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 with traverse of Group I, claims 1-11, 13, and 15-20, drawn to a polypeptide variant of a member of a Sac7d family, pharmaceutical composition, or medicament thereof, in addition to the species election of SEQ ID NO: 58, in the reply filed on 5/11/2026 is acknowledged. The traversal is on the ground(s) that the claims are drawn to a single general inventive concept that constitutes as special technical feature and the restriction requirement failed to apply art to break the described unity of invention. This is found persuasive and the restriction requirement is hereby withdrawn.
Further, claims 1-13 and 15-20 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claim 14, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 3/13/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The following is the closest prior art for the species listed in claims 6-8:
SEQ ID NO: 38 is 85.8% identical to SEQ ID NO: 42 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 48 is 75.4% identical to SEQ ID NO: 41 of US 9422548B2, filed 12/4/2006
SEQ ID NO: 51 is 73.4% identical to SEQ ID NO: 42 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 55 is 77.5% identical to SEQ ID NO: 41 of US 9422548B2, filed 12/4/2006
SEQ ID NO: 58 is 75.7% identical to SEQ ID NO: 42 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 62 is 74.3% identical to SEQ ID NO: 41 of US 9422548B2, filed 12/4/2006
SEQ ID NO: 65 is 72.4% identical to SEQ ID NO: 42 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 69 is 69.1% identical to SEQ ID NO: 5 of US 11597751B2, filed 5/16/2019
SEQ ID NO: 72 is 63% identical to SEQ ID NO: 42 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 76 is 70.8% identical to SEQ ID NO: 14 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 79 is 63% identical to SEQ ID NO: 42 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 83 is 68% identical to SEQ ID NO: 14 of US 11932674B2, effectively filed 11/14/2017
SEQ ID NO: 86 is 64.4% identical to SEQ ID NO: 42 of US 11932674B2, effectively filed 11/14/2017
None of the above art teaches further modifying the polypeptides by introducing K22W, W24L, T33K, and R42Y mutations. These substitutions are not obvious to make as they are not conservative. It is also not obvious to select the four positions nor make the claimed substitutions and expect the Sac7d polypeptide to engage mouse and human serum albumin, particularly because the naturally-occurring binding interface of Sac7d family members indiscriminately binds DNA rather than proteins. Thus, the polypeptides claimed are novel and non-obvious.
Claim Status
Claims 1-20 are pending under examination. Claims 1-15 are currently amended. Claims 16-20 are new.
Priority
The instant application is the 371 national stage entry of PCT/EP2022/053476, filed 2/14/2022, which claims priority to EP21305193.1, filed 2/15/2021. The priority date of 2/15/2021 is acknowledged.
Information Disclosure Statement
The IDS filed on 8/14/2023 is under consideration.
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
1. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
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 sequence identifiers, 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.
See Tables 1 and 4, last row of each table
2. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
See Figure 1
3. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Pg 22, lines 8-11 and 23). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms tween20 (Pg 34, line 30) and Nanofitin (Pg 21, line 24; Pg 32, lines 16, 22, 26, 30; Pg 33, lines 4, 10, 19, 26, 27; Pg 34, lines 5, 6, 7, 10, 11 (two instances), 14, 16, 18, 21, 26, 28, 24; Pg 35, lines 1, 5, 9, 10, 12, 15, 18) which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear 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.
The disclosure is objected to because of the following informalities: Pg 13, line 27 indicates that polypeptide F06 is equivalent to SEQ ID NO: 62 but Pg 32, line 26 indicates that it is equivalent to SEQ ID NO: 65. Appropriate correction is required.
Claim Interpretation
The claims are drawn to variants of members of the Sac7d family of proteins. The members of said Sac7d family of proteins are being interpreted as consisting of or limited to only SEQ ID NO: 1-16, wherein SEQ ID NO: 16 represents a consensus sequence of SEQ ID NO: 1-9 and SEQ ID NO: 12-15 (see instant Pg 19, line 25 – Pg 20, line 2).
Examiner’s Note
A rejection under 35 U.S.C. 112(a) written description was considered for claims 1-5 and 9-20 but not rendered for the following reasons: As recited above in the Claim Interpretation section, the claims are drawn to variants of the Sac7d family of proteins. The instant specification defines that Sac7d family protein members includes SEQ ID NO: 1-15 (see instant Pg 19, line 25 – Pg 20, line 2). SEQ ID NO: 1-15 are highly conserved, as shown in Figure 1, thus resulting in the generation of the consensus sequence SEQ ID NO: 16. The instant application further states that the mutations K22W, W24L, T33K, and R42Y mediate binding of said Sac7d family members to human and mouse serum albumin (see instant Pg 13, lines 13-16 and Pg 16, lines 5-8). The prior art demonstrates that the structure of Sac7d is well-known, and extensive experimentation aimed at altering the naturally-occurring binding interface to engage other types of proteins or molecules has been conducted (see, for instance, WO2008/068637 or Traxlmayr et al., 2016, cited on IDS filed 8/14/2023); through these efforts, nearly every residue in the binding interface has been altered previously. Thus, it would be evident to one skilled in the art how to introduce 4-20 additional mutations into a Sac7d family variant comprising the mutations K22W, W24L, T33K, and R42Y and maintain its functionality.
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.
Claim 15 is 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.
Claim 15 recites a medicament comprising or consisting of a conjugated polypeptide of claim 10. The scope of this claim is indefinite as it is unclear whether the medicament comprises the conjugated polypeptide, in which case it may include additional unrecited features in addition to the polypeptide, or consists of the conjugated polypeptide and, thus, is limited to only said polypeptide. For purposes of examination, the claim is being interpreted as comprising the conjugated polypeptide, which may or may not include additional features.
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 5 and 18 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. As described above in the Claim Interpretation section, members of the Sac7 family are being interpreted as limited to SEQ ID NO: 1-16, which correspond to the Sac7 species recites in claims 5 and 18. Therefore, neither claim 5 nor 18 further limits from their parent claim. 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.
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 1-9, 13-14, and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,548,945 B2 (US ‘945). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims anticipate the claims of US ‘945.
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
The claims of US ‘945 are drawn to a method for administering a topical ophthalmic composition comprising a variant of an wild-type OB-fold protein with 5-20 mutations in its binding interface, wherein the wild-type OB-fold protein is selected from Sac7d or Sac7e and other family species and the mutated residues include those recited in the instant claim 3. The instant specification teaches the instantly claimed Sac7d family polypeptide variants can be used for the treatment of a disease (Pg 3, lines 14-16).
Claims 1-9, 13-14, and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 10-21 of U.S. Patent No. 10,293,025 B2 (US ‘025). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims anticipate the claims of US ‘025.
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
The claims of US ‘025 are drawn to an oral administration composition comprising a variant of an wild-type OB-fold protein with 5-32 mutations in its binding interface where it binds its natural ligand. The instant specification teaches Sac7d family polypeptides and variants thereof are representative species of OB-fold domains (Pg 19, lines 26-29) and the instantly claimed Sac7d family polypeptide variants can be used for the treatment of a disease (Pg 3, lines 14-16).
Claims 1-9, 13-14, and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,898,542 B2 (US ‘542). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims anticipate the claims of US ‘542.
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
The claims of US ‘542 are drawn to a method for administering a topical ophthalmic composition comprising a variant of an wild-type OB-fold protein with 5-20 mutations in its binding interface, wherein the wild-type OB-fold protein is selected from Sac7d or Sac7e and other family species and the mutated residues include those recited in the instant claim 3. The instant specification teaches the instantly claimed Sac7d family polypeptide variants can be used for the treatment of a disease (Pg 3, lines 14-16).
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-23 of copending Application No. 18/435,494 (‘494 reference application; claim set filed 12/31/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims anticipate those of copending Application No. ‘494.
The claims of copending Application No. ‘494 are drawn to a polypeptide comprising a modified antibody wherein at least one variant of a protein of the Sac7d family is fused to at least one heavy or light chain of the antibody, wherein the variant comprises 4-20 mutated residues in addition to mutations at the residues recited in the instant claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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