DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-10 and 12-15 are pending in the application.
Applicant’s claim listing filed June 22, 2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Restriction/Election
Applicant's election with traverse of:
Group I, claims 1-10, drawn to the technical feature of a DNase variant, comprising at least two substitutions selected from the group consisting of A111P, D32E, V35I, S69V, Q102E, K105N and G181N, wherein position numbers are based on the numbering of SEQ ID NO: 1, wherein the variant has a sequence identity of at least 60% but less than 100% to the polypeptide of SEQ ID NO: 1, SEQ ID NO: 2 or SEQ ID NO: 3, and wherein the variant has DNase activity, and a detergent composition thereof,
Species election A: A111P and V35I in claim 1, and
Species election B: D32E+V35I+K65E+K67A+K105N+A111P+G181N+S182Y in claim 7
in the reply filed June 22, 2026 is acknowledged.
The traversal is on the grounds that Oestergaard et al. (US Patent No. 11,732,252 B2, available as prior art under 35 U.S.C. 102(a)(2) with priority at least as early as October 14, 2016; cited on Form PTO-892 filed May 27, 2026; hereafter “Oestergaard”) do not teach or suggest a DNase variant of the claim 1 of this application. This is not found persuasive because, contrary to applicant’s position, Oestergaard teaches or suggests a DNase variant of claim 1 of this application. As stated in the previous Office action, Oestergaard discloses a DNase variant, which: (a) has at least 90% sequence identity to SEQ ID NO: 1 (SEQ ID NO: 1 of Oestergaard is identical to SEQ ID NO: 1 of this application); (b) comprises a substitution at one or more positions corresponding to the positions selected from the group consisting of 32, 35, 105, 111 and 181 of SEQ ID NO: 1; (c) has DNase activity; and (d) has improved stability as compared to the polypeptide of SEQ ID NO: 1 (claim 1 of Oestergaard), which comprises a substitution at a position corresponding to position 32 of SEQ ID NO: 1 with Glu (claim 3 of Oestergaard), which comprises a substitution at a position corresponding to position 35 of SEQ ID NO: 1 with lle (claim 4 of Oestergaard), wherein the substitution at a position corresponding to position 105 of SEQ ID NO: 1 is K105N (claim 6 of Oestergaard), which comprises a substitution at a position corresponding to position 111 of SEQ ID NO: 1 with Pro (claim 9 of Oestergaard), and which comprises a substitution at a position corresponding to position 181 of SEQ ID NO: 1 with Asn (claim 10 of Oestergaard). Thus, Oestergaard teaches or suggests a DNase variant of claim 1 of this application.
The requirement is still deemed proper and is therefore made FINAL.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-3 and 5-10 are being examined on the merits to the extent the claims read on the elected subject matter.
Priority
This application is filed under 35 U.S.C. 371 as a national stage of international application PCT/EP2023/054907, filed February 28, 2023, which claims foreign priority under 35 U.S.C. 119(a-d) to European application 22160258.4, filed March 4, 2022. A certified copy of the foreign priority document has been filed in this application on July 23, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 23, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Specification/Informalities
The use of the term “Triton,” which is a trade name or a mark used in commerce, has been noted in this application (specification at p. 48, line 33). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1 is objected to in the recitation of “the variant has a sequence identity of at least 60% but less than 100% to the polypeptide of SEQ ID NO: 1” and in the interest of improving claim form, it is suggested that the noted phrase be amended to recite (with markings to show changes made) “the amino acid sequence of the variant has sequence identity to the amino acid sequence
Claim 6 is objected to in the recitation of “the variant has at least 80% but less than 100% sequence identity to the polypeptide of SEQ ID NO: 1” and in the interest of improving claim form, it is suggested that the noted phrase be amended to recite (with markings to show changes made) “the amino acid sequence of the variant has at least 80% but less than 100% sequence identity to the amino acid sequence
Claim Rejections - 35 USC § 112(b)
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.
Claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 recites “e.g. wherein the improved stability is selected from…” The recitation of “e.g.” is the abbreviation for “for example" and renders the claim indefinite because it is unclear whether the limitations following “e.g.” are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-3, 5, and 7-10 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states 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. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
MPEP § 2163 further states that “[s]atisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. 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…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’"
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
The claims are drawn to or recite (in relevant part) a genus of DNase variants, comprising at least A111P and V35I substitutions, wherein position numbers are based on the numbering of SEQ ID NO: 1, wherein the variant has a sequence identity of at least 60% but less than 100% to the polypeptide of SEQ ID NO: 1, SEQ ID NO: 2 or SEQ ID NO: 3, and wherein the variant has DNase activity.
Claim 8 is drawn to the variant of claim 7, wherein the variant comprises or consists of SEQ ID NO: 1, SEQ ID NO: 2 or SEQ ID NO: 3 with one of said sets of substitutions. The recitation of “with” in the phrase “with one of said sets…” is interpreted as being synonymous with “comprising” and encompasses additional unrecited substitutions, deletions, additions, and/or insertions within the recited percent identity limitation.
Given that the genus of DNase variants includes species having amino acid modifications (substitutions, deletions, additions, and/or insertions) of up to 40% of the amino acids of SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3, the genus is considered to encompass polypeptides with widely variant amino acid sequences.
The specification discloses the actual reduction to practice of the following representative species of the genus of DNase variants – a polypeptide comprising the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3 except for a substitution set recited in claim 7. Other than the disclosed substitutions, the specification and prior art of record fail to provide guidance and direction regarding other amino acid modifications to SEQ ID NO: 1.
Regarding the level of skill and knowledge in the art of amino acid modification, the reference of Singh et al. (Curr. Protein Pept. Sci. 18:1-11, 2017; cited on the attached Form PTO-892) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top). Also, the unpredictability associated with amino acid substitution is exemplified by the reference of Zhang et al. (Structure 26:1474-1485, 2018; cited on the attached Form PTO-892), which discloses that a substitution of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
Given that the specification discloses only a relative few representative species of a widely variant genus of polypeptides, and aside from the disclosed substitutions, there is a high level of unpredictability, the representative species are considered to be insufficient to describe the widely variant genus. 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 recited genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Claim Rejections - 35 USC § 103
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 1-3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Oestergaard et al. (US Patent No. 11,732,252 B2; cited on Form PTO-892 filed May 27, 2026; hereafter “Oestergaard”).
The claims are drawn to (in relevant part) a DNase variant, comprising at least A111P and V35I substitutions, wherein position numbers are based on the numbering of SEQ ID NO: 1, wherein the variant has a sequence identity of at least 60% but less than 100% to the polypeptide of SEQ ID NO: 1, SEQ ID NO: 2 or SEQ ID NO: 3, and wherein the variant has DNase activity.
Claim 10 is drawn to a detergent composition comprising the DNase variant of claim 1 and at least one detergent adjunct ingredient.
Regarding instant claims 1, 2, 6, and 9, Oestergaard generally teaches DNase variants having an improved property as compared to a parent DNase comprising SEQ ID NO: 1 (column 1, lines 26-29; column 2, lines 21-22).
Claim 1 of Oestergaard recites a DNase variant, which:
(a) has at least 90% sequence identity to SEQ ID NO: 1;
(b) comprises a substitution at one or more positions corresponding to the positions selected from the group consisting of 32, 35, 105, 111 and 181 of SEQ ID NO: 1;
(c) has DNase activity; and
(d) has improved stability as compared to the polypeptide of SEQ ID NO: 1;
claim 4 of Oestergaard recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 35 of SEQ ID NO: 1 with Ala, Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Trp or Tyr; and
claim 9 of the patent recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 111 of SEQ ID NO: 1 with Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr.
SEQ ID NO: 1 of Oestergaard is identical to instant SEQ ID NO: 1.
Oestergaard provides extensive teachings for preparing the DNase variants and testing their stability relative to the DNase of SEQ ID NO: 1 (see Examples 1 and 2 beginning at column 158, line 54).
Oestergaard does not teach the DNase variant comprises the combination of A111P and V35I substitutions. However, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of Oestergaard to comprise a combination of A111P and V35I substitutions. This is because Oestergaard acknowledges a desire to make DNase variants having an improved property as compared to a parent DNase comprising SEQ ID NO: 1, Oestergaard taught a limited, finite number of substitution positions of the specific sequence of SEQ ID NO: 1, Oestergaard taught a limited, finite number of replacement amino acids at positions 35 and 111 of SEQ ID NO: 1, and Oestergaard provides extensive teachings for preparing the DNase variants and testing their stability relative to the DNase of SEQ ID NO: 1.
Regarding instant claim 3, claim 8 of Oestergaard recites the DNase variant of claim 7, wherein the substitution at a position corresponding to position 105 of SEQ ID NO: 1 is K105E, K105N, K105T or K105D.
Oestergaard does not teach the DNase variant comprises the combination of A111P, V35I, and K105N substitutions. However, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of Oestergaard to comprise a combination of A111P, V35I, and K105N substitutions. This is because Oestergaard acknowledges a desire to make DNase variants having an improved property as compared to a parent DNase comprising SEQ ID NO: 1, Oestergaard taught a limited, finite number of substitution positions of the specific sequence of SEQ ID NO: 1, Oestergaard taught a limited, finite number of replacement amino acids at positions 35, 105, and 111 of SEQ ID NO: 1, and Oestergaard provides extensive teachings for preparing the DNase variants and testing their stability relative to the DNase of SEQ ID NO: 1.
Regarding instant claims 5, 7, and 8, claim 3 of Oestergaard recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 32 of SEQ ID NO: 1 with Ala, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr.
Oestergaard does not explicitly teach the DNase variant comprises the combination of A111P, V35I, and D32E substitutions. However, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of Oestergaard to comprise a combination of A111P, V35I, and D32E substitutions. This is because Oestergaard acknowledges a desire to make DNase variants having an improved property as compared to a parent DNase comprising SEQ ID NO: 1, Oestergaard taught a limited, finite number of substitution positions of the specific sequence of SEQ ID NO: 1, Oestergaard taught a limited, finite number of replacement amino acids at positions 32, 35, and 111 of SEQ ID NO: 1, and Oestergaard provides extensive teachings for preparing the DNase variants and testing their stability relative to the DNase of SEQ ID NO: 1.
In the interest of clarity, it is noted that the instant rejection is directed to the non-elected species of “D32E+V35I+A111P” in claim 7. The non-elected species has yet to be searched and examined on the merits because the teachings of the prior art directed to the non-elected species were identified during a search of the elected species.
Regarding instant claim 10, claim 17 of Oestergaard recites a detergent composition comprising the DNase variant.
Therefore, claims 1-3 and 5-10 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim Rejections - 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.
U.S. Patent No. 11,732,252 B2
Claims 1-3 and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, 8, 9, and 17 of U.S. Patent No. 11,732,252 B2 (cited on Form PTO-892 filed May 27, 2026).
Regarding instant claims 1, 2, 6, and 9, claim 1 of the patent recites a DNase variant, which:
(a) has at least 90% sequence identity to SEQ ID NO: 1;
(b) comprises a substitution at one or more positions corresponding to the positions selected from the group consisting of 32, 35, 105, 111 and 181 of SEQ ID NO: 1;
(c) has DNase activity; and
(d) has improved stability as compared to the polypeptide of SEQ ID NO: 1;
claim 4 of the patent recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 35 of SEQ ID NO: 1 with Ala, Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Trp or Tyr; and
claim 9 of the patent recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 111 of SEQ ID NO: 1 with Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr.
SEQ ID NO: 1 of the patent is identical to instant SEQ ID NO: 1.
The claims of the patent do not recite the DNase variant comprises the combination of A111P and V35I substitutions. However, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of the claims of the patent to comprise a combination of A111P and V35I substitutions. This is because the claims of the patent are directed to DNase variants having an improved stability as compared to the parent DNase of SEQ ID NO: 1, the claims of the patent recite a limited, finite number of substitution positions of the specific sequence of SEQ ID NO: 1, the claims of the patent recite a limited, finite number of replacement amino acids at positions 35 and 111 of SEQ ID NO: 1, and no more than routine experimentation would have been required to prepare the DNase variants and test their stability relative to the DNase of SEQ ID NO: 1.
Regarding instant claim 3, claim 8 of the patent recites the DNase variant of claim 7, wherein the substitution at a position corresponding to position 105 of SEQ ID NO: 1 is K105E, K105N, K105T or K105D.
The claims of the patent do not recite the DNase variant comprises the combination of A111P, V35I, and K105N substitutions. However, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of the claims of the patent to comprise a combination of A111P, V35I, and K105N substitutions. This is because the claims of the patent are directed to DNase variants having an improved stability as compared to the parent DNase of SEQ ID NO: 1, the claims of the patent recite a limited, finite number of substitution positions of the specific sequence of SEQ ID NO: 1, the claims of the patent recite a limited, finite number of replacement amino acids at positions 35, 105, and 111 of SEQ ID NO: 1, and no more than routine experimentation would have been required to prepare the DNase variants and test their stability relative to the DNase of SEQ ID NO: 1.
Regarding instant claims 5, 7, and 8, claim 3 of the patent recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 32 of SEQ ID NO: 1 with Ala, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr.
The claims of the patent do not recite the DNase variant comprises the combination of A111P, V35I, and D32E substitutions. However, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of the claims of the patent to comprise a combination of A111P, V35I, and D32E substitutions. This is because the claims of the patent are directed to DNase variants having an improved stability as compared to the parent DNase of SEQ ID NO: 1, the claims of the patent recite a limited, finite number of substitution positions of the specific sequence of SEQ ID NO: 1, the claims of the patent recite a limited, finite number of replacement amino acids at positions 32, 35, and 111 of SEQ ID NO: 1, and no more than routine experimentation would have been required to prepare the DNase variants and test their stability relative to the DNase of SEQ ID NO: 1.
In the interest of clarity, it is noted that the instant rejection is directed to the non-elected species of “D32E+V35I+A111P” in claim 7. The non-elected species has yet to be searched and examined on the merits because the patent claim(s) directed to the non-elected species was identified during a search of the elected species.
Regarding instant claim 10, claim 17 of the patent recites a detergent composition comprising the DNase variant.
Therefore, claims 1-3 and 5-10 of this application are unpatentable over claims 1, 3, 4, 6, 8, 9, and 17 of the patent.
U.S. Patent No. 12,060,589 B2
Claims 1, 6, 9, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10, and 18 of U.S. Patent No. 12,060,589 B2 (cited on the attached Form PTO-892).
Regarding instant claims 1, 6, and 9, claim 1 of the patent recites a DNase variant, which:
(a) has at least 90% sequence identity to SEQ ID NO: 1;
(b) comprises a substitution at one or more positions corresponding to the positions selected from the group consisting of 65, 67, 69, 102 and 182 of SEQ ID NO: 1;
(c) has DNase activity; and
(d) has improved stability as compared to the polypeptide of SEQ ID NO: 1,
claim 8 of the patent recites wherein the substitution at a position corresponding to position 69 is S69V, and
claim 10 of the patent recites wherein the substitution at a position corresponding to position 102 is Q102E.
SEQ ID NO: 1 of the patent is identical to instant SEQ ID NO: 1.
In the interest of clarity, it is noted that the instant rejection is directed to the non-elected species of S69V and Q102E in claim 1. The non-elected species have yet to be searched and examined on the merits because the patent claim(s) directed to the non-elected species was identified during a search of the elected species.
Regarding instant claim 10, claim 18 of the patent recites a composition comprising: (a) at least 0.002 ppm of the DNase variant of claim 17; (b) 2 wt % to 60 wt % of at least one surfactant; and (c) 5 wt % to 50 wt % of at least one builder, which is considered to be a detergent composition.
Therefore, claims 1, 6, 9, and 10 of this application are unpatentable over claims 1, 8, 10, and 18 of the patent.
Claims 2, 3, 5, 7, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 10, 12, 15, 16, and 18 of U.S. Patent No. 12,060,589 B2 in view of Oestergaard.
Claims 1, 8, 10, and 18 of the patent as applied to instant claims 1, 6, 9, and 10 are set forth above.
Regarding claims 2, 5, 7, and 8 of this application, claim 15 of the patent recites (in relevant part) the DNase variant of claim 1, further comprising one or more additional alterations at one or more positions corresponding to positions 32, 35, 105, 111 and 181, and
claim 16 of the patent recites (in relevant part) the substitutions D32E, V35I, and A111P.
The claims of the patent do not recite the DNase variant comprises the combination of D32E, V35I, and A111P substitutions.
Oestergaard generally teaches DNase variants having an improved property as compared to a parent DNase comprising SEQ ID NO: 1 (column 1, lines 26-29; column 2, lines 21-22). SEQ ID NO: 1 of Oestergaard is identical to instant SEQ ID NO: 1.
Claim 1 of Oestergaard recites a DNase variant, which:
(a) has at least 90% sequence identity to SEQ ID NO: 1;
(b) comprises a substitution at one or more positions corresponding to the positions selected from the group consisting of 32, 35, 105, 111 and 181 of SEQ ID NO: 1;
(c) has DNase activity; and
(d) has improved stability as compared to the polypeptide of SEQ ID NO: 1;
claim 3 of Oestergaard recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 32 of SEQ ID NO: 1 with Ala, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr,
claim 4 of Oestergaard recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 35 of SEQ ID NO: 1 with Ala, Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Trp or Tyr; and
claim 9 of the patent recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 111 of SEQ ID NO: 1 with Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr.
SEQ ID NO: 1 of Oestergaard is identical to instant SEQ ID NO: 1.
Oestergaard provides extensive teachings for preparing the DNase variants and testing their stability relative to the DNase of SEQ ID NO: 1 (see Examples 1 and 2 beginning at column 158, line 54).
In view of Oestergaard, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of claim 15 of the patent to further comprise a combination of substitutions at positions 32, 35, 105, 111 and 181. One would have been motivated and expected success for the DNase variant of claims 15 and 16 of the patent to comprise a combination of substitutions at positions 32, 35, 105, 111 and 181 because claims 15 and 16 of the patent recite the DNase variant further comprises one or more additional alterations at one or more positions corresponding to positions 32, 35, 105, 111 and 181, and Oestergaard taught a DNase variant of SEQ ID NO: 1 with substitutions at positions 32, 35, 105, 111 and 181 and having improved stability.
Oestergaard does not explicitly teach the DNase variant comprises the combination of A111P, V35I, and D32E substitutions. However, it would have been obvious to one of ordinary skill in the art before the effective filing date for a combination of A111P, V35I, and D32E substitutions. This is because Oestergaard acknowledges a desire to make DNase variants having an improved property as compared to a parent DNase comprising SEQ ID NO: 1, Oestergaard taught a limited, finite number of substitution positions of the specific sequence of SEQ ID NO: 1, Oestergaard taught a limited, finite number of replacement amino acids at positions 32, 35, and 111 of SEQ ID NO: 1, and Oestergaard provides extensive teachings for preparing the DNase variants and testing their stability relative to the DNase of SEQ ID NO: 1.
Regarding instant claim 3, claim 4 of the patent recites wherein the substitution at a position corresponding to position 65 is K65E and claim 12 of the patent recites wherein the substitution at a position corresponding to position 182 is S182V or S182Y.
Therefore, claims 2, 5, 7, and 8 of this application are unpatentable over claims 1, 4, 8, 10, 12, 15, 16, and 18 of the patent in view of Oestergaard.
Co-pending Application No. 18/728,035
Claims 1-3 and 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 16 of co-pending application no. 18/728,035 (reference application) in view of Oestergaard.
Regarding instant claims 1-3 and 5-9, claim 12 of the reference application recites a composition for cleaning a medical device, comprising a surfactant and two or more enzymes selected from the group consisting of a protease, an enzyme having DNase activity and an enzyme having hexosaminidase activity;
claim 16 of the reference application recites the composition according to claim 12, wherein the enzyme having DNase activity is a variant of SEQ ID NO: 2, comprising one or more alterations selected from the group consisting of S26 D32E,Q, V35I, K36C,H, G37R, F43W, D46G, A55I, N68D, S69V, A76I, K82S,T, P84D,T, K86E,G,L,N,Q,T,V,Y, A91R, L92E, K95I, P97E,N, A101E, Q102E, K105N,G,Q,T,D, A111P, F112Y,W, S115T, V127T, L129K, N133Q, G137R, V138C, N140H, G141Q,R, S144E, N146A, K147N,E, V148I, A149D,E,F, Q150D,E, P153D,V, S154E, K155E,F,L,S,T, Q157D,E, Q158D, T159Q, K160D, G161R, T170Q, A172D,E,H,R, G181N, K185*, V187N,Y, N191*, K192A,I, D197K,S, G199Q, Q208V, E211Y,T,P, N213S, N214D, N217A and Y218D,E, wherein position numbers correspond to the positions of SEQ ID NO: 2, wherein the variant has at least 80%, such as at least 85%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99%, but less than 100% sequence identity to the polypeptide of SEQ ID NO: 2 or 3.
SEQ ID NO: 2 of the reference application is identical to instant SEQ ID NO: 1.
The claims of the reference application do not recite the DNase variant comprises the combination of D32E, V35I, and A111P substitutions.
Oestergaard generally teaches DNase variants having an improved property as compared to a parent DNase comprising SEQ ID NO: 1 (column 1, lines 26-29; column 2, lines 21-22). SEQ ID NO: 1 of Oestergaard is identical to instant SEQ ID NO: 1.
Claim 1 of Oestergaard recites a DNase variant, which:
(a) has at least 90% sequence identity to SEQ ID NO: 1;
(b) comprises a substitution at one or more positions corresponding to the positions selected from the group consisting of 32, 35, 105, 111 and 181 of SEQ ID NO: 1;
(c) has DNase activity; and
(d) has improved stability as compared to the polypeptide of SEQ ID NO: 1;
claim 3 of Oestergaard recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 32 of SEQ ID NO: 1 with Ala, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr,
claim 4 of Oestergaard recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 35 of SEQ ID NO: 1 with Ala, Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Trp or Tyr; and
claim 9 of the patent recites the DNase variant of claim 1, which comprises a substitution at a position corresponding to position 111 of SEQ ID NO: 1 with Asp, Glu, Phe, Gly, His, Ile, Lys, Leu, Met, Asn, Pro, Gln, Arg, Ser, Thr, Val, Trp or Tyr.
SEQ ID NO: 1 of Oestergaard is identical to instant SEQ ID NO: 1.
Oestergaard provides extensive teachings for preparing the DNase variants and testing their stability relative to the DNase of SEQ ID NO: 1 (see Examples 1 and 2 beginning at column 158, line 54).
In view of Oestergaard, it would have been obvious to one of ordinary skill in the art before the effective filing date for the DNase variant of claim 16 of the reference application to comprise a combination of D32E, V35I, and A111P substitutions. One would have been motivated and expected success for the DNase variant of claim 16 of the reference application to comprise a combination of D32E, V35I, and A111P substitutions because Oestergaard taught a DNase variant of SEQ ID NO: 1 with substitutions at positions 32, 35, and 111, including D32E, V35I, and A111P, and having improved stability, and the claims of the reference application recite a DNase variant of the same sequence with one or more of the substitutions D32E, V35I, and A111P.
Regarding instant claim 10, claim 17 of Oestergaard recites a detergent composition comprising the DNase variant and given that claim 12 of the reference application recites a composition for cleaning a medical device, it would have been obvious to one of ordinary skill in the art for the cleaning composition of claim 12 of the reference application to be a detergent composition.
Therefore, claims 1-3 and 5-10 of this application are unpatentable over claims 12 and 16 of the reference application in view of Oestergaard. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Status of the claims:
Claims 1-10 and 12-15 are pending.
Claims 4 and 12-15 are withdrawn.
Claims 1-3 and 5-10 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MANJUNATH N RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/David Steadman/Primary Examiner, Art Unit 1656
Prosecution Insights