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 .
Note: The examiner of this application has changed. Filings for this application should be addressed to examiner Valerie Rodriguez-Garcia.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/21/2026 has been entered.
Receipt of claim amendments and arguments filed on April 21, 2026 is acknowledged. Rejections and objections not reiterated herein have been withdrawn.
Claims 21-22, 24-25, 27 and 30-32 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected inventions, there being no allowable generic or linking claim.
Claims 1, 3, 6, 9-11, 13, 18 and 19 are the subject of this Office Action.
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.
Claims 1, 3, 6, 9-11, 13, 18 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a lack of written description rejection.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, 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 courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications Under 35 USC 112, ¶1, “Written Description” Requirement (Federal Register, Vol. 66, No. 4, pg. 1105, column 3), in accordance with MPEP § 2163, specifically state that for each claim drawn to a genus the written description requirement may be satisfied through sufficient description of a representative number of species by a) actual reduction to practice; b) reduction to drawings or structural chemical formulas; c) disclosure of relevant, identifying characteristics (ie. structure) by functional characteristics coupled with a known or disclosed correlation between function and structure.
The specification fails to describe how to make/use the full scope of the claimed process.
Applicant claims a process of recovering 3-hydroxypropionic acid, comprising producing a fermented solution comprising 3-hydroxypropionic acid by fermenting a strain having a 3-hydroxypropionic acid-producing capacity;
forming a concentrate containing the 3-hydroxypropionic acid in an amount of 350 g/L or more to 900 g/L or less by concentrating the fermented solution; etc.
The claims recite that a purity of the 3-hydroxypropionate contained in the crystals is 90% or more.
Applicant has stated that the present invention has a unique recovery process that achieves high purity and high yield of 3HP from a 3HP fermentation broth. Applicant has stated that this is accomplished by concentrating a 3HP fermentation broth in the presence of the specific % of metal salts claimed to a concentration in a range of 350 g/L to 900 g/L. See applicant’s arguments.
The instant claims encompass the process of concentrating a 3HP fermentation broth in the presence of the specific % of metal salts claimed to a concentration in a range of 350 g/L to 900 g/L to obtain a purity of 90% or more. However, the instant specification describes that the fermented solution (broth) is first clarified by removing cells from it, and then it is purified by treatment with activated carbon and filtration. After this process, the clarified, purified fermented solution is then concentrated to the claimed concentration of 350 g/L or more to 900 g/L or less to obtain crystals at the 90% or more purity. See p. 28-29, Example 1. That is the only process performed in this application that supports the instant claims.
Concentrating a fermented solution, such as a 3HP fermentation broth, without clarification and purification, will produce a concentrated mixture of microbial cells, cell debris, insoluble medium components and other metabolic components. Obtaining crystals of 3-HP from concentrating such mixture, and further, obtaining them at the 90% or more purity claimed, was not described in this application. This application does not describe how to perform the full scope of the claimed process.
One of skill in the art would not recognize from the disclosure that the applicant was in possession of the whole genus claimed. 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).
Note a recent decision, Ariad Pharmaceuticals v. Eli Lilly and Company, 94 USPQ2d 1161 regarding description requirements in the chemical arts, in particular, at p.1171: "But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Later on the same page is stated:" And again in Enzo we held that generic claim language in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus claimed. 323 F,3d at 968".
This rejection could be overcome by amending claim 1 to recite the following after the producing of the fermented solution:
“removing cells from the fermented solution, adding activated carbon, mixing, removing it and filtering the solution to obtain a purified fermented solution;”
At the next step in the claim the “fermented solution” should be referred to as “the purified fermented solution”. Cancelation of claim 18 will be required.
Conclusion
Claims 1, 3, 6, 9-11, 13, 18 and 19 are rejected. No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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, Clinton Brooks can be reached at 571-270-7682. 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.
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
Prosecution Insights