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
Claims 1-17 and 19-37 are pending. Claims 18 and 38-63 are cancelled.
Response to Arguments
Applicant's arguments filed 4/10/2026 do not pertain to the new grounds of rejection set forth in this action under 35 U.S.C. 112(b) and 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112
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.
(New Rejection Necessitated by Amendment) Claims 1-17 and 19-37 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 1 and 19 are indefinite because there are multiple reasonable interpretations for “an exogenously introduced secretion enhancing protein gene expressing said secretion enhancing protein under the control of said heterologous promoter.” In one interpretation, the exogenously introduced secretion enhancing protein is under the control of the same heterologous promoter as the endogenous secretion enhancing protein. In a second interpretation, the exogenously introduced secretion enhancing protein is the same protein as the endogenous secretion enhancing protein gene under the control of a heterologous promoter endogenous to the host cell, but the exogenously introduced secretion enhancing protein is not required to be under the control of the same heterologous promoter endogenous to the host cell.
Claim 1 recites the limitation "the level of said secretion enhancing protein" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether said secretion enhancing protein refers back to the endogenous or the exogenously introduced secretion enhancing protein.
Claim 19 recites the limitation "the level of said secretion enhancing protein" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-17 and 20-37 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
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.
(New Rejection Necessitated by Amendment) Claims 1-17 and 19-37 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 recites an engineered Trichoderma filamentous fungus host cell comprising an endogenous secretion enhancing protein gene under the control of a heterologous promoter endogenous to the host cell and an exogenously introduced secretion enhancing protein gene expressing said secretion enhancing protein under the control of said heterologous promoter, wherein the level of said secretion enhancing protein in said host cell is increased as compared with a corresponding host cell not having the exogenously introduced secretion enhancing protein gene. This is new matter because the specification does not disclose such a host cell in which the same heterologous promoter regulates the expression of an endogenous secretion enhancing protein gene and an exogenously introduced secretion enhancing protein gene. Rather, the specification discloses a fungus comprising native bip1 under the control of its own promoter and exogenously introduced bip1 under the control of pki, which is a heterologous promoter endogenous to the host cell (Table 5). The specification also discloses the integration of an expression cassette comprising bip1 under the control of the cbh1 promoter into the genome of the fungus (Example 12, lines 15-17 and 26-27 on page 48). The specification also defines "over-expression of a gene" means the introduction of an additional copy or copies of an expression cassette consisting of the gene controlled by either a native or heterologous promoter sequence; or increasing expression of the gene compared to a parent strain by replacing the native promoter with a heterologous promoter in the endogenous gene locus (page 15, lines 29-33). However, the specification never discloses the same heterologous promoter controlling both the endogenous and exogenously introduced secretion enhancing protein genes.
(New Rejection Necessitated by Amendment) Claim 1-17 and 19-37 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “An engineered Trichoderma filamentous fungus host cell comprising an endogenous secretion enhancing protein gene under the control of a heterologous promoter endogenous to the host cell, and an exogenously introduced secretion enhancing protein gene expressing said secretion enhancing protein under the control of said heterologous promoter wherein the level of said secretion enhancing protein in said host cell is increased as compared with a corresponding host cell not having the exogenously introduced secretion enhancing protein gene.
Claim 19 is drawn to a method for production of a secretable polypeptide in the engineered Trichoderma filamentous fungus host cell comprising expressing a heterologous gene in the host cell. The host cell has the same structural requirements as those described above.
The person of ordinary skill in the art would not have recognized that the inventors, at the time the application was filed, had possession of the claimed genus of host cells.
Independent claims 1 and 19 require expressing an endogenous secretion enhancing protein gene and an exogenously introduced secretion enhancing protein gene under the control of the same heterologous promoter endogenous to the host cell.
The specification discloses a fungus comprising native bip1 and exogenously introduced bip1 under the control of pki, which is a heterologous promoter endogenous to the host cell (Table 5). The specification also discloses the integration of an expression cassette comprising bip1 under the control of the cbh1 promoter into the genome of the fungus (Example 12, lines 15-17 and 26-27 on page 48). The specification also defines "over-expression of a gene" as the introduction of an additional copy or copies of an expression cassette consisting of the gene controlled by either a native or heterologous promoter sequence; or increasing expression of the gene compared to a parent strain by replacing the native promoter with a heterologous promoter in the endogenous gene locus (page 15, lines 29-33). None of the examples in the specification describe controlling expression of an endogenous secretion enhancing protein and an exogenous secretion enhancing protein with the same heterologous promoter.
Goedegebuur teaches an engineered chymosin-producing strain of T. reesei comprising a bip1 expression vector ([0060] and [0074]). Bip1 is a secretion enhancing protein (Goedegebuur claim 1). Bip1 is also an endogenous protein of T. reesei ([0068]). The bip1 expression vector is exogenously introduced ([0068]). Thus, Goedegebuur teaches an engineered T. reesei comprising both an endogenous bip1 secretion enhancing protein under the control of its own native promoter and an exogenously introduced bip1 expression vector. Goedegebuur also teaches a method for production of a secretable polypeptide in a filamentous fungal host comprising expressing a secretion enhancing protein in a filamentous host containing a secretable polypeptide, wherein the secretion enhancing protein is bip1 and the secretable polypeptide is a chymosin (Goedegebuur claim 1). The filamentous fungal host is T. reesei (Goedegebuur claim 4). The chymosin is bovine chymosin (Goedegebuur claim 6), so the T. reesei host cell comprises a heterologous (not native) gene. The chymosin is expressed through a promoter of the filamentous fungal host (Goedegebuur claim 7). In some embodiments, the chymosin is expressed under a cbh1 promoter in T. reesei (Goedegebuur claim 8).
In summary, Goedegebuur teaches a Trichoderma host cell comprising an endogenous secretion enhancing protein (bip1) and also an exogenously introduced secretion enhancing protein under the control of cbh1, which is a heterologous protein endogenous to the Trichoderma host cell. However, the cbh1 promoter does not control the expression of the endogenous bip1, which is under the control of its own promoter rather than a heterologous promoter.
AddGene (cited in the Non-Final Action mailed on 1/13/2026) teaches that a promoter is a region of DNA where transcription of a gene is initiated (paragraph 1 on page 1). Promoters control the binding of the RNA polymerase to DNA. RNA polymerase transcribes DNA to mRNA, which is ultimately translated into a functional protein (paragraph 1 on page 1). Promoters are about 100-1000 base pairs long and adjacent and typically upstream (5’ end) of the coding strand of the transcribed gene (paragraph 1 on page 1, Figure 1).
Based on the teachings of AddGene, the person of ordinary skill in the art would have understood that placement of the promoter upstream of the gene is required for controlling its expression. However, an “exogenously introduced secretion enhancing protein gene” encompasses an expression cassette and “endogenous secretion enhancing protein gene” occurs in the genome of the host cell. These are two separate locations for genetic material and the specification discloses no mechanism by which the same heterologous promoter can be located 5’ to the endogenous secretion enhancing protein gene and also 5’ to the exogenously introduced secretion enhancing protein gene.
Therefore, the person of ordinary skill in the art would not have recognized that the inventors, at the time the invention was filed, had possession of the claimed invention.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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