DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on June 12, 2025, has been received and entered.
Claim Disposition
3. Claim 13 has been added. Claims 1-13 are pending. Claims 1-11 and 13 are under examination. Claim 12 is withdrawn as directed to a non-elected invention. The claims have been amended to recite “an amino acid or nucleic acid” which would have been subject to a Restriction Requirement, as the scope of the claims appear to be more towards “an amino acid” the claims are being construed as such, and it is suggested that applicant amends the claims.
Specification Objection
4. Claims 1-11 and 13 are objected to for the following informalities:
The specification is objected to because the priority information is not listed on page 1.
Appropriate correction is required.
Claim objection
5. Claims 1-11 and 13 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “A method for manufacturing an amino acid, comprising:
preparing a fermentation vessel and a sensor device for measuring properties of liquid inside the fermentation vessel, wherein the fermentation vessel has a mixture of bubbles and crystals with an average particle size of 5…..”. The dependent claims hereto are also included.
For clarity it is suggested that claims 2-11 and 13 are amended to read “The method of claim 1 [for manufacturing an amino acid or nucleic acid]….”.
For clarity and consistency it is suggested that claim 13 is amended to recite, “….wherein the [[said]] amino acid……….inosine, [[and]] guanosine, and adenine”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1-11 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or
a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to a method for manufacturing an amin acid or nucleic acid by operation of a fermentation vessel wherein bubbles are mixed and crystals with an average particle size of 5 micro meter or greater are formed in a liquid… (see claim 1 in its entirety).
The claimed invention is not adequately described with respect to the fermentation products which can be an amino acid or nucleic acid because the claimed invention encompasses a large variable genus. It is well established the 20 naturally occurring amino acids, however there are several non-natural ones and derivatives etc. and the genus of nucleic acids is very large. Moreover, the claimed embodiment reflects cysteine (see claim 10) and a grouping found in claim 13, however this does not limit claim 1. The claimed invention is also solely geared towards an amino acid manufacture and separation. Therefore, the claimed invention is not adequately described and encompasses a large variable genus of fermentation products.
The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed structure of the encompassed genus of products made by fermentation, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
7. Claims 10 and 13 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.
Claims 10 and 13 are indefinite for the recitation of “amino acid or nucleic acid” because the method is manufacturing an amino acid and recites cysteine and other amino acids like glutamic acid.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be addressed herein as applicant’s comments are moot. The rejections of record have been maintained, however, have been amended to reflect changes made to the claims. Applicant traverses the rejections by stating that the claims have been amended, however, the issues raised remain for the reasons stated above and herein. The 112 first paragraph issues remain because the claims recite amino acid or nucleic acid which are broad categories. The claimed invention has a large variable genus of proteins and genes that are not adequately describe. Suggestions have been made as to how to clarify the claim language (see the objections). Therefore, the rejection remains.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
Prosecution Insights