see [0016]).
Regarding claims 7 and 9, Sandvang anticipates a feed composition comprising the bacteria Bacillus coagulans (see [0289]) in pelleted form (see [0077]). Bacillus coagulans is immediately envisioned as it is a preferred embodiment of the bacterial species taught. Sandvang does not specify that the Bacillus strain was specifically NRRL No. B-67744, however it teaches a Bacillus coagulans species that has the same function to improve the health of the animal (see [0016]) as the B-67744 deposited strain does. Therefore, it appears the prior art teaches the same strain based on the function or an obvious variant.
Alternatively, regarding claims 7 and 9, if the strains are not the same but are obvious variants, it would be obvious to one of ordinary skill in the arts before the effective filing date to use any Bacillus coagulans strain with the same function including instant B-67744 in the composition taught by Sandvang. One would be motivated to do so because Sandvang teaches that the Bacillus strain in the pelleted feed composition has the same function of improving the health of the animal (see [0016]) as the deposited Bacillus strain in the commercial package. So it would be prima facie obvious to do a simple substitution of one Bacillus strain for another as they are functionally the same and one would have had a reasonable expectation of success in doing so.
Regarding claim 8, Sandvang teaches that the feed composition comprising Bacillus bacteria (see [0289]). Since the recitation of intended use does not impart a structural limitation, the prior art is capable of performing the intended use. See MPEP 2111.02.
Regarding claim 10, Sandvang teaches the composition includes a salt and sugar carrier (e.g. a dextrin) (see [0252]).
Regarding claim 12, Sandvang teaches the feed composition comprises a clay binder (see [0255]).
Regarding claim 13, Sandvang teaches the same structure as claimed and therefore it reads on a ”dietary nutrient composition.”
Claims 7-10 and 12-13 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Johnson (Pre-Grant Publication No. WO 2019/147799 A1 – date of patent 8/1/2019).
Johnson’s general disclosure relates to the administering of a pelleted feed supplement (see pg. 35, ¶ 1) comprising Bacillus bacteria to animals (see pg. 1 – “Field”).
Regarding claims 7 and 9, Johnson anticipates a feed supplement comprising Bacillus coagulans (see pg. 62, claim 1). Johnson recites a composition comprising several Bacillus species, including Bacillus coagulans. Johnson does not specify that the Bacillus strain was specifically NRRL No. B-67744, however it teaches Bacillus coagulans species that has the same function to improve the health of the animal (see pg. 6, ¶ 4) as theB-67744 deposited strain does. Therefore, it appears the prior art teaches the same strain based on the function or an obvious variant.
Alternatively, regarding claims 7 and 9, if the strains are not the same but are obvious variants, it would be obvious to one of ordinary skill in the arts before the effective filing date to use any Bacillus coagulans strain with the same function including instant B-67744 in the composition taught by Johnson. One would be motivated to do so because Johnson teaches that the Bacillus strain in the feed supplement has the same function of improving the health of the animal (see pg. 6, ¶ 4) as the deposited Bacillus strain in the claimed commercial package. So it would be prima facie obvious to do a simple substitution of one Bacillus strain for another as they are functionally the same and one would have had a reasonable expectation of success in doing so.
Regarding claim 8, Johnson teaches that the feed supplement comprising Bacillus bacteria (see pg. 62, claim 1). However, the body of the claim wherein the Bacillus strain causes an effect of improving the health of the animal merely recites the intended use of the commercial package rather than any distinct definition of the claimed invention limitations. Therefore since the prior art teaches the structure of the claimed invention, the prior art is capable of performing the intended use. See MPEP 2111.02.
Regarding claim 10, Johnson teaches the carrier comprises a salt, a sugar, and a maltodextrin (see pg. 59, Statement 21). Maltodextrin is a type of dextrin and so reads on the dextrin carrier as claimed by the applicant.
Regarding claim 12, Johnson teaches the composition of a clay binder (see pg. 35, ¶ 1).
Regarding claim 13, Johnson teaches the same structure as claimed and therefore it reads on ”dietary nutrient composition.”
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 7-10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-7 of copending Application No. 18/481,999.
This is a provisional nonstatutory double patenting rejection. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
• a commercial package comprising an isolated Bacillus strain NRRL No. B-67744 in pellet form (claims 7-10 and 12-13)
• a commercial package further comprising a dextrin carrier and a clay binder (claims 10 and
12)
Copending Application No. 18/481,999 claims are directed towards:
• a commercial package comprising an isolated Bacillus strain NRRL No. B-67744 in pellet form (claims 1 and 3-7)
• a commercial package further comprising a dextrin carrier and a clay binder (claims 4 and 6)
The claims of both the instant application and the copending application are directed towards a composition of a Bacillus bacteria strain and excipients of dextrin and clay. As such, both applications are claiming similar compositions as they contain the same structural components. Although the copending application claims additional Bacillus strains in the composition, the instant application recites comprising language in claim 1 which allows for the inclusion of additional Bacillus strains into the instant composition.
Response to Arguments
Applicant's arguments filed on 8/6/2026 have been fully considered but they are not persuasive.
Sandvang
The applicant argues that the prior art reference Sandvang discloses the Bacillus coagulans species in a “laundry list” of possible bacterial strains used in the composition and fails to provide motivation as to why it was selected. The applicant argues that Bacillus coagulans is not a preferred embodiment of bacteria as it was not elaborated on in the prior art paragraphs [290-293], comparing it to other Bacillus strains discussed in the aforementioned sections. The applicant argues that the prior art paragraph [0016] fails to disclose a particular Bacillus strain administered to have “the same function to improve the health of the animal as the deposited strain does” and that the proceeding paragraphs discuss the composition administered instead as comprising polypeptides and merely using bacterial strains as a supplemental component. Furthermore, the applicant argues that the prior art does not provide data to prove utility of the Bacillus coagulans strain specifically over other strains to improve gastrointestinal health of an animal.
However, prior art Sandvang explicitly states that the Bacillus coagulans strain is a “preferred embodiment” of the bacterial species used in the feed composition in paragraph [0289] regardless of further embodiments of strains described in paragraphs [0290-0293]. Thus, it would be clear to the ordinary artisan to select a preferred strain such as Bacillus coagulans suggested by the prior art in contrast of the broader list of genera listed in paragraph [0288]. Additionally, the prior art teaches the administered feed composition has the ability to improve the health of the animal in paragraph [0016]. Although the paragraph does not specify the Bacillus coagulans strain alone is capable of this, it states the feed composition is capable of this function. As the feed comprises Bacillus coagulans, the strain is also capable of performing this function. The presence of other composition materials such as polypeptides is inconsequential as long as it is established that the composition at least comprises the Bacillus strain. Finally, it should be noted that the burden lies on the applicant to provide statistically significant proof that the difference in the claimed results and the prior art are unexpected, critical, and unobvious. See MPEP 716.02.
Johnson
The applicant argues that the prior art reference Johnson does not teach a composition comprising a single Bacillus coagulans strain as the active agent but instead teaches that a composition of three or four Bacillus strains. They further argue that the prior art does not teach the unique deposit number strains BC1 and BCP2 and thus cannot anticipate and/or make obvious the claimed product. The applicant claims the deposited strains, BC1 and BCP2, have demonstrated efficacy when administered alone and thus function differently than the prior art strain of merely Bacillus coagulans administered combined with other strains. Applicant concludes that one Bacillus coagulans strain cannot be simply substituted for another as strain-level genetic differences can produce structural and functional distinctions even within a specific species.
In response, the prior art Johnson does indeed teach Bacillus coagulans in a multiple bacterial species composition. However, the instant claims make no mention of a commercial package of solely an isolated Bacillus coagulans strain. Instead the claim language recites “comprising” which is open-ended and does not exclude additional strains from the composition. See MPEP 2111.03. Regardless of the demonstrated efficacy of the BC1 and BCP2 strains when they are alone in a composition versus the prior art teaching Bacillus strains combined, the language of the instant claims leave room for other strains to be included in the commercial package and thus it is unclear how the deposited strains are required to be isolated to function as intended if so. If the deposited strains do in fact produce a strain-level genetic difference resulting in a function that is markedly different than the prior art strain, then the burden lies on the applicant to provide statistically significant proof of such a claim. See MPEP 716.02. Thus as the claimed deposited strains and the prior art strains have overlapping functions to improve the health of the animal, they are still considered functionally similar strains or obvious variants of one another.
Double Patenting
In response to applicant’s request to hold the provisional non-statutory double patenting rejections of claims 7-10 and 12-13 until either application ‘999 or ‘000 is found allowable, they are advised to review MPEP 804(I)(B)(1). The applicant did not demonstrate that the pending claims are patentably distinct from the reference claims, nor was a terminal disclaimer filed in accordance with 37 CFR 1.321 in the pending application. Thus the double patenting rejection still stands.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMALEE R WILLIAMS/ Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
