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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8 Jan 2026 has been entered.
Response to Amendment
The 112(b) rejection over claims 2-3 are maintained. See response to arguments below.
The 112(d) rejection over claim 22 is maintained.
The prior art has been maintained. See response to arguments below.
Claims 1-12, 22-23 are currently pending in this Office Action.
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 2-3 is/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.
Regarding Claim 2, the claim recites further comprising at minimum 10 wt% of a milk component; however, it is unclear as to how the claimed composition can comprise up to 90 wt% of a cereal component, if the minimum of each of the other components add up to 19.5% (1wt% fibre + 4wt% protein + 1wt% fat + 2wt% dried fruits or vegetable + 1wt% micronutrients +0.5 wt% additives + 10 wt% milk component).
Claim 3 is rejected based on its dependency on a rejected claim.
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 22 is 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. The claim depends on 19 which has been canceled. 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 § 103
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.
Claim(s) 1, 4-12, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mintel 1 (Cereals and Fruits- cited in IDS filed 12/15/2022) in view of Ekundayo (US 2018/0332883 Al), Favre et al. (WO 2018/215189 A1).
Regarding Claim 1, Mintel 1 discloses a cereal composition for instant preparation with the addition of a liquid (, the cereal composition comprising one or more of the following:
- from 82 wt.% of a cereal component based on dry weight of the cereal composition (pre-cooked rice flour, pre-cooked millet flour, pre-cooked buckwheat flour),
- 4.7 wt. % of fibre based on dry weight of the cereal composition,
- 9.4 wt. % of protein based on dry weight of the cereal composition,
- 3.5 wt. % of fat based on dry weight of the cereal composition,
- from 11 wt. % of dried fruits based on dry weight of the cereal composition (fruit powder, banana, apple, see Ingredients and Nutrition, page 2),
While Mintel 1 discloses several ingredients that may contribute micronutrients (fruit powder, sodium), and also ingredients that may constitute additives (i.e. rice syrup, seaweed), Mintel 1 does not specifically recite comprising:
- from 1 to 10 wt.% micronutrients based on dry weight of the cereal composition,
- from 0.5 to 10 wt.% of additives based on dry weight of the cereal composition.
- at least 0.01 %wt. and a maximum of 15 wt%, based on dry weight of the cereal composition, of a mixture of human milk oligosaccharides, wherein said mixture of human milk oligosaccharides consists of 2-FL, 3-FL, LNT, 3-SL, and 6-SL.
As to the additives, since rice syrup and seaweed are listed on the ingredients after fruit powder, it is construed that Mintel 1 comprises no more than 7 wt% in additives. That is, the ingredients are in order by amount, where 82 wt% is the cereal component, and 11 wt% is the fruit powder, leaving the balance to be about 7 wt%. Since rice syrup and seaweed are listed as the next largest quantity of ingredients, there is a reasonable expectation that Mintel 1 comprises close to 7wt% in additives.
As to the micronutrients, Ekundayo is relied on to teach a cereal composition for instant preparation with the addition of a liquid (see abstract), wherein salt, which is construed as a micronutrient for sodium, can be added to the composition to provide flavor and seasoning (paragraph 43). This can be added in an amount of 0.1 to about 8 wt% of the food composition. Therefore, it would have been obvious to one of ordinary skill in the art to add micronutrients such as sodium based on the desired flavor.
As to the mixture of human milk oligosaccharides, Favre is relied on to teach an infant cereal composition (page 7, second to last paragraph) supplemented with 0 to 2.1 wt% of breast milk oligosaccharide (see abstract and page 17, fourth paragraph). Breast milk oligosaccharides provide the function of modulating infant gut microbiota, and provide the beneficial effects of developing a child’s physiology, metabolism, and immunity (see page 3, third paragraph-page 4 first paragraph). Therefore, since Favre incorporates the mixture of HMOs into infant formulas (ready-to-drink compositions, see page 6 last paragraph), it would have been obvious to one of ordinary skill in the art to incorporate HMOs in similar amounts to impart the health benefits of human breast milk into infant formula. Favre discloses several combinations of suitable HMOs, and identifies 2-FL, 3-FL (page 9, second to last paragraph), LNT (page 10, first paragraph), 3-SL and 6-SL (page 10, second paragraph) as suitable HMOs used in the infant formula. Therefore, since each of 2-FL, 3-FL, LNT, 3-SL, and 6-SL are all known HMOS suitable for infant formula, it would have been obvious to one of ordinary skill in the art to comprise a mixture consisting of 2-FL, 3-FL, LNT, 3-SL, and 6-SL based on the health benefits desired.
Regarding Claim 4, Mintel 1 further teaches wherein the cereal composition is present in a form of powders (pre-cooked flours, fruit powders, see Ingredients (On Pack)).
Regarding Claim 5, Mintel 1 is silent to wherein the liquid is selected from the group consisting of water, milk, and juice. Ekundayo is relied on to further teach a powdered formula that is reconstituted with water or other fluids (see abstract). Since both Mintel 1 and Ekundayo are directed to powdered food composition for instant preparation, it would have been obvious to one of ordinary skill in the art to reconstitute the powder with water.
Regarding Claim 6, Mintel 1 further teaches wherein the cereal component is present in a form of cereal flour (pre-cooked flours, see Ingredients).
Regarding Claim 7, Mintel 1 further teaches wherein the cereal component is wheat, rice, and millet (see Ingredients).
Regarding Claim 8, Mintel 1 further teaches wherein the dried fruits are present in the form of a powder (fresh fruit powder, see Product Description).
Regarding Claim 9, Mintel 1 further teaches wherein the dried fruits are selected are banana and apple (see Product Description).
Regarding Claim 10, the claim is rejected in view of Mintel teaching fruits because Claim 1 recites vegetable in the alternative and therefore is not required.
Regarding Claim 11, Mintel 1 further teaches wherein the micronutrients also includes calcium and vitamins (see Nutrition).
Regarding Claim 12, Mintel 1 further teaches wherein the additives are sweeteners (rice syrup, see Ingredients).
Regarding Claim 22, the combination is silent to further comprising at least one monosaccharide, and wherein the at least one monosaccharide is selected from L-fucose and sialic acid. Favre is relied on to teach an infant formula comprising a mix of human milk oligosaccharides (as applied to the rejection of Claims 17-18), and further comprises salic acid and fucose as precursors (see page 17, third paragraph). A precursor of HMO is a key compound that intervenes in the manufacture of HMO such (see Page 10, fifth paragraph). Therefore, since Favre incorporates the mixture of HMOs into infant formulas (ready-to-drink compositions, see page 6 last paragraph), it would have been obvious to one of ordinary skill in the art to further comprise salic acid to impart the health benefits of human breast milk into infant formula.
Regarding Claim 23, the prior art do not specifically recite the particular amounts of each oligosaccharides. However, in view of the combination as applied to Claim 1, since the prior art discloses a mixture comprising the claimed oligosaccharides and combinations thereof, and is also directed to an infant nutritional formula that is personalized to each pediatric subject, the particular amounts of each oligosaccharides would have been obvious to one of ordinary skill in the art based on the nutritional requirements of the pediatric subject. 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). See MPEP 2144.04.II.A.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 1, further in view of Mintel 2 (Organic Milk Cereal with Millet – cited in IDS filed 12/15/2022).
Regarding Claims 2 and 3, Mintel 1 is silent to further comprises from 10 to 50 wt.%, based on dry weight of the cereal composition, of a milk component. Mintel 2 is relied on to teach a similar food product comprising a cereal composition (millet) for instant preparation (see Product Description) suitable for infants from four months. Mintel 2 further teaches a composition comprising skimmed milk powder (required by Claim 3) at 21 wt% of the composition (see Ingredients). Therefore, since both Mintel 1 and Mintel 2 are directed to similar cereal product suitable for infants, it would have been obvious to one of ordinary skill in the art to further incorporate skimmed milk powder based on flavor and desired nutrition.
Response to Arguments
In response to Applicant’s traversal over Claims 2-3 under 35 U.S.C. 112(b), Applicant maintains the position that Claims 2 and 3 are definite on the basis that one of ordinary skill in the art would understand the claim. Specifically, Applicant asserts that the components may be selected in varied combinations to sum up to 100% and therefore if a milk component was at 10%, the remaining ingredients would sum to no more than 90%. However, this is not the issue that the rejection is addressing. Applicant’s argument is understood by the Examiner and is the reason why Claim 1 does not have a similar issue because should the cereal component approach 90 wt%, the other ingredients will reduce within their respective range recited such that the balance remains at 100% total. The indefinite issue arises when the milk component is recited in Claim 2 at 10 to 50 wt%. The recited maximum value of each component can be achieved by reducing the amount of the other components EXCEPT the cereal component because the minimums of the other components sum to 19.5 wt%. Therefore, within the scope of Claim 2, it is IMPOSSIBLE for the cereal component to ever reach 90 wt% because the minimum values of the other components will not allow for it. In this case, the cereal component at most can be 80.5 wt%. In other words, the scope of Claim 2 includes the cereal component at 80.5 wt% to 90% but this range is impossible to reach and therefore renders the claim indefinite.
As to Applicant’s response regarding the prior art, Applicant argues that one of ordinary skill in the art would not have thought to combine the Ekundayo reference because Ekundayo is directed to a composition not suitable for babies by comprising chocolate and noodles. The argument is found not persuasive because each of the ingredients listed in paragraph 43 are optional ingredients for the purpose of flavoring and seasoning. Therefore, Ekundayo does not teach away from combining with the Mintel1 reference because there is no requirement to incorporate chocolate or noodles. Rather, Ekundayo is relied on to modify flavors of similar food composition, and particularly powdered cereal product. It is maintained that Ekundayo provides one of ordinary skill in the art known combinations of nutrients, ingredients and additives with cereal compositions, therefore suggesting the selection of the listed ingredients based on desired flavors and nutrition profile.
Applicant argues that one of ordinary skill in the art would not combine the Favre reference because Favre is directed to a dairy product whereas Mintel1 requires a plant-based, dairy-free cereal. The argument is not persuasive because Mintel1 is merely a product that is selectively configured to be a plant-based and dairy-free product. That is, it would have been an obvious matter of product choice to further comprise milk components with the expectation that the product is on longer a 100% plant-based and dairy free product as is the case with the Mintel2 reference. Furthermore, there is no reason or evidence that one of ordinary skill in the art seeking to modify the Mintel1 reference would be required to maintain a 100% plant-based and dairy-free product because a product similar to Mintel2 also exist in the market. Furthermore, a consumer who purchases the product disclosed in Mintel1 would be capable of preparing the cereal product with milk as an alternative to water based on preference. Lastly, there is no evidence to suggest that the milk components would have an adverse effect with the composition of Mintel1.
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.
For these reasons, the prior art has been maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANH H NGUYEN whose telephone number is (571)270-0346. The examiner can normally be reached 10am-6pm.
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/T.H.N/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792