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 20-25 and 27-36 are pending.
Response to Amendment
Applicant amended claim 20 and added new limitation “wherein the method results in up to 25% body weight increase in the infants or young children receiving the nutritional composition compared to the infants and young children not receiving the nutritional composition”.
Applicant amended claims 22, 25, 29, and 34.
The rejection of claims 22, 25, 29, and 34 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
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 20-21, 23-24, 27-28 and 30-36 remain rejected under 35 U.S.C. 103 as being unpatentable over Potappel (US20170296563) in view of Rigo et al. (British journal of nutrition 117.2 (2017): 209-217, hereinafter “Rigo”, in IDS 04/07/2021) and Ciarlet (Journal of Virology 76.1 (2002): 41-57).
Regarding claims 20-21, Potappel teaches a nutritional composition that is an infant or follow on formula, comprising a fermented milk substrate using Bifidobacterium breve and Streptococcus thermophilus and comprising galacto-oligosaccharides and fructo-oligosaccharides ([0087], claim 25, Table 2). Potappel teaches that the composition has a synergistic effect on immune response (Example 3 title). Potappel teaches using 3 wt. % of fermented milk and 1 wt. % of nondigestible oligosaccharide mixture (GF) containing transgalacto-oligosaccharides (GOS) and fructooligosaccharide (FPS) (i.e. ratio of 3) ([0119], [0125]).
Potappel does not teach that the composition treats rotavirus infection.
However, Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula (i.e. milk substrate that is fermented by lactic acid producing bacteria) and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides (Abstract). Rigo teaches that the group receiving the composition gained weight (i.e., improved growth) (Fig. 1). Rigo teaches that the compositions caused amelioration of the clinical symptoms, modulated the immune response, which seemed to be enhanced earlier and was accompanied by a faster resolution of the process, and decreased viral shedding and teaches that the composition may solve the infection rapidly (Abstract, Fig. 4, page 216 right column first para.). Rigo suggests the compositions tested can be considered for inclusion in infant formula or supplements (page 216 right column last para.). Rigo teaches administering 3g/100g of body weight of milk substrate fermented by lactic acid producing bacteria and administering 0.8g/100g of body weight of composition of galacto-oligosaccharides and fructo-oligosaccharides (i.e., ratio of 3.75) (page 210 par. “Dietary supplementation”).
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 Potappel by administering the composition to infants with rotavirus infection, and to use this composition to solve the infection rapidly, as suggested by Rigo. One of ordinary skill in the art would be motivated to do so in order to treat rotavirus infection in infants. Since Rigo teaches a desire to treat rotavirus infection and teach that the components found in Potappel’s composition (i.e., fermented milk and galacto-oligosaccharides/fructo-oligosaccharides) each have an effect on treating rotavirus infection, there is a reasonable expectation of success. MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”
Potappel and Rigo do not teach that rotavirus infection induces weight loss.
However, Ciarlet teaches that the progression of the rotavirus infection causes weight loss in rats compared to a group not infected with the virus (FIG. 9).
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 Potappel by administering the composition to infants with rotavirus infection and symptoms such as diarrhea and weight loss, as suggested by Rigo and Ciarlet. One of ordinary skill in the art would be motivated to do so in order to clear the virus and treat its symptoms such as diarrhea and weight loss. Since Rigo teaches administering the composition to treat the rotavirus infection, and since Ciarlet teaches that the progession of the viral infection causes weight loss, there is a reasonable expectation of success.
Regarding the limitation “wherein the method results in up to 25% body weight increase in the infants or young children receiving the nutritional composition compared to the infants and young children not receiving the nutritional composition”, MPEP 2111.04 states that claim scope is not limited by claim language that suggest or makes optional but does not require steps to be performed, and that whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
Regarding claim 23, Potappel teaches that the milk is fermented with B. breve and Streptococcus thermophilus ([0059], claims 25 and 27). Rigo teaches that the milk is fermented using Bifidobacterium and Streptococcus strains (Abstract). Applicant discloses that these two bacteria are lactic acid producing bacteria (Specification page 5 lines 32-33)
Regarding claim 24, Potappel teaches that the bacteria are inactivated (claims 25 and 27). Rigo teaches that the strains are heat-treated (i.e., inactivating the bacteria) (page 210 para. “Experimental design”).
Regarding claim 28, Potappel teaches that the composition is a nutritional composition for an infant or follow on formula ([0087]). Rigo suggests the compositions tested can be considered for inclusion in infant formulae or supplements (page 216 right column last para.).
Regarding claims 30-31, Potappel teaches that the milk is fermented using Bifidobacterium and Streptococcus strains (claims 25 and 27, [0117])). Rigo teaches that the milk is fermented using Bifidobacterium and Streptococcus strains (Abstract).
Regarding claim 32, Potappel teaches that the composition comprises galacto-oligosaccharides and fructo-oligosaccharides (claim 25, Table 2).
Regarding claim 34, the limitation “wherein the duration of rotavirus infection is reduced with respect to the administration of a nutritional composition not comprising a milk substrate fermented by lactic acid producing bacteria and non-digestible oligosaccharides in ratio in the range of 2 - 4.9” is the result of the active method step. Whereby 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 35, Rigo teaches that the composition is administered for a period of 14 days and teaches that the treated rats had an increase in body weight similar to non-infected rats (Fig. 1).
Regarding claim 36, Rigo teaches administering the composition daily by oral gavage from day 3 of age through day 21 and teaches infecting the animals with the virus on day 7 (i.e., treatment occurs in a period after infection) (page 210 “Dietary supplementation”, Fig. 1)
Claims 22, 25, and 29 remain rejected under 35 U.S.C. 103 as being unpatentable over Potappel, Rigo and Ciarlet as applied to claim 20 above, and further in view of Ludwig (WO-2015065194, published May 2015, of record in Office Correspondence mailed on 04/05/2024, hereinafter “Ludwig”).
Regarding claim 22, Potappel, Rigo, and Ciarlet do not teach that the sum of lactic acid and lactate is 0.1 to 1.5 wt.% of the dry weight of the composition.
However, Ludwig teaches a fermented infant formula and teaches that the sum of lactate and lactic acid is 0.25 to 1.5 wt.% of the dry weight of the infant formula and the sum of L-lactic acid and L-lactate is more than 50 wt.% of the sum of total lactic acid and lactate (page 10 lines 13-24, claim 1).
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 taught by Potappel by adding 0.1 to 1.5 wt.% of the sum of lactic acid and lactate based on dry weight of the composition as taught by Ludwig. One of ordinary skill in the art would be motivated to do so in order to give the infant a safe, effective, and nutritious composition as suggested by Ludwig.
Regarding claim 25, Ludwig teaches that the non-digestible oligosaccharides are 0.5 to 20 wt.% of the dry weight of the infant (claim 1). While the exact concentration is not disclosed by Ludwig, it is generally noted that differences in concentration do not support the patentability of subject matter encompassed by the prior. “[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 claim 29, Ludwig teaches that the sum of lactate and lactic acid is 0.25 to 1.5 wt.% of the dry weight of the infant formula and the sum of L-lactic acid and L-lactate is more than 50 wt.% of the sum of total lactic acid and lactate (claim 1). 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 taught by Potappel by using a composition where the sum of L-lactic acid and L-lactate is more than 50 wt.% based on the sum of total lactic acid and lactate as taught by Ludwig. One of ordinary skill in the art would be motivated to do so in order to give the infant a safe, effective, and nutritious composition as suggested by Ludwig.
Claims 27 and 33 remain rejected under 35 U.S.C. 103 as being unpatentable over Potappel, Rigo, and Ciarlet as applied to claim 20 above, and further in view of Rigo‑Adrover (European journal of nutrition 56.4 (2017): 1657-1670, of record in Office Correspondence mailed on 09/02/2025).
Regarding claims 27 and 33, Potappel and Rigo do not teach that the composition does not comprise pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides.
However, Rigo-Adrover teaches administering to rats with rotavirus infection a composition consisting of a combination of galacto-oligosaccharides and fructo-oligosaccharides (scGOS and lcFOS) added to infant formula at a dose of 0.8g/100g of body weight (group PRE), and a composition comprising Bifidobacterium breve and galacto-oligosaccharides and fructo-oligosaccharides (group SYN) (page 1659 paras “Experimental design and dietary supplementation” and “Virus inoculation”. Rigo-Adrover teaches that the combination of galacto-oligosaccharides and fructo-oligosaccharides reduced the viral shedding in fecal sample (Fig. 4) and binds to the virus resulting in lower adhesion of the virus to the host and consequently leading to a lower infection incidence and severity (Table 4, page 1666 right column first para.). Rigo-Adrover teaches that the compositions showed beneficial effects on RV-induced gastroenteritis and suggests administering these compounds to protect against human RV-induced diarrhea in children (page 1667 left column last para.).
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 taught by Potappel by excluding pectin-derived acidic oligosaccharides and galacturonic acid oligosaccharides from the composition as suggested by Rigo-Adrover. One of ordinary skill in the art would be motivated to do so in order to save on the cost of the composition without affecting its activity against rotavirus. Since Rigo-Adrover teaches that galacto-oligosaccharides/fructo-oligosaccharides are the compounds with an effect on rotavirus, there is an expectation of success.
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 20-25 and 27-36 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-12 and 14 of U.S. Patent No. 11,642,359 in view of Ludwig, Rigo, and Ciarlet.
Regarding instant claims 20-21 and 34-36, patent claim 11 recites a method for improving intestinal barrier integrity in an infant or toddler by administering a nutritional composition selected from an infant formula or a follow-up formula and which is not human milk, that comprises a 2'-fucosyllactose. Patent claim 12 recites wherein the improvement of intestinal barrier integrity is a reduction in the permeability of the intestinal barrier. Patent claim 14 recites wherein the non-digestible oligosaccharides are selected from the group consisting of fructo-oligosaccharides and galacto-oligosaccharides. Patent claims 11-12 and 14 do not recite milk substrate that is fermented by lactic acid producing bacteria, and does not recite a ratio.
However, Ludwig teaches a fermented infant formula comprising non-digestible oligosaccharides (claim 1) and teaches the formula is fermented using lactic acid bacteria (page 6 lines 16-18).
Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula (i.e. milk substrate that is fermented by lactic acid producing bacteria) and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides (Abstract). Rigo teaches both compositions showed protective properties against rotavirus infection. Rigo suggests the compositions stimulate changes in the mucus and reinforcing the epithelial barrier (page 216 left column last para.). Rigo suggests the compositions tested can be considered for inclusion in infant formulae or supplements (page 216 right column last para.). Rigo teaches administering 3g/100g of body weight of milk substrate fermented by lactic acid producing bacteria and administering 0.8g/100g of body weight of composition of galacto-oligosaccharides and fructo-oligosaccharides (i.e., ratio of 3.75) (page 210 par. “Dietary supplementation”). Rigo does not teach that rotavirus infection induces weight loss.
However, Ciarlet teaches that the progression of the rotavirus infection causes weight loss (FIG. 9).
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 recited in patent claims 11-12, and 14 by adding a milk substrate fermented by lactic acid producing bacteria and a ratio of milk substrate to fructo-oligosaccharides and/or galacto-oligosaccharides of 3, and to administer the composition to treat rotavirus infection and the weight loss caused by the virus as suggested by Ludwig, Rigo, and Ciarlet. One of ordinary skill in the art would be motivated to do so in order to provide the infant with a nutritional composition as suggested by Ludwig, and to treat rotavirus infection and its symptoms such as diarrhea and weight loss as suggested by Rigo and Ciarlet.
Regarding claims 22 and 29, Ludwig teaches the composition wherein 0.25 to 1.5 wt.% of the sum of lactate and lactic acid based on dry weight of the infant formula and wherein the sum of L-lactic acid and L-lactate is more than 50 wt.% based on the sum of total lactic acid and lactate (claim 1).
Regarding instant claims 23 and 30-31, Ludwig teaches the lactic acid bacteria include Bifidobacterium and Streptococcus (page 6 lines 16-18). Rigo teaches the milk is fermented using Bifidobacterium and Streptococcus strains (Abstract).
Regarding claim 24, Ludwig teaches the lactic acid bacteria are subjected to a heat treatment and inactivated (page 7 lines 12-14). Rigo teaches the strain are heat-treated (i.e., inactivating the bacteria) (page 210 para. “Experimental design”).
Regarding instant claim 25, Ludwig teaches the infant formula comprises 0.5 to 20 wt.% non-digestible oligosaccharides based on dry weight of the infant (claim 1).
Regarding instant claim 32, patent claim 14 recites wherein the non- digestible oligosaccharides are selected from the group consisting of fructo-oligosaccharides and galacto-oligosaccharides.
Regarding instant claims 27 and 33, patent claim 14 does not recite pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides, thus the limitation of “wherein the nutritional composition does not comprise pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides” is met.
Regarding instant claim 28, patent claim 11 recites wherein the nutritional composition is selected from an infant formula and a follow-on.
Regarding instant claim 35, Rigo teaches the composition is administered for a period of 14 days and teaches at 14 days the treated rats had increase in body weight similar to non-infected rats (Fig. 1).
Regarding instant claim 36, Rigo teaches administering the composition daily by oral gavage from day 3 of age through day 21 and teaches infecting the animals with the virus on day 7 (i.e., treatment occurs in a period after infection) (page 210 “Dietary supplementation”, Fig. 1).
Claims 20-25 and 27-36 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 9,585,416 in view of Ludwig, Rigo, and Ciarlet.
Regarding instant claims 20-21 and 34, patent claim 1 recites a method for stimulating the development of a healthy intestinal flora and/or decreasing the occurrence of intestinal pathogens in infants delivered via caesarean section comprising administering within 3 months of birth to the infant delivered via caesarean section a composition that is not human milk and comprises: (a) 0.5 to 75 g of non-digestible oligosaccharides per 100 g dry weight of the composition, wherein the nondigestible oligosaccharides comprise galacto-oligosaccharides having at least 50% of its saccharide units of the galacto-oligosaccharides as galactose units, and (b) at least one Bifidobacterium. Patent claim 5 recites wherein the composition comprises galacto-oligosaccharides and/or fructo-oligosaccharides. Patent claims 1 and 5 do not recite milk substrate that is fermented by lactic acid producing bacteria, does not recite a ratio, and does not recite the composition is used in rotavirus infection
However, Ludwig teaches a fermented infant formula comprising non-digestible oligosaccharides (claim 1) and teaches the formula is fermented using lactic acid bacteria (page 6 lines 16-18).
Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula (i.e. milk substrate that is fermented by lactic acid producing bacteria) and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides (Abstract). Rigo teaches both compositions showed protective properties against rotavirus infection. Rigo suggests the compositions stimulate changes in the mucus and reinforcing the epithelial barrier (page 216 left column last para.). Rigo suggests the compositions tested can be considered for inclusion in infant formulae or supplements (page 216 right column last para.). Rigo teaches administering 3g/100g of body weight of milk substrate fermented by lactic acid producing bacteria and administering 0.8g/100g of body weight of composition of galacto-oligosaccharides and fructo-oligosaccharides (i.e., ratio of 3.75) (page 210 par. “Dietary supplementation”). Rigo does not teach that rotavirus infection induces weight loss.
However, Ciarlet teaches that the progression of the rotavirus infection causes weight loss (FIG. 9).
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 recited in patent claims 1 and 5 by adding a milk substrate fermented by lactic acid producing bacteria and a ratio of milk substrate to fructo-oligosaccharides and/or galacto-oligosaccharides of 3, and to administer the composition to treat rotavirus infection and the weight loss caused by the virus as suggested by Ludwig, Rigo, and Ciarlet. One of ordinary skill in the art would be motivated to do so in order to provide the infant with a nutritional composition as suggested by Ludwig, and to treat rotavirus infection and its symptoms such as diarrhea and weight loss as suggested by Rigo and Ciarlet.
Regarding claims 22 and 29, Ludwig teaches the composition wherein 0.25 to 1.5 wt.% of the sum of lactate and lactic acid based on dry weight of the infant formula and wherein the sum of L-lactic acid and L-lactate is more than 50 wt.% based on the sum of total lactic acid and lactate (claim 1).
Regarding instant claims 23 and 30-31, Ludwig teaches the lactic acid bacteria include Bifidobacterium and Streptococcus (page 6 lines 16-18). Rigo teaches the milk is fermented using Bifidobacterium and Streptococcus strains (Abstract).
Regarding claim 24, Ludwig teaches the lactic acid bacteria are subjected to a heat treatment and inactivated (page 7 lines 12-14). Rigo teaches the strain are heat-treated (i.e., inactivating the bacteria) (page 210 para. “Experimental design”).
Regarding instant claim 25, Ludwig teaches the infant formula comprises 0.5 to 20 wt.% non-digestible oligosaccharides based on dry weight of the infant (claim 1).
Regarding instant claim 32, patent claim 5 recites wherein the composition comprises galacto-oligosaccharides and/or fructo-oligosaccharides.
Regarding instant claims 27 and 33, patent claim 5 does not recite pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides, thus the limitation of “wherein the nutritional composition does not comprise pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides” is met.
Regarding instant claim 28, Ludwig teaches the composition is an infant formula.
Regarding instant claim 35, Rigo teaches the composition is administered for a period of 14 days and teaches at 14 days the treated rats had increase in body weight similar to non-infected rats (Fig. 1).
Regarding instant claim 36, Rigo teaches administering the composition daily by oral gavage from day 3 of age through day 21 and teaches infecting the animals with the virus on day 7 (i.e., treatment occurs in a period after infection) (page 210 “Dietary supplementation”, Fig. 1)
Claims 20-25 and 27-36 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 6,863,918 in view of Ludwig, Rigo, and Ciarlet.
Regarding instant claims 20-21, 28, 32 and 34, patent claim 5 recites an infant formula comprising a prebiotic component, selected from lacto N-tetraose, lacto-N-fuco-pentaose, lactulose, lactosucrose, raffinose, galacto-oligosaccharides, fructo-oligo-saccharides, oligosaccharides derived from soybean polysaccharides, mannose-based oligosaccharides, arabino-oligosaccharides, xylo-oligosaccharides, isomaltooligo-saccharides, glucas, sialyl oligosaccharides and fucooligosaccharides. Patent claim 5 does not recite milk substrate that is fermented by lactic acid producing bacteria and does not recite the composition is administered to infant with rotavirus infection.
However, Ludwig teaches a fermented infant formula comprising non-digestible oligosaccharides (claim 1) and teaches the formula is fermented using lactic acid bacteria (page 6 lines 16-18).
Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula (i.e. milk substrate that is fermented by lactic acid producing bacteria) and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides (Abstract). Rigo teaches both compositions showed protective properties against rotavirus infection. Rigo suggests the compositions stimulate changes in the mucus and reinforcing the epithelial barrier (page 216 left column last para.). Rigo suggests the compositions tested can be considered for inclusion in infant formulae or supplements (page 216 right column last para.). Rigo teaches administering 3g/100g of body weight of milk substrate fermented by lactic acid producing bacteria and administering 0.8g/100g of body weight of composition of galacto-oligosaccharides and fructo-oligosaccharides (i.e., ratio of 3.75) (page 210 par. “Dietary supplementation”). Rigo does not teach that rotavirus infection induces weight loss.
However, Ciarlet teaches that the progression of the rotavirus infection causes weight loss (FIG. 9).
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 recited in patent claim 5 by adding a milk substrate fermented by lactic acid producing bacteria and a ratio of milk substrate to fructo-oligosaccharides and/or galacto-oligosaccharides of 3, and to administer the composition to treat rotavirus infection and the weight loss caused by the virus as suggested by Ludwig, Rigo, and Ciarlet. One of ordinary skill in the art would be motivated to do so in order to provide the infant with a nutritional composition as suggested by Ludwig, and to treat rotavirus infection and its symptoms such as diarrhea and weight loss as suggested by Rigo and Ciarlet.
Regarding claims 22 and 29, Ludwig teaches the composition wherein 0.25 to 1.5 wt.% of the sum of lactate and lactic acid based on dry weight of the infant formula and wherein the sum of L-lactic acid and L-lactate is more than 50 wt.% based on the sum of total lactic acid and lactate (claim 1).
Regarding instant claims 23 and 30-31, Ludwig teaches the lactic acid bacteria include Bifidobacterium and Streptococcus (page 6 lines 16-18). Rigo teaches the milk is fermented using Bifidobacterium and Streptococcus strains (Abstract).
Regarding claim 24, Ludwig teaches the lactic acid bacteria are subjected to a heat treatment and inactivated (page 7 lines 12-14). Rigo teaches the strain are heat-treated (i.e., inactivating the bacteria) (page 210 para. “Experimental design”).
Regarding instant claim 25, Ludwig teaches the infant formula comprises 0.5 to 20 wt.% non-digestible oligosaccharides based on dry weight of the infant (claim 1).
Regarding instant claims 27 and 33, patent claim 5 does not recite pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides, thus the limitation of “wherein the nutritional composition does not comprise pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides” is met.
Regarding instant claim 35, Rigo teaches the composition is administered for a period of 14 days and teaches at 14 days the treated rats had increase in body weight similar to non-infected rats (Fig. 1).
Regarding instant claim 36, Rigo teaches administering the composition daily by oral gavage from day 3 of age through day 21 and teaches infecting the animals with the virus on day 7 (i.e., treatment occurs in a period after infection) (page 210 “Dietary supplementation”, Fig. 1)
Claims 20-25 and 27-36 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,638,438 in view of Ludwig, Rigo, and Ciarlet.
Regarding instant claims 20-21, 28, 32, and 34, patent claim 1 recites a method of reducing the risk of occurrence of fatty liver disease in a human subject above 5 years of age, comprising administering to the human subject when 0 to 36 months of age a nutritional composition, comprising Bifidobacterium breve and a mixture of galacto-oligosaccharides and fructo-oligosaccharides, wherein the nutritional composition is an infant formula or follow on formula or young child formula. Patent claim 1 does not recite milk substrate that is fermented by lactic acid producing bacteria and does not recite the composition increases gut barrier function during rotavirus infection.
However, Ludwig teaches a fermented infant formula comprising non-digestible oligosaccharides (claim 1) and teaches the formula is fermented using lactic acid bacteria (page 6 lines 16-18).
Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula (i.e. milk substrate that is fermented by lactic acid producing bacteria) and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides (Abstract). Rigo teaches both compositions showed protective properties against rotavirus infection. Rigo suggests the compositions stimulate changes in the mucus and reinforcing the epithelial barrier (page 216 left column last para.). Rigo suggests the compositions tested can be considered for inclusion in infant formulae or supplements (page 216 right column last para.). Rigo teaches administering 3g/100g of body weight of milk substrate fermented by lactic acid producing bacteria and administering 0.8g/100g of body weight of composition of galacto-oligosaccharides and fructo-oligosaccharides (i.e., ratio of 3.75) (page 210 par. “Dietary supplementation”). Rigo does not teach that rotavirus infection induces weight loss.
However, Ciarlet teaches that the progression of the rotavirus infection causes weight loss (FIG. 9).
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 recited in patent claim 1 by adding a milk substrate fermented by lactic acid producing bacteria and a ratio of milk substrate to fructo-oligosaccharides and/or galacto-oligosaccharides of 3, and to administer the composition to treat rotavirus infection and the weight loss caused by the virus as suggested by Ludwig, Rigo, and Ciarlet. One of ordinary skill in the art would be motivated to do so in order to provide the infant with a nutritional composition as suggested by Ludwig, and to treat rotavirus infection and its symptoms such as diarrhea and weight loss as suggested by Rigo and Ciarlet.
Regarding claims 22 and 29, Ludwig teaches the composition wherein 0.25 to 1.5 wt.% of the sum of lactate and lactic acid based on dry weight of the infant formula and wherein the sum of L-lactic acid and L-lactate is more than 50 wt.% based on the sum of total lactic acid and lactate (claim 1).
Regarding instant claims 23 and 30-31, Ludwig teaches the lactic acid bacteria include Bifidobacterium and Streptococcus (page 6 lines 16-18). Rigo teaches the milk is fermented using Bifidobacterium and Streptococcus strains (Abstract).
Regarding claim 24, Ludwig teaches the lactic acid bacteria are subjected to a heat treatment and inactivated (page 7 lines 12-14). Rigo teaches the strain are heat-treated (i.e., inactivating the bacteria) (page 210 para. “Experimental design”).
Regarding instant claim 25, Ludwig teaches the infant formula comprises 0.5 to 20 wt.% non-digestible oligosaccharides based on dry weight of the infant (claim 1).
Regarding instant claims 27 and 33, patent claim 1 does not recite pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides, thus the limitation of “wherein the nutritional composition does not comprise pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides” is met.
Regarding instant claim 35, Rigo teaches the composition is administered for a period of 14 days and teaches at 14 days the treated rats had increase in body weight similar to non-infected rats (Fig. 1).
Regarding instant claim 36, Rigo teaches administering the composition daily by oral gavage from day 3 of age through day 21 and teaches infecting the animals with the virus on day 7 (i.e., treatment occurs in a period after infection) (page 210 “Dietary supplementation”, Fig. 1)
Claims 20-25 and 27-36 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 8,119,142 in view of Ludwig, Rigo, and Ciarlet.
Regarding instant claims 20-21 and 34, patent claim 11 recites a method to reduce the risk of developing obesity in a non-obese human infant comprising feeding a human infant younger than 36 months of age with a nutritional composition that comprises a lipid component, a protein component and a digestible carbohydrate component, wherein said soluble, nondigestible oligosaccharide is selected from the group consisting of fructo-oligosaccharides, galacto-oligosaccharides, gluco-oligosaccharides, arabino-oligosaccharides, mannanoligosaccharides, xylo-oligosaccharides, fuco-oligosaccharides, arabinogalacto-oligosaccharides, glucomanno-oligosaccharides, galactomanno-oligosaccharides, sialic acid comprising oligosaccharides and uronic acid oligosaccharides. Patent claim 12 recites composition comprises galacto-oligosaccharides. Patent claim 13 recites composition comprises fructo-oligosaccharides. Patent claim 11 does not recite milk substrate that is fermented by lactic acid producing bacteria and does not recite the composition increases gut barrier function during rotavirus infection.
However, Ludwig teaches a fermented infant formula comprising non-digestible oligosaccharides (claim 1) and teaches the formula is fermented using lactic acid bacteria (page 6 lines 16-18).
Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula (i.e. milk substrate that is fermented by lactic acid producing bacteria) and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides (Abstract). Rigo teaches both compositions showed protective properties against rotavirus infection. Rigo suggests the compositions stimulate changes in the mucus and reinforcing the epithelial barrier (page 216 left column last para.). Rigo suggests the compositions tested can be considered for inclusion in infant formulae or supplements (page 216 right column last para.). Rigo teaches administering 3g/100g of body weight of milk substrate fermented by lactic acid producing bacteria and administering 0.8g/100g of body weight of composition of galacto-oligosaccharides and fructo-oligosaccharides (i.e., ratio of 3.75) (page 210 par. “Dietary supplementation”). Rigo does not teach that rotavirus infection induces weight loss.
However, Ciarlet teaches that the progression of the rotavirus infection causes weight loss (FIG. 9).
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 recited in patent claims 11-13 by adding a milk substrate fermented by lactic acid producing bacteria and a ratio of milk substrate to fructo-oligosaccharides and/or galacto-oligosaccharides of 3, and to administer the composition to treat rotavirus infection and the weight loss caused by the virus as suggested by Ludwig, Rigo, and Ciarlet. One of ordinary skill in the art would be motivated to do so in order to provide the infant with a nutritional composition as suggested by Ludwig, and to treat rotavirus infection and its symptoms such as diarrhea and weight loss as suggested by Rigo and Ciarlet.
Regarding claims 22 and 29, Ludwig teaches the composition wherein 0.25 to 1.5 wt.% of the sum of lactate and lactic acid based on dry weight of the infant formula and wherein the sum of L-lactic acid and L-lactate is more than 50 wt.% based on the sum of total lactic acid and lactate (claim 1).
Regarding instant claims 23 and 30-31, Ludwig teaches the lactic acid bacteria include Bifidobacterium and Streptococcus (page 6 lines 16-18). Rigo teaches the milk is fermented using Bifidobacterium and Streptococcus strains (Abstract).
Regarding claim 24, Ludwig teaches the lactic acid bacteria are subjected to a heat treatment and inactivated (page 7 lines 12-14). Rigo teaches the strain are heat-treated (i.e., inactivating the bacteria) (page 210 para. “Experimental design”).
Regarding instant claim 25, Ludwig teaches the infant formula comprises 0.5 to 20 wt.% non-digestible oligosaccharides based on dry weight of the infant (claim 1).
Regarding instant claims 27 and 33, patent claim 11 does not recite pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides, thus the limitation of “wherein the nutritional composition does not comprise pectin-derived acidic oligosaccharides or galacturonic acid oligosaccharides” is met.
Regarding claim 28, Ludwig teaches the composition is an infant formula.
Regarding instant claim 32, Rigo teaches both galacto-oligosaccharides and fructo-oligosaccharides.
Regarding instant claim 35, Rigo teaches the composition is administered for a period of 14 days and teaches at 14 days the treated rats had increase in body weight similar to non-infected rats (Fig. 1).
Regarding instant claim 36, Rigo teaches administering the composition daily by oral gavage from day 3 of age through day 21 and teaches infecting the animals with the virus on day 7 (i.e., treatment occurs in a period after infection) (page 210 “Dietary supplementation”, Fig. 1)
Claims 20-21, 23-25, 27-28 and 30-36 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4-7 of U.S. Patent No. 10,124,016 in view of Rigo and Ciarlet.
Regarding instant claims 20-21, 23-25, 27-28, and 30-34, patent claim 4 recites nutritional composition comprising, based on total dry weight of the composition: (a) 0.5 to 10 wt.% of the sum of galacto-oligosaccharides and fructo-oligosaccharides, and
(b) 5 to 99.5 wt.% of a preparation obtained by a process comprising: (i) inoculating bifidobacteria in an aqueous substrate in amount of between 1x107 to 1x1011 cfu bifidobacteria/ml, said aqueous substrate having a pH of between 4 and 8, and comprising at least one selected from the group consisting of milk, milk protein, whey, whey protein, whey protein hydrolysate, casein hydrolysate, and lactose; (ii) incubating the bifidobacteria in the aqueous medium, under aerobic or anaerobic conditions and
at a temperature of 20° C. to 50° C., for at least 2 h, to obtain a first incubated mixture;
(iii) inactivating the bifidobacteria from the first incubated mixture; and (iv) combining the incubated mixture with fructo-oligosaccharides and galacto-oligosaccharides, wherein the bifidobacteria in (i) belong to the species B. breve, and wherein the nutritional composition comprises less than 103 cfu living Bifidobacteria per g dry weight of the
preparation. Patent claim 5 recites the bifidobacteria are inactivated by heat treatment. Patent claim 6 recites the composition further comprises (c) 2 to 94.5 wt. % of the preparation obtained by (v) incubating Streptococcus thermophilus, with a substrate selected from the group consisting of milk, milk protein, whey, whey protein, whey protein hydrolysate, casein, casein hydrolysate, and lactose, to obtain a
second incubated mixture; (vi) optionally inactivating the S. thermophilus by heating the second incubated mixture of (v); and (vii) combining the first and second incubated mixtures. Patent claim 7 recites the S. thermophilus is inactivated by heating the
second incubated mixture of (v). Patent claim 4 does not recite the composition is an infant formula and is administered to infant with rotavirus infection.
However, Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides (Abstract). Rigo teaches both compositions showed protective properties against rotavirus infection. Rigo suggests the compositions stimulate changes in the mucus and reinforcing the epithelial barrier (page 216 left column last para.). Rigo suggests the compositions tested can be considered for inclusion in infant formulae or supplements (page 216 right column last para.). Rigo teaches administering 3g/100g of body weight of milk substrate fermented by lactic acid producing bacteria and administering 0.8g/100g of body weight of composition of galacto-oligosaccharides and fructo-oligosaccharides (i.e., ratio of 3.75) (page 210 par. “Dietary supplementation”). Rigo does not teach that rotavirus infection induces weight loss.
However, Ciarlet teaches that the progression of the rotavirus infection causes weight loss (FIG. 9).
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 4 by administering the composition to treat rotavirus infection and the weight loss caused by the virus as suggested by Rigo and Ciarlet. One of ordinary skill in the art would be motivated to do so in order to treat rotavirus infection and its symptoms such as diarrhea and weight loss as suggested by Rigo and Ciarlet.
Regarding instant claim 35, Rigo teaches the composition is administered for a period of 14 days and teaches at 14 days the treated rats had increase in body weight similar to non-infected rats (Fig. 1).
Regarding instant claim 36, Rigo teaches administering the composition daily by oral gavage from day 3 of age through day 21 and teaches infecting the animals with the virus on day 7 (i.e., treatment occurs in a period after infection) (page 210 “Dietary supplementation”, Fig. 1)
Response to Arguments
Applicant's arguments filed 07/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the method as claimed results in up to 25% body weight increase in the infants or young children receiving the nutritional composition compared to the infants and young children not receiving the nutritional composition, and argues that none of the cited prior art documents teach or render obvious that fermented milk substrate and non-digestible oligosaccharides in a ratio between 2 and 4.9 can be used for the treatment of rotavirus induced weight loss in infants and young children suffering from rotavirus-induced weight loss. Applicant argues that Rigo explicitly teaches that rotavirus infection does not cause weight loss in its model. Applicant argues that Ciarlet's weight loss data relates exclusively to the highly virulent RRV strain, whereas Rigo employs the less sever SA-11 strain. Applicant argues neither reference teach the use of a fermented milk substrate in combination with non-digestible oligosaccharides at the claimed ratio of 2-4.9, and that Rigo employs a prebiotic-only GOS/FOS intervention. Applicant argues that Rigo-Adrover also does not teach rotavirus induced weight loss.
In response to the argument, Rigo teaches administering to a rotavirus infection suckling rat model animal a composition comprising Bifidobacterium breve and Streptococcus thermophilus fermented formula and a composition comprising galacto-oligosaccharides and fructo-oligosaccharides, and teaches the compositions solve the infection rapidly (Abstract, Fig. 4, page 216 right column first para.). Rigo tested the weight of the animals up to day 14 (i.e., 7 days post virus inoculation). Similarly, Rigo-Adrover teaches weighing the rats up to 7 days post RV inoculation (Fig. 2). Applicant discloses the weight loss was not seen at day 14 (i.e., 7 days post virus inoculation), which is similar to the observation taught by Rigo and Rigo-Adrover. Applicant discloses the weight loss was seen in the untreated group at day 21 (Table 1). It is thus understood that the weight loss was not observed in Rigo and Rigo-Adrover because the experiment was not extended beyond day 7 post infection.
Regarding the limitation “wherein the method results in up to 25% body weight increase in the infants or young children receiving the nutritional composition compared to the infants and young children not receiving the nutritional composition”, MPEP 2111.04 states that claim scope is not limited by claim language that suggest or makes optional but does not require steps to be performed, and that whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Table 1 (specification page 22) shows that the REF control group (not infected with rotavirus and received no dietary intervention) and the FM+G/F group (infected with rotavirus and supplemented with the composition) had an increase in weight of about 25% compared to the RV group (infected with rotavirus and received no dietary intervention). The lower weight gain seen in group RV is understood to be the result of an untreated infection with rotavirus. Since Rigo teaches the composition treats the infection rapidly in the subject, the weight increase in treated population is not an unexpected result.
Prior art Ciarlet teaches that rotavirus caused weight loss in animals and that the difference in weight between infected and non-infected animals is bigger at day 16 post infection than at day 7 (Fig. 9). (FIG. 9). Furthermore, the claims do not limit the virus to be SA-11 strain or a more virulent strain.
Since Rigo teaches administering the composition to rats inoculated with the rotavirus and teaches the composition treats the infection and its symptoms such as diarrhea, then it is expected that other symptoms and disorders caused by the virus would also be cleared since the virus and infection are treated. Furthermore, since Ciarlet teaches another symptom of the rotavirus infection is weight loss, then a person of ordinary skill in the art would be motivated to administer the composition to treat the rotavirus and its symptoms such as diarrhea and weight loss as suggested by Rigo and Ciarlet.
Applicant requests that the double patenting rejections be held in abeyance. A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filled by applicant at this time.
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.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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