DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Receipt of Remarks/Amendments filed on 09/01/2026 is acknowledged. Claims 1-22 are pending. Applicant elected Group I (Claims 1-17) without traverse. Claims 18-22 are non-elected claims, and are withdrawn. Claims 1-17 presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Claim Objections
Claims 3 and 6 are objected to because of the following informalities:
Claim 3, last line recites “and or”, which should be changed to “and/or”. Additionally, the word “capsule” is recited twice.
Claim 6 recites “plus” which is an informal/narrative language, and should be replaced with “and an additional” or something similar.
Appropriate correction is required.
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 1-2, 8, 11, 14 and 16 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.
Claim 1 requires at least one prebiotic component and/or at least one probiotic component and/or at least one postbiotic constituent component and/or at least one bacteriophage component; Claim 2 requires both the at least one prebiotic component and the at least one probiotic component; Claim 8 recites wherein the at least one prebiotic component of Claim 1 comprises a sourced inulin fructooligosaccharide (FOS); Claim 11 recites wherein the composition comprises a liquid…or other food product; Claim 14 requires the composition further comprises “essential oils, spices, herbs, natural sweeteners, phytonutrients, vitamins, minerals…”; Claim 16 requires the composition is in food form; Claim 17 requires that the composition is free of artificial flavors, preservatives, colors, binders, and fillers. A judicial exception is not integrated into a practical application because the limitations are not markedly different from the naturally occurring counterpart, i.e. there is no characteristics (i.e. structural and/or functional) that are different between the claimed composition and the naturally occurring product and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The rational follows:
Step 1: Determine if the claims are directed to a process, machine, manufacture or composition of matter. YES, the claims are directed to a composition of matter, therefore the claims fall within one of the four categories of patent eligible subject matter.
Step 2a: Determine if the claims are directed to a judicial exception to patent eligibility (i.e., law of nature, natural phenomenon, or an abstract idea). YES, the claims are composition claims requiring at least one prebiotic component and/or at least one probiotic component; wherein the at least one prebiotic component is inulin FOS; wherein the composition comprises a food product; and further comprises essential oils,…natural sweeteners, phytonutrients, vitamins, minerals…, which is not markedly different in structure or characteristics (i.e. function) from original source natural product. There is no evidence in the disclosure as filed that the composition presently claimed confers different characteristic to that of a Jerusalem artichoke. Mendez-Yanez et al. (Horticulturae 2022, 8, 620) teaches that Jerusalem artichoke tubers are edible, and a source of chlorophyll, protein, vitamins, minerals, and inulin, which is useful as a prebiotic and probiotic in human (Abstract; p. 2, Section 2.3; p. 3, Table 2; p. 4, section 4.3). Further, the Jerusalem artichoke tubers are product of nature and therefore free of artificial flavors, preservatives, colors, binders, and fillers. Thus, the claims do not recite something significantly different than a judicial exception (i.e., natural products which are not markedly different in structure form naturally occurring products). To show a marked difference, the characteristic(s) must be changed as compared to nature. Inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
Step 2b: Determine if the claims recited additional elements that amount to significantly more than the judicial exception. NO, the claims are directed to a composition comprising at least one prebiotic and probiotic, a sourced inulin FOS, wherein the composition comprises a food product/form, and comprises vitamins and minerals, with no other components, including being free of artificial flavors, preservatives, colors, binders, and fillers. No other specific limitations other than what is well-understood, routine and conventional in the field have been added in these claims, that would be differentiated from the naturally occurring Jerusalem artichoke tuber as taught by Mendez-Yanez et al. See MPEP 2106.05(d) “If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.” As such, these claims are not eligible subject matter under current 35 USC 101 standards.
Claim Rejections - 35 USC § 112
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 1-17 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.
Claims 1, 3-4, 6-7, 15, recites prebiotic, probiotic, and/or postbiotic “constituent component” and refers to the bacteriophage only as “component” . It is unclear how component vs. constituent components are being used herein. The instant Specification refers to the prebiotic, probiotic, postbiotic, and/or bacteriophage “constituent component” in [0053]. The Examiner interprets both constituent and component to be the same, i.e. parts of the composition. As such, one skilled in the art would not be available to ascertain the metes and bounds of these claims. Clarification is requested. All claims depending from Claim 1 are also rejected.
Claim 3 is rejected for indefiniteness for the recitation of “wherein the at least one…. are delivered in freeze dried, spray dried, spray….” It is unclear as to what “freeze dried, spray dried…” refers to, i.e. if it’s the form of the composition or if the composition is in a specific freeze-dried product. There appears to be a missing word, and the claim is indefinite. For compact prosecution, the Examiner will interpret the claim to refer to the form of the composition.
Claim 3 is further rejected for indefiniteness for the recitation of “spray dried” and “spray”; and “capsule”, “dual chamber capsule”, “liquid capsule” and “caplet”. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language, e.g. “liquid capsule” is (a) merely exemplary of the remainder of the claim, i.e. “capsule”, and therefore not required, or (b) a required feature of the claims.
Claim 4 recites “sublimation drying method or other high pressure method”. One skilled in the art would not be able to ascertain what “other high pressure method” of drying are being claimed.
Claim 5 is indefinite for reciting “one probiotic component are sourced from human, animal or plant natural fermentation synthesis using a low temperature….” First, it is unknown what is meant by “sourced from human, animal…”. To move prosecution forward, the Examiner will interpret this to mean that humans serve as host to the probiotic bacteria. Second, the Examiner cannot ascertain what is meant by “plant natural fermentation synthesis”, which appears to be grammatically incorrect because “fermentation synthesis” is not a term of the art, and if Applicant means synthesis via fermentation, it is unknown what “plant natural fermentation synthesis” means, and whether the fermentation synthesis also refers to human and animal.
Claim 5 is further indefinite for the recitation of “and/or other low temperature drying methods”. It is unclear what other drying methods is being claimed. As such, the metes and bounds of the claim is unclear and the claim is rejected.
Claim 6 is indefinite for reciting “one separate prebiotic or prebiotic fibrous constituent component plus 24 probiotic strains”. It is unclear if the options are for i) one prebiotic or ii) prebiotic fibrous constituent component plus 24 probiotic strains, OR if the plus 24 probiotic strains also refers to the probiotic, i.e. ) one prebiotic plus 24 probiotic strains or ii) prebiotic fibrous constituent component plus 24 probiotic strains.
Claim 8 is indefinite for a recitation of “a sourced inulin”. It is unknown what is meant by “sourced” and how this is different from any inulin. Clarification is required.
Claim 11 recites in the alternative: “mixed drink, food additive, smoothie, fruit drink, shake, flavoring, baby food, sports supplemental product, baked good, pet product, or other food product.” One skilled in the art would not know what differentiates mixed drink, smoothie, fruit drink, and shake, as well as food additive, flavoring, and other food product, and also baked good or baby food with “other food product”. Furthermore, the skilled artisan has no guidance on what is being excluded and included in the claimed “other food product”. As such, the claim is indefinite and rejected.
Claim 16 recites “food form” which is vague and indefinite because the Specification does not define the metes and bounds of the “food form” being claimed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-2, 8, 10-11, 14 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mendez-Yanez et al. (Horticulturae 2022, 8, 620), hereinafter Mendez-Yanez.
Regarding Claims 1-2 and 8, Mendez-Yanez teaches that Jerusalem artichoke tuber is a source of chlorophyll, protein, and inulin, which is useful as a prebiotic and probiotic in human (Abstract; p. 2, Section 2.3; p. 4, section 4.3).
Regarding the recitation of the sterilized package or container in Claim 10, how or where one stores the composition does not materially affect its components. It is the Applicant’s burden to show that the storage/packaging is also an integral part of the claim. See MPEP 2106.07(a). As recited, the container or packaging is not a patentable feature, and Claim 10 is anticipated.
Because Jerusalem artichoke tubers are edible, they read on the food product/form feature in Claim 11 and 16 (Introduction, 2nd paragraph). Jerusalem artichoke contains vitamins and minerals, which reads on Claim 14 (p. 3, Table 2).
Regarding Claim 17, the Jerusalem artichoke tubers are product of nature, plant native to North America according to Mendez Yanez, and therefore free of artificial flavors, preservatives, colors, binders, and fillers (Introduction, 1st paragraph).
Claims 1-3 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Simmons et al. (US 2023/0241129 A1), hereinafter Simmons.
Regarding Claims 1 and 2, Simmons discloses compositions, systems and methods of improving the health of the microbiome of an individual's skin using formulations containing beneficial bacteria, postbiotics, metabolites and other microbe components to foster the growth and maintenance of a healthy skin microbiome (Abstract). One embodiment includes a topical application of Lactobacillus Crispatus to ameliorate skin barrier damage and inflammation using unique combinations of probiotics, prebiotics, postbiotics, and other skin beneficial ingredients, effectively treating inflammatory skin diseases (Abstract).
Simmons teaches an aspect of the present invention directed to using human specific species of bacteria that are modified to enhance one or more characteristics deemed beneficial to the skin microbiome, including bacteria that have been modified via a CRISPR-Cas9 and/or Cpfl system to either repress the expression of a particular protein or lipid, or to increase the production of beneficial microbial secretions ([0025]]-[0026]; Claim 1).
Simmons teaches topically applying live probiotic lactobacilli to beneficially modulate cutaneous microbial interactions and host inflammatory responses in individuals with skin diseases; postbiotic formulations derived from Lactobacilli-which may include bacterial lysates, supernatants, and/or purified supernatants or metabolites, are applied to an individual's skin [0038].
Regarding Claim 3, Simmons teaches the formulations may include microcapsules, topical creams, emulsifiers etc. [0039].
Regarding the recitation of the sterilized package or container in Claim 10, how or where one stores the composition does not materially affect its components. It is the Applicant’s burden to show that the storage/packaging is also an integral part of the claim. See MPEP 2106.07(a). As recited, the container or packaging is not a patentable feature, and Claim 10 is anticipated.
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.
Claims 6-7, 9, 11-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons, as applied to Claims 1-3 and 10 above, as evidenced by Bull et al. (The life history of Lactobacillus acidophilus as a probiotic: a tale of revisionary taxonomy, misidentification and commercial success. FEMS Microbiol Lett, 349: 77-87. 2013).
The teachings of Simmons have been set forth supra.
Regarding Claims 6 and 9, Simmons teaches that to further enhance the ability of desired bacteria to be maintained on the skin of an individual, prebiotic are administered to the individual’s skin, wherein the prebiotic comprises a nutrient source for the bacteria [0039]. Specific examples of probiotic microorganisms also suitable for the invention include: Bifidobacterium adolescentis, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium infantis, Bifidobacterium pseudocatenulatum, Lactobacillus acidophilus (NCFB 1748); Lactobacillus amylovorus, Lactobacillus casei (Shirota), Lactobacillus rhamnosus (strain GG), Lactobacillus brevis, Lactobacillus crispatus, Lactobacillus delbrueckii (subsp bulgaricus, lactis), Lactobacillus fermentum, Lactobacillus helveticus, Lactobacillus gallinarum, Lactobacillus gasseri, Lactobacillus johnsonii (CNCM 1-1225), Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus salivarius, Lactobacillus alimentarius, Lactobacillus curvatus, Lactobacillus casei subsp. casei, Lactobacillus sake, Lactococcus lactis, Enterococcus (faecalis, faecium ), Lactococcus lactis (subsplactis or cremoris), Leuconostoc mesenteroides subsp dextranicum, Pediococcus acidilactici, Sporolactobacillus inulinus, Streptococcus salvarius subsp. thermophilus, Streptococcus thermophilus, Staphylococccus carnosus, Staphylococcus xylosus, Saccharomyces(cerevisiae or else boulardiO, Bacillus (cereus var toyo or subtilis), Bacillus coagulans, Bacillus licheniformis, Escherichia coli strain nissle, Propionibacterium freudenreichii, and mixtures thereof [0207]. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use any number or all of the probiotics disclosed by Simmons in a mixture, and the prebiotic disclosed by Simmons. Regarding the probiotic strain in Claim 9, as listed in Table 1, Simmons teaches L. acidophilus La-14 [0128]. Importantly, Simmons teaches L. Johnsonni, which is the same as L. acidophilus La-1 in the instant Specification Table 1 (Claims 1 and 14; Fig. 15). This is evidenced by Bull et al. (p. 81, last paragraph to p. 82, 1st paragraph).
Regarding Claim 7, Simmons has taught the prebiotic and probiotic strains above. Simmons teaches embodiments wherein the composition includes postbiotic formulations derived from Lactobacilli- which may include bacterial lysates, supernatants, and/or purified supernatants or metabolites, are applied to an individual's skin [0038]-[0039]. Simmons appreciates that probiotics are not necessarily related to their viability, given that dead cells can confer biological responses equal or superior to their live counterparts, and as such, compounds/molecules derived from inactivated probiotics can be obtained either from metabolites generated during microbial growth or from intact (i.e., inanimate) dead strains after cell disruption and fragmentation [0074].
Simmons also teaches that certain bacteriophages are suitable for incorporating into certain antiperspirant and deodorant compositions, and are effective and specific in fighting against bacteria causing odor without irritating the skin or damaging the germs in the flora of the skin which have a positive effect; effective bacteriophages include Staphylococcus aureus and/or Staphylococcus hominis and/or Corynebacterium tuberculostearicum and/or Anaerococcus octavius and/or Staphylococcus lugdunensis and/or Finegol diamagna and/or Corynebacterium amycolatum and/or Corynebacterium afermentans and/or Staphylococcus epidermidis and/or Staphylococcus capitis and/or Staphylococcus haemolyticus and/or Propionibacterium avidum and/or Corynebacterium kroppenstedtii and/or Peptinophilus spec [0162].
As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to incorporate postbiotics which can confer biological responses equal or superior to their live counterparts, and also use any number or all of the bacteriophages disclosed by Simmons for use in antiperspirant and deodorant compositions.
Regarding Claims 11-13 and 16, Simmons discloses that its compositions may take the form of a gel, a cream, a lotion, an ointment, a solution, a solid "stick" etc., that can be rubbed or sprayed onto the skin [0186]. As one skill in the art will appreciate, a suitable topical composition comprising a population of the above bacteria can be, in various embodiments, a cream, lotion, emulsion, gel, ointment, liquid or spray [0187].
Regarding Claim 14, Simmons teaches embodiments wherein the formulation includes a probiotic, heat-killed bacteria, and/or postbiotic metabolite, in conjunction with a topically applied vitamin, such as niacinamide, or botanical extract [0252].
Regarding Claim 15, Simmons teaches that administration by topical application is at least 1.5% of the probiotic bacterium [0141]. Simmons also teaches at least 1% postbiotic [0250]. Simmons clearly envisaged inclusion of prebiotic and bacteriophage. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to add the prebiotic and bacteriophage starting at the same amounts of postbiotic or probiotic, and adjusting as needed.
An improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue.
Regarding Claim 17, the composition of Simmons does not require artificial flavors, preservatives, colors, binders, and fillers (Abstract; [0012]).
Claims 3-5 and 8, are rejected under 35 U.S.C. 103 as being unpatentable over Simmons, as applied to Claims 1-4, 6-7, 9-14, and 16-17 above, and in view of Wang et al. (CN 114287632A; machine translated in IP.com), hereinafter Wang.
Further regarding Claim 3, and also applies to Claim 4, these claims are product-by-process claims, however, patentability is based on the product itself. If the product is the same as a product from the prior art, the claim is unpatentable. The MPEP indicates that the process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art”. See MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). In the instant case, the burden is on the applicant to show that there exists a structural difference when the delivery of the at least one prebiotic/probiotic/postbiotic constituent is done by another method as compared to the freeze drying, spray drying, spraying in Claim 3, and the dehydration is done by another technique in comparison to the low temperature drying method, sublimation or other high pressure method recited in Claim 4.
Regarding the drying method in Claim 5, Simmons is silent on this method. However, this is also a product-by-process claim.
Nevertheless, Wang is in the same field and teaches the invention of inulin probiotic microcapsules, wherein the microcapsule core material is prepared from inulin and probiotics (Abstract).
Regarding Claim 5, Wang teaches a step in the preparation of the inulin probiotic microcapsules wherein, the wet microcapsule is placed in in a low-temperature refrigerator at-80 ˚C for pre-freezing, and placing in a vacuum freeze-drying machine, freezing at-80 ˚C for 24 hr, and drying to obtain microcapsule powder.
Simmons comprehends its formulations may be in microcapsule form [0039]. As such, Wang is compatible with Simmons. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date and with reasonable expectations of success to combine the teachings of Wang with that of Simmons and prepare the microcapsule of probiotic using freeze-drying. Freeze-drying of probiotic is a known technique in the art, as evidenced by Wang. Hence, one with ordinary skill in the art would have applied the known technique with reasonable expectations of success. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding Claim 8, Simmons comprehend that fructooligosaccharide is a conventional prebiotic nutrient source and that its formulations may be in microcapsule form [0015]. Wang teaches that inulin is a natural water-soluble dietary fiber, utilized by beneficial microorganisms in colon, which improves the intestinal microbiome, making it a good prebiotic (p. 5, Background, 2nd paragraph). In addition, inulin also has effects of lowering blood sugar, promoting mineral absorption, and treating obesity (p. 5, Background, 2nd paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to inulin as the prebiotic in the composition of Simmons because Wang has taught the beneficial properties of inulin.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
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