DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 06/15/2026 is acknowledged. The traversal is on the ground(s) that the restriction addresses that the composition can be used for a different method such as a method for muscle growth and Applicant asserts that there for no reasons or examples to support a conclusion of patentable distinctness between the groups wherein the restriction would be withdrawn. This is not found persuasive because a composition comprising iron and amino acids like methionine and threonine, and are known to be useful for muscle development/growth see for example Bauer et al. (EP 1330957) and Farmer et al. (U.S. Pat. 2012/0251512).
Applicant also asserts that there is no species requirement for Group II which is incorrect as the requirement is present on Pages 6-7 of the prior action. Applicant had recited an election of species for the additional active to be histidine with tryptophan with traverse asserting that there is no reasons or examples to support a conclusion of patentable distinctness which is not persuasive as the prior action addresses that the species have distinctly different chemical structure and activities wherein the search for one would not necessarily yield a search for the other
The requirement is still deemed proper and is therefore made FINAL.
Upon review, the election of species is withdrawn.
Status of Application
Applicant has elected Group II in response to restriction requirement and elected the species histidine with tryptophan for the examination. Upon review, the election of species is withdrawn.
Due to restriction, based on election of Group II, claims 1-10 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-20 are pending.
Claims 11-20 are present for examination at this time.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17-18 are rejected under 35 U.S.C. 101 because the claim appears to be directed to more than one statutory category The claimed invention must be to one of the four statutory categories. However, as written the claims are dependent from claim 11 which is to a method of use/treatment which is to one of the four statutory categories, but claims 17-18 then appears to recite method of making recitations when already directed to a method of use which is a different statutory category and appears to be to more than one statutory category and the claimed invention can only be to ONE statutory category. This is also confusing and unclear. Therein the claims is subject to the 101 rejection presented and the 112 rejection below.
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 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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 pre-AlA the applicant regards as the invention.
Claims 17-18 recites bending ratios for methionine, threonine, and the iron compound with part weight ratios. This is confusing as it appears to be a process step directed to the means of making the composition used for administration for the method of treatment, wherein it is unclear if directed to a different/another statutory category which is a 101 issue as addressed above; or a product by process recitation to the product used for administration which is treated as the composition used for the administration as process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art absent evidence of criticality for the process step to produce a material different composition for administration. For the purposes of prior art it is treated to be a product by process recitation which is treated as a product for the recited utility.
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.
Claims 1, 13, 16-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 112409202).
The 101 and 112 issues with regards to dependent claims 17-18 are addressed above and for the purposes of prior art it is treated as a product for the recited utility.
Rejection:
Li et al. teaches treating and preventing iron deficiency anemia with the administration of an animo acid Fe(III) chelate comprising ferric acid salt (calculated as iron ions), regulator, amino acid, and water (claim 1). Administration is by the gastrointestinal tract (i.e. orally [69]). The amino acid is glycine, methionine, hydroxymethionine, lysine, threonine, valine, leucine, isoleucine, alanine, phenylalanine, cystine, proline, hydroxyproline, citrulline, ornithine, or mixtures thereof (claim 3). Example 3 has a mixture of glycine, methionine, lysine, threonine, and leucine in a 1:1 ratio [48-51]. The concentration of the ferric salt in solution is from 1.5-6.5%wt. (claim 2). The mass percentage of the animo acid Fe(III) chelate is 10.5%-21.7% ferric salt (calculated as iron ions), 5%-12.5% regulator, 30%-65% amino acid, and the balance being deionized water (claim 1, see full document specifically areas cited).
While Li et al. does not exemplify treating/preventing the iron deficiency with the composition, Li et al. does expressly teach treating/preventing the iron deficiency with the composition wherein exemplification of the express teaching of Li et al. is prima facie obvious with a reasonable expectation of success. It is also implicit if not prima facie obvious that treatment of the iron deficiency anemia would improve/prevent symptoms of the condition.
Li et al. does not expressly teach the exact claimed ratio of 1 part weight methionine to threonine (0.0001-1000 parts wt., 0.003-300parts wt.) to iron compound (0.0001-1 part wt., 0.001-0.5 parts weight), Li et al. does expressly teach the amino acids to be 30-65%wt. with the iron compound to be 10.5-21.7%wt. and exemplification of methionine and threonine with other amino acids at a 1:1 ratio (falling within the ratio); the taught amount/parts of iron overlaps the instant claimed range and even a slight overlap in range establishes a prima facie case of obviousness wherein it is obvious to optimize the amount of iron and amino acids as a means of attaining the desired therapeutic profile absent evidence of criticality for the claimed ratio/amounts. While Li et al. does not recited the exact claimed values of methionine (0.5-30%wt.) with threonine (0.5-60%wt.) and ornithine (0.5-30%wt.), it does teach values for the total amino acids that overlap it wherein it would be prima facie obvious to one or ordinary skill in the art to optimize the amount for the amino acids and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 112409202) as applied to claims 1, 13, 16-18, 20 above, in view of American Society of Hematology (Iron-Deficiency Anemia-How is Iron Deficiency Anemia Diagnosed?).
Rejection:
The teachings of Li et al. are addressed above.
Li et al. does not expressly recite the serum iron level or hemoglobin level in iron deficiency anemia.
American Society of Hematology addresses that one with iron deficiency anemia usually present with low hemoglobin and low serum iron.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that one that presents with iron deficiency anemia would present with low hemoglobin and low serum iron as taught by the American Society of Hematology wherein as one is treated for the condition, it is implicit if not prima facie obvious that the levels improve with treatment producing the claimed invention.
Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 112409202) as applied to claims 1, 13, 16-18, 20 above, in view of Asami (WO 2007/029730).
Rejection:
The teachings of Li et al. are addressed above.
Li et al. does not expressly recite the inclusion of histidine and tryptophan but does teach treating anemia.
Asami teaches that amino acids like histidine (His) and tryptophan (Trp) are useful for treating anemia at 1-8% and 13-25% respectively ([59] of translation), and is also known to be combined with methionine and Thr (also known as threonine or threione, claim 1, [22] of translation).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate histidine and tryptophan as suggested by Asami and produce the claimed invention, and it is prima facie obvious to incorporate additional components useful for the same condition for its additive effect with a reasonable expectation of success. It is also prima facie obvious to incorporate the histidine at its taught amounts (falling within the claimed range) and while the Asami does not teach the exact amount of tryptophan claimed a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close as the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties MPEP 2144.05 (I).
Conclusion
Claims 11-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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