DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 5, 2026 has been entered.
The amendment filed June 5, 2026 has been entered. Claims 1 and 14 have been amended, claims 2, and 8, 10-11 are cancelled, and claims 15-16 were added.
Applicant’s arguments filed June 5, 2026 were fully considered but they were not persuasive. Rejections and response to arguments are addressed below.
Claims 1, 3-7, 9, and 12-16 are pending in this application.
Priority
This application 371 of PCT/EP2021/083927 filed December 2, 2021 and claims foreign priority to EP 20211796.6 filed December 4, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received.
Claim Interpretation
Claim 1 recites the phrase “promoting the postnatal growth in the preterm infant as early as 2 weeks after the administering”. The phrase “as early as 2 weeks” is interpreted as a minimum and is not particularly limiting. For example wherein growth is established several months later, would meet the limitation of the claim.
Claim 1 recites inter alia “….wherein the preterm infant was born prior to 37 weeks of gestation and/or (i) has a body weight from 1500 to 2500 g….”. The phrase “and/or” is interpreted that the recited birth weights are either additional or alternative limitations. In other words, the subject claimed includes a preterm infant, that does not fall within the claimed weight ranges.
Claim Objections
Claim 15 is objected to because of the following informalities:
In claim 15 the phrase “range are” should read “ranges from”. This objection is based on page 7 of the instant specification (lines 16-17).
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-7, 9, and 12-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 3-7, 9, and 12-16: Claim 1 recites the method comprises “administering to the preterm infant an aqueous composition since birth” and also recites “wherein the aqueous composition is administered since a time during day 1 to day 7 of life after birth”. These two limitations conflict with one another as one suggests since birth (i.e. day 1), and the other suggests administration can occur after birth (days 2-7). These result in a lack of clarity in scope, thereby rendering the claim indefinite. Claims 3-7, 9, and 12-16 which depend from claim 1 are similarly rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 7, 9, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia-Rodenas (WO 2019/122190, IDS filed June 2, 2023, hereinafter referred to as Garcia) as evidenced by De Castro (WO 2016/066735, IDS filed June 2, 2023) and Cleveland Clinic (Preterm Birth, 2026, cited in previous action).
Regarding claims 1, 3-5, 7, 9, 12, and 14: Garcia teaches a nutritional composition comprising at least one N-acetylated oligosaccharide for use in the promotion of growth of the intestinal muscles in an infant (abstract). The method promotes enteral feeding tolerance (i.e. prior to full enteral feeding (FEF)), thus administration is prior to FEF, pg. 1, lines 5-12). Garcia teaches a supplement for preterm infants comprising the following daily dose and 0.34 g/kg 2-FL and 0.034 g/kg of LNnT (i.e. 10:1 ratio, no other nutrients, pg. 34, example 4). According to Cleveland Clinic the phrase “preterm birth” occurs when a baby is born at 37 weeks or earlier (pg. 1, para. 1). Garcia teaches the composition can be given immediately after birth of infants, this may especially be the case when the infant is premature (i.e. within one week of life, pg. 27, lines 6-19). Garcia teaches administration of compositions on postnatal day 2 after birth of rats (pg. 31, lines 5-20) Garcia teaches when the supplement is in the form of syrup, the HMOs are preferably dissolved or suspended in water acidified with citrate (i.e. a buffering agent, pg. 21, lines 22-26). According to the instant specification, citric acid is a buffering agent (pg. 6, lines 5-6). De Castro discloses nutritional compositions comprising Fut2-dependent oligosaccharides for promoting brain growth and development in infants in the very early postnatal period (i.e. as soon as possible after birth, abstract). De Castro discloses that low Fut2 activity in mothers breast milk is associated with less head circumference that correlates with lower levels of both 2’-FL and LNnT (pg. 41, lines 1-7, lines 25-30, pg. 41, table 3). According to the instant specification administration of an HMO supplement comprising 2’FL and LNnT in 10:1 ratio (0.34 and 0.034 g/kg body weight, i.e. same composition of Garcia) resulted in increase in weight, length and head circumference at day 14 (pg. 12, lines 4-16). Although Garcia does not describe what days the increase in length or head circumference is following administration, wherein Garcia teaches the general method of administering the oligosaccharides in effective amounts for the promotion of growth as instantly claimed, this is an inherent property of the method, absent evidence to the contrary. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference (See MPEP 2122 (II)).
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.
Claims 1, 3-5, 7, 9, 12-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Rodenas (WO 2019/122190, IDS filed June 2, 2023, hereinafter referred to as Garcia), De Castro (WO 2016/066735, IDS filed June 2, 2023) and Cleveland Clinic (Preterm Birth, 2026, cited in previous action) as applied to claims 1, 3-5, 7, 9, 12, and 14 above in view of Morrow (US 2018/0153915, cited in previous action).
Regarding claims 1, 3-5, 7, 9, 12, and 14: Even if assuming for the sake of argument the claims were interpreted in such a way as to not teach administration prior to achieving FEF. The claims would still have been rendered obvious in view above. As discussed above Garcia teaches all of the above but does not specifically state wherein the subject is treated prior to achieving FEF.
However, Morrow teaches a method of decreasing time to full enteral feeding in a subject (e.g., a pre-term infant, or a subject who has undergone an intestinal surgery), the method comprising administering to a subject in need thereof an effective amount of a composition comprising a fucosylated oligosaccharide such as 2'FL (pgs. 8-9, para. 0102). In some embodiments, decreasing time to full enteral feeding means decreasing the time to less than 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, or 10 days (pgs. 8-9, para. 0102).. In some embodiments, decreasing time to full enteral feeding means decreasing the time to full enteral feeding compared to a subject that has not received the composition (pgs. 8-9, para. 0102). Morrow teaches measuring infant growth until discharge (pg. 1,, para. 0122).
Taken together it would have been prima facie obvious to apply the method of Garcia for promoting enteral feeding to a preterm infant prior to full enteral feeding as suggested by Morrow. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as the composition of Garcia comprises 2’FL and is capable of promoting enteral feeding and the art recognizes that such compositions can decrease time to full enteral feeding. A person of ordinary skill would recognize the applicability of the method of Garcia in the preterm infants of Morrow.
According to the instant specification administration of an HMO supplement comprising 2’FL and LNnT in 10:1 ratio (0.34 and 0.034 g/kg body weight, i.e. same composition of Garcia) resulted in increase in weight, length and head circumference at day 14 (pg. 12, lines 4-16).Although Garcia does not describe what days the increase in length or head circumference is following administration, wherein Garcia teaches the general method of administering the oligosaccharides in effective amounts for the promotion of growth as instantly claimed, these results naturally flow as a result of practicing the method.
Regarding claim 13: As discussed above Garcia teaches the method of claim 1. Garcia does not teach wherein the concentration of 2’-Fl and LNnT ranges from 8 to 35% w/w of the aqueous composition.
However, Morrow teaches the use of oligosaccharides, such as 2'-fucosyllactose, for increasing weight gain in a subject, such as premature infants (abstract). Morrow teaches it is known in the art that the human milk oligosaccharide 2’-FL provides a growth recovery (catch up growth) benefit in preterm infants (<29 weeks) (pg. 11, para. 0120). Morrow teaches supplementation with 2’FL for improving weight gain in preterm infants compared to infants who did not receive supplementation (i.e. growth, pg. 4, para. 0062, pg. 11, paras. 0125, 0128). The concentration of oligosaccharides in the composition is at least 30% or at least 5 % by weight (pg. 6, para. 0079, para. 0081).
Taken together, it would have been prima facie obvious to modify the method of Garcia to optimize the concentration of oligosaccharides as suggested by Morrow. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes that premature formulas have previously been demonstrated in the art to possess oligosaccharide concentrations within the claimed range. Where 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 (See MPEP 2144.05 (II)).
Regarding claim 16: As discussed above, Garcia teaches the method of claim 1. Garcia teaches a supplement for preterm infants comprising the following daily dose and 0.34 g/kg 2-FL and 0.034 g/kg of LNnT (i.e. 10:1 ratio, no other nutrients, pg. 34, example 4). Garcia that these doses are preferred for low birth weight and small for gestational age infants (pg. 5, lines 9-12, pg. 17, lines 23-26). Garcia defines an infant having a low birth weight as an infant with a body weight from 1500 to 2500 g at birth (pg. 7, lines 4-8). Garcia also states a low birth weight infant also encompasses very low birth weight (1000 to 1500 g), and extremely low birth weight (under 1000 g).
Although Garcia does not specifically state the infant weighs less than 1700 g, wherein Garcia teaches the definition of low birth weight overlaps with the claimed range, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (see MPEP 2144.05 (I)).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Rodenas (WO 2019/122190, IDS filed June 2, 2023, hereinafter referred to as Garcia), De Castro (WO 2016/066735, IDS filed June 2, 2023), Cleveland Clinic (Preterm Birth, 2026, cited in previous action), and Morrow (US 2018/0153915, cited in previous action) as applied to claims 1, 3-5, 7, 9, 12-14, and 16 above in view of McSweeney (Food Hydrocolloids, 2004, cited in previous action).
Regarding claim 6: As discussed above Garcia and Morrow render obvious the method of claim 1. Garcia teaches the pH of the liquid product can be conveniently adjusted (pg. 25, lines 18-24).
Garcia does not teach wherein the pH ranges from 4 to 7.
However, McSweeney teaches that the pH of a given model infant formula effects heat stability characteristics (abstract). McSweeney teaches infant formulas in the art can range be stable at pH values in the range of 6.5-7.4. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)). Thus, McSweeney establishes pH in infant formulas as a result effecting variable.
Taken together, it would have been prima facie obvious to modify the method of Garcia to optimize the pH of the solution to fall within the claimed range as suggested by McSweeney. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes that pH in infant formula is a known result effecting variable, and known infant formulas are known to have a pH within the claimed range. Where 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 (See MPEP 2144.05 (II)).
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Rodenas (WO 2019/122190, IDS filed June 2, 2023, hereinafter referred to as Garcia), De Castro (WO 2016/066735, IDS filed June 2, 2023), Cleveland Clinic (Preterm Birth, 2026, cited in previous action), and Morrow (US 2018/0153915, cited in previous action) as applied to claims 1, 3-5, 7, 9, 12-14, and 16 above in view of Modi (Pediatric Research, 2010, cited on PTO-892).
Regarding claim 15: As discussed above, Garcia and Morrow render obvious the method of claim 1. The method promotes enteral feeding tolerance (i.e. reducing the time to full enteral feeding (FEF)), thus administration is prior to FEF, pg. 1, lines 5-12). Garcia teaches the N-acetylated oligosaccharide is provided in the nutritional composition or growing-up milk of the present invention in such an amount that normal consumption of the nutritional composition or growing-up milk would provide to the infant or young child, respectively the child, consuming it a total daily dose of 0.05-1 g/day. The daily dose for preterm, low birth weight and small for gestational age infants is 0.034 g per kg of body weight and per day (pg. 15, lines 9-12). Garcia teaches the fucosylated oligosaccharide is provided in the nutritional composition or growing-up milk of the present invention in such an amount that normal consumption of the nutritional composition or growing-up milk would provide to the infant or young child, respectively the child, consuming it a total daily dose of 0.012-2.6-2.6 g per day (pg. 17, lines 16-20). Garcia teaches for preterm, low birth weight and small for gestational age infants, the daily dose of fucosylated oligosaccharides is preferably 0.34 g per kg of body weight and per day (pg. 17, lines 23-24). Thus Garcia teaches composition comprising the claimed oligosaccharides can be administered continuously throughout the child’s life.
Garcia does not explicitly teach wherein the dosage amounts of the 2’FL and LNnT for pre-FEF are 0.21-0.63 g/day and dosage amounts of the 2’-FL and LNnT for FEF range are 0.43-0.82 g/day.
However, Modi teaches breast milk prebiotic oligosaccharides are believed to promote enteral tolerance (abstract). Modi teaches that enteral feeds were commenced as early as possible within the first 24 hours of birth, and doses were based on how early infant was born, and doses were increased based on birth weight until birth weight was regained, then on actual weight (pg. 441, col. 1, para. 2). Modi teaches the primary outcome (PO) was defined as the number of days from birth to establish a total daily enteral intake of 150 mL/kg. and the principal secondary outcome (PSO) was defined as the proportion of days between birth and 28 d or discharge (whichever came first) that a total daily milk intake of at least 150 mL/kg was tolerated (pg. 441, col. 1, para. 3). According to the instant specification, the term Full Enteral Feeding (FEF) is defined as end of parenteral nutrition and when minimum enteral intake of 150 ml/kg/day is attained and the term pre Full Enteral Feeding (pre-FEF) refers to the period from the day of birth till FEF is attained. (pg. 5, lines 17-19). Thus, Modi establishes that enteral feeding doses vary depending on how early infant was born, and increase based on weight, establishing daily dosing of oligosaccharides is an optimizable variable.
Taken together it would have been prima facie obvious to optimize the daily intake of 2’-4FL and LNnT for pre-FEF and FEF in the nutritional composition of Garcia as suggested by Modi and arrive at the claimed range through routine optimization. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art recognizes increasing daily intake as the infant grows and can tolerate higher feeds and Garcia teaches daily intake doses of each oligosaccharide overlap with the claimed ranges. Where 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 (See MPEP 2144.05 (II)).
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 1, 3-7, 9, 12-14, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim of copending Application No. 18/255,751 (US 2024/0033276, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed towards the same method, but are merely limited by a different result (reaching enteral feeding in preterm infants vs growth in the instant application). The changes in postnatal growth are necessarily present in the method of the copending application.
The copending claims teach a method for reducing the time to reach full enteral feeding in preterm infants comprising administering an aqueous composition comprising at least one human milk oligosaccharide to an infant a time period between day 1 and 7 of life (copending claim 1). The composition is a milk fortifier or supplement (copending claim 2). The pH of the composition ranges from 4 to 7 (copending claim 3). The composition can includes a pH modulator (i.e. a buffer agent, copending claim 5). The at least one oligosaccharide is selected from 2’-FL, DFL, LNnT and LNT (copending claim 6). The composition can comprise only 2’-FL and LNnT at ratio of 10:1 (copending claim 7). The composition does not comprise other nutrients (copending claim 8). The concentration of oligosaccharides can be at a concentration of 8 to 35 % w/w of the composition (copending claim 9). The copending claims teach wherein the preterm infant has a weight of less than 1500 g at birth (copending claim 11.
Although the copending claims do not recite the impact on postnatal growth or brain-catchup growth, wherein the general method, subject population, and composition of the copending claims is the same as the instant claims, these results naturally flow as a result of practicing the method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim of copending Application No. 18/255,751 (US 2024/0033276, cited in previous action) as applied to claims 1, 3-7, 9, 12-14, and 16 above in view of Garcia-Rodenas (WO 2019/122190, IDS filed June 2, 2023, hereinafter referred to as Garcia) and Modi (Pediatric Research, 2010, cited on PTO-892).
Regarding claim 15: As discussed above, the copending claims teach the method of claim 1. The method reduces the time to full enteral feeding (FEF), thus administration is prior to FEF.
The copending claims do not explicitly teach wherein the dosage amounts of the 2’FL and LNnT for pre-FEF are 0.21-0.63 g/day and dosage amounts of the 2’-FL and LNnT for FEF range are 0.43-0.82 g/day.
However, Garcia teaches the N-acetylated oligosaccharide is provided in the nutritional composition or growing-up milk of the present invention in such an amount that normal consumption of the nutritional composition or growing-up milk would provide to the infant or young child, respectively the child, consuming it a total daily dose of 0.05-1 g/day. The daily dose for preterm, low birth weight and small for gestational age infants is 0.034 g per kg of body weight and per day (pg. 15, lines 9-12). Garcia teaches the fucosylated oligosaccharide is provided in the nutritional composition or growing-up milk of the present invention in such an amount that normal consumption of the nutritional composition or growing-up milk would provide to the infant or young child, respectively the child, consuming it a total daily dose of 0.012-2.6-2.6 g per day (pg. 17, lines 16-20). Garcia teaches for preterm, low birth weight and small for gestational age infants, the daily dose of fucosylated oligosaccharides is preferably 0.34 g per kg of body weight and per day (pg. 17, lines 23-24). Thus Garcia teaches composition comprising the claimed oligosaccharides can be administered continuously throughout the childs life.
Modi additionally teaches breast milk prebiotic oligosaccharides are believed to promote enteral tolerance (abstract). Modi teaches that enteral feeds were commenced as early as possible within the first 24 hours of birth, and doses were based on how early infant was born, and doses were increased based on birth weight until birth weight was regained, then on actual weight (pg. 441, col. 1, para. 2). Modi teaches the primary outcome (PO) was defined as the number of days from birth to establish a total daily enteral intake of 150 mL/kg. and the principal secondary outcome (PSO) was defined as the proportion of days between birth and 28 d or discharge (whichever came first) that a total daily milk intake of at least 150 mL/kg was tolerated (pg. 441, col. 1, para. 3). According to the instant specification, the term Full Enteral Feeding (FEF) is defined as end of parenteral nutrition and when minimum enteral intake of 150 ml/kg/day is attained and the term pre Full Enteral Feeding (pre-FEF) refers to the period from the day of birth till FEF is attained. (pg. 5, lines 17-19). Thus, Modi establishes that enteral feeding doses vary depending on how early infant was born, and increase based on weight, establishing daily dosing of oligosaccharides is an optimizable variable.
Taken together it would have been prima facie obvious to optimize the daily intake of 2’-4FL and LNnT for pre-FEF and FEF in the nutritional composition of the copending claims as suggested by Garcia and Modi and arrive at the claimed range through routine optimization. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art recognizes increasing daily intake as the infant grows and can tolerate higher feeds and Garcia teaches daily intake doses of each oligosaccharide overlap with the claimed ranges. Where 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 (See MPEP 2144.05 (II)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed June 5, 2026 the claims have been fully considered but they are not persuasive.
On page 5 of Applicant’s response, Applicant argues the the cited references alone or in combination do not disclose or suggest administering to a preterm infant an aqueous composition that comprises 2’-FL and LNnT as the only human milk oligosaccharides in the aqueous composition, the aqueous composition is administered since a time during day 1 to day 7 of life after birth, and the aqueous composition is administered before achieving full enteral feeding (FEF) (last para.). Applicant argues the rejections are overcome due to the arguments presented in the after-final response filed June 5, 2026. On pages 7-8 of Applicant’s after final response, Applicant argues that Garcia does not teach wherein the postnatal growth comprises increase in head circumference and/or increase in length and does not describe what days the increase in length or head circumference occur following administration (bridging para.). On page 8 of Applicants response, Applicant argues that 2-FL is not required for the composition of Garcia and Garcia does not specifically define timing of effects observed relative to birth and does not disclose growth endpoints at specific postnatal timepoints.
However, Garcia points to premature/preterm infants being a subject population to be treated: Garcia teaches a supplement for preterm infants comprising the following daily dose and 0.34 g/kg 2-FL and 0.034 g/kg of LNnT (i.e. 10:1 ratio, no other nutrients, pg. 34, example 4). According to Cleveland Clinic the phrase “preterm birth” occurs when a baby is born at 37 weeks or earlier (pg. 1, para. 1). Garcia teaches the composition can be given immediately after birth of infants, this may especially be the case when the infant is premature (i.e. within one week of life, pg. 27, lines 6-19).”. De Castro discloses nutritional compositions comprising Fut2-dependent oligosaccharides for promoting brain growth and development in infants in the very early postnatal period (i.e. as soon as possible after birth, abstract). De Castro discloses that low Fut2 activity in mothers breast milk is associated with less head circumference that correlates with lower levels of both 2’-FL and LNnT (pg. 41, lines 1-7, lines 25-30, pg. 41, table 3). According to the instant specification administration of an HMO supplement comprising 2’FL and LNnT in 10:1 ratio (0.34 and 0.034 g/kg body weight, i.e. same composition of Garcia) resulted in increase in weight, length and head circumference at day 14 (pg. 12, lines 4-16). The instant specification concludes, when given as soon as possible after birth (as is taught by Garcia), HMO supplementation supported age-appropriate z scores in length and head circumference (pg. 12, lines 25-27). As a result, HMO supplement may support improved early postnatal growth, especially in head growth (pg. 23, lines 27-28). Although Garcia does not describe what days the increase in length or head circumference is following administration, wherein Garcia teaches the general method of administering the oligosaccharides in effective amounts for the promotion of growth to the same subject population as instantly claimed, this is an inherent property of the method, absent evidence to the contrary. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference (See MPEP 2122 (II)). Simply because a fact that occurs was not observed and/or measured, does not mean that fact did not occur.
On pages 8-9 of Applicants after final response, Applicant argues that the obviousness rejections are similarly overcome for the reasons argued above (bottom of page 8, top half of page 9).
See response to arguments above
On page 6 of Applicant’s response filed June 6, 2026, Applicant addressed possible indefinite/redundancy issues cited in the advisory action with regard to administering before achieving FEF and/or starting prior to achieving FEF.
The explanation provided was found to be persuasive. However, see 112(b) rejections above with regard to administering since birth.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 102, 103, and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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/SAMUEL L GALSTER/Examiner, Art Unit 1693
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