DETAILED ACTION
Claims 48, 72, and 74 remain withdrawn.
The Terminal Disclaimer filed on 12/22/2025 is acknowledged.
All objections and rejections raised in prior Office Actions are withdrawn unless restated below.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/22/2026 has been entered.
Claim Interpretation
Claim 11 recites “comprises no modification from 2 to 300 amino acid positions.” A polypeptide, for example identical to SEQ ID NO: 1 except having modification at one position (i.e. at a position not recited in claim 1) “comprises” no modification at 2, 3, 4, 5, 6, 7, . . . . . 100, 101, 102, 103, 104, . . . . 297, 298, 299 and 300 amino acid positions. “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” MPEP 2111.03(I). As such, claim 11 does not exclude the presence of additional positions of “no modification” and recites a minimum number and not a maximum number of “no modifications” present. Claim 11 does not require at least 80% identity to SEQ ID NO: 1.
In view of the above, upon addressing the rejection under 35 U.S.C. 112(a) set forth above, claim 11 may be considered to properly depend from claim 7 under 35 U.S.C. 112(d). SEQ ID NO: 1 has 468 amino acid residues. As such, a polypeptide required to have at least 80% identity to SEQ ID NO: 1 already requires 375 amino acid residues to not be modified relative to SEQ ID NO: 1 such that claim 11. As such, claim 11 reciting a requirement of no modification at only two positions would apparently broaden the scope of claim 7 if claim 7 were to be amended to require at least 80% identity to SEQ ID NO: 1.
Claim Objections
Claims 9 and 11 are objected to because of the following informalities:
Claim 9 recites “with at last 80% sequence identity to an amino sequence referenced as SEQ ID NO: 1” and “at least 85 . . . sequence identity . . . to an amino acids sequence referenced as SEQ ID NO: 1.” The rejections under 35 U.S.C. 112(a) below are referenced. The scope of claim 9 can only be defined by one requirement for a numerical percent identity to SEQ ID NO: 1 (or any fragment thereof). The scope of claim 1 is understood to be defined by the narrower scope recited that is “at least 85 . . . sequence identity . . . to an amino acids sequence referenced as SEQ ID NO: 1.” As such, the recitation of “with at last 80% sequence identity to an amino sequence referenced as SEQ ID NO: 1” is superfluous, surplus claim language and should be removed from claim 9.
In claim 9, line 7, the underlined “s” appears extraneous and should be removed: “an amino acids sequence.”
Claim 11 appears to recite a requirement for identity to SEQ ID NO: 11 both in terms number of positions not modified (from 2 to 300) and by a percent identity (at least 80% sequence identity). Only one such limitation being the narrowest limitation controls the scope of the claim wherein the other limitation is surplus language. Only one definition for identity to SEQ ID NO: 1 should be recited in the claim whether by a percent identity or number of positions not modified, but not both within the same claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7, 9-12, 24, 41 and 46 (all non-withdrawn claims) 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.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“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 applicant was in possession of the claimed genus.” MPEP 2163.
Furthermore, 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. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163.
Claims 1 and 24 set forth the following claims language:
“the consensus sequence of Loop A is the amino acid sequence set forth in SEQ ID NO: 5 and the consensus sequence of Loop B is the amino acid sequence set forth in SEQ ID NO: 6.”
The recitation of the definite article “the” as underlined indicates the specific amino acid of the full-length of SEQ ID NO: 5 and 6.”
In contrast, the following claim language in claims 1, 7, 9 and 24 (and repeated in dependent claims 2 and 11) recite an indefinite article an as underlined:
“at least 80% sequence identity to an amino acid sequence referenced as SEQ ID NO: 1.”
Claim 9 similarly recites:
“at least 85% . . . sequence identity, or is identical, to an amino acids sequence referenced as SEQ ID NO: 1.”
The differential use of “an” and “the” in references to sequences in the claims means that the same have different meanings. As reviewed in more detail below, “an amino acid sequence referenced as SEQ ID NO: 1” is a reference to a genus of plural amino acid sequences that can be any fragment of SEQ ID NO: 1.
This rejection can be obviated by removing use of an indefinite article, for example:
“at least 80% sequence identity to the amino acid sequence referenced as SEQ ID NO: 1,” or
“at least 80% sequence identity to SEQ ID NO: 1.”
Claims 1 and 24, part (a), claim 7 and claim 9 recite a polypeptide comprising an amino acid sequence referenced as SEQ ID NO: 1 having four or more substitutions, the polypeptide required to have aldehyde dehydrogenase activity. Claim 2 recites said amino acid sequence having at least 85% identity to an amino acid sequence referenced in SEQ ID NO: 1.
A polypeptide comprising an amino acid sequence is a genus of plural amino acid sequences that can be any fragment of SEQ ID NO: 1 having some recognizable sequence alignment with SEQ ID NO: 1 provided that the presence of any four substitutions as recited can be identified. Such a genus encompasses a very broad range of structural diversity including sequences that are much shorter than SEQ ID NO: 1 and/or have no minimum identity to SEQ ID NO: 1 but are nevertheless required to have the recited aldehyde dehydrogenase activity.
“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 applicant was in possession of the claimed genus.” The specification discloses embodiments of the claims identical to SEQ ID NO: 1 but for the inclusion of a single digit number of substitutions. Such a disclosure does not allow for the identification of other included species that have low or fragmentary identity to SEQ ID NO: 1 as encompassed by the genera of claims 1, 7, 9 and 24 as discussed. Stated in other words, disclosure of species having almost 100% identity to SEQ ID NO: 1 does not provide for a disclosure of a representative number of species nor disclosure of relevant, identifying characteristics of included species having low or fragmentary identity to SEQ ID NO: 1 such that the genera of claims 1, 7, 9 and 24 have inadequate written description in the specification.
Claims 2 and 11 is included in this rejection since these claims also recites “an amino acid sequence referenced in SEQ ID NO: 1” that includes fragments of SEQ ID NO: 1. This rejection may be obviated by requiring a specific present identity to “the” amino acid sequence of SEQ ID NO: 1 for all embodiments of the claims as indicated above.
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 1-4, 7, 9-12, 24, 41, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 12-14, 24, 25, 28, 29, 33, 42, 45, 46, 50-51, 54, 55, 59, and 61 of copending Application No. 18/702,714. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons below.
Claims 1-4, 7, 9-12, 24, 41, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 8, 13, 15, 20-22, 29, 38, 39, 41-43, 47, 51, 55, 56, 59, 60, 62, 65, 68-69, 71, 74 and 75 of copending Application No. 18/701,533. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons below.
Claims of ‘714 are:
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75
670
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Claim 1 of ‘533 is:
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106
692
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An alignment between recited SEQ ID NO: 1 and SEQ ID NO: 3 of the reference claims is as follows:
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644
677
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As can be seen from the above alignment, SEQ ID NO: 3 of the reference claims has over 95% identity to SEQ ID NO: 1 and at least substitutions S174S, M204R, C220V, C267A and A467V. As such, the reference claims recite a aldehyde dehydrogenase polypeptide meeting the features of the same recited in the rejected claims. Claim 61 of ‘714 recites a composition comprising the aldehyde dehydrogenase polypeptide. Claim 75 of ‘533 recites a composition comprising the aldehyde dehydrogenase polypeptide.
Regarding claims reciting an isolated nucleic acid or vector claims 39 and 41 of ‘533 recite a vector and recombinant nucleic acid.
Regarding claims reciting a non-naturally occurring cell or a culture medium containing the same, claims 42 and 56 of ‘533 recite such a non-naturally occurring cell/microbial organism and a method of culturing the same (i.e. a culture). Claims 28 and 42 of ‘714 recite such a non-naturally occurring cell/microbial organism and a method of culturing the same (i.e. a culture).
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
It is noted that these rejections will be withdrawn if they remain provisional and are the only rejections remaining.
Claims 1-4, 7, 9-12, 24, 41, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 88, and 90-106 of copending Application No. 19/252,918 further in view of Pharykya et al. (U.S. 2014/0371417). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons below.
The reference claims recite:
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At least copending claim 92 recites an aldehyde dehydrogenase having the required identity to SEQ ID NO: 1 and required 4 or 5 substitutions as recited including a nucleic acid containing the same. Since reference claim 88 directly recites expressing the polypeptide by expressing an encoding nucleic acid in a cell, the same is understood as teaching that the encoding nucleic acid is an expression vector by definition transformed into a host cell. Further, performance of the methods of the copending claims necessarily forms a composition containing the polypeptide.
Regarding recitation of a culture medium containing a cell as recited in claim 46, claim 88 recites a method of producing a polypeptide from a cell, but is not explicit regarding a culture medium. Pharkya, in at least claims 1, 4, 6 and 13 teach that it is well known in the prior art to produce a polypeptide by culturing a cell with a recombinant nucleic acid encoding such polypeptide in a culture medium such that an ordinarily skilled artisan at time of filing would have understood that it is advantageous to perform the “expressing” step of reference claim 88 by culturing such a cell in a culture medium.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to arguments
Applicant argues:
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The claims do not recite “at least 80% sequence identity to SEQ ID NO: 1” anywhere in the claims. The claims recite “at least 80% sequence identity to an amino acid sequence referenced as SEQ ID NO: 1.”
Conclusion
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
Prosecution Insights