DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 7/15/25 has been entered in full. Claims 1, 23, 31, 37-39 and 49 are amended. Claims 1, 9-10, 17, 23, 31, 34-35, 37-39 and 44-50 are pending.
Election/Restrictions
For the record, it is clarified that in the restriction requirement mailed on 3/17/25, claim 23 was inadvertently listed as claim 27.
Applicants' election without traverse of Group I, claims 1, 9, and in the alternative, claims 23, 31, 34-35, 37-39 and 49-50, drawn to an isolated antibody that binds a conformational epitope of AS-SPIK that comprises residues L14, L15, S16, L17, D24, S25, C58, V59, L60, C61 and F62, in the reply filed on 7/15/25 is acknowledged.
Claims 10, 17 and 44-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The election of “hepatocellular carcinoma” as the species of disorder in the reply filed on 7/31/25 is also acknowledged. Claim(s) 37-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1, 9, 23, 31, 34-35 and 49-50 are under consideration, as they read upon the elected invention and the elected species.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because it is directed to epitopes, but the claims are directed to antibodies rather than epitopes, which are a portion of the target that the antibody binds to. A new title is required that is clearly indicative of the invention to which the claims are directed. The following possibilities are suggested: “Anti-Serine Protease Inhibitor Kazal (SPIK) Antibodies” or “Antibodies That Bind Epitopes of Serine Protease Inhibitor Kazal (SPIK)”.
---The disclosure is objected to because it contains two embedded hyperlinks (browser-executable code) in ¶ 187 and page 41. Applicant is required to remove the embedded hyperlink; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01 (VII).
---The following Figures include amino acid sequences that are covered by the sequence rules but are not accompanied by the required SEQ ID NO either in Brief Description of the Drawings in the specification or in the Figure itself: Figures 2 (two sequences), 3 (two sequences), 6 (four sequences), 8 (14 sequences) and 14 (26 sequences).
Appropriate correction is required.
Drawings
Corrected drawings in compliance with 37 CFR 1.121(d) are required because:
---In Fig 2, the text “Edman N-terminal analysis of AS-SPIK” appears twice.
---Figures 8, 12, 13, 14, each contain a paragraph of descriptive text below the figure that should be moved to the Brief Description of the Figure in the specification.
---Figures 15 and 16 do not comply with 37 C.F.R. 1.84(U)(1), which states that partial views of a drawing which are intended to form one complete view, whether contained on one or several sheets, must be identified by the same number followed by a capital letter. Figure 15, for example, is presented on two separate sheets, labeled "FIG. 15" and "FIG. 15 (cont)". These two sheets should be renumbered "FIG. 15A" and "FIG. 15B". Figure 16 should be corrected in the same manner. Furthermore, once the drawings are changed to meet the separate numbering requirement of 37 C.F.R. 1.84(U)(1), references to the figures in the Brief Description of the Drawings and the rest of the specification should be updated accordingly.
Applicants are advised to employ the services of a competent patent draftsperson outside the Office, as the USPTO no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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).
Claim Objections
Claims 1, 9, 23, 31, 34-35 and 49-50 are objected to because of the following informalities:
In claim 1, the acronyms “AS-SPIK” and NS-SPIK” should be accompanied by the full terminology the first time they are used in a series of claims; e.g., “AS-SPIK (Abnormal Secreted Serine Protease Inhibitor Kazal)” and “NS-SPIK (Normal Secreted Serine Protease Inhibitor Kazal)”.
Claims 23, 31, 34-35 and 49-50 are each objected to for encompassing the subject matter of a non-elected invention, Group II of the restriction requirement mailed on 3/17/25, which is directed to a different product from that of Group I.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), written description
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, 9, 23, 31, 34-35 and 49-50 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a), it is necessary to understand what Applicants are claiming and what Applicants have possession of.
Independent claim 1 is a product claim directed to an isolated antibody that specifically binds to a conformational epitope of an AS-SPIK protein (SEQ ID NO: 2) and does not specifically bind to a NS-SPIK protein (SEQ ID NO: 4), wherein the conformational epitope of the AS-SPIK protein comprises amino acids L14, L15, S16, L17, D24, S25, C58, V59, L60, C61 and F62 of SEQ ID NO: 2. Dependent claim 9 limits the antibody to one comprising complementarity-determining regions (CDRs) having specific consensus amino acids. Dependent claim 23 limits the antibody to a monoclonal antibody. Claims 31 and 34-35 are directed to a method of treatment using the antibody, wherein the treatment is for a disorder characterized by expression of AS-SPIK; the elected species of which under consideration is hepatocellular carcinoma. Claims 49 and 50 are directed to a kit comprising the antibody.
The specification teaches that the protein SPIK, or Serine Protease Inhibitor Kazal, also known as SPINK1, is a “small secreted protein of 79 amino acids” that functions in the pancreas as “an inhibitor of the autoactivation of trypsinogen”, a protease (¶ 5 on page 2). The specification teaches that “[r]ecent studies have suggested that expression of SPIK is elevated in liver cancer such as hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), but has limited or no activity in normal tissues including liver, but outside of pancreas” (¶ 5). The term “AS-SPIK” refers to an “abnormally secreted” version of the protein SPIK. In the normally secreted protein, termed NS-SPIK, the N-terminus is removed, resulting in a protein sequence of 56 amino acids (SEQ ID NO: 4); AS-SPIK instead consists of the full 79 amino acids (SEQ ID NO: 2). The antibodies of the invention bind to AS-SPIK but not NS-SPIK, allowing for targeting of AS-SPIK in treatment or diagnostics. In AS-SPIK, “[r]retaining the additional 23 amino acids in its N-terminus significantly alters the conformation of AS-SPIK relative to NS-SPIK” (¶ 112 on page 20).
The prior art recognizes that antibodies bind to epitopes of 5-7 amino acids (Benjamini et al, 1991. Immunology: A Short Course, 2nd edition, page 40 only). The AS-SPIK protein of SEQ ID NO: 4 consists of 79 amino acids, and thus comprises a multitude of combinations of five amino acids that can serve as confirmational epitopes. The claims are limited to epitopes of AS-SPIK that comprise 11 of the 79 amino acids: L14, L15, S16, L17, D24, S25, C58, V59, L60, C61 and F62. However, the claim does not require that an encompassed antibody bind to all of the 11 amino acids, only that the conformational epitope comprises these 11 amino acids and that the antibody binds to the epitope; as such, the claim broadly encompasses antibodies that bind to less than all eleven amino acids of the epitope; e.g., antibodies that bind to only one amino acid of the conformational epitope.
While the general structure of an antibody was well-known in the prior art, it is the structure of the six complementarity-determining regions (CDRs) that determines the specificity of a particular antibody, and the structure of the set of CDRs is not predictable based on the epitope to which it binds. Thus, even knowing the structure (CDRs) of one antibody does not allow the skilled artisan to predict the structure of other antibodies that bind to the same epitope or to the other epitopes in the same protein. The relevant art, Ferrara et al (2015. mAbs. 7(1): 32-41) teaches that there is substantial variation in the structure of antibodies that bind to a single protein, on the order of hundreds of different sequences; specifically, see page 36: "The number of different HCDR3s selected against the test antigens ranges from 74 to 460 (Table 3), with the actual number of different antibodies likely to be significantly higher when different VL chains and additional VH mutations are taken into account” (pg 36). Thus, there are at least hundreds of different antibody structures that bind to an AS-SPIK protein of 79 amino acids. While the number of antibodies that bind to AS-SPIK but not NS-SPIK at one of the required amino acids will be much lower, the possible variation indicates that the pool of antibodies from which these will be selected is very large, and that the CDRs of the different antibodies will vary greatly from each other.
Therefore, with respected to the elected invention, the claims are genus claims because they encompass use of a genus of antibodies with differing CDRs that have the required functional characteristics. The decision of the Federal Circuit in Amgen v. Sanofi, 872 F.3d 1367 (Fed. Circ. 2017) held that a claim directed to an antibody requires written description of the antibody itself rather than being satisfied solely by a written description of the antigen to which it binds (the so-called "newly characterized antigen" test). Thus, a description of the target protein (e.g., AS-SPIK of SEQ ID NO: 2 or a conformational epitope of such) itself is not sufficient to provide a written description of the genus of antibodies binding to said target protein.
Furthermore, a genus of antibodies defined by function, e.g., binding to AS-SPIK and not to NS-SPIK, is not sufficient to describe the genus because such a definition only indicates what the antibody does, rather than what it is; i.e., the specific structure of the antibody. It is only a definition of a useful result rather than a definition of what achieves that result. Per MPEP 2124, "describing a composition by its function alone typically will not suffice to sufficiently describe the composition".
To describe the claimed genus, the specification provides four representative examples of monoclonal antibodies, which are termed A1, B10, CA22 and CA18. The six CDRs of each antibody are fully disclosed (Figure 9), and because the CDRs of the antibodies provide the functionality, the disclosure of each set of CDRs is sufficient to provide a written description for each of these antibodies in and of itself. However, these limited examples are not sufficient to described the genus of antibodies that bind to AS-SPIK at one or more amino acids of the required conformational epitope but not to NS-SPIK, because the four examples are not representative of the full scope of what is encompassed. Per MPEP 2163, "A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
The specification further provides a comparison of each CDR from of each of the antibodies, and identifies “consensus” amino acids that are present in each, which are recited in dependent claim 9. However, the CDRs have a great deal of variation among them, and the resulting “consensus” CDRs are very limited in description, and none corresponds to a full CDR sequence. Instead, the consensus amino acids are limited to 1 amino acid for CDRH1, 5 amino acids for CDRH2, 2 amino acids for CDRH3, 2 amino acids for CDRL1, 4 amino acids for CDRL2, and 4 amino acids for CDRL3. These limited “consensus” amino acids are not sufficient to describe additional full CDRs that will bind as required to the conformational epitope of AS-SPIK, particularly when used in combination with five other CDRs. For example, the “consensus” HCDR3 consists of two amino acids, G4 and Y7, and the HCDR3 from antibodies A1, B10, CA22 and C18 vary from between 7 and 14 amino acids, which means that the claims encompass other HCDR3s that have any amino acid at positions 1-3, 5, 6, and potentially up to amino acid 14. However, the specification does not demonstrate that other sequences having G4 and Y7 for HCDR3 can still bind to AS-SPIK when placed in combination with other CDRs, and therefore the skilled artisan would instead to make these additional CDRs and test them for functionality to determine whether they are encompassed by the claims. Thus, in the instant case, the specification does not establish a correlation between structure and function, which means the structures of the various anti-AS-SPIK antibodies that bind to the conformational epitope is not predictable based on the disclosed function alone.
MPEP 2163 provides guidance for complying with the written description requirement of 35 U.S.C. 112(a) 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, 1355 (Fed. Cir. 2010)). Written description for a claimed genus may be satisfied through sufficient description of a relevant number of species. This is dependent on whether one of skill in the art would recognize necessary common attributes or features possessed by the members of the genus. Generally, in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Written description for a claimed genus can also be satisfied when relevant identifying characteristics are disclosed. Per MPEP 2163, “[d]etermine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function.” However, claiming by function does not necessarily satisfy the written description requirement. “[A] generic statement such as "vertebrate insulin cDNA" or "mammalian insulin cDNA," without more, is not an adequate written description of the genus because it does not distinguish the claimed genus from others, except by function. It does not specifically define any of the genes that fall within its definition. It does not define any structural features commonly possessed by members of the genus that distinguish them from others … A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. It is only a definition of a useful result rather than a definition of what achieves that result” (Regents of the University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)). Also, “[w]hen a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)), and “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69).
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (pg 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (pg 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of anti-AS-SPIK antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483 (BPAI 1993). In Fiddes, claims directed to mammalian FGFs were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, with respect to the elected invention under consideration, only
(1) an isolated antibody that specifically binds to a conformational epitope of an AS-SPIK protein (SEQ ID NO: 2) and does not specifically bind to a NS-SPIK protein (SEQ ID NO: 4), wherein the conformational epitope of the AS-SPIK protein comprises amino acids L14, L15, S16, L17, D24, S25, C58, V59, L60, C61 and F62 of SEQ ID NO: 2, and wherein the antibody comprises (a) CDRH1-3 of SEQ ID NO: 19, 23 and 27 and CDRL1-3 of SEQ ID NO: 31, 35 and 39; (b) CDRH1-3 of SEQ ID NO: 20, 24 and 28 and CDRL1-3 of SEQ ID NO: 32, 36 and 40; (c) CDRH1-3 of SEQ ID NO: 21, 25 and 29 and CDRL1-3 of SEQ ID NO: 33, 37 and 41; or (d) CDRH1-3 of SEQ ID NO: 22, 26 and 30 and CDRL1-3 of SEQ ID NO: 34, 38 and 42;
(2) a kit comprising an antibody of (1); and
(3) a method for the treatment of a disorder characterized by expression of AS-SPIK, comprising administering to a subject with said disorder an antibody of (1),
but not the full breadth of the claims meets the written description provision of 35 U.S.C. §112(a). Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (pg 1115).
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 23, 31, 34-35 and 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 17 and 18 of U.S. Patent No. 12,377,162, issued 8/5/25, and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claim 1 encompasses an isolated antibody that specifically binds to a conformational epitope of an AS-SPIK protein (SEQ ID NO: 2) and does not specifically bind to a NS-SPIK protein (SEQ ID NO: 4), wherein the conformational epitope of the AS-SPIK protein comprises amino acids L14, L15, S16, L17, D24, S25, C58, V59, L60, C61 and F62 of SEQ ID NO: 2. The specification provides antibody A1 having CDRH1-3 of SEQ ID NO: 19, 23 and 27 and CDRL1-3 of SEQ ID NO: 31, 35 and 39 as an example of such an antibody; see Figure 15.
Claim 1 of ‘162 encompasses, in the alternative, an antibody that specifically binds to AS-SPIK and does not bind to NS-SPIK comprising CDRH1-3 of SEQ ID NO: 21, 31 and 41, and CDRL1-3 of SEQ ID NO: 51, 61, 71. These CDR sequences are identical to the CDR sequences of the A1 antibody of the instant application. Thus, claim 1 of ‘162, in the alternative is directed to an embodiment that is encompassed by instant claim 1, and therefore anticipates instant claim 1.
Instant claims 23, 49 and 50 depend from claim 1 and each further limit the antibody to embodiments that correspond to the further limitations of the antibody or method of the dependent claims of ‘162 in the following manner:
Instant Claim
Claim of ‘162
23
8
49
17
50
18
Instant claim 31 encompasses a method of treatment of a disorder characterized by expression of AS-SPIK, comprising administering to a subject with said disorder an antibody of claim 1. Claims 34 and 35 encompass a method of claim 31 wherein the disorder is a liver disorder (claim 34) that is hepatocellular carcinoma (claim 35). While the claims of ‘162 do not include claims expressly directed to a method of treatment, per MPEP 804.II.B.2, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
The disclosure of the ‘162 patent teaches that one utility for the anti-AS-SPIK antibodies of the invention is for treatment of hepatocellular carcinoma. See ¶ 25. As such, instant claims 31, 35 and 35 are also not patentably distinct from the claims of ‘162.
Claims 1, 23, 31, 34-35 and 49-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11 and 12 of U.S. Patent No. 12,180,301, issued 12/31/24, and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claim 1 encompasses an isolated antibody that specifically binds to a conformational epitope of an AS-SPIK protein (SEQ ID NO: 2) and does not specifically bind to a NS-SPIK protein (SEQ ID NO: 4), wherein the conformational epitope of the AS-SPIK protein comprises amino acids L14, L15, S16, L17, D24, S25, C58, V59, L60, C61 and F62 of SEQ ID NO: 2. The specification provides antibody CA18 having CDRH1-3 of SEQ ID NO: 15, 19 and 23, and CDRL1-3 of SEQ ID NO: 27, 31 and 35 as an example of such an antibody; see Figure 15.
Claim 1 of ‘301 encompasses an antibody that specifically binds to AS-SPIK and does not bind to NS-SPIK, and in embodiment (a), comprises CDRH1-3 of SEQ ID NO: 15, 19 and 23, and CDRL1-3 of SEQ ID NO: 27, 31 and 35. The disclosure indicates that these CDRs are from an antibody termed “CA18” (Figure 19). These CDR sequences are identical to the CDR sequences of the CA18 antibody of the instant application, which are shown in Figure 9. Thus, claim 1 of ‘301, in the alternative, is directed to an embodiment that is encompassed by instant claim 1, and therefore anticipates instant claim 1.
Instant claims 23, 49 and 50 depend from claim 1 and each further limit the antibody to embodiments that correspond to the further limitations of the antibody or method of the dependent claims of ‘301 in the following manner:
Instant Claim
Claim of ‘301
23
8
49
11
50
12
Instant claim 31 encompasses a method of treatment of a disorder characterized by expression of AS-SPIK, comprising administering to a subject with said disorder an antibody of claim 1. Claims 34 and 35 encompass a method of claim 31 wherein the disorder is a liver disorder (claim 34) that is hepatocellular carcinoma (claim 35). While the claims of ‘162 do not include claims expressly directed to a method of treatment, per MPEP 804.II.B.2, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
The disclosure of the ‘301 patent teaches that one utility for the anti-AS-SPIK antibodies of the invention is for treatment of hepatocellular carcinoma; e.g., col 4, lines 38-48. Thus, instant claims 31, 34 and 35 are directed to a disclosed utility for the antibody of the claims of ‘301, and thus these instant claims are also not patentably distinct from the claims of ‘301.
Claims 1, 23, 31, 34-35 and 49-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of copending application 18/953,861, filed 11/20/24, and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The ‘861 application claims priority as a continuation from application 16/978,634, from which the ‘301 patent cited above issued.
Instant claim 1 encompasses an isolated antibody that specifically binds to a conformational epitope of an AS-SPIK protein (SEQ ID NO: 2) and does not specifically bind to a NS-SPIK protein (SEQ ID NO: 4), wherein the conformational epitope of the AS-SPIK protein comprises amino acids L14, L15, S16, L17, D24, S25, C58, V59, L60, C61 and F62 of SEQ ID NO: 2. The specification provides antibody CA18 having CDRH1-3 of SEQ ID NO: 15, 19 and 23, and CDRL1-3 of SEQ ID NO: 27, 31 and 35 as an example of such an antibody; see Figure 15.
Dependent claim 5 of ‘861 encompasses an antibody that specifically binds to AS-SPIK and does not bind to NS-SPIK, and in embodiment (a), comprises CDRH1-3 of SEQ ID NO: 15, 19 and 23, and CDRL1-3 of SEQ ID NO: 27, 31 and 35. The disclosure indicates that these CDRs are from an antibody termed “CA18” (Figure 19). These CDR sequences are identical to the CDR sequences of the CA18 antibody of the instant application, which are shown in Figure 9. Claim 5 of ‘861 depends from claims 1 and 4.
Thus, claims 1, 4, and 5 of ‘861 each encompass an antibody that is also encompassed by instant claim 1, and therefore the two sets of claims are not patentably distinct.
Instant claims 23, 31, 34-35 and 49-50 depend from claim 1 and each further limit the antibody to embodiments that correspond to the further limitations of the antibody or method of the dependent claims of ‘861 in the following manner:
Instant Claim
Claim of ‘861
23
18
31
21
34
24
35
25
49
39
50
40
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674