DETAILED ACTION
Notice of Pre-AlA 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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20, 2025, has been entered.
Claim Disposition
3. Claims 2-6, 8-12, 15-20, 26-31, 33, 35-40, 42, 44-48, 50-59, 62-67, 71-72, 74-79, 81-85, 87, 89, 91 and 95 have been cancelled. Claims 1,7, 3-14, 21-25, 32, 34, 41, 43, 49, 60-61, 68-70, 73, 80, 86, 88, 90, 92-94 and 96-97 are pending and are under examination.
Claim Objection
4. Claims 1,7, 3-14, 21-25, 32, 34, 41, 43, 49, 60-61, 68-70, 73, 80, 86, 88, 90, 92-94 and 96-97 are objected to for the following informalities:
For clarity it is suggested that claim 1 is amended to read, “….the 3-HPDH [[results in production of]] produces 3-HP by the recombinant host cell”. See also claim 7 with similar language. The dependent claims hereto are also included.
For clarity and consistency it is suggested that claims 32, 34, 73 and 94 are amended to recite, “wherein……, and wherein….”, to link the two ‘wherein clause’.
For clarity it is suggested that claim 43 is amended to read, “A recombinant Escherichia coli (E. coli) host cell…”.The dependent claims hereto are also included.
For clarity it is suggested that claim 60 is amended to read, “The recombinant yeast host cell of claim 49,….”.
For clarity it is suggested that claims 68-70 are amended to read, “The recombinant E. coli host cell of claim 43…..:.”.
For clarity and precision of claim language it is suggested that claim 70 is amended to delete “capable of producing” and instead recite, “produces”. Note that the method of the invention is directed to producing the product using the host cell recited in claim 43. Thus the claim needs to provide a positive recitation of the activity.
For clarity it is suggested that claim 73 is amended to read, “The recombinant E. coli host cell of claim 43, wherein the recombinant E. coli host cell further comprises an exogenous promoter [[in operable linkage]] operably linked with an endogenous pyruvate….. and wherein….”.
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.
5. Claims 1,7, 3-14, 21-25, 32, 34, 41, 43, 49, 60-61, 68-70, 73, 80, 86, 88, 90, 92-94 and 96-97are 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 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 as amended is directed to “a method for producing 3-HP by providing a recombinant host cell having separate polynucleotides encoding enzymes (OAADC and 3-HPDH) and culturing said host cell in a culture medium comprising a substrate under anaerobic conditions suitable for the host to convert the substrate to 3-HP and result in production of 3-HP, however, the claimed invention is not adequately described because there are no indicia as to what gene encodes 3-HPDH and the invention as set forth in claims 1 and 7 do not establish if the gene is endogenous, recombinant or exogenous. No structure-function correlation is made for the gene either. An ordinary skilled worker cannot envision what structure is encompassed in the method that involves another recombinant gene and recombinant host to in combination produce the desired product. It is noted that dependent claims 23-25 recites that the gene can be endogenous, recombinant and provide a structure, however, the independent claims need to stand on their own. The claimed invention lacks adequate description because the gene is undefined and the art generally establishes that several different genes can encode the same protein.
In addition, the claimed invention as set forth in claims 7 and 49 encompasses a large variable genus of yeast host cells that is not adequately described that are recited as being ‘recombinant’. The claimed invention is overly broad and applicant has not demonstrated possession of all the possible yeast cell (recombinant) in association with this method and production of the desired product. It is noted that claim 43 recites the structure of the OAADC enzyme and that the gene that encodes 3-HPDH is endogenous or that the 3-HPDH comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 122-130, 154 and 159, however it is not clearly described if the endogenously produced enzyme corresponds to those structures or if they are recombinant since it is disclosed that the gene can be recombinant and claims 43 and 49 recites the embodiments in the alternative. In addition, the gene is disclosed as recombinant, however, the sequence of the enzyme is provided and having the amino acid structure does not necessarily equate to having a single gene, since multiple genes can encode the same protein that can be different structurally and functionally. The claimed invention is also not adequately described because the method indicates that host cell comprising the genes results in the production of 3-HP, however, claim 70 directed to the same host cell recites that the cell is ‘capable of producing’ which is not the same positive recitation of the activity.
The claimed invention is directed to a large variable genus of polynucleotides and yeast cells, that are not adequately described. The art generally acknowledges that several different genes can encode the same protein, yet the claimed invention is devoid of a specific gene structure and activity of the expression product. Thus, no structure-function correlation is made. For example, the invention set forth in claim 80 is directed to a vector that comprises a gene encoding an amino acid sequence that is selected from SEQ ID NOs: 145, 146, 148 and 166, which encompasses a large variable genus not adequately described; and is devoid of activity for the recited expression product. The invention of claim 32 is not linked in any manner to the production of 3-HP, thus no nexus is provided between this gene and method claimed (a gene encoding PEPCK, however, no nexus is made with the production of 3-HP). The claimed invention is overly broad and encompasses a large variable genus of host cells, genes and enzymes (claim 32 is directed to further polynucleotides that could possibly encode a different enzyme than is recited in claim 1; and claims 34, 73, 76 and 79, for example). Thus, the claimed invention is not adequately described and devoid of any activity, thus no structure-function correlation is made.
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.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, 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 chemical structure of the encompassed genus of genes and expression products/ host cells 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).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims, which is vast.
Response to Arguments
6. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Upon due reconsideration, note that new objections and rejections have been made above for the aforementioned reasons.
Conclusion
7. No claims are presently allowable.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652