DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 1-5, 7, 9, 11-13, 15-16, 18-25, 27, 29-31, 34-35, 37, 39, 41, 45, and 51-52 are pending following the Reply filed 02/23/2026. Claims 11-13, 15-16, 18-19, 24 and 30 have been amended without introducing new matter. Claims 32-33 have been cancelled. Claims 51-52 have been newly added. All pending claims have been considered on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, 7, 9, 11-13, 15-16, 18-25, 27, 29-31, 34-35, 37, 39, 41 and 45, directed to a multi-biotic supplement or a kit comprising at least one multi-biotic supplement, in the reply filed on 02/23/2026 is acknowledged.
All claims drawn to the nonelected invention, i.e., Group II, claims 32-33, have been cancelled by Applicant.
Newly added claims 51-52 read on the elected invention and are considered herein.
Priority
Applicant’s claim for benefit under 35 U.S.C. 119 (e) of Provisional application No. 63/481,990 filed on 01/27/2023 is acknowledged. The present application and all claims are being examined with the earliest effective filing date of 01/27/2023.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/29/2025 has been considered by the examiner.
Specification
The use of the terms “BB-12” and “SHIME”, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The examiner notes that while these terms include the proper symbol in some sections of the specification (see, e.g., pgs. 41-42, para. [0130] and [0131]), they do not include the proper symbol in other sections of the specification (see, e.g., pg. 2, para. [0008]; pg. 9, para. [0026]; and pg. 42, para. [0132]).
Claim Objections
Claim 25 is objected to because of the following informalities: for consistency, please amend the term “user” recited in line 3 to recite “subject”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 7, 9, 13, 15-16, 19, 29-31, 37, 39, 45 and 51 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
Claim 7 recites the broad recitation “a medium-chain triglyceride (MCT) oil”, and the claim also recites “a coconut MCT oil” which is the narrower statement of the range/limitation.
Claim 16 recites the broad recitation “at least 2 billion colony-forming units (CFU) of bacteria”, and the claim also recites “at least 11 billion CFU of bacteria” which is the narrower statement of the range/limitation.
Claim 37 recites the broad recitation “wherein the bottle comprises a desiccant disposed therein”, and the claim also recites “wherein… a layer of desiccant is affixed to an interior surface of the bottle” which is the narrower statement of the range/limitation.
Claim 39 depends from claim 37 and fails to rectify the indefiniteness of the base claim.
Claim 45 recites the broad recitation “wherein the scented insert comprises a plant oil or at least one compound derived from plants”, and the claim also recites “wherein the scented insert comprises peppermint oil or a citrus oil” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the interest of compact prosecution, claims 7, 16, 37, 39 and 45 are given their broadest reasonable interpretation, i.e., they are each interpreted as requiring the broader of the two limitations discussed above.
Claim 9 recites the limitation, “wherein the supplement is essentially free of ingredients derived from animals”, which renders the claim indefinite, because it is unclear whether the entire supplement, including its contents, must be essentially free of any ingredient derived from animals. Probiotics, for example, are commonly known to be derived from animals, which includes humans (e.g., fecal samples). Therefore, it is unclear whether the claim excludes the limitation of “a probiotic blend”, which can be interpreted as being derived from animals. A narrower interpretation of the claim may be that the “first capsule” and/or “second capsule” is essentially free of ingredients derived from animals. However, the claim depends from claim 1, which does not recite the first and second capsules. Furthermore, while this narrower interpretation appears to have support in the specification (see, e.g., paras. [0046] and [0050]), limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In the interest of compact prosecution, the claim is reasonably interpreted as requiring the supplement to be essentially free of ingredients derived from animals, with the exception of the probiotics, prebiotics and/or postbiotics themselves.
Suggestion to obviate the rejection: Applicant may, for example, amend the claim to depend from claim 2 to recite: “The multi-biotic supplement of claim 2, wherein the first capsule and the second capsule are essentially free of ingredients derived from animals.”
The term “about” in claims 13, 19, 29-31 and 39 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Per MPEP 2173.05(b), in determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991) (Emphasis added).
In the instant case, as noted in the prior art rejections of the claims above, the prior art of record discloses ranges, amounts, or proportions that are considered to be close, similar, or overlapping to those of the limitations which recite the term “about”. See Rejections under 35 U.S.C. 102 and 35 U.S.C. 103 for further discussion.
Claims 15 and 51 contain the trademark/trade name “BB-12”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a Bifidobacterium animalis ssp. lactis BB-12® strain, which contains a registered trademark (BB-12®), and, accordingly, the identification/description is indefinite.
The examiner notes that while the term LGG® is a trademark used in commerce, the term “Lactobacillus rhamnosus GG” or “GG” by itself do not appear to be registered trademarks, and are therefore not a basis for this rejection.
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, 5-6, 9, 11-13, 15-16 and 18-19 are rejected under 35 U.S.C. § 101 because the claims as a whole are not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, these claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is in keeping with the latest guidance regarding analysis of judicially excepted subject matter.
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step 1 – Is the claim directed to a process, machine, manufacture, or composition of matter?
Step 2A – Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Step 2A, prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Step 2A, prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step 2B – If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step 2A, Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step 1: It must first be determined if the claim is to a statutory category and, if so, proceed to step 2A, prong 1.
The claims are directed to a supplement comprising a postbiotic or postbiotic precursor, a probiotic blend, and/or a prebiotic blend and fall within the statutory category of a composition of matter.
Step 2A. prong 1: Prong 1 requires the Examiner to evaluate whether the claim recites a judicial exception and, if so, proceed to prong 2.
In this case, claim 1 recites a “multi-biotic supplement comprising a postbiotic or postbiotic precursor; a probiotic blend; and/or prebiotic blend”. The recitation of a “multi-biotic supplement” recited in the preamble is directed to an intended use and does not reasonably limit the composition to any particular structures other than what it recited in the body of the claim.
It is interpreted that the recited supplement may comprise (1) at least one postbiotic or postbiotic precursor, (2) two or more probiotics (i.e., “a blend”), (3) two or more prebiotics (i.e., “a blend”), or (4) any combination thereof. The claim is analyzed according to each of these respective embodiments:
(1) At least one postbiotic or postbiotic precursor: The specification states that a postbiotic or postbiotic precursor may be isolated from a microorganism (see pg. 3, para. [0016]). Therefore, a composition comprising a postbiotic or postbiotic precursor is directed to a natural product.
(2) Two or more probiotics: According to Hill et al. (The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol 11, 506–514 (2014); cited on Form 892), probiotics are defined as “live microorganisms which when administered in adequate amounts confer a health benefit on the host” (see pg. 506, col. 1) which are often sourced from commensal bacteria of the gut and may also be found in fermented foods and faecal microbiota transplants (FMT) (see pg. 507, col. 2, para. 1). Hill, et al. also acknowledges that a number of genera and species are associated with gut microbiota compositions (see pg. 509, col. 2, para. 3). Therefore, a composition comprising two or more probiotics also includes natural products.
(3) Two or more prebiotics: The specification states that a prebiotic is any non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon (see pg. 12, para. [0030]). According to Millet, et al. (US 2020/0360418 A1; cited on Form 892), prebiotics include substrates that are fermentable by microorganisms of the large intestine, such as fructans, galactans, inulin, xylans, acacia fiber, vegetable fibers, fruit fibers, grain fibers, psyllium husk fibers, other plant-based fibers, resistant starches, glucans, beta-glucans, cellulose, pectin, etc. (see pg. 2, para. [0021]). Therefore, a composition comprising two or more prebiotics also includes natural products.
(4) Any combination thereof: According to Scarpellini, et al. (From Pre- and Probiotics to Post-Biotics: A Narrative Review. Int J Environ Res Public Health. 2021 Dec 21;19(1):37; cited on Form 892), the human GI tract hosts over 100 trillion microbes, the vast majority being bacteria (see pg. 2, para. 3). Scarpellini, et al. teach that prebiotics are food components beneficially affecting gut microbiota, the main examples being human milk oligosaccharides, lactulose, fructo-oligosaccharides and inulin (see pg. 2, last paragraph), and postbiotics are defined as beneficial substances, resulting from microbiota metabolism and having a beneficial effect on the microbiota itself as well as the host (see pg. 3, para. 5). Scarpellini, et al. states that the term “postbiotic” has also been defined as “any substance released by or produced by or produced through the metabolic activity of the microorganism, which exerts a beneficial (direct or indirect) effect on the host” (see pg. 3, para. 5).
Per MPEP 2106.04(c), the markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions. If the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception. However, if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception. Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.
In the instant case, the composition of claim 1 includes both nature-based products by themselves (i.e., a postbiotic, prebiotic blend, or a probiotic blend) as well as in combination. Even when in combination, these natural products are found together in nature and would be expected to function together as they do in nature (i.e., in the human gut), as discussed above. Therefore, it cannot be said that even the claimed composition comprising each of these elements in combination, recited generically as to include any combination of these elements, including those already found together in nature, would have markedly different characteristics from their naturally-occurring counterparts. This is because any naturally occurring probiotic (i.e., bacterium) would be expected to be found in the presence of naturally occurring prebiotics (e.g., fructans or other substrates), which the bacteria metabolizes in order to produce postbiotics, which are themselves natural products produced by said bacteria. There is no evidence that these ingredients, as recited, would have any markedly different characteristics in their structure or biological function when provided in combination compared to their naturally-occurring counterparts (e.g., fecal matter), as such counterparts are already known to possess these structures (i.e., bacteria and their metabolites) and be involved in the same functions (i.e., metabolism).
Therefore, claim 1 and its dependents include natural products, and claim 1 is directed to the judicial exception.
Claim 5 recites the multi-biotic supplement “wherein the postbiotic or postbiotic precursor is in a solution, and wherein the solution comprises an oil”. The specification states that the postbiotic may be, for example, a carboxylic acid, a short-chain fatty acid, or a caproic acid (see instant specification at pg. 3, para. [0016]). According to Gershuni, V. (Saturated Fat: Part of a Healthy Diet. Curr Nutr Rep 7, 85–96 (2018); cited on Form 892), fatty acids are the simplest class of lipid and are structurally composed of a hydrocarbon chain that terminates in a carboxylic acid group (see pg. 86, para. 3). Hence, it should be noted that any fatty acid could reasonably be considered a “carboxylic acid”. Gershuni teaches that short chain fatty acids (two to six carbons) are naturally occurring components in several dietary fats and frequently found alongside medium and long-chain fatty acids in biological lipids (see pg. 86, col. 1, para. 4) ranging from animal-derived oils, such as milk fat and butter (see pg. 86, col. 2, para. 4 to pg. 87, col. 1, para. 1) to plant-derived fats like coconut oil (see pg. 87, para. 5). Therefore, the combination of the elements recited in the claim (i.e., postbiotic and oil), necessarily includes naturally occurring oils containing short chain fatty acids and other carboxylic acid-containing fatty acids. It cannot be said that the claimed combination (i.e., a short-chain fatty acid in an oil) would have markedly different characteristics from its closest naturally-occurring counterpart (i.e., coconut oil), as each of these elements are found to already occur together in nature and would necessarily have the same structural and functional characteristics. Therefore, the claim is still directed to the judicial exception.
Claim 6 recites the multi-biotic supplement of claim 5, wherein the oil is a medium-chain triglyceride (MCT) oil, or a coconut MCT oil. Gershuni, et al. (cited above) teaches that coconut oil is composed of primarily medium-chain fatty acids (see pg. 87, col. 1, para. 5). According to Eyres, et al. (Coconut oil consumption and cardiovascular risk factors in humans. Nutr Rev. 2016 Apr;74(4):267-80; cited on Form 892), coconut oil contains caproic acid which is a 6-carbon (6:0) short-chain fatty acid (see Table 2). The specification states that postbiotics include caproic acid, as previously discussed. Hence, even naturally occurring coconut oil comprises MCTs and SCFAs (e.g., caproic acid), and therefore comprises all the required limitations of the claim (i.e., SCFA, MCT and oil). Therefore, these same elements are found to already occur together in nature and would necessarily have the same characteristics while in combination when compared to their closest naturally-occurring counterpart (i.e., coconut oil). Therefore, the claim is still directed to the judicial exception.
Claim 11 recites the multi-biotic supplement “comprising the postbiotic precursor, the probiotic blend, and the prebiotic blend.” As discussed regarding claim 1 above, the composition is directed to a combination of natural products which are found together in nature that would be expected to function together as they do in nature (i.e., in the gut). There is no evidence that they would have any markedly different characteristics in their structure or biological function when provided in combination when compared to their naturally-occurring counterparts (e.g., in fecal matter). Therefore, the claim is still directed to the judicial exception.
Claim 12 recites the multi-biotic supplement “comprising the postbiotic precursor, wherein the postbiotic precursor comprises tributyrin”. Hence, the claim is directed to a composition comprising tributyrin and requires no further elements. In view of He, et al. (Effect of Tributyrin on Growth Performance and Pathway by which Tributyrin Regulates Oligopeptide Transporter 1 in Juvenile Grass Carp (Ctenopharyngodon idellus). Animals (Basel). 2022 Sep 20;12(19):2498; cited on Form 892), tributyrin is a triglyceride that is naturally present in milk fat, as commonly found in butter (see pg. 1, last paragraph). Therefore, the claim is still directed to the judicial exception.
Claim 15 recites the multi-biotic supplement “comprising the probiotic blend, wherein the probiotic blend comprises Lactobacillus rhamnosus GG and Bifidobacterium animalis ssp. Lactis BB-12”. According to Segers, et al. (Towards a better understanding of Lactobacillus rhamnosus GG--host interactions. Microb Cell Fact. 2014 Aug 29;13 Suppl 1(Suppl 1):S7; cited on Form 892), Lactobacillus rhamnosus GG was originally isolated from fecal samples of a healthy human adult (see pg. 1, col. 1, para. 1). According to Jungersen, et al. (The Science behind the Probiotic Strain Bifidobacterium animalis subsp. lactis BB-12(®). Microorganisms. 2014 Mar 28;2(2):92-110; cited on Form 892), Bifidobacterium animalis (later reclassified to Bifidobacterium lactis) BB-12 was similarly isolated from fecal mucus (see pg. 94, para. 2; pg. 97, para. 3). Therefore, these probiotics are understood to be naturally occurring bacterial strains found in human feces (i.e., derived from the gut), which are found together in nature. There is no evidence that they would have any markedly different characteristics in their structure or biological function when provided in combination compared to their naturally-occurring counterparts. Hence, these probiotic strains would not be expected to have any markedly different characteristics when used in combination compared to their naturally-occurring counterparts. Therefore, the claim is still directed to the judicial exception.
Claim 18 recites the multi-biotic supplement “comprising the prebiotic blend, wherein the prebiotic blend comprises LH01-Myroviridae, LL5-Siphoviridae, T4D-Myroviridae, and LL12-Myroviridae. In view of the prior art of Febvre, et al. (PHAGE Study: Effects of Supplemental Bacteriophage Intake on Inflammation and Gut Microbiota in Healthy Adults. Nutrients. 2019 Mar 20;11(3):666; cited on Form 892) and Grubb, et al. (PHAGE-2 Study: Supplemental Bacteriophages Extend Bifidobacterium animalis subsp. lactis BL04 Benefits on Gut Health and Microbiota in Healthy Adults. Nutrients. 2020 Aug 17;12(8):2474; cited on Form 892), these are E. coli targeting bacteriophages that were isolated from naturally-occurring bacteria, and there is no evidence that these strains were altered compared to the naturally-occurring phages from which they were derived (see Febvre at pg. 2, para. 2 and pg. 3, para. 2; Grubb at pg. 3, para. 3; pg. 13, “Acknowledgements”). Furthermore, each of these strains target E. coli and can be isolated from E. coli, and there is no evidence that they would have any markedly different characteristics in their structure or biological function when provided in combination compared to their naturally-occurring counterparts. Therefore, the claim is still directed to the judicial exception.
Step 2A, prong 2: Step 2A, prong 2 requires the Examiner to evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception and, if not, proceed to step 2B. In order to integrate the recited judicial exception into a practical application, the claim will apply, rely on, or use the judicial exception that imposes a meaningful limit such that the claim is more than a drafting effort to monopolize the judicial exception. Examiners evaluate integration by identifying additional elements in the claim beyond the judicial exception and evaluating those elements individually and in combination to determine whether they integrate the exception in to a practical application. Examples that have been found by the Courts in which the exception was not integrated into a practical application include:
- Mere instructions to implement an abstract idea on a computer
- Adding generic instructions that the judicial exception should be used ("apply it")
-Adding insignificant extrasolution activity to the exception ("mere data gathering")
- Generally linking the use of the exception to a particular technological environment or
field of use
In this case, claims 1, 9, 12-13 and 16 recite a product of nature without requiring any additional elements to integrate the exception into a practical application.
Claims 5-6, 11, 15 and 18-19 recite nature-based products produced by combining multiple nature-based product limitations. As discussed under Step 2A, Prong One, these combinations of nature-based products lack any markedly different characteristic (e.g., in structure or function) when compared to their closest naturally-occurring counterparts.
Per MPEP 2106.04(II)(B), a claim may recite multiple judicial exceptions. During examination, examiners should apply the same eligibility analysis to all claims regardless of the number of exceptions recited therein. Unless it is clear that a claim recites distinct exceptions, such as a law of nature and an abstract idea, care should be taken not to parse the claim into multiple exceptions. Accordingly, if possible, examiners should treat the claim for Prong Two and Step 2B purposes as containing a single judicial exception.
In this case, claims 5-6, 11, 15 and 18-19 recite a combination of nature-based products that even when viewed as a whole are still directed to the judicial exception, and there are no further elements, beyond the judicial exception itself, to integrate the exception into a practical application.
Step 2B: Step 2B requires the Examiner to first identify whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluate those additional elements individually and in combination to determine whether they contribute to an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
In this case, claims 1, 9, 12-13 and 16 recite a product of nature without requiring any additional elements to integrate the exception into a practical application. Hence, there are no elements beyond the naturally occurring product to consider as amounting to significantly more than the judicial exception.
Claims 5-6, 11, 15 and 18-19 recite nature-based products produced by combining multiple nature-based components. As discussed under Step 2A, Prong One, these combinations of nature-based products lack any markedly different characteristic (e.g., in structure or function) when compared to their closest naturally-occurring counterparts.
Therefore, claims 5-6, 11, 15 and 18-19 recite a combination of nature-based products that even when viewed as a whole are still directed to the judicial exception, and there are no further elements, beyond the judicial exception itself, that amounts to significantly more than the judicial exception.
In conclusion, claims 1, 5-6, 9, 11-13, 15-16 and 18-19 are directed to patent ineligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1-2 and 4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dhir, et al. (US 2024/0082165 A1; effectively filed 01/26/2021; cited on Form 892), hereafter, “Dhir”.
Regarding claim 1, Dhir teaches a swallowable capsule for enteral administration of a symbiotic composition, comprising (a) an inner capsule, comprising a probiotic component comprising a consortium of microbial strains and (b) an outer capsule, surrounding and enclosing the inner capsule, comprising a prebiotic component (see claim 1). Hence, Dhir teaches a capsule comprising a probiotic blend (“consortium of microbial strains”), which meets the claim.
Regarding claim 2, Dhir teaches the swallowable capsule comprising an inner capsule and an outer capsule (see claim 1), which meets the claim.
Regarding claim 4, Dhir teaches the inner capsule is enclosed within the outer capsule (see pg. 11, para. [0126]), as shown in FIG. 1B below:
PNG
media_image1.png
303
667
media_image1.png
Greyscale
Claim(s) 1, 5, 7 and 12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Davis, et al. (US 2023/0241048 A1; effectively filed 01/28/2022; cited on Form 892), hereafter, “Davis”.
Regarding claim 5, Davis teaches a pharmaceutical composition comprising a lipophilic oil (see claim 1), wherein the lipophilic oil comprises a mixture of a medium-chain triglyceride oil and tributyrin oil (see claim 2). In view of the instant claims, the postbiotic precursor includes tributyrin (see instant claim 12). Hence, Davis teaches a composition comprising a postbiotic precursor (tributyrin) in an oil, which meets the claim.
Regarding claim 7, Davis teaches a pharmaceutical composition comprising a lipophilic oil (see claim 1), wherein the lipophilic oil comprises a mixture of a medium-chain triglyceride oil (i.e., MCT oil) and tributyrin oil (see claim 2), which meets the claim.
Regarding claim 12, Davis teaches the composition comprising tributyrin oil, as discussed above.
Claim(s) 1, 9, 16, 24, 34-35, 41 and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bucci, et al. (US 2019/0091242 A1; cited on Form 892), hereafter, “Bucci”.
Regarding claim 9, Bucci teaches a dietary supplement composition comprising a plurality of solid beadlets and oil, wherein the beadlets comprise at least one nutrient and the oil comprises at least one nutrient (see pg. 2, para. [0025]). Bucci teaches the dietary supplement is contained within a capsule shell that is essentially free of components derived from animals (see pg. 2, para. [0026]). Bucci teaches the “nutrient” includes probiotics (see pg. 2, para. [0027]). Bucci teaches the beadlets comprising more than one probiotic (see pg. 5, para. [0062]). Hence, Bucci teaches a dietary supplement comprising a probiotic blend contained within a capsule shell that is essentially free of ingredients derived from animals, which meets the claim.
Regarding claim 16, Bucci teaches the dietary supplement, wherein the probiotic content is between 2 billion to about 5 billion CFUs, which meets the limitation of “at least 2 billion colony-forming units (CFU)”.
Regarding claim 24, Bucci teaches that each beadlet comprises a core, wherein the core comprises cellulose, such as microcrystalline cellulose (see pg. 2, para. [0031]).
Regarding claim 34, Bucci teaches a kit comprising the dietary nutrient composition and a container, wherein the container comprises a bottle and a removable screw-top lid, and wherein the kit comprises a scented insert located within the container (see pgs. 18-19, para. [0165]).
Regarding claim 35, Bucci teaches the kit, wherein the container is a bottle and comprises plastic (see pg. 19, para. [0165]).
Regarding claim 41, Bucci teaches the container may comprise one or more markings (see pg. 18, para. [0161]).
Regarding claim 45, Bucci teaches the scented insert may comprise an odorant agent, wherein the odorant agent comprises a plant oil (see pg. 17, para. [0153]).
Claim(s) 1 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Millet, et al. (US 2020/0360418 A1; cited on Form 892), hereafter, “Millet”.
Regarding claim 11, Millet teaches an autobiotic composition for supporting a subject’s gastrointestinal tract, comprising (a) a prebiotic component and (b) a postbiotic component (see claim 1). Millet teaches the prebiotic component comprising a combination of fructan, galactan, and xylan (see claim 2), which meets the limitation of a “prebiotic blend”. Millet teaches the postbiotic component comprises tributyrin (see claim 7), which, in view of the dependent claims (e.g., instant claim 12), meets the limitation of a “postbiotic precursor”. Millet teaches the autobiotic composition further comprising a seedbiotic composition (see claim 9) wherein the seedbiotic composition is a probiotic and a fecal microbiota transplant (see claim 10), which reasonably meets the limitation of a “probiotic blend”. Hence, Millet teaches an autobiotic composition comprising a postbiotic precursor (tributyrin), a probiotic blend, and a prebiotic blend, which meets the claim.
Regarding claim 12, Millet teaches the postbiotic component comprises tributyrin, as discussed above.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chichlowski, et al. (US 2015/0305384 A1; cited on Form 892), hereafter, “Chichlowski”.
Regarding claim 15, Chichlowski teaches a nutritional composition comprising Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 (see pg. 4, para. [0052]), which meets the claim.
Claim(s) 1 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deaton, et al. (US 2019/0255122 A1; cited on Form 892), hereafter, “Deaton”.
Regarding claim 18, Deaton teaches a commercial preparation (PreforPro®) comprising four supplemental bacteriophage strains, LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae and LL12-Myoviridae (see pg. 3, para. [0035]), which meets the claim.
Regarding claim 19, Deaton discloses the mixture of four bacteriophages above (PreforPro®) in the form of 15 mg consumable capsules (pg. 3, para. [0034]), which meets the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-4, 13, 20-23, 25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dhir as applied to claims 1-2 and 4 above, and further in view of Millet, as applied to claims 1 and 11-12 above.
Regarding claim 3, Dhir teaches a swallowable capsule for enteral administration of a symbiotic composition, comprising (a) an inner capsule, comprising a probiotic component comprising a consortium of microbial strains and (b) an outer capsule, surrounding and enclosing the inner capsule, comprising a prebiotic component (see claim 1). Hence, Dhir teaches a capsule comprising a probiotic blend (“consortium of microbial strains”) and a prebiotic component, wherein the supplement comprises a first capsule and a second capsule, as discussed regarding claims 1-2. See also FIG. 1B from Dhir below:
PNG
media_image1.png
303
667
media_image1.png
Greyscale
Dhir teaches that this delivery capsule allows for improved stability and viability through the gastrointestinal tract, resulting in 100% or nearly 100% survival of the probiotic organisms through the stomach, jejunum, duodenum, and ileum until arriving in the colon (see pg. 11, para. [0126]).
Regarding the limitation of a prebiotic “blend”, Dhir teaches that the prebiotic component
comprises at least one compound that can be converted, by a microbial strain present in the healthy human gut microbiota, into a bioactive metabolite (see claim 7). Dhir teaches wherein the at least one compound comprises at least one punicalagin (see claim 8), wherein the at least one punicalagin is derived from at least one pomegranate (see claim 9), and wherein the prebiotic component further comprises at least one additional compound derived or extracted from at least one pomegranate (see claim 10). Hence, Dhir reasonably suggests the prebiotic component to comprise a “blend”.
Dhir does not explicitly teach either capsule comprising a “postbiotic or postbiotic precursor”.
However, Dhir teaches that bacterial members of the microbiome can impact health and disease by at least four separate pathways, including immunomodulation, pathogen inhibition, improved epithelial barrier integrity, and the production of beneficial metabolites or the removal of detrimental molecules (see pg. 1, para. [0006]). In particular, butyrate has a range of human health benefits (see pg. 19, para. [0190]) and Dhir discloses that butyrate-producing bacteria were relatively depleted in samples derived from individuals with cardiovascular disease (see pg. 3, paras. [0024]-[0025]).
Dhir teaches that organic acid production is an important feature by which microorganisms modulate the metabolic output of the gut microbiota and engage with host cells. In particular, short-chain fatty acids (SCFAs), such as acetic, propionic, and butyric acids are the most studied and are found in high concentrations in the intestinal tract where they are taken up by intestinal epithelial cells and used as a substrate for oxidative production of adenosine triphosphate (ATP). In addition, these molecules act as a link between the microbiota and the immune system by modulating different aspects of intestinal epithelial cells and the development, survival, and function of leukocytes. Furthermore, SCFAs have been shown to maintain intestinal homeostasis by protecting epithelial barrier integrity, promoting B-cell IgA production, and regulating T-cell differentiation. See pg. 17, para. [0172].
In view of the instant specification, postbiotics are bioactive compounds produced by microorganisms during a fermentation process and include short-chain fatty acids, such as acetic acid, propionic acid and butyric acid (see pg. 3, para. [0016]).
Millet, as previously discussed, teaches an autobiotic composition for supporting a subject’s gastrointestinal tract, comprising a prebiotic component, a postbiotic component (see claim 1), and further, a “seedbiotic component” comprising probiotics (see claims 9-10).
Millet teaches that the postbiotic component is an exogenous form of fermentation byproducts generated by the microbiota in a healthy colon, and/or compounds that readily convert to such byproducts after ingestion (i.e., precursors). Millet teaches that the postbiotic component functions at least in part to support the health and function of the intestinal lining, including the microbiota. One example of a postbiotic is butyrate (or the free acid version butyric acid) and/or an ester thereof, such as tributyrin. See pg. 2, para. [0022].
The examiner notes that Millet teaches that tributyrin is a particularly preferred short chain triglyceride formed from three butyrate groups bonded to a glycerol backbone (see pg. 3, para. [0037]), which may better enable the delivery of butyrate groups to where they can be effective (see pg. 2, para. [0022]). Hence, Millet teaches tributyrin to serve as an advantageous postbiotic precursor for the postbiotic, butyrate (or butyric acid), which Dhir teaches to be a beneficial SCFA.
Similar to Dhir, Millet teaches the autobiotic composition in a dosage form of a dual chamber capsule having an inner chamber and an outer chamber, wherein the postbiotic is contained in the outer chamber and the prebiotic is contained within the inner chamber (see claim 12). Millet teaches the multi-chamber capsule may first release the postbiotic in the intestines to provide a healthy boost to the intestinal lining prior to releasing the prebiotic to enhance growth and colonization of the microbiome (see pg. 9, para. [0108]).
Taken together, both Dhir and Millet teach dual chamber capsule or capsule-within-capsule dosage forms comprising probiotics and prebiotics. Dhir teaches that the probiotics are contained within an inner capsule, for delivery to the colon, while Millet teaches the prebiotics are contained within the inner “chamber”, for the growth and colonization of microbes, while the postbiotics are contained in the outer chamber for earlier release in the intestines.
Therefore, it would have been obvious at the time of filing for a person of ordinary skill in the art to have arrived at the claimed invention by combining the teachings of Dhir and Millet to provide a dual chamber capsule comprising postbiotics, as well as probiotic and prebiotic blends, because both references teach the benefits of delivering these compounds to the gastrointestinal intestinal tract in a sequential manner to promote health and prevent disease. One would have recognized that both references teach the benefits of bacterial metabolites, such as short-chain fatty acids, which can be synthesized endogenously by beneficial bacteria or delivered exogenously as taught by Millet. One would have also recognized that including prebiotics would be beneficial in order to provide both endogenous and exogenous bacteria the necessary substrates for producing beneficial metabolites that support a healthy human intestinal epithelium and microbiome. Therefore, one would have been motivated to combine these elements for the multiple benefits they are taught in the art to confer to the gastrointestinal system, such as improved immune system function, increased epithelial cell integrity, and overall intestinal homeostasis. One could have combined each element claimed (i.e., postbiotics, probiotics, prebiotics, capsules) by known methods, and one would have recognized that in combination each element merely performs the same function as it does separately. Therefore, one of ordinary skill would have recognized the results of the combination were predictable and would have had a reasonable expectation of success. Hence, the combination would have been readily apparent and deemed to be a mere (A) combining of prior art elements according to known methods to yield predictable results (see MPEP 2143(I): Rationales to support rejections under 35 U.S.C. 103).
Regarding claim 4, Dhir teaches the capsule wherein probiotics are contained within an inner capsule, for delivery to the colon, while Millet teaches the prebiotics are contained within the inner chamber, for the growth and colonization of probiotics, while the postbiotics are contained in the outer chamber for earlier release in the intestines. Therefore, it would have been obvious to have provided the multi-biotic supplement, wherein the second capsule (comprising probiotic and prebiotic blends) was disposed within the first capsule (comprising a postbiotic).
Regarding claim 13, Millet teaches an autobiotic daily dose may include about 250 mg to about 2.5 g of the postbiotic component (see pg. 9, para. [0110]), which overlaps and includes the claimed range.
In view of Applicant’s Examples, a sample multi-biotic supplement formulation (Supplement A) included 350 mg of tributyrin in the outer capsule (see, pg. 41, Table 1). However, these examples do not provide any comparison to other dosages to demonstrate that the claimed dosage range was critical to the results achieved by the inventors.
See MPEP 2144.05(I) which states, "a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also MPEP 2144.05(II)(A) which states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Emphasis added)
See also MPEP III 2144.05(III)(A) which states:
"The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (Emphasis added)
In the instant case, the claimed range falls within the prior art range, and, without any evidence of the claimed range being critical to the claimed invention (e.g., achieves unexpected results), it would have been prima facie obvious for a person of ordinary skill to have selected a value of about 250 mg to 350 mg of tributyrin in view of Millet.
Regarding claim 20, Millet teaches that the chambers of the dual capsule can be designed to break down at different rates in order to deliver the prebiotic and postbiotic components at different times and/or locations within the gastrointestinal tract (see pg. 10, para. [0114]). Millet teaches that the postbiotic can be protected from being released too early, such as in the stomach where it can be utilized in digestion and absorbed before reaching the intestines (see pg. 10, para. [0115]). Millet teaches that the dosage form can be configured to release the postbiotic in the intestines, preferably in the latter portion of the small intestine (see pg. 10, para. [0115]). Therefore, it would have been obvious to have configured the first capsule (outer capsule) to be a delayed release capsule, because Millet teaches it would be more desirable for the postbiotic to be released in the small intestine, rather than in the stomach.
Regarding claim 21, Dhir teaches the outer capsule may be constructed of hypromellose (see pg. 11, para. [0127]).
Regarding claim 22, Millet teaches that the dosage form can be configured to release the postbiotic in the intestines, preferably in the latter portion of the small intestine and/or large intestine (see pg. 10, para. [0115]). Dhir teaches that the delivery capsule allows for improved stability and viability through the gastrointestinal tract, resulting in 100% or nearly 100% survival of the probiotic organisms through the stomach, jejunum, duodenum and ileum until arriving in the colon (see pg. 11, para. [0126]). Therefore, it would have been obvious to have configured the inner capsule (second capsule) to be immediate release, because if the first capsule is a delayed release capsule that breaks down between the latter portion of the small intestine (ileum) and the start of the large intestine (cecum), it would have been desirable for the probiotics to be released immediately after for delivery into the colon.
Regarding claim 23, Dhir teaches that the inner capsule may be constructed of hypromellose (see pg. 11, para. [0127]).
Regarding claim 25, Millet teaches that the dosage form can be configured to release the postbiotic in the intestines, preferably in the latter portion of the small intestine (see pg. 10, para. [0115]). Hence, it would have been obvious to have configured the first capsule (outer capsule/ chamber) to bypass the stomach and release its contents after entering the intestines.
Regarding claim 27, Dhir teaches that the delivery capsule allows for improved stability and viability through the gastrointestinal tract, resulting in 100% or nearly 100% survival of the probiotic organisms through the stomach, jejunum, duodenum and ileum until arriving in the colon (see pg. 11, para. [0126]). Hence it would have been obvious to have configured the second capsule (inner capsule/chamber) to bypass the stomach and small intestine and to release its contents after entering the colon.
Claim(s) 29-31 and 51-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dhir and Millet as applied above, and further in view of Deaton, as applied to claims 1, 18-19, and Tanbonlion, et al. (US 2013/0344042 A1; cited on Form 892), hereafter, “Tanbonliong”.
Regarding claim 29, limitation “a)”, as discussed regarding claim 13, it would have been prima facie obvious for a person of ordinary skill to have selected a value of about 250 mg to 350 mg of tributyrin in view of Millet
Deaton, as previously discussed, teaches a commercial preparation (PreforPro®) comprising four supplemental bacteriophage strains, LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae and LL12-Myoviridae provided in the amount of 15 mg within a consumable capsule (see pg. 3, para. [0035]). Deaton teaches that the bacteriophage containing composition can be used as a prebiotic supplementation to support gastrointestinal microflora by promoting the growth of beneficial bacteria and decreasing harmful bacterial populations, while releasing nutrients into the environment for good bacteria in the digestive system (see Abstract). Deaton teaches that PreforPro® is commonly used as an ingredient in probiotic formulations (see pg. 10, para. [0094]). Deaton also teaches that PreforPro® may be used in an effective total daily dose from about 10 mg to about 20 mg (see pg. 2, para. [0019]).
Hence, providing the tributyrin in an amount of 250 mg to 350 mg and the PreforPro® phage composition (prebiotic) in an amount of about 10 mg to about 20 mg would reasonably render weight ratios of about 20:1. For example, 300mg of tributyrin and 15 mg of the prebiotic blend would render a weight ratio of exactly 20:1. It should also be noted that instant claim 30, which depends from the present claim, requires “about 10 mg to about 20 mg of the prebiotic blend”, which is the same broader range taught by Deaton.
Furthermore, in view of Applicant’s Examples, a sample multi-biotic supplement formulation (Supplement A) included 350 mg of tributyrin in the outer capsule and 15 mg of the same prebiotic blend taught by Deaton (LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae) in the inner capsule (see, pg. 41, Table 1), which is also acknowledged as being PreforPro® (see pg. 43, para. [0135]). Hence, the inventors exemplified a weight ratio of about 23:1 (postbiotic to prebiotic blend). Moreover, Applicant’s examples do not provide any comparison to other weight ratios to demonstrate either the exemplified (23:1) or claimed weight ratio (20:1) to have been critical to the results achieved by the inventors. See MPEP 2144.05(II)(A) and MPEP III 2144.05(III)(A), as previously cited.
Regarding limitation “b)”, Dhir, Millet and Deaton do not explicitly teach a “weight” of the probiotic blend.
However, Millet teaches that a recommended dose of a standard probiotic supplement typically ranges from 1 billion to 10 billion colony-forming units (CFUs) (see pg. 4, para. [0039]), and a person of ordinary skill would have recognized this to be a result-effective variable.
Tanbonliong teaches nutritional compositions comprising Lactobacillus rhamnosus GG (LGG) that are useful to promote healthy intestinal growth and development of a subject (see Abstract; pg. 4, para. [0057]). Tanbonliong teaches that the nutritional composition may also provide beneficial nutrients, such as a prebiotic component (see pgs. 4-5, para. [0058]).
Tanbonliong teaches that live probiotics such as LGG are thought to impart anti-inflammatory effects through interaction with specific receptors and other cellular effects that are thought to be involved in the modulation of inflammation (see pg. 4, para. [0056]). Tanbonliong also teaches that the nutritional composition may contain one or more additional probiotics together with the LGG, particularly strains of Lactobacillus and Bifidobacterium (see pg. 4, para. [0050]). Hence, Tanbonliong teaches the composition further comprising a probiotic blend.
The examiner notes that Dhir also teaches the symbiotic composition further comprising what appears to be a closely related L. rhamnosus GG strain (“SD-GG-BE”) and discloses this particular strain to have several beneficial effects on the health of the host (see Dhir at pg. 1, para. [0009]; pg. 4, para. [0036]; see pg. 9, para. [0106]; claim 16).
Tanbonliong teaches that a sufficient amount of LGG may vary within a broad range, depending on, for example, the total amount of cells of the LGG, the total daily dose desired and on other properties and ingredients of the nutritional composition(s) (see pgs. 3-4, para. [0044]). Tanbonliong teaches, for example, the nutritional composition can comprise 108 to 1011 cfu of LGG per gram composition (see pg. 4, para. [0044]). Tanbonliong also teaches the composition may comprise live probiotics in a daily dosage amount of 1x106 to 1x109 CFU per kg of body weight (see pg. 4, para. [0055]).
Therefore, a person of skill would have recognized from Tanbonliong that the amount of probiotics in a composition may vary depending on the desired dose and would have sufficient reason to optimize the composition.
For example, if one sought to provide a dosage of 10 billion CFUs, as taught by Millet, a probiotic blend comprising between 1010 to 1011 CFUs per gram could provide 10 billion CFUs by the addition of 120 mg of the probiotic blend. In a composition comprising 15 mg of the prebiotic blend, this would result in a ratio of about 8:1, probiotics to prebiotics.
Therefore, in view of Millet and Tanbonliong’s teachings, a person of ordinary skill could have arrived at the claimed ratio through no more than routine optimization. Furthermore, in view of Applicant’s examples, the probiotic blend in the inner capsule contained a total of 11 billion CFUs and a total weight of 135 mg (see, pg. 41, Table 1). This amounts to about 8.1x1010 CFUs per gram of the probiotic blend, which is also within the range taught by Tanbonliong. As previously discussed, Applicant’s examples do not provide any comparison to other weight ratios to demonstrate that the claimed weight ratio was critical to the results achieved by the inventors. See MPEP 2144.05(II)(A) and MPEP III 2144.05(III)(A), as previously cited. Moreover, it was well within the ordinary skill in the art to have arrived at an effective ratio of probiotics to prebiotics when provided result-effective variables, such as the recommended doses of probiotics in CFUs and the PreforPro® formulation provided in mg.
Therefore, it would have been obvious at the time of filing for a person of ordinary skill in the art to have arrived at the claimed invention by further combining the teachings of Deaton and Tanbonliong, because each reference teaches effective prebiotic and/or probiotic formulations that are expected to provide a benefit to human microflora and intestinal health. One would have recognized from Deaton that the bacteriophages of the disclosure could provide prebiotic supplementation to support gastrointestinal microflora by promoting the growth of beneficial bacteria and decreasing harmful bacterial populations, while releasing nutrients into the environment for good bacteria in the digestive system. One would have recognized from Tanbonliong that live probiotics such as LGG, as well as other Lactobacillus and Bifidobacterium strains, are known in the art to impart anti-inflammatory effects. Furthermore, one would have recognized that the bacteriophage mixture taught by Deaton was already commonly incorporated into probiotic compositions as a prebiotic component. Therefore, one would have been motivated to combine these elements for the multiple benefits they are taught in the art to confer to the gastrointestinal system and could have combined each element claimed (i.e., postbiotics, probiotics, prebiotics, capsules) by known methods. Thus, one would have recognized the results of the combination to be predictable and would have had a reasonable expectation of success in formulating an effective nutritional supplement having these disclosed effects. Hence, the combination would have been readily apparent and deemed to be a mere (A) combining of prior art elements according to known methods to yield predictable results (see MPEP 2143(I): Rationales to support rejections under 35 U.S.C. 103).
Regarding claim 30, it would have been obvious to have provided the first capsule with about 250 mg to about 350 mg of tributyrin and the second capsule with about 10 mg to 20 mg of the prebiotic blend for the same reasons discussed regarding claims 13 and 29 above.
Regarding the limitation of “about 110 mg to about 130 mg of the probiotic blend” a person of ordinary skill could have arrived at the claimed amount, for example, 120 mg, to provide 10 billion CFUs of the probiotics through no more than routine optimization, as discussed regarding claim 29. As previously discussed, there is no evidence provided in Applicant’s Examples to demonstrate that the claimed range was critical to the results achieved by the inventors. See MPEP 2144.05(II)(A) and MPEP III 2144.05(III)(A), as previously cited.
Regarding claim 31, Millet teaches that a recommended dose of a standard probiotic supplement typically ranges from 1 billion to 10 billion colony-forming units (CFUs) (see pg. 4, para. [0039]). Here, 10 billion CFUs is reasonably “about” 11 billion CFUs.
Furthermore, in view of Applicant’s Examples, a sample multi-biotic supplement formulation (Supplement A) included 10 billion CFUs of Lactobacillus rhamnosus GG and 1 billion CFUs Bifidobacterium animalis ssp. Lactis BB-12 (see, pg. 41, para. [0130]). It should be noted that these examples do not provide any comparison to other dosages to demonstrate that the claimed dosage range was critical to the results achieved by the inventors.
Furthermore, a person of skill would have recognized from Tanbonliong that the amount of probiotics in a composition may vary depending on the desired dose and would have sufficient reason to optimize the composition, as discussed regarding claim 29.
For example, if one sought to provide a dosage of 10-11 billion CFUs, a probiotic blend comprising between 1010 to 1011 CFUs per gram could provide 10-11 billion CFUs by the addition of 120 mg of the probiotic blend. In a composition comprising 15 mg of the prebiotic blend, this would result in a ratio of about 8:1, probiotics to prebiotics. Therefore, it would have been obvious to have arrived at this amount through no more than routine optimization using the result-effective variables that are known within the art.
Regarding claim 51, Deaton teaches the prebiotic blend comprising LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae and LL12-Myoviridae, as discussed above. Tanbonliong teaches nutritional compositions comprising a probiotic blend of Lactobacillus rhamnosus GG (LGG) and strains of Bifidobacterium, as discussed above. Specifically, Tanbonliong teaches the nutritional composition may contain an additional probiotic that is Bifidobacterium animalis subsp. lactis BB-12. Hence, it would have been obvious to have selected this strain for the probiotic blend.
Regarding claim 52, the claim is obvious for the same reasons discussed regarding claims 20 and 30.
Claim(s) 37 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bucci as applied to claims 1, 9, 16, 24, 34-35, 41 and 45 above, and further in view of Freedman, et al. (US 2020/0255206 A1; cited on Form 892), hereafter, “Freedman”.
Regarding claim 37, Bucci teaches a dietary supplement comprising a probiotic blend contained within a capsule shell, and further teaches a kit comprising the dietary nutrient supplement and a container, wherein the container comprises a bottle and a removable screw-top lid, and wherein the kit comprises a scented insert located within the container, as discussed regarding claim 34.
Bucci does not explicitly teach the bottle comprises a desiccant disposed therein and/or a layer of desiccant affixed to an interior surface of the bottle.
Freedman teaches containers adapted to house products that are sensitive to ambient
conditions, such as certain medications and probiotics (see pg. 1, para. [0002]). Freedman teaches that it has been found that pharmaceutical administration forms comprising a living microorganism culture (e.g., probiotic microorganism), may be degraded by moisture (see pg. 1, para. [0003]).
Freedman teaches a method for storing and preserving moisture sensitive products by providing a moisture tight container formed of a polymeric material, the container having an internal volume in a range of 12 mL to 30 mL, the container comprising an insert secured within the interior of the container body, the insert comprising a base material and a desiccant, wherein the base material provides structure to the insert and is a polymer, the insert having an insert opening leading to an interior compartment configured for housing moisture sensitive products (see claim 1).
It would have been obvious at the time of filing for a person of ordinary skill in the art to have arrived at the claimed invention by combining the teachings of Bucci and Freedman, because Freedman teaches probiotics are sensitive to moisture and discloses a desiccant insert for inserting into a bottle to preserve moisture sensitive products, such as probiotics. One would have been motivated to have combined these teachings, because Freedman teaches probiotics are sensitive to moisture. One could have combined each element claimed (i.e., probiotics, bottle, scented insert, desiccant insert) by known methods, and one would have recognized that in combination each element merely performs the same function as it does separately. Therefore, one of ordinary skill would have recognized the results of the combination were predictable and would have had a reasonable expectation of success. Hence, the combination would have been readily apparent and deemed to be a mere (A) combining of prior art elements according to known methods to yield predictable results (see MPEP 2143(I): Rationales to support rejections under 35 U.S.C. 103).
Regarding claim 39, Freedman teaches physical absorption desiccants may include molecular sieves, e.g., 4A molecular sieves (see pg. 10, para. [0127]). Freedman teaches the internal volume of the container is in the range of 12 mL to 30 mL, as discussed above. Freedman teaches the mass of the of the insert comprising the desiccant may be 1.5 to 2.75 g (see pg. 2, para. [0011]). Therefore, the ratio of the container size (cm3 = mL) to desiccant (g) may be as high as 120 to 6, which is near the claimed ratio of 130 to 6.
In view of the instant specification, there is no apparent disclosure of any evidence or even any discussion regarding the criticality of the claimed ratio.
See MPEP 2144.05(I) which states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, particularly when there was no showing of criticality of the claimed range. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See also MPEP 2144.05(II)(A) and MPEP III 2144.05(III)(A), as previously cited. In the instant case, there is no evidence to suggest that the claimed ratio was critical, and it would have been obvious to have routinely optimized these amounts. Furthermore, it is apparent in view of the art that the size of the container (bottle) provided in such a kit may vary, and that the mass of the desiccant itself may also vary. Hence, it would have been obvious to have provided, for example, a larger bottle, or less desiccant, according to the needs and the resources of an ordinary artisan, and effective volumes and amounts (or ratios thereof) could have been arrived upon through no more than routine optimization.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS ARMATO whose telephone number is (703)756-5348. The examiner can normally be reached Mon-Fri 11:00am-7:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
Prosecution Insights