Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 15-21 are pending.
The previous rejection of claims 15-21 under 35 U.S.C. §112(a) as failing to comply with the enablement requirement, in the Non-Final Office Action mailed on 19 May 2025, is withdrawn in view of Applicants' remarks received 18 November 2025.
Applicant stated in a Declaration (filed as Document Type "Miscellaneous Incoming Letter" (LET.) on 06 June 2024 that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent, and also stated that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto (pp. 1-2).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. As noted in the Non-Final Office Action mailed 19 May 2025, Applicant has claimed the benefit of the filing date of the prior application, and designates the instant application as a "CON" of 17/354,208. Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c).
Claims 15 and 17 have the effective filing date of 25 September 2017.
Claims 16 and 18-21 have the effective filing date of 25 September 2018.
Claim Rejections - 35 U.S.C. § 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 15-21 are rejected under 35 U.S.C. §101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The judicial exception is not integrated into a practical application, and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
[This rejection cited in the Non-Final Office Action mailed 19 May 2025.]
The instant claims were analyzed for eligibility pursuant to the Patent Subject Matter Eligibility Guidance as presented in MPEP 2106. The instant claims are drawn to a spore-forming composition.
As such, the instant claims are drawn to a composition of matter, which is a statutory category of invention (STEP 1: YES).
The claimed composition comprises a naturally occurring Bacillus subtilis subspecies (sbsp) inaquosorum bacterium. The specification recites: “DE111 is an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989” (originally-filed specification, pg. 27, para. [0091]); and “All references in this application to Bacillus subtilis DE111 or its mutants refer to bacteria that have been isolated from nature and are grown by humans, for example, in the laboratory or under industrial conditions” (pg. 28, para. [0094]). That is, the B. subtilis sbsp inaquosorum bacterium does not appear to have been genetically-modified, but isolated from an environmental source. That is, it is naturally occurring.
Nothing in the instant specification suggests that the claimed B. subtilis sbsp inaquosorum bacterium exhibits any markedly different characteristics, with respect to structure and/or function, so as to distinguish it from its naturally occurring counterpart. That is, the above cited B. subtilis sbsp inaquosorum bacterium does not appear to result in a composition that is markedly different from the contribution of the individual (inherent) characteristics of the bacterium (MPEP 2106.04 (c)(II)(A)). In addition, the composition also comprises a pharmaceutically acceptable carrier (per instant claim 15), which could be water. Claim 15 also describes a dosage form range as CFU (colony forming units) per day.
As such, the instant claims recite a judicial exception (natural phenomenon/product of nature) in the form of a composition comprising a naturally occurring B. subtilis sbsp inaquosorum bacterium (STEP 2A, PRONG ONE: YES).
The instant claims are drawn to a composition that is a judicial exception and not a method of administering the composition. The courts have identified limitations that did not integrate a judicial exception into a practical application, which includes: “Generally linking the use of a judicial exception to a particular technological environment or field of use” (MPEP 2106.04 (d)(I)). Claim 16 describes an embodiment in which the composition comprises spores or vegetative cells or transition state cells. Spores are a naturally occurring form of Bacillus subtilis bacteria. Claims 17 and 18 describe the intended uses of the composition as a nutritional or dietary supplement or as a nutraceutical, respectively. Claim 19 describes a form of the composition as being a pharmaceutical preparation and includes a capsule, which can contain the B. subtilis sbsp inaquosorum bacterium in an unmodified form. Claim 20 describes examples of a spore germination inhibitor, which includes a hyper-saline carrier, which can be considered to be salt in water, which is a combination of naturally occurring components. Claim 21 describes the amount of spore germinator inhibitor present in the composition by weight.
With regard to the pharmaceutical preparation being a capsule, the elements of the preparation (here, a capsule and spore-forming composition) are considered separately, because these elements can be separated from each other. The spore-forming composition is, as noted above, a naturally occurring composition (as its closest naturally occurring counterpart). It is not clear that the spore-forming composition has been integrated into the capsule, per se, as a practical application. For example, a pharmaceutical preparation as a tablet, pill or gum would require actually physically integrating the spore-forming composition into a compound/material in order to form the tablet, pill or gum. A capsule, as an individual element, is well understood, routine & conventional in the medical arts; i.e., it is routine to provide therapeutics in capsules. Therefore, the additional element does not provide significantly more.
As such, the instant claims do not recite additional elements that integrate the judicial exception(s) into a practical application of the exception(s) (STEP 2A, PRONG TWO: NO).
As noted above, the claimed composition comprises a naturally occurring Bacillus subtilis subspecies (sbsp) inaquosorum bacterium. Nothing in the instant specification suggests that the claimed B. subtilis sbsp inaquosorum bacterium exhibits any markedly different characteristics, with respect to structure and/or function, so as to distinguish it from its naturally occurring counterpart. That is, the above cited B. subtilis sbsp inaquosorum bacterium does not appear to result in a composition that is markedly different from the contribution of the individual (inherent) characteristics of the bacterium (MPEP 2106.04 (c)(II)(A)). In addition, the composition also comprises a pharmaceutically acceptable carrier (per instant claim 15), which could be water.
As such, the instant claims do not recite any additional elements that amount to significantly more than the judicial exception (STEP 2B: NO).
In summary, the claimed subject matter is not integrated into a practical application, and, as individual elements and as a combination of elements, does not recite ‘significantly more’ than the judicial exception.
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. §101.
Claim Rejections - 35 U.S.C. § 112
35 U.S.C. § 112(a)
This language overcomes the 35 USC §112(a) rejection.
35 U.S.C. § 112(b)
Some of the rejections of Claims 15-21 under 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention, in the Non-Final Office Action mailed on 19 May 2025, is withdrawn in view of Applicants’ amendment received on 18 November 2025, in which the cited claims were amended.
Other rejections are withdrawn for other reasons.
With regard to claim 20 and the recitation of the relative term "hyper" in 'hyper-saline carrier', Applicant remarks that a hyper-saline solution in a physiological context, as set forth in the specification, is known as a salt solution having greater than physiological isotonic salt concentration, or greater than 0.9% salt, e.g., sodium chloride (Applicant remarks filed 18 November 2025, pg. 9, para. 2).
With regard to claim 21 and the recitation of the relative term "about", the document filed as Document Type "Auxiliary PDF of Application" (AUX.PDF), which appears to be a substitute specification, recites: "Use of the term 'about' is intended to describe values either above or below the stated value in a range of approximately ±10%; in other embodiments, the values may range in value above or below the stated value in a range of approximately ± 5%; in other embodiments, the values may range in value above or below the stated value in a range of approximately ± 2%; in other embodiments, the values may range in value above or below the stated value in a range of approximately ± 1%" (AUX.PDF filed 06 June 2024, pg. 96, para. [0911]).
The following is a quotation of 35 U.S.C. §112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. §112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-21 are rejected under 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 15 recites: A spore-forming probiotic composition comprising a therapeutically effective amount of a spore-forming Bacillus subtilis subspecies inaquosorum having accession...in a dose from 5 X 109 CFU per day to about 1 X 1011 CFU per day,... Claim 15 describes a composition and recites a limitation of a dose per day, which is interpreted to be an administrative dose. Claim 15 is uncertain as to whether the claimed composition is required to comprise NRRL B-67989 Bacillus subtilis inaquosorum in the amount range from 5 X 109 CFU to 1 X 1011 CFU.
Claims 16-21 are dependent on claim 15, contain the limitations of claim 16, and, therefore, are rejected for the same reason.
Claims 15-21 are indefinite because the metes and bounds of the claimed subject matter are not clear.
Claim Interpretations
(1) Claim 15 recites: “…comprising…Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989…”
The specification recites: “One useful Bacillus subtilis-containing composition is DE111 ® ("DE111"), available from Deerland Enzymes, Inc...DE111 is an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989” (originally-filed specification, pg. 27, para. [0091]); and “Embodiments of the present invention encompass methods of improving body composition in an individual, by administering a composition comprising (i) Bacillus subtilis DE111,…” (pg. 17, para. [0056]). That is, it appears as though the B. subtilis sbsp inaquosorum strain cited in claim 15 is the same as Bacillus subtilis strain DE111.
For the purpose of examination, prior art which shows Bacillus subtilis strain DE111 or a bacterial or Bacillus strain identified as DE111 will be considered to be applicable prior art.
(2) Claim 15 recites inherent limitations in its preamble language.
Claim 15 recites: “A spore-forming probiotic composition comprising…Bacillus subtilis subspecies inaquosorum…”
Casula et al. ((2002) Appl. Env. Microbiol. 68(5): 2344-2352 (cited in the Non-Final Office Action mailed 19 May 2025 and on the record)) teaches that spores of Bacillus species are being used commercially as probiotics…” (pg. 2344, Abstract); and spores of Bacillus subtilis are being used as probiotics and competitive exclusion (CE) agents for both human and animal consumption (pg. 2344, column 1, para. 1). That is, the intended use language in the preamble language of claim 15 will be considered to be an inherent feature of the composition; i.e., that all Bacillus subtilis strains (can) produce spores.
Therefore, for the purpose of examination, prior art which shows a composition comprising Bacillus subtilis subspecies inaquosorum (or DE111) will be considered to be a spore-forming probiotic composition.
(3) Claim 15 recites the term "pharmaceutically acceptable carrier".
The specification recites: "Pharmaceutically acceptable carrier" means any carrier, diluent, or excipient that is compatible with the other ingredients of the formulation and not deleterious to the user. Useful excipients include, but are not limited to, microcrystalline cellulose, magnesium stearate, calcium stearate, any acceptable sugar (e.g., mannitol, xylitol), and the like, and for cosmetic use, an oil-base is preferred" (originally-filed specification, pg. 31, para. [0107] thru pg. 32, cont. para. [0107]).
Therefore, for the purpose of examination, prior art which cites any of the excipients recited in the specification will be considered to be showing a pharmaceutically acceptable carrier.
(4) Claims 17, 18 and 19 recite intended use language.
Claim 17 recites: “…, wherein said composition is a nutritional or dietary supplement.”
Claim 18 recites: “…, wherein said composition is a nutraceutical.”
Claim 19 recites: “…, wherein the composition is a pharmaceutical preparation…”
For the purpose of examination, prior art which shows a composition comprising Bacillus subtilis subspecies inaquosorum (or DE111) will be considered to be a nutritional supplement, a dietary supplement, a nutraceutical and/or a pharmaceutical preparation.
On the other hand, prior art which addresses these limitations may be indicated at the discretion of the Examiner.
Claim Rejections - 35 U.S.C. § 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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. §103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 15-19 are rejected under 35 U.S.C. §103 as being unpatentable over Gould et al. (Pub. No. US 2018/0042972 A1; Filed: Jan. 6, 2017).
Regarding claim 15, 17 and 18, Gould et al. teaches formulations for providing one or more active probiotics to an individual. Formulations described herein are configured for oral ingestion by a human or animal in order to provide an active probiotic that is capable of providing systemic and/or gastro-intestinal ("GI") benefits to the human or animal who has ingested said formulation (pg. 1, para. [0006]). The composition comprises at least one spore-forming bacterial species (pg. 1, para. [0010]). In some embodiments, the first spore forming bacteria comprises about 1.5 billion to about 2.5 billion colony forming units (CFU) of Bacillus subtilis (pg. 1, para. [0013]). In some embodiments, the base substance in the composition comprises sweeteners such as, for example, sucrose, fructose, glucose or other sugars (pg. 3, para. [0024]), which are considered pharmaceutical carriers. In some embodiments of the described compositions, the strain of B. subtilis that is used is DE-111 (pg. 6, para. [0046]). Table 1 shows the same Bacillus subtilis strain designated as “DE111” (pg. 4, para. [0035]; and Table 1 [i.e., without the hyphen]). Table 1 shows an exemplary embodiment of the composition which also contains beta-glucan (pg. 4, para. [0035]; and Table 1). In addition, probiotics are generally grouped within the category of foods and nutritional supplements (pg. 1, para. [0003]).
Further regarding claim 15, pertaining to 5x109 CFU to about 1x1011 CFU, Gould et al. teaches that, in some embodiments, the composition comprises 5 billion CFU, 6 billion CFU, 7 billion CFU, 8 billion CFU, 9 billion CFU or 10 billion CFU of B. subtilis (pg. 5, para. [0043] [5 billion = 5x109]).
Regarding claim 16, in some embodiments, B. coagulans and B. subtilis organisms within the composition are encapsulated in protective spores within the composition. In these embodiments the composition is configured so that B. coagulans and B. subtilis mostly remain in a dormant state (i.e. in spore form) until they pass through the stomach so that they are protected and able to survive until reaching the lower GI tract (pg. 5, para. [0044]).
Regarding claim 19, pertaining to a gummy, confection, Gould et al. shows that some embodiments of the described compositions comprise a confection such as, for example, a gummy (pg. 2, para. [0019]).
Gould et al. does not explicitly teach a dose from 5x109 CFU per day to about 1x1011 CFU per day, although it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the spore-forming probiotic composition comprising a therapeutically effective amount of a Bacillus subtilis subspecies inaquosorum species having accession number NRRL B-67989, and a pharmaceutically acceptable carrier, as taught by Gould et al., by adjusting the concentration of the spore-forming B. subtilis as a dose on a per day basis, with a reasonable expectation of success, because Gould et al. suggests that, in some embodiments, the composition comprises 5, 6, 7, 8, 9 or 10 billion CFU of Bacillus subtilis (DE111) (MPEP 2143 (I)(G)). It would have further been obvious to one of ordinary skill in art of formulating a nutritional or pharmaceutical supplement to have determined, via routine optimization, the optimal amount of Bacillus subtilis DE111 (e.g., 5, 6, 7, 8, 9 or 10 billion CFU) to have been included in the composition as a dosage form on a per day basis (MPEP 2144 (I)), because Gould et al. teaches that the described compositions are configured to release one or more active ingredients into the GI system of an individual who ingests the composition, wherein the active ingredients are selected to exert either local (i.e. local to the GI tract) or systemic effects or both on the individual (pg. 2, para. [0018]). That is, the composition has been optimized as a therapeutically effective pharmaceutical composition.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 20 and 21 are rejected under 35 U.S.C. §103 as being unpatentable over Gould et al., as applied to claims 15-19 above, and further in view of Farmer et al. (U.S. Patent No.7,374,753 B1; Date of Patent: May 20, 2008).
Gould et al. does not teach: 1) the pharmaceutical preparation further comprises a spore germination inhibitor selected from the group consisting of a hyper-saline carrier, methylparaben, guar gum, and polysorbate [Claim 20]; and 2) the spore germination inhibitor is present in an amount of about 1% by weight of the composition [Claim 21].
Farmer et al. shows a composition comprising viable non-pathogenic lactic
acid bacterium in a pharmaceutically acceptable carrier suitable for oral administration to the digestive tract of a human (column 4, lines 27-31 [nexus to Gould et al.- microbial composition comprising a pharmaceutically acceptable carrier]). Non-pathogenic lactic acid bacteria are preferably used, with spore-forming Bacillus species (column 4, lines 20-22 [nexus to Gould et al.- a spore-forming probiotic composition]). There are several Bacillus species particularly useful according to the present invention, including, minimally, Bacillus coagulans and Bacillus subtilis (column 6, lines 30-33 [nexus to Gould et al.- probiotic composition containing B. subtilis (and B. coagulans)]). In one embodiment, a Bacillus coagulans strain is included in the composition in the form of spores (column 4, lines 31-32 [nexus to Gould et al.- the composition comprises spores]).
Regarding claim 20, Farmer et al. teaches that where a liquid-based composition containing spores is provided, it is desirable to include a spore germination inhibitor to promote long term storage. Any inhibitor can be used, and therefore the invention is not to be construed as limiting. Typical and preferred inhibitors include hypersaline carriers, methylparaben, guar gum, polysorbates, preservatives, and the like germination inhibitors well known in the art (column 13, lines 13-20).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the spore-forming probiotic composition comprising a therapeutically effective amount of a Bacillus subtilis subspecies inaquosorum species having accession number NRRL B-67989, as taught by Gould et al., by including in the composition a spore germination inhibitor selected from the group consisting of a hyper-saline carrier, methylparaben, guar gum, and polysorbate, with a reasonable expectation of success, because Farmer et al. teaches a spore-forming probiotic composition comprising a therapeutically effective amount of a Bacillus subtilis strain and a pharmaceutically acceptable carrier, which is the composition taught by Gould et al. (MPEP 2143 (I)(G)).
Regarding claim 21, Gould et al. shows that salts (as exemplary flavorants) may be included in the composition (pg. 3, para. [0024]) (MPEP 2143 (I)(G)). Therefore, it would have been obvious to one of ordinary skill in the art to have adjusted the salt concentration (e.g., so as to be considered a hyper-saline concentration) such that said salt could also perform the function of spore germination inhibitor in addition to flavorant (MPEP 2144 (I)). It would have been further obvious to have included the spore germination inhibitor in an amount of about 1% by weight of the composition as routine optimization in order to have determined the optimal amount of spore germination inhibitor to be included in the composition, depending on, for example, the number or concentration of spores in the composition or how long the composition is expected to be held in long term storage (MPEP 2144 (III)) and MPEP 2144.05 (II)(III)). One of ordinary skill in the art would have been motivated to have made that modification, because Farmer et al. teaches that where a liquid-based composition containing spores is provided, it is desirable to include a spore germination inhibitor to promote long term storage (column 13, lines 13-15).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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.
(1) Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Patent No. 11,160,838 B2 in view of Farmer et al. (US 7,374,753 B1).
The claimed subject matter of instant Application No. 18/735,583 is:
Claim 1. A spore-forming probiotic composition. The composition comprises (a) a therapeutically effective amount of a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 and (b) a pharmaceutically acceptable carrier. The composition is in a dose of from 5x109 CFU per day to about 1x1011 CFU per day.
The claimed subject matter of Patent No. 11,160,838 is:
Claim 1. A method of inhibiting growth or activity of bacteria on skin or a mucous membrane in a mammal. The method comprises the steps of: (a) providing a composition comprising Accession no. NRRL B-67989, which is an isolated strain of Bacillus subtilis subspecies inaquosorum; and (b) administering the composition to the skin or mucous membrane of the mammal in an amount effective to remove, reduce and/or treat a bacterial infection.
The claims of Patent No. 11,160,838 do not show: 1) the composition comprises a pharmaceutically acceptable carrier; and 2) a dose of from 5x109 CFU per day to about 1x1011 CFU per day.
Farmer et al. shows a composition comprising viable non-pathogenic lactic acid bacterium in a pharmaceutically acceptable carrier (column 4, lines 27-31]). Non-pathogenic lactic acid bacteria are preferably used, with spore-forming Bacillus species (column 4, lines 20-22). There are several Bacillus species particularly useful according to the present invention, including, minimally, Bacillus coagulans and Bacillus subtilis (column 6, lines 30-33).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the claims of Patent No. 11,160,838, with the pharmaceutically acceptable carrier shown by Farmer et al., with a reasonable expectation of success, because Farmer et al. shows a composition which comprises a Bacillus subtilis strain, which is the composition recited in the claims of Patent No. 11,160,838.
One of ordinary skill in the art would have been motivated to have made that modification because one could have modified the method of inhibiting growth or activity of bacteria by providing a composition comprising an isolated strain of Bacillus subtilis subspecies inaquosorum with the pharmaceutically acceptable carrier, shown by Farmer et al., with a reasonable expectation of success.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the spore-forming probiotic composition comprising a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 cited in the claims of instant Application No. 18/735,583, is obvious over the subject matter cited in the claims of Patent No. 11,160,838 B2, which is a method providing a composition comprising an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989, in view of the cited secondary reference.
It is noted that the specification of Patent No. 11,160,838 describes the composition as being administered in an effective daily dose of from about 1x103 CFU Bacillus subtilis DE111 to about 1x1015 CFU Bacillus subtilis DE111 (column 31, lines 32-39).
(2) Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 17/353,418 in view of Farmer et al. (US 7,374,753 B1).
The claimed subject matter of instant Application No. 18/735,583 is:
Claim 1. A spore-forming probiotic composition. The composition comprises (a) a therapeutically effective amount of a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 and (b) a pharmaceutically acceptable carrier. The composition is in a dose of from 5x109 CFU per day to about 1x1011 CFU per day.
The claimed subject matter of copending Application No. 17/353,418 is:
Claim 1. A method of treating gastrointestinal irregularity in an individual. The method comprises: (a) administering to the individual a composition consisting essentially of an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989.
Claim 5. the composition consists essentially of Bacillus subtilis subspecies inaquosorum in a dose of 1x109 CFU per day.
The claims of copending Application No. 17/353,418 do not show that the composition comprises a pharmaceutically acceptable carrier.
Farmer et al. shows a composition comprising viable non-pathogenic lactic acid bacterium in a pharmaceutically acceptable carrier (column 4, lines 27-31]). Non-pathogenic lactic acid bacteria are preferably used, with spore-forming Bacillus species (column 4, lines 20-22). There are several Bacillus species particularly useful according to the present invention, including, minimally, Bacillus coagulans and Bacillus subtilis (column 6, lines 30-33).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the claims of copending Application No. 17/353,418 with the pharmaceutically acceptable carrier, shown by Farmer et al., with a reasonable expectation of success, because Farmer et al. shows a composition which comprises a Bacillus subtilis strain, which is the composition recited in the claims of copending Application No. 17/353,418.
One of ordinary skill in the art would have been motivated to have made that modification because one could have modified the method of treating a gastrointestinal irregularity in an individual by administering a composition consisting essentially of an isolated strain of Bacillus subtilis subspecies inaquosorum with the pharmaceutically acceptable carrier, shown by Farmer et al., with a reasonable expectation of success.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the spore-forming probiotic composition comprising a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 cited in the claims of instant Application No. 18/735,583, is obvious over the subject matter cited in the claims of copending Application No. 17/353,418, which is a method comprising administering a composition consisting essentially of an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989, in view of the cited secondary reference.
This is a provisional nonstatutory double patenting rejection because the patentably distinct claims have not been patented.
(3) Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of Patent No. 12,005,087 B2 in view of Farmer et al. (US 7,374,753 B1).
The claimed subject matter of instant Application No. 18/735,583 is:
Claim 1. A spore-forming probiotic composition. The composition comprises (a) a therapeutically effective amount of a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 and (b) a pharmaceutically acceptable carrier. The composition is in a dose of from 5x109 CFU per day to about 1x1011 CFU per day.
The claimed subject matter of Patent No. 12,005,087 is:
Claim 1. A method of improving body composition in a female human individual. The method comprises the step of: (a) administering to the female human individual a composition consisting essentially of an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989.
Claim 2. the dose is from about 1x109 CFU per day to about 1x1010 CFU per day.
The claims of Patent No. 12,005,087 do not show that the composition comprises a pharmaceutically acceptable carrier.
Farmer et al. shows a composition comprising viable non-pathogenic lactic acid bacterium in a pharmaceutically acceptable carrier (column 4, lines 27-31]). Non-pathogenic lactic acid bacteria are preferably used, with spore-forming Bacillus species (column 4, lines 20-22). There are several Bacillus species particularly useful according to the present invention, including, minimally, Bacillus coagulans and Bacillus subtilis (column 6, lines 30-33).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the claims of Patent No. 12,005,087 with the pharmaceutically acceptable carrier, shown by Farmer et al., with a reasonable expectation of success, because Farmer et al. shows a composition which comprises a Bacillus subtilis strain, which is the composition recited in the claims of Patent No. 12,005,087.
One of ordinary skill in the art would have been motivated to have made that modification because one could have modified the method of improving body composition in a female human individual, comprising administering to said individual a composition comprising an isolated strain of Bacillus subtilis subspecies inaquosorum with the pharmaceutically acceptable carrier, shown by Farmer et al., with a reasonable expectation of success.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the spore-forming probiotic composition comprising a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 cited in the claims of instant Application No. 18/735,583, is obvious over the subject matter cited in the claims of Patent No. 12,005,087 B2, which is a method comprising administering a composition comprising an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989, in view of the cited secondary reference.
(4) Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5 of copending Application No. 17/872,540.
The claimed subject matter of instant Application No. 18/735,583 is:
Claim 1. A spore-forming probiotic composition. The composition comprises (a) a therapeutically effective amount of a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 and (b) a pharmaceutically acceptable carrier. The composition is in a dose of from 5x109 CFU per day to about 1x1011 CFU per day.
Claim 2. The Bacillus subtilis subspecies inaquosorum generally comprises spores, vegetative cells or transition state cells.
The claimed subject matter of copending Application No. 17/872,540 is:
Claim 1. A method for demonstrating effective germination of Bacillus spp. spores in the ileum of a human. The method comprises the steps of: (a) providing a Bacillus-containing composition comprising one or more probiotic Bacillus spp. spores; (b) administering the Bacillus-containing composition to the human; and (c) observing and measuring the effective germination of Bacillus ssp. spores to form vegetative Bacillus cells over the course of 24 hours.
Claim 3. The Bacillus-containing composition includes Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989.
Claim 5. The Bacillus-containing composition includes 0.1-10% by weight probiotic Bacillus spp. spores and 90- 99.9% by weight one or more carriers.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the Bacillus-containing composition, which includes Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989, and which, in turn, comprises spores and the method for its use, described in copending Application No. 17/872,540 exhibits minor species modifications that anticipate the spore-forming probiotic composition comprising Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989, described in instant Application No. 18/735,583.
The minor species variation is the recitation of one or more carriers rather than a pharmaceutically acceptable carrier. Because the method cited in copending Application No. 17/872,540 comprises administering the Bacillus-containing composition to a human, it would be obvious to expect that the one or more carriers, cited in claim 5 of the copending Application, would be of pharmaceutically acceptable grade.
It is noted that the specification recites: "...the concentration of the probiotic microorganism (or combination of probiotic organisms or species) in the composition may be at least about...5x109 CFU/g,..., or at least about 1x1011 CFU/g (pg. 6, lines 1-8); and "...effective dosages may be in the millions of CFUs, and are usually in the hundreds of millions of CFUs or higher" (pg. 5, lines 25-27).
This is a provisional nonstatutory double patenting rejection because the patentably distinct claims have not been patented.
(5) Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/508,430 in view of Farmer et al. (US 7,374,753 B1).
The claimed subject matter of instant Application No. 18/735,583 is:
Claim 1. A spore-forming probiotic composition. The composition comprises (a) a therapeutically effective amount of a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 and (b) a pharmaceutically acceptable carrier. The composition is in a dose of from 5x109 CFU per day to about 1x1011 CFU per day.
The claimed subject matter of copending Application No. 18/508,430 is:
Claim 1. A method of improving physical performance in a human. The method comprises the steps of: (a) administering to the human a composition comprising an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 in a dose of from about 1x108 CFU per day to about 1x1011 CFU per day; and (b) measuring TNF-α level in the blood plasma of the human.
The claims of copending Application No. 18/508,430 do not show that the composition comprises a pharmaceutically acceptable carrier.
Farmer et al. shows a composition comprising viable non-pathogenic lactic acid bacterium in a pharmaceutically acceptable carrier (column 4, lines 27-31]). Non-pathogenic lactic acid bacteria are preferably used, with spore-forming Bacillus species (column 4, lines 20-22). There are several Bacillus species particularly useful according to the present invention, including, minimally, Bacillus coagulans and Bacillus subtilis (column 6, lines 30-33).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the claims of copending Application No. 18/508,430 with the pharmaceutically acceptable carrier, shown by Farmer et al., with a reasonable expectation of success, because Farmer et al. shows a composition which comprises a Bacillus subtilis strain, which is the composition recited in the claims of copending Application No. 18/508,430.
One of ordinary skill in the art would have been motivated to have made that modification because one could have modified the method for improving physical performance in a human by administering a composition comprising an isolated strain of Bacillus subtilis subspecies inaquosorum with the pharmaceutically acceptable carrier, shown by Farmer et al., with a reasonable expectation of success.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the spore-forming probiotic composition comprising a spore-forming Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989 cited in the claims of instant Application No. 18/735,583, is obvious over the subject matter cited in the claims of copending Application No. 18/508,430, which is a method comprising administering a composition comprising an isolated strain of Bacillus subtilis subspecies inaquosorum having accession number NRRL B-67989, in view of the cited secondary reference.
This is a provisional nonstatutory double patenting rejection because the patentably distinct claims have not been patented.
Response to Arguments
Applicant’s arguments, pp. 10-12, filed on 18 November 2025, with respect to the prior art references cited in the 35 U.S.C. §103 rejections, and the 35 U.S.C. §101 rejection, have been fully considered but they are either not persuasive or are moot because the arguments do not apply to the references as they are applied in the context of the current rejection, or as new grounds necessitated by Applicant’s amendment, in which claim 15 was amended.
1. Applicant remarks (pg. 9, para. 4 thru pg. 10), with regard to the 101 rejection, that the active agent in the composition may be combined with at least one excipient selected from the group consisting of fillers, binders, humectants, disintegrating agents, solution retarders, absorption accelerators, wetting agents, absorbents, and lubricating agents. Other useful excipients include, but are not limited to, magnesium stearate, calcium stearate, mannitol, xylitol, sweeteners, starch, carboxymethylcellulose, microcrystalline cellulose, silica, gelatin, silicon dioxide, and the like. These additional excipients are not found in nature but are industrial products and as such are, in combination with the B. subtilis subspecies inaquosorum, significantly and markedly different from the contribution of the individual (inherent) characteristics of the active ingredient.
However, in response to Applicant, the excipients or pharmaceutically acceptable carriers cited above are not recited in independent claim 15 (nor in dependent claims 16-21) which requires a composition comprising B. subtilis subspecies inaquosorum, and an unspecified pharmaceutically acceptable carrier (which could be naturally occurring).
2. Applicant remarks (pg. 10) that the excipients in combination with the active ingredient are a practical application of the exceptions to patentability, satisfying Prong 2A of the patentability analysis. Furthermore, the claimed composition has a demonstrably therapeutically effective dosage of about 1 X 108 CFU per day to about 1 X 1011 CFU, as found in the specification as filed, pp. 30-31, para. [0104]-[0105]. Thus, the claimed compositions provide additional elements that amount to significantly more than known bacterial natural components or blends, thus satisfying prongs 2A and 2B of the patentable subject matter analysis.
However, in response to Applicant, again, the excipients or pharmaceutically acceptable carriers cited above are not recited in the claimed subject matter. In addition, Applicant describes the term "per day" in the context of a method step which is described at the pages/para. in the specification cited by Applicant above. However, the claimed subject matter is a composition, not a method. As noted in the 112(b) rejection above, although a method step is not explicitly described in instant claim 15, the term 'per day' implies the method step of administering. Also, as noted above, a claim which recites a product and method step limitations in the same claim is indefinite under 112(b).
Therefore, the composition described as a spore-forming probiotic composition in instant claim 15 does not satisfy prongs 2A and 2B of the patentable subject matter analysis.
3. Applicant remarks (pg. 10, para. 3 thru pg. 11), with regard to the 103 rejection, that Gould does not teach or suggest, much less enable the claimed invention, as amended. A therapeutically effective dose of 5 X 109 CFU per day to about 1 X 1011 CFU per day is a significantly higher range than any amount of B. subtilis described in Gould. Even at the bottom of the dose range, there is no demonstration in Gould of any specific testing or results which might enable a skilled person to determine the effectiveness of this dose to provide a useful structure or function. In distinct contrast, Example 1 of the present specification tested in humans a dose of at least 5 X 109 CFU per day for up to 70 days to demonstrate a useful reduction in body fat of up to 1-2%. There is no reasonable expectation that the "B. subtilis DE111" of Gould is the same strain or formulation as that claimed herein, without more.
However, in response to Applicant, MPEP 2112.01 (I) states, with regard to product and apparatus claims, that when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. MPEP 2112.01 (II) states that if the composition is physically the same, it must have the same properties. MPEP 2112 (II) states that an inherent feature need not be recognized at the time of the invention. That is, Gould et al. shows the probiotic composition of claim 15; therefore, the composition, shown by Gould et al., is understood to have the same properties as the probiotic composition of claim 15.
4. Applicant remarks (pg. 11, para. 2 thru pg. 12) that Applicant respectfully traverses the rejections of claims 15-21 as improper application of hindsight based on the cited references by Gould and Farmer, which lack motivation to combine the teachings of the references, and even when doing so still do not arrive at every limitation of Applicant's claimed invention. The office action states that although Gould teaches salt as a flavorant, salts "may be included in a formulation [ ... ] it would have been obvious to try by one of ordinary skill in the art to have adjusted the salt concentration (e.g. so as to be considered a hyper-saline solution) such that said salt could also perform the function of spore germination inhibitor in addition to flavorant." This improper reliance on "common sense" hindsight and motivation to fill gaps in prior art references has been held to be improper.
However, in response to Applicant, the nexus of Farmer et al. to Gould et al. is not only based on the description of the inclusion of salt in the B. subtilis composition, shown by Gould et al. Farmer et al. also shows a composition comprising viable spore-forming Bacillus species including B. subtilis (see 103 rejection). This composition may include spore germination inhibitors such as hypersaline carriers, methylparaben, guar gum and polysorbates. Therefore, because Gould et al. shows the same B. subtilis spore-forming composition as described in Farmer et al., it would have been obvious to have also included spore germination inhibitors in the composition shown by Gould et al. with the reasonably predictable expectation that said spore germination inhibitors would have successfully inhibited spore germination in the composition.
The teaching of salt inclusion in the composition shown by Gould et al. provides additional motivation for adjusting the concentration of said salt so that it is considered to be a hyper-saline carrier.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON M PAPCIAK whose telephone number is (571)272-6235. The examiner can normally be reached M-F 8:30am-5:00pm.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/SMP/Examiner, Art Unit 1657