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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/30/2026 has been entered.
Application Status
Amended claim 26-29, 33 and new claim 34 and 35 are under examination.
Claim 16-25 and 30-32 are withdrawn from examination.
Claim 1-15 are canceled.
Claim 26-29 and 33-35 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 26-29, 34 and 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 26 and new claim 35 recites limitation of “…wherein the infant formula, follow on formula or young child formula is a hypoallergenic formula…” is not supported in the specification as originally filed. Applicant asserted supports in specification [0003], however the Examiner disagrees. The instant specification paragraph [0003] is directed to background prior art and not disclosure of the claimed invention. Additionally, the instant specification paragraph [0141] and [0143] discloses the protein is hypoallergenic and not the infant formula, follow on formula or young child formula as hypoallergenic formula; hence the limitation is new matter. Claim 27-29 and 34 are also rejected since the claims are depended upon claim 27.
Applicant is required to remove new matter in response to 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.
Claim 34 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.
The term “extensively” in claim 34 is a relative term which renders the claim indefinite. The term “extensively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 26, 27, 28, 29, 33, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Rosado Loria et al. (US 2013/0115336 A1) and in view of Rueda et al. (US 2008/0003329 A1) as evidenced by Wittke (US 8,425,955).
Regarding claim 26, 27, 28, 29, 34 and 35, Rosado Loria et al. (Rosado Loria) discloses an infant formula comprising L-lysine and L-typtophan (free amino acids) (‘336, claim 20, claim 21) and Vitamin A in an amount of 357.95 IU, retinol equivalent per 100 kcal of the composition (‘336, [0034], Example 1), which corresponds to 107.39 ug Vitamin A per 100 kcal of composition.
With respect to new limitation in claim 26, the recitation of “….wherein at least 90 wt% of the hydrolyzed protein. based on the dry weight of total protein, is derived from milk of a species belonging to the genus Bos, Bison, Bubalus, or Capra…”, and in new claim 34, recitation to hydrolyzed protein is extensively hydrolyzed protein, is based on alternative selection of hydrolyzed protein or free amino acids in claim 26 line 7; hence the L-lysine and L-typtophan (free amino acids) being the taught by Rosado Loria and meets the claim. With respect to the limitation of “a source of protein solely comprising free amino acids” in new claim 25, Rosado Loria clearly teaches the infant formula comprising the L-lysine and L-typtophan (free amino acids) (‘336, claim 20, claim 21) as a source of protein.
Rosadio Loria does not discloses the cited range of the Vitamin A.
However, Rueda et al. (Rueda) teaches commercial infant formula comprising Vitamin A is 75 to 225 mcg (ug) per 100 kcal of the formula (‘329, [0004]) which overlaps the cited range, as standards per regulation under government rules (‘329, [0004]). Rueda and Rosado Loria are of the same field of endeavor, infant formula composition comprising Vitamin A. It would have been obvious to one ordinary skill in the art to use regulated amounts of Vitamin A as disclose by Rueda in Rosado Loria’s infant formula since amounts of Vitamin A are known and regulated amounts. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Additionally, the term Rosadio Loria’s Vitamin A encompass retinol, retinoic acid, retinyl palmitate as evidenced by Wittke (‘955, col. 13, ln. 1-3).
With respect to claim 26, 27, and 28, modified Rosado Loria discloses the infant formula comprising a combination of galacto-oligosaccharides and fucto-oligosaccharides (‘336, claim 1, claim 7). Rosada Loria discloses the galacto-oligosaccharides in an amount of 4.79 g per 100 g per the formula and the fucto-oligosaccharides in an amount of 0.53 g per 100 g per the formula (‘336, [0034], Example 1), which corresponds to 53.2 mg per gram of the formula, which is in range with the cited range.
Regarding claim 33, Rosado Loria et al. (Rosado Loria) discloses an infant formula comprising free amino acids (‘336, [0027], claim 20) and Vitamin A in an amount of 357.95 IU, retinol equivalent per 100 kcal of the composition (‘336, [0034], Example 1), which corresponds to 107.39 ug Vitamin A per 100 kcal of composition.
Rosadio Loria does not discloses the cited range of the Vitamin A.
However, Rueda et al. (Rueda) teaches commercial infant formula comprising Vitamin A is 75 to 225 mcg (ug) per 100 kcal of the formula (‘329, [0004]) which overlaps the cited range, as standards per regulation under government rules (‘329, [0004]). Rueda and Rosado Loria are of the same field of endeavor, infant formula composition comprising Vitamin A. It would have been obvious to one ordinary skill in the art to use regulated amounts of Vitamin A as disclose by Rueda in Rosado Loria’s infant formula since amounts of Vitamin A are known and regulated amounts. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Additionally, the term Rosadio Loria’s Vitamin A encompass retinol, retinoic acid, retinyl palmitate as evidenced by Wittke (‘955, col. 13, ln. 1-3).
Modified Rosado Loria discloses the infant formula comprising a combination of galacto-oligosaccharides and fucto-oligosaccharides (‘336, claim 1, claim 7). Rosada Loria discloses the galacto-oligosaccharides in an amount of 4.79 g per 100 g per the formula and the fucto-oligosaccharides in an amount of 0.53 g per 100 g per the formula (‘336, [0034], Example 1), which corresponds to 53.2 mg per gram of the formula, which is in range with the cited range.
When reading the preamble in the context of the entire claim, the recitation “…for treating, preventing, reducing the risk of allergy and/or inducing/enhancing oral immune tolerance to an allergen…” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
Applicant asserts “…Rosado Loria is silent on an amino acid based formula, and Rosado Loria teaches away from cow's milk protein in order to arrive at the anti-allergenic effect, see par. [0003] of Rosado Loria..”
Applicant’s remarks are not convincing. Rosado Loria et al. (Rosado Loria) discloses an infant formula comprising L-lysine and L-typtophan (free amino acids) (‘336, claim 20, claim 21). Rosado discloses cow’s milk protein as known allegrans but does not criticize as a teaching away from hydrolyzed proteins in infant formula. Second Applicant’s remarks do not commensurate the instant claims. With respect to new limitation in claim 26, the recitation of “….wherein at least 90 wt% of the hydrolyzed protein. based on the dry weight of total protein, is derived from milk of a species belonging to the genus Bos, Bison, Bubalus, or Capra…”, and in new claim 34, recitation to hydrolyzed protein is extensively hydrolyzed protein, is based on alternative selection of hydrolyzed protein or free amino acids in claim 26 line 7; hence the L-lysine and L-typtophan (free amino acids) being the taught by Rosado Loria and meets the claim. With respect to the limitation of “a source of protein solely comprising free amino acids” in new claim 25, Rosado Loria clearly teaches the infant formula comprising the L-lysine and L-typtophan (free amino acids) (‘336, claim 20, claim 21) as a source of protein.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Rosadio Loria does not discloses the cited range of the Vitamin A.
However, Rueda et al. (Rueda) teaches commercial infant formula comprising Vitamin A is 75 to 225 mcg (ug) per 100 kcal of the formula (‘329, [0004]) which overlaps the cited range, as standards per regulation under government rules (‘329, [0004]). Rueda and Rosado Loria are of the same field of endeavor, infant formula composition comprising Vitamin A. It would have been obvious to one ordinary skill in the art to use regulated amounts of Vitamin A as disclose by Rueda in Rosado Loria’s infant formula since amounts of Vitamin A are known and regulated amounts. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Additionally, the term Rosadio Loria’s Vitamin A encompass retinol, retinoic acid, retinyl palmitate as evidenced by Wittke (‘955, col. 13, ln. 1-3).
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the unexpected effect on reducing allergic reaction) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, in response, although the experiment provided in the pending Specification is appreciated, it does not amount to a proper showing of unexpected results. The standard for showing unexpected results (see MPEP 716.02(d).II
A proper showing includes:
A description of precisely what was tested.
A description of all of the test conditions.
Test results, including:
The actual steps carried out, the materials employed, and the results obtained should be spelled out. Nothing concerning the work relied upon should be left to conjecture.
The results of the test performed on the invention as claimed.
A showing of statistical and practical significance of the criticality. (i.e. several data points that confirm the test result was not just a statistical flier.)
An analysis of the test results, including:
Conclusory statements.
The results must be due to the claimed features (including how the ranges for the components are established, in other words how the specifically claimed ranges provide the unexpected result), not to unclaimed features, including a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.
In this case, there is no description of how the taste test was performed, and no showing of all the test conditions. Test results also did not provide this. There is no showing of statistical and practical significance of the criticality. (i.e. several data points that confirm the test result was not just a statistical flier.) The results are not shown to be due to the claimed features (including how the ranges for the components are established, in other words how the specifically claimed ranges provide the unexpected result), not to unclaimed features, including a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bindels et al. (DE 60018604 T3, published 02/13/2014) discloses an infant nutrition comprising free amino acids, hydrolyzed protein from source cow’s milk (pg. 4, 7-8th paragraph).
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/HONG T YOO/Primary Examiner, Art Unit 1792