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 without traverse of claims 1-6 and 16-17, as well as the species election of SEQ ID NO: 23, in the reply filed on 2/23/2026 is acknowledged.
Claims 9, 12, 14, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2/23/2026.
In view of the prior art search, the species election is withdrawn.
Priority
This application is a 371 of PCT/EP2021/081438 (11/11/2021) which claims priority to EP20207536.2 (11/13/2020) as reflected in the filing receipt issued on 9/19/2023.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 5/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84(u)(1) states “View numbers must be preceded by the abbreviation “FIG.”.
In the current case, the view numbers for Figures 1-5 are preceded by the word “Figure” instead of the abbreviation “FIG.”. View numbers should be updated to recite the abbreviation “FIG.”. Any changes to the drawings should also be reflected in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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.
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 1-5 and 16-17 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding written description, 35 U.S.C. 112(a) and the first paragraph of pre-AlA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention (MPEP § 2163(I)).
MPEP 2163(II)(A)(3)(a)(i and ii) states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., .759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, claim 1 recites a binding protein for complement factor H (CFH) comprising an amino acid sequence with at least 89.5 % sequence identity to the amino acid sequence of SEQ ID NO: 13. There is not sufficient written description support for a protein having a sequence with 89.5% identity and retaining the claimed function of the binding protein. There is no disclosure of which regions of SEQ ID NO: 13 are critical for function and therefore can or cannot be mutated while maintaining protein function. There is written description support for the specific sequences disclosed with 89.5% identity and a binding affinity of less than 1 μM for CFH, i.e. SEQ ID NOs: 7, 9, 10, 14, 15, 16, 17, 18, 19 and 23. However, these sequences are not representative of the entire genus of proteins having sequences that are 89.5% identical to SEQ ID NO: 13, and it is not clear which of the many possible variants would have the claimed activity.
For this reason, claim 1 fails to comply with the written description requirement, as it is not clear that the applicant had possession of the full scope of the invention at the time of filing.
Claims 2-5 and 16-17 are included in the rejection because they depend on a rejected claim and do not clarify the issue.
Claim Rejections - 35 USC § 102
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 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Knick et al., US 2019/0177376 A1.
Regarding claim 1, Knick teaches an immunoglobulin (lg) binding protein with a sequence that is 89.7% identical to instant SEQ ID NO: 13 (see Knick SEQ ID NO: 55 or 28; sequence alignment in OA appendix).
Regarding claims 1 and 2, the limitations “has a binding affinity of less than 1 µM for CFH” or “has a binding affinity of less than 500 nM for CFH” are functional limitations of the claimed protein. Absent any essential unclaimed features, any protein having the same structure as the protein of claim 1 must be capable of performing the claimed function. The structure of the protein as set forth in claim 1 is an amino acid sequence with at least 89.5% identity to SEQ ID NO: 13. As Knick teaches a protein with this structure (SEQ ID NO: 28 or 55), it is considered to have the binding activity to CFH as claimed.
Regarding claims 3 and 4, Knick teaches that the lg binding protein comprises preferably 2, 3, 4, 5, or 6, lg binding domains linked to each other, i.e. a multimer, and that in preferred embodiments, the multimer is a homo-multimer (Knick p. 8 para. 103-105). SEQ ID NO: 28, which is 89.7% identical to instant SEQ ID NO: 13, is a homo-multimer (Knick p. 9 para. 106-108).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Knick in view of Barlow et al., US 2019/0100563 A1.
Knick teaches the binding protein of claim 1 as set forth above. Knick does not teach that the binding protein further comprises at least one non-Ig binding protein or diagnostically active moiety (claims 5, 16, 17).
Regarding claim 5, Barlow teaches recombinant CFH binding proteins, specifically Streptococcus pneumoniae PspC truncation (PspCN) that binds CFH (Barlow p. 1 para. 5). Barlow teaches that PspCN can be fused to non-Ig binding proteins such as an antibody fragment to collagen IV or horseradish peroxidase (Barlow p. 8 para. 132; p. 9 para. 157).
Regarding claims 16 and 17, Barlow teaches that the PspCN can comprise fluorescent tags or may be fused with an enzyme (Barlow p. 9 para. 156-157). Barlow teaches that this modified CFH binding protein can be used in a diagnostic method, i.e., comprises a diagnostically active moiety including fluorescent proteins or enzymes (Barlow p. 9 para. 157).
It would have been obvious for a skilled artisan to modify the binding protein of Knick with a non-Ig binding protein and diagnostically active moiety as taught by Barlow. Both of these references are directed to binding proteins. It would have been obvious to a person having ordinary skill in the art that the binding protein of Knick could be modified with additional diagnostic moieties in a similar manner to that of Barlow.
A person of ordinary skill in the art would have been motivated to make this modification to the binding protein of Knick because the addition of moieties such as fluorescent proteins or enzymes is useful in diagnostic purposes, for example detecting the presence of CFH in a biological sample from a subject, e.g. a sample of blood (Barlow p. 9 para. 157). Thus, it would be considered beneficial to add such a moiety to a protein as taught by Knick to achieve these functions.
A skilled artisan would have had a reasonable expectation of success in making this modification because Barlow successfully teaches adding additional diagnostically active moieties to a CFH binding protein, and therefore a skilled artisan could expect success in doing so with a similar binding protein as taught by Knick.
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 1-5 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 6-7 of copending Application No. 18/036,142 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to binding proteins with the same structure.
Regarding instant claims 1 and 2, claim 17 of ‘142 recites a binding protein with an amino acid sequence having at least 90% identity to SEQ ID NO: 27 or 34. SEQ ID NO: 27 is 91.4% identical to instant SEQ ID NO: 13 and SEQ ID NO: 34 is 90.5% identical to instant SEQ ID NO: 13 (see sequence alignment in OA Appendix). Thus, these proteins have the same structure as the instantly claimed protein of SEQ ID NO: 13. Regarding the functional limitations in claims 1 and 2 directed to binding affinity, it is considered that any protein having the same structure (89.5% sequence identity to SEQ ID NO: 13) is capable of performing this same function.
Regarding instant claims 3-5 and 16-17, the limitations of these dependent claims are recited in claims 1, 3-4, and 6-7 of of copending ‘142.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 6 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.
Claim 6 appears to be allowable over the prior art. Sequence searches of SEQ ID NOs: 7, 9, 10, 14, 15, 16, 17, 18, 19 and 23 did not reveal any sequences comprising any of these SEQ ID NOs. The closest prior art is Knick et al., US 2019/0177376 A1.
SEQ ID NO: 55 as taught by Knick is 91.4% identical to instant SEQ ID NOs: 7, 9, 16, and 18; 92.2% identical to instant SEQ ID NO: 10; 89.7% identical to SEQ ID NOs: 14, 15, and 17; 90.5% identical to SEQ ID NO: 19; and 89.5% identical to SEQ ID NO: 23 (see sequence alignment in OA appendix). Knick does not teach a sequence that is 100% identical to any of these SEQ ID NOs. There is no prior art directed to a binding protein comprising any of the sequences of SEQ ID NOs: 7, 9, 10, 14, 15, 16, 17, 18, 19 and 23.
Conclusion
Claims 1-5 and 16-17 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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