DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application is being examined under the pre-AIA first to invent provisions. Claims 1, 6, 14-19, 21, 23, 25, 27, 29-30, 32-33, 36, 38, 40, 42, 51-52, 73-78, 80-81, 84, 90-94, 98-99, 101-102, 105-111, 127-129, 133-134 and 137 are pending.
Election/Restrictions
Applicants' election without traverse of Invention I, claims 1, 6, 14-19, 21, 23, 25, 27, 29-30, 32-33, 36, 38, 40, 42, 51-52, 73, 80-81, 84, 99, 105-111, and 127-128, in the reply filed on 2/6/26 is acknowledged. Claims 74-78, 90-94, 98, 101-102 129, 133-134 and 137 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 elections without traverse of (1) Ab BNJ383 as the species of antibody that binds human C5a, and (2) acute respiratory distress syndrome (ARDS) as the species of complement-associated disorder, in the reply are also acknowledged. Applicants indicate that claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, 73, 80-81, 84, 99, and 127-128 read on the elected species. Claims 16-17, 19, 21, 23, 25, 27, 29-30, 33, 36, 38 and 105-111 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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, 6, 14-15, 18, 32, 40, 42, 51-52, 73, 80-81, 84, 99, and 127-128 are under consideration, as they read upon the elected species.
Claim Objections
Claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, 73, 80-81, 84, 99, and 127-128 are objected to because of the following informalities:
In claim 1, line 4, the abbreviation “KD” should be accompanied by the full term; e.g., “…dissociation constant (KD)…”; see ¶ 212 of the specification as published.
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, 6, 14-15, 18, 32, 40, 51, 52, 73, 80, 81, 84 and 99 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.
Per MPEP 2163, 35 U.S.C. 112(a) requires, “separate and distinct from the enablement requirement”, that the “specification shall contain a written description of the invention…” (Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010)). 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.
The instant claims are directed to a product; specifically, an isolated antibody or antigen-binding fragment thereof, that binds to free C5a (complement component 5a) polypeptide, wherein the free C5a is a human polypeptide having the amino acid sequence of SEQ ID NO: 1, and wherein the antibody binds to the free C5a in vitro with a dissociation constant (KD) less than 1.25 x 10-9 in the presence of a molar excess of un-cleaved, native human C5. The elected species of antibody under consideration is Ab BNJ383, which comprises an LC of SEQ ID NO: 40 comprising an LCVR of SEQ ID NO: 42 comprising LCDRs1-3 of SEQ ID NO: 20-22; and an HC of SEQ ID NO: 49 comprising an HCVR of SEQ ID NO: 45 comprising HCDRs1-3 of SEQ ID NO: 28, 46 and 47 (per Applicants’ 2/6/26 reply at page 3).
In the independent claim, the product is limited structurally only to an “antibody”, and then is limited further only by functionality, i.e., binding to human C5a with certain conditions. The genus “antibody” encompasses the full range of monoclonal antibodies, which are each limited to a single defined antibody structure binding to a target antigen.
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 human C5a protein is 74 amino acids in length, as disclosed in instant SEQ ID NO: 1. Thus, even considering only continuous epitopes, C5a comprises many different regions of five amino acids that can serve as epitopes (e.g., residues 1-5, 2-6, 3-7, up to residues 69-74). While the general structure of an antibody was well-known in the prior art, it is the structure of the complementarity-determining regions (CDRs) that determines the specificity of a particular antibody, and said CDR structure 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 the C5a protein, and some subset of these will also bind with the specified dissociation constant under the specified conditions; i.e., in the presence of un-cleaved, native human C5.
Thus, the claims are genus claims because they encompass use of a genus of antibodies having the required functionality, i.e., binding to human C5a with the specified affinity under the specified conditions. However, a product defined by function is not in and of itself sufficient to describe the product because it is only an indication of what the product does, rather than what it is; i.e., the specific structure of the product. 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". Furthermore, in the instant case the specification does not establish a correlation between structure and function; i.e., the structure of one anti-C5a antibody does not provide predictability regarding other antibody structures having the same functionality. Furthermore, 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. C5a) is not in and of itself sufficient to provide a description of the genus of antibodies binding to said target.
Written description for a genus may also 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 description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. 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)). “[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).
In support of the genus of inhibitory anti-C5a antibodies, the specification provides a limited number of examples of monoclonal antibody sequences. The specification teaches that “all of the humanized anti-C5a antibodies described herein bind to free C5a with a KD that is less than 1.25 nanomolar” (¶ 17, published application). However, the humanized antibodies shown in Table 2 all share the same two related HCDR3 sequences, SEQ ID NO: 30 (GFYDGYSPMDY) or SEQ ID NO: 47 (SGSYDGYYAMDY). However, a description of two antibody structures, as represented by the primary binding determinant HCDR3, that are defined by amino acid sequences is not representative of a genus of anti-C5a antibodies encompassing hundreds or more members having different structures. 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.")
With respect to claims 15, 18, 32 and 40, these claims are included in the rejection because they contain less than a full assortment of six defined LCDR1-3 and HCDR1-3 that form the antigen-binding site, and thus encompass variants in which one or more of the other CDRs is changed, without limit, and the instant specification does not provide a written description of other sequences that can substitute for the missing CDRs.
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).
Therefore, only an antibody of claim 1 comprising the CDRs of the elected species of antibody (i.e., light chain CDR1-3 of SEQ ID NO: 20-22 and heavy chain CDR1-3 of SEQ ID NO: 28, 46, and 47); or the CDRs of one of the other species of antibody disclosed in the specification having the required functionality defined in claim 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.
(1) Claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, 73, and 127-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,011,852, issued 4/21/15 (cited on an 9/7/22 IDS), 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 claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, and 127-128 are directed to an isolated antibody that binds to a free C5a polypeptide, and each of these claims encompasses the elected species of Ab BNJ383, as indicated in Applicants’ reply filed on 2/6/26. This antibody comprises an LC of SEQ ID NO: 40 comprising an LCVR of SEQ ID NO: 42 comprising LCDRs1-3 of SEQ ID NO: 20-22; and an HC of SEQ ID NO: 49 comprising an HCVR of SEQ ID NO: 45 comprising HCDRs1-3 of SEQ ID NO: 28, 46 and 47.
Claim 1 of ‘852 is also directed to an isolated antibody that binds C5a, and encompasses the same antibody having the same CDRs (SEQ ID NO: 20-22 and 28, 46 and 47), in part (n). Dependent claims 4 and 5 further limit the antibody to one comprising an LCVR selected from a group including SEQ ID NO: 42 (claim 4) or an HCVR selected from a group including SEQ ID NO: 45 (claim 5). Dependent claims 8 and 9 further limit the antibody to one comprising an LC of SEQ ID NO: 40 (claim 4) or an HC of SEQ ID NO: 49 (claim 5). Independent claim 6, in the alternative in part (m), further limits the antibody to one comprising the same LCVR (SEQ ID NO: 42) and HCVR (SEQ ID NO: 45), and claim 14 depends from claim 6 and limits the antibody to one comprising the same LC (SEQ ID NO: 40) and HC (SEQ ID NO: 49). As such, the instant claims are not patentably distinct from the claims of ‘852.
Instant claim 73 is directed to a pharmaceutical composition comprising an antibody of claim 1 and a pharmaceutically acceptable carrier, which corresponds to claim 18 of ‘852, also directed to a pharmaceutical composition comprising an antibody of claim 1 of ‘852 and a pharmaceutically acceptable carrier. As such, instant claim 73 is also not patentably distinct from the claims of ‘852.
(2) Claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, 73, and 127-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,371,378, issued 6/21/16 (cited on an 9/7/22 IDS), 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 claims of the ‘378 patent are also directed to antibodies that encompass the elected species of anti-C5a antibody, Ab BNJ383. Claim 1 of ‘378 is directed to an antibody that binds C5a and comprises the LCVR of SEQ IDNO: 42 and the HCVR of SEQ ID NO: 45, and independent claim 4 encompasses an antibody that binds human C5a and comprises the LC of SEQ ID NO: 40 and the HC of SEQ ID NO: 49. As such, the instant claims are not patentably distinct from the claims of ‘378.
Instant claim 73 is directed to a pharmaceutical composition comprising an antibody of claim 1 and a pharmaceutically acceptable carrier, which corresponds to claim 10 of ‘378, also directed to a pharmaceutical composition comprising an antibody of claim 1 or 4 of ‘378 and a pharmaceutically acceptable carrier. As such, instant claim 73 is also not patentably distinct from the claims of ‘378.
(3) Claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, 73, and 127-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,450,370, issued 10/22/19 (cited on an 9/7/22 IDS), 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 claims of the ‘370 patent are also directed to antibodies that encompass the elected species of anti-C5a antibody, Ab BNJ383. Claim 1 of ‘370 is directed to an antibody that binds C5a and competes for binding with an antibody comprising the LCVR of SEQ IDNO: 42 and the HCVR of SEQ ID NO: 45, which encompasses an antibody comprising said sequences (because such an antibody will inherently compete with itself). As such, the instant claims are not patentably distinct from the claims of ‘370.
Instant claim 73 is directed to a pharmaceutical composition comprising an antibody of claim 1 and a pharmaceutically acceptable carrier, which corresponds to claim 6 of ‘370, also directed to a pharmaceutical composition comprising an antibody of claim 1 or 4 of ‘370 and a pharmaceutically acceptable carrier. As such, instant claim 73 is also not patentably distinct from the claims of ‘370.
(4) Claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, 73, and 127-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 23 of U.S. Patent No. 11,407,821, issued 8/9/22 (cited on an 9/7/22 IDS), 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 claims of the ‘821 patent are also directed to antibodies that encompass the elected species of anti-C5a antibody, Ab BNJ383. Dependent claim 2 of ‘821 is directed to an antibody that binds C5a and comprising the LCVR of SEQ IDNO: 42 or the HCVR of SEQ ID NO: 45, which indicates that independent claim 1 of ‘821 also encompasses such an antibody. As such, the instant claims are not patentably distinct from the claims of ‘821.
Instant claim 73 is directed to a pharmaceutical composition comprising an antibody of claim 1 and a pharmaceutically acceptable carrier, which corresponds to claim 12 of ‘821 also directed to a pharmaceutical composition comprising an antibody of claim 2 of ‘821 and a pharmaceutically acceptable carrier. As such, instant claim 73 is also not patentably distinct from the claims of ‘821.
(5) Claims 1, 6, 14-15, 18, 32, 40, 42, 51-52, and 127-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,963,503, issued 5/8/2018 (cited on an 9/7/22 IDS), 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 claims of the ‘503 patent are directed to a method of producing an antibody that binds C5a, including a final step of recovering the antibody. These antibodies encompass the elected species of anti-C5a antibody, Ab BNJ383. Claim 1 of ‘503 produces an antibody that binds C5a and comprises the LCVR of SEQ ID NO: 42 and the HCVR of SEQ ID NO: 45, and claim 2 of ‘503 produces an antibody that binds C5a and comprises the LC of SEQ ID NO: 40 and the HC of SEQ ID NO: 49. Because the final produced product is the same as that which is claimed in the instant claims, the instant claims are not patentably distinct from the claims of ‘503.
Claims 80-81, 84 and 99 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-20 of U.S. Patent No. 9,011,852, issued 4/21/15; (2) claims 1-10 of U.S. Patent No. 9,371,378, issued 6/21/16; (3) claims 1-6 of U.S. Patent No. 10,450,370, issued 10/22/19; (4) claims 1-12 and 23 of U.S. Patent No. 11,407,821, issued 8/9/22; or (5) claims 1-2 of U.S. Patent No. 9,963,503, issued 5/8/2018 (each reference cited on an 9/7/22 IDS), each of which shares the same applicant and inventors with the instant application, and each further in view of U.S. Patent Application Publication 2012/0225056, published 9/6/12 and claiming priority to 11/10/08.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 80, 81 and 84 each encompass a kit comprising an antibody of claim 1 and a syringe. The term “kit” is broadly interpreted as encompassing any combination of the recited components; i.e., any combination of the antibody and a syringe. As set forth above, each of U.S. Patents (1)-(5) claims an antibody that binds C5a encompassed by the instant claims. The claims of (1)-(5) do not include a combination of this antibody with a syringe. ‘056 teaches a kit comprising an anti-C5a antibody and a syringe for administering the antibody for treatment of a complement-mediated disorder (¶ 242). As such, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to place the antibody of the claims of any of (1)-(5) in a kit also comprising a syringe as taught by ‘056, for the purposes of providing a means of administration of the antibody for treatment of a complement-mediated disorder. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claim 99 encompasses an “article of manufacture” comprising a container comprising a label; and a composition comprising the antibody of claim 1, wherein the label indicates that the composition is to be administered to a human having a complement-associated disorder. MPEP 2111.05 provides guidance for consideration of claim limitations directed to printed matter. As stated therein:
The first step of the printed matter analysis is the determination that the limitation in question is in fact directed toward printed matter. "Our past cases establish a necessary condition for falling into the category of printed matter: a limitation is printed matter only if it claims the content of information." See In re DiStefano, 808 F.3d 845, 848, 117 USPQ2d 1265, 1267 (Fed. Cir. 2015). "[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." Id. at 850, 117 USPQ2d at 1268. If a new and nonobvious functional relationship between the printed matter and the substrate does exist, the examiner should give patentable weight to printed matter. See In re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004); In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 403-04 (Fed. Cir. 1983). The rationale behind the printed matter cases, in which, for example, written instructions are added to a known product, has been extended to method claims in which an instructional limitation is added to a method known in the art. Similar to the inquiry for products with printed matter thereon, in such method cases the relevant inquiry is whether a new and nonobvious functional relationship with the known method exists. See In re DiStefano, 808 F.3d 845, 117 USPQ2d 1265 (Fed. Cir. 2015); In re Kao, 639 F.3d 1057, 1072-73, 98 USPQ2d 1799, 1811-12 (Fed. Cir. 2011); King Pharmaceuticals Inc. v. Eon Labs Inc., 616 F.3d 1267, 1279, 95 USPQ2d 1833, 1842 (Fed. Cir. 2010).
In the instant case, the container with the label is distinguished from a prior art content only by the content of information on the label; specifically, the instructions for the use of the antibody. As such, the label limitation is considered printed matter. Furthermore, this label is not functionally related to the associated physical substrate, because it does not perform any function with respect to the antibody to which it is associated. This is in accord with the following example given in MPEP 2111.05, "For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals". As such, the instructions on the label are owed no patentable weight with respect to the prior art.
As set forth above, each of U.S. Patents (1)-(5) claims an antibody that binds C5a encompassed by the instant claims. The claims of (1)-(5) do not include a combination of this antibody a container with a label. ‘056 teaches an article of manufacture comprising a container with a label comprising an anti-C5a antibody (¶ 242). ‘056 further teaches that the antibody can be administered for treatment of a complement-mediated disorder (¶ 242). As such, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to place the antibody of the claims of any of (1)-(5) in an article of manufacture also comprising a container with a label, for purposes of providing a practitioner with the antibody for purposes of treatment of a complement-mediated disorder. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
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
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