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 .
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 1-10 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.
Claim 1 correlates the kynurenic acid concentration required for the method to the “concentration of kynurenic acid in the breast milk of the nursing mother”. It is unclear from the claim how this correlation must be undertaken. It is not clear if the concentration of kynurenic acid must correlate to the concentration of the infant’s actual mother or some other nursing mother. Different nursing mothers express different levels of kynurenic acid. According to O’Rourke (“The Relationship Between Maternal Tryptophan Metabolism, Cytokines and Cortisol in Term and Preterm Expressed Breast Milk” 2014 Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting in Vancouver, BS, Canada) the levels of kynurenic acid (a tryptophan metabolite) is different between mothers who carry their children to pre-term and term as well as being subject to dynamic and qualitative changes during lactation including circadian rhythms. (O’Rourke Pg. 12) As such, depending on who is “the nursing mother” the same concentration of kynurenic acid could fall both inside or outside the scope of the claims.
Applicant’s assertion on page 6 of the remarks dated 3/13/25 that the specification identifies concentrations of kynurenic acid that “preferably” correspond to various ages does not solve the issue with the claim requiring correlation with “a nursing mother”.
For the purpose of examination providing nutrition comprising kynurenic acid to a child will be interpreted to read on claim 1. Claims 2-10 depend from claim 1 and necessarily inherit the deficiencies therein. Appropriate correction is required.
Claims 4-10 recite methods “designed” for a child of a specific age. It is unclear if these methods are limited to only feeding children of the identified age group or if the methods are merely intended to encompass feeding any child nutrition with the claimed kynurenic acid content. For the purpose of examination either embodiment will be interpreted to read on the claim. Appropriate correction is required.
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.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over O’Rourke “The Relationship Between Maternal Tryptophan Metabolism, Cytokines and Cortisol in Term and Preterm Expressed Breast Milk” 2014 Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting in Vancouver, BS, Canada (hereafter referred to as O’Rourke) and Beal USPN 6265442 (hereafter referred to as Beal).
Regarding claim 1, in light of the disclosures of O’Rourke and Beal, it would have been obvious to try correlating the concentration of kynurenic acid (or salt) in formula fed to infants. (See MPEP 2143 I E) To reject a claim based on this rationale, Office personnel must resolve the Graham factual inquiries. Then, Office personnel must articulate the following:
(1) a finding that at the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
(3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Regarding factor (1), O’Rourke identifies that tryptophan and its metabolites are delivered through infant nutrition. (Pg. 1) Kynurenic acid, a tryptophan metabolite, is also present in breast milk. (Fig. 2) Kynurenic acid is a neuroprotective compound. (Pg. 1) O’Rourke posits that low levels of tryptophan and its metabolites in infant nutrition could have negative effects on neurological development. (Pg. 13) O’Rourke states that optimizing formula milk to match the full complement of tryptophan and its metabolites present in breast milk. (Pg. 14.
Regarding factor (2), O’Rourke identifies that the solution to the problem is to identify the concentration of tryptophan and its metabolites present in expressed breast milk (EBM) at different stages of infant development and correlate those concentrations to optimized infant formula for a particular age. (Pg. 14-15)
Regarding factor (3), one of ordinary skill in the art could pursue the solution proposed because O’Rourke demonstrates that it was known how to measure tryptophan and its metabolites in expressed breast milk for a given infant age and Beal demonstrates that it was known that kynurenic acid can be delivered to humans through dietary supplementation. (Beal, Col. 1, line 66-Col. 2, line 4)
In light of these findings and the knowledge of those of ordinary skill in the infant formula art that the goal in designing infant formula is to recreate breast milk, the method recited in claims 1-10 where the kynurenic acid content is correlated to breast milk at a given age is merely the obvious result of trying the solutions suggested by the prior art.
Response to Arguments
Applicant's arguments filed 3/13/25 have been fully considered but they are not persuasive.
Applicant’s assertions on page 6 regarding “a nursing mother” have been addressed in the rejection under 35 U.S.C. 112(b) above.
Applicant’s remarks regarding the translation of the instant application have been considered but are not found persuasive as they have not been accompanied by a new certified translation of the foreign priority document. Nonetheless, given the nature of the art, one of ordinary skill would reasonably interpret the whole of applicant’s disclosure to include separate oral and enteral embodiments and therefore applicant’s amendments to the specification and claims are not found to contain new matter.
Applicant states on page 9 of the remarks that it is not obvious in view of O’Rourke that kynurenic acid can be provided in concentrations associated with mother’s breast milk. This statement has no rational underpinning. O’Rourke states that matching the full term complement of tryptophan and its metabolites (i.e. kynurenic acid) could inform the “optimal formula milk composition”. O’Rourke recognizes that the concentration of tryptophan and its metabolites changes in breast milk over time. The entire infant formula industry seeks to mimic breast milk. Clearly, it is well within the ambit of a practitioner to correlate the concentration of any component of breast milk to the concentration in an infant formula.
Applicant further states on page 9 “it is not obvious that the amounts of kynurenic acid described in the method of the invention would be beneficial to particular age groups of children”. Given that the benefit of various concentrations of kynurenic acid that correlate with age is the entire inventive concept of applicant’s invention, it appears applicant has conceded there is no criticality to the concentrations of kynurenic acid recited in the method claimed. Given this lack of criticality, in addition to the rejection above, applicant has identified that the claimed method does not provide a patentable distinction over the prior art.
Applicant states on page 11 that “equating the existence of tryptophan with kynurenic acid is a far reach”. This argument is not germane as the rejection does not rely on equating the existence of tryptophan with kynurenic acid. Page 1 of O’Rourke identifies kynurenic acid as a tryptophan metabolite that is present in breast milk. As such, applicant has failed to rebut elements (1) and (2) of the rejection.
Regarding element (3) of the rejection, applicant states on page 12 of the remarks that O’Rourke did not demonstrate how to measure the concentration of kynurenic acid. This assertion is inaccurate. Pages 5-6 of O’Rourke clearly enumerate how the concentration of kynurenic acid was determined.
Applicant disparages the Beal references as failing to provide evidence that kynurenic acid can be provided through diet. While Beal may not be directed towards infant nutrition, the teachings therein logically recommend themselves to O’Rourke because they provide evidence that the solution proposed by O’Rourke (dietary supplementation of kynurenic acid) would have a reasonable expectation of success. Applicant’s description of admitted prior art in [0011] of applicant’s specification further demonstrates that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success as [0011] discloses that kynurenic acid is used in the preparation of medicaments. As such, applicant’s assertions regarding element (3) of the rejection are also not found persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michele L Jacobson whose telephone number is (571)272-8905. The examiner can normally be reached Monday through Friday from 10-6.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793