DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
The preliminary amendment filed 7/25/24 is acknowledged. Claims 1-154 are cancelled. New claims 155-169 are added. Claims 155-169 are pending. Claims 155-169 are currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statement filed on 3/20/24 has been considered. A signed copy is enclosed.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
Trademarks
The specification is objected to for improperly marked trademarks. These include CASCADE, TEXAS RED, OREGON GREEN, ALEXA FLUOR, NORDOTROPIN, NUTROPIN, GENOTROPIN, SOMATROPE, PROTEON, AFFINIPURE, BIACORE, LUMINEX, BIOPLEX, and possibly others. They should be capitalized wherever they appear and be accompanied by the generic terminology.
Although the use of trademarks is 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 trademarks. It is noted that the cited occurrences of improper use are only exemplary and applicant should review the specification to correct any other use of trademarks.
Claim Objections
Claims 155 is objected to because the term “IL-33” contains an acronym and/or abbreviation that should be spelled out upon first occurrence.
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.
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 155-166 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.
Claim 155 recites the phrase “treating a disease or disorder associated with IL-33-mediated signaling,” which renders the claim indefinite. The specification does not define the term “associated with.” It is unclear from the phrase if IL-33 mediated signaling is required, or if the disease must only be a type of disease that commonly comprises IL-33 mediated signaling.
Double Patenting
Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 167-169 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 13, and 25 of prior U.S. Patent No. 11,965,029. This is a statutory double patenting rejection.
Non-Statutory
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 155-169 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 9,982,054. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are directed to a method of treating a disease or disorder associated with IL33-mediated signaling comprising administering to the patient a therapeutically effective amount of an antibody that binds to ST2, wherein the antibody comprises a light chain variable domain that comprises CDRS set forth in SEQ ID NO:107, 118, and 129, and a heavy chain variable region domain that comprises CDRS set forth in SEQ ID NO:41, 52, and 63. The heavy chain variable region and light chain variable regions must comprise an amino acid sequence that is at least 90%, 95%, or 99% identical to SEQ ID NO:30 and 96, respectively. The antibody can bind with an affinity of less than 1x10-10M, which can be determined by surface plasmon resonance. The antibody can inhibit binding of ST2 to IL-33, can reduce human IL-33 mediated signaling in ST2 expressing cells, inhibit binding of cynomolgus monkey ST2 to cynomolgus monkey IL-33, and the antibody can be a human antibody.
The reference patent claims a method of treating inflammation in a patient with an autoimmune or inflammatory disorder (see e.g. claims 1-14), a method of treating asthma (see e.g. claims 15-24), or a method of treating COPD (see e.g. claims 25-34), comprising administering to the patient a therapeutically effective amount of an antibody that binds to ST2, wherein the antibody comprises a light chain variable domain that comprises CDRS set forth in SEQ ID NO:107, 118, and 129, and a heavy chain variable region domain that comprises CDRS set forth in SEQ ID NO:41, 52, and 63 (see e.g. claims 1-34). The amino acid sequences of the reference patent are identical to the instant sequences, and are numbered with identical SEQ ID NO. The heavy chain variable region and light chain variable regions can comprise amino acid sequences that are identical to SEQ ID NO:30 and 96, respectively (see e.g. claims 9, 23, and 33) . The antibody can bind with an affinity of less than 1x10-10M, which can be determined by surface plasmon resonance (see e.g. claims 2-3, 16-17, and 26-27). The antibody can inhibit binding of ST2 to IL-33, can reduce human IL-33 mediated signaling in ST2 expressing cells, inhibit binding of cynomolgus monkey ST2 to cynomolgus monkey IL-33 (see e.g. claims 4-7, 18-21, and 28-31). The antibody can be a human antibody (see e.g. claim 8, 22, and 32).
The reference patent anticipates the instant claims. However, the reference patent differs from the instant claims by reciting an antibody genus that encompasses the antibodies of the instant claims. The scope of the reference patent also encompasses antibody species that are not encompassed by the instant claim, since only the CDRs are required in the reference patent base claim, whereas the instant claims require sequence identity with specific heavy and light chain variable regions. Therefore, the scope of the claimed invention in the reference patent overlaps with the instant claims, but is not identical.
Claims 155-166 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 11,965,029. Although the claims at issue are not identical, they are not patentably distinct from each other. Claims 167-169 is/are rejected above under 35 U.S.C. 101 for statutory double patenting as claiming the same invention as that of claims 1, 13, and 25 of U.S. Patent No. 11,965,029.
The instant claims are directed to a method of treating a disease or disorder associated with IL33-mediated signaling comprising administering to the patient a therapeutically effective amount of an antibody that binds to ST2, wherein the antibody comprises a light chain variable domain that comprises CDRS set forth in SEQ ID NO:107, 118, and 129, and a heavy chain variable region domain that comprises CDRS set forth in SEQ ID NO:41, 52, and 63. The heavy chain variable region and light chain variable regions must comprise an amino acid sequence that is at least 90%, 95%, or 99% identical to SEQ ID NO:30 and 96, respectively. The antibody can bind with an affinity of less than 1x10-10M, which can be determined by surface plasmon resonance. The antibody can inhibit binding of ST2 to IL-33, can reduce human IL-33 mediated signaling in ST2 expressing cells, inhibit binding of cynomolgus monkey ST2 to cynomolgus monkey IL-33, and the antibody can be a human antibody.
The reference patent claims a method of treating inflammation in a patient with an autoimmune or inflammatory disorder (see e.g. claims 1-12), a method of treating asthma (see e.g. claims 13-24), or a method of treating COPD (see e.g. claims 25-36), comprising administering to the patient a therapeutically effective amount of an antibody that binds to ST2, wherein the antibody comprises a light chain variable domain that comprises CDRS set forth in SEQ ID NO:107, 118, and 129, and a heavy chain variable region domain that comprises CDRS set forth in SEQ ID NO:41, 52, and 63 (see e.g. claims 1-36). The amino acid sequences of the reference patent are identical to the instant sequences, and are numbered with identical SEQ ID NO. The heavy chain variable region and light chain variable regions can comprise amino acid sequences that are 90% identical to SEQ ID NO:30 and 96, respectively (see e.g. claims 1, 13, and 25) . The antibody can bind with an affinity of less than 1x10-10M, which can be determined by surface plasmon resonance (see e.g. claims 6-7, 18-19, and 30-31). The antibody can inhibit binding of ST2 to IL-33, can reduce human IL-33 mediated signaling in ST2 expressing cells, inhibit binding of cynomolgus monkey ST2 to cynomolgus monkey IL-33 (see e.g. claims 8-11, 20-23, and 30-35). The antibody can be a human antibody (see e.g. claim 12, 24, and 36).
The reference patent anticipates the instant claims. The reference patent differs from the instant claims by reciting specific species of diseases and disorders that are encompassed by the instant claims. Therefore, the scope of the claimed invention in the reference patent overlaps with the instant claims, but is not identical.
Prior Art Cited But Not Relied Upon
Chakerian et al (US 8,187,596 B1; filed 7/13/09; priority date of 7/20/06): Chakerian et al describe an antibody that binds to ST2 within residues 19-556, which comprises residues 19-322. The antibody inhibits IL-33 signal transduction (see claim 1). The antibody can be a human antibody (see claim 3). The antibody is an antagonist of IL-33 binding to ST2 (see column 3). The affinity of the antibody can be 1 x10^-10 M or lower (see column 8). The antibody of Chakerian can be used to treat an immune condition or disorder, such as asthma and others (see e.g. column 3, lines 15-30). However, Chakerian does not teach the specific amino acid sequences of the instant claims, and therefore does not read on the antibody recited in the instant claims.
Snider (US 8,420,785; filed 4/8/11; published 4/16/13): Snider teaches antibodies and antigen-binding fragments that bind to ST2 protein (see e.g. abstract and column 1, lines 10-20). The antibodies can bind competitively with or are the antibody produced from the hybridomas deposited with ATCC under the accession numbers PTA-10431 and PTA-10432 (see e.g. column 2, lines 5-40). The antibody can have an affinity equal to or less than 8.59x10-10M, which overlaps with the range of the instant claims’ required antibody affinity (see e.g. column 2, lines 5-40). The antibody can be used to predict risk of death within one year in a subject, select treatment for a subject, and/or quantitate ST2 in a human subject (see e.g. column 2, line 55 to column 3, line 15, and column 3, lines 35-50). Snider does not teach administration of the antibodies for treating the claimed mechanism or encompassed disorders, and does not describe the same amino acid sequences as the instant claims. Therefore, Snider does not read on the instant claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA MCCOLLUM whose telephone number is (571)272-4002. The examiner can normally be reached 9:00 AM to 6:00 PM EST.
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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
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