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 .
Priority
This application claims benefit of priority to Republic of India Application No. IN20221061309 filed 10/27/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The Drawings filed 05/25/2023 are accepted by the Examiner.
Information Disclosure Statement
The Information Disclosure Statement filed 03/27/2024 has been acknowledged and considered.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-17, in the reply filed on 02/25/2026 is acknowledged. Applicant further elected whey protein as the specific protein or protein derivative, a probiotic blend comprising Bacillus coagulans, Bacillus clausii, Bacillus subtilis, Lactobacillus plantarum and Lactobacillus acidophilus, and protease as the specific type of enzyme. The traversal is on the ground(s) that examination without election would not present an undue search burden as all of the claims are sufficiently related. This is not found persuasive because, as stated in the Restriction Requirement mailed 10/03/2025, the inventions have acquired a separate status in the art in view of their different classification and the inventions require a different field of search.
The requirement is still deemed proper and is therefore made FINAL.
Amendments and Claim Status
In the reply filed 02/25/2026, Applicant amended claims 1, 7-8 and 10-17 and canceled claims 3, 5-6 and 9. Claims 18-19 are not encompassed by the elected group and are therefore withdrawn.
Claims 1-2, 4, 7-8 and 10-19 are currently pending.
Claims 18-19 are withdrawn as they are not encompassed by Applicant’s election.
Claims 1-2, 4, 7-8 and 10-17 are under examination.
Objections - Specification
The disclosure is objected to because of the following informalities: The Specification recites multiple bacterial species without the proper capitalization and without being italicized. Some examples include Paragraphs [0018] and [0055]. Appropriate correction is required.
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 4 and 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.
Claim 4 recites “wherein the gut microbiota has more diverse strains and an increase in the amount of beneficial bacteria” in lines 1-2 of the claim. The claim is overall unclear. It is unclear if the claim is attempting to limit the population, being a population with more beneficial bacteria, if the claim is reciting the outcome of protein indigestion or if the claim is reciting the outcome of taking the composition. Thus, the claim is overall unclear and indefinite. For the purposes of compact prosecution, the claim is being interpreted as meaning the outcome of taking the composition is an increase in the amount of beneficial bacteria.
Claim 17 recites “a combination of the probiotic blend and the protease are consumed at a dose of 0.01 to 10% of the weight of the protein” in lines 1-3 of the claim. It is unclear how the weight of the probiotic blend can be added to the weight of the protease and subsequently be compared to the amount of protein considering the amount of probiotic is measured in CFUs, or colony forming units. CFUs are a measurement of how many bacteria are present, not the weight of the bacteria. Thus, it is unclear how one of ordinary skill in the art would determine if the combination of the probiotic blend and the protease are consumed at a dose of 0.01 – 10% of the protein when the bacteria making up the probiotic blend and the protein are measured in completely different type of measurement.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 7-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Deaton et al. (US 20190125811 A1, 05/02/2019).
Regarding claim 1, Deaton et al. disclose probiotics enhance the function of the intestinal barrier and thereby serve as a preventative agent that defends against the adverse effects of pathogens and promotes positive effects on digestion and immune health (Paragraph [0015]). In this regard, Deaton et al. disclose a method of administration of probiotic supplements, being a Bacillus subtilis containing composition, for improving body composition in a human subject (Paragraph [0022]), or a combination of B. subtilis and metabolites of B. subtilis (Paragraph [0101]). As a component of the human microbiome, Bacillus subtilis has the ability to promote gastrointestinal health, including helping its host in digestion, making it an ideal probiotic (Paragraph [0067]). The probiotic supplement can contain additional components, such as whey protein (Paragraph [0022]). Additionally, compositions administered according to the methods of the invention may further include or be administered with other probiotics (Paragraph [0103]). Useful bacterial strains for probiotic compositions include Lactobacillus plantarum, Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bacillus coagulans, Bacillus subtilis and the like (Paragraph [0059]). Additionally, one of the most commonly used strains of probiotics includes Bacillus clausii (Paragraph [0074]). In a specific study disclosed by Deaton et al., the median duration of diarrhea was significantly shorter and the frequency was lower only in those who received mixes of four bacterial strains (Paragraph [0074]). Deaton et al. further disclose B. subtilis is the main component in the alkaline fermentation of soybeans without salt. Protease and amylase produced by the bacteria decompose protein and insoluble sugar in the raw soybeans, thus increasing the nutritional value (Paragraph [0062]). Deaton et al. saw increased protein absorption when a probiotic was taken and postulated the increased protein absorption contributed to improvements in body composition via increased dietary protein induced thermogenesis and altered satiety signaling (Paragraph [0892]). Deaton et al. further state amino acid uptake was increased with the probiotic which may have been what allowed for more efficient protein digestion (Paragraph [0892]).
Regarding the limitations of the preamble, since the method steps of administering whey protein, protease and a probiotic blend are taught by the prior art, the effects recited in the preamble would be inherent since the preamble does not set forth any specific population.
Deaton et al. do not disclose all of the probiotic strains within one embodiment nor do Deaton et al. disclose administering a protease in addition to the whey protein and probiotic.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included additional probiotics, including B. coagulans, B. clausii, L. acidophilus and L. plantarum, in the probiotic supplement of Deaton et al., which already contains B. subtilis, because Deaton et al. specifically state their method can include additional probiotics and all of the just recited bacterial strains are known and effective probiotics as taught by Deaton et al. Additionally, it would have been obvious to include additional probiotics in the supplement of Deaton et al. because it was known to combine multiple bacterial strains and that a combination of multiple strains provided an effect that individual strains did not as taught by Deaton et al. Thus, it would be obvious to create a probiotic blend comprising B. subtilis, B. coagulans, B. clausii, L. acidophilus and L. plantarum because all are known and commonly used strains of probiotics as taught by Deaton et al. motivated by the desire to create an effective probiotic composition.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a protease in the method of Deaton et al. because Deaton et al. specifically state their method can include a combination of B. subtilis and metabolites of B. subtilis, and protease are metabolites of B. subtilis. known to decompose protein and insoluble sugar, thereby increasing nutritional value, as taught by Deaton et al. and the method of Deaton et al. is directed to promoting positive effects on digestion and improving body composition.
Regarding claim 2, Deaton et al. disclose on training days, supplementation occurred immediately post-workout with a protein and carbohydrate recovery drink (Paragraph [0878]). Consuming a protein recovery drink as a supplement reads on excess protein intake as the protein drink is introducing additional protein.
Regarding claim 4, see 112b above. Deaton et al. disclose the participants consumed the probiotic daily (Paragraph [0878]). Thus, the gut microbiota would have an increase in the amount of beneficial bacteria as the probiotic bacteria, reading on beneficial bacteria, are introduced into the gut microbiota.
Regarding claim 7, Deaton et al. disclose participants consumed the probiotic supplement in conjunction with a recovery drink immediately following training (Paragraph [0841]), reading on the probiotic and the protein being consumed in the same day. Deaton et al. further state the probiotic should be taken with meals if the probiotic is being used to help with digestion (Paragraph [0090]).
As discussed above, Deaton et al. do not disclose administering a protease nor do Deaton et al. disclose taking the protease simultaneously or serially.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a protease in the method of Deaton et al. because Deaton et al. specifically state their method can include a combination of B. subtilis and metabolites of B. subtilis, and protease are metabolites of B. subtilis that are known to decompose protein and insoluble sugar, thereby increasing nutritional value, as taught by Deaton et al.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the protease at the same time the protein and probiotic are administered because the protease break down protein as taught by Deaton et al. Thus, it would have been obvious to administer the protease and protein simultaneously, just as the protein and probiotic were administered simultaneously, so the protease would begin breaking down the protein as soon as it was consumed.
Regarding claim 8, it is noted the claims are directed to a method of administration, not an assay. Thus, since the prior art teaches administering the composition, the increased bioavailability would be inherent and capable of being measured.
Regarding claims 10-14, as Deaton et al. disclose the claimed method steps, the outcome would be implicit by following the suggestion of the prior art to administer whey protein, protease and probiotics. .
Claims 1-2, 4, 7-8 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Deaton et al. (US 20190125811 A1, 05/02/2019) in view of Gould et al. (US 20180042972 A1, 02/15/2018).
The teachings of Deaton et al. are discussed above.
Regarding claim 15, Deaton et al. disclose administering a composition comprising about 1 x 108 (0.1 billion) to about 1 x 1011 (100 billion) CFU Bacillus subtilis (Paragraph [0024]).
Deaton et al. do not disclose a probiotic blend that includes 0.05 billion to 100 billion CFU of each of B. coagulans, B. clausii, L. acidophilus and L. plantarum.
However, Gould et al. disclose formulations for providing one or more active probiotics to an individual (See entire document, Abstract). Specific microorganisms suitable for use in the compositions of the invention include multiple Lactobacillus species, including L. acidophilus and L. plantarum, and multiple Bacillus species, including B. subtilis and B. coagulans (Paragraph [0028]). In a specific embodiment, Gould et al. disclose a composition comprising both B. subtilis and B. coagulans, reading on a probiotic blend, wherein the B. subtilis is present in an amount of about 1.5 billion to about 2.5 billion CFUs and the B. coagulans is present in an amount of about 0.5 billion to about 1 billion colony forming units. (Paragraph [0012]). In some embodiments, the composition comprises a homogenous mixture of B. coagulans and B. subtilis (Paragraph [0012]).
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize B. coagulans, B. clausii, L. acidophilus and L. plantarum, in the probiotic supplement of Deaton et al. because Deaton et al. specifically state their method can include additional probiotics and all of the just recited bacterial strains are known and effective probiotics as taught by Deaton et al.
It would have been further obvious to one of ordinary skill in the art to include the B. coagulans, B. clausii, L. acidophilus and L. plantarum in the composition of Deaton et al. in a similar amount to the amount of B. subtilis included in the composition, being about 0.1 billion to about 100 billion CFU, motivated by the desire to create a homogenous mixture of the utilized probiotic strains as this was a known and effective means of creating a probiotic blend as taught by Gould et al.
Claims 1-2, 4, 7-8 and 10-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Deaton et al. (US 20190125811 A1, 05/02/2019) in view of Kiarie et al. (WO 2017083196 A1, 05/18/2017).
Regarding claim 16, Deaton et al. do not disclose the protease comprises 1 mg to 5 g in each serving.
However, Kiarie et al. disclose direct-fed microbials (DFM) or probiotics are dietary supplements that inhibit gastrointestinal infection and provide optimally regulated microbial environments in the digestive tract (Page 1, Lines 11-13). Kiarie et al. further disclose the combination of DFMs with one or more enzymes can improve nutrient utilization production performance characteristics (Page 1, Lines 17-19). In an embodiment, Kiarie et al. disclose a feed additive composition consisting essentially of a DFM comprising one or more bacterial strains in combination with at least one protease (Page 2, Lines 2-4). The DFM comprises at least three bacterial strains selected from different bacterial species, two of which are Lactobacillus and Bacillus (Page 2, Lines 6-7). The protease is present in a range of about 1000 PU/kg to about 200,000 PU/kg of feed (Page 15, Lines 1-2).
Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges through routine experimentation. See MPEP 2144.05(II)(A). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal concentrations of the claimed component (i.e., protease) because the claimed component is an art-recognized result-effective variable that would have been routinely and predictably optimized. Although the prior art does not teach the specific amount of protease claimed, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the amount of protease motivated by the desire to create a composition that can improve nutrient utilization as taught by Kiarie et al.
Regarding claim 17, see 112b above. Deaton et al. disclose the probiotic supplement consisted of 5 billion CFU of Bacillus subtilis and the protein supplement contained 20 grams of protein (Paragraph [0878]).
Deaton et al. do not disclose the combination of the probiotic blend and the protease are consumed at a dose of 0.01 to 10% of the weight of the protein.
However, as discussed above, Kiarie et al. disclose direct-fed microbials (DFM) or probiotics are dietary supplements that inhibit gastrointestinal infection and provide optimally regulated microbial environments in the digestive tract. Kiarie et al. further disclose the combination of DFMs with one or more enzymes can improve nutrient utilization production performance characteristics, wherein the enzyme is a protease. The protease is present in a range of about 1000 PU/kg to about 200,000 PU/kg of feed.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized an amount of protease in a range of about 1000 PU/kg to about 200,000 PU/kg of feed in the composition of Deaton et al. because that is a known and effective range utilized in the prior art in a composition comprising probiotic bacterial strains and a protease useful for improving nutrient utilization production performance characteristics as taught by Kiarie et al. 1000 PU/kg equates to 1 PU/g, so 1 PU/g per gram of feed, with the protein being the feed in this instant case, falling within the claimed range of 0.01 to 10% of the weight of the protein. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Conclusion
Claims 1-2, 4, 7-8 and 10-17 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 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, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights