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 .
Election/Restrictions
In the April 24, 2026 response, claims 1, 4, 5, 9, 10-15, and 21 were amended, claim 3 was cancelled, and claims 22-28 were added. A restriction requirement was made and in the reply filed on August 18, 2026 Applicant elected Group I, claims 1, 4, 5, 9, 22, and 23, without traverse. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 10-15, 21, and 24-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 18, 2026.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “paediatric supplement or human milk fortifier composition” or similar.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 5, 9, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Magliola (CA 2767960) in view of Hansen (US 6753350), Binia (WO 2019008104A1; citations are to US 2020/0305488), and Perrin (US 2013/0011377).
Magliola teaches nutritional supplement compositions for breast-fed infants, “aimed at preserving exclusive breast feeding in infants” and “for use in improving the health of breast-fed infants” (title; abstract; see entire document). In a preferred embodiment, the composition includes a mixture of docosahexaenoic acid (DHA) and alpha-linolenic acid (ALA) (p.9 lines 13-16). A daily dose of 1 ml comprises 45 mg ALA and 20 mg DHA (p.17 lines 10-19). These dosages are within the ranges in instant claim 1.
Magliola further teaches prebiotics including fucosyl oligosaccharides and other human milk oligosaccharides (p.10 lines 28-32, p.11 lines 12-16). The prebiotic dose is 0.1-7 g/day, and “more preferably 0.5 to 3 g/day” (p.12 lines 6-9), which ranges include the range of 2’-FL in claim 1 and the sum of 2’-FL in claim 1 and LNnT in claims 4, 5, and 22. Other suitable nutrients include those in instant claims 4 and 5 (p.7 lines 4-16; claims 2-3) and thiamin (claim 3).
Magliola does not specifically teach eicosapentanoic acid (EPA), 2-fucosyllactose (2’-FL), lacto-N-neotetraose (LNnT), and thiamin monophosphate in claims 1, 4, 5, 22, and 23.
Hansen is drawn to a method for reducing the incidence of intraventricular hemorrhage in preterm infants, involving the administration to those infants of a combination of docosahexaenoic acid and arachidonic acid (abstract; see entire document), substantially free of EPA or “less than about 16 mg EPA/100 kcal” (col. 6 lines 31-47). Hansen teaches including “low EPA tuna fish oil” comprising about 5.6% EPA to mimic “EPA … in the range of that present in breast milk” (col. 8 lines 15-19).
Binia teaches a fortifier composition “for use to supplement the breast milk produced for an infant of up to 1 month of age by a mother who has given birth by C-section”, comprising human milk oligosaccharides among which 2’-FL and LNnT are “particularly beneficial” (para. 0011; see entire document including title; abstract; paras. 0010-14). Binia teaches including 2’-FL at 33-800 mg/L or 400-10000 mg/L, and LNnT at 0.1-43 mg/L or 22-650 mg/L (para. 0061 Table II, para. 0064 Table III). An example formulation comprises thiamin or vitamin B1 at 0.159 mg per 100 kCal (Example 4, Table XVI). Other nutrients include ALA, other polyunsaturated fatty acids in instant claims 4 and 5 (paras. 0072, 0076).
Perrin is drawn to nutritional supplement compositions comprising ALA, DHA, EPA, and vitamin B1, among others (title; abstract; paras. 0013, 0019; claims 1, 2, 24, 28). Perrin teaches vitamin B1 may be provided in a “form selected from one or more of the group consisting of thiamine, thiamine monophosphate, thiamine diphosphate,…” (para.0013). Substituting equivalents known for the same purpose, where the equivalency has been recognized in the prior art, presents strong evidence of obviousness; an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. MPEP §2144.06 (II) (citations omitted).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Magliola, Hansen, Binia, and Perrin and include ALA, DHA, EPA, 2’-FL, LNnT, and thiamin monophosphate at quantities within respective reference guidelines. The skilled person would have been motivated to do so because all are drawn to infant nutritional compositions comprising LC-PUFAs, Magliola teaches including ALA and DHA (at doses within the ranges in instant claim 1), 2’-FL and other human milk oligosaccharides (at 0.1-7 g/day, and “more preferably 0.5 to 3 g/day” (p.12 lines 6-9)), and Hansen and Binia provide further dosage guidelines for EPA, 2’-FL, and LNnT. A person of ordinary skill in feeding infants would know that the feeding volume and nutrient load depend on the infant’s weight as a primary factor, and the skilled person thus could optimize within prior art guidelines. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted). Also it is noted that the claims here are drawn to “pediatric supplement or human milk fortifier”, not infant formulas or breast milk replacement as the main diet for infants. The claims recite a “daily amount” for supplementing an infant’s main diet. Moreover all of the recited nutrients are known as beneficial for human infant growth and development. Thus the fact that the dose ranges are lower than in typical infant formulas is not seen as lending patentable significance or aid in overcoming prima facie obviousness without more.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 5, 9, 22, and 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 4, 5, 9, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 8, 21, 27, and 28 of copending Application No. 18/695455 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a pediatric supplement or human milk fortifier comprising identical ingredients at identical dose ranges or amounts within the ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants states that the provisional double patenting rejection(s) is premature for a terminal disclaimer and will reconsider when claims are found allowable. (Remarks, 10, April 24, 2026.)
The provisional double patenting rejection is maintained for the reasons discussed herein. They will be maintained until Applicant submits properly executed terminal disclaimer or arguments that effectively overcome the rejection(s).
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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