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 Preliminary Amendment filed on March 16, 2026, has been received and entered.
3. Applicant’s election of Group I (with species) without traverse on March 16, 2026 is acknowledged. In addition, a telephonic election was made by Mr. Chester Moore on May 11, 2026 of SEQ ID NOs: 249 for the gene and SEQ ID NO: 250 for the expression product without traverse. The claims are only being examined to the extent that they pertain to the elected species.
Claim Disposition
4. Claims 1-24 are pending. Claims 1-2,7-9, 11 and 20-21 and are under examination. Claims 3-6, 10, 12-19 and 22-24 are withdrawn from consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Drawings
5. The Drawings filed on June 23, 2023, are accepted by the examiner.
Information Disclosure Statement
6. The Information Disclosure Statement filed on June 23, 2023 has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action. Note that some references have been lined through because they have an improper date.
Specification objection
7. The specification is objected to for the following informalities:
The specification is objected to because the priority information needs to be updated because US Application NO. 16/834756 is now US Patent No. 11,725,223.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following is suggested: "Microorganisms for recombinant production of steviol or steviol glycosides".
The specification is objected to for typographical error of “yoghurt” for ‘yogurt’ (see page 46, for example).
The specification is objected to because the organism names are not italicized, see pages 62-68, for example.
The specification is objected to because Table 6 is missing a sequence for the ‘Terminator’ in line 1.
Appropriate correction is required.
Claim objection
8. Claims 1-2,7-9, 11 and 20-21 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to delete all reference to ‘capable of’, see for example, “capable of producing” and instead recite the activity in a positive way such as “….microorganism produces”. The dependent claims hereto are also included.
For clarity it is suggested that claim 1 is amended to delete “whereby” and instead recite “wherein”.
Claim 1 should be amended read, “…[[such that it results in]] to result in a deficiency….”. A method of preparing fibronectin concentrates from a pool of cryoprecipitate anti-hemolytic factor by using plasma precipitates…”.
For clarity it is suggested that claim 1 is amended to read, “….(AHF) from plasma precipitates, [[the method]] comprising:……form a heterogenous pool [[of high molecular weight proteins]], wherein….plasma units that have been chill treated [[such that high molecular weight proteins precipitate out of the plasma units]] to precipitate out of the plasma units of the high molecular weight proteins….different donor, [[and]] wherein….weight proteins [[include]] have fibronectin……concentration of fibronectin, and wherein the irradiation is….”. The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claim 2 is amended to recite, “….wherein the heterogenous pool…”.
For clarity it is suggested that claim 4 is amended to “….wherein [[the]] adjusting the concentration….”.
For clarity it is suggested that claims 2, 7-9, 11 and 20-21 are amended to recite “of” instead of “according to”.
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.
9. Claims 1-2,7-9, 11 and 20-21 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 pre-AlA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to “a recombinant microorganism capable of producing steviol or steviol glycosides comprising nucleotide sequences encoding 4 different enzymes (see claim 1 in its entirety) and the microorganism is modified in its genome such that it results in a deficiency in the production of one or more of 9 proteins and/or enzymes”. The claimed method is not adequately described because the claimed products are not adequately described as no correlation is made between structure and function. In addition, the host microorganism is modified in its genome but not enough information is provided as to how said modification is done or what specifically is modified. The claimed invention encompasses a broad variable genus of microorganisms, structures and modifications that are not adequately described.
The claimed invention is devoid of a structure-function. The claimed invention is overly broad and encompasses a large variable genus of compounds. The specification fails to provide any additional representative species of 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.
Accordingly, in the absence of sufficient recitation of distinguishing identifying
characteristics of the claimed method, method steps, host organism and the genus of products encompassed, the specification does not provide adequate written description of the claimed invention, as a whole. 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.
10. Claims 1-2,7-9, 11 and 20-21 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.
Claim 1 and the dependent claims hereto are indefinite for the recitation of “”microorganism capable of producing steviol or steviol glycosides” in the preamble and then the recitation of “microorganism ..ability to produce at least steviol..”, this introduces ambiguity into the claim.
Appropriate correction is required.
Double Patenting
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple a assignees. A nonstatutory double paten ting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference cl aim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Ci r. 1998); In re Goodman, 11 F.3d 1046,29 USPQ2d 2010 (Fed. Ci r. 1993); In re Longi, 759 F.2d 887,225 USPQ645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937,214USPQ761 (CCPA1982); In re Vogel, 422 F.2d 438,164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528,163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP §2159. See MPEP §§706.02(l)(l) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed incompliance with 3 7 CFR 1.321(b). The USPTO Inter net website contains terminal disclaimer forms which may be used. Please visit www.usDto.oov/patent/Datents-forms.The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AI A/26) should be used. A web-based eTerminal Disclaimer maybe filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
12. Claims 1-2,7-9, 11 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 17-18 of US Patent No.10,689,681.
The instant claims are directed to a recombinant microorganism capable of producing steviol or steviol glycosides the a nucleotide encoding several enzymes. The patented claims are directed to terpene or glycosylated diterpene comprising fermenting a recombinant microorganism comprising one or more nucleotide sequence encoding several enzymes….. The patented claims are directed to a recombinant yeast cell that has the same gene encoding the same enzymes.
The difference between the two sets of claims is the recitation of a different arrangement of the same limitations, for instance the patented claims recites the organism in claim 1 and the instant claims recites the same ones in dependent claims”. Although the two sets of claims differ in scope, the two sets of claims are obvious variation of each other, thus prima facie obvious.
Conclusion
13. No claims are presently allowable.
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.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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