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 .
DETAILED ACTION
Applicant’s election without traverse of Group I, claims 1-10 and 14-20 in the reply filed on October 24, 2025 is acknowledged.
Applicant’s election with traverse of species: 1) the antibody with the specific combination of HCDRs 1-3 as provided in SEQ ID NO: 35 and LCDRs 1-3 as provided in SEQ ID NO: 36; 2) option (b) X1QX2YX3X4X5X6T, wherein X1 is Q, X2 is S, X3 is S, X4 is N, X5 is P, and X6 is R; 3) the specific dual-variable domain antibody of claim 19; in the reply filed on October 24, 2025 is acknowledged.
Applicants traversed the species election requirement on the ground that the species encompassed by the claims can be examined without serious burden on the office. The traversal is not found to be persuasive because the claims encompass an enormous number of species. For example, Table 3 lists 16 antibodies which have 48 HCDRs and LCDRs. Claim 1 also encompasses CDR variants which can have up to 30% of mutations. Given Broadest Reasonable Interpretation, claim 1 would encompasses billions of species. Similarly, claim 14 encompasses thousands of different CDRL3 sequences. To search all the species would be a serious burden on the office. Thus the requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending.
Claims 11-13 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions or species, there being no allowable generic or linking claim.
Claims 1-10 and 14-19 are pending and under consideration.
It is noted that prior art does not teach/suggest an antibody or antigen-binding fragment specifically binds to a CCHFV protein Crimean Congo Hemorrhagic Fever Virus (CCHFV) protein comprising the elected CDRH1-3 and CDRL1-3 combination (the CDR combination of antibody: ADI-36121). The search has extended to other antibodies encompassed by claim 1 with written description support: 15 antibodies listed in Table 3: ADI-36120, ADI-36122, ADI-36125, ADI-36145, ADI-36193, ADI-37801, ADI-37817, ADI-37836, ADI-37842, ADI-37847, ADI-37849, ADI-42437, ADI-42462, ADI-42479, ADI-42623. Prior art does not teach/suggest these antibodies. However, the claims are not limited to these antibodies, but encompass a broad genus of antibodies or antigen-binding fragments thereof which do not have written description support (see 112(a) rejection below).
Priority
It is acknowledged that this application is a continuation-in-part of U.S. Patent Appl. No. 17/308,753 filed May 5, 2021, which claims the benefit of priority to U.S. Provisional Patent Appl. No. 63/021,004 filed May 6, 2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Examiner has established a priority date of May 5, 2021 (US Application No. 17/308,753) for claims 15-20 because the claims as currently constituted recite dual-variable domain antibodies and a review of the provisional application (63/021,004) does not reveal the broadly claimed dual-variable domain antibodies. Applicant is invited to submit evidence pointing to the serial number, page and line where support can be found establishing an earlier priority date.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. §1.56).
Specification
The disclosure is objected to because of the following informalities:
Table 3, on page 67, for light chain variable region of ADI-36125, the Descriptions states: “The CDRL1-3 sequences, shown in the order as they appear in the sequence on the left, are underlined”. However, the sequence on the left has only two CDRL regions underlined.
Table 3, on page 70, the sequence of heavy chain variable region of ADI-37847 is different from SEQ ID NO: 53 in Sequence Listing filed August 5/2025. The sequence of SEQ ID NO: 53 according to the Sequence Listing is shown below:
QVQLVQSGAEVKKPGASVKVSCKASGYSFTGYSMHWVRQAPGQGLEWMGWISPSSGVANYAQKFQGRVTMTTDTSITTAYMELSRLRSDDTAVYYCARDERAEQHFDYWGQGTLVTVSS
The CDRH-3 region in Table 3 has an “E” deletion at position 4 of underlined region.
Appropriate correction is required.
Drawings
The drawings are objected to because the legends of Figs. 16A-I are illegible. 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 Objections
Claims 1, 3-5, 16 and 17 are objected to because of the following informalities: these claims refer to Table 3. MPEP 2173.05(s) state: Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “at least one the CDRH1…”, at line 5, should be “at least one of the CDRH1…”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities:
“c) QQYX1X2WPX3X4T” should be “c) QQYX1X2WPX3X4T (SEQ ID NO: 67)”;
“d) QQX1X2X3WPX4X5T” should be “d) QQX1X2X3WPX4X5T (SEQ ID NO: 65)”;
“e) QX1YGX2SPX3X4T” should be “e) QX1YGX2SPX3X4T (SEQ ID NO: 66)”.
Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “is i) a light chain variable…”, at line 9, should be “i) is a light chain variable…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-10 and 15-19 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.
The term “a clean or low polyreactivity” in claim 1 is a relative term which renders the claim indefinite. The term “clean or low polyreactivity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, Figs 6 and 7 show that different antibodies have different binding profiles (e.g. cross-reactivity), it is unclear what parameters are used to evaluate whether an antibody has “a clean or low polyreactivity”.
Section 2171 of the M.P.E.P. states
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of applicant or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
In the instant case of “a clean or low polyreactivity”, one of skill in the art could find representative examples in the art which have been defined in such terms, however, it is unclear at what point one of skill in the art would be infringing on the claims without limitations as to the metes and bounds of “a clean or low polyreactivity”.
Regarding claim 1, the phrase "(IC50)" renders the claim indefinite because it is unclear if the neutralization potency is limited to being an IC50 value or not.
Claims 2-10 and 15-19 are also rejected because these claims depend on claim 1 directly or indirectly.
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, 7-10 and 14-18 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. This is a WRITTEN DESCRIPTION rejection.
Claim 1 is drawn to an isolated human antibody or an antigen-binding fragment thereof that specifically binds to a Crimean Congo Hemorrhagic Fever Virus (CCHFV) protein, wherein at least one of the CDRH1, a CDRH2, a CDRH3, a CDRL1, a CDRL2, and CDRL3 amino acid sequence of the antibody or the antigen-binding fragment thereof is at least 70% identical to at least one the CDRH1, a CDRH2, a CDRH3, a CDRL1, a CDRL2, and/or a CDRL3 amino acid sequences disclosed in Table 3 of an antibody selected from Antibody Number 1 through Antibody Number 16 as disclosed in Table 3. Given Broadest Reasonable Interpretation (BRI), the claim encompasses a broad genus of antibodies or antigen-binding fragments with any number of CDRs (e.g. 1, 2, 3, 4, 5, or 6) and any combination of the CDRs listed in Table 3. By reciting at least 70% identical to the listed CDRs in Table 3, the claim further encompasses an enormous number of CDR variants. Table 3 of the specification describes 16 antibodies, each of which has complete CDRH1-3 and CDRL1-3 structure. The specification does not disclose any antibody or antigen-binding fragment without complete CDRH1-3 and CDRL1-3 structure as set forth in the Antibody Number 1 through Antibody Number 16, or any antibody or antigen-binding fragment with CDR variants recited by the claim. Thus, the specification lacks written description support for the claimed antibodies or antigen-binding fragments that specifically binds to a CCHFV protein.
MPEP 2163 II A 3(a) states: Disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).
By the time the invention was made, it is well established in the art that the formation of an intact antigen-binding site in an antibody usually required the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three "complementarity determining regions" ("CDRs") which provide the majority of the contact residues for the binding of the antibody to its target epitope. Even a single point mutation in HCDR1 region could lead to antibody lose its binding activity (Ni et al., The Protein Journal, 43, pp. 683-696, July 2024, see Abstract). Thus, one ordinary skill in the art would not be able to visualize other antibody encompassed by the claims, except Antibody Number 1 through Antibody Number 16, which binds to a CCHFV protein.
In the instant case, Table 3 of the specification describes 16 antibodies, each of which has complete CDRH1-3 and CDRL1-3 structure. The specification also discloses that the antibodies can bind to GnGc of CCHFV (Table 2, Fig. 5 and paragraph [0236] of the instant publication US 2023/0000979 A1). However, these antibodies would not tell the structure of other antibodies, variants or antigen-binding fragments thereof encompassed by the claim.
In addition, the claims identify the antibodies by function only, where the function is to:
specifically binds to a CCHFV protein;
cross-competes with said antibody or antigen-binding fragment thereof for binding to CCHFV;
displays a clean or low polyreactivity profile;
displays neutralization activity toward CCHFV in vitro;
displays an in vitro neutralization potency (IC50) of between about 0.5 microgram/milliliter (μg/ml) to about 5 μg/ml;
binds to at least one of Gn, Gc, and a GnGc complex.
The specification has not established the relationship between the claimed functions and the structure of the antibody. One of ordinary skilled in the art would not be able to readily recognize/visualize an antibody or antigen-binding fragments thereof with required functions. Taken together, the specification has not provided sufficient evidence to show that the inventors possess a genus of antibodies or antigen-binding fragments as claimed.
Although Applicants may argue that it is possible to screen for antibodies with claimed properties/functions, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. "As we held in Lilly, "[a]n adequate written description of a DNA ... 'requires a precise definition, such as by structure, formula, chemical name, or physical properties,' not a mere wish or plan for obtaining the claimed chemical invention." 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171 ). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions." Knowledge of screening methods provides no information about the structure of any future antibodies or antibody fragments yet to be discovered that may function as claimed.
Claim 2 also encompasses a broad genus of antibodies or antigen-binding fragments with any number of CDRs (e.g. 1, 2, 3, 4, 5, or 6) and any combination of the CDRs listed in Table 3. In addition, the claim further encompasses an enormous number of CDR variants.
Claims 3 encompasses a broad genus of antibodies or antigen-binding fragments with any number of CDRs (e.g. 1, 2, 3, 4, 5, or 6) and any combination of the CDRs listed in Table 3. As set forth above, the specification does not have written description for a broad genus of antibodies with only partial CDRH1-3 and CDRL1-3 structure.
Claim 4 encompasses antibodies with any combination of heavy chain (HC) and light chain (LC) of Antibody Numbers: 1-16. As set forth above, the specification does not support random combinations of HC and LC. In addition, the specification discloses the heavy chain variable region (VH) and light chain variable region (VL) of Antibody Number 1 through Antibody Number 16 (SEQ ID NOs: 33-64, see Table 3), but not the sequences of complete heavy chain and complete light chain of these antibodies.
Claim 5 recites antibodies at least 80% identical to any one of Antibody Number 1 through Antibody Number 16. Given BRI, the claim encompasses a broad genus antibody variants which may not have the complete CDRH1-3 and CDRL1-3 structure as any one of Antibody Number 1 through Antibody Number 16.
Claims 7-10, 15-18 also encompass a broad genus of antibodies or antigen-binding fragments with any number of CDRs (e.g. 1, 2, 3, 4, 5, or 6) and any combination of the CDRs listed in Table 3. In addition, the claim further encompasses an enormous number of CDR variants.
Claim 14 is drawn to a CCHFV antibody and/or antigen-binding fragment comprising a CCHFV binding domain, CDRL3, wherein the CDRL3 binding domain comprises a consensus motif comprising the sequence: a) X1X2X3X4X5X6X7X8T, wherein X1 is Q or H, X2 is Q or H, X3 is Y or F,X4 is A, G, S, T, E, or D, X5 is T, S, or I, X6 is S or Y, X7 is P, L, or R, and X8 is W, F, R, or Y; b) X1QX2YX3X4X5X6T, wherein X1 is Q or L, X2 is S, T, or Y, X3 is S or T,X4 is N, H, L, I, or V, X5 is S or P, and X6 is L or R; c) QQYX1X2WPX3X4T, wherein X1 is S or N, X2 is D or N, X3 is G, S, P, or T, and X4 is Y or W; d) QQX1X2X3WPX4X5T, wherein X1 is F or Y, X2 is N or G, X3 is H, N, or K, X4 is P or L, and X5 is G, I, or L; or e) QX1YGX2SPX3X4T, wherein Xi is H or Q, X2 is N, T, R, or S, X3 is E, P, or T, and X4 is W or Y”. Thus, this claim encompass a broad genus of antibody and/or antigen-binding fragments defined by a single CDR (CDRL3). As set forth above, the specification does not provide written description support for antibodies with the complete CDRH1-3 and CDRL1-3 combination as any one of the Antibody Number 1 through Antibody Number 16. In addition, claim 14 encompassed more than three thousands of CDRL3 sequences. The specification does not provide evidence that all the CDRL3 sequences encompassed by the claim can be used in a CCHFV antibody.
Taken together, the instant specification has not provided a sufficient description showing the necessary functional characteristics coupled with a known or disclosed correlation between functions and the structure. Thus, the specification is not sufficient to show the applicant was in possession of the genus of antibodies, variants, antibody fragments broadly encompassed for the claimed method.
Double Patenting
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 1, 2, 4-10, and 14 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 2, 4-10, and 14 of copending Application No. 17/308,753 (hereinafter Appl. 753).
It is noted that the instant application is a continuation-in-part of Appl. 753. Thus, the instant application share the same disclosure as Appl. 753, including Sequence Listing.
The claims of Appl. 753 teach:
1. An isolated human antibody or an antigen-binding fragment thereof that specifically binds to a Crimean Congo Hemorrhagic Fever Virus (CCHFV) protein, wherein at least one of the CDRH1, a CDRH2, a CDRH3, a CDRL1, a CDRL2, and CDRL3 amino acid sequence of the antibody or the antigen-binding fragment thereof is at least 70% identical to at least one the CDRH1, a CDRH2, a CDRH3, a CDRL1, a CDRL2, and/or a CDRL3 amino acid sequences disclosed in Table 3 of an antibody selected from Antibody Number 1 through Antibody Number 16 as disclosed in Table 3; and wherein said antibody or the antigen-binding fragment thereof also has one or more of the following characteristics: a) the antibody or antigen-binding fragment thereof cross-competes with said antibody or antigen-binding fragment thereof for binding to CCHFV; b) the antibody or antigen-binding fragment thereof displays a clean or low polyreactivity profile; c) the antibody or antigen-binding fragment thereof displays neutralization activity toward CCHFV in vitro; d) the antibody or antigen-binding fragment thereof displays an in vitro neutralization potency (IC5o) of between about 0.5 microgram/milliliter (pg/ml) to about 5 pg/ml; or e) the antibody or antigen-binding fragment thereof binds to at least one of Gn, Gc, and a GnGc complex. Thus, claim 1 of Appl. 753 is identical to the instant claim 1.
2. The isolated antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof comprises: at least two of characteristics a) through e). Thus, claim 2 of Appl. 753 is identical to the instant claim 2.
4. The isolated antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof comprises: a) a heavy chain (HC) amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3; and b) a light chain (LC) amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3. Thus, claim 4 of Appl. 753 is identical to the instant claim 4.
5. The isolated antibody or antigen-binding fragment thereof of claim 1, wherein the antibody is selected from the group consisting of antibodies that are at least 80% identical to any one of the antibodies designated as Antibody Number 1 through Antibody Number 16 as disclosed in Table 3. Thus, claim 5 of Appl. 753 is identical to the instant claim 5.
6. The isolated antibody or antigen-binding fragment thereof of claim 4, wherein the antibody is selected from the group consisting of the antibodies designated as Antibody Number 1 through Antibody Number 16 as disclosed in Table 3. Thus, claim 6 of Appl. 753 is draw to the same antibodies as the instant claim 6.
7. An isolated nucleic acid sequence encoding an antibody or antigen- binding fragment thereof according to claim 1. Thus, claim 7 of Appl. 753 is identical to the instant claim 7.
8. An expression vector comprising the isolated nucleic acid sequence according to claim 7. Thus, claim 8 of Appl. 753 is identical to the instant claim 8.
9. A host cell transfected with the expression vector according to claim 8. Thus, claim 9 of Appl. 753 is identical to the instant claim 9.
10. A pharmaceutical composition comprising: one or more of the isolated antibodies or antigen-binding fragments thereof according to claim 1 and a pharmaceutically acceptable carrier and/or excipient. Thus, claim 10 of Appl. 753 is identical to the instant claim 10.
14. A CCHFV antibody and/or antigen-binding fragment comprising a CCHFV binding domain, CDRL3, wherein the CDRL3 binding domain comprises a consensus motif comprising the sequence: a) XiX2X3X4X5X6X7X8T, wherein Xi is Q or H, X2 is Q or H, X3 is Y or F, X4 is A, G, S, T, E, or D, X5 is T, S, or I, X6 is S or Y, X7 is P, L, or R, and X8 is W, F, R, or Y;b) X1QX2YX3X4X5X6T, wherein Xi is Q or L, X2 is S, T, or Y, X3 is S or T, X4 is N, H, L, I, or V, X5 is S or P, and X6 is L or R; c) QQYXiX2WPX3X4T (SEQ ID NO: 67), wherein Xi is S or N, X2 is D or N, X3 is G, S, P, or T, and X4 is Y or W; d) QQXIX2X3WPX4XST (SEQ ID NO: 65), wherein Xi is F or Y, X2 is N or G, X3 is H, N, or K, X4 is P or L, and Xs is G, 1, or L; or e) QXIYGX2SPX3X4T (SEQ ID NO: 66), wherein Xi is H or Q, X2 is N, T, R, or S, X3 is E, P, or T, and X4 is W or Y. Thus, claim 14 of Appl. 753 is identical to the instant claim 14.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 17/308,753 (hereinafter Appl. 753).
It is noted that the instant application is a continuation-in-part of Appl. 753. Thus, the instant application share the same disclosure as Appl. 753, including Sequence Listing.
As set forth above, claim 1 of Appl. 753 is identical to the instant claim 1.
Regarding claim 3, although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 3 of Appl. 753 teach that the isolated antibody or antigen-binding fragment thereof of claim 2, wherein the antibody or antigen-binding fragment thereof comprises at least one of: a) the CDRH3 amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3; b) the CDRH2 amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3; c) the CDRH1 amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3; d) the CDRL3 amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3; e) the CDRL2 amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3; or f) the CDRL1 amino acid sequence of any one of the antibodies designated Antibody Number 1 through Antibody Number 16 as disclosed in Table 3.
Claim 2 of Appl. 753 teach that the isolated antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof comprises: at least two of characteristics a) through e).
Taken together, the difference between the instant claim 3 and claim 3 of Appl.753 is that claim 3 of Appl. 753 requires the isolated antibody or antigen-binding fragment comprises at least two of characteristics a) through e), but the instant claim 3 requires at least one of characteristics a) through e). Thus, the antibodies encompassed by claim 3 of Appl. 753 are subset of antibodies encompassed by the instant claim 3. Accordingly, claim 3 of Appl. 753 would anticipate the instant claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of copending Application No. 17/308,753 (hereinafter Appl. 753), as applied to claims 1-10 and 14 above, in view of Asokan (Asokan et al., Journal of Virology, Volume 89, Number 24, 12501-12512, Publication Date: 10/7/2015) and Brinkmann (Brinkmann et al., MABS, 2017, VOL. 9, NO. 2, 182-212, Publication Date: 01/10/2017)
The claims of Appl. 753 teach Antibody Number 1 through Antibody Number 16 of Table 3 which reads the antibodies of instant claim 1, as set forth above. However, the claims of Appl. 753 do not teach dual-variable domain antibodies in a format as defined by claims 15-19.
Asokan teaches the physical combination of two neutralizing antibodies may improve coverage and neutralization potency over the individual parental antibodies (Abstract). Asokan teaches that the ability of bispecific IgGs to recognize either of two neutralization epitopes led to improved neutralization coverage and may have advantages with regard to preventing neutralization escape (page 12510, col. 2, para. 2).
Brinkmann teaches various ways to make bispecific antibody, for example DVD-Ig format (Fig. 2, box 12), in which the first heavy chain variable domain is liner to a second heavy chain variable domain through a linker and the first light chain variable domain is liner to a second light chain variable domain through a linker.
Brinkmann teaches that dual-variable-domain antibody (DVD-Ig) format have been widely used in the field (page 197, col. 2, para. 2).
Brinkmann teaches that the linkers connecting two variable domains within one chain, usually 5 to 13 residues (page 197, col. 2, para. 2).
Brinkmann teaches that in DVD-Ig format, the outer binding site is highly mobile and can fold out of the plane to allow binding of the inner binding site (page 197, col. 2, para. 2).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to modify the antibody taught by the claims of Appl. 753, such as ADI-36121 and ADI-37801, and to make a bispecific antibody by physically linking the antibodies, because Asokan teaches bispecific IgGs to recognize either of two neutralization epitopes led to improved neutralization coverage and may have advantages with regard to preventing neutralization escape, and to use the DVD-Ig format to make the bispecific antibodies, because Brinkmann teaches that the DVD-Ig format have been widely used in the field and maintain binding activity for both antigen-binding domains. Based on the teachings of the claims of Appl. 753 , Asokan and Brinkmann, one of ordinary skill in the art would have had a reasonable expectation that the combination of ADI-36121 and ADI-37801 in a DVD-Ig format would generate a dual-variable domain antibody with improved neutralization coverage and have advantages with regard to preventing neutralization escape. The motivation would have been to develop a more potent antibody for neutralizing CCHFV.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/CHENG LU/ Examiner, Art Unit 1642