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
Claims 15-22, 24, 26, and 28-29 are pending. Claims 16-19 are withdrawn.
Response to Amendment
Applicant amended claim 15, replaced “0.075 g” with “0.75 g”, deleted the limitation “the nutritional composition improves the immune responsiveness in a synergistic manner compared to the improvement based on individual ingredients”, and added new limitation “improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels”.
The rejection of claims 15, 20-22, 24, 26 and 28-29 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
Claim Objections
Claim 15 is objected to because of the following informalities: the acronyms “IL10” and “CCL20” should be replaced by their full name the first time they appear. Appropriate correction is required.
Maintained rejections
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.
Claims 15, 22, 24, and 28-29 remain rejected under 35 U.S.C. 103 as being unpatentable over Buck (US-20120171165, published 07/05/2012, hereinafter “Buck”, of record in Office Correspondence mailed on 10/18/2024 ) in view of Donovan (US 2019/0099501 A1, published 04/04/2019, of record in Office Correspondence mailed on 02/24/2026).
Regarding claims 15 and 24, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition), which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition further comprises galactooligosaccharides, fructooligosaccharides ([0020]), and tributyrin ([0163]). Applicant discloses tributyrin is a triglyceride with butyric acid (specification page 4 line 40). The limitations “40 mg to 0.5 g 2'fucosyllactose (2'-FL) per 100 ml nutritional composition; (ii) 0.3 to 3.75 wt.% 2'-FL based on dry weight; and/or (iii) 0.06 to 0.75 g 2'-FL per 100 kcal” and “ 0.035 to 0.175 g dietary butyrate per 100 ml; (ii) 0.05 to 0.25 g dietary butyrate per 100 kcal; and/or (iii) 0.25 to 1.3 wt.% dietary butyrate” are understood as equal amounts expressed in different units. Buck does not teach an amount of tributyrin.
However, Donovan teaches mixing 0.2 g of tributyrin with 4 oz of infant formula (i.e., 0.169 g dietary butyrate per 100 ml infant formula) ([0170], Table 6) with falls within the claimed range of 0.035 to 0.175 g per 100 ml. Donovan teaches butyrate improved intestinal health ([0169]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Buck by administering a formula comprising 0.5 mg/ml to about 1 mg/ml of 2’-fucosyllactose and 0.169 g tributyrate as suggested by Donovan. One of ordinary skills in the art would be motivated to do so in order to improve the gastrointestinal tract of the subject as taught by Donovan. Since Buck and Donovan teach a desire to administer a composition of infant formula with health benefits, there is a reasonable expectation of success.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding claim 22, Buck teaches the composition comprises DHA, ARA, and EPA ([0141]).
Regarding claim 28, Buck teaches the composition comprises FOS and GOS which are present in an amount of 2 mg/mL to about 8 mg/mL (i.e., 0.2 to g per 100 ml ([0117]-[0118]).
Regarding claim 29, Buck teaches content of LCPUFAs does not exceed 3% by weight of the total fat content ([0142]). Buck teaches the composition comprises 1.4 wt.% of sum of DHA and ARA ([0182]).
Claims 20 and 26 remain rejected under 35 U.S.C. 103 as being unpatentable over Buck and Donovan as applied to claim 15 above, and further in view of Tzortzis (WO2010023422, of record in Office Correspondence mailed on 10/18/2024).
Regarding claims 20 and 26, Buck and Donovan do not teach the composition comprises beta3’-galactosyllactose.
However, Tzortzis teaches a composition for prevention or treatment of inflammation in humans comprising galactooligosaccharide such as trisaccharide Gal-(β 1-3)-Gal (β1-4)-Glc (claims 5 and 17). Applicant discloses 3’-galactosyllactose is the trisaccharide Gal-(beta 1,3)-Gal-(beta 1,4)-Glc (specification page 5 line 35). Tzortzis teaches the galactooligosaccharide composition is known as Bimuno which comprises 49% w/w of galactooligosaccharide (page 3 lines 29-30 through page 4 line 1) and teaches administering 5g/L of the Bimuno which is a mixture of 8 galactooligosaccharides (5g/L Bimuno comprises 2.45g/L or 245 mg/100ml of galactooligosaccharides) (page 2 last para through page 3 first para., page 11 line 1). One of ordinary skill in the art could envision a concentration of beta3’-GL equals to 30.6 mg per 100 ml of composition (245 mg divided by 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Buck by adding 30.6 mg per 100 ml of beta3’-GL, as suggested by Tzortzis. One of ordinary skill in the art would be motivated to do so since such composition would help prevent or treat inflammation in the human as taught by Tzortzis.
Claim 21 remains rejected under 35 U.S.C. 103 as being unpatentable over Buck and Donovan as applied to claim 15 above, and further in view of Bouritius (WO 2015065194-A1, published 05/2015, of record in Office Correspondence mailed on 08/17/2023).
Regarding claim 21, Buck teaches the composition comprises lactic acid bacteria ([0126]). Buck and Donovan do not teach the nutritional composition is at least partly fermented by lactic acid producing bacteria and comprises 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition, and wherein at least 90 wt.% of the sum of lactic acid and lactate is L-lactic acid and L-lactate.
However, Bouritius teaches a method of reducing the incidence of colic in an infant by administering an infant formula comprising fermented ingredient and non-digestible oligosaccharides (claim 1). Bouritius teaches that the composition comprises non-digestible oligosaccharides such as 2’fucosyllactose (page 11, line 25), fructo-oligosaccharides and galacto-oligosaccharides (claim 5). Bouritius teaches that the infant formula is partly fermented (page 2, line 7) and teaches the composition is fermented by lactic acid bacteria (page 2, line 19, claim 10). Bouritius teaches that the formula comprises 0.25 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the infant or follow on formula, and the sum of L-lactic acid and L-lactate is more than 90 wt.% based on the sum of total lactic acid and lactate (page 10, lines 11-20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Buck by partly fermenting the composition by lactic acid producing bacteria. One of ordinary skill in the art would be motivated to do so in order to improve digestion of the composition and gastrointestinal tolerance in the infant.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15, 20, 22, 24, 26, and 28-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, and 8 of US 12,508,273 in view of Buck and Donovan.
Regarding instant claims 15, 20, 22, 24, 26, and 28-29, patent claims 1-2 and 6 recite a composition and a method for increasing the intestinal barrier function and/or for prevention and/or treatment of intestinal barrier disruption in infants or young children that suffer from food allergy and/or atopic dermatitis comprising administering an infant formula, follow on formula of young child formula to the infants or young children, wherein the infant formula, follow on formula or young child formula comprises: LC-PUPA selected from the group consisting of DHA, EPA and ARA, wherein the sum of DHA, ARA and EPA is at least 1 wt % based on total fatty acids, and ii. at least 0.1 wt% EPA based on total fatty acids and at least 0.5 wt% DHA based on total fatty acids, and at least 0.25 wt % ARA based on total fatty acids, 0.25 to 2.5 g galacto-oligosaccharides per 100 ml of ready to drink formula, wherein the galacto-oligosaccharides comprise Gal (beta 1-3)-Gal (beta 1-4)-Glc in an amount of 10 to 50 mg per 100 ml ready to drink formula; 0.025 to 0.25 g fructo-oligosaccharides per 100 ml. Patent claim 4 recites wherein the infant formula, follow on formula or young child formula comprises 0.07 to 3.75 wt% Gal (beta 1-3)-Gal (beta 1-4)-Glc, based on dry weight of the nutritional composition, and/or wherein the daily dose administered is 0.10 to 6 g Gal (beta 1-3)-Gal (beta 1-4)-Glc. Patent claim 5 wherein the infant formula, follow on formula or young child formula comprises 0.35 to 3.7 g galacto-oligosaccharides per 100 kcal of the formula. Patent claims 1-2 and 4-6 do not recite the composition comprises 2'fucosyllactose and dietary butyrate.
However, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition further comprises galactooligosaccharides, fructooligosaccharides ([0020]), and tributyrin ([0163]). Buck does not teach an amount of tributyrin.
However, Donovan teaches mixing 0.2 g of tributyrin with 4 oz of infant formula (i.e., 0.169 g dietary butyrate per 100 ml infant formula) ([0170], Table 6) with falls within the claimed range of 0.035 to 0.175 g per 100 ml. Donovan teaches butyrate improved intestinal health ([0169]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited patent claims 1-2 and 4-6 by adding 2’fucosyllactose and butyric acid as suggested by Buck and Donovan in order to improve the gastrointestinal tract of the subject as suggested by Buck and Donovan. Since Buck and Donovan teach a desire to administer a composition of infant formula with health benefits, there is a reasonable expectation of success.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Claim 21 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, and 8 of US 12,508,273 in view of Buck, Donovan, and Bouritius.
Regarding claim 21, patent claims 1-2 and 4-6 do not recite the nutritional composition is at least partly fermented by lactic acid producing bacteria and comprises 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition, and wherein at least 90 wt.% of the sum of lactic acid and lactate is L-lactic acid and L-lactate.
However, Bouritius teaches an infant formula comprising fermented ingredient and non-digestible oligosaccharides (claim 1). Bouritius teaches the composition comprises non-digestible oligosaccharides such as 2’fucosyllactose (page 11, line 25). Bouritius teaches the composition comprises non-digestible oligosaccharides such as fructo-oligosaccharides and galacto-oligosaccharides (claim 5). Bouritius teaches the infant formula is partly fermented (page 2, line 7) and teaches the composition is fermented by lactic acid bacteria (page 2, line 19, claim 10). Bouritius teaches the formula comprises 0.25 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the infant or follow on formula, and the sum of L-lactic acid and L-lactate is more than 90 wt.% based on the sum of total lactic acid and lactate (page 10, lines 11-20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition recited in claims 1-2 and 4-6 by partly fermenting the composition by lactic acid producing bacteria as suggested by Bouritius. One of ordinary skill in the art would be motivated to do so in order to improve digestion of the composition and gastrointestinal tolerance in the subject.
Claims 15, 22, 24, and 28-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 8 of US 10,420,784 in view of Buck and Donovan.
Regarding instant claims 15, 22, 24, and 28-29, patent claims 1 and 6 recite a composition and a method of stimulating the immune system comprising administering nutritional composition comprising 2'-fucosyllactose and betagalacto-oligosaccharides. Patent claim 2 recites the composition comprises fructo-oligosaccharide. Patent claim 5 recites the composition having 0.07 to 1 wt. % 2'-fucosyllactose and/or 0.25 wt % to 15 wt % of the sum of betagalacto-oligosaccharides and fructo-oligosaccharide. Patent claim 8 recites the mammal is an infant. Patent claims 1-2, 5-6, and 8 do not recite the composition comprises dietary butyrate.
However, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition further comprises galactooligosaccharides, fructooligosaccharides ([0020]) and tributyrin ([0163]). Buck teaches the composition comprises LC-PUFA such as DHA, ARA, and EPA ([0141]). Buck teaches content of LCPUFAs does not exceed 3% by weight of the total fat content ([0142]). Buck teaches the composition comprises 1.4 wt.% of sum of DHA and ARA ([0182]).
Buck does not teach an amount of tributyrin.
However, Donovan teaches mixing 0.2 g of tributyrin with 4 oz of infant formula (i.e., 0.169 g dietary butyrate per 100 ml infant formula) ([0170], Table 6) with falls within the claimed range of 0.035 to 0.175 g per 100 ml. Donovan teaches butyrate improved intestinal health ([0169]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited patent claims 1-2, 5-6, and 8 by adding tributyrin as suggested by Buck and Donovan in order to improve the gastrointestinal tract of the subject as suggested by Buck and Donovan. Since Buck and Donovan teach a desire to administer a composition of infant formula with health benefits, there is a reasonable expectation of success.
Claim 21 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 8 of US 10,420,784 in view of Buck, Donovan, and Bouritius.
Regarding claim 21, patent claims 1-2, 5-6, and 8 do not recite the nutritional composition is at least partly fermented by lactic acid producing bacteria and comprises 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition, and wherein at least 90 wt.% of the sum of lactic acid and lactate is L-lactic acid and L-lactate.
However, Bouritius teaches an infant formula comprising fermented ingredient and non-digestible oligosaccharides (claim 1). Bouritius teaches the composition comprises non-digestible oligosaccharides such as 2’fucosyllactose (page 11, line 25). Bouritius teaches the composition comprises non-digestible oligosaccharides such as fructo-oligosaccharides and galacto-oligosaccharides (claim 5). Bouritius teaches the infant formula is partly fermented (page 2, line 7) and teaches the composition is fermented by lactic acid bacteria (page 2, line 19, claim 10). Bouritius teaches the formula comprises 0.25 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the infant or follow on formula, and the sum of L-lactic acid and L-lactate is more than 90 wt.% based on the sum of total lactic acid and lactate (page 10, lines 11-20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition recited in claims 1-2, 5-6, and 8 by partly fermenting the composition by lactic acid producing bacteria, as suggested by Bouritius. One of ordinary skill in the art would be motivated to do so in order to improve digestion of the composition and gastrointestinal tolerance in the subject.
Claims 20 and 26 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 8 of US 10,420,784 in view of Buck, Dong (Clinical nutrition 35.2 (2016): 399-407, of record in Office Correspondence mailed on 10/18/2024), and Tzortzis.
Regarding claim 20, patent claims 1-2, 5-6, and 8 do not recite beta3’-GL.
However, Tzortzis teaches a composition for prevention or treatment of inflammation in humans comprising galactooligosaccharide such as trisaccharide Gal-(β 1-3)-Gal (β1-4)-Glc (claims 5 and 17). Applicant discloses 3’-galactosyllactose is the trisaccharide Gal-(beta 1,3)-Gal-(beta 1,4)-Glc (specification page 5 line 35). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition recited in patent claims 1-2, 5-6, and 8 by adding beta 3’galactosyllactose as suggested by Tzortzis. One of ordinary skill in the art would be motivated to do so in order to prevent or treat inflammation in the human as taught by Tzortzis.
Regarding claim 26, Tzortzis teaches the galactooligosaccharide composition is known as Bimuno which comprises 49% w/w of galactooligosaccharide (page 3 lines 29-30 through page 4 line 1) and teaches administering 5g/L of the Bimuno (page 11 line 1) which equals to 0.245 g galactooligosaccharide per 100 ml of composition. Tzortzis teaches Bimuno is a mixture of 8 galactooligosaccharides (page 2 last para through page 3 first para.). Thus, it is understood that the concentration of beta 3’-GL is lower than 0.245 g per 100 ml and more than 0.
Claims 15, 22, 24, and 28-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 11,559,539 in view of Buck and Dong.
Regarding instant claims 15, 22, 24, and 28-29, patent claim 1 recites method of enhancing vaccine specific immune response in a male human infant, comprising administering to the infant: non-digestible human milk oligosaccharide 2'-fucosyllactose, wherein the composition further comprises short chain galactooligosaccharide and long chain fructooligosaccharide. Patent claim 1 does not recite an amount of 2’fucosyllactose and does not recite the composition comprises dietary butyrate.
However, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition can further comprise tributyrin ([0163]). Applicant discloses tributyrin is a triglyceride with butyric acid (specification page 4 line 40). The limitations “40 mg to 0.5 g 2'fucosyllactose (2'-FL) per 100 ml nutritional composition; (ii) 0.3 to 3.75 wt.% based on dry weight; and/or (iii) 0.06 to 0.75 g per 100 kcal” and “ 0.035 to 0.175 g dietary butyrate per 100 ml; (ii) 0.05 to 0.25 g per 100 kcal; and/or (iii) 0.25 to 1.3 wt.%” are understood as equal amounts expressed in different units. Buck teaches the composition comprises LC-PUFA such as DHA, ARA, and EPA ([0141]). Buck teaches the rapidly-fermented oligosaccharides comprising FOS and GOS are present in an amount of 2 mg/mL to about 8 mg/mL (i.e., 0.2 to g per 100 ml ([0117]-[0118]). Buck teaches content of LCPUFAs does not exceed 3% by weight of the total fat content ([0142]). Buck teaches the composition comprises 1.4 wt.% of sum of DHA and ARA ([0182]). Buck do not teach an amount of tributyrin.
However, Dong teaches butyrate has an effect on the immunity and has anti-inflammatory effects (page 400 left column first para.) and teaches supplementing subjects with 0.1% tributyrin (i.e., 0.1 g per 100 ml composition) with falls with the claimed range of 0.035 to 0.175 g per 100 ml (Abstract). Dong teaches subjects supplemented with tributyrin exhibited a better-developed spleen and small intestines, improved intestinal villus morphology, increased intestinal villus surface areas, enhanced digestive enzyme activities, and up-regulated expression of IgG and GPR41 mRNA. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by using 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml and 1% tributyrate as suggested by Buck and Dong. One of ordinary skills in the art would be motivated to do so in order to improve the gastrointestinal tract of the subject as taught by Buck and Dong.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Claims 15, 22, 24, and 28-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, and 7 of US 11,642,359 in view of Buck and Dong.
Regarding instant claim 15, patent claim 1 recites a method for the treatment of rotavirus induced intestinal barrier disruption in an infant or toddler by administering a nutritional composition that comprises 2'-fucosyllactose, wherein the nutritional composition is selected from an infant formula and a follow-on and which is not human milk. Patent claim 4 recites composition comprises non- digestible oligosaccharides selected from the group consisting of fructo-oligosaccharides and galacto-oligosaccharides. Patent claim 1 does not recite an amount of 2’fucosyllactose and does not recite the composition comprises dietary butyrate.
However, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition can further comprise tributyrin ([0163]). Applicant discloses tributyrin is a triglyceride with butyric acid (specification page 4 line 40). The limitations “40 mg to 0.5 g 2'fucosyllactose (2'-FL) per 100 ml nutritional composition; (ii) 0.3 to 3.75 wt.% based on dry weight; and/or (iii) 0.06 to 0.75 g per 100 kcal” and “ 0.035 to 0.175 g dietary butyrate per 100 ml; (ii) 0.05 to 0.25 g per 100 kcal; and/or (iii) 0.25 to 1.3 wt.%” are understood as equal amounts expressed in different units. Buck do not teach an amount of tributyrin. However, Dong teaches butyrate has an effect on the immunity and has anti-inflammatory effects (page 400 left column first para.) and teaches supplementing subjects with 0.1% tributyrin (i.e., 0.1 g per 100 ml composition) with falls with the claimed range of 0.035 to 0.175 g per 100 ml (Abstract). Dong teaches subjects supplemented with tributyrin exhibited a better-developed spleen and small intestines, improved intestinal villus morphology, increased intestinal villus surface areas, enhanced digestive enzyme activities, and up-regulated expression of IgG and GPR41 mRNA. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by using 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml and 1% tributyrate as suggested by Buck and Dong. One of ordinary skills in the art would be motivated to do so in order to improve the gastrointestinal tract of the subject as taught by Buck and Dong.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding instant claim 22, patent claim 5 recites wherein the nutritional composition further comprises at least one long chain polyunsaturated fatty acids (LC-PUPA) selected from the group consisting of eicosapentaenoic acid (EPA, 20:5 n3), docosahexaenoic acid (DHA, 22:6 n3), arachidonic acid (ARA, 20:4 n6) and docosapentaenoic acid (DPA, 22:5 n3).
Regarding instant claim 24, patent claim 7 recites the composition is an infant formula.
Regarding claim 28, Buck teaches the composition comprises FOS and GOS which are present in an amount of 2 mg/mL to about 8 mg/mL (i.e., 0.2 to g per 100 ml ([0117]-[0118]).
Regarding claim 29, Buck teaches content of LCPUFAs does not exceed 3% by weight of the total fat content ([0142]). Buck teaches the composition comprises 1.4 wt.% of sum of DHA and ARA ([0182]).
Claim 21 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, and 7 of US 11,642,359 in view of Buck, Dong, and Bouritius.
Regarding claim 21, patent claims 1, 4-5 and 7 do not recite the nutritional composition is at least partly fermented by lactic acid producing bacteria and comprises 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition, and wherein at least 90 wt.% of the sum of lactic acid and lactate is L-lactic acid and L-lactate.
However, Bouritius teaches an infant formula comprising fermented ingredient and non-digestible oligosaccharides (claim 1). Bouritius teaches that the composition comprises non-digestible oligosaccharides such as 2’fucosyllactose (page 11, line 25), fructo-oligosaccharides, and galacto-oligosaccharides (claim 5). Bouritius teaches that the infant formula is partly fermented (page 2, line 7) and teaches the composition is fermented by lactic acid bacteria (page 2, line 19, claim 10). Bouritius teaches that the formula comprises 0.25 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the infant or follow on formula, and the sum of L-lactic acid and L-lactate is more than 90 wt.% based on the sum of total lactic acid and lactate (page 10, lines 11-20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition recited in patent claims 1, 4-5 and 7 by partly fermenting the composition by lactic acid producing bacteria and to comprise 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition as suggested by Bouritius. One of ordinary skill in the art would be motivated to do so in order to improve digestion of the composition and gastrointestinal tolerance in the subject.
Claims 20 and 26 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, and 7 of US 11,642,359 in view of Buck, Dong, and Tzortzis.
Regarding claim 20, patent claims 1, 4-5, and 7 do not recite beta3’-GL.
However, Tzortzis teaches a composition for prevention or treatment of inflammation in humans comprising galactooligosaccharide such as trisaccharide Gal-(β 1-3)-Gal (β1-4)-Glc (claims 5 and 17). Applicant discloses 3’-galactosyllactose is the trisaccharide Gal-(beta 1,3)-Gal-(beta 1,4)-Glc (specification page 5 line 35). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition recited in patent claims 1, 4-5, and 7 by adding beta 3’galactosyllactose as suggested by Tzortzis. One of ordinary skill in the art would be motivated to do so in order to prevent or treat inflammation in the human as taught by Tzortzis.
Regarding claim 26, Tzortzis teaches the galactooligosaccharide composition is known as Bimuno which comprises 49% w/w of galactooligosaccharide (page 3 lines 29-30 through page 4 line 1) and teaches administering 5g/L of the Bimuno (page 11 line 1) which equals to 0.245 g galactooligosaccharide per 100 ml of composition. Tzortzis teaches Bimuno is a mixture of 8 galactooligosaccharides (page 2 last para through page 3 first para.). Thus, it is understood that the concentration of beta 3’-GL is lower than 0.245 g per 100 ml and more than 0.
Claims 15, 22, 24, and 28-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, and 10 of US 11,090,321 in view of Buck and Dong.
Regarding instant claim 15, patent claim 1 recites a nutritional composition comprising 2'-fucosyllactose and betagalacto-oligosaccharides and fructo-oligosaccharides. Patent claim 10 recites a method of enhancement of a vaccination response in a mammal comprising administering to the mammal a nutritional composition, comprising: (a) 2'-fucosyllactose and betagalacto-oligosaccharides. Patent claim 5 recites the composition is an infant formula. Patent claim 6 recites a method of stimulating the immune system, comprising administering to a mammal in need thereof a nutritional composition, comprising 2'-fucosyllactose. Patent claim 4 recites the composition having 0.07 to 1 wt. % 2'-fucosyllactose. Patent claim 1 does not recite the composition comprises dietary butyrate.
However, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition can further comprise tributyrin ([0163]). Applicant discloses tributyrin is a triglyceride with butyric acid (specification page 4 line 40). The limitations “40 mg to 0.5 g 2'fucosyllactose (2'-FL) per 100 ml nutritional composition; (ii) 0.3 to 3.75 wt.% based on dry weight; and/or (iii) 0.06 to 0.75 g per 100 kcal” and “ 0.035 to 0.175 g dietary butyrate per 100 ml; (ii) 0.05 to 0.25 g per 100 kcal; and/or (iii) 0.25 to 1.3 wt.%” are understood as equal amounts expressed in different units. Buck do not teach an amount of tributyrin.
However, Dong teaches butyrate has an effect on the immunity and has anti-inflammatory effects (page 400 left column first para.) and teaches supplementing subjects with 0.1% tributyrin (i.e., 0.1 g per 100 ml composition) with falls with the claimed range of 0.035 to 0.175 g per 100 ml (Abstract). Dong teaches subjects supplemented with tributyrin exhibited a better-developed spleen and small intestines, improved intestinal villus morphology, increased intestinal villus surface areas, enhanced digestive enzyme activities, and up-regulated expression of IgG and GPR41 mRNA. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claims 1, 4-5, and 10 by using 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml and 1% tributyrate as suggested by Buck and Dong. One of ordinary skills in the art would be motivated to do so in order to improve the gastrointestinal tract of the subject as taught by Buck and Dong.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding claim 22, Buck teaches the composition comprises LC-PUFA such as DHA, ARA, and EPA ([0141]).
Regarding instant claim 24, patent claim 5 recites the composition is an infant formula.
Regarding instant claim 28, patent claim 4 recites the composition having 0.25 wt % to 15 wt % of the sum of betagalacto-oligosaccharides and fructo-oligosaccharides.
Regarding claim 29, Buck teaches content of LCPUFAs does not exceed 3% by weight of the total fat content ([0142]). Buck teaches the composition comprises 1.4 wt.% of sum of DHA and ARA ([0182]).
Claims 20 and 26 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, and 10 of US 11,090,321 in view of Buck, Dong, and Tzortzis.
Regarding claim 20, patent claims 1, 4-6, and 10 do not recite beta3’-GL.
However, Tzortzis teaches a composition for prevention or treatment of inflammation in humans comprising galactooligosaccharide such as trisaccharide Gal-(β 1-3)-Gal (β1-4)-Glc (claims 5 and 17). Applicant discloses 3’-galactosyllactose is the trisaccharide Gal-(beta 1,3)-Gal-(beta 1,4)-Glc (specification page 5 line 35). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition recited in patent claims 1, 4-6, and 10 by adding beta 3’galactosyllactose as suggested by Tzortzis. One of ordinary skill in the art would be motivated to do so in order to prevent or treat inflammation in the human as taught by Tzortzis.
Regarding claim 26, Tzortzis teaches the galactooligosaccharide composition is known as Bimuno which comprises 49% w/w of galactooligosaccharide (page 3 lines 29-30 through page 4 line 1) and teaches administering 5g/L of the Bimuno (page 11 line 1) which equals to 0.245 g galactooligosaccharide per 100 ml of composition. Tzortzis teaches Bimuno is a mixture of 8 galactooligosaccharides (page 2 last para through page 3 first para.). Thus, it is understood that the concentration of beta 3’-GL is lower than 0.245 g per 100 ml and more than 0.
Claim 21 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, and 10 of US 11,090,321 in view of Buck, Dong, and Bouritius.
Regarding claim 21, patent claims 1, 4-6 and 10 do not recite the nutritional composition is at least partly fermented by lactic acid producing bacteria and comprises 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition, and wherein at least 90 wt.% of the sum of lactic acid and lactate is L-lactic acid and L-lactate.
However, Bouritius teaches an infant formula comprising fermented ingredient and non-digestible oligosaccharides (claim 1). Bouritius teaches the composition comprises non-digestible oligosaccharides such as 2’fucosyllactose (page 11, line 25). Bouritius teaches the composition comprises non-digestible oligosaccharides such as fructo-oligosaccharides and galacto-oligosaccharides (claim 5). Bouritius teaches the infant formula is partly fermented (page 2, line 7) and teaches the composition is fermented by lactic acid bacteria (page 2, line 19, claim 10). Bouritius teaches the formula comprises 0.25 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the infant or follow on formula, and the sum of L-lactic acid and L-lactate is more than 90 wt.% based on the sum of total lactic acid and lactate (page 10, lines 11-20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition recited in patent claims 1, 4-6, and 10 by partly fermenting the composition by lactic acid producing bacteria and to comprise 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition as suggested by Bouritius. One of ordinary skill in the art would be motivated to do so in order to improve digestion of the composition and gastrointestinal tolerance in the subject.
Claims 15, 22, 24, and 28-29 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 10 of US 11,135,290 in view of Buck and Dong.
Regarding claim 15, patent claim 1 recites a method for treating viral diarrhea caused by rotavirus, comprising administering to a subject in need thereof a composition comprising 1 mg to 3 g per 100 ml composition of 2' fucosyllactose wherein the composition is not human milk, and wherein the administration stimulates natural killer cell activity and/or natural killer cell proliferation. Patent claim 5 recites the composition comprises betagalacto-oligosaccharides and fructo-oligosaccharides. Patent claim 10 recites wherein the composition comprises 0.07 to 1 wt % fucosyllactose, based on dry weight of the composition. Patent claim 1 does not recite the composition comprises dietary butyrate.
However, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition can further comprise tributyrin ([0163]). Applicant discloses tributyrin is a triglyceride with butyric acid (specification page 4 line 40). The limitations “40 mg to 0.5 g 2'fucosyllactose (2'-FL) per 100 ml nutritional composition; (ii) 0.3 to 3.75 wt.% based on dry weight; and/or (iii) 0.06 to 0.75 g per 100 kcal” and “ 0.035 to 0.175 g dietary butyrate per 100 ml; (ii) 0.05 to 0.25 g per 100 kcal; and/or (iii) 0.25 to 1.3 wt.%” are understood as equal amounts expressed in different units. Buck do not teach an amount of tributyrin. However, Dong teaches butyrate has an effect on the immunity and has anti-inflammatory effects (page 400 left column first para.) and teaches supplementing subjects with 0.1% tributyrin (i.e., 0.1 g per 100 ml composition) with falls with the claimed range of 0.035 to 0.175 g per 100 ml (Abstract). Dong teaches subjects supplemented with tributyrin exhibited a better-developed spleen and small intestines, improved intestinal villus morphology, increased intestinal villus surface areas, enhanced digestive enzyme activities, and up-regulated expression of IgG and GPR41 mRNA.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by using 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml and adding 1% tributyrate as suggested by Buck and Dong. One of ordinary skills in the art would be motivated to do so in order to improve the gastrointestinal tract of the subject as taught by Buck and Dong.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding instant claim 22, patent claim 7 recites wherein the composition additionally comprises long chain poly-unsaturated fatty acids (LC-PUPA).
Regarding instant claim 24, patent claim 2 recites the subject is an infant.
Regarding claim 28, Buck teaches the rapidly-fermented oligosaccharides comprising FOS and GOS are present in an amount of 2 mg/mL to about 8 mg/mL (i.e., 0.2 to g per 100 ml ([0117]-[0118]).
Regarding claim 29, Buck teaches content of LCPUFAs does not exceed 3% by weight of the total fat content ([0142]). Buck teaches the composition comprises 1.4 wt.% of sum of DHA and ARA ([0182]).
Claims 15, 20-22, 24, 26, and 28-29 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 5-6, 9-10, 15 of copending Application No. 17/429645. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Regarding instant claims 15, 20-22, 24, and 26, copending claims 1 and 15 recite a composition and a method for improving the intestinal barrier function the method comprising administering to a subject in need thereof a nutritional composition for infants or young children, which is a formula feeding and which is not human milk, comprising: a. 2'fucosyllactose (2'-FL) in an amount of (i) 0.01 to 1 g per 100 ml nutritional composition; (ii) 0.075 to 7.5 wt.% based on dry weight; and/or (iii) 0.015 to 1.5 g per 100 kcal, and b. beta 3'galactosyllactose (beta3'-GL) in an amount of(i) 0.010 to 0.500 g per 100 ml; (ii) 0.075 to 3.75 wt.% based on dry weight and/or (iii) 0.015 to 0.75 g per 100 kcal. Copending claim 2 recites the composition comprises dietary butyrate. Copending claim 3 recites the composition is at least partly fermented by lactic acid producing bacteria and comprises 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the nutritional composition, and wherein at least 90 wt.% of the sum of lactic acid and lactate is L-lactic acid and L-lactate. Copending claim 4 recites the composition further comprises LC-PUFA selected form the group of DHA, ARA, and EPA comprising at least 1 wt.% of the sum of DHA, ARA and EPA based on total fatty acids. Copending claim 5 recites the formula further comprises galacto-oligosaccharides and/or fructo-oligosaccharides. Copending claim 6 recites the nutritional composition is selected from the group consisting of infant formula, a follow on formula or a young child formula. Copending claim 9 recites the composition comprising (i) 0.3 to 5 wt.% dietary butyrate based on total fatty acids; (ii) 10 mg to 175 mg per 100 ml; (iii) 15 to 250 mg per 100 kcal; and/or (iv) 0.075 to 1.3 wt.% based on dry weight. Copending claim 10 recites the composition comprising (i) 0.2 to 5 g of the sum of galacto-oligosaccharides and fructo-oligosaccharides per 100 ml; (ii) 0.3 to 7.5 g per 100 kcal; and/or (iii) 1.5 to 35 wt.% based on dry weight.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 15, 22, 24, and 28-29 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 9-10 of copending Application No. 18/563390 in view Buck and Dong.
Regarding instant claims 15 and 24, copending claim 1 recites an infant formula suitable for feeding infants who receive both infant formula and human breast milk (mixed milk fed infants), comprising 2'-fucosyllactose (2'-FL). Copending claim 5 recites wherein 2'- FL is present in a concentration in the range of 500 g/ml - 1500 g/ml, preferably in the range of 750 pg/ml - 1250 pg/ml; or in the range of 375 mg/100 g dry weight - 1125 mg/100 g dry weight, preferably in the range of 560 mg/100 g dry weight - 940 mg/100 g dry weight; or in the range of 75 mg/100 kcal - 225 mg/100 kcal, preferably in the range of 110 mg/100 kcal - 190 mg/100 kcal. Copending claims 9 and 10 recite the composition comprises comprising fructo-oligosaccharides and galacto-oligosaccharides. Copending claims 1, 5, and 9-10 do not recite the composition comprises dietary butyrate.
However, Buck teaches a nutritional composition such as synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range of 40 mg to 0.5 g per 100 ml composition ([0006], claim 11). Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck teaches the nutritional composition can further comprise tributyrin ([0163]). Applicant discloses tributyrin is a triglyceride with butyric acid (specification page 4 line 40). The limitations “40 mg to 0.5 g 2'fucosyllactose (2'-FL) per 100 ml nutritional composition; (ii) 0.3 to 3.75 wt.% based on dry weight; and/or (iii) 0.06 to 0.75 g per 100 kcal” and “ 0.035 to 0.175 g dietary butyrate per 100 ml; (ii) 0.05 to 0.25 g per 100 kcal; and/or (iii) 0.25 to 1.3 wt.%” are understood as equal amounts expressed in different units. Buck do not teach an amount of tributyrin.
However, Dong teaches butyrate has an effect on the immunity and has anti-inflammatory effects (page 400 left column first para.) and teaches supplementing subjects with 0.1% tributyrin (i.e., 0.1 g per 100 ml composition) with falls with the claimed range of 0.035 to 0.175 g per 100 ml (Abstract). Dong teaches subjects supplemented with tributyrin exhibited a better-developed spleen and small intestines, improved intestinal villus morphology, increased intestinal villus surface areas, enhanced digestive enzyme activities, and up-regulated expression of IgG and GPR41 mRNA.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in copending claims 1, 5, and 9-1022 by using 2’-fucosyllactose present at a concentration of from about 0.5 mg/ml to about 1 mg/ml and adding 1% tributyrate as suggested by Buck and Dong. One of ordinary skills in the art would be motivated to do so in order to improve the gastrointestinal tract of the subject as taught by Buck and Dong.
The limitation “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels” does not require steps to be performed. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Regarding claim 22, Buck teaches the composition comprises LC-PUFA such as DHA, ARA, and EPA ([0141]).
Regarding claim 28, Buck teaches the rapidly-fermented oligosaccharides comprising FOS and GOS are present in an amount of 2 mg/mL to about 8 mg/mL (i.e., 0.2 to g per 100 ml ([0117]-[0118]).
Regarding claim 29, Buck teaches content of LCPUFAs does not exceed 3% by weight of the total fat content ([0142]). Buck teaches the composition comprises 1.4 wt.% of sum of DHA and ARA ([0182]).
Response to Arguments
Applicant's arguments filed 05/22/2026 have been fully considered but they are not persuasive.
Applicant argues that the claimed composition has beneficial effects on immune responsiveness and release of the cytokines IL10 and CCL20 in human peripheral blood mononuclear cells (PBMCs) as disclosed in Example 5 and Tables 6 and 7. Applicant argues a synergistic effect and an unexpected improved modulation in responsiveness of the human PBMCs in the presence of a combination of 2'-FL and butyrate. Applicant argues Buck is silent on improvement of immune responsiveness wherein the improvement in immune responsiveness is characterized by increasing IL10 and CCL20, and argues that Buck’s improved immunity is through stimulation of GI maturation.
In response to the argument, an infant formula comprising 2’-FL and dietary butyrate is not novel in view of prior art Buck. Buck teaches a synthetic infant formula or synthetic child formula comprising 2’-fucosyllactose, galactooligosaccharides, fructooligosaccharides ([0020]) and tributyrin (i.e., triglyceride with butyric acid, dietary butyrate) ([0163]. Buck teaches the concentration of 2’-fucosyllactose as 0.5 mg/ml to about 1 mg/ml (i.e., 50 mg to 0.1 g per 100 ml composition) which falls with the claimed range. Buck teaches the composition is for improving immunity, and for improved growth and maturation of an individual's immune system and teaches HMOs such as 2'-fucosyllactose improve immune system ([0006], [0017], [0175]). Buck is silent on a concentration of dietary butyrate. Prior art Donovan teaches the claimed concentration of dietary butyrate. Donovan teaches adding tributyrin to infant formula in a concentration of 0.169 g dietary butyrate per 100 ml infant formula) ([0170], Table 6), and teaches butyrate improved intestinal health ([0169]). In view of the prior art, the claimed composition and the method of administering this composition to a subject are not novel. Regarding the newly added limitation of “wherein improving the immune responsiveness is characterized by increasing IL10 and CCL20 levels”, Applicant discloses that 0.2% w/v 2'-FL (i.e., 0.2 g/100ml 2'-FL) and 0.2 mM butyrate (i.e., 0.0017 g/100 ml butyrate) are individually capable of increasing IL10 and CCL20 levels compared to blanc (See pages 26-27 Tables 6 and 7). In response to applicant's argument regarding the synergistic effect of 2'-FL and butyrate, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that the claimed composition cannot be seen as an inherent feature of the composition disclosed in Buck as not all elements of the composition are disclosed in Buck.
In response to the argument, the reasoning of an inherent feature was not relied upon in the rejections nor in the Response to Arguments. The statement “the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious” found in the Response to Arguments mailed on 02/24/2026 does not state that the effect is an inherent feature.
Applicant argues that Donovan does not teach or suggest using a combination of tributyrin and 2'-FL, argues that the examiner relies on an improper combination of Buck with Donovan which is based on hindsight, and that there is lack of suggestion or motivation for combining the two ingredients into one single composition.
In response to the argument, the combination of tributyrin and 2'-FL is taught in Buck. The prior art Buck teaches an infant formula comprising tributyrin and 2'-FL. Donovan is relied upon for teaching a concentration of tributyrin which is administered in infant formula. One of ordinary skill in the art would be motivate to modify the teaching of Buck by using the concentration of dietary butyrate taught by Donovan. One of ordinary skill in the art would be motivated to do so in order to administer a safe and effective dose on dietary butyrate.
Conclusion
THIS ACTION IS MADE FINAL. 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 MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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