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 .
Amendment after Non-final office action filed on September 24, 2025 is acknowledged.
New claims 14-20 have been added.
Claims 1-12 and 14-20 are pending in this application.
Applicant elected without traverse of Group 1 (claims 1-3) and elected infant formula as the species of and optimizing the growth factor and/or the development in an infant or child in the reply filed on May 13, 2025. Restriction was deemed to be proper and was made FINAL in the previous office action. Claims 4-12 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 1-3 and 14-20 are examined on the merits in this office action.
Withdrawn Objections
Objection to the abstract is hereby withdrawn in view of Applicant’s amendment to the abstract.
Objection to claim 1 is hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained and Revised Rejection
U.S.C. 102
8. 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.
9. 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.
10. Claim(s) 1-3 and 14-16 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu patent (US Patent No. 6312755, filed with IDS). This rejection is maintained and revised in view of Applicant’s amendment to the claims.
11. Wu patent teaches a method of making an alpha-lactalbumin enriched whey protein product, the method involves the treatment of a whey protein product with an acid to lower the pH of the whey protein product to 4.0 or below, and the pH lowering step allows alpha-lactalbumin molecules to be concentrated more efficiently (see abstract). Wu patent teaches a method of processing whey to obtain a filtrate or precipitate having a high concentration of alpha-lactalbumin. The method involves the addition of an acid during the processing method to lower the pH of the whey to less than 4.0, with a preferred pH range being from about 3.3-3.8. The pH adjustment results in an enriched alpha-lactalbumin fraction after further processing. This pH adjustment process may be accommodated to membrane filtration and precipitation methods (see column 2, lines 17-25). Wu patent teach that the pH of the unconcentrated or concentrated why is then lowered to pH 4.0 or below as already described…This pH lowering steps causes the calcium ions to disassociate from the alpha-lactalbumin molecules (see column 4, lines 12-16). Wu patent teaches that the retentate is then ultrafiltered, and optionally, diafiltered with deionized water until the calcium to protein ratio is less than about 0.001, and preferably less than about 0.0004 (see column 4, lines 17-20), meeting the limitation of instant claim 1. Wu patent further teaches that the precipitation of alpha-lactalbumin and other proteins is induced by diluting the retentate with deionized water. The purpose of dilution is to facilitate precipitate formation and promote subsequent separation…the pH is then adjusted to a range of 4-5, and a preferred range of 4.5-4.7 (see column 4, lines 27-33), meeting the limitation of instant claim 1 sub-steps (I) and (II). Wu patent teaches the precipitated protein (alpha-lactalbumin, BSA, Ig) can be separated from the soluble proteins (beta-lactoglobulin and casein peptides) by centrifugation or microfiltration. The precipitate stream is alpha-lactalbumin-enriched and can be dried or neutralized…The stream containing the soluble proteins is low in fat and can be made into whey protein isolate after further concentration (see column 4, lines 39-45), meeting the limitation of instant claim 1 sub-step (III), in part. Wu patent further teaches that the alpha-lactalbumin concentrate may be included in a variety of food products, especially nutritional formulas. Such formulas include infant formulas, adult nutritional formulas, sport formulas, medical formulas and enteral formulas (see column 4, lines 52-56), meeting the limitation of instant claims 1 sub-step (III) and 14. Wu patent additionally teach the method of processing whey to obtain a protein fraction having a high concentration of alpha-lactalbumin (see column 1, lines 64-67) and a low concentration of beta-lactoglobulin (see column 2, lines 1-3), meeting the limitation of instant claim 16. Wu patent is silent as to the isolated cholesterol. Therefore, this meets the limitation of instant claim 15.
Since the WU patent teaches ALL of the active method steps, the alpha-lactalbumin enriched whey protein extract (WPE) would be a source of cholesterol in a synthetic nutritional composition (i.e., infant formula). Additionally, the method would produce WPE with a cholesterol content in the ranges from 90-150 mg/L of instant claim 2. Furthermore, with respect to “wherein the effective amount of the alpha-lactalbumin enriched WPE also optimizes the concentration of alpha-lactalbumin in said synthetic nutritional composition for an infant or child…(claim 3)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Since ALL of the active method steps are taught by Wu patent, the method would inherently produce the same WPE as a source of cholesterol in the same synthetic nutritional composition (i.e., infant formula). Therefore, Wu patent anticipates instant claims 1-3 and 14-16.
Response to Applicant’s Arguments
12. Applicant argues that “Wu fails to teach or suggest alpha-lactalbumin enriched whey protein extract (WPE) as a source of cholesterol…fails to teach the active step of adding the alpha-lactalbumin enriched WPE to the synthetic nutritional composition in an effective amount sufficient to ensure that said synthetic nutritional composition has a final concentration of cholesterol found in human breast milk as required by the present claims.”
13. Applicant’s arguments have been fully considered but are not found persuasive. Wu patent explicitly teaches that “drying the alpha-lactalbumin (alpha-La) concentrate allows for easier packaging and the product remains stable for a longer period of time than raw concentrate in liquid or frozen from…the alpha-La concentrate may be included in a variety of foods, supplements, infant formulas, etc., (see column 4, lines 1-7). Wu patent explicitly teaches that “these food products are conventionally formulated in a liquid form…” (see column 4, lines 58-67). Thus, the active step of “adding” is inherent. Wu patent further teaches that “Whey protein have been used in infant formula and as a protein source in nutritional mixtures for humans and animals. Since beta-lactoglobulin (beta-lg) is not a protein found in human breast-milk, it acts as an allergen to infants. It is therefore desirable for whey proteins in breast-milk substitutes to have either a low concentration of beta-lg to reduce the concentration of allergen of a relatively high concentration of alpha-La to make it more similar to human milk” (see column 1, lines 35-42). Thus, the method for preparing a synthetic nutritional composition comprising an alpha-lactalbumin enriched whey protein extract (WPE) as a source of cholesterol the method comprising all of the active method steps of instant claims are anticipated by Wu patent. Thus, the rejection is deemed to be proper and is maintained and revised herein.
New Rejections
U.S.C. 112(b)
14. 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.
15. Claim 18 is 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.
16. Claim 18 recites, “The method of claim 1, wherein a protein content of the synthetic nutritional composition is at most 20 g/L.” It is unclear what recitation of “protein content” is referring to. Claim 1 refers to whey protein extract (WPE), acidified why protein product, and proteins in the precipitate from the soluble protein. The metes and bounds of the claim is unclear.
U.S.C. 103
17. 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.
18. 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.
19. 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.
20. 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.
21. Claim(s) 1-3 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu patent (US 6312755, filed with IDS) in view of Davis et al (US 2005/0142249).
22. Wu patent teaches a method of making an alpha-lactalbumin enriched whey protein product, the method involves the treatment of a whey protein product with an acid to lower the pH of the whey protein product to 4.0 or below, and the pH lowering step allows alpha-lactalbumin molecules to be concentrated more efficiently (see abstract). Wu patent teaches a method of processing whey to obtain a filtrate or precipitate having a high concentration of alpha-lactalbumin. The method involves the addition of an acid during the processing method to lower the pH of the whey to less than 4.0, with a preferred pH range being from about 3.3-3.8. The pH adjustment results in an enriched alpha-lactalbumin fraction after further processing. This pH adjustment process may be accommodated to membrane filtration and precipitation methods (see column 2, lines 17-25). Wu patent teach that the pH of the unconcentrated or concentrated why is then lowered to pH 4.0 or below as already described…This pH lowering steps causes the calcium ions to disassociate from the alpha-lactalbumin molecules (see column 4, lines 12-16). Wu patent teaches that the retentate is then ultrafiltered, and optionally, diafiltered with deionized water until the calcium to protein ratio is less than about 0.001, and preferably less than about 0.0004 (see column 4, lines 17-20), meeting the limitation of instant claim 1. Wu patent further teaches that the precipitation of alpha-lactalbumin and other proteins is induced by diluting the retentate with deionized water. The purpose of dilution is to facilitate precipitate formation and promote subsequent separation…the pH is then adjusted to a range of 4-5, and a preferred range of 4.5-4.7 (see column 4, lines 27-33), meeting the limitation of instant claim 1 sub-steps (I) and (II). Wu patent teaches the precipitated protein (alpha-lactalbumin, BSA, Ig) can be separated from the soluble proteins (beta-lactoglobulin and casein peptides) by centrifugation or microfiltration. The precipitate stream is alpha-lactalbumin-enriched and can be dried or neutralized…The stream containing the soluble proteins is low in fat and can be made into whey protein isolate after further concentration (see column 4, lines 39-45), meeting the limitation of instant claim 1 sub-step (III), in part. Wu patent further teaches that the alpha-lactalbumin concentrate may be included in a variety of food products, especially nutritional formulas. Such formulas include infant formulas, adult nutritional formulas, sport formulas, medical formulas and enteral formulas (see column 4, lines 52-56), meeting the limitation of instant claims 1 sub-step (III) and 14. Wu patent additionally teach the method of processing whey to obtain a protein fraction having a high concentration of alpha-lactalbumin (see column 1, lines 64-67) and a low concentration of beta-lactoglobulin (see column 2, lines 1-3), meeting the limitation of instant claim 16. Wu patent is silent as to the isolated cholesterol. Therefore, this meets the limitation of instant claim 15.
Since the WU patent teaches ALL of the active method steps, the alpha-lactalbumin enriched whey protein extract (WPE) would be a source of cholesterol in a synthetic nutritional composition (i.e., infant formula). Additionally, the method would produce WPE with a cholesterol content in the ranges from 90-150 mg/L of instant claim 2. Furthermore, with respect to “wherein the effective amount of the alpha-lactalbumin enriched WPE also optimizes the concentration of alpha-lactalbumin in said synthetic nutritional composition for an infant or child…(claim 3)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Since ALL of the active method steps are taught by Wu patent, the method would inherently produce the same WPE as a source of cholesterol in the same synthetic nutritional composition (i.e., infant formula). Therefore, Wu patent anticipates instant claims 1-3 and 14-16.
The difference between Wu patent and the instant claims is that the Wu patent does not teach milk, lactose, vegetable oils, and fat soluble vitamins in water to create a blend, and the concentration of WPE.
23. However, in regards to claims 14 and 16, Davis et al teach infant formula comprising alpha-lactalbumin (28%-40%) and beta-lactoglobulin (8-33%) (see abstract). In regards to claims 19-20, Davis et al teach that the “present infant formula may be prepared by blending appropriate quantities of an alpha-lactalbumin-enriched whey protein concentrate with skimmed milk, lactose, vegetable oils and fat soluble vitamins in deionized water…the mixture is then homogenized and cooled (see for example, paragraph [0031]). In regards to claim 15, Davis et al is silent as to isolated cholesterol. In regards to claims 17-18, Davis et al teach that prominent quantitative differences include a lower total protein content of human milk (11 g/L) compared to cow’s milk (33 g/L) (see paragraph [0004]). Davis et al teach that most current infant formulas made with unmodified bovine milk as the only protein source contain about 15-16 g/L of protein, are casein-predominant and contains only 0.5 g/L of alpha-lactalbumin (see paragraph [0035]). Davis et al teach the following amount of alpha-lactalbumin and beta-lactoglobulin in the infant formula:
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218
478
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Greyscale
(see Table 3). Thus, Davis et al teach that the total protein is 14 g/L.
24. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wu patent and Davis et al, since both references teach a method of preparing a synthetic nutritional composition that is an infant formula comprising an alpha-lactalbumin. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Davis et al teach that additional components may be added and blended to reduce adverse effects of feeding formula to infants. The MPEP states the following: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” Therefore, one of ordinary skill in the art would be motivated to combine and optimize with a reasonable expectation of success.
CONCLUSION
No claim is allowed.
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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
1/5/2026
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