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 and the engineered galactose oxidase of SEQ ID NO: 52, which corresponds to SEQ ID NO:38 with the substitution set 437N/462A, corresponding to claims 1, 4, 12-17, and 19-21 in the reply filed on 08/14/2025 is acknowledged.
Claims 2-3, 5-10, 22, 23, and 25-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/14/2025.
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. 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.
Claim Objections
Claims 1, 4, 12-17, and 19-21 are objected to because of the following informalities:
Claims 1, 4, 12-17, and 19-21, the recitation of “Claim”should be amene to recite “claim”
Claim 15, line 2, the recitation of “a polypeptide sequence” should be amended to recite “the polypeptide sequence”
Appropriate correction is required.
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.
Claims 12-15 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.
Instant claim 1, as elected, requires an engineered galactose oxidase comprising a polypeptide sequence having at least 85%, 86%, 87%, 88%, 89%, 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to SEQ ID NO: 38 or a functional fragment thereof, wherein said engineered galactose oxidase comprises at least one substitution or substitution set in said polypeptide sequence, and wherein the amino acid positions of said polypeptide sequence are numbered with reference to SEQ ID NO: 38.
However, instant claims 12-15, which all depend from instant claim 1, appear to encompass, inter alia, an engineered galactose oxidase having 100% identity to SEQ ID NO: 38, i.e., without at least one substitution or substitution set in said polypeptide sequence relative to SEQ ID NO: 38. As such, it is unclear how instant claims 12-15 differ from instant claim 1.
For purposes of compact prosecution and applying prior art, instant claims 12-15 were interpreted herein to require at least one substitution or substitution set in SEQ ID NO: 38. It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC § 112
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.
Claims 12-15 are 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.
Instant claim 1, as elected, requires an engineered galactose oxidase comprising a polypeptide sequence having at least 85%, 86%, 87%, 88%, 89%, 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to SEQ ID NO: 38 or a functional fragment thereof, wherein said engineered galactose oxidase comprises at least one substitution or substitution set in said polypeptide sequence, and wherein the amino acid positions of said polypeptide sequence are numbered with reference to SEQ ID NO: 38.
However, instant claims 12-15, which all depend from instant claim 1, appear to encompass, inter alia, an engineered galactose oxidase having 100% identity to SEQ ID NO: 38, i.e., without at least one substitution or substitution set in said polypeptide sequence relative to SEQ ID NO: 38. As such, instant claims 12-15 appear broader in scope than instant claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For purposes of compact prosecution and applying prior art, instant claims 12-15 were interpreted herein to require at least one substitution or substitution set in SEQ ID NO: 38.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
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, 4, 12-17, and 19-21 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.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Instant claims 1, 12-15, and 20-21 broadly encompasses an engineered galactose oxidase comprising a polypeptide sequence having at least 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to SEQ ID NO: 114, 4, 6, 38, 50, 226, and/or 262, or a functional fragment thereof, wherein said engineered galactose oxidase comprises at least one substitution or substitution set in said polypeptide sequence, and wherein the amino acid positions of said polypeptide sequence are numbered with reference to SEQ ID NO: 114, 4, 6, 38, 50, 226, and/or 262.
Instant claims 4 further recites specific substitutions at particular positions within elected SEQ ID NO: 38 while maintaining at least 85% sequence identity to that sequence. Instant claims 16-17 and 19 further require at least one improved property compared to wild-type F. graminearium galactose oxidase, including improved activity on a substrate or improved stereoselectivity.
The Specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genus as to establish a structure-function relationship with respect to galactose oxidase activity.
SEQ ID NO: 38 is 650 amino acids in length. A variant sharing only 85% identity to SEQ ID NO: 38 can have anywhere from 1 to 98 substitutions, deletions or additions in any combination along any length of the sequence. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genus (2098 = 3.17 x 10127) comprising trillions upon trillions of sequences and countless “functional fragments thereof.”
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successfully reduced to practice specific point mutations within SEQ ID NO: 38 disclosed in Table 4-1. As such, the Specification reasonably demonstrates that Applicant was in possession of variants having at least 95% sequence identity to SEQ ID NO: 38 containing the point mutations disclosed in Table 4-1. However, this is not representative of the extremely large genus of sequences claimed, since all the mutations were derived from the “backbone” SEQ ID NO: 38 and not the innumerable sequences contained within a genus of sequences having only 85% identical to SEQ ID NO: 38 and functional fragments thereof.
Moreover, the data in Table 4-1 is highly variable and is limited to variants having improved galactose oxidase activity for the formation of ethynyl glyceraldehyde phosphate, while instant claim 16 contemplates any nebulous “improved property compared to wild-type F. graminearium galactose oxidase,” and instant claims 17 and 19 require “improved activity on a substrate” and “improved stereoselectivity,” respectively.
The data generated for the select variants of SEQ ID NO: 38 described in the Specification cannot reasonably be extrapolated and applied to support possession of the entire claimed genus of variants and functional fragments thereof because no one species, combination, or variant accounts for the variability amongst the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
At best, the Specification contemplates the use of BLAST to identify functional homologs based on sequence homology. However, this is not sufficient to describe members of the claimed genus because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Thus, one of skill in the art would readily appreciate that relying on a non-patent source that is continuously subject to change as a means to identify members of the claimed genus does not sufficiently meet the written description requirement.
Moreover, Friedberg (Brief Bioinformatics, 7:225-242 (2006)) teaches that homology-based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub-regions is critical to functional annotation, and that often addition, deletion, or re-shuffling
of domains can lead to errors in annotation (page 227, second column; page 228, first paragraph). Furthermore, Friedberg teaches that sequence-based tools are just not sensitive enough to identify functional protein similarity as databases get larger, and diversity of sequences gets larger (page 228, first full paragraph).
Thorton et al. (Nature Struct. Biol, Struct. Genom. Suppl. Nov., 991-994 (2000), hereinafter “Thorton”) teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thorton further describes examples of little correlation between specific enzyme function and overall protein structure (page 992, right column, at lines 2-10). Thus, when taken with the teachings of Friedberg and Thorton, one of skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function.
In the absence of a representative number of examples, the Specification must at least
describe the structural features that are required for the claimed function, in this case galactose oxidase activity. However, as discussed above, the Specification fails to describe any
substantive structural limitations as to establish a structure-function relationship with respect to
galactose oxidase activity, let alone the various improved properties required throughout the instant claims. The Specification also fails to describe which regions, domains, etc. of the variant sequences must be retained in order to have a “functional fragment” of the variant. Instead, Applicant merely offers a cursory statement that any variant or “functional fragment thereof” having galactose oxidase activity will work.
Accordingly, the claims as currently written are not adequately described and one of skill
in the art would readily appreciate that Applicant was not in possession of the claimed genus at
the time of filing.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 12-15, and 20-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106.04 for analysis parameters.
The claims are drawn to an engineered galactose oxidase comprising a polypeptide sequence having at least 85%, 86%, 87%, 88%, 89%, 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to SEQ ID NO: 114, 4, 6, 38, 50, 226, and/or 262, or a functional fragment thereof, wherein said engineered galactose oxidase comprises at least one substitution or substitution set in said polypeptide sequence, and wherein the amino acid positions of said polypeptide sequence are numbered with reference to SEQ ID NO: 114, 4, 6, 38, 50,226, and/or 262, which is a composition of matter, i.e., a statutory category of invention (Step 1: YES). The broadest reasonable interpretation of the claims would include, e.g., a galactose oxidase having at least 85% identity to SEQ ID NO: 38 since this would encompass a galactose oxidase having at least one substitution relative to SEQ ID NO: 38.
A0A4U9F9V9_GIBZA evidence a naturally occurring galactose oxidase sharing 91.1% identity with SEQ ID NO: 38. (see alignment below).
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A0AAN6HGK3_FUSAU evidences a naturally occurring galactose oxidase sharing 91.7% identity with SEQ ID NO: 38 (see alignment below).
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As such, the instant claims, given their extremely broad scope, will invariably encompass naturally occurring galactose oxidases. While the instant claims recite an “engineered galactose oxidase,” the term “engineered” does not result in a galactose oxidase that exhibits any markedly different characteristics with respect to structure, function, or any other property to distinguish an “engineered galactose oxidase” from its naturally occurring counterpart having an identical amino acid sequence.
Stated another way, an “engineered galactose oxidase” having the same amino acid sequence as a naturally occurring galactose oxidase would be indistinguishable with respect to structure, function, or any other property—the recitation of the word “engineered” in the claims does not impart any markedly different characteristics. As such, the instant claims recite a judicial exception (JE) in the form of a natural phenomenon (Step 2A, Prong One: YES).
The instant claims are limited to only the JE and, therefore, do not recite any additional elements that integrate the JE into a practical application (Step 2A, Prong Two: NO).
Since the instant claims are limited to only the JE, the instant claims as a whole do not amount to significantly more the JE (Step 2B: NO).
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC §§ 102/103
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.
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.
Claims 1, 12-17 and 19-21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Huffman et al. (WO 2020/014041, hereinafter “Huffman”).
Instant claims 1, 12-17 and 19-21 were was broadly interpreted herein to encompasses a galactose oxidase having at least 85% identity to SEQ ID NO: 38 since this would encompass a galactose oxidase having at least one substitution relative to SEQ ID NO: 38.
Regarding instant claims 1 and 12-15 Huffman discloses a Fusarium graminearum galactose “variant” oxidase having 99.8% sequence identity to SEQ ID NO: 38 with a substitution at position 407 relative to SEQ ID NO: 38 (Huffman, SEQ ID NO: 18; page 54, Galactose Oxidase (GOase) = Variant of Galactose Oxidase from Fusarium graminearum, alignment below).
Regarding instant claims 20-21, Huffman further discloses that the galactose oxidase is provided as a lyophilized composition in a vial, which reasonably encompasses a composition comprising purified galactose oxidase (page 45, Enzyme immobilization procedure).
Regarding instant claims 16-17 and 19, given that the variant galactose oxidase taught by Huffman is 99.8% to SEQ ID NO: 38, the variant galactose oxidase would, absent evidence to the contrary, inherently exhibit the improved properties recited by instant claims 16-17 and 19.
In the alternative, it would have been prima facie obvious the time of filing to purify the galactose oxidase taught by Huffman because Huffman further teaches that the galactose oxidase can be immobilized for the enzymatic synthesis of 4'-ethynyl-2'-deoxy nucleosides (Abstract; page 45, Method H3).
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Accordingly, Hoffman anticipates the claimed invention or, in the alternative, renders the claimed invention prima facie obvious.
Double Patenting
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, 12-17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,466,259. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to an engineered galactose oxidase comprising a polypeptide sequence having at least 95%, sequence identity to SEQ ID NO: 2, or a functional fragment thereof, wherein said engineered galactose oxidase comprises substitutions in said polypeptide sequence at positions 331, 406, and 465, and wherein said engineered galactose oxidase does not comprise substitutions at positions 11 and 71, and wherein the amino acid positions of said polypeptide sequence are numbered with reference to SEQ ID NO: 2, and wherein said engineered galactose oxidase comprises production of 2-ethynylglyceraldehyde with increased enantiomeric excess of the R-stereoisomer as compared to wild-type F. graminearium galactose oxidase.
SEQ ID NO: 2 shares 92.7% sequence identity with instant SEQ ID NO: 38 (see alignment below). As such, the conflicting claims encompass a galactose oxidase having at least 85% identity to SEQ ID NO: 38 with at least one substitution relative to SEQ ID NO: 38.
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Claims 1, 12-17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,012,618. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to 1. An engineered galactose oxidase comprising a polypeptide sequence having at least 95% sequence identity to SEQ ID NO: 1912, or a functional fragment thereof, wherein said engineered galactose oxidase comprises substitutions as compared to SEQ ID NO: 1912 in said polypeptide sequence at positions 291, 375, 453, and 465, and wherein the amino acid positions of said polypeptide sequence are numbered with reference to SEQ ID NO: 1912.
SEQ ID NO: 1912 shares 98.7% sequence identity with instant SEQ ID NO: 38 (see alignment below). As such, the conflicting claims encompass a galactose oxidase having at least 85% identity to SEQ ID NO: 38 having at least one substitution relative to SEQ ID NO: 38.
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Claims 1, 12-17, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-19 of copending Application No. 18657101 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a polynucleotide sequence encoding at least one engineered galactose oxidase, wherein said polynucleotide sequence comprises at least 90% sequence identity to SEQ ID NOS: 1911, 2079, 2299, and/or 2423, wherein the polynucleotide sequence of said engineered galactose oxidase comprises at least one substitution at one or more positions, and wherein the engineered galactose oxidase has substitutions at positions 291, 375, 453, and 465 wherein the amino acid positions are numbered with reference to SEQ ID NO: 1912.
SEQ ID NO: 1912 shares 98.7% sequence identity with instant SEQ ID NO: 38 (see alignment below). As such, the conflicting claims encompass a galactose oxidase having at least 85% identity to SEQ ID NO: 38 with at least one substitution relative to SEQ ID NO: 38.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
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/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672