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 Status
Claims 1-9 are rejected.
Claims 10-13 are cancelled.
Claims 14-16 are withdrawn.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 7, 2026, has been entered.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 1-2 and 4 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Toda et al. (JP H05155820A) [hereinafter Toda] [citations are based on English Machine Translation provided by applicant on IDS filed on September 27, 2023].
With respect to claim 1, Toda discloses a manufacturing method for a compound, including the steps of: adding a synthesized or recrystallized solid product to propanol in a vessel to obtain a mixture (see paragraph 0013); stirring the mixture (see paragraph 0013); filtering the mixture so as to separate the synthesized or recrystallized solid product from the propanol (see paragraph 0013); and drying the filtered product (see paragraph 0013).
Toda does not disclose the filtered product having less coloring impurities than the added synthesized or recrystallized solid product. However, since Toda teaches all the recited method steps, therefore, it is inherent and/or obvious that the same results may be achieved.
With respect to claim 2, Toda discloses wherein the propanol is 2-propanol (see paragraph 0013).
With respect to claim 4, Toda discloses wherein the chemical process includes forming a salt of the synthesized or recrystallized solid product (see paragraph 0013).
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.
Claim(s) 3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Toda et al. (JP H05155820A) [hereinafter Toda] [citations are based on English Machine Translation provided by applicant on IDS filed on September 27, 2023].
With respect to claim 3, Toda lacks wherein the synthesized or recrystallized solid product is selected from the group consisting of: an amino acid, an amino acid dimer, an amino acid salt, an amino acid dimer salt, a nucleoside, a nucleoside dimer, a nucleoside salt, and a nucleoside dimer salt. However, Toda teaches a method to form a crystalline polymorph of N-tert-butyl-1-methyl-3,3-diphenylpropylamine hydrochloride, which is a salt. It would have been obvious to one of ordinary skill in the art to use the specific materials claimed by applicant since one of ordinary skill would recognize to use a desired material according to a desired application (see MPEP 2144.07 which states as obvious “The selection of a known material based on its suitability for its intended use”).
With respect to claim 5, Toda lacks wherein the propanol is added to the vessel in an amount of from 0.5 kg to 5 kg 2-propanol per kg of the synthesized or recrystallized solid product. However, this would have been obvious to one of ordinary skill in the art since one of ordinary skill would be able to discover the optimum amount of propanol required during routine experimentation (see MPEP 2144.04 IIA which states “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”).
With respect to claim 6, Toda lacks wherein stirring is carried out at a temperature of from 5 to 80° C. However, this would have been obvious to one of ordinary skill in the art since one of ordinary skill would be able to discover the optimum temperature required during routine experimentation (see MPEP 2144.04 IIA which states “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”).
With respect to claim 7, Toda discloses wherein stirring comprises a first stirring step which is carried out at a first temperature (see paragraph 0013). Toda lacks a second stirring step which is carried out at a second temperature, wherein the second temperature is lower than the first temperature. However, this would have been obvious to one of ordinary skill in the art since one of ordinary skill would be able to discover the amount of stirring needed and the optimum temperature required during routine experimentation (see MPEP 2144.04 IIA which states “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”).
With respect to claims 8-9, Toda discloses wherein drying comprises a first drying step which is carried out at a first temperature (see paragraph 0013). Toda lacks a second drying step which is carried out at a second temperature, wherein the second temperature is higher than the first temperature; and wherein the first drying step is carried out for a greater period of time than the second drying step. However, this would have been obvious to one of ordinary skill in the art since one of ordinary skill would be able to discover the amount of drying needed and the optimum temperature required during routine experimentation (see MPEP 2144.04 IIA which states “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant’s argument that Fearon lacks the new limitations of amended claim 1: The new limitations of claim 1 are taught by Toda, as stated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE GONZALEZ whose telephone number is (571)272-5502. The examiner can normally be reached M-F 9-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MADELINE GONZALEZ/Primary Examiner, Art Unit 1773
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