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 .
Specification
The amendment to the specification and claims filed on 2/2/24 has been entered.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 102-106 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating or ameliorating a disease associated with dysregulation of the complement alternative pathway in a subject, does not reasonably provide enablement for preventing the disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention broadly reads on using the compound of claim 95 (modified antisense oligonucleotide) to treat, prevent or ameliorate a disease associated with dysregulation of the complement alternative pathway.
The prior art teaches that it was routine in the prior art for a skilled artisan to use an antisense oligonucleotide (AON) to treat or ameliorate a disease associated with the complement alternative pathway in a subject. For example, see US20080075720 and US20100120665.
However, the prior art does not teach that it was routine in the prior art for a skilled artisan to use an AON to prevent a disease associated with the complement alternative pathway.
The specification of the instant disclosure does not provide a working example of using an antisense oligonucleotide to prevent a disease associated with the complement alternative pathway in a subject.
Furthermore, other than contemplating the method and studying complement factor B (CFB) mRNA expression and/or tolerability of the compound in cell lines and animal models (mice, rats and primates), the specification of the instant application does not disclose how to use the full scope of the claimed invention. See Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: "Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention." Applicant cannot rely on the knowledge of one skilled in the art to supply information on the novel aspects of the claimed invention. Thus, in view of the reasons set forth above, it would take an undue amount of experimentation for one of skill in the art to practice the full scope of the claimed invention.
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 95, 97, and 99-106 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11732265. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims are directed to a compound comprising a gapmer antisense oligonucleotide comprising a nucleobase sequence recited in SEQ ID NO: 455, and a pharmaceutically acceptable carrier; and using the compound to treat a kidney disease or wet aged macular degeneration (wet AMD), wherein the compound further comprises a conjugate group. The structural limitations of the modified oligonucleotide recited in instant claim 95 is disclosed in claims 2 and 23 of ‘265.
Claims 95, 96, and 99-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10570169. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims are directed to a compound comprising a gapmer antisense oligonucleotide, and a pharmaceutically acceptable carrier, wherein the compound further comprises a conjugate group. The only difference between the instant claims and the claims of ‘169 is the claims from ‘169 do not specifically recite instant SEQ ID NO: 440. However, the structural limitations of the modified oligonucleotide recited in instant claims 95, wherein the oligonucleotide is SEQ ID NO: 440 is disclosed in SEQ ID NO: 87 in column 171 of the ‘169 specification. One of ordinary skill in the art looking for how to use the antisense oligonucleotide would look to this section of the ‘169 specification and arrive at the claimed product. See MPEP 804(II)B.1. Construing the Claim Using the Reference Patent or Application Disclosure.
Claims 95-96 and 99-106 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10280423. Although the claims at issue are not identical, they are not patentably distinct from each other because both set of claims are directed to a compound comprising a gapmer antisense oligonucleotide comprising a nucleobase sequence recited in SEQ ID NO: 440, and a pharmaceutically acceptable carrier; and using the compound to treat a kidney disease or wet aged macular degeneration (wet AMD), wherein the compound further comprises a conjugate group. The structural limitations of the modified oligonucleotide recited in instant claim 95 is disclosed in claims 26-29 of ‘423.
Allowable Subject Matter
Claim 98 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
See attached PTO-326 for disposition of claims.
The art made of record and not relied upon is considered pertinent to applicant's disclosure. Example 8 on page 169 of WO2004024749 discloses an antisense primer (SEQ ID NO: 19) for human B-factor properdin (BF) that is at least 20 nucleotides in length and has at least 16 contiguous bases of instant SEQ ID NO: 598. However, neither ‘749 nor the prior art teach or suggest making a gapmer antisense oligonucleotide for use as an antisense primer for BF.
Isis Pharmaceuticals (WO 2015168635, published 11/5/15 and EFD 5/1/14). ‘635 teaches a compound comprising a gapmer antisense oligonucleotide comprising a nucleobase sequence recited in SEQ ID NOs: 440 and 455 (see SEQ ID NOs: 440 and 455 on page 489), and a pharmaceutically acceptable carrier; and using the compound to treat a kidney disease or wet aged macular degeneration (wet AMD), wherein the compound further comprises a conjugate group. See page 543. The structural limitations of the modified oligonucleotide recited in instant claim 95 is disclosed in pages 477-504 of ‘635. However, the instant application enjoys priority to provisional application 61877624 filed on 9/13/13. Thus, ‘635 does not qualify as prior art under 102(a)(1) or (2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Whiteman whose telephone number is (571)272-0764. The examiner can normally be reached on Monday thru Friday; 6:00 AM to 3:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at (571)-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636
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