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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/26/2026 has been entered.
Status of Claims and Election/Restriction
Applicant’s remarks and amendment, filed 08/26/2026, are acknowledged. Claims 4, 15, and 20-21 are cancelled. Claims 24-37 are new. Claims 1-3, 5-14, 16-19, and 22-23 were previously found allowable. Claims 1-3, 5-14, 16-19, and 22-37 are pending claims.
Claims 24-37 have been newly added and have not been previously examined. Since Applicant has received an action on the merits for the originally presented invention directed to the composition claims, this invention has been constructively elected by original presentation. Please see 37 C.F.R. 1.142(b) and MPEP 812.03. As stated in MPEP 818.02(a), “The claims originally presented and acted upon by the Office on the merits determine the invention elected by an Applicant in the application, and in any request for continued examination (RCE) which has been filed for the application. Subsequently presented claims to an invention other than that acted upon should be treated as provided in MPEP 821.03.” See Restriction Requirement infra. For these reasons, Claims 33-35, drawn to related sleep-inducing compositions are joined with Claims 1-3, 5-14, 16-19, and 22-23. Claims 1-3, 5-14, 16-19, and 22-35 are examined herein; Claims 36-37, drawn to method claims, are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
RESTRICTION REQUIREMENT
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-3, 5-14, 16-19, 22-23 and 33-35, drawn to a sleep-inducing protein shake, a sleep inducing ready to mix protein shake powder, a stabilizer composition, and a sleep-inducing composition, classified in at least A61K 47/38 and A23L 29/272.
Claim 36, drawn to a method of producing a sleep-inducing ready-to-drink protein shake, classified in at least A23J 3/225 and A23V 2300/26.
Claim 37, drawn to a method of producing a ready-to-mix sleep-inducing protein shake powder, classified in at least A61J 1/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II, and I and III are related as products and processes of making sleep-inducing protein shake composition and stabilizer for said shake composition. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the processes of Inventions II and III does not require the use of a stabilizer composition comprising cellulose gel/gum, a starch, a gellan gum, or combination thereof, which is required by Invention I.
Inventions II and III are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are not obvious variants. Invention II is drawn to a sleep-inducing protein shake, which requires the steps of heating the components to a sterilization temperature by injecting steam into the mixture, and aseptic homogenization. This process is not required in Invention III, which is drawn to a sleep-inducing protein shake powder, which requires screening, blending, and packaging steps not required in Invention II.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention I would require a search in at least A61K 47/38 and A23L 29/272 along with a unique text search; Invention II would not be searched as above and would require a search in at least A23J 3/225 and A23V 2300/26, along with a unique text search; Invention III would require a search in at least A61J 1/00 along with a unique text search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The Examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
The following objections/rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Specification
The use of the trademark in the disclosure have been noted in this application, specifically in paragraphs [0035], [0059], and [0062]. LACTIUM® should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3, 5-14, 16, 19, 22-32, and 35 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.
Claims 1, 19, and 35 contain the trademark/trade name Lactium®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe patented, natural-origin milk protein hydrolysate containing a bioactive decapeptide and, accordingly, the identification/description is indefinite. All claims depending on Claim 1 are also rejected.
Claim 5 is rejected for indefiniteness for the recitation of “further includes a starch”. It is unknown how this starch differs from the starch in Claim 1, i.e. if the at least one stabilizing agent in Claim 1 is a starch, one skilled in the art would not know if the starch referred to in Claim 5 is the same starch, or if it is required to be different. Clarification is requested.
Claim 10 recites “wherein the fiber source has a concentration of about 0.7 g per 1 ounce”. It is unknown what the 1 ounce refers to, i.e. if it is per 1 oz of the composition, or of carbohydrate source, or of something else. Clarification is requested.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 34-35 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 34-35, drawn to sleep-inducing compositions, improperly depend from Claim 36, which is a method claim. For compact prosecution, Claims 34-35 will be interpreted to depend from independent Claim 33, which is drawn to a sleep-inducing composition.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 33-34 are rejected under 35 U.S.C. 102(a1)/(a2) as being anticipated by Larson et al. (US 4,497,800), hereinafter Larson.
Larson teaches a nutritionally complete ready-to-use liquid diet for providing total patient nourishment comprising a source of protein equivalent; a carbohydrate source; a lipid component; nutritionally significant amounts of all essential vitamins and minerals; and stabilizers; all in an acidic aqueous emulsion which can be sterilized (Claim 1; Abstract).
Regarding Claim 33, Larson teaches an example liquid ready to use diet comprising the following components and amounts in a 10L instant diet (Col. 6, lines 45-52; Table in Col. 6-7). Larson teaches its liquid composition to comprise casein hydrolysate, zinc, calcium, magnesium, vitamin A, vitamin K, vitamin E, vitamin D, vitamin B6, vitamin C, folate, and choline (Table)
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With regards to the intended use (“a sleep-inducing composition”), Larson teaches liquid ready-to-use food composition (Claim 12). Nothing precludes the use of the composition of Larson as instantly claimed (see MPEP 2112.02(II), nor does the recitation impart any structural characteristic that would distinguish it from the prior art composition. "It is not invention to perceive that the product which others had discovered had qualities they failed to detect". See 67 USPQ 155, 326 US 242, 249 (1945).
Regarding Claim 34, Larson teaches the protein hydrolysate is comprised of a mixture of amino acids and small peptides, ranging in size from dipeptides to decapeptides (Claim 15).
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 1-3, 5, 9-14, 16, 18-19, 27-29, 32, 35 are rejected under 35 U.S.C. 103 as obvious over Larson, as applied to Claims 33-34 above, in view of Franca, C. (BR 102016008839 A2), and as evidenced by GZCardlo (Diacetyl Tartaric Acid Esters of Mono and Diglycerides (DATEM). Obtained from Wayback Machine on 10/02/2026. Publication date Apr. 9, 2019 from URL: <https://web.archive.org/web/20190409121950/https:/www.gzcardlo.com/product-27.html>).
The anticipatory teachings of Larson have been set forth supra.
Regarding Claims 1 and 18, the claim recites “cellulose gel/gum, a starch, a gellan gum, and any combination thereof” in the alternative. Larson teaches an example liquid ready to use diet comprising the following components and amounts in a 10L instant diet (Col. 6, lines 45-52; Table in Col. 6-7).
As such, Larson teaches the protein; the stabilizing composition by teaching a starch (corn starch), potassium citrate at 0.26%, esters of mono-diglycerides, which reads on the emulsifier; casein hydrolysate, zinc, calcium, magnesium, vitamin A, vitamin K, vitamin E, vitamin D, vitamin B6, vitamin C, folic acid, and choline (Table; Claims 1-2, 4-9). Safflower and soy oil reads on the food additive (Table).
As above, Larson does not expressly tech the casein hydrolysate is Lactium® containing decapeptide per se. However, Larson teaches the protein hydrolysate is comprised of a mixture of amino acids and small peptides, ranging in size from dipeptides to decapeptides (Claim 15).
Franca also teaches a nutritional composition intended for human consumption which affects sleep, and comprises Lactium® a casein peptide, which reduces typical stress and anxiety symptoms, improving sleep quality and sleep balance, vitamins, zinc, magnesium and flavoring (Abstract; Claims 1-2). Franca teaches that the decapeptide is present in Lactium® has been shown to have GABA receptor affinity (p. 2, top paragraph). The composition of Franca should be consumed half to one hour before bed, and helps with stress, anxiety, and difficulty in sleeping (p. 2, top paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Franca to that of Larson and add Lactium® containing decapeptide in the composition of Larson in order to improve upon the nutritional composition of Lactium® and add the benefits provided by Lactium®, which includes reducing symptoms of stress and anxiety, and improving sleep quality.
with regards to the intended use (“a sleep-inducing composition”), Larson teaches liquid ready-to-use food composition (Claim 12). Nothing precludes the use of the composition of Larson as instantly claimed (see MPEP 2112.02(II), nor does the recitation impart any structural characteristic that would distinguish it from the prior art composition. "It is not invention to perceive that the product which others had discovered had qualities they failed to detect". See 67 USPQ 155, 326 US 242, 249 (1945).
Because gellan gum and cellulose gel/gum are recited in the alternative to starch, and Larson has rendered starch obvious, Claims 2-3 are also obvious.
Regarding Claim 5, the corn starch of Larson is present at 1.3% (Table).
Regarding Claim 9, Larson recognizes the suitability of soybean protein (Col. 5, lines 15-19).
Regarding Claim 10, Larson teaches maltodextrin, which reads on the fiber source at about 10.3% by Examiner’s calculation (Table).
Regarding Claim 11, Larson teaches diacetyl tartaric acid esters of mono-diglycerides at 0.02% by Examiner’s calculation, which is near the 0.03% minimum claimed.
Because lecithin is recited in the alternative to other emulsifiers including polyglycerol esters, which Larson teaches, Claim 12 is also obvious.
Regarding Claim 13, Larson teaches phosphorous (Claim 7).
Regarding Claim 14, Larson teaches safflower and soy oil reads on the food additive (Table; Claims 3 and 12).
Regarding Claim 16, Larson teaches liquid ready-to-use food, but does not teach “shake” per se (Claim 1). However, the instant Specification does not define “shake”, and the Examiner gives it the broadest reasonable interpretation to mean that it is a liquid food. As such, the claim is obvious.
Regarding Claims 19, Larson teaches all the claimed components in percentages and not weight in the composition. However, Applicant did not indicate the total amount of composition. an improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
Regarding Claims 27-28, Larson teaches diacetyl tartaric acid ester of mono- and diglycerides (DATEM), which has an HLB (hydrophilic-lipophilic balance) value of is 8 to 10, as evidenced by GZCardlo.
Regarding Claims 29, by Examiner’s calculation, Larson expressly teaches 0.3% oil in its sample composition (Table).
Regarding Claim 32, how protein is derived is not germane to the composition claim. This is a product-by-process claim; however, patentability is based on the product itself. If the product is the same as a product from the prior art, the claim is unpatentable. The MPEP indicates that the process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art”. See MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). In the instant case, the burden is on the Applicant to show that there exists a structural difference when the protein is derived by a fermentation process or via cell culture in comparison to other means, in order to have patentable weight.
Regarding Claim 35, Larson teaches its liquid ready-to-use food composition to comprise 30-43 g protein per liter diet. Applicant did not indicate the total amount of the sleep-inducing composition. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to adjust the amount of protein based on factors inter alia the total volume of the liquid diet.
Claims 6-8, 17, 22-25, and 30-31 are rejected under 35 U.S.C. 103 as obvious over Larson in view of Franca, as applied to Claims 1-3, 5, 9-14, 16, 18-19, 27-29, 32, 35 above, and further in view of Walton et al. (US 2016/0037815 A1; Of record), hereinafter Walton.
Regarding Claim 6, Larson does not teach other citrate salts. Regarding Claim 7, Larson recognizes the use of fish proteins and peptides derived from fish in diet emulsions, but not plant or dairy proteins (Col. 3, lines 14-18). Regarding Claims 17 and 22-23, Larson is silent on the sunflower oil.
Walton also teaches a nutritional composition comprising protein, with calcium caseinate as one source of protein (Claims 1 and 4). Walton teaches embodiments wherein the composition comprises additional minerals including zinc [0077]. Walton expressly teaches compositions comprising calcium, magnesium (Table 3); and teaches embodiments wherein the composition comprises vitamins inter alia A, K, E, D2 and D3, C, pyridoxine, which is the same as vitamin B6, and folic acid which encompasses folate, and choline [0076]. The nutritional composition may be a liquid product such as meal replacement products, hot or cold beverages, carbonated or noncarbonated beverages, juices or other acidified beverages, milk or soy-based beverages, shakes etc. [0032]. As such, Walton is highly compatible with Larson.
Regarding Claim 6, Walton relates the longstanding problems with manufacturing nutritional compositions, particularly liquid formulations, that include protein and calcium HMB, including, but not limited to, interaction issues such as precipitation, sedimentation, stability etc. which is resolved by the use of sodium and potassium citrates ([0038], [0099]). teaches 2 kg potassium citrate and 0.65 kg sodium citrate in 1000 kg composition (Table 3). The Examiner calculates the percentage to be 0.27%, which is within the claimed range.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Walton with Larson and use potassium and sodium citrates in combination, which Walton included in its invention and identified to stabilize the nutritional composition, preventing the interaction or reaction between divalent calcium ions and protein.
Regarding Claims 7-8, Walton teaches that at least one source of protein may include, but is not limited to, intact, hydrolyzed, and partially hydrolyzed protein, which may be derived from milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable (e.g., soy, pea), and combinations thereof [0044]. Non-limiting examples of the protein source include milk protein isolates, milk protein concentrates, casein protein isolates, whey protein concentrates, whey protein isolates, whey protein hydrolysates, sodium or calcium caseinates, soy protein isolates, soy protein concentrates, soy protein hydrolysates, pea protein concentrates etc. ([0044], Claim 4).
It would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date to substitute the casein protein source in Larson with whey protein, pea protein etc. taught by Walton. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
Regarding Claims 17 and 22-23, Walton teaches its nutritional composition comprises fat selected from the group consisting of high oleic safflower oil, high oleic sunflower oil, canola oil, soy oil, and combinations thereof (Claim 3).
It would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date to substitute the safflower and/or soy oil in Larson with sunflower oil or the high oleic sunflower oil taught by Walton. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
Alternatively, one would add the different oils and protein sources taught by Walton and Larson in the composition as these were found suitable for nutritional compositions. Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding Claims 24 and 30, Walton teaches its nutritional composition comprises optional ingredients such as fructooligosaccharides (FOS), galactooligosaccharides ([0072], [0080]). Walton expressly teaches FOS powder at 13.1 kg per 1000 kg of the product, which the Examiner calculates to be equal to 1.31% and is within the claimed range in Claim 25.
Regarding the amount of fiber source in Claim 31, in addition to 1.31% FOS, Walton teaches 32.9 kg soluble fiber in 1000 kg batch of product, which the Examiner calculates to be 3.29%. As such, the total amount of FOS and soluble fiber corresponds to 4.6%, which is within the claimed range.
Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Claim 26 is rejected under 35 U.S.C. 103 as obvious over Larson in view of Franca, as applied to Claims 1-3, 5, 9-14, 16, 18-19, 27-29, 32, 35 above, and further in view of Benyacoub et al. (WO 2011/069987 A1), hereinafter Benyacoub.
Regarding Claim 26, Larson is silent on the milk fat globule membrane.
Benyacoub also teaches nutritional composition, comprising a probiotic and milk fat globule membrane (MFGM), which promote complementary beneficial protective mechanisms and synergy in promoting immune maturation, enhancing or regulating sleep or sleep patterns etc. (Abstract; Claims 1 and 3). While Benyacoub teaches the effect of the combination of MFGM and probiotic, the art also teaches that MFGM can have strong effects on adaptive immune B cells on its own (Fig. 8; p. 23).
The nutritional composition can be an infant formula, infant cereals, baby food or health care nutritional product (Abstract; Claim 2). The infant formula comprises nutrients which are also in the composition of Larson including Vit. A, D, E, K, C B6, and folic acid, choline, Ca, Mg, P, etc. (Example 1).
Benyacoub teaches that its composition contains milk fat globule membrane ranging from 0.1 % to 10% of the total protein of the composition or formula, preferably from 0.5% to 2% of the total protein of the composition or formula (p. 6, lines 17-23).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the MFGM taught in the nutritional composition of Benyacoub in the composition of Larson to obtain a nutritional composition that promote immune maturation and enhance/regulate sleep. The total protein in the example composition of Larson is 464.83 g in 10 L diet, which corresponds to 4.6%. In this example, the MFGM would have a maximum of 0.46% concentration, which is within the claimed range, per the teaching of Benyacoub, i.e. max 10% of the total protein of the composition.
Claims 1-3, 5-14, 16, 18-19, 29, and 32-35 are rejected under 35 U.S.C. 103 as obvious over Hahn et al. (CA 2163379 A1), hereinafter Hahn, in view of Franca.
Hahn discloses a liquid nutritional composition comprising hydrolyzed casein, formulated to provide partial or complete nutrition to patients suffering from a wide variety of ailments and conditions (p. 2, 1st paragraph; Claim 1; Abstract).
Regarding Claims 1, 18, 33-34, Hahn teaches its composition comprises protein, the cellulose gel, 0.4% potassium citrate, lecithin emulsifier, zinc, calcium, magnesium, vitamin A, vitamin K, alpha tocopheryl acetate (vitamin E), vitamin D, ascorbate (vitamin C), folate, choline, and pyridoxine (vitamin B6) (Example 1, Table 1). Hahn also teaches that optional ingredients can be added including fiber, sweetening agents, flavoring agents, coloring agents etc. (p. 8, 1st paragraph).
Hahn does not teach the casein hydrolysate is Lactium® containing decapeptide.
Franca also teaches a nutritional composition intended for human consumption which affects sleep, and comprises Lactium® a casein peptide, which reduces typical stress and anxiety symptoms, improving sleep quality and sleep balance, vitamins, zinc, magnesium and flavoring (Abstract; Claims 1-2). Franca teaches that the decapeptide is present in Lactium® has been shown to have GABA receptor affinity (p. 2, top paragraph). The composition of Franca should be consumed half to one hour before bed, and helps with stress, anxiety, and difficulty in sleeping (p. 2, top paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Franca to that of Hahn and add Lactium® containing decapeptide in the composition of Hahn in order to improve upon the nutritional composition of Lactium® and add the benefits provided by Lactium®, which includes reducing symptoms of stress and anxiety, and improving sleep quality.
Regarding Claim 2, Hahn teaches cellulose gel at 0.126% and teaches microcrystalline cellulose (Table I; Example 1).
Because gellan gum is recited in the alternative to cellulose gel/gum in Claim 1, Claim 3 has been rendered obvious.
Regarding Claims 5 and 10, Hahn teaches maltodextrin as carbohydrate source in commercial compositions, and also expressly teaches its incorporation as preferred (pp. 2-3; p. 5, 2nd to last paragraph; Example 1). Hahn teaches 15.8% hydrolyzed cornstarch, which appears to be the maltodextrin in Example I. Applicant did not indicate the total amount of composition, and there are indefiniteness issues in Claims 5 and 10. Nevertheless, an improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
Regarding Claim 6, Hahn teaches addition of 0.03% sodium citrate and 0.4% potassium citrate, which are within the claimed amounts.
Regarding Claims 7-8, Hahn teaches whey peptides are present in commercial nutritional composition Reabilin HN in combination with casein (Example II, p. 2. Last paragraph).
Regarding the amount in Claim 35, Hahn teaches 3.87% casein hydrolysate in its composition (Example 1, Table 1).
Applicant did not indicate the total amount of the sleep-inducing composition. However, it is within the ordinary skills of an artisan to determine the weight based on the total amount of the composition. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to adjust the amount of protein based on factors inter alia the total volume of the liquid composition.
Because plant protein is recited in the alternative to dairy proteins in Claim 7, Claim 9 has been rendered obvious.
Regarding Claims 11-12, Hahn teaches 0.078% soy lecithin (Table I).
Regarding Claims 13, Hahn teaches calcium phosphate tribasic, which comprises phosphorous (Table I).
Regarding Claims 14, Hahn teaches soybean oil(Table I).
Regarding Claim 16, Hahn teaches liquid nutritional composition, but does not teach “shake” per se (Claim 1). However, in the absence of a definition of “shake” in the instant Specification, the Examiner gives it the broadest reasonable interpretation to be encompassed by liquid nutritional composition.
Regarding Claims 19, Hahn teaches all the claimed components in percentages and not weight in the composition (Example I). However, as noted supra, Applicant did not indicate the total amount of composition, and finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. Id.
Regarding Claim 29, Hahn teaches soybean oil at 0.6%, which is in the claimed range.
Regarding Claim 32, how protein is derived is not germane to the composition claim. This is a product-by-process claim; however, patentability is based on the product itself. If the product is the same as a product from the prior art, the claim is unpatentable. The MPEP indicates that the process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art”. See MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences' distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). In the instant case, the burden is on the Applicant to show that there exists a structural difference when the protein is derived by a fermentation process or via cell culture in comparison to other means, in order to have patentable weight.
Claims 17, 22-25, and 30-31 are rejected under 35 U.S.C. 103 as obvious over Hahn in view of Franca, as applied to Claims 1-3, 5-14, 16, 18-19, and 32-35 above, and further in view of Walton.
The teachings of Hahn, Franca, and Wanton have been set forth supra.
Regarding Claims 17 and 22-23, Hahn is silent on the sunflower oil.
Walton teaches its nutritional composition comprises fat selected from the group consisting of high oleic safflower oil, high oleic sunflower oil, canola oil, soy oil, and combinations thereof (Claim 3).
It would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date to substitute the soybean oil in Hahn with sunflower oil or the high oleic sunflower oil taught by Walton, or use the oils together. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
Alternatively, one would add the different oils and protein sources taught by Walton and Hahn in the composition as these were found suitable for nutritional compositions. Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding Claims 24 and 30, Walton teaches its nutritional composition comprises optional ingredients such as fructooligosaccharides (FOS), galactooligosaccharides ([0072], [0080]). Walton expressly teaches FOS powder at 13.1 kg per 1000 kg of the product, which the Examiner calculates to be equal to 1.31% and is within the claimed range in Claim 25.
Regarding the amount of fiber source in Claim 31, in addition to 1.31% FOS, Walton teaches 32.9 kg soluble fiber in 1000 kg batch of product, which the Examiner calculates to be 3.29%. As such, the total amount of FOS and soluble fiber corresponds to 4.6%, which is within the claimed range.
One would have been motivated to add FOS and the fiber at the concentration taught by Walton as carbohydrate component in the composition of Hahn, which Hahn requires. See In re Levin. Id.
Claims 33-35 are rejected under 35 U.S.C. 103 as obvious over Ribeiro et al. (BR 102019017927 A2), hereinafter Ribeiro, in view of Zou et al. (CN 101502519 A, machine translation in IP.com), hereinafter Zou, as evidenced by Kim et al. (European Journal of Clinical Nutrition (2007) 61, 536-541; Of record), hereinafter Kim.
Regarding Claim 33, Ribeiro discloses the invention of a formulation for nutritious soup composition comprising collagen, Vitamin A, D, E, K, C, B1, B2, B3, B5, B6, B12, choline, Lactium®, calcium, magnesium, zinc etc. (Abstract). Ribeiro recognizes that Lactium® is a biopeptide isolated from casein, which has relaxing properties, and promotes better sleep quality [022]-[024].
Ribeiro does not expressly teach folate. However, the deficiency is cured by Zou. Zou teaches the novel medicinal effects of vitamin B6 and folic acid, particularly relating the tranquilizing, hypnotizing, and synergistic analgesic effect (Abstract; p. 7, last paragraph). Zou describes how folic acid and Vitamin B6 combination induces sleep and prolongs the length of sleep (p. 3, last 2 paragraphs, p. 4, top paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Zou with that of Ribeiro and add folic acid to the composition of Ribeiro already comprising Vitamin B6 and obtain the folic acid-Vitamin B6 combination to induce and prolong sleep.
Furthermore, as a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. In the instant case, both the compositions of Ribeiro and Zou comprises substances that help regulating sleep and has relaxing properties.
Because Ribeiro has taught Lactium® (vide supra), which comprises a bioactive decapeptide (αs1-casein-(f91-100), α-casozepine), as evidenced by Kim, Claim 34 is also obvious. (p. 537, L. Col., 4th paragraph).
Regarding Claim 35, Ribeiro teaches Lactium® concentration ranging from 0.05g to 0.150g in a soup composition (p. 9, last paragraph). Ribeiro expressly teaches an example composition wherein Lactium® is 0.050g [036]-[037].
Regarding the rejections supra, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Conclusion
No claims are allowed.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
