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
1. Applicant’s election of Group I (claims 1-2, 7-8, 13, 15, 20-22, 29 & 38) and species – alteration at position L273 of SEQ ID NO: 3; without traverse in the reply filed on 6/26/26 is acknowledged.
2. Claims withdrawn:
Claims 39, 41-43, 47, 51, 55-56, 59-60, 62, 65, 68-69, 71, 74-75 and all the remaining variants/mutants are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
3. Priority
Applicant’s claim for domestic priority under 35 U.S.C. 119(e), filed 10/20/21, is acknowledged.
4. IDS filed 6/26/26 is considered.
5. Drawings filed 4/15/24 is acknowledged.
6. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
7. Claim Rejections - 35 USC § 112, first paragraph (Enablement)
Claims 1-2, 7-8, 13, 15, 20-22, 29 & 38 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1-2, 7-8, 13, 15, 20-22, 29 & 38 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for- An engineered aldehyde dehydrogenase that is 95% identical to an amino acid sequence SEQ ID NO: 3 and wherein the engineered aldehyde dehydrogenase comprises an alteration at amino acid position L273 with a different amino acid, does not reasonably provide enablement for - An engineered aldehyde dehydrogenase comprising any variant in the amino acid sequence SEQ ID NO: 3 or a functional fragment thereof, wherein the engineered aldehyde dehydrogenase comprises one or more alterations at a position described in TABLE 2 (claim 1, for example) or wherein the engineered aldehyde dehydrogenase comprises a combination of alterations described in TABLE 3, TABLE 4, TABLE 5 or TABLE 6 (claim 21, for example) or the numerous variants/alterations listed in the various claims – or wherein the one or more amino acid alterations comprise at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 alterations (claim 21); or wherein “The engineered aldehyde dehydrogenase of claim 1, wherein the amino acid sequence, other than the one or more amino acid alterations, has at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 98% or at least 99% sequence identity to the amino acid sequence referenced in SEQ ID NO: 3 (claim 29). 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 the invention commensurate in scope with these claims.
According to MPEP 2164.01(a), factors considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
MPEP§ 2164.04 states that while the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection. The language should focus on those factors, reasons, and evidence that lead the examiner to conclude that the specification fails to teach how to make and use the claimed invention without undue experimentation, or that the scope of any enablement provided to one skilled in the art is not commensurate with the scope of protection sought by the claims. Accordingly, the factors most relevant to the instant rejection are addressed in detail below.
The scope of the claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of heparin synthase broadly encompassed by the claims. Since the amino acid sequence of a protein determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence, if any, are tolerant of modification and which are conserved (i.e. expectedly intolerant to modification), and detailed knowledge of the ways in which the proteins' structure relates to its function. However, in this case the disclosure is limited to the nucleotide sequence of SEQ ID NO: 2 and the encoded amino acid sequence of aldehyde dehydrogenase of SEQ ID NO: 3.
While recombinant and mutagenesis techniques are known, it is not routine in the art to screen for multiple substitutions or multiple modifications, as encompassed by the instant claims, and the positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
The specification does not support the broad scope of the claims which encompass all modifications of any aldehyde dehydrogenase by modifying the DNA to have a homology of at least 65%-90% of the encoding aldehyde dehydrogenase of SEQ ID NO: 3 or a derivative derived from such a sequence by insertion, deletion or substitution, and encoding a protein which has the activity of a aldehyde dehydrogenase and the variants thereof, because the specification does not establish: (A) regions of the protein structure which may be modified without effecting aldehyde dehydrogenase activity; (B) the general tolerance of aldehyde dehydrogenase to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any aldehyde dehydrogenase residues with an expectation of obtaining the desired biological function; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful.
Without such guidance, the experimentation left to those skilled in the art is undue. Including in the claims the exact nature of the hybridization conditions used to isolate the claimed polynucleotides would aid in overcoming this portion of the rejection.
Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including aldehyde dehydrogenase with an enormous number of nucleic acid/amino acid modifications of the of SEQ ID NO: 1/2 [as a result of modifying the DNA]. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of the numerous DNA encoding aldehyde dehydrogenase having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
8. Claim Rejections - 35 USC § 112 (second paragraph)
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 1-2, 7-8, 13, 15, 20-22, 29 & 38 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 pre-AIA the applicant regards as the invention.
Claims 1 & 21 recite – large tables in claims 1 & 21 reciting numerous variants/mutants for example. These claims are rejected as being indefinite and is further explained as follows.
"Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table 'is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.' Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)" (MPEP 2173.05(s)).
Applications in TC 1600 commonly include tables with large numbers of genes, proteins, small molecule biomarkers, diseases, acceptable excipients, etc. Claims cannot refer back to these tables in the specification; e.g., TABLE 2 (claim 1, for example) or wherein the engineered aldehyde dehydrogenase comprises a combination of alterations described in TABLE 3, TABLE 4, TABLE 5 or TABLE 6 (claim 21, for example) or the numerous variants/alterations listed in the various claims. Such claims are rejected under §112(b), and Applicants instructed to copy the table contents into the claim itself. There is no limit to the length of a claim. If the subject matter can be listed in the specification, that list can be copied and pasted into a claim.
Claims 2, 7-8, 13, 15, 20, 22, 29 & 38 are included in the rejection for failing to correct the defect present in the base claim(s).
9. Claims 1-2, 7-8, 13, 15, 20-22, 29 & 38 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 pre-AIA the applicant regards as the invention.
Claim 1 for example recite Table 2 and Applicants elected ‘alteration at position L273 with reference to SEQ ID NO: 3. Applicants’ SEQ ID NO: 3 as presented below already presents a mutation/variant/alteration at position 273, wherein ‘L’ or ‘leucine’ is modified to ‘N’ or ‘Asparagine’, i.e. L273N. The claim is confusing and indefinite.
Applicants’ SEQ ID NO: 3 moltype = AA length = 468
MIKDTLVSIT KDLKLKTNVE NANLKNYKDD SSCFGVFENV ENAISNAVHA QKILSLHYTK60
EQREAMITEI RKAALENKEI LATMILEETH MGRYEDKILK HELVAKYTPG TEDLTTTAWS120
GDNGLTVVEM SPYGVIGAIT PSTNPTETVI CNSIGMIAAG NTVVFNGHPG AKKSVAFAVE180
MINKAIISCG GPENLVTTIK NPTRDSLDAI IKHPSIKLLV GTGGPGMVKT LLNSGKKAIG240
AGQGNPPVIV DDTADIEKAG KSIIEGASFD NNLPCIAEKE VFVFENVADD LISNMLKNNA300
VIINEDQVSK LIDLVLQKNN ETQEYSINKK WVGKDAKLFL DEIDVESPSS VKCIITEVSA360
SHPFVMTELM MPILPIVRVK DIDEAIEYAK IAEQNHKHSA YIYSKNIDNL NRFEREIDTT420
IFVKNAKSFA GVGYEAPGFT TNTIAGSTGE GITSARNFTR QRRIVLVG 468
Claims 2, 7-8, 13, 15, 20, 22, 29 & 38 are included in the rejection for failing to correct the defect present in the base claim(s).
9. 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 7-8, 13, 15, 20-22, 29 & 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/068900 A1 (Genomatica) (IDS filed 6/26/26). WO 2020/068900 A1 teaches an engineered aldehyde dehydrogenase comprising a variant of amino acid sequence, wherein the engineered aldehyde dehydrogenase is similar to SEQ ID NO: 3 comprising one or more alteration selected to be amino acid substitution K65A, C33, E437, F429, F442, G167 among numerous others [00212]. [0048] In some embodiments, the nucleic acid molecule is an isolated nucleic acid molecule encoding a variant of a reference polypeptide (the reference polypeptide having an amino acid sequence of SEQ ID NO: 1, 2 or 3 or those in Table 4), wherein the variant (i) comprises one or more amino acid substitutions of a corresponding variant selected from Table 1-3, (Abstract, invention provides polypeptides and encoding nucleic acids of aldehyde dehydrogenase variants; Claim 11, isolated polypeptide comprising an amino acid sequence referenced as SEQ ID NO: 1, 2 or 3 or in Table 4, wherein said amino acid sequence comprises an amino acid substitution corresponding to position 166, wherein the amino acid sequences of Genomatica comprise 99.7% sequence identity to instant SEQ ID NO: 3.
11. An isolated polypeptide comprising an amino acid sequence referenced as SEQ ID NO: 1, 2 or 3 or in Table 4, wherein said amino acid sequence comprises an amino acid substitution corresponding to position 166.
12. The isolated polypeptide of claim 11, wherein the amino acid substitution at position 166 is an amino acid substitution as set forth in Table 1, 2 and/or 3.
13. The isolated polypeptide of claim 11 or 12, wherein the amino acid sequence, in addition to the substitution corresponding to amino acid position 166, comprises one or more amino acid substitutions at other amino acid variant positions set forth in Table 1, 2 and/or 3.
14. The isolated polypeptide of any one of claims 11-13, wherein the amino acid sequence, in addition to the substitution at position 166, comprises one or more of the amino acid substitutions set forth in Table 1, 2 and/or
3.
15. An isolated polypeptide comprising an amino acid sequence referenced as SEQ ID NO: 1, 2 or 3 or in Table
[00212] Describes the individual ALD variants such as those described above can be used alone, or can be combined with any other variant amino acid position, including 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16, that is, up to all variant amino acid positions as disclosed herein (see Tables 1-3), to generate additional variants having desirable activities. Exemplary ALD variants include, but are not limited to, single substitutions, or a combination of one or more of the substitutions, at amino acid positions disclosed in any of Tables 1-3, for example, at amino acid position 12, 19, 33, 44, 65, 66, 72, 73, 107, 122, 129, 139, 143, 145, 155, 163, 167, 174, 189, 204, 220, 227, 229, 230, 243, 244, 254, 267, 315, 353, 356, 396, 429, 432, 437, 440, 441, 442, 444, 447, etc.
See claims 11-21 & the entire WO 2020/068900 A1 patent.
While elected species L273 is not taught in WO 2020/068900 A1, numerous other variants are still present in the currently pending claims. Hence this rejection.
10. Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US Patent 11,299,716. US Patent 11,299,716 teaches ALD variants – and the specifically elected species of L273 reads upon the SEQ ID NO: 3 of the US Patent 11,299,716. The sequence alignment between Applicants’ SEQ ID NO: 3 and US Patent 11,299,716 SEQ ID NO: 34 is presented below showing L273I.
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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 assignees. A nonstatutory double patenting 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 claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); 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 § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/AIA /26) should be used. A web-based eTerminal Disclaimer may be 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 7-8, 13, 15, 20-22, 29 & 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 of U.S. Patent No. US 11634692 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because Table 2 of instant application presents numerous variants including substitution I66M.
Instant claim 1 is drawn to - An engineered aldehyde dehydrogenase comprising a variant of amino acid sequence SEQ ID NO: 3 or a functional fragment thereof, wherein the engineered aldehyde dehydrogenase comprises one or more alterations at a position described in TABLE 2. SEQ ID NO: 3 in the instant claim 1 is about 97% identical to SEQ ID NO: 1 of the US Patent 11,634,692.
Although the claims at issue are not identical, they are not patentably distinct from each other because Table 2 of instant application presents numerous variants including substitution I66M, F442N, etc.
Claims 1-10 of US Patent 11,634,692 are drawn to as follows.
6. An isolated polypeptide comprising an amino acid sequence that is a variant of SEQ ID NO: 1, wherein said amino acid sequence comprises the amino acid substitution I66M, wherein the amino acid sequence has at least 90% sequence identity to the amino acid sequence of SEQ ID NO:1 and wherein the isolated polypeptide has aldehyde dehydrogenase activity.
7. The isolated polypeptide of claim 6, wherein the amino acid sequence, in addition to the substitution I66M, comprises one or more amino acid substitutions at other amino acid variant positions set forth in Table 1, 2 and/or 3.
8. The isolated polypeptide of claim 6, wherein the amino acid sequence comprises at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 of the amino acid substitutions set forth in Table 1, 2 and/or 3.
9. The isolated polypeptide of claim 6, wherein the amino acid sequence comprises the amino acid substitutions of a variant as set forth in Table 1, 2 and/or 3.
10. The isolated polypeptide of claim 6, wherein the polypeptide: (a) can convert 3-hydroxybutyryl-CoA to 3-hydroxybutyraldehyde; (b) can convert 4-hydroxybutyryl-CoA to 4-hydroxybutyraldehyde; (c) has higher activity relative to the parental a polypeptide consisting of SEQ ID NO: 1; (d) has higher activity for 3-hydroxy-(R)-butyryl-CoA over 3-hydroxy-(S)-butyryl-CoA; (e) has higher specificity for 4-hydroxybutyryl-CoA over acetyl-CoA; (f) produces decreased byproducts in a cell or cell extract relative to a cell or cell extract comprising a polypeptide consisting of SEQ ID NO: 1, wherein optionally the byproduct is ethanol or 4-hydroxy-2-butanone; and/or (g) has a higher kcat relative to a polypeptide consisting of SEQ ID NO: 1.
Given the fact pattern of the instant case as well as the patent the species claims of the patent anticipates the instant genus claims.
12. Claims 1-2, 7-8, 13, 15, 20-22, 29 & 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 & 22-25 of U.S. Patent No. US 12,371,673 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because Table 2 of instant application presents numerous variants including substitution I66M, F442N, etc.
Instant claim 1 is drawn to - An engineered aldehyde dehydrogenase comprising a variant of amino acid sequence SEQ ID NO: 3 or a functional fragment thereof, wherein the engineered aldehyde dehydrogenase comprises one or more alterations at a position described in TABLE 2. SEQ ID NO: 3 in the instant claim 1 is about 97% identical to SEQ ID NO: 1 of the US Patent 12,371,673 B2.
6. An isolated polypeptide comprising an amino acid sequence that is a variant of SEQ ID NO: 1, wherein said amino acid sequence comprises the amino acid substitution I66M and F442N, wherein the amino acid sequence has at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 1 and wherein the isolated polypeptide has aldehyde dehydrogenase activity.
7. The isolated polypeptide of claim 6, wherein the amino acid sequence, in addition to the substitution I66M and F442N, comprises one or more amino acid substitutions selected from the group consisting of K65A, A73S, C174S, M204R, C220V, M2271, T230C, A243P, A243Q, C267A, C356T, R396H, E437P, S447P, C4641 and A467V, as compared to the amino acid sequence of SEQ ID NO: 1.
8. The isolated polypeptide of claim 6, wherein the amino acid sequence comprises at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 of the amino acid substitutions selected from the group consisting of K65A, A73S, C174S, M204R, C220V, M2271, T230C, A243P, A243Q, C267A, C356T, R396H, E437P, S447P, C4641 and A467V.
9. The isolated polypeptide of claim 6, wherein the amino acid sequence comprises one of the following groups of amino acid substitutions: A) K65A, C174S, M204R, C220V, A243Q, C267A, C356T, R396H, E437P, C4641 and A467V; B) K65A, A73S, C174S, M204R, C220V, M2271, T230C, A243P, C267A, C356T, R396H, E437P, S447P, C4641 and A467V; C) C174S, M204R, C220V, A243Q, C267A, C356T, R396H, E437P, C4641 and A467V; D) C174S, M204R, C220V, A243P, C267A, C356T, R396H, E437P, C4641 and A467V and E) K65A, C174S, M204R, C220V, A243P, C267A, C356T, R396H, E437P, C4641 and A467V.
10. The isolated polypeptide of claim 6, wherein the polypeptide: (a) can convert 3-hydroxybutyryl-CoA to 3-hydroxybutyraldehyde; (b) can convert 4-hydroxybutyryl-CoA to 4-hydroxybutyraldehyde; (c) has higher activity relative to a polypeptide consisting of SEQ ID NO: 1; (d) has higher activity for 3-hydroxy-(R)-butyryl-CoA over 3-hydroxy-(S)-butyryl-CoA; (e) has higher specificity for 4-hydroxybutyryl-CoA over acetyl-CoA; (f) produces decreased byproducts in a cell or cell extract relative to a cell or cell extract comprising a polypeptide consisting of SEQ ID NO: 1, wherein optionally the byproduct is ethanol or 4-hydroxy-2-butanone; and/or (g) has a higher kcat relative to a polypeptide consisting of SEQ ID NO: 1.
22. The isolated polypeptide of claim 6, wherein the amino acid sequence has at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 1.
23. The isolated polypeptide of claim 6, wherein the amino acid sequence has at least 98% sequence identity to the amino acid sequence of SEQ ID NO: 1.
24. The isolated polypeptide of claim 6, wherein the amino acid sequence has at least 99% sequence identity to the amino acid sequence of SEQ ID NO: 1.
25. The isolated polypeptide of claim 6, wherein the amino acid sequence is identical to the amino acid sequence referenced as SEQ ID NO: 1 with the exception of the amino acid substitution 166M and F442N.
Given the fact pattern of the instant case as well as the patent the species claims of the patent anticipates the instant genus claims.
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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 B 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
Prosecution Insights