*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 .
Applicant’s response dated June 12, 2026, is acknowledged.
Priority
This application claims benefit in provisional application 63/527,374 filed on July 18, 2023.
Claim Status
Claims 1-20 are pending. Claims 10-20 are withdrawn. Claims 1-9 are examined.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1-9), drawn to a composition in the reply filed on June 12, 2026, is acknowledged.
In the remarks, the applicant stated that claims 1-16 are in Group I. This is not correct because claims 10-16 are method claims and they are part of Group II.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Response to the restriction requirement of April 16, 2026 was timely filed.
Claims 1-9 are examined on the merits.
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, and 6-8 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 2 requires an amount of magnesium compound ranging from 5 to 50 mM (about 0.6 to 6.0 grams) and glutamine in an amount in the range from 4 to 50 mM (about 0.586 to 7.5 g). The claim is indefinite because it is not clear if the weight range in the parentheses is part of the claimed invention or optional because the meaning of parentheses is not clear. For the purpose of applying prior art, the weight range is interpreted as an alternative to the mM concentration range. For example, an amount of magnesium compound ranging from 5 mM to 50 mM or from about 0.6 g to 6.0 grams, and glutamine in an amount in the range from 4 mM to 50 mM or from about 0.586 g to 7.5 g.
The term “low bioavailability magnesium compound” in claim 3 is a relative term which renders the claim indefinite. The term “low bioavailability magnesium compound” 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.
The term “high bioavailability magnesium compound” in claim 3 is a relative term which renders the claim indefinite. The term “high bioavailability magnesium compound” 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 6 recites the limitation "said magnesium compound(s)" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 provides support for "said magnesium compound.
Claim 7 recites the limitation "said magnesium compound(s)" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 provides support for "said magnesium compound.
Claim 8 recites the limitation "said magnesium compound(s)" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 provides support for "said magnesium compound.
Claim Rejections – 35 USC § 102
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 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.
Claims 1, 2, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patterson (WO 97/42943 Published November 20, 1997).
The claims encompass a composition as described.
The teachings of Patterson are related to oral rehydration products comprising glutamine (Abstract). Table I on page 5 discloses four compositions, all of which anticipate the claimed composition because each of the exemplified compositions contains magnesium acetate in a concentration of 6 mM and glutamine in a concentration of 5 mM, 30 mM, 45 mM, and 60 mM. The compositions could have been used for the claimed intended purpose because they contain the same components as claimed and as evidenced by instant claim 2, both components are present in an effective amount. The concentration range of magnesium compound in claim 2 is anticipated because it encompasses 6 mM. The concentration of glutamine is anticipated because it encompasses 5 mM, 30 mM, and 45 mM. Claim 9 is anticipated because Patterson teaches that the compositions are intended for oral administration and compositions in Table I read on a single composition for oral administration.
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.
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, 2, and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Patterson.
The claims encompass a composition as described.
The teachings of Patterson are related to oral rehydration products comprising glutamine (Abstract). Table I on page 5 discloses four compositions, all of which disclose the claimed composition because each of the exemplified compositions contains magnesium acetate in a concentration of 6 mM and glutamine in a concentration of 5 mM, 30 mM, 45 mM, and 60 mM. The compositions could have been used for the claimed intended purpose because they contain the same components as claimed and as evidenced by instant claim 2, both components are present in an effective amount. The concentration range of magnesium compound in claim 2 is anticipated because it encompasses 6 mM. The concentration of glutamine is anticipated because it encompasses 5 mM, 30 mM, and 45 mM. Claim 9 is anticipated because Patterson teaches that the compositions are intended for oral administration and compositions in Table I read on a single composition for oral administration.
Regarding claims 6-8, it would have been obvious to have varied the concentration of glutamine from 5 mM to 60 mM while maintaining glutamine concentration at 6 mM because Patterson teaches compositions having 5, 30, 45, and 60 mM and thereby teaches endpoints where the broadest range extends from 5 mM to 60 mM. A molar ratio of glutamine to magnesium would range from 6:5 to 6:60, which is equivalent to 1.2:1 to 0.1:1. The claimed ranges of ratios are obvious over the prior art because prior art range overlaps with claimed ranges. The specification was reviewed and there is no evidence that the claimed ranges of ratios are critical.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Portman (WO 00/27408 Published May 18, 2000).
The teachings of Portman are related to compositions for optimizing muscle performance during exercise (Abstract). Table C teaches an example of a liquid composition comprising 0.10 wt. % (equivalent to 0.42 g) glutamine and 0.09 wt. % (equivalent to 0.40 g) of magnesium oxide (page 17), among other components.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition in Table C by varying the concentration of glutamine from 0.08 wt. % to 0.4 wt. % and by varying the concentration of magnesium oxide from 0.05 wt. % to 0.4 wt. %, with a reasonable expectation of success because Portman teaches in Table B on pages 14 and 15 suitable ranges of each component in a liquid drink form where the concentration of glutamine ranges from 0.08 wt. % to 0.4 wt. % and the concentration of magnesium compounds ranges from 0.05 wt. % to 0.4 wt. %. Thus, the composition would contain glutamine in an amount of in the range from 0.336 g (0.08 wt.%) to 1.68 g (0.4 wt. %); and the composition would contain magnesium compound in the range from 0.22 g (0.05 wt. %) to 1.78 g (0.4 wt. %).
Composition in Table C modified as suggested above renders claim 1 obvious because it contains magnesium oxide in an amount of 0.22-1.78g and glutamine in an amount of 0.336-1.68g. As evidenced by claim 2, magnesium oxide and glutamine are present in an effective amount. The composition in Table C could have been used for the claimed intended purpose because it contains the same components as claimed and in amounts that are considered effective for the intended purpose.
Regarding claim 2, the range of magnesium compound is obvious because 0.6-6 g overlaps with 0.22-1.78g and the range of glutamine is obvious because 0.586-7.5g overlaps with 0.336-1.68 g.
Regarding claims 3 and 4, it would have been obvious to have modified the composition in Table C by adding magnesium aspartate, with a reasonable expectation of success because Portman teaches that the magnesium compound includes magnesium oxide, magnesium aspartate, among others, and combinations thereof (Portman’s claim 10). The composition in Table C would contain a mixture of magnesium oxide and magnesium aspartate.
Regarding claim 5, it would have been obvious to have modified the composition in Table C by replacing magnesium oxide with magnesium sulfate with a reasonable expectation of success because Portman teaches that the magnesium compounds are selected from the group consisting of magnesium oxide, magnesium sulphate, among others, and combinations thereof. Magnesium oxide and magnesium sulphate are considered equivalent magnesium compounds and replacing one equivalent with another to obtain a predictable result supports obviousness.
Regarding claims 6-8, magnesium oxide has a molecular weight of 40.304 g/mole. An amount of magnesium oxide of 0.22-1.78g is equivalent to 0.00545 moles to 0.044 moles. Glutamine has a molecular weight of 146.14 g/mole. An amount of glutamine of 0.336-1.68 g is equivalent to 0.0023 moles to 0.0115 moles.
The molar ratio of glutamine to magnesium ranges from 0.0023:0.044 to 0.0115:0.00545 which is equivalent to 0.05:1 to 2.1:1. The claimed molar ratios ranges in claims 6-8 are obvious because the ranges overlap with Portman’s range 0.05:1 to 2.1:1. The specification was reviewed and there is no evidence that the claimed ranges are critical.
Regarding claim 9, the liquid composition in Table C is considered as single composition for oral administration.
Conclusion
No claims are allowed.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617
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