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 .
DETAILED ACTION
This office action is in reply to the Applicant’s Arguments/Remarks filed on 11 May 2026 for application 18/562,666 filed on 20 November 2023, 371 of PCT/KR2022/007224 filed 20 May 2022, claiming priority from KR10-2021-0065600 filed 21 May 2021. Claims 11-20 are new. Currently, claims 1-20 are pending.
REJECTIONS – MAINTAINED & NEW
Applicant’s amendments adding claims 11-20 have resulted in the below new prior art rejections.
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.
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 non-obviousness.
(Maintained) Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Method for crystallization of branched chain amino acids with a sustainable cycle of ammonia, KR 2010152229, 2019) in view of Qingyang et al. (L-Tyrosine genetically engineer bacterium and L-tyrosine production method thereof, CN109266592, 2019).
Kim discloses a method that produces a branched chain amino acid crystal comprising the steps of: (a) mixing a reaction solution containing a branched chain amino acid crystal with ammonia to a pH of 9-12 (para. 0021), as compared to claim 5, obtaining a solution in which the branched chain amino acid crystal is dissolved (b) the step of obtaining the concentrate, which is 1 to 2 times the concentration of the non-concentrated solution (para. 0026), as compared to claim 6, which crystallizes and includes the branched chain amino acid (para. 0023), as compared to claim 9, (c) the step of obtaining the mixing gas which includes the steam which becomes in the crystallization process and ammonia and where the pH of the solution is 5.5 to less than 8 (para. 0030), as compared to claim 7, (d) the step of reusing the ammonia originating from the mixed gas (para. 0032), as compared to claim 8, performing steps (b) and (c) simultaneously or sequentially (para. 0029), as compared to claim 1. A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP $2144.05
Kim does not, however, disclose the application of this method to aromatic amino acids.
Qingyang rectifies this deficiency by teaching about an invention to produce L-tyrosine, as compared to claim 2, an essential aromatic amino acid and a ketogenic and glucogenic amino acid that appears as white crystalline powder, with applications in pharmaceuticals as a raw material, food as a nutritional supplement, and live-stock feed. This invention utilizes a fermentation broth of genetically engineered bacterium where the L-tyrosine synthesis related gene in Escherichia coli is modified at the genetic level, including the blocking of the phenylalanine synthesis pathway, eliminating the feedback inhibition and transcriptional negative regulation of key enzymes, inducing the RNA polymerase derived from the T7 phage by introduction of a xylose promoter, and high-efficiency expression of another key enzyme gene in combination with the T7 start subsystem, as compared to claims 3 and 4. By utilizing this system, Qingyang describes obtaining 37.8 g/L of bacteria from 5L of fermentation broth capable of producing L-tyrosine in a scalable, controllable, and economic manner (pg. 2).
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, to apply the crystallization method of Kim to the invention of Qingyang, which produces L- tyrosine through a genetically engineered bacterium of E-Coli as a means to purify the resulting crude material to obtain crystalline L-tyrosine, as compared to claims 9 and 10.
(New) Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Qingyang as applied to claims 1-10 above, and further in view of Mijts et al. (Method for producing objective substance, US 2019/0249206 A1, 2019).
Kim discloses a method of producing branched chain amino acid crystals in a procedure using ammonia. Qingyang teaches a method to produce L-tyrosine utilizing genetically engineered bacterium .
They do not, however, teach the application to the other aromatic amino acids L-tryptophan, L-phenylalanine, and L-histidine.
Mijts addresses this paucity by teaching that L-tryptophan can be derived from L-tryptophan biosynthesis enzymes such as 3-deoxy-D-arabinoheptulosonate-7-phosphate synthase (para. 0134), that L-histidine can be derived from L-histidine biosynthesis enzymes such as ATP phosphoribosyltransferase (para. 0135), that L-phenylalanine can be derived from L-phenylalanine biosynthesis enzymes such as chorismite mutase (para. 0137), and that these substances can be collected from the culture medium through several methods including crystallization (para. 0254).
As such, it would have been prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to take the teachings of Mijts and Qingyang on the biosynthetic methods of producing the aromatic amino acids of choice and apply the purification methods of Kim to realize crystallized aromatic amino acids with a reasonable expectation of success.
(New) Regarding the limitations of claims 12-14 and 17-20, where the aromatic amino acids are L-tyrosine, L-phenylalanine, and L-histidine, are met as both Mijts and Qingyang teach about the biosynthetic production of these aromatic amino acids while Kim provides the method of purification through crystallization in ammonia.
(New) Concerning the limitations of claims 15-16, where steps (b) and steps (c) are conducted simultaneously (claim 15) or sequentially (claim 16), are met as Kim teaches that the steps may be performed simultaneously or sequentially (para. 0029).
Response to Arguments
The office kindly thanks the Applicant for their consideration and arguments to the previous office action. Responses are detailed below.
Applicant's arguments filed 13 May 2026 have been fully considered but they are not persuasive. On pg. 2, Remarks, the Applicant argues:
…Applicant respectfully submits that the present application claims priority to KR 10-2021-0065600 filed on May 21, 2021, and thus Kim published after the effective filing date is not a prior art under 35 U.S.C. 102(a)(1) to the instant application…
In response to Applicant’s arguments, Kim published 25 November 2019, more than one year before KR 10-2021-0065600 and therefore falls outside the grace period afforded by 35 U.S.C. 102(a)(1).
On pg. 2, Remarks, the Applicant argues:
…In addition, Kim’s later filed PCT application (i.e. PCT/KR2020/015633) is cannot prior art under 35 U.S.C. 102(a)(2) as Applicant submits a Common Ownership Statement below, applying the exception under 35 U.S.C. 102(b)(2)(C) for PCT/KR2020/015633…
As PCT/KR2020/015633 is not utilized as prior art in the rejection, the exception provided by 35 U.S.C. 102(b)(2)(C) does not apply. Additionally, no Common Ownership Statement was found to have been filed to date in the current prosecution. Furthermore, exceptions under 35 U.S.C. 102(b)(2)(C) apply to PCT applications designating the US, which does not occur here.
On pg. 2, Remarks, the Applicant argues:
…moreover, Qingyang fails to teach or suggest “a method for crystallization of an aromatic amino acids” as set forth in the present claims”…
In response to applicant's arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is the combination of Kim and Qingyang that results in the obviousness rejection as Kim does teach crystallization while Qingyang teaches aromatic amino acids.
Summary
Claims 1-20 are rejected under 35 U.S.C. 103.
Conclusion
No claims are allowed.
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.
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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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