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.
Response to Amendment
The amendment filed January 30, 2026 has been entered. Claims 1, 3-7, 9, and 12-14 have been amended, claims 2, and 8, 10-11 are been cancelled. Applicant’s amendments to the claims have overcome the specification objections, claim objections, the 112b rejections, the 112d rejections, and 102 rejections over De Castro, Morrow previously set forth in the Non-Final Office Action mailed November 10, 2025. Applicants cancellation of claims 2, and 8, 10-11 have rendered the corresponding rejections/objections moot. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments filed January 30, 2026 were fully considered but they were not persuasive. Maintained/Modified rejections and response to arguments are addressed below.
Claims 1, 3-7, 9, and 12-14 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 growth in preterm infants as early as 3 weeks after supplementation”. The phrase “as early as 3 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.
Maintained/Modified 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, 3-7, 9, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marzorati (WO 2020/120426, IDS filed June 2, 2023) as evidenced by De Castro (WO 2016/066735, IDS filed June 2, 2023) and Cleveland Clinic (Preterm Birth, 2026, cited on PTO-892). The applied reference (Marzorati) has a common applicant with the instant application, but names different inventors.
Regarding claims 1, 3-7, 9, and 12-14: Marzorati teaches a stable aqueous composition comprising oligosaccharides having a glucose unit at the reducing end and characterized in that the pH of such aqueous composition ranges from 5.5 to 6.5. (abstract). Marzorati teaches wherein the composition comprises oligosaccharides 2'-FL, 3'-SL, 6'-SL, DFL and LNT at a concentration of 8 to 35% w/w of the composition, a pH modulator, the pH of such aqueous composition ranges from 5.5 to 6.5 and doesn’t comprise other nutrients in addition to the oligosaccharides (pg. 24, lines 19-26). The pH modulator can be a buffering agent (pg. 14, lines 1-3). The composition can be in form of a supplement or fortifier for preterm infants (pg. 1, lines 5-14, pg. 26, lines 11-21). According to Cleveland Clinic the phrase “preterm birth” occurs when a baby is born at 37 weeks or earlier (pg. 1, para. 1). A person of ordinary skill in the art upon reading the reference would recognize administering the composition following birth (i.e. within the first week, days 1-7). Marzorati teaches in an alternative embodiment the composition comprises 2'-FL and LNnT in a ratio of 10:1 (pg. 11, lines 8-9). 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). Although Marzorati does not describe at what days the increase in length or head circumference is following administration, Marzorati teaches the general method of administering these two oligosaccharides in the claimed amounts to preterm infants, the claimed increase in growth 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)).
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 on PTO-892).
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. reducing the time 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). 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, 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)).
Modified/New 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.
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) and Cleveland Clinic (Preterm Birth, 2026, cited on PTO-892) as applied to claims 1, 3-5, 7, 9, 12, and 14 above in view of McSweeney (Food Hydrocolloids, 2004, cited on PTO-892).
Regarding claim 6: As discussed above Garcia teaches 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)).
Claim 13 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) and Cleveland Clinic (Preterm Birth, 2026, cited on PTO-892) 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 claim 13: Regarding claim 6: 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)).
Maintained 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, and 12-14 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 specification). 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).
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.
Response to Arguments
Applicant’s arguments filed January 30, 2026 the claims have been fully considered but they are not persuasive.
On page 6 of Applicant’s response, Applicant argues Marzorati is silent regarding postnatal growth, such as increase in head circumference or length. Marzorati is silent to administering the composition to the preterm infant since birth (paras. 5-7). Applicant argues that because Marzorati does not specifically teach these limitations, Marzorati cannot anticipate the present claims.
However, given that Marzorati teaches the claimed composition and teaches it is to be administered to preterm infants as soon as possible following birth, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination (See MPEP 2131.02 (II). Thus, as soon as possible after birth, would anticipate a claim that includes day 1 of life, as it being the soonest possible time frame. Additionally, given that Marzorati teaches the claimed composition in the claimed amounts and administers it to the claimed subject population the result of increased head circumference and body length an inherent property of the method. 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 2112 (II)).
On page 7 of Applicant’s response, Applicant has amended the claims to incorporate dependent subject matter which was not anticipated over De Castro, Morrow, and Garcia-Rodenas, and as such these 102 rejections should be withdrawn (paras. 1-5).
See modified 103 rejections above.
On page 7 of Applicant’s response, Applicant argues Garcia-Rodenas is entirely directed to the intestinal motility, such as promoting the growth and/or development of intestinal muscles in an infant, but does not disclose a preterm infant or the increase in head circumference and/or length as required by the instant claims (last para.).
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).”. Given that Garcia teaches the claimed composition and teaches it is to be administered to the claimed subject population, preterm infants, the result of increased head circumference and body length an inherent property of the method. 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 2112 (II)).
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 and 103 rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693