DETAILED ACTION
Acknowledgment and entry of the Amendment submitted on 8/17/26 is made.
Claims 1-3, 5-11 and 13-21 are currently pending.
The instant specification shows that the introduction into Bacillus subtilis of yvyD overexpression cassettes with promoter swap mutations (spoVG promoter or hbs promoter replacing the native promoter) leads to increased expression of heterologous reporter proteases.
SEQ ID NO: 18= coding sequence of the yvyD gene
SEQ ID NO: 23 = ydyD gene promoter + coding sequence
SEQ ID NO: 26 = YvyD protein sequence
The amendment to the claims has obviated the former rejections under 35 USC 102, 35 USC 103 and 35 USC 112, second paragraph.
The following rejections were necessitated by the amendments to the claims.
Claim Rejections - 35 USC § 112-Scope of Enablement
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, 5-11 and 13-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A recombinant Bacillus subtilis in which the native promoter of the yvyD gene (SEQ ID NO: 23) is replaced with the spoVG promoter (SEQ ID NO: 25) or hbs promoter (SEQ ID NO: 22) and wherein the B. subtilis overexpresses heterologous protease in Bacillus subtilis strains expressing 2 copies of a protease reporter gene.
, does not reasonably provide enablement for:
A recombinant Bacillus sp. cell comprising an engineered nucleic acid arrangement comprising a heterologous promoter operably linked to a yvyD gene coding sequence comprising at least 80% identity to the yyyD gene of SEQ ID NO: 18; and wherein the heterologous promoter increases expression of the yvyD gene encoding sequence relative to expression of the yvyD coding sequence from a native yvyD promoter in an otherwise identical Bacillus sp. cell lacking the engineered nucleic acid arrangement.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The instant specification shows that replacing the native promoter with the spoVG promoter or hbs promoter leads to increased heterologous protease activity in Bacillus subtilis strains expressing 2 copies of a protease reporter gene (see examples 1-3, Figs. 2-5). The replacing the native yvyD gene promoter with a stronger promoter, is neither taught nor suggested in the cited prior art. The claims fail to recite the stronger promoters required for this function. They merely recite the functional limitation of ‘the heterologous promoter increases expression of the yyD gene coding sequence. There is furthermore no teaching or suggestion for the skilled person to increase expression of the yvyD gene in order to increase the amount of produced protein (claims 13-18).
With respect to the 80% identity to SEQ ID NOS: 18 and 26, the specification states that substitutions, additions, or deletions, may be made to the defined sequences; however, the specification provides no guidance as which amino acids may be changed without causing a detrimental effect to the enzyme and with the added enzymatic function requirement. It is unpredictable as to which amino acids could be removed and which could be added. While it is known that many amino acid substitutions are possible in any given protein, the position within the protein’s sequence where amino acid substitutions can be made with a reasonable expectation of success are limited. Other positions are critical to the protein’s structure/function relationship, e.g., such as various positions or regions directly involved in binding, catalysis in providing the correct three-dimensional spatial orientation of binding and catalytic sites. These regions can tolerate only very little or no substitutions. Selective point mutation to one key residue could eliminate the function of the polypeptide. It could eliminate its functional properties. If the range of decreased binding ability after single point mutation of a protein antigen varies, one could expect point mutations in the protein antigen to cause varying degrees of loss of protection/function, depending on the relative importance to the binding interaction of the altered residue. Alternatively, the combined effects of multiple changes, as instantly claimed, in an antigenic determinant could again result in loss of function. A protein having multiple point mutations, or accumulated point mutations at key residues could create a new antigen that is precipitously or progressively unrecognizable. As stated above, Applicants have not shown the particular substitution and the result it produces. Applicants have provided no guidance to enable one of ordinary skill in the art how to determine, without undue experimentation, the effects of different amino substitutions and the nature and extent of the changes that can be made. It is expensive and time consuming to make amino acid substitutions at more than one position, in a particular region of the protein, in view of the many fold possibilities for change in structure and the uncertainty as to what utility will be possessed. The three-dimensional structure of molecules is important for their biological function and even a single amino acid difference may account for markedly different biological activities. Amino acids owe their ‘significance’ to their inclusion in a pattern which is directly involved in recognition by, and binding to, the receptor and the significance of the particular amino acids and sequences for different amino acids cannot be predicted a priori, but must be determined from case to case by painstaking experimental study. The instant claims allow for substitutions with amino acids of vastly different properties, and they do not recite the specific changes in the claims. With respect to claim 21, the claims fail to provide the sequence information in the claim leaving the name alone confusing. Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
Response to Applicants’ arguments:
Applicants argue for example:
that the specification provides representative working embodiments that fall squarely within amended claim 1. Section II describes yvyD overexpression integration cassettes designed for introduction into exemplary Bacillus host cells, where the integration fragments were designed to integrate at the yvzG-yvyD intergene region and replace/substitute the native yvyD promoter with a heterologous promoter. The disclosed cassettes include PspoVG-yvyD and Phbs-yvyD arrangements. The Brief Description of Drawings and sequence listing further identify the yvzG-yvyD intergene::lox-SpecR-lox-PspoVG-ywyD cassette as SEQ ID NO: 19 and the yvzG-yvyD intergene::lox-SpecR-lox-Phby-ywyD cassette as SEQ ID NO: 20.
The disclosure also supports the amended claim requirement that the heterologous promoter increases expression relative to the native yvyD promoter. Section II explains that recombinant Gram-positive cells/strains may express a yvyD coding sequence from a promoter that produces higher steady-state mRNA levels than the native yyyD promoter. The specification further reproduces transcriptomic data showing that spoVG and hbs steady-state mRNA levels are higher than yvyD under multiple industrially relevant growth/fermentation conditions, and states that spoVG and hbs mRNA levels are higher than yyyD in more than 80% and more than 85%, respectively, of 53 transcriptome data points. This disclosure provides a technical rationale for selecting heterologous promoters that increase yvyD expression relative to the native yyyD promoter. The Examples further demonstrate that the claimed engineered promoter/yvyD arrangements can be made and used to increase POI production. Example 2 describes construction of recombinant Bacillus cells comprising two copies of genes encoding exemplary reporter proteins, including Protease-1, Protease-2, or Protease-3, and introducing the promoter-swap yvyD integration cassettes into those cells. Example 3 reports comparative protease activity assays showing that PspoVG-yvyD increased Protease-1 and Protease-2 production, and Phbs-yvyD increased Protease-2 and Protease-3 production. These data are significant for enablement because they are not limited to a single promoter or a single reporter protein. Rather, the disclosure demonstrates the design principle using two heterologous promoter arrangements and three different protease reporter proteins, with comparisons to corresponding control strains cultivated under the same conditions. The specification also defines "increased protein production" as an increased amount of protein produced, including increased maximal enzyme activity or total extracellular protein relative to a parental/control cell, and explains that control and modified cells are compared under the same cultivation/fermentation conditions.
These arguments have been fully and carefully considered but are not deemed persuasive. The breadth of the instant claims is much greater than the yvzG-yvyD intergene::lox-SpecR-lox-PspoVG-ywyD cassette as SEQ ID NO: 19 and the yvzG-yvyD intergene::lox-SpecR-lox-Phby-ywyD cassette as SEQ ID NO: 20 which are not recited in the instant claims. . The specification further reproduces transcriptomic data showing that spoVG and hbs steady-state mRNA levels are higher than yvyD under multiple industrially relevant growth/fermentation conditions, and states that spoVG and hbs mRNA levels are higher than yyyD in more than 80% and more than 85%, respectively, of 53 transcriptome data points. “This disclosure provides a technical rationale for selecting heterologous promoters that increase yvyD expression relative to the native yyyD promoter.”
The specification does not enable other promoters/cassettes. Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353
Claim Rejections - 35 USC § 112-Written Description
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, 5-11 and 13-18 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 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.
Instant claim 1 has been amended to recite:
A recombinant Bacillus sp. cell comprising an engineered nucleic acid arrangement comprising a heterologous promoter operably linked to a yvyD gene coding sequence comprising at least 80% identity to the yyyD gene of SEQ ID NO: 18; and wherein the heterologous promoter increases expression of the yvyD gene encoding sequence relative to expression of the yvyD coding sequence from a native yvyD promoter in an otherwise identical Bacillus sp. cell lacking the engineered nucleic acid arrangement.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed recombinant Bacillus sp. cells comprising an engineered nucleic acid arrangement comprising a heterologous promoter operably linked to a yvyD gene coding sequence comprising at least 80% identity to the yyyD gene of SEQ ID NO: 18; and wherein the heterologous promoter increases expression of the yvyD gene encoding sequence relative to expression of the yvyD coding sequence from a native yvyD promoter in an otherwise identical Bacillus sp. cell lacking the engineered nucleic acid arrangement such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
It is unclear what the rest of the structure would need to be to possess any of the enzymatic activities recited in the instant claims. Even with the designation of “80% identical to SEQ ID NO:18 or 26” in some claims, the written description is inadequate to support this breadth. Additionally, applicants have not defined the genus of “heterologous promoters increase expression of the yvyD gene encoding sequence relative to expression of the yvyD coding sequence from a native yvyD promoter in an otherwise identical Bacillus sp. cell lacking the engineered nucleic acid arrangement.” The specification only provides written description for the spoVG promoter (SEQ ID NO: 25) or hbs promoter (SEQ ID NO: 22). This is not sufficient to provide written description for the full Genus.
With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed promoters/nucleic acid arrangements such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed. The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Devos et al., (Proteins: Structure, Function and Genetics, 2000, Vol. 41: 98-107), teach that the results obtained by analyzing a significant number of true sequence similarities, derived directly from structural alignments, point to the complexity of function prediction. Different aspects of protein function, including (i) enzymatic function classification, (ii) functional annotations in the form of key words, (iii) classes of cellular function, and conservation of binding sites can only be reliably transferred between similar sequences to a modest degree. The reason for this difficulty is a combination of the unavoidable database inaccuracies and plasticity of proteins (Abstract, page 98) and the analysis poses interesting questions about the reliability of current function prediction exercises and the intrinsic limitation of protein function prediction (Column 1, paragraph 3, page 99) and conclude that "Despite widespread use of database searching techniques followed by function inference as standard procedures in Bioinformatics, the results presented here illustrate that transfer of function between similar sequences involves more difficulties than commonly believed. Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (column 2, paragraph 2, and page 105).
Whisstock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340,) highlights the difficulties associated with "Prediction of protein function from protein sequence and structure": "To reason from sequence and structure to function is to step onto much shakier ground", closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer (page 309, paragraph 4), it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (page 312, paragraph 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (page 313, paragraph 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein's role fundamentally (page 323, paragraph 1). C. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function, and many functionally similar proteins will have little or no structural homology to the disclosed proteins. For example, proteins having similar structures have different activities (structure does not always correlate to function);
Because the art is unpredictable, in accordance with the Written Description Guidelines, the recitation of "a sequence at least 80% identical to oneof SEQ ID Nos: 18 and 26” with any changes (and any combination of changes) or the recitation of any heterologous promoter by function alone is not adequate. The scope of the claim includes numerous structural variants and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described. There are no drawings or structural formulas disclosed of any of these fragments or variants of the claimed polynucleotides. There is no teaching in the specification regarding which 20% of the structure can be varied and still produce a polypeptide which has the recited enzymatic activities. Although the disclosure of SEQ ID NO: 2 combined with the knowledge in the art, may put one in possession of peptides that are at least 80% identical to SEQ ID NO: 2, the level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of those peptides would have the required functional activities. Based on the lack of knowledge and predictability in the art, those of ordinaryskill in the art would not conclude that the applicant was in possession of theclaimed genus of polypeptides.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov
Status of Claims:
No claims are presently allowed.
The amendments to the claims have overcome the former 35 USC 102 rejections of Wang et al (WO 02/02766; provided by Applicants) and Drzewiecki et al (J. Bacteriol. ASM, US, vo. 180(24): 6674-6680, Dec. 1998; provided by Applicants) which do not teach the promoters operably linked to a yvyD gene, etc.
With respect to, Frisch et al (WO2022178432, 8/25/22, priority Feb. 22, 2021; provided by Applicants), Frisch also does not teach the yvyD gene linked to the heterologous promoters, such as hbs and spoVG. Frisch discloses a Bacillus strain expressing two copies of a protein of interest (POI) (2x GG36 protease) and overexpressing the yvmA gene under the control of the heterologous Phbs promoter (paragraphs 154 and 248, example 7). Paragraph [0157] In other embodiments, Frisch constructed Bacillus licheniformis strains expressing the B. subtilis YvmA protein (SEQ ID NO: 30). More particularly, as described in Example 12, B. licheniformis strains were constructed to express functional B. subtilis YvmA protein (SEQ ID NO: 30) under the control of heterologous promoters (hbs promoter, spoVG promoter). For example, two (2) independent isolates with the correct sequence for amyL::[Phbs-yvmA tetR] (SEQ ID NO: 33) were stored as strains BF1175 and BF1176; and two (2) independent isolates with the correct sequence for amyL::[PspoVG-yvmA tetR] (SEQ ID NO: 40) were stored as strains BF1177 and BF1178 (Example 12; TABLE 5). [0182] Any overexpression of the yvyD gene was a result of the overexpression of the yvmA gene.
Prior art not presently relied upon
Wang et al (WO200202766-A2; Jan 10, 2002) 100% identical to SEQ ID NO: 18 (yvyD).
Ye et al (US20020155612A1) ); 100% identity to SEQ ID NO: 23; 100% identity to SEQ ID NO: 18;
US Patent No. 6617148; 100% identical to SEQ ID NO: 18 (yvyD).
Soldo et al (Microbiology 142 (Pt 11), 3079-3088 (1996); 100% identity to SEQ ID NO: 23; 100% identity to SEQ ID NO: 18;
WO2006069610-A2. Fructose production-related protein, SEQ:30815. 100% identity to SEQ ID NO: 26
Chen et al (J. Bacteriol. 176, 3093-3101, 1994) ribosomal protein S30AE family homolog yvyD - Bacillus subtilis; 100% identity to SEQ ID NO: 26
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.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 9/24/26
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