hdDETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-17, 19, 35-38, and 40 are pending in the instant application.
Claims 1 and 2 are independent.
Applicant’s election without traverse of the invention of group I, drawn to methods of administering ravulizumab to treat HSCT-TMA in the reply filed on December 1, 2025 is acknowledged.
Claim 40 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 1, 2025.
Claims 1-17, 19, and 35-38 are under examination in this office action.
Information Disclosure Statement
The IDS forms received 7/25/2023, 4/30/2025, and 12/1/2025 are acknowledged and the references cited therein have been considered.
Claims 1-17, 19, and 35-38 are allowable.
Applicant has claimed methods of treating human patients having hematopoietic stem cell transplant-associated thrombotic micoangiopathy (HSCT-TMA) by administering an anti-C5 antibody according to a specific protocol. The working examples disclosed in the specification describe administering ravulizumab to such a patient population, and this antibody has the heavy and light chains of SEQ ID NOs:14 and 11 respectively (see claim 5), the VH and VL of SEQ ID NOs:12 and 8 respectively (see claim 3), and the six CDRs of SEQ ID NOs:19, 18, and 3-6 (see independent claims 1 and 2). It should be noted that raviluzimab was known in the prior art (aka ULTOMIRIS/ALXN1210/BNJ441 see for example WO 2019/084438, particularly page 3) as being an engineered sequence variant of eculizumab that has increased serum half-life that can be used for the same clinical indications as eculizumab (see for example Tomazos et al., particularly the abstract, and note there are 4 substitution mutations, 2 in the VH CDRs and 2 in the Fc as evidenced by Ladwig when comparing raviluzimab to parental eculizumab). Notably, administration of eculizumab to successfully treat HSCT-TMA is known in the prior art as evidenced by Jodele et al. (US 10,815,296, see entire document particularly the claims) and thus administering an improved version of a product to treat the same condition is hardly surprising and non-obvious. However, the instant claims are very specific in that they require a particular amount of drug to be administered on days 1, 5, 10, 15, and every four weeks thereafter at doses that vary based upon the mass of the patient as well as the day (for example, a 50 kg patient has an initial dose of 2400 mg on day 1, a dose of 600 mg on days 5 and 10, and then a dose of 3000 mg on day 15 and every 4 weeks thereafter). Such a dosing protocol does not appear to be disclosed in the prior art. Indeed, clinical trial NCT04557735 which appears to correspond to example 1 of the instant specification (children 1 month to 18 yrs old) and was submitted after the filing date of the instant application (note that all current claims are supported by provisional application 63/065,107 filed 8/13/2020) also does not provide the detailed dosing protocol needed to perform the methods as presently claimed, such information being first disclosed in Table 1 on page 46 of the instant specification as originally filed. Similarly, NCT04543591 reasonably corresponds to example 2 of the instant specification (12 years to adult), is post filing, and also fails to disclose sufficient details concerning the timing and doses of drugs to be administered to arrive at that which is presently claimed. Note that the currently claimed dosing protocol for ravulizumab is quite different from that used to treat other conditions, as is readily seen by inspection of the prescribing information for ULTOMIRIS (of record as reference 1 on the 4/30/2025 IDS, see entire document). While the instant specification fails to disclose any data from their clinical trial, based upon the data of Jodele et al. demonstrating efficacy when treating HSCT-TMA with eculizimab, artisans would more than reasonably expect the instant claimed methods to work and indeed post filing data by Schoettler indicates that the claimed methods do in fact work (see entire document). In view of all of the above the instant claimed methods have been found to be allowable.
Claims 1-17, 19, and 35-38 are allowable. Claim 40, previously withdrawn from consideration as a result of a restriction requirement, comprises all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I and II, as set forth in the Office action mailed on October 2, 2025, is hereby withdrawn and claim 40 is hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 40 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrien et al. (US 9,079,949).
Andrien et al. disclose and claim raviluzimab, an antibody that binds C5 and has the CDRs of SEQ ID NOs:19, 18, and 3-6, the VH of SEQ ID NO:12, the VL of SEQ ID NO:11, the heavy chain of SEQ ID NO:14, and the light chain of SEQ ID NO:11 (see entire document, particularly the abstract and claims as well as the enclosed sequence alignments). Notably kits comprising the antibody are explicitly claimed (see issued claim 16 in particular).
It is noted that while the kits of the issued claims are recited as comprising dosing instructions, such instructions cannot reasonably match the dosing information disclosed in the instant specification. However, applicant has claimed a product in claim 40, not a method of using a product (such as is reasonably presented in instant claims 1 and 2) and a product is limited by what it actually is, i.e. its structure. As set forth in MPEP 2112.01, the courts have long ruled that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). More specifically, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself. Cancelation of the claim is very strongly recommended.
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 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,079,949. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is anticipated by the issued claims.
Specifically, the issued claims recite antibodies that bind C5 and kits comprising such antibodies. The issued antibodies are defined by SEQ ID number at the level of CDRs, VH/VL pair, and HC/LC pair, all of which are the same as the biological sequences recited in the instant claims. Importantly, while instant claim 40 recites the CDRs relative to fully defined VH and VL, the underlying biological sequences are the same whether recited as individual SEQ ID numbers as was done in issued claim 1 or by reference to longer VH and VL in which such CDR are embedded as applicant has done in instant claim 40. The issued independent claim is further limited as having specific Fc mutations whereas the antibody of the instant claimed ”kit” does not necessarily have any Fc whatsoever, and thus the issued “kit” claim is narrower in scope than that which is presently claimed. With regard to the printed instructions, a) the issued “kit” is recited as comprising printed instructions (albeit likely of different wording) and b) as set forth in MPEP 2112.01, the courts have long ruled that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). To put it another way, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,371,377. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is anticipated by the issued claims.
Specifically, the issued claims recite antibodies that bind C5 and kits comprising such antibodies. The issued antibodies are defined by SEQ ID number at the level of CDRs, VH/VL pair, and HC/LC pair, all of which are the same as the biological sequences recited in the instant claims. Importantly, while instant claim 40 recites the CDRs relative to fully defined VH and VL, the underlying biological sequences are the same whether recited as individual SEQ ID numbers as was done in issued claim 1 or by reference to longer VH and VL in which such CDR are embedded as applicant has done in instant claim 40. The issued independent claim 12 (from which the “kit” claim depends) is further limited as having a half life in serum of 25 days whereas the antibody of the instant claimed ”kit” does not necessarily have any Fc whatsoever (and note a Fab generally has a half life of less than 1 day), and thus the issued “kit” claim is narrower in scope than that which is presently claimed. With regard to the printed instructions, a) the issued “kit” is recited as comprising printed instructions (albeit likely of different wording) and b) as set forth in MPEP 2112.01, the courts have long ruled that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). To put it another way, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,663,574. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention is anticipated by the issued claims.
Specifically, the issued claims recite antibodies that bind C5 and kits comprising such antibodies. The issued antibodies are defined by SEQ ID number at the level of CDRs, VH/VL pair, and HC/LC pair, all of which are the same as the biological sequences recited in the instant claims. Importantly, while instant claim 40 recites the CDRs relative to fully defined VH and VL, the underlying biological sequences are the same whether recited as individual SEQ ID numbers as was done in issued claim 1 or by reference to longer VH and VL in which such CDR are embedded as applicant has done in instant claim 40. The issued independent claim 1 (from which the “kit” claim depends) is further limited as having a half life in serum of 40 days whereas the antibody of the instant claimed ”kit” does not necessarily have any Fc whatsoever (and note a Fab generally has a half life of less than 1 day), and thus the issued “kit” claim is narrower in scope than that which is presently claimed. With regard to the printed instructions, a) the issued “kit” is recited as comprising printed instructions (albeit likely of different wording) and b) as set forth in MPEP 2112.01, the courts have long ruled that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). To put it another way, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 9,206,251 in view of Andrien et al. (US 9,079,949).
The issued claims recite nucleic acids encoding anti-C5 antibodies, vectors, host cells and methods of producing antibodies using such nucleic acids and host cells. Notably the polypeptide sequences encoded by the claimed nucleic acids match those of the instant claimed antibodies (i.e. ravulizumab, see enclosed alignments). Such inventions differ from what is presently claimed in that the issued claims do not claim the antibodies per se, nor do they recite kits comprising such antibodies.
Andrien et al. disclose and claim raviluzimab, an antibody that binds C5 and has the CDRs of SEQ ID NOs:19, 18, and 3-6, the VH of SEQ ID NO:12, the VL of SEQ ID NO:11, the heavy chain of SEQ ID NO:14, and the light chain of SEQ ID NO:11, as well as methods of administering such antibodies to treat various human diseases (see entire document, particularly the abstract and claims as well as the enclosed sequence alignments). Notably kits comprising the antibody are explicitly claimed (see issued claim 16 in particular).
Therefore, it would have been obvious to artisans at the time of the invention that the antibodies made by the method claims of the ‘251 patent could be placed into kits such as those disclosed by Andrien et al. Artisans would be motivated to do this so that the antibodies made by the methods of the ‘251 patent could be more readily administered to patients as per the therapeutic administration methods also disclosed by Andrien et al. Additionally, as set forth in MPEP 2112.01, the courts have long ruled that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product and thus questions concerning the dosing protocol disclosed in the instant application relative to that of Andrien et al. are immaterial to the patentability of the antibody kit product itself which is simply a kit comprising raviluzimab and a piece of paper.
Further, it is worth pointing out that the application which gave rise to the ‘251 patent does not appear as a priority document in the most recent filing receipt mailed 03/22/2024. As applicant is undoubtedly aware, recent court decisions, including Pfizer v. Teva and Amgen Inc. v. F. Hoffman-La-Roche Ltd., have made it abundantly clear that “the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Given that the instant application is not a divisional of the application which gave rise to the issued patent, any restriction requirements (or the lack thereof) appearing in unrelated lineages do not serve to shield the instant application. Therefore the instant rejection has been set forth.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,459,992 in view of Andrien et al. (US 9,079,949).
The issued claims recite methods of treating myasthenia gravis in a patient by administering an anti-C5 antibody having a heavy chain of SEQ ID NO:14, and a light chain of SEQ ID NO:11, and these biological sequences are identical to those disclosed in the instant application (for example compare instant claim 5 and issued claim 1). Indeed, the issued claims explicitly state that the name of the administered antibody is ALXN1210 (BNJ441) which are alternate names for ravulizumab (see issued claims 14 and 15), and note that instant claim 40 is broader in scope than ravulizumab. Such inventions differ from what is presently claimed in that the issued claims are methods of using raviluzimab rather than raviluzimab itself, and the issued claims do not recite the administered raviluzimab comes from a kit.
Andrien et al. disclose and claim raviluzimab, an antibody that binds C5 and has the CDRs of SEQ ID NOs:19, 18, and 3-6, the VH of SEQ ID NO:12, the VL of SEQ ID NO:11, the heavy chain of SEQ ID NO:14, and the light chain of SEQ ID NO:11, as well as methods of administering such antibodies to treat various human diseases (see entire document, particularly the abstract and claims as well as the enclosed sequence alignments). Notably kits comprising the antibody are explicitly claimed (see issued claim 16 in particular).
Therefore, it would have been obvious to artisans at the time of the invention that the antibodies administered by the method claims of the ‘992 patent could be placed into kits such as those disclosed by Andrien et al. Artisans would be motivated to do this so that the antibodies necessarily administered by the methods of the ‘992 patent could be more readily administered to patients by practicing artisans. Additionally, as set forth in MPEP 2112.01 and In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004), printed materials, such as instructions, that do not alter the physical form of the product do not impart patentable distinctiveness. To put it another way, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself. The instant claimed “kit” is simply the prior art antibody raviluzimab and a piece of paper. It should also be exceeding apparent that in order to actual administer an antibody the practitioner must necessarily first be in possession of the antibody product itself.
Further, it is worth pointing out that the application which gave rise to the ‘992 patent does not appear as a priority document in the most recent filing receipt mailed 03/22/2024. As applicant is undoubtedly aware, recent court decisions, including Pfizer v. Teva and Amgen Inc. v. F. Hoffman-La-Roche Ltd., have made it abundantly clear that “the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Given that the instant application is not a divisional of the application which gave rise to the issued patent, any restriction requirements (or the lack thereof) appearing in unrelated lineages do not serve to shield the instant application. Therefore the instant rejection has been set forth.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,227,400 in view of Andrien et al. (US 9,079,949).
The issued claims recite methods of treating atypical hemolytic uremic syndrome in a patient by administering an anti-C5 antibody having a heavy chain of SEQ ID NO:14, and a light chain of SEQ ID NO:11, and these biological sequences are identical to those disclosed in the instant application (for example compare instant claim 5 and issued claim 4). Note that the biological sequences of SEQ ID NOs:11 and 14 are those of ravulizumab/ALXN1210/BNJ441 and as such the full length antibody is more limited than the genus of antibodies defined by CDR sequence as set forth in instant claim 40. Such inventions differ from what is presently claimed in that the issued claims are methods of using raviluzimab rather than raviluzimab itself, and the issued claims do not recite the administered raviluzimab comes from a kit.
Andrien et al. disclose and claim raviluzimab, an antibody that binds C5 and has the CDRs of SEQ ID NOs:19, 18, and 3-6, the VH of SEQ ID NO:12, the VL of SEQ ID NO:11, the heavy chain of SEQ ID NO:14, and the light chain of SEQ ID NO:11, as well as methods of administering such antibodies to treat various human diseases (see entire document, particularly the abstract and claims as well as the enclosed sequence alignments). Notably kits comprising the antibody are explicitly claimed (see issued claim 16 in particular).
Therefore, it would have been obvious to artisans at the time of the invention that the antibodies administered by the method claims of the ‘400 patent could be placed into kits such as those disclosed by Andrien et al. Artisans would be motivated to do this so that the antibodies necessarily administered by the methods of the ‘400 patent could be more readily administered to patients by practicing artisans. Additionally, as set forth in MPEP 2112.01 and In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004), printed materials, such as instructions, that do not alter the physical form of the product do not impart patentable distinctiveness. To put it another way, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself. The instant claimed “kit” is simply the prior art antibody raviluzimab and a piece of paper. It should also be exceeding apparent that in order to actual administer an antibody the practitioner must necessarily first be in possession of the antibody product itself.
Further, it is worth pointing out that the application which gave rise to the ‘400 patent does not appear as a priority document in the most recent filing receipt mailed 03/22/2024. As applicant is undoubtedly aware, recent court decisions, including Pfizer v. Teva and Amgen Inc. v. F. Hoffman-La-Roche Ltd., have made it abundantly clear that “the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Given that the instant application is not a divisional of the application which gave rise to the issued patent, any restriction requirements (or the lack thereof) appearing in unrelated lineages do not serve to shield the instant application. Therefore the instant rejection has been set forth.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,803,007 in view of Andrien et al. (US 9,079,949).
The issued claims recite methods of treating paroxysmal nocturnal hemoglobinuria in a patient by administering an anti-C5 antibody having a heavy chain of SEQ ID NO:14, and a light chain of SEQ ID NO:11, and these biological sequences are identical to those disclosed in the instant application (for example compare instant claim 5 and issued claim 4). Note that the biological sequences of SEQ ID NOs:11 and 14 are those of ravulizumab/ALXN1210/BNJ441 and as such the full length antibody is more limited than the genus of antibodies defined by CDR sequence as set forth in instant claim 40. Such inventions differ from what is presently claimed in that the issued claims are methods of using raviluzimab rather than raviluzimab itself, and the issued claims do not recite the administered raviluzimab comes from a kit.
Andrien et al. disclose and claim raviluzimab, an antibody that binds C5 and has the CDRs of SEQ ID NOs:19, 18, and 3-6, the VH of SEQ ID NO:12, the VL of SEQ ID NO:11, the heavy chain of SEQ ID NO:14, and the light chain of SEQ ID NO:11, as well as methods of administering such antibodies to treat various human diseases (see entire document, particularly the abstract and claims as well as the enclosed sequence alignments). Notably kits comprising the antibody are explicitly claimed (see issued claim 16 in particular).
Therefore, it would have been obvious to artisans at the time of the invention that the antibodies administered by the method claims of the ‘007 patent could be placed into kits such as those disclosed by Andrien et al. Artisans would be motivated to do this so that the antibodies necessarily administered by the methods of the ‘007 patent could be more readily administered to patients by practicing artisans. Additionally, as set forth in MPEP 2112.01 and In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004), printed materials, such as instructions, that do not alter the physical form of the product do not impart patentable distinctiveness. To put it another way, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself. The instant claimed “kit” is simply the prior art antibody raviluzimab and a piece of paper. It should also be exceeding apparent that in order to actual administer an antibody the practitioner must necessarily first be in possession of the antibody product itself.
Further, it is worth pointing out that the application which gave rise to the ‘007 patent does not appear as a priority document in the most recent filing receipt mailed 03/22/2024. As applicant is undoubtedly aware, recent court decisions, including Pfizer v. Teva and Amgen Inc. v. F. Hoffman-La-Roche Ltd., have made it abundantly clear that “the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Given that the instant application is not a divisional of the application which gave rise to the issued patent, any restriction requirements (or the lack thereof) appearing in unrelated lineages do not serve to shield the instant application. Therefore the instant rejection has been set forth.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,107,861 in view of Andrien et al. (US 9,079,949).
The issued claims recite methods of treating C5 mediated complement associated conditions including atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria in a patient by administering an anti-C5 antibody having a heavy chain of SEQ ID NO:14, and a light chain of SEQ ID NO:11, and these biological sequences are identical to those disclosed in the instant application (for example compare instant claim 5 and issued claim 4). Note that the biological sequences of SEQ ID NOs:11 and 14 are those of ravulizumab/ALXN1210/BNJ441 and as such the full length antibody is more limited than the genus of antibodies defined by CDR sequence as set forth in instant claim 40. Such inventions differ from what is presently claimed in that the issued claims are methods of using raviluzimab rather than raviluzimab itself, and the issued claims do not recite the administered raviluzimab comes from a kit.
Andrien et al. disclose and claim raviluzimab, an antibody that binds C5 and has the CDRs of SEQ ID NOs:19, 18, and 3-6, the VH of SEQ ID NO:12, the VL of SEQ ID NO:11, the heavy chain of SEQ ID NO:14, and the light chain of SEQ ID NO:11, as well as methods of administering such antibodies to treat various human diseases (see entire document, particularly the abstract and claims as well as the enclosed sequence alignments). Notably kits comprising the antibody are explicitly claimed (see issued claim 16 in particular).
Therefore, it would have been obvious to artisans at the time of the invention that the antibodies administered by the method claims of the ‘861 patent could be placed into kits such as those disclosed by Andrien et al. Artisans would be motivated to do this so that the antibodies necessarily administered by the methods of the ‘861 patent could be more readily administered to patients by practicing artisans. Additionally, as set forth in MPEP 2112.01 and In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004), printed materials, such as instructions, that do not alter the physical form of the product do not impart patentable distinctiveness. To put it another way, dosing information in no way alters the structure of the antibody product to be anything different than the antibody itself and thus printed instructions for how to use the antibody cannot provide patentable distinctiveness to the antibody product itself. The instant claimed “kit” is simply the prior art antibody raviluzimab and a piece of paper. It should also be exceeding apparent that in order to actual administer an antibody the practitioner must necessarily first be in possession of the antibody product itself.
Further, it is worth pointing out that the application which gave rise to the ‘861 patent does not appear as a priority document in the most recent filing receipt mailed 03/22/2024. As applicant is undoubtedly aware, recent court decisions, including Pfizer v. Teva and Amgen Inc. v. F. Hoffman-La-Roche Ltd., have made it abundantly clear that “the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Given that the instant application is not a divisional of the application which gave rise to the issued patent, any restriction requirements (or the lack thereof) appearing in unrelated lineages do not serve to shield the instant application. Therefore the instant rejection has been set forth.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,434,280 in view of Andrien et al. (US 9,079,949).
The issued claims recite antibody products, including the named antibody BNJ441 (see all issued claims, most particularly claim 17). Note that BNJ441 is an alternate name for ravulizumab/ALXN1210, and antibody which have the full length heavy and light chains of SEQ ID NOs:14 and 11 respectively. Further, a full length antibody is more limited than the genus of antibodies defined by CDR sequence as set forth in instant claim 40. Such inventions differ from what is presently claimed in that the issued claims do not recite that BNJ441/ALXN1210/raviluzimab comes from a kit.
Andrien et al. disclose and claim raviluzimab, an antibody that binds C5 and has the CDRs of SEQ ID NOs:19, 18, and 3-6, the VH of SEQ ID NO:12, the VL of SEQ ID NO:11, the heavy chain of SEQ ID NO:14, and the light chain of SEQ ID NO:11, as well as methods of administering such antibodies to treat various human diseases (see entire document, particularly the abstract and claims as well as the enclosed sequence alignments). Notably kits comprising the antibody are explicitly claimed (see issued claim 16 in particular).
Therefore, it would have been obvious to artisans at the time of the invention that the antibodies of the ‘280 patent could be placed into kits such as those disclosed by Andrien et al. Artisans would be motivated to do this so that the antibodies of the ‘280 patent could be more readily administered to patients as per the therapeutic administration methods also disclosed by Andrien et al. Additionally, as set forth in MPEP 2112.01, the courts have long ruled that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product. Therefore, questions concerning the dosing protocol disclosed in the instant application relative to that of Andrien et al. are immaterial to the patentability of the antibody kit product itself which is simply a kit comprising raviluzimab and a piece of paper.
Further, it is worth pointing out that the application which gave rise to the ‘280 patent does not appear as a priority document in the most recent filing receipt mailed 03/22/2024. As applicant is undoubtedly aware, recent court decisions, including Pfizer v. Teva and Amgen Inc. v. F. Hoffman-La-Roche Ltd., have made it abundantly clear that “the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.” Given that the instant application is not a divisional of the application which gave rise to the issued patent, any restriction requirements (or the lack thereof) appearing in unrelated lineages do not serve to shield the instant application. Therefore the instant rejection has been set forth.
Claims 1-17, 19, and 35-38 are allowable. Claim 40 is not allowable.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641