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 .
Finality Withdrawn:
The finality of the previous office action mailed on 07/27/2026 is withdrawn.
The amendment and response filed on July 15, 2026 are received.
Claim 17 is canceled, and new claims 18-23 are added.
Claims 1-13, 16 and 18-23 are pending, claims 1-4 and 6-13 are withdrawn from further consideration, and claims 5, 16 and 18-23 are being examined.
Answer to Arguments:
Withdrawn Rejection(s):
The rejection of claims 5 and 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. as evidenced by Wikipedia, is withdrawn due to the amendment to the claims filed on 07/15/2026.
Applicant arguments with respect to the above-mentioned rejection is moot because the rejection is withdrawn, and further in view of the new grounds of rejection issued due to the amendment to claims filed on 07/15/2026.
Applicant's amendment to claim 5 necessitated the new ground(s) of rejection presented in this Office action.
Objection(s):
Claims 5, 16 and 18-23 are objected to because of the following informalities:
In claims 5, 16 and 18-23, line 1, after the claim numbers insert --.--.
Appropriate correction is required.
Claim Rejection - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 16 and 18-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strains: Lactobacillus acidophilus La-14, Bifidobacterium lactis BI-04, Lactobacillus rhamnosus GG, Bifidobacterium longum BL- 05, Lactobacillus plantarum Lp-115, Bifidobacterium bifidum Bb-06, and Lactobacillus gasseri Lg-36.
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit.
Further it is unclear if the starting materials were readily available to the public at the time of invention.
It is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Copy of deposit receipt is/are required.
Claim Rejection - 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.
Claims 5, 16 and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Mercado et al. (AU 2016100865 A4; English translation, published 7/14/2016, 24 pages of PDF) and Roughead et al (US Patent No. 9,192,179; published 11/24/2015).
In short, Mercado et al explicitly teach a composition comprising six of the seven specifically-recited bacterial strains from instant claim 5 and also suggest the addition of fiber and the seventh strain to a composition comprising the six recited strains.
Claim Interpretation – Claim 5 is representative of the claims under examination and reads as follows:
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Base claim 5 is directed to a method of improving gastrointestinal health comprising administering to a subject a combination of (i) at least one fiber, and (ii) a probiotic mixture comprising seven very specific bacterial strains:
Lactobacillus acidophilus La-14,
Bifidobacterium lactis BI-04,
Lactobacillus rhamnosus GG,
Bifidobacterium longum BL-05,
Lactobacillus plantarum Lp-115,
Bifidobacterium bifidum Bb-06, and
Lactobacillus gasseri Lg-36.
Note that claim 5 doesn't preclude the presence of any additional bacterial strains, also that claim 5 asserts that the method comprises “enhancing resilience of the microbiome in the subject” as part of improving gastrointestinal health of the subject. The instant specification defines the term “enhancing” as follows:
The relative terms "promote," "improve," "increase," "enhance" and like terms refer to resilience of the microbiome of the subject (i.e., resistance to challenge and/or recovery from challenge), after administration of the composition disclosed herein (which comprises a fiber and a probiotic), relative to the resilience of the microbiome of the subject obtained by administration of a composition lacking the fiber and/or the probiotic but otherwise identically formulated.” (see paragraph [0028] page 4).
In addition, the specification defines the term “resilience” as follows:
“As shown in FIG. 1, microbiota resilience is defined as the capacity to resist or fully and quickly recover from challenge or perturbation.”
Thus, it is reasonable to interpret claim 5 as reciting that the administration of at least one fiber and a mixture of the seven specifically-recited bacterial strains to a subject is intended to result in an enhancement of the subject microbiome to resist and/or quickly recover from a challenge. The specification goes on to define a ‘stressor’ or challenge as including one’s diet (e.g., a high fat diet, the Western diet, ketogenic diet or a low carbohydrate diet) (e.g., [0038] at page 6). The working examples of the instant disclosure describe experiments that feature an embodiment of the claimed invention and which demonstrate that a composition administered to subjects comprising a fiber and the seven recited bacterial strains was able to improve the gastrointestinal health of the subjects (e.g., [0066] at page 10 to [0076] at page 11; Figures 1-12; etc.). Note that Figure 3B shows a product used in the experiments that includes each of the seven recited bacterial strains at amounts ranging from 5 X 109 to 1.5 X 1010 CFU. Note also that Figures 8A-8C show that the treated subjects had a higher resistance to the high fat challenge and that Figure 9 shows that intervention with the recited probiotic mixture results in quicker recovery after challenge.
Finally, it is worth noting that claim 5 is extremely generic with regard to the type of fiber used, the amounts of the different bacterial strains comprised within the probiotic mixture, the degree of enhancement of resilience and the challenge to which the enhancement is determined.
Mercado et al. (i.e., ‘the ‘865 publication) teach a multi-strain probiotic composition that can comprise each of the instantly recited bacterial strains in combination (e.g., the Title; [0010]; [0020]; [0022-0023], claims 4-5; etc.). For example, each of the recited strains is taught at multiple locations within the publication as a strain that can be used to form a mixture that is a probiotic that can be used to treat a loss of balance in the microbiota of an individual (i.e., ‘dysbiosis’). The publication teaches that dysbiosis may be linked to health problems such as functional bowel disorders, inflammatory bowel disease, allergies, obesity and diabetes and that a number of environmental factors can lead to dysbiosis, such as chronic stress, chronic infection, diet, environmental insults, antibiotic and other medications (e.g., [0005]; [0007]; etc.). The ‘865 publication teaches that it is desirable to restore balance in the microbiota of an individual and to treat or avoid dysbiosis quickly and effectively, which is reasonably considered as encompassing the concepts of resilience and recovery from challenge as defined in the instant disclosure and is consistent with the teachings of the instant disclosure regarding dysbiosis (e.g., see [0002] and [0004] of the instant disclosure).
Regarding the seven specific strains as recited in the instant claims, they are described throughout the ‘865 publication as being present in a probiotic mixture comprising various different bacterial strains (e.g., [0020]; [0022-0023]; etc.). For example, the publication states at [0016] that the composition of the invention comprises at least 8 probiotic strains in a total amount of greater than 500 billion CFU (e.g., 5 X 1011 colony forming units; at page 4). The publication also teaches at paragraph [0022] that while some strains may be preferable, it is understood that any strain of the species described in the publication and combined according to the invention will be sufficient and that the invention will not be limited to a particular strain of each species. This paragraph also teaches that in one embodiment the at least 8 bacterial strains are chosen from a Markush group of strains that include 6 of the seven strains recited in the instant claims (e.g., . Lactobacillus acidophilus La-14, Bifidobacterium lactis BI-04, Bifidobacterium longum BL-05, Lactobacillus plantarum Lp-115, Bifidobacterium bifidum Bb-06, and Lactobacillus gasseri Lg-36.). A similar composition is described in Example 2 with the 6 different strains present in the described mixture at between 5.00 X 109 and 2.20 X 1011 CFU (e.g., [0056] at page 33):
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Regarding the remaining specifically-recited strain from the instant claims, Lactobacillus rhamnosus GG, Mercado et al teach that it is also a desirable strain for incorporation into the probiotic compositions of their invention (e.g., [0020] at page 7; [0058] in Example 3 at page 35; [0059] in Example 4 at page 36; claims 4-5; etc.). For example, paragraph [0020] states that it will be apparent to the skilled artisan that any bacterial strain that has probiotic activity may be used in the composition of the invention and that the strains of the invention are preferably chosen from a Markush list of species that are generic to the specific strains recited in the instant claims and which also lists Lactobacillus rhamnosus GG as a preferred strain:
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In addition, the Mercado et al. publication teaches that the compositions of their invention may comprise any one or more of additional constituents that are favorable for re-colonizing a microbiota and/or to treat or prevent dysbiosis in a subject, or that may enhance the activity of the probiotic composition of the invention (e.g., see [0033] at page 9). These additional components of the probiotic mixtures can include fiber (e.g., fiber FOS or MOS (i.e., fructooligosaccharides and maltooligosaccharides, respectively); see also claim 3 of the publication).
Regarding claim 16, Mercado et al. teach at least one fiber is selected from the group consisting of insoluble fiber, soluble fiber, and a mixture thereof (inulin, a soluble fiber) (See paragraph [0033]).
Regarding claim 21, Mercado et al. teach the probiotic is administered to the subject as a daily dose of 1 x 107 to 1 x 1011 colony forming unit (cfu) (100 billion to 500 billion CFU) (See for example, p. 7 paragraph [0032]).
Regarding claim 22, Mercado et al. teach oral administration of the composition (formulated for )(See for example, p. 7 paragraph [0034]).
Regarding claim 23, Mercado et al. teach the composition comprising the combination of at least one fiber and probiotic is selected from the group consisting of milk powder based products, instant drinks, ready-to-drink formulations, nutritional powders, nutritional liquids, milk-based products, cereal products, beverages, water, coffee, cappuccino, malt drinks, chocolate flavored drinks, culinary products, soups, tablets, and syrups (oral powder form sachet, add to juice of water) (See for example, paragraph [0057]).
Mercado et al. do not teach all seven of the specifically-recited strains from instant claim 5, the at least one fiber is selected from the group consisting of xylooligosaccharides, flax seed, partially hydrolyzed guar gum (PHGG), glucomannan, cellulose, prune powder, pectin, apple peel pectin, and mixtures thereof (claim 18), the at least one fiber comprises a blend of insoluble fiber and soluble fiber (claim 19), and the at least one fiber is administered to the subject as a daily dose of about 15 to about 25 grams (claim 20).
However, Roughead et al. (e.g., the ‘179 patent) teach methods for promoting gut microbiota balance comprising the administration of compositions comprising fibers such as fructooligosaccharide (FOS) (e.g., Title; Abstract; etc.). The ‘179 patent teaches that the term ‘prebiotic’ includes a food substance that selectively promotes the growth of beneficial bacteria or inhibits the growth or mucosal adhesion of pathogenic bacteria in the intestines (e.g., column 1, lines 45-55; column 10, lines 21-41; etc.). The patent also teaches that prebiotic compositions comprising FOS were known and available in the prior art prior to the EFD for the instant claims (e.g., column 2, lines 26-36; etc.).
Also, Roughead et al. (e.g., the ‘179 patent) teach 15 g/L fiber including pectin (See for example, column 16 Table 1).
Therefore, it would have been obvious to the ordinarily skilled artisan prior to the effective filing date (EFD) of the claimed invention to prepare and administer a probiotic composition comprising each of the seven specifically-recited compositions from instant claim 5 because the ‘865 publication from Mercado et al teaches that it is desirable and within the skill of the art to do so. For example, Mercado et al describe a single embodiment that comprise six of the seven recited species and specifically suggests that the seventh species, Lactobacillus rhamnosus GG, can be included to positive effect in any probiotic mixture of their invention. One would have been motivated to do so in order to achieve the effect of treating or preventing dysbiosis of a subject’s microbiome, as suggested by Mercado et al. One would have had a reasonable expectation of doing so, absent any evidence to the contrary.
Regarding the limitation that the seven recited strains are administered in combination with fiber, it would have been obvious to one of ordinary skill in the art prior to the EFD for the instant claims to have included an FOS-containing prebiotic with the bacterial mixture because it is explicitly suggested by Mercado et al and because Roughead et al make clear that such prebiotic compositions comprising that type of fiber were known in the art prior to the EFD for the instant claims. One would have been motivated to do so in order to achieve the result of promoting the growth of desirable bacterial strains and inhibiting the growth or presence of undesirable bacterial strains within the microbiome of the subject, as suggested by both Mercado et al and Roughead et al.
Regarding the recited limitation that the method of improving gastrointestinal health is one that comprises “enhancing resilience of the microbiome in a subject”, it is respectfully submitted that this limitation is an intended result of the claimed method and not necessarily required by the claimed method. All that is absolutely required by the method of claim 5 is that a composition comprising fiber and the seven specific strains is administered to a subject.
In addition, it is respectfully submitted that the composition comprising fiber in combination with the seven specifically-recited strains made and administered according to the teachings of the cited references would inherently achieve the effect of improving gastrointestinal health by enhancing the ability of the subject’s microbiome to be resistant to and recover from challenge (e.g., a poor, fiber-deficient diet). For example, claim 5 doesn’t require any specific amounts or ratios of the recited bacterial strains and fiber in the claimed composition. As such, claim 5 and the instant disclosure imply that any composition comprising those specific strains and any fiber will meet the intended outcome for the claimed method (i.e., improving gastrointestinal health by enhancing resilience of the microbiome in the subject). The Mercado et al publication teaches such compositions. In addition, the amounts of each bacterial species taught in the instant disclosure as achieving the desired outcome(s) (e.g., 5.5 X109 to 1.5 X 1010 CFU in Figure 3B; see outcomes in Figures 8A-8C; etc.) are consistent with the amounts taught by Mercado et al for the recited strains (e.g., 5.0 X109 to 5 X 1010 CFU). One of skill in the art would also recognize that the amounts of each strain in the compositions of Mercado et al (e.g., CFU) are a result effective variable that can be optimized. Therefore, each limitation of base claim 5 is obvious over the combined teachings of Mercado et al and Roughead et al.
Conclusion(s):
No claim(s) is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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