DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 4-5, 7, 9-10, 12-14, 16-18, 22, 24, 26, and 28) in the reply filed on July 7, 2026 is acknowledged.
Claims 34-35, 43, and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 7, 2026.
Claims 1, 4-5, 7, 9-10, 12-14, 16-18, 22, 24, 26, and 28 are under examination.
Information Disclosure Statement
The Information Disclosure Statements filed January 23, 2023; May 17, 2024; and November 3, 2025 have been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
It is noted that the Sequence Listing Incorporation by Reference paragraph lists the size of the ASCII text file as 182,826 bytes, but the file itself, filed April 5, 2023 is 183,566 bytes.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at page 29, lines 14, 16, and 17. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms TWEEN20 at page 42, line 17; CAPTURESELECT at page 45, line 1; page 46, line 15; page 52, line 8; page 53, lines 4 and 23; page 54, line 15; and page 55, line 29; NANODROP at page 47 line 5 and page 54, line 12; GENSCRIPT at page 44, lines 4 and 7; page 51, lines 9, 11 and 19; and page 55, lines 6 and 13; GIBSON ASSEMBLY at page 51, line 19; IRDYE at page 45, line 2; page 47, line 10; page 50, line 6; page 52, line 9; page 53, lines 7 and 8; page 54, lines 17 and 18; and page 55, line 30; and ÄKTA at page 46, lines 16 and 22; page 53, line 24; and page 54, line 3; which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claim 22 is rejected under 35 U.S.C. § 112, first paragraph, because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention, because the specification does not provide evidence that the claimed biological materials are (1) known and readily available to the public; (2) reproducible from the written description.
It is unclear if the Thermothelomyces heterothallica C1 strain is are known and publicly available, or can be reproducibly isolated without undue experimentation. Therefore, a suitable deposit for patent purposes is suggested. Without a publicly available deposit of the above Thermothelomyces heterothallica C1 strain, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of: (1) the claimed Thermothelomyces heterothallica C1 strain; (2) methods of creating the Thermothelomyces heterothallica C1 strain; and/or (3) methods of replication a template plasmid using the Thermothelomyces heterothallica C1 strain.
For example, Thermothelomyces heterothallica C1 strain made by modification of a the KEX2 and/or ALP7 genes can result in a wide variety of different mutants having a variety of different phenotypes. The results indicate that modification of bacterial strains results in deletions and/or insertions that can have an effect on the Thermothelomyces heterothallica C1 strains that are obtained. Therefore, it would require undue experimentation to reproduce the claimed Thermothelomyces heterothallica C1 strain.
Exact replication of a mutant bacteria is an unpredictable event. Although applicant has provided a written description of a method for selecting a Thermothelomyces heterothallica C1 strain, this method will not necessarily reproduce bacterial strains which are phenotypically, chemically and structurally identical to those claimed. It is unclear that one of skill in the art could produce a Thermothelomyces heterothallica C1 strain identical to those claimed. Undue experimentation would be required to screen all of the possible species to obtain the claimed Thermothelomyces heterothallica C1 strains.
Because one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed in the absence of the availability of the claimed Thermothelomyces heterothallica C1 strain, a suitable deposit is required for patent purposes, evidence of public availability of the claimed cell line or evidence of the reproducibility without undue experimentation of the claimed Thermothelomyces heterothallica C1 strains, is required.
While the deposit of the claimed Thermothelomyces heterothallica C1 strain appears to have been made under the provisions of the Budapest Treaty, the filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit of the cell lines has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If, however, the deposit of the Thermothelomyces heterothallica C1 strain was not made under the provisions of the Budapest Treaty, then in order to certify that the deposit complies with the criteria set forth in 37 CFR 1.801-1.809 regarding availability and permanency of deposits, assurance of compliance is required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request:
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application:
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
Amendment of the specification to recite the date of deposit and the complete name and address of the depository is required. As an additional means for completing the record, applicant may submit a legible copy of the contract with the depository for deposit and maintenance of each deposit.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the applicant's possession at the time the application was filed. See MPEP 2406 and 37 CFR 1.804(b).
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
The specification discloses deposit information in at pages 1-2, but the deposit information does not include the requisite statements regarding the availability of the deposited material upon issuance of a patent.
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.
Claims 1, 4-5, 7, 9-10, 12-14, 16-18, 22, 24, 26, and 28 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.
At claim 1, lines 2 and 5, the phrase “protein of interest” is unclear because protein may be of interest to one practitioner, but not another. The subjective nature of the term “of interest” renders the claim indefinite. It is suggested that “of interest” be deleted in each occurrence.
Claims 4-5, 7, 9-10, 12-14, 16-18, 22, 24, 26, and 28 depend from claim 1, and are therefore included in this rejection.
At claim 16, line 3, the phrase “protein of interest” is unclear because protein may be of interest to one practitioner, but not another. The subjective nature of the term “of interest” renders the claim indefinite. It is suggested that “of interest” be deleted.
At claim 24, line 2, the phrase “protein of interest” is unclear because protein may be of interest to one practitioner, but not another. The subjective nature of the term “of interest” renders the claim indefinite. It is suggested that “of interest” be deleted.
Claim 28 depends from claim 24, and is therefore included in this rejection.
At claim 28, line 2, the phrase “protein of interest” is unclear because protein may be of interest to one practitioner, but not another. The subjective nature of the term “of interest” renders the claim indefinite. It is suggested that “of interest” be deleted.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 22 recites that the ascomycetous filamentous fungus is Thermothelomyces heterothallica C1. Claim 18, from which claim 22 depends, recites that the ascomycetous filamentous fungus is of a genus within Pezizomycotina. The specification notes that the fungus is of a genus within the group Pezizomycotina. The specification further states that the fungus is of a genus selected from the group that includes Thermothelomyces. Thus, because the groups of claims 18 and 22 appear to be different, claim 22 does not further limit claim 18.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 9-10, 16-17, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (89 Applied Microbiology and Biotechnology 747-759 (2011), and cited in the Information Disclosure Statement filed January 23, 2023) in view of Visser et al. (Visser I, 7(3) Industrial Biotechnology 215-227 (2011), and cited in the Information Disclosure Statement filed January 23, 2023) and Idiris et al. (86 Applied Microbiology and Biotechnology 403-417 (2010)).
Regarding claim 1 and 4, Yoon discloses disruption of ten protease genes in Aspergillus oryzae improves production of heterologous proteins (abstract). Yoon discloses that the ten genes includes ALPA (i.e., ALP1) (page 750, paragraph bridging columns 1 and 2).
Regarding claim 9, Yoon discloses additional proteases having reduced expression/activity (abstract).
Regarding claim 10, Yoon discloses additional proteases include pepA (i.e., pep1) (abstract).
Regarding claims 16 and 17, Yoon discloses that protease disruption can provide highly enhanced levels and stability of recombinant protein production (page748, column 2, first full paragraph and Figure 2).
Regarding claim 24, Yoon discloses production of human lysozyme and bovine chymosin (abstract).
Yoon fails to explicitly disclose that the proteases having reduced expression are KEX2 and ALP7. Yoon fails to disclose other filamentous fungi for the production of proteins.
Regarding claims 1 and 4, Visser I discloses development of a filamentous fungus which can be used as an expression platform for screening and producing a variety of industrial enzymes (i.e., proteins). Visser I discloses deletion of the protease alp1 (Figure 5A). Visser I further discloses that knockout of proteases improves the yield of recombinantly expressed proteins (page 218, column 2, final paragraph to page 220, column 1, second paragraph).
Regarding claim 22, Visser I discloses use of the filamentous fungi Myceliophthora thermophila C1 (now known as Thermothelomyces heterothallica C1) (abstract).
Regarding claims 1 and 4, Idiris discloses disruption of protease genes in Aspergillus oryzae improves production of heterologous proteins (page 409, column 2, final full paragraph). Idiris discloses that the KEX2 can be deleted to increase protein production (paragraph bridging pates 408 and 409). Idiris discloses that genes in the alkaline phosphatase pathway (ALP) provides for transport of proteins to a vacuole (paragraph bridging pages 407 and 408).
Regarding claim 9, Idiris discloses disruption of additional genes which can control protein degradation in the secretion pathway (paragraph bridging pages 408 and 409).
Regarding claim 10, Idiris discloses that PEP4, PRB1, CPY1, YPS1 can also be deleted (paragraph bridging pages 408 and 409).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to knock out or reduce the expression of the KEX2 and ALP genes of Idiris instead of Visser I’s alp1 because both Yoon and Visser I disclose that reduction of protease expression improves the yield of recombinantly produced proteins in a variety of filamentous fungi, including Yoon’s Aspergillus oryzae and Visser’s Thermothelomyces heterothallica C1. As such, because both Yoon and Visser I disclose improvement of protein production in the variety of filamentous fungi, one of ordinary skill in the art would have had a predictable and reasonable expectation of success in knocking out or reducing expression of Idiris’ KEX2 and ALP genes in either Yoon’s Aspergillus oryzae or Visser I’s Thermothelomyces heterothallica C1. It would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that reduction of ALP7 protease would also improve the protein production because it is a member of the ALP gene family disclosed by both Visser I and Idiris.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Visser I and Idiris as applied to claims 1, 4, 9-10, 16-17, and 24 above, and further in view of Berka et al. (29(10) Nature Biotechnology 922-927, Online Methods (2011)) and Visser et al. (Visser II, PCT Patent Application Publication No. WO 2012/048334, published April 12, 2012).
Yoon, Visser I, and Idiris disclose and suggest methods of protein production in filamentous fungi, as discussed above.
Yoon, Visser I, and Idiris fail to disclose or suggest the sequences of Thermothelomyces heterothallica C1 KEX2 or ALP7.
Berka discloses genomic analysis of Myceliophthora thermophila (now Thermothelomyces heterothallica C1) (abstract). Berka discloses the sequence of Myceliophthora thermophila ALP7 (Appendix I, SEQ ID NO: 14) (page 20, line 22).
Visser II discloses production of enzymes in a variety of filamentous fungi, including Myceliophthora thermophila (now Thermothelomyces heterothallica C1) (paragraph [049]. Visser II discloses the sequence of Myceliophthora thermophila ALP7 (Appendix II, SEQ ID NO: 13) (SEQ ID NO: 386) (page 20, line 22).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to target Berka’s Thermothelomyces heterothallica KEX2 or Visser II’s Thermothelomyces heterothallica ALP7 because, as disclosed by Yoon, Visser I, and Idiris because, when using the filamentous fungi Thermothelomyces heterothallica, one of ordinary skill in the art would want to use the exact sequences of the KEX2 of Berka and ALP7 of Visser II to target for reduced expression/activity in order to provide a higher protein production of a desired protein.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Visser I and Idiris as applied to claims 1, 4, 9-10, 16-17, and 24 above, and further in view of Arvas et al. (12 BMC Genomics 616, 1025 (2011)).
Yoon, Visser I, and Idiris disclose and suggest methods of protein production in filamentous fungi, as discussed above.
Yoon, Visser I, and Idiris fail to disclose or suggest that the filamentous fungus is a genus within Pezizomycotina.
Arvas discloses gene expression and protein production in Pezizomycotina (paragraph bridging pages 1 and 2). Arvas discloses that Pezizomycotina T. reesei is a known producer of cellulase and hemicellulose enzymes, as well as recombinant proteins (page 2, paragraph bridging columns 1 and 2).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to target Arvas’ Pezizomycotina T. reesei for the production of proteins because, as disclosed by Yoon, Visser I, and Idiris because one of ordinary skill in the art would be able to use Arvas’ Pezizomycotina T. reesei in place of the filamentous fungi of Yoon, Visser I, and/or Idiris because each of the fungi are known to be able to produce recombinant proteins. As such, one of ordinary skill in the art would have had a predictable and reasonable expectation of success in modifying any of Yoon’s, Visser I’s, Idiris’, and/or Arvas’ fungi to produce recombinant proteins at a high and stable level.
Claims 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Visser I and Idiris as applied to claims 1, 4, 9-10, 16-17, and 24 above, and further in view of Allgaier et al. (37 Biologicals 128-132 (2009).
Yoon, Visser I, and Idiris disclose and suggest methods of protein production in filamentous fungi, as discussed above.
Yoon, Visser I, and Idiris fail to disclose or suggest that the protein is fused to a tag or that the protein is a viral component.
Regarding claim 26, Allgaier discloses that the vaccine antigens can be fused to a tag, such as a histidine tag (9 x His) (page 129, column 1, second full paragraph, paragraph bridging pages 129 and 130, and Figure 1).
Regarding claim 28, Allgaier discloses production of vaccines in the filamentous fungus Neurospora crassa (abstract). Allgaier discloses that the vaccine can be production and purification of influenza hemagglutinin and neuraminidase antigens (abstract).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to produce Allgaier’s vaccine antigens, including the His-tagged hemagglutinin in the filamentous fungus system of Yoon, Visser I, and Idiris in order to provide improvement of protein production in the variety of filamentous fungi. As disclosed by Yoon, Visser I, and Idiris, reduction of protease genes provide for higher production and stability of proteins, including the His-tagged influenza hemagglutinin of Allgaier. Thus, one of ordinary skill in the art would have had a predictable and reasonable expectation of success in knocking out or reducing expression of Idiris’ KEX2 and ALP genes in either Yoon’s Aspergillus oryzae or Visser I’s Thermothelomyces heterothallica C1 in order to produce Allgaeir’s His-tagged influenza hemagglutinin at a high level in order to prepare vaccines against influenza.
Allowable Subject Matter
Although the prior art discussed above discloses that protease disruption provides for higher and more stable protein production in filamentous fungi, the prior art fails to disclose or suggest genetically modified filamentous fungi having reduces expression and/or activity of all of the thirteen claimed proteins (claims 12 and 13) or all of the fourteen claimed proteins (claim 14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Emalfarb et al. (U.S. Patent No. 8,268,585, issued September 18, 2012, and cited in the Information Disclosure Statement filed January 23, 2023) disclose transformation systems for filamentous fungus hosts for the expression and secretion of heterologous proteins (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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, NEIL HAMMELL can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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