Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 June 2026 has been entered.
Applicant’s amendment dated 26 June 2026, in which claims 1-2, 11, 12, 17, 18 have been amended, is acknowledged.
Claims 1-8, 11-13, 15-20 are pending in the instant application.
Claims 1-8, 11-13, 15-20 are examined on their merits herein.
Information Disclosure Statement
The information disclosure statement submitted on 24 April 2026 is acknowledged and considered.
Response to arguments of 26 June 2026
In view of Applicant’s amendment of 26 June 2026, the objections to claims 2, 17, 18 are herein withdrawn. The language of the claims has been clarified.
On 26 June 2026, Applicant has amended independent claim 1 to be drawn to
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Applicant argues (Remarks of 26 June 2026, pages 5-6) that none of the references used in the rejections of the claims, alone or in combination, teach or suggest administering 3-hydroxybutyric acid to a subject having impaired microbiota that has less than 80% Actinobacteriaceae based on the total bacteria in the microbiota.
In response, modified rejections are made below, based on Applicant’s amendment of 26 June 2026.
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 1-8, 11-13, 15-20 are rejected under 35 U.S.C. 103 as obvious over Bradley et al. (US 2020/0030266, published 30 January 2020, cited in PTO-892 of 5 November 2025), in view of Korpela et al. (Current Opinion in Microbiology 2018, 44, 70-78, cited in PTO-892 of 5 November 2025), in further view of Chernikova et al. (Pediatric Research 2018, 84, 71-79, cited in PTO-892 of 5 November 2025).
Bradley teaches a pharmaceutical composition comprising 3-hydroxybutyric acid (3-HB) [0086] formulated to deliver 3-HB to the GI tract by oral administration [0083]. Thus, Bradley teaches administration to a subject (human [0148]) in need thereof of a composition comprising 3-hydroxybutyric acid (3-HB), which is the very compound in instant claim 1.
Bradley teaches [0161] that the compositions of the invention can be used for preventing or treating dysbiosis (impaired microbiota), such as dysbiosis from the administration of antibiotics [0161].
Thus, Bradley teaches a method of treating dysbiosis by administering to a subject having an impaired microbiota/dysbiosis, as in instant claims, a therapeutically effective amount of 3-hydroxybutyric acid.
Bradley teaches [0141] that the therapeutically effective amount of 3-HB for oral administration may be, for example, 10 mg, or 50 mg; a single unit dose may contain, for example, about 50 mg, which is within the range in instant claim 15, and a total daily dose may be, for example, 30 mg, or 240 mg, or 300 mg [0143], which is within the range in instant claim 16. The dose can be administered as part of a meal or liquid, for example water or fruit juice [0144].
Bradley teaches that the pharmaceutical compositions comprising 3-HB of the invention contain up to 99% of the active agent [0075]; the pharmaceutical compositions can be solid, as a powder or tablet [0075], or liquid [0077].
While Bradley does not specifically teach a method for improving gastrointestinal barrier in a subject/human upon administering a composition comprising 3-hydroxybutyric acid, as in instant claims, by improving barrier protection, as in instant claims 4-6, and prevention of barrier leakiness, as in instant claims 7-8, the ability to improve GI barrier protection and prevent barrier leakiness is an inherent property of 3-hydroxybutyric acid. In this case, prior art by Bradley teaches the very composition taught in the instant application, containing the very same 3-hydroxybutyric acid, administered to the same patient population, subjects with dysbiosis/impaired microbiota. Administration of a composition comprising 3-hydroxybutyric acid to the same patient population, namely subjects with dysbiosis/impaired microbiota, will inherently have the same effect on the GI barrier of the subjects.
Bradley does not teach administering 3-HB to treat dysbiosis/impaired bacteria in children under the age of 12 months, as in instant claim 2, or in children 3 years old, as in instant claim 3, or in premature infants, as in instant claim 13.
Bradley does not teach that the impaired microbiota in the subjects with dysbiosis to be treated has less than 80% of Actinobacteriaceae based on the total bacteria in the microbiota, as in instant claim 1, and less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota, as in instant claims 11-12.
Bradley does not teach that 3-hydroxybutyric acid is present in an amount of 0.01 mg/L to 10 g/L in the composition, as in instant claim 1, nor does he teach that 3-HB is part of an infant formula or growing-up milk, as in instant claims 17-18, or a human milk fortifier, as in instant claims 19, 20.
Korpela (Current Opinion in Microbiology 2018, 44, 70-78) teaches (page 74, right column, last paragraph) that a very common disturbance to infant microbiota is antibiotic use (Figure 3). Antibiotics given in early life usually deplete especially the bifidobacterial community (Figure 3c).
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Korpela teaches (Figure 3c) that infants and children (age 0.25 months to 48 months, who are subjects in instant claims 2, 3) who are administered antibiotics have an impaired microbiota that has less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota, as in instant claims 11-12.
Korpela teaches that differences in colonization ability between bacterial taxa (Figures 1, 2) are likely attributable to the early life milk-based diet, including human milk oligosaccharides, which determines which bacteria are able to grow in the infant gut (page 74, left column, third paragraph).
Korpela teaches (page 75, left column, last paragraph) that knowledge on the development of infant microbiota provides opportunities to normalize the impact of disturbances.
Korpela teaches (page 70, right column, second paragraph, also Figure 1) the relative abundance of the five most abundant bacterial classes from early life (0 to 24 months, Figure 1) microbiota studies, namely Bacilii, Proteobacteria, Bifidobacteria, Bacteroidia, Clostridia, each present at less than 80% relative abundance based on the total bacteria in the microbiota (Figure 1, also Supplementary Table 1). Of the 5 most abundant bacterial classes, Bifidobacterium is the only genus that is included in the Actinobacteria phylum (the others are unrelated). Thus, Korpela teaches that Actinobacteriaceae represented by Bifidobacterium is present at less than 80% based on the total bacteria in the microbiota in said children, which satisfies the limitation in instant claim 1.
Chernikova et al. (Pediatric Research 2018, 84, 71-79) teach that the premature infant gut microbiome during the first 6 weeks of life differs based on gestational maturity at birth. Chernikova teaches (Figure 1a) that premature infants (Table 2, those extremely preterm, or very preterm are also administered antibiotics), who are subjects in instant claim 13, have impaired microbiota.
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Of the 10 most abundant bacterial classes in Figure 1a above, Bifidobacterium is the only genus that is included in the Actinobacteria phylum (the others are unrelated). Thus, Chernikova (Figure 1a) teaches that Actinobacteriaceae represented by Bifidobacterium is present at 3% based on the total bacteria in the microbiota in premature infants, and at 15% based on the total bacteria in the microbiota in term infants, which satisfies the limitation in instant claim 1.
It would have been obvious for a person of ordinary skill in the art to combine the teachings of Bradley, Korpela and Chernikova to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to administer 3-hydroxybutyric acid to an infant or child (age 0.25 months to 48 months, who are subjects in instant claims 2, 3) who is administered antibiotics, or to a preterm infant (including an extremely preterm, or very preterm infant who is are also administered antibiotics), because
Bradley teaches that 3-HB is effective to treat dysbiosis/impaired microbiota in human subjects with impaired microbiota, such as dysbiosis from the administration of antibiotics;
Korpela teaches that infants or children (age 0.25 months to 48 months) who are administered antibiotics have an impaired microbiota that has less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota; and
Chernikova teaches that premature infants, including preterm infants who are administered antibiotics, have impaired microbiota.
Thus, the person of ordinary skill in the art would have administered 3-hydroxybutyric acid to an infant or child age 0.25 months to 48 months who is administered antibiotics and has an impaired microbiota that has less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota, with the expectation that 3-HB is effective to treat dysbiosis/impaired microbiota in said infant or child.
Regarding claim 13, the person of ordinary skill in the art would have administered 3-hydroxybutyric acid to a preterm infant, including an extremely preterm, or very preterm infant who is also administered antibiotics, and has an impaired microbiota, with the expectation that 3-HB is effective to treat dysbiosis/impaired microbiota in said preterm infant.
Further, the person of ordinary skill in the art would have been motivated to provide a dry dose of 3-hydroxybutyric acid for mixing or combining with a meal, snack or liquid, and optimize the amount of meal/snack/liquid added to arrive at the claimed concentration of 3-hydroxybutyric acid in the composition, because Bradley teaches that the therapeutically effective dose of 3-hydroxybutyric acid can be administered as part of a meal or snack or liquid. Such optimization of the amount of carrier/meal/snack/liquid added to the active ingredient in order to obtain a composition is routine, well within the skill of the artisan.
Further, regarding claims 15-16, the person of ordinary skill in the art would have determined the therapeutically effective amount of 3-hydroxybutyric acid in the method of Bradley, because Bradley teaches that the therapeutically effective amount of 3-HB for oral administration may be, for example, 10 mg, or 50 mg; a single unit dose may contain, for example, about 50 mg, which is within the range in instant claim 15, and a total daily dose may be, for example, 30 mg, or 240 mg, or 300 mg [0143], which is within the range in instant claim 16.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) "[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). MPEP 2144.05.
It is well within the skill of the art to determine the effective amount within a range through routine experimentation. It is noted that "[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.)
Regarding claims 17-20, the person of ordinary skill in the art would have administered the therapeutically effective amount of 3-hydroxybutyric acid combined with milk, as an infant formula or growing-up milk, or in a starter infant formula, or as a human milk fortifier for premature babies, because infants, preterm infants and children are fed milk/formula, and further because Bradley teaches that the therapeutically effective dose of 3-hydroxybutyric acid can be administered as part of a meal or snack or liquid, and the subject is provided with a dry dose of 3-hydroxybutyric acid for mixing or combining with the meal, snack or liquid.
As such, claims 1-8, 11-13, 15-20 are rejected as prima facie obvious.
Claims 1-8, 11-13, 15-20 are rejected under 35 U.S.C. 103 as obvious over Bradley et al. (US 2020/0030266, published 30 January 2020, cited in PTO-892 of 5 November 2025), in view of Santschi et al. (J. Dairy Sci. 2016, 99, 9263-9270, cited in IDS) and Martinez et al. (AJDC 1985, 139, 1010-1018, cited in PTO-892 of 5 November 2025), in further view of Korpela et al. (Current Opinion in Microbiology 2018, 44, 70-78, cited in PTO-892 of 5 November 2025), and Chernikova et al. (Pediatric Research 2018, 84, 71-79, cited in PTO-892 of 5 November 2025).
Bradley teaches a pharmaceutical composition comprising 3-hydroxybutyric acid (3-HB) [0086] formulated to deliver 3-HB to the GI tract by oral administration [0083]. Thus, Bradley teaches administration to a subject (human [0148]) in need thereof of a composition comprising 3-hydroxybutyric acid (3-HB), which is the very compound in instant claim 1.
Bradley teaches [0161] that the compositions of the invention can be used for preventing or treating dysbiosis (impaired microbiota), such as dysbiosis from the administration of antibiotics [0161].
Thus, Bradley teaches a method of treating dysbiosis by administering to a subject having an impaired microbiota/dysbiosis, as in instant claims, a therapeutically effective amount of 3-hydroxybutyric acid.
Bradley teaches [0141] that the therapeutically effective amount of 3-HB for oral administration may be, for example, 10 mg, or 50 mg; a single unit dose may contain, for example, about 50 mg, which is within the range in instant claim 15, and a total daily dose may be, for example, 30 mg, or 240 mg, or 300 mg [0143], which is within the range in instant claim 16. The dose can be administered as part of a meal or liquid, for example water or fruit juice [0144].
Bradley teaches that the pharmaceutical compositions comprising 3-HB of the invention contain up to 99% of the active agent [0075]; the pharmaceutical compositions can be solid, as a powder or tablet [0075], or liquid [0077].
While Bradley does not specifically teach a method for improving gastrointestinal barrier in a subject/human upon administering a composition comprising 3-hydroxybutyric acid, as in instant claims, by improving barrier protection, as in instant claims 4-6, and prevention of barrier leakiness, as in instant claims 7-8, the ability to improve GI barrier protection and prevent barrier leakiness is an inherent property of 3-hydroxybutyric acid. In this case, prior art by Bradley teaches the very composition taught in the instant application, containing the very same 3-hydroxybutyric acid, administered to the same patient population, subjects with dysbiosis/impaired microbiota. Administration of a composition comprising 3-hydroxybutyric acid to the same patient population, namely subjects with dysbiosis/impaired microbiota, will inherently have the same effect on the GI barrier of the subjects.
Bradley does not teach administering 3-HB to treat dysbiosis/impaired bacteria in children under the age of 12 months, as in instant claim 2, or in children 3 years old, as in instant claim 3, or in premature infants, as in instant claim 13.
Bradley does not teach that the impaired microbiota in the subjects with dysbiosis to be treated has less than 80% of Actinobacteriaceae based on the total bacteria in the microbiota, as in instant claim 1, and less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota, as in instant claims 11-12.
Bradley does not teach that 3-hydroxybutyric acid is present in an amount of 0.01 mg/L to 10 g/L in the composition, as in instant claim 1, nor does he teach that 3-HB is part of an infant formula or growing-up milk, as in instant claims 17-18, or a human milk fortifier, as in instant claims 19, 20.
Santschi teaches (abstract) that milk from Holstein cows contains ≥ 0.20 mmol/L beta-hydroxybutyrate (BHB).
0.20 mmol/L BHB corresponds to (0.20 mmol x 104.1 mg/mmol)/L = 20.8 mg/L BHB, which is within the range in instant claim 1.
Thus, Santschi teaches administering a nutritional composition which is cow’s milk, which contains beta-hydroxybutyrate, to human subjects. It is well known that children, including 3 to 8-year old children, as in instant claim 3, consume cow’s milk.
Martinez et al. (AJDC 1985, 139, 1010-1018) teaches feeding cow’s milk to children under the age of 12 months (6.5-8.4-month old, or 8.5-10.4-month old, Table 6), or to young children between 1 year and less than 3 years (12/5-13.4-month old children, Table 6), which is the population in instant claim 2. The cow’s milk used to feed children is a growing-up milk, as in instant claims 17, 18.
Korpela (Current Opinion in Microbiology 2018, 44, 70-78) teaches (page 74, right column, last paragraph) that a very common disturbance to infant microbiota is antibiotic use (Figure 3). Antibiotics given in early life usually deplete especially the bifidobacterial community (Figure 3c).
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Korpela teaches (Figure 3c) that infants and children (age 0.25 months to 48 months, who are subjects in instant claims 2, 3) who are administered antibiotics have an impaired microbiota that has less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota, as in instant claims 11-12.
Korpela teaches that differences in colonization ability between bacterial taxa (Figures 1, 2) are likely attributable to the early life milk-based diet, including human milk oligosaccharides, which determines which bacteria are able to grow in the infant gut (page 74, left column, third paragraph).
Korpela teaches (page 75, left column, last paragraph) that knowledge on the development of infant microbiota provides opportunities to normalize the impact of disturbances.
Korpela teaches (page 70, right column, second paragraph, also Figure 1) the relative abundance of the five most abundant bacterial classes from early life (0 to 24 months, Figure 1) microbiota studies, namely Bacilii, Proteobacteria, Bifidobacteria, Bacteroidia, Clostridia, each present at less than 80% relative abundance based on the total bacteria in the microbiota (Figure 1, also Supplementary Table 1). Of the 5 most abundant bacterial classes, Bifidobacterium is the only genus that is included in the Actinobacteria phylum (the others are unrelated). Thus, Korpela teaches that Actinobacteriaceae represented by Bifidobacterium is present at less than 80% based on the total bacteria in the microbiota in said children, which satisfies the limitation in instant claim 1.
Chernikova et al. (Pediatric Research 2018, 84, 71-79) teach that the premature infant gut microbiome during the first 6 weeks of life differs based on gestational maturity at birth. Chernikova teaches (Figure 1a) that premature infants (Table 2, those extremely preterm, or very preterm are also administered antibiotics), who are subjects in instant claim 13, have impaired microbiota.
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Of the 10 most abundant bacterial classes in Figure 1a above, Bifidobacterium is the only genus that is included in the Actinobacteria phylum (the others are unrelated). Thus, Chernikova teaches that Actinobacteriaceae represented by Bifidobacterium is present at 3% based on the total bacteria in the microbiota in premature infants, and at 15% based on the total bacteria in the microbiota in term infants, which satisfies the limitation in instant claim 1.
It would have been obvious for a person of ordinary skill in the art to combine the teachings of Bradley, Korpela and Chernikova to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to administer 3-hydroxybutyric acid to an infant or child (age 0.25 months to 48 months, who are subjects in instant claims 2, 3) who is administered antibiotics, or to a preterm infant (including an extremely preterm, or very preterm infant who is are also administered antibiotics), because
Bradley teaches that 3-HB is effective to treat dysbiosis/impaired microbiota in human subjects with impaired microbiota, such as dysbiosis from the administration of antibiotics;
Korpela teaches that infants or children (age 0.25 months to 48 months) who are administered antibiotics have an impaired microbiota that has less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota; and
Chernikova teaches that premature infants, including preterm infants who are administered antibiotics, have impaired microbiota.
Thus, the person of ordinary skill in the art would have administered 3-hydroxybutyric acid to an infant or child age 0.25 months to 48 months who is administered antibiotics and has an impaired microbiota that has less than 20% Bifidobacterium bifidum relative to the total bacteria in the microbiota, with the expectation that 3-HB is effective to treat dysbiosis/impaired microbiota in said infant or child.
Regarding claim 13, the person of ordinary skill in the art would have administered 3-hydroxybutyric acid to a preterm infant, including an extremely preterm, or very preterm infant who is also administered antibiotics, and has an impaired microbiota, with the expectation that 3-HB is effective to treat dysbiosis/impaired microbiota in said preterm infant.
Further, the person of ordinary skill in the art would have been motivated to provide 3-hydroxybutyric acid as a composition which is milk from Holstein cows (Santschi) that contains ≥ 0.20 mmol/L beta-hydroxybutyrate (BHB) (20.8 mg/L BHB), and would have administered said cow milk to children having impaired microbiota, including 3 to 8-year old children, as in instant claim 3, or to children under the age of 12 months, or to young children between 1 year and less than 3 years, as in instant claim 2, because Martinez teaches feeding cow’s milk to children under the age of 12 months, or to young children between 1 year and less than 3 years, which is the population in instant claim 2, where said cow’s milk used to feed children is a growing-up milk, as in instant claims 17, 18.
Alternatively, the person of ordinary skill in the art would have been motivated to provide 3-hydroxybutyric acid as dry dose for mixing or combining with a meal or liquid such as milk, and optimize the amount of meal /liquid added to arrive at the concentration of 3-hydroxybutyric acid in the milk taught by Santschi, because Bradley teaches that the therapeutically effective dose of 3-hydroxybutyric acid can be administered as part of a meal or liquid. A person of ordinary skill in the art would have prepared a composition such as milk, or formula, or growing-up milk, of human milk fortifier containing 3-hydroxybutyric acid at the concentration present in cows’ milk (Santschi), and would have used the resulting composition/milk in the method of Bradley with the expectation of achieving therapeutic effect against impaired microbiota.
Further, regarding claims 15-16, the person of ordinary skill in the art would have determined the therapeutically effective amount of 3-hydroxybutyric acid in the method of Bradley, because Bradley teaches that the therapeutically effective amount of 3-HB for oral administration may be, for example, 10 mg, or 50 mg; a single unit dose may contain, for example, about 50 mg, which is within the range in instant claim 15, and a total daily dose may be, for example, 30 mg, or 240 mg, or 300 mg, which is within the range in instant claim 16.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) "[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). MPEP 2144.05.
It is well within the skill of the art to determine the effective amount within a range through routine experimentation. It is noted that "[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.)
Regarding claims 17-20, the person of ordinary skill in the art would have administered the therapeutically effective amount of 3-hydroxybutyric acid as cow milk, combined with milk, as an infant formula or growing-up milk, or in a starter infant formula, or as a human milk fortifier for premature babies, because infants, preterm infants and children are fed milk/formula, and further because Bradley teaches that the therapeutically effective dose of 3-hydroxybutyric acid can be administered as part of a meal or snack or liquid, and the subject is provided with a dry dose of 3-hydroxybutyric acid for mixing or combining with the meal, snack or liquid.
As such, claims 1-8, 11-13, 15-20 are rejected as prima facie obvious.
Conclusion
Claims 1-8, 11-13, 15-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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