DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s response and amendments received May 19, 2026 are acknowledged.
Claims 1-32, 36, and 37 have been canceled.
Claims 33 and 35 have been amended,
Claims 38-48 have been added.
Claims 33-35 and 38-48 are pending in the instant application.
Applicant’s election without traverse of the invention of group III, drawn to methods of treating disease by administering anti-factor H antibodies in the reply filed on May 19, 2026 is acknowledged.
Claims 33-35 and 38-48 are under examination in this office action.
Information Disclosure Statement
The IDS form received 2/25/2025 is acknowledged and the references cited therein have been considered.
The listing of references in the specification beginning on page 62 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.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
The instant application was filed 10/16/2023 as a continuation of 16/961,737 (see the filing receipt of 12/7/2023) and as such applicant has correctly submitted a sequence listing under ST.26. As applicant is undoubtedly aware, under ST.26 amino acid sequences less than 4 residues cannot be identified via SEQ ID number, and indeed sequences shorter than 4 residues appear as “blank” data in the sequence listing (i.e. “skipped sequences”) which is 100% correct. However, the claims still recite sequences shorter than 4 residues by reference to SEQ ID numbers. Specifically, in independent claim 33, “ATS” is referred to as “(SEQ ID NO:2)” while “ASS” is referred to as “(SEQ ID NO:14)”. Given that under ST.26 sequences shorter than 4 residues cannot be given SEQ ID numbers, the recitation of SEQ ID numbers in the claims for such sequences is improper. It is suggested that the SEQ ID numbers in question be deleted as only the tripeptide sequence in single letter code is appropriate nomenclature in a specification that conforms to the convention of ST.26. More explicitly, the preferred language based upon claim 33 as presently constructed is “ … - a light chain CDR2 sequence comprising the sequence ATS or the sequence ASS, …”. Obviously alternative recitations are possible and the short CDR sequences at issue are recited in dependent claims as well which require similar fixing. Technically, in addition to the claims, the specification also should not refer to such shorth sequences via SEQ ID number as is done in for example Table 1 beginning on page 23 of the instant specification.
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 33-35 and 38-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant has broadly claimed methods of “treating, alleviating, or preventing” disorders associated with alternative pathway complement activation, such as age-related macular degeneration (AMD), atypical hemolytic uremic syndrome (aHUS), and paroxysmal nocturnal hemoglobinuria (PMH), by administering antibodies that bind to the complement control protein domain 18 of factor H, wherein the administered antibodies are minimally defined as having six CDR sequences defined by SEQ ID number. To support such claims the specification discloses humanization of lead antibody clones and in vitro functional assays. The specification does not appear to disclose any human clinical or animal model data concerning in vivo administration for any disease or condition.
The specification indicates what applicant intends the term “treating” to encompass in paragraph [0038] but no such guidance appears to be set forth concerning “alleviating” or “prevention”. However, it should be noted that paragraph [0038] states:
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In view of such guidance it is unclear how “treating” is or can be distinct from “amelioration/alleviation”. Notably the term “prevention” is not discussed. Thus such a term can reasonably be interpreted as a term of degree/efficacy, such that for example upon administration clinical signs and symptoms of the disease in question are undetectable (i.e. prevention = total cessation, total efficacy). It could also be interpreted as a timing limitation, such a prophylactic administration, as logically an administration cannot stop (i.e. “prevent”) a disease from occurring in the first place if the clinical signs and symptoms are already present (noting that if clinical signs are present the subject is “treated” as “prevention” is no longer possible), or some combination of timing and efficacy limitations. Based upon the in vitro efficacy data disclosed in the instant specification, as well as data in the prior art such as that of WO 2016/028150 (see entire document) artisans would reasonably expect the instant claimed methods to be effective in treating the indicated conditions. However, there is insufficient evidence that such diseases can be fully prevented (i.e. 100% efficacy), which is the scope of the ordinary definition of "preventing". For example, claim 34 lists membranoproliferative glomerulonephritis (MPGN) as one such disease to be prevented, while the art recognizes "there may be no way to prevent most forms of glomerulonephritis" (Mayo, see entire document). Where the solution is previously attempted but unattained, the evidence that Applicant's contribution solves this previously unsolvable problem is necessarily high. The evidence is inadequate to conclude that full prevention of all alternative pathway complement activation mediated diseases, or prevention of the five diseases of claim 34, is attainable without undue unpredictable basic science research and experimentation.
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 33-35 and 38-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,820,814 in view of Kuijpers et al. (WO 2016/028150).
The issued claims recite antibodies and antigen binding fragments thereof that bind the CCP18 domain of factor H and are defined by SEQ ID numbers identical to those of the instant application (note the sequences are the same as the instant application is a continuation of the application which gave rise to the ‘814 patent). Such antibodies are defined at the level of six CDRs (see for example issued claim 1) as well as pairs of complete VH and VL domains (see for example issued claims 10-13). The issued antibodies are recited as being Fab fragments (see issued claim 16), as comprising various functional properties (for example compare instant claim 45 to issued claim 14 as well as instant claim 43 to issued claim 8), as comprising antibody constant domains including IgG4 (see particularly issued claims 15, 18, 21, and 22), and as being conjugated to PEG (see issued claims 19 and 20). The issued claims differ from the instant claimed inventions in that the issued claims do not recite administering the claimed anti-factor H antibodies to subjects to treat disease.
Kuijpers et al. disclose that antibodies that bind complement factor H, particularly those binding to the CCP18 domain of factor H, are to be administered to treat alternative complement activation pathway mediated disorders including age-related macular degeneration (AMD), atypical hemolytic uremic syndrome (aHUS), and paroxysmal nocturnal hemoglobinuria (PMH) (see entire document, particularly the abstract and claims, most particularly claims 18 and 19).
Therefore, it would have been obvious to an ordinary artisan to administer the antibodies of the issued claims to subjects to treat diseases including AMD, aHUS, and PMH. Artisans would be motivated to do so with a reasonable expectation of success as antibodies that bind the CCP18 domain of factor H are known to be therapeutically useful in treating such diseases based upon the data and teachings of Kuijpers et al.
As indicated above, the instant application is a continuation of the application which gave rise to the ‘814 patent, and no restriction requirement was set forth during the prosecution of the parental application (i.e. 17/627,503). Thus the filing of the claims of the instant application was not due to a restriction requirement in the parent. As has been made abundantly clear in court decisions, including Pfizer v. Teva and Amgen Inc. v. F. Hoffman-La-Roche Lid., “the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Given that the instant application cannot be a divisional of the application which gave rise to the issued patent, the instant claimed invention is not entitled to the protections of 35 USC 121 and therefore the instant rejection has been set forth.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
Prosecution Insights