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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/EP2019/083932 filed 12/06/2019, which claims the benefit of the priority of European Patent Application No. 18215528.3 filed 12/21/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-2, 6, 8-18, 20-25 are pending. Claims 1-2, 6, 8-11, 13-18, 20, 22 are amended. Claims 23-25 are new. Claims 1-2, 6, 8-18, 20-25 are being examined on the merits in this office action.
Claim Objections - Withdrawn
The objection to claim 13 is withdrawn in view of the claim amendment.
Claim Rejections - 35 USC § 112 - Withdrawn
The rejection of claims 11 and 22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 103 – Maintained and updated
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.
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.
This rejection has been updated to include the rejection of new claims 23-25.
Claims 1-2, 6, 8-18, 20-25 remain rejected under 35 U.S.C. 103 as being unpatentable over O’Regan et al. WO2018202636A1 (hereinafter “O’Regan”-cited and enclosed in the previous office action) in view of Bovetto et al. WO 2012/045801A1 (hereinafter “Bovetto” - cited and enclosed in the previous office action) and Degonda et al. US 2014/0242050A1 (hereinafter “Degonda” - cited and enclosed in the previous office action).
O’Regan teaches an infant composition that comprises protein sources (e.g., α-Lactalbumin-enriched whey protein concentrate), carbohydrate sources (e.g. lactose), and lipid sources (e.g. Docosahexaenoic acid) (See Table 1, on page 10-11). O’Regan further teaches a composition that comprises Whey, lactose, lipids, vitamins and minerals and alpha-lactalbumin and that the amount of alpha-lactalbumin is 2.3 g of 9.5 of alpha-lactalbumin enriched WPE (See Table 5 on page 17). Examiner notes that 2.3 of 9.5 is about 24% which reads on ALAC is 20-35%.
O’Regan does not teach that lactoferrin form an ionic complex with acid milk protein, does not teach the energy density as recited in claim 12 and does not teach the method as recited in claim 13.
Bovetto teaches a composition comprising a complex of beta-lactoglobulin, alpha- lactalbumin and that the composition comprises a complex between lactoferrin and the other protein e.g., beta-lactoglobulin, alpha-lactalbumin (Claims 1-2; Page 3, line 9-14; Page 4 line 18-23). Bovetto teaches that the composition comprises carbohydrate and proteins (Page 2, line 4-5). Bovetto teaches the ζ-potential as a function of pH for LF, B-lactoglobulin (BLG) and a LF/BLG mixture at 0.1 wt% (total protein concentration) and that BLG is positively charged for pH below its IEP, i.e. 4.5. The ζ-potential then turns into negative for higher pH values and teaches a ratio of 1:1 ( See Fig. 3; Page 12, line 28-33). Bovetto teaches that the complex forms at pH range of 4.0 to 8.0 (claim 5). Bovetto further teaches wherein the complex coacervate has a ζ-potential of between + 15 and -15 mV (claim 4). Bovetto teaches that the composition of the present invention may also be used in increasing satiation and/or prolonging satiety (Page 9, line 23-24). Bovetto teaches that the composition is easy to prepare and to incorporate into food products and that exhibits a delayed digestion, so that it allows an improved metabolic control and a reduced food intake (Page 3, line 4-8). Bovetto further teaches Lactoferrin and the at least one other protein e.g. alpha-lactalbumin, may be present in a weight ratio in the range of 5:1 to 1:5, e.g., 3:1 to 1:3, or 2:1 to 1:2 (Page 6, line 20-22).
Degonda teaches a nutritional composition that can also be an infant formula that comprises a protein source such as whey, or protein sources based on whey, casein and mixtures thereof, or may be based on acid whey or sweet whey or mixtures thereof and may include alpha-lactalbumin and beta-lactoglobulin [0041], that the composition further comprises a carbohydrate source conventionally such as lactose, saccharose, maltodextrin, starch and mixtures thereof [0043], that the composition further comprises a source of lipids such as linoleic and α-linolenic acid [0044]. Degonda teaches the composition for improving the maturation of sleep patterns in infants, young children or young animals and/or for reducing sleep disturbances and/or improving sleep patterns (Abstract, claim 1). Degonda teaches that the composition reduces sleep disturbances and improve sleep patterns in different phases of the life [0011]. Degonda teaches that the composition comprises Fe, Vit B12, Vit D in the amounts of 1.2mg/100kcal, 0.3mg/100kcal and 1.5 mg/100kcal respectively (Example 1 in [0060]). Degonda teaches that the energy is 100 kcal per liter (Example 1 in [0060]), which translates to about 10 kcal/ 100ml.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of O’Regan and include a lactoferrin-based complex with milk protein acid such as alpha-lactalbumin in the infant composition as taught by Bovetto because Bovetto teaches that the composition comprising the complex induced delayed protein digestion improving satiety (Abstract). Further it would be obvious to modify O’Regan and prepare the composition wherein the Lactoferrin and the at least one other protein e.g. alpha-lactalbumin is in the recited ratio since Bovetto teaches that the composition provided improved satiety (Abstract). Further it would be obvious to modify O’Regan with the teachings of Degonda and prepare a composition with the excipients and energy density as taught by Degonda since Degonda teaches that the composition was effective for improving the maturation of sleep patterns in infants, young children or young animals and/or for reducing sleep disturbances and/or improving sleep patterns (Abstract, claim 1). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the teaching of O’Regan with the teachings of Bovetto and Degonda so as to have a composition for use to increase satiety and improve sleep patterns. The disclosures render obvious claim 1 and 13.
Regarding claim 2, Degonda teaches that protein sources based on whey, casein and mixtures thereof may be used [0041], and that and that the composition may have whey and casein (for example 70% whey and 30% casein) [0060, 0061]. Examiner notes that the discloses ration falls between the instantly recited ratio.
Regarding claims 6 and 18, Bovetto teaches a composition comprising a complex of beta-lactoglobulin, alpha- lactalbumin and that the composition comprises a complex between lactoferrin and the other protein e.g., beta-lactoglobulin, alpha-lactalbumin (Claims 1-2; Page 3, line 9-14; Page 4 line 18-23) and that the milk proteins such as whey are preferred. Bovetto further teaches that the LF/BLG mixture at 2 wt% (Page 17, line 28-30). It would have been obvious to modify the composition of O’Regan wherein the lactoferrin in the ionic complex is between 1-20%.
Regarding claim 8, Bovetto teaches that the ζ-potential as a function of pH for LF, B-lactoglobulin (BLG) and a LF/BLG mixture at 0.1 wt% (total protein concentration) and further teaches on Fig. 1, the LF/ALAC mixture at 0.1 wt% (total protein concentration) and Fig. 1 shows that at pH of 7, the ζ-potential is between -10 and -20 (See Fig. 1; Page 12, line 28-33). It would have been obvious to modify the teachings of O’Regan and include a lactoferrin-based complex with milk protein acid such as alpha-lactalbumin in the infant composition with the ζ-potential taught by Bovetto.
Regarding claim 9, O’Regan teaches a composition that comprises lipids such as linoleic acid, DHA and ARA (See Table 5 on Page 17-18).
Regarding claim 10, O’Regan teaches a composition that comprises carbohydrate at 73.6g and that 68.6g of it is lactose (See Table 5 on Page 17-18). This reads on at least 90%.
Regarding claims 11 and 22, Degonda teaches a composition that comprises Fe, Zn, Mg, Vitamin D, K, and Vitamin B12, in the amounts of 1.2mg/100kcal, 0.75 mg/100kcal, 7mg/100kcal, 1.5 mg/100kcal, 89mg/100kcal and 0.3mg/100kcal respectively (Example 1 and 2 in [0060-0061]). It would have been obvious to modify O’Regan and include the vitamins and minerals as taught by Degonda so as to arrive to a composition that reduces sleep disturbances and improve sleep patterns.
Regarding claim 12, Degonda teaches that the energy is 100 kcal per liter (Example 1 and 2 in [0060-0061]), which translates to about 10 kcal/ 100ml which reads on the instant claim. Degonda further teaches in Example 2 energy density of 630kcal/L which is 63kcal/100mL which reads on the instant amounts. It would have been obvious to modify O’Regan with the teachings of Degonda to arrive to a composition with the recited energy density.
Regarding claim 13, the instant composition is rendered obvious by the teachings of O’Regan, Bovetto and Degonda. Bovetto teaches that the composition of the present invention may also be used in increasing satiation and/or prolonging satiety (Page 9, line 23-24). Bovetto teaches that the composition is easy to prepare and to incorporate into food products and that exhibits a delayed digestion, so that it allows an improved metabolic control and a reduced food intake (Page 3, line 4-8). Further, Degonda teaches that the composition reduces sleep disturbances and improve sleep patterns in different phases of the life [0011]. It would have been obvious to modify the teachings of O’Regan and use the composition to provide satiety and better sleep as taught by Bovetto and Degonda.
Regarding claim 14, Bovetto teaches that the composition comprising the complex induced delayed protein digestion improving satiety (Abstract). It would have been obvious to modify O’Regan with the teachings of Degonda and use the composition to slow digestion of proteins.
Regarding claims 15-17, Degonda teaches that the subject suffers from disturbed sleep pattern, such as fragmented sleep, nightmares or insomnia [0040], that the composition for improving the maturation of sleep patterns in infants, young children or young animals and/or for reducing sleep disturbances and/or improving sleep patterns (Abstract, claim 1). Degonda further teaches that the composition reduces sleep disturbances and improve sleep patterns in different phases of the life [0011] and that the composition is a starter infant formula or a follow-up infant formula (claim 20). It would have been obvious to modify O’Regan and include the vitamins and minerals as taught by Degonda so as to arrive to a composition that reduces sleep disturbances and improve sleep patterns.
Regarding claim 20, Bovetto teaches the composition comprises a complex between lactoferrin and the other protein e.g. beta-lactoglobulin, alpha-lactalbumin, bovine serum albumin, whey protein isolate, (Page 3, line 9-14; Page 4 line 18-23). Bovetto further teaches Lactoferrin and the at least one other protein may be present in a weight ratio in the range of 5:1 to 1:5, e.g., 3:1 to 1:3, or 2:1 to 1:2 (Page 6, line 20-22). ). It would have been obvious to modify the teachings of O’Regan and include a lactoferrin-based complex with milk protein acid such as alpha-lactalbumin in the infant composition at the ratios taught by Bovetto.
Regarding claim 21, Bovetto teaches the composition comprises a complex with a temperature range of 1 to 50°C, e.g., 10 to 40°C or 15 to 25°C (Page 6, line 16-17). The instant invention defines ambient temperature as 15-25°C. It would have been obvious to modify the teachings of O’Regan and include a lactoferrin-based complex with milk protein acid such as alpha-lactalbumin at temperatures taught by Bovetto.
Regarding claims 23-25, Degonda teaches that protein sources based on whey, casein and mixtures thereof may be used [0041], and that and that the composition may have whey and casein (for example 70% whey and 30% casein) [0060, 0061]. Examiner notes that the discloses ration falls between the instantly recited ratios of claims 23-25. It would have been obvious to one of ordinary skill in the art to prepare the composition wherein the ratio of whey protein to casein is 70:30 as taught by Degonda.
Response to Arguments
Applicant's arguments filed 07/07/2025 have been fully considered but they are not persuasive.
Applicant Argument
Applicant argues that O'Regan does not teach or suggest ionic complexes of lactoferrin and acid milk proteins as required by the claims. O'Regan also fails to disclose the specific lactoferrin-to- protein weight ratios recited in the claims, nor does it provide any surface charge (zeta potential) data associated with such complexes, wherein the ionic complexes have a negative charge at the pH of the infant formula, as required by the claims. These deficiencies cannot be remedied by Bovetto and Degonda, alone or in combination.
Applicant argues that Bovetto does not disclose, teach, or suggest the use of ALAC-enriched whey proteins at the claimed concentration range (20-35 wt%). The zeta potential data in Bovetto relate solely to lactoferrin and 3-lactoglobulin mixtures under specific test conditions unrelated to infant formula formulations and that a skilled artisan would have no rationale to combine ALAC-enriched whey proteins as described in O'Regan with the ionic coacervates of lactoferrin and other proteins disclosed in Bovetto to achieve the claimed nutritional composition. Nor is there any indication that such a combination would provide beneficial nutritional outcomes such as improved satiety or sleep in infants.
Applicant argues that Degonda discloses infant nutritional compositions intended to improve sleep quality in infants, containing common protein sources such as whey and casein along with carbohydrates, lipids, and vitamins. However, Degonda does not disclose or suggest the formation of protein complexes involving lactoferrin or ALAC, nor any coacervation or ionic complexation features as required by the claims.
Applicant argues that Degonda discloses in Example 1 in [0060] is an energy density of 670 kcal per liter, which translates to 67 kcal/100 ml-which is outside of the claimed range of less than 65 kcal/100ml.
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that O’Regan teaches an infant composition that comprises protein sources (e.g., α-Lactalbumin-enriched whey protein concentrate), carbohydrate sources (e.g. lactose), and lipid sources (e.g. Docosahexaenoic acid) (See Table 1, on page 10-11). O’Regan further teaches a composition that comprises Whey, lactose, lipids, vitamins and minerals and alpha-lactalbumin and that the amount of alpha-lactalbumin is 2.3 g of 9.5 of alpha-lactalbumin enriched WPE (See Table 5 on page 17). Examiner notes that 2.3 of 9.5 is about 24% which reads on ALAC is 20-35%. Examiner notes that O’Regan teaches all the components of the instant composition but O’Regan does not teach that lactoferrin form an ionic complex with acid milk protein. However, this limitation is cured by Bovetto teaches a composition comprising a complex of beta-lactoglobulin, alpha- lactalbumin and that the composition comprises a complex between lactoferrin and the other protein e.g., beta-lactoglobulin, alpha-lactalbumin (Claims 1-2; Page 3, line 9-14; Page 4 line 18-23). Bovetto teaches that the composition comprises carbohydrate and proteins (Page 2, line 4-5). Further, Bovetto teaches the ζ-potential as a function of pH for LF, B-lactoglobulin (BLG) and a LF/BLG mixture at 0.1 wt% (total protein concentration) and that BLG is positively charged for pH below its IEP, i.e. 4.5. The ζ-potential then turns into negative for higher pH values and teaches a ratio of 1:1 ( See Fig. 3; Page 12, line 28-33). Bovetto teaches that the complex forms at pH range of 4.0 to 8.0 (claim 5). Bovetto further teaches wherein the complex coacervate has a ζ-potential of between + 15 and -15 mV (claim 4). Bovetto teaches that the composition of the present invention may also be used in increasing satiation and/or prolonging satiety (Page 9, line 23-24). Bovetto teaches that the composition is easy to prepare and to incorporate into food products and that exhibits a delayed digestion, so that it allows an improved metabolic control and a reduced food intake (Page 3, line 4-8). Bovetto further teaches Lactoferrin and the at least one other protein e.g. alpha-lactalbumin, may be present in a weight ratio in the range of 5:1 to 1:5, e.g., 3:1 to 1:3, or 2:1 to 1:2 (Page 6, line 20-22). Examiner notes that the secondary references teach all the missing limitation from O’Regan.
Further, Applicant’s assertion that the zeta potential data in Bovetto relate solely to lactoferrin and 3-lactoglobulin mixtures under specific test conditions unrelated to infant formula formulations and that a skilled artisan would have no rationale to combine ALAC-enriched whey proteins as described in O'Regan with the ionic coacervates of lactoferrin and other proteins disclosed in Bovetto to achieve the claimed nutritional composition is unpersuasive. Examiner notes that indeed the composition of Bovetto is directed to be used in infants and children. Further, Bovetto teaches that the composition comprises a complex of alpha- lactalbumin and lactoferrin and further teaches the instant zeta potential. Examiner notes that indeed one of ordinary skill in the art would be motivated to combine the teachings of O’Regan and Bovetto to arrive to the instant composition because both references teach compositions that comprise the instant ingredients, and teach that the compositions are used for infants, and Bovetto teaches that the composition improves satiety.
Applicant’s argument that Degonda does not disclose or suggest the formation of protein complexes involving lactoferrin or ALAC, nor any coacervation or ionic complexation features as required by the claims. This argument is unpersuasive. This teaching or limitation is already taught by Bovetto and the motivation to combine is to improve satiety on the infant. Examiner notes that the Degonda reference teaches all the components of the claimed composition, i.e. proteins, carbohydrates and lipids. Further, Applicant’s assertion that the energy density of Degonda is outside of the claimed range of less than 65 kcal/100ml is unpersuasive. Examiner notes that Degonda teaches in Example 2 energy of 65 kcal/100ml which reads on the instant amounts.
Examiner notes that it appears that Applicant is arguing the references individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145 (IV). In response to Applicant’s assertion that the primary reference O’Regan does not teach ionic complexes of lactoferrin and acid milk proteins, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). MPEP 2145 (IV). Further, Bovetto teaches an infant composition comprising teach ionic complexes of lactoferrin and acid milk proteins. Examiner notes that the cited references all teach infant compositions comprising proteins, carbohydrates and lipids and all the limitations of the instant claims are taught by the cited references. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981) (See MPEP 2145 (III). The arguments are unpersuasive and the rejection is maintained.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LI N KOMATSU/Primary Examiner, Art Unit 1658