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, 8-11, 13-18, 20, 22-27 are pending. Claims 1, 8, 13 are amended. Claims 3-5, 7, 12, and 19, 21 are canceled. Claims 26-27 are new. Claims 1-2, 6, 8-11, 13-18, 20, 22-27 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Claim Objections - Withdrawn
The objection to claim 13 is withdrawn in view of the claim amendment.
Claim Rejections - Withdrawn
The rejection of claims 1, 8, and 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the claim amendments.
The rejection of claims 1-2, 6, 8-9, 13-14, 18, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US20160193302A1 – hereinafter “Wang”) in view of Bovetto et al. (WO 2012/045801A1 - hereinafter “Bovetto”) is in view of the claim amendments.
The rejection of claims 10-11, 15-17, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US20160193302A1 – hereinafter “Wang”) in view of Bovetto et al. WO 2012/045801A1 (hereinafter “Bovetto”) as applied to claim 1 and 13 above, and further in view of Degonda et al. US 2014/0242050A1 (hereinafter “Degonda”) is in view of the claim amendments.
Claim Rejections - 35 USC § 101 - New
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 6, 9-10, 13, 18, 20, and 23-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Claim 1 recites a nutritional composition that comprises proteins, carbohydrates and lipids, wherein the acid milk proteins comprises whey protein enriched with ALAC at 20-30% of the whey protein, comprise casein, and the weight ratio of lactoferrin and ALAC is 1:0.25 to 1:3, and comprise ionic complexes of lactoferrin with acid milk protein, which is not markedly different from its naturally occurring counterpart because it conveys the same composition as human, camel or bovine milk. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. This judicial exception is not integrated into a practical application because the composition being claimed is naturally occurring. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the following reasons.
The rationale for this determination is explained below and is based on the analysis presented in the USPTO's "2014 Interim Eligibility Guidance" as set forth on December 16, 2014, Revised Guidance set forth on May 2016, and 2019 Revised patent Subject Matter Eligibility Guidance set forth on January 7, 2019. Please see MPEP 2106.
Step 1 : Is the claim to a process, machine, manufacture or composition of matter? The instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2a Prong 1 : Is the claim directed to a law of nature, a natural phenomenon (Product of nature), or an abstract idea? The claims are directed to a natural phenomenon, specifically a natural-based product limitation.
Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? This judicial exception is not integrated into a practical application because the peptides being claimed are naturally occurring.
As evidenced by Abbas et al. (International Researchers, June 2013), Camel milk comprises whey proteins and casein, specifically 1.63 to 2.76 percent casein protein, and α-lactalbumin constitute 25 percent of the total whey protein (Section 1.2.2 -1.2.3). Abbas teaches that the camel milk comprises 0.22mg/ml lactoferrin (Section 1.4.2). Additionally, Nagasawa et al. (J. of Dairy Sc., 12:1651-1659, 1972) teaches that human milk comprises proteins, carbohydrates and lipids, wherein the acid milk proteins comprises ALAC at 32% of the whey protein (See Table 5), that the ratio of casein to lactoferrin is about 1:1 (See Page 1657, right col., 1st paragraph). Additionally, it is known in the art (Croguennec et al. (International Dairy Journal 27 (2012) 34-39) that ionic complexes naturally form with lactoferrin and acid milk protein such as casein and carry a negative charge at natural pH (see Abstract and Introduction on Page 34). Regarding energy density, it is known in the art as taught by Lewis et al. (Advances in Nutrition 16 (2025) 100501), that human milk can have an energy density including 60.7 kcal/100ml (See Table 1-2; Results section, page 6, right col., 1st and 2nd paragraph). Lewis teaches the human milk comprises lipids such as linoleic acid (LA, C18:2) and α-linolenic acid (ALA, C18:3) (Page 4, right col.). Macy et al. (Amer. J. of Diseases of children) teaches that human milk comprises lactose (Page 593, 2nd paragraph; Table 1) and comprises vitamins and elements recited in claims 9-10 (Table 1). Additionally, it is known in the art that the human milk is administered to infants to provide satiety feeling, which is natural process such as nursing. Thus claim 13 is also included in this rejection.
Thus, the instant composition does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not include any elements in addition to the natural product.
In sum, when the relevant steps are analyzed, they weigh against a significant difference. Accordingly, claims 1-2, 6, 9-10, 13, 18, 20, and 23-25 does not qualify as eligible subject matter.
Claim Rejections - 35 USC § 112 -New
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 1-2, 6, 8-11, 13-18, 20, 22-27 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.
Claim 1 recites the limitation "…lactoferrin to the BLG ranges…. " in line 14. There is insufficient antecedent basis for this limitation in the claim. Claim 13 and 20 have a similar issue. Claims 2, 6, 8-11, 14-18, 22-27 are rejected because they depend on the rejected claims.
Claim Rejections - 35 USC § 103 – New
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.
Claims 1-2, 6, 8-9, 13-14, 18, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US20160193302A1 – hereinafter “Wang”) in view of Bovetto et al. (WO 2012/045801A1 - hereinafter “Bovetto”) and Tikanmaki et al. (US20180242608A1 – hereinafter “Tikanmaki”).
Wang teaches an infant composition that comprises a protein source, a lipid source and a carbohydrate source [0059], wherein the protein source includes whey protein or mixtures as well as alpha-lactalbumin and beta-lactoglobulin [0062]. That the carbohydrate source includes lactose, saccharose, maltodextrin, starch and mixtures thereof [0063], and the lipid source includes linoleic and [alpha]-linolenic acid, arachidonic acid and docosahexaenoic acid [0064]. Wang teaches that the protein fraction in whey comprises protein fractions, for example beta-lactoglobulin, alpha-lactalbumin, that preferably at least 75% by weight of the protein source is whey protein [0072]. Examiner notes that this particular disclosure reads on ALAC being 25% of the whey protein. Wang teaches that the composition comprises lactoferrin [0036-0040]. Wang teaches that the lactoferrin can be in the composition in an amount between 0.01 to 100g [0050] and that the protein source which includes ALAC can be in the amount between 1.4 and 100g [0071]. Examiner notes that this disclosure reads on the recitation of the weight ratio of lactoferrin and ALAC. Wang teaches that the composition has an energy density of between 60 and 75 kcal/100ml [0060-0061].
The difference between the teachings of Wang and the instant claims is that Wang does not mention that the lactoferrin and ALAC are in a complex and does not teach the addition of whey protein concentrate as recited in claim 26-27. However, it is known in the art that lactoferrin and ALAC form a complex as taught by Bovetto.
Specifically, Bovetto teaches a composition comprising 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 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). 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).
Regarding the addition of WPC, Tikanmaki teaches a composition that comprises a ratio of whey protein to casein in the range from about 25:75 to about less than 50:50, wherein the composition comprises α-lactalbumin in the amout including 25% or 30% [0003-0008, 0013, 0021], and that the composition comprises whey protein concentrate [0003, 0021, 0031]. Tikanmaki teaches that the composition has a pleasant taste and favorable nutritive composition [0012].
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 Wang 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). Additionally, it would have been obvious to modify Wang include WPC in the composition so as to have a composition with pleasant taste and favorable nutritive composition as taught by Tikanmaki. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the teaching of Wang with the teachings of Bovetto so as to have a composition for use to increase satiety and improve sleep patterns. The disclosures render obvious claims 1 and 13.
Regarding claim 2, Wang teaches that the ration of whey to casein includes 38:12 [0119], which is about 3:1 and thus falls with the instant range.
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 Wang 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 Wang 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, Wang teaches a composition wherein the lipid source includes linoleic and [alpha]-linolenic acid, arachidonic acid and docosahexaenoic acid [0064].
Regarding claim 13, the instant composition is rendered obvious by the teachings of Wang and Bovetto. 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). It would have been obvious to modify the teachings of Wang and use the composition to provide satiety as taught by Bovetto.
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 Wang with the teachings of Bovetto and use the composition to slow digestion of proteins.
Regarding claim 20, Wang teaches that the lactoferrin can be in the composition in an amount between 0.01 to 100g [0050] and that the protein source which includes ALAC can be in the amount between 1.4 and 100g [0071]. Examiner notes that this disclosure reads on the recitation of the weight ratio of lactoferrin and ALAC. Further, 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 Wang and include a lactoferrin-based complex with milk protein acid such as alpha-lactalbumin in the infant composition at the ratios taught by Bovetto.
Claims 10-11, 15-17, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US20160193302A1 – hereinafter “Wang”) in view of Bovetto et al. WO 2012/045801A1 (hereinafter “Bovetto”) and Tikanmaki et al. (US20180242608A1 – hereinafter “Tikanmaki”) as applied to claim 1 and 13 above, and further in view of Degonda et al. US 2014/0242050A1 (hereinafter “Degonda”).
The teachings of Wang, Bovetto, and Tikanmaki are disclosed above and incorporated herein by reference.
Wang teaches that the composition comprises vitamin B12, vitamin D, iron, magnesium, zinc, potassium, but does not teach the concentrations as recited in claim 11.
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]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang with the teachings of Degonda and prepare a composition with the excipients 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 Wang with the teachings of Degonda so as to have a composition for use to increase satiety and improve sleep patterns.
Regarding claim 10, Degonda teaches a composition that comprises carbohydrate and the only carbohydrate in the composition is lactose which reads on 100% (See Example 1 on [0060]). It would have been obvious to modify Wang and include lactose as the carbohydrate so as to arrive to a composition that reduces sleep disturbances and improve sleep patterns.
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 Wang 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 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 Wang 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 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, see Applicant Arguments, filed 05/21/2026, with respect to the rejection(s) of claim(s) 1-2, 6, 8-11, 13-18, 20, 22-25 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 Tikanmaki et al.
Conclusion
Due to new grounds of rejection, this action is Non-Final.
No claims are allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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