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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 1, 2025 has been entered.
Status of Claims
Claims 17-23, 26-31 and 33-43 are pending in this application. Claims 26-31 and 33-40 are withdrawn. Claims 17-23 and 41-43 are under examination. Any objections or rejections not repeated below have been withdrawn.
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.
Claims 17-22 and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Van Goudoever et al. US 20150272191, in view of Erabit et al. WO 2018178271 (cited on IDS dated 06/07/2022), as evidenced by European Commission, Chlorate, May 23, 2017 Action Plan, Website: https://food.ec.europa.eu/plants/pesticides/maximum-residue-levels/chlorate_en# (cited on IDS dated 05/15/2023; hereinafter European Commission).
Please note the rejection below is based off of paragraph numbers added to the PE2E English translation of Erabit and European Commission references supplied with the rejection.
Regarding claims 17-21 and 42-43, Van Goudoever teaches an edible composition comprising non-dairy protein selected from vegetable protein, where in one embodiment the protein can be a combination of vegetable protein and algal protein, as required by claims 17, 21 and 43, where the vegetable protein is rice protein, as required by claim 19 and 21, and the algal protein is spirulina, as required by claim 20 and 21 (infant formula containing protein, where the protein is from rice protein isolate and spirulina ; Abstract, [0178], Table 6 pg. 23, [0396]).
Van Goudoever does not state the amount of non-dairy protein in the edible composition, as required by claims 17 and 43, but only states the amount of protein in the liquid form of the edible composition (infant formula; [0031]).
Erabit teaches a preparation of a non-dairy protein selected from vegetable protein for use in baby food, such as infant formula [0001], [0004], where the vegetable protein may be soy protein, rice protein, pea protein, etc. [0009]. Erabit teaches the edible composition (infant formulation) has a non-dairy protein (vegetable protein) concentration between 10 to 30 wt. % [0006] [0042]. This is within the claimed range for claims 17 and 43 of 7-30 wt. % of non-dairy protein. Erabit states a formulation with this amount of non-dairy protein (vegetable protein) concentration is a desirable composition that meets European regulations, is able to deliver a dairy free formula, meets stringent requirements in terms of quality and amino acid profile, and infant formulas where vegetable protein is substituted for milk protein generally comprise between 10-30 wt. % vegetable protein [0005-0006], [0042].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Van Goudoever to incorporate the teachings of Erabit by having the amount of vegetable protein within the claimed range because this provides a formulation that is a desirable composition, that meets European regulations, meets stringent requirements in terms of quality and amino acid profile, and infant formulas where vegetable protein is substituted for milk protein generally comprise between 10-30 wt. % vegetable protein, as recognized by Erabit [0005-0006], [0042].
Van Goudoever teaches the non-dairy protein may be non-hydrolyzed (may contain intact proteins; Abstract, [0103]), as required by claims 17 and 43. Additionally, Van Goudoever recognizes that non-hydrolyzed proteins (intact proteins) and other protein types are suitable for infant formula and suitable for a human infant (Abstract, [0001], [0007]).
Van Goudoever is silent as to the amount of chlorate per kg of the non-dairy protein, as required by claims 17, 18 and 43, and the amount of chlorate per 100 g of the edible composition, as required by claims 17, 42 and 43.
Erabit teaches the non-dairy protein (vegetable protein) provides less than or equal to 0.10 mg/kg, or less than or equal to 100 micrograms chlorate per kg of the non-dairy protein (vegetable protein; [0039]). This is within the claimed range of between about 0 to 700 micrograms chlorate per kg of the non-dairy protein required by claims 17 and 43, and within the claimed range of between about 0 to 400 micrograms chlorate per kg of non-dairy protein required by claim 18. Erabit teaches that vegetable proteins must meet the most stringent requirements in terms of quality and food safety, in terms of chlorate, to obtain a safe finished product in compliance with current regulations [0005].
Erabit teaches the edible composition (infant formulation) has contaminant contents lower than the regulatory requirements, specifically taking into account the European (EU) regulations in force [0006]. Thus, the edible composition of Erabit is viewed as meeting the EU regulations in force for chlorate at the time of the application filing date for Erabit in 2018. As evidenced by European Commission, the maximum residue level (MRL) for foods intended for infants and young children in the EU, which includes infant formula, as stated in the May 2017 action plan, is 0.01 mg/kg, or 1 microgram chlorate/100 g edible composition (infant formula) or 10 micrograms chlorate/kg edible composition [0003], [0006]. Therefore, Erabit is viewed as meeting these requirements and the edible composition (infant formula) of Erabit has a MRL of less than 1 microgram chlorate/100g edible composition or less than 10 micrograms chlorate/kg edible composition, since the edible composition of Erabit meets European regulations in force, and specifically has contaminant contents lower than the regulatory requirements [0006]. This is within the claimed range of between 0 to 10 microgram chlorate per 100 g of the edible composition, as required by claims 17 and 43; and within the claimed range of below 66 microgram chlorate per kg edible composition, as required by claim 42.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Van Goudoever to incorporate the teachings of Erabit as evidenced by the European Commission by having the chlorate of the non-dairy protein be less than 100 micrograms per kg and the chlorate content of the edible composition be less than 10 micrograms per 100 g, because being within this range allows the edible composition to have chlorate contaminant contents lower than the regulatory requirements, taking into account the European regulations in force at the time, and meets the most stringent requirements in terms of quality and food safety to obtain a safe finished product, as recognized by Erabit [0005-0006].
Van Goudoever states the edible composition is an infant formula (formula intended as a complete nutrition for infants; [0184]), as required by claim 17.
Van Goudoever teaches the edible composition may be a liquid infant formula (ready-to-use liquid food; [0029]), as required by claim 43. Van Goudoever teaches the liquid infant formula comprises 0.9 to 1.4 g of protein per 100 mL of infant formula [0031]. This overlaps the claimed range of 1.0-3.0 g protein per 100 ml. See MPEP 2144.05(I).
Regarding claim 22, Van Goudoever discloses the edible composition as described above in claim 17. Van Goudoever teaches the edible composition also comprises lipids and digestible carbohydrates [0185].
Van Goudoever discloses the edible composition provides between 7.5 and 12.5 en % non-dairy protein, between 35 and 50 en % lipid, and between 35 and 80 en % carbohydrate [0171], [0185]. It is noted, en is defined by Van Goudoever as energy percentage [0185]. These ranges of Van Goudoever fall within the claimed ranges of non-dairy protein, lipids and carbohydrates.
Regarding claim 41, Van Goudoever discloses the edible composition as described above in claim 17. Van Goudoever teaches the edible composition comprises 1.4-2.1 g non-dairy protein per 100 kcal [0031]. This overlaps the claimed range of 1.5-4.0 g non-dairy protein per 100 kcal. See MPEP 2144.05(I). Van Goudoever teaches in some embodiments the edible composition (proteinaceous composition) does not contain diary protein (does not comprise an animal-milk-derived (e.g., dairy) protein; [0173]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Van Goudoever et al. US 20150272191, in view of Erabit et al. WO 2018178271, as applied to claim 17 above, and further in view of Stahl et al. US 20120177691.
Regarding claim 23, Van Goudoever discloses the edible composition as described above in claim 17. Van Goudoever does not teach the edible composition comprises 2’-fucosyllactose. Stahl teaches a nutritional composition that is suitable for infants and contains 2’-fucosyllactose (Abstract, [0027]), which helps treat and prevent viral infections and enhances vaccination response to vaccination with viral antigens [0018], [0022]. Stahl discloses the composition comprises 0.007 to 20 wt% 2’-fucosyllactose and more preferably 0.15 to 1 wt% [0027], [0029]. This is within the claimed range of 0.075-7.5 wt. % of 2’-fucosyllactose.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Van Goudoever in view of Erabit to incorporate the teachings of Stahl by incorporating 2’-fucosyllactose in the amount stated by Stahl and within the claimed range because it would help treat and prevent viral infections and enhances vaccination response to vaccination with viral antigens, as recognized by Stahl [0018], [0022].
Response to Arguments
Applicant’s arguments, see pgs. 7-9, filed December 1, 2025, with respect to the rejection(s) of claim(s) 17-22 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Van Goudoever et al. US 20150272191, in view of Erabit et al. WO 2018178271, as evidenced by European Commission, Chlorate, May 23, 2017 Action Plan. Thus, Applicant’s arguments with respect to claim(s) 17-22 are moot because the new ground of rejection does not rely on any teaching or matter specifically challenged in the argument.
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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