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 .
Application Status
Amended claim 26-29 and 33-35 are under examination.
Claim 16-25 and 30-32 are withdrawn from examination.
Claim 1-15 are cancelled.
Withdrawn Rejection
The 112 first paragraph rejection over claim 35 has been withdrawn in light of Applicant’s amendment to remove new matter as discussed in previous office action.
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 and 34 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.
The 112, first paragraph over claim 26 with respect to the limitation of “…wherein the infant formula, follow on formula or young child formula is a hypoallergenic formula…” is maintained from previous office action. The limitation is not supported in the specification as originally filed.
Applicant asserted support 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. As the passage [0003] inserted herein:
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wherein discusses prior art “…[s]pecial formulae have been designed for infant that are allergic…[s]uch formulae typically are hypoallergenic or allergen free…” however, the passage does not support Applicant’s procession of the claimed infant formula, follow on formula or young child formula is a hypoallergenic formula as recited in claim 26. However, the instant specification paragraph [0141] and [0143] discloses the protein is hypoallergenic and no support for the infant formula, follow on formula or young child formula is hypoallergenic formula. In other words, a fraction, i.e. protein is hypoallergenic in a whole, i.e. infant formula, and does not support the whole, i.e. infant formula as hypoallergenic; wherein the infant formula may contain allergens and not considered hypoallergenic; hence the limitation is new matter.
Claim 27-29 and 34 are also rejected since the claims depend upon claim 26.
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 112, second paragraph rejection over term “extensively hydrolyzed protein” in claim 34 is maintained, wherein the term 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 the limitation of “a source of protein solely comprising free amino acids” in the claim 35, 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, wherein the L-lysine and L-typtophan (free amino acids) is considered a protein fraction of a total protein in the infant formula.
Rosadio Loria does not disclose 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 disclosed 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.
With respect to 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.
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 disclose 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 disclosed 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 argument filed 07/01/2016 have been fully considered but they are not persuasive.
Applicant asserts “Independent claim 35, as amended, recites an infant formula, follow on formula or young child formula comprising, inter alia, "a protein fraction wherein the protein fraction consists solely of free amino acids." Independent claim 26, as amended, similarly recites "a source of protein solely comprising free amino acids.".
In response to Applicant’s remarks, first it is noted claim 26 does not recite "a source of protein solely comprising free amino acids", hence Applicant’s remarks does not commensurate the scope of the claim. Second, claim 35 recites “comprising” in the permeable, and considered open-end language to include other ingredients. With respect to the limitation of “a source of protein solely comprising free amino acids” in the claim 35, 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, wherein the L-lysine and L-typtophan (free amino acids) is considered a protein fraction of a total protein in the infant formula.
Applicant submits that the skilled person would not be motivated to replace Rosado Loria's hydrolyzed rice protein with a protein fraction consisting solely of free amino acids. Such a modification would eliminate the very feature that Rosado Loria teaches provides the anti- allergenic benefit and would reintroduce the problems of expense and poor taste that Rosado Loria seeks to avoid. A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference. Here, Rosado Loria's express teaching that hydrolyzed rice protein provides superior tolerability and palatability compared to amino acid formulas would discourage one of ordinary skill from making such a substitution. The proposed modification would render Rosado Loria unsatisfactory for its intended purpose.
Applicant’s remarks does not commensurate the scope of the claims. The instant claims recites “comprising” in the permeable, and considered open-end language to include other ingredients, including other proteins. 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, wherein the L-lysine and L-typtophan (free amino acids) is considered a protein fraction of a total protein in the infant formula.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zihua Ao et al. (TW 201446154, Machine Translation English) discloses an infant formula (pg. 3) comprising free amino acids (pg. 6, 4th- 5th paragraph), fuco-oligosaccharide, galacto-oligosaccharide (pg. 7, 4th-5th paragraph), and Vitamin A which includes retinol, retinol esters, retinyl palmitate, retinyl acetate (pg. 9, 5th paragraph).
THIS ACTION IS MADE FINAL. 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 HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ERIK KASHNIKOW can be reached at (571)270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG T YOO/Primary Examiner, Art Unit 1792
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