DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response and amendments received June 4, 2026 are acknowledged.
Claims 1-12 have been canceled.
Claims 13-25 are pending in the instant application.
Applicant’s election of the invention of group I, drawn to antibodies that bind complement factor H, presently claims 13-19 in the reply filed on June 4, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 20-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 4, 2026.
Claims 13-19 are under examination in this office action.
Information Disclosure Statement
The IDS forms received 10/23/2024, 12/02/2024, and 3/24/2025 are acknowledged and the references cited therein have been considered.
Claim Objections
Claim 7 is objected to as the typographical error “a human igG3 constant” should be “a human IgG3 constant”. Appropriate correction is required.
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.
Claim 17 is 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.
In the independent claim, applicant has claimed a genus of antibody molecules that comprise two antibody domains, specifically one VH and one VL, wherein said domains are defined by SEQ ID number. Claim 17 depends directly from independent claim 13, and recites that the claimed type of antibody is a “single domain antibody”. As per their name, “single domain antibodies” contain only one, rather that they typical pair, of variable antigen binding domains found in conventional antibodies. See for example Yu et al. Given that the independent claim recites a paired VH and VL by SEQ ID number, the claimed antibody must have a conventional antibody binding domain that comprise the VH and VL. A single domain antibody which would comprise either a VH or a VL, but not both, is impossible to make as per the requirements of the independent claim.
Claim 17 also recites that the claimed antibody is “an affinity matured”. Besides grammatically lacking the word “antibody” as part of the recited Markush member, affinity maturation in the art means mutating the biological sequence of a lead clone, typically by CDR mutations but frameworks can also be modified, in order to arrive at a new biological sequence which binds to the antigen in question with higher affinity as compared to the starting clone (see for example paragraph [00126] of the instant specification). However, the independent claim fixes the biological sequences of the antigen binding domain such that no mutations are permissible. Thus the claims do not allow for mutation of the biological sequences recited in the independent claim. It should be noted that the working examples do not appear to indicate that the instant claimed sequences are the result of in vitro mutagenesis studies of a lead antibody clone such that the recited sequences are in fact already “affinity matured”. It should be noted that if the instant recited sequences are indeed “affinity matured”, reciting that fact in a dependent claim is not further limiting, which is not permitted as per 112(d). Thus, it is strongly suggested that “an affinity matured” be deleted as such a limitation is either a) impossible as no mutations allowed or b) not further limiting necessitating a rejection under 112(d) for that particular member of the recite Markush. It should also be noted that the other members of the Markush (apart from “single domain antibody discussed supra) do appear to be antibody structures that a) could readily be made and used by artisans and b) further limit the independent claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2014/197885.
The ‘885 document discloses numerous anti-CFH antibodies, including those disclosed in the instant application including mAb7962 (VH and VL which are 100% identical to instant SEQ ID NOs:7 and 47) and Ab 7966 (the VH and VL of which are 100% to instant SEQ ID NOs:9 and 49 respectively, see entire document particularly the abstract, claims, and Tables 1, 2, and 7, as well as the enclosed sequence alignments). Such antibodies are disclosed as being made into multiple antigen binding structures, such as Fab and scFv, as not cross-reacting with the autoantigens recited in instant claim 16, and as having a myriad of constant domains including human IgM, IgE, IgG1, IgG2, IgG3, IgG4, and IgA (see particularly page 4). Administering such antibodies in a pharmaceutical composition to increase complement dependent lysis is disclosed (see for example paragraph [0020] spanning pages 9 and 10). Note that binding to the PIDNGDIT epitope is disclosed (see for example paragraph [00122]) but even if it were not, the antigen to which an antibody binds is an inherent property of the antibody itself, and determining the epitope to which an antibody binds in no way changes the structure of the antibody. Given that the exact same biological sequences are disclosed for the anti-CFH antibodies of the ‘885 document and those presently claimed, any and all functional properties must be the same as the antibody products are identical. Applicant is reminded that the courts have long ruled "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See also MPEP 2112.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite antibodies that bind complement factor H and comprise VH/VL pairs defined by SEQ ID number. These exact antibody sequences are disclosed in the specification as having been obtained by sequencing peripheral blood mononuclear cells (PBMCs) obtained from human patients having autoantibodies to complement factor H following single cell cloning (see most particularly paragraphs [00217] and [00218] and Table 1 of the instant specification). As such, the antibodies recited by SEQ ID number naturally occurred in the human patients from which the PBMC were obtained (as per Table 1, SEQ ID NOs:7 and 47 are Ab7962 while SEQ ID NOs:9 and 49 are Ab7966), and thus the breadth of applicant’s instant claims encompasses naturally occurring products/antibodies. Products of nature are a judicial exception, and this judicial exception is not integrated into a practical application because the independent claim simply recites the VH and VL pairs (as per Table 1, SEQ ID NOs:7 and 47 are Ab7962 while SEQ ID NOs:9 and 49 are Ab7966) obtained by single cell cloning and sequencing, while dependent claims recite inherent properties of the autoantibodies, such as lack of cross-reactivity to other antigens, the exact epitope in CFH which is bound, and that any human Fc can be present, all of which are properties that are pre-existing in the natural products. As applicant is undoubtedly aware, in In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP 2112. While it is true that Crish discusses inherency versus the prior art, the idea that sequencing something already known to exist, such as a naturally occurring antibody (which is a product of nature and thus a judicial exception) does not miraculously transform the thing known to exist (i.e. the anti-CFH patient autoantibodies) into something distinct from the starting product. Such logic also applies to functional properties like epitopes bound. If the sequence/structure is the same, it must do the same things even if no one appreciated what those thing were until applicant characterized the natural product further to identify such properties. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above they simply disclose functional activities present, and such properties are inherently present in the naturally occurring autoantibody products as the amino acid sequences of said natural products are 100% identical to the pairs of SEQ ID numbers presently recited. Amending the independent claim to require some structural element that isn’t present in the natural antibodies, for example making the claimed antibodies all be scFv, a non-naturally occurring antibody format in contrast to the recited “human antibody” which is also recited in instant claim 17, would be one way to differentiate the instant claimed products from those that naturally occur in the patients used by applicant in the working examples of the instant specification. Other amendments are undoubtably possible to structurally distinguish that which is claimed from that which is naturally occurring.
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 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,865,238. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate that which is presently claimed.
It should be noted that the application giving rise to the ‘238 patent is the grandparent of the instant application, related via a series of continuations, and no terminal disclaimer is present in the instant application. As such all SEQ ID numbers and their representative sequences are identical when comparing the instant and issued claims. The issued claims recite antibodies that comprise the VH of SEQ ID NO:7 and the VL of SEQ ID NO:47, as well as antibodies which comprise the VH of SEQ ID NO:9 and the VL of SEQ ID NO:49 (see all issued claims, most particularly issued claim 4). The issued antibodies are further recited as being present in a variety of well-known physical forms including humanized, scFv, and Fab (see most particularly issued claim 6) and as comprising a wide assortment of human constant domains including IgM and IgG1 (see particularly issued claim 7). Pharmaceutical compositions comprising such antibodies are also claimed (see particularly issued claim 8). The issued claims also indicate the epitope bound by the claimed antibodies (compare issued claim 2 to instant claim 14, and issued claim 3 to instant claim 15) and that the claimed antibodies do not cross-react with other recited autoantigens (compare issued claim 5 to instant claim 16). In view of all of the above, the issued claims anticipate that which is presently claimed.
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
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