DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response and amendments received November 20, 2025 are acknowledged.
Claims 4, 12, 13, 15, 19-33, and 37-39 have been canceled.
Claim 2 has been amended.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are pending in the instant application.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are under examination in this office action.
Information Disclosure Statement
The IDS form received 11/20/2025 is acknowledged and the references cited therein have been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been rendered moot by applicant’s claim amendments received November 20, 2025.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The rejection of claims 1-3, 5-11, 14, 16-18, and 34-36 under 35 U.S.C. 103 as being unpatentable over Shafner et al (WO 2019/084438, of record) on view of Saad et al. has been withdrawn in view of applicant’s persuasive arguments and further consideration.
Specifically, applicant has argued on two main grounds, first that the teachings of Shafner et al. are not applicable to the instant claimed invention as their working examples specifically excluded pregnancies and second that “The single patient reported by Saad et al. was treated via plasmapheresis and their condition was resolved as shown by elevated platelet counts (i.e. two consecutive days above 150,000 platelets per mm3 (which is the clinical threshold below which thrombocytopenia is diagnosed), stable hemoglobin level and near normal lactate dehydrogenase level leading to discharge 19 days after admission with eculizumab being administered only 27 days after discharge (which is 46 days after patient admission/first observation of clinical signs and symptoms of disorder).” Thus applicant argues the patient was successfully treated by plasmapheresis alone (as evidenced by PE discontinuance), improvement of clinical markers including platelet count and discharge from the hospital) with administration of the anti-C5 antibody eculizumab serving to improve long term outcomes by inhibiting reoccurrence of symptoms (i.e. prophylaxis rather than treatment of an active disorder).
Such arguments have been considered with only one being considered persuasive. Applicant’s first argument that Shafner et al. specifically excluded pregnant women from their clinical trial as evidenced by their working example 3 and thus artisans would not combine such teachings with those treating pregnant women and/or [pregnancy related conditions. Such an argument is not persuasive as pregnant women have long been excluded from clinical trials (see for example the US FDA page for the Division of Pediatric and Maternal Health – Clinical Trial in Pregnant Women), ostensibly due to concerns about risks to the fetus, which actually increases risk as then there is no data upon which to draw when determining how to treat a pregnant woman and thus increasing risk to the fetus as set forth by Tolber (see entire document). Given the unfortunately routine nature of excluding pregnant women from all clinical trials, and the data of Shafner et al. is from a clinical trial, contrary to applicant’s assertions artisans would in no way be dissuaded from combining such teachings with those that actually do treat pregnant women.
With regard to applicant’s second argument concerning the timing of administration by Saad et al., more specifically that it is too late as it occurs after the resolution of clinical symptoms and thus there is no data indicating a reasonable expectation of success in actual treatment, i.e. in a patient actually experiencing clinical signs and symptoms of p-aHUS, such an argument is persuasive.
As such the rejection of record has been withdrawn.
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.
The rejection of claims 1-3, 5-11, 14, 16-18, and 34-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,128,101 in view of Saad et al. has been withdrawn in view of applicant’s persuasive arguments concerning the teachings of Saad et al. as discussed supra.
The rejection of claims 1-3, 5-8, 18, and 34-36 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 Saad et al. has been withdrawn in view of applicant’s persuasive arguments concerning the teachings of Saad et al. as discussed supra.
The rejection of claims 1-3, 5-8, 18, and 34-36 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 Saad et al. has been withdrawn in view of applicant’s persuasive arguments concerning the teachings of Saad et al. as discussed supra.
The rejection of claims 1, 3, 5-8, 18, and 34-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,584,164 in view of Saad et al. has been withdrawn in view of applicant’s persuasive arguments concerning the teachings of Saad et al. as discussed supra.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-19, 27, 31-33, and 37-39 of copending Application No. 18/011,698. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate or render obvious that which is presently claimed.
Specifically, the copending claims recite treating complement-associated conditions in human patients by administering anti-C5 antibodies that have the same biological sequences as those recited in the instant claims (see all copending claims , particularly claims 1 and 12-14). Notably, pregnancy-induced aHUS is explicitly recited as being a complement-associated disorder (see particularly claim 18). The antibodies administered in the copending methods are further recited as comprising the same Fc mutations as those of the instant claims (compare instant claim 2 to copending claim 6) and as being administered at masses or drug and timing intervals that match those of the instant claims (for example compare instant claim 9 to copending claim 5). The copending claims also recite numerous indicia of effective treatment with anti-C5 antibodies that match those of the instant claims (compare instant claim 18 to copending claim 19). The copending claims recite that the anti-C5 antibodies can be administered intravenously and/or subcutaneously (see particularly copending claim 4).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant's arguments filed November 20, 2025 have been fully considered but they are not persuasive. Applicant argues the copending application is later filed and cites MPEP 804(I)(B)(1)(b)(i) for its removal.
This argument is not persuasive as this NSDP rejection is NOT the only ground of rejection remaining in the instant application and thus the guidance of MPEP 804(I)(B)(1)(b)(i) is premature.
The provisional rejection of claims 1-3, 5-11, 14, 16-18, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15, 18, 19, 27-34, 36, and 37 of copending Application No. 18/272,906 in view of Saad et al. has been withdrawn in view of applicant’s persuasive arguments concerning the teachings of Saad et al. as discussed supra.
The provisional rejection of claims 1-3, 5-11, 14, 16-18, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60-79 of copending Application No. 19/014,677 in view of Saad et al. has been withdrawn in view of applicant’s persuasive arguments concerning the teachings of Saad et al. as discussed supra.
Upon further search and consideration, the following new grounds of rejection have been set forth.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Shafner et al (WO 2019/084438, of record) on view of De Sousa Amorim et al.
Shafner et al. disclose that antibodies that bind and neutralize C5 are to be administered to human patients to treat atypical hemolytic Uremic Syndrome (aHUS) as well as other thrombotic microangiopathies (see entire document, particularly the title, abstract, page 3, and claims). They disclose that the anti-C5 antibody named ravulizumab/ULTOMIRIS/ALXN1210/BNJ441 is particularly suitable for administration as part of their disclosed methods as it provides the advantage of binding C5 and preventing the cleavage of C5 into C5a and C5b thus preventing release of the proinflammatory mediator C5a and the formation of the pore-forming membrane attack complex (see for example lines 17-32 of page 3, lines 19-30 of page 20, and the claims). It should be noted that the biological sequences recited in the instant claims are the same sequences present in ravulizumab (see particularly the admission by applicant from line 19 of page 20 to line 7 of page 21 of the instant specification). The administered anti-C5 antibodies are disclosed as having the same binding affinities as those recited in the instant claims (compare lines 11-16 of page 4 as well as claims 10 and 11 to the text of instant claims 6 and 7). Such administered antibodies are further disclosed as comprising Fc mutations including M428L and N434S per EU numbering (see for example pages 3 and 4) and as being administered intravenously (see for example page 33 as well as claim 21). The dosing information, including both mass of drug as well as the timing of administration are the same when comparing the teachings of Shafner to that which is presently claimed (compare claims 1 and 2 to instant claims 9 and 10, and claims 12-14 to instant claim 11). Continued administration out to two years is also taught (compare claim 20 to instant claim 17). Conditions other than aHUS disclosed as amenable to treatment via the methods of Shafner et al. include HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count, a complication of pregnancy), spontaneous fetal loss and recurrent fetal loss (see particularly page 44). These teachings differ from the instant claimed invention in that Shafner et al. disclose treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
De Sousa Amorim et al. disclose treatment of a 41 year old woman suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections). Specifically, the woman was initially treated by plasmapheresis for five days which failed to improve renal function (see particularly the left column of page 642). At that time the woman was started on eculizumab, PE was discontinued, and four days later renal function improved (see particularly the right column of page 642). A renal biopsy confirmed the presence of thrombotic microangiopathy (TMA), with a follow up renal biopsy nine months later showing no signs of TMA prior to discontinuation of eculizumab therapy (ibid). They further report that multiple clinicians have successfully administered eculizumab to treat p-aHUS patients, specifically revert complement activation and induce remission (see particularly the left column of page 645 and Table I).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS disclosed by Shafner et al on p-aHUS patients. This is because Shafner et al. teach their methods are generically useful in treating all forms of aHUS while De Sousa Amorim et al. specifically teach that anti-C5 antibodies revert complement activation and induce remission in p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patient of De Sousa Amorim et al. as well as all of those patients summarized in the data of Table I of De Sousa Amorim. As such the prior art provides guidance, direction, and an expectation of success in selecting p-aHUS as a specific patient subpopulation to be treated within the larger genus of all aHUS as is taught by Shafner et al.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Shafner et al (WO 2019/084438, of record) on view of Huerta et al.
Shafner et al. disclose that antibodies that bind and neutralize C5 are to be administered to human patients to treat atypical hemolytic Uremic Syndrome (aHUS) as well as other thrombotic microangiopathies (see entire document, particularly the title, abstract, page 3, and claims). They disclose that the anti-C5 antibody named ravulizumab/ULTOMIRIS/ALXN1210/BNJ441 is particularly suitable for administration as part of their disclosed methods as it provides the advantage of binding C5 and preventing the cleavage of C5 into C5a and C5b thus preventing release of the proinflammatory mediator C5a and the formation of the pore-forming membrane attack complex (see for example lines 17-32 of page 3, lines 19-30 of page 20, and the claims). It should be noted that the biological sequences recited in the instant claims are the same sequences present in ravulizumab (see particularly the admission by applicant from line 19 of page 20 to line 7 of page 21 of the instant specification). The administered anti-C5 antibodies are disclosed as having the same binding affinities as those recited in the instant claims (compare lines 11-16 of page 4 as well as claims 10 and 11 to the text of instant claims 6 and 7). Such administered antibodies are further disclosed as comprising Fc mutations including M428L and N434S per EU numbering (see for example pages 3 and 4) and as being administered intravenously (see for example page 33 as well as claim 21). The dosing information, including both mass of drug as well as the timing of administration are the same when comparing the teachings of Shafner to that which is presently claimed (compare claims 1 and 2 to instant claims 9 and 10, and claims 12-14 to instant claim 11). Continued administration out to two years is also taught (compare claim 20 to instant claim 17). Conditions other than aHUS disclosed as amenable to treatment via the methods of Shafner et al. include HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count, a complication of pregnancy), spontaneous fetal loss and recurrent fetal loss (see particularly page 44). These teachings differ from the instant claimed invention in that Shafner et al. disclose treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
Huerta disclose treatment of 10 women suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections as well as Table 1). Notably they disclose that plasmapheresis was unsuccessful in the majority of patients in contrast to the excellent responses to eculizumab in all patients thus treated (see particularly the fourth paragraph of the right column of page 456). Indeed, they report that eculizumab treatment was successful with normalization of all hematologic parameters and preservation of renal function in all 10 patients (see particularly the bottom of the right column of page 456 and Figure 2). They report that in 9 of the 10 women treated with eculizumab, the decision to begin eculizumab administration was made because of a lack of clinical response to plasma therapies (see particularly the first paragraph of the section titled “Treatment and evolution” on page 453). Huerta et al. teach that “As a whole, our study illustrates the complete efficacy of eculizumab to treat p-aHUS in 13 p-aHUS patients (2 were treated twice), without any adverse situations reported in any of them.” (see particularly the last sentence of the paragraph bridging pages 456 and 457).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS disclosed by Shafner et al on p-aHUS patients. This is because Shafner et al. teach their methods are generically useful in treating all forms of aHUS while Huerta et al. specifically teach that anti-C5 antibodies had complete efficacy in treating p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patients of Huerta et al. As such the prior art provides guidance, direction, and an expectation of success in selecting p-aHUS as a specific patient subpopulation to be treated within the larger genus of all aHUS as is taught by Shafner et al.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,128,101 in view of De Sousa Amorim et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating atypical hemolytic uremic syndrome at doses that match those recited in the instant claims concerning mass of drug per patient mass as well as timing intervals (see all issued claims, particularly independent claim 1). Such methods are also recited as being performed when the anti-C5 antibodies have the same Fc mutations as recited in the instant claims (see most particularly issued independent claim 2). The issued claims recite various clinical effects of the claimed administration methods, many of which are the same as those presently claimed including terminal complement inhibition (compare issued claim 12 to instant claim 18 for example). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
De Sousa Amorim disclose treatment of a 41 year old woman suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections). Specifically, the woman was initially treated by plasmapheresis for five days which failed to improve renal function (see particularly the left column of page 642). At that time the woman was started on eculizumab, PE was discontinued, and four days later renal function improved (see particularly the right column of page 642). A renal biopsy confirmed the presence of thrombotic microangiopathy (TMA), with a follow up renal biopsy nine months later showing no signs of TMA prior to discontinuation of eculizumab therapy (ibid). They further report that multiple clinicians have successfully administered eculizumab to treat p-aHUS patients, specifically revert complement activation and induce remission (see particularly the left column of page 645 and Table I).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while De Sousa Amorim et al. specifically teach that anti-C5 antibodies revert complement activation and induce remission in p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patient of De Sousa Amorim et al. as well as all of those patients summarized in the data of Table I of De Sousa Amorim.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,128,101 in view of Huerta et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating atypical hemolytic uremic syndrome at doses that match those recited in the instant claims concerning mass of drug per patient mass as well as timing intervals (see all issued claims, particularly independent claim 1). Such methods are also recited as being performed when the anti-C5 antibodies have the same Fc mutations as recited in the instant claims (see most particularly issued independent claim 2). The issued claims recite various clinical effects of the claimed administration methods, many of which are the same as those presently claimed including terminal complement inhibition (compare issued claim 12 to instant claim 18 for example). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
Huerta et al. disclose treatment of 10 women suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections as well as Table 1). Notably they disclose that plasmapheresis was unsuccessful in the majority of patients in contrast to the excellent responses to eculizumab in all patients thus treated (see particularly the fourth paragraph of the right column of page 456). Indeed, they report that eculizumab treatment was successful with normalization of all hematologic parameters and preservation of renal function in all 10 patients (see particularly the bottom of the right column of page 456 and Figure 2). They report that in 9 of the 10 women treated with eculizumab, the decision to begin eculizumab administration was made because of a lack of clinical response to plasma therapies (see particularly the first paragraph of the section titled “Treatment and evolution” on page 453). Huerta et al. teach that “As a whole, our study illustrates the complete efficacy of eculizumab to treat p-aHUS in 13 p-aHUS patients (2 were treated twice), without any adverse situations reported in any of them.” (see particularly the last sentence of the paragraph bridging pages 456 and 457).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while Huerta et al. teach that anti-C5 antibodies had complete efficacy in treating p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patients of Huerta et al.
Claims 1-3, 5-8, 18, and 34-36 are 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 De Sousa Amorim et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating a patient afflicted with a C5 mediated complement condition, with atypical hemolytic uremic syndrome (aHUS) being explicitly recited (see all issued claims, particularly claims 1, 10, 11, 15, 16, and 18). Such methods are also recited as being performed when the anti-C5 antibodies have the same Fc mutations as recited in the instant claims (in particular compare issued claims 1 and 11 to instant claim 2). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
De Sousa Amorim disclose treatment of a 41 year old woman suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections). Specifically, the woman was initially treated by plasmapheresis for five days which failed to improve renal function (see particularly the left column of page 642). At that time the woman was started on eculizumab, PE was discontinued, and four days later renal function improved (see particularly the right column of page 642). A renal biopsy confirmed the presence of thrombotic microangiopathy (TMA), with a follow up renal biopsy nine months later showing no signs of TMA prior to discontinuation of eculizumab therapy (ibid). They further report that multiple clinicians have successfully administered eculizumab to treat p-aHUS patients, specifically revert complement activation and induce remission (see particularly the left column of page 645 and Table I).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while De Sousa Amorim et al. specifically teach that anti-C5 antibodies revert complement activation and induce remission in p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patient of De Sousa Amorim et al. as well as all of those patients summarized in the data of Table I of De Sousa Amorim.
Claims 1-3, 5-8, 18, and 34-36 are 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 Huerta et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating a patient afflicted with a C5 mediated complement condition, with atypical hemolytic uremic syndrome (aHUS) being explicitly recited (see all issued claims, particularly claims 1, 10, 11, 15, 16, and 18). Such methods are also recited as being performed when the anti-C5 antibodies have the same Fc mutations as recited in the instant claims (in particular compare issued claims 1 and 11 to instant claim 2). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
Huerta et al. disclose treatment of 10 women suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections as well as Table 1). Notably they disclose that plasmapheresis was unsuccessful in the majority of patients in contrast to the excellent responses to eculizumab in all patients thus treated (see particularly the fourth paragraph of the right column of page 456). Indeed, they report that eculizumab treatment was successful with normalization of all hematologic parameters and preservation of renal function in all 10 patients (see particularly the bottom of the right column of page 456 and Figure 2). They report that in 9 of the 10 women treated with eculizumab, the decision to begin eculizumab administration was made because of a lack of clinical response to plasma therapies (see particularly the first paragraph of the section titled “Treatment and evolution” on page 453). Huerta et al. teach that “As a whole, our study illustrates the complete efficacy of eculizumab to treat p-aHUS in 13 p-aHUS patients (2 were treated twice), without any adverse situations reported in any of them.” (see particularly the last sentence of the paragraph bridging pages 456 and 457).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while Huerta et al. teach that anti-C5 antibodies had complete efficacy in treating p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patients of Huerta et al.
Claims 1-3, 5-8, 18, and 34-36 are 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 De Sousa Amorim et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating atypical hemolytic uremic syndrome (aHUS) wherein such antibodies also comprise the specific Fc mutations recited in instant claim 2 (see all issued claims, particularly claims 1-4). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
De Sousa Amorim et al. disclose treatment of a 41 year old woman suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections). Specifically, the woman was initially treated by plasmapheresis for five days which failed to improve renal function (see particularly the left column of page 642). At that time the woman was started on eculizumab, PE was discontinued, and four days later renal function improved (see particularly the right column of page 642). A renal biopsy confirmed the presence of thrombotic microangiopathy (TMA), with a follow up renal biopsy nine months later showing no signs of TMA prior to discontinuation of eculizumab therapy (ibid). They further report that multiple clinicians have successfully administered eculizumab to treat p-aHUS patients, specifically revert complement activation and induce remission (see particularly the left column of page 645 and Table I).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while De Sousa Amorim et al. specifically teach that anti-C5 antibodies revert complement activation and induce remission in p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patient of De Sousa Amorim et al. as well as all of those patients summarized in the data of Table I of De Sousa Amorim.
Claims 1-3, 5-8, 18, and 34-36 are 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 Huerta et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating atypical hemolytic uremic syndrome (aHUS) wherein such antibodies also comprise the specific Fc mutations recited in instant claim 2 (see all issued claims, particularly claims 1-4). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
Huerta et al. disclose treatment of 10 women suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections as well as Table 1). Notably they disclose that plasmapheresis was unsuccessful in the majority of patients in contrast to the excellent responses to eculizumab in all patients thus treated (see particularly the fourth paragraph of the right column of page 456). Indeed, they report that eculizumab treatment was successful with normalization of all hematologic parameters and preservation of renal function in all 10 patients (see particularly the bottom of the right column of page 456 and Figure 2). They report that in 9 of the 10 women treated with eculizumab, the decision to begin eculizumab administration was made because of a lack of clinical response to plasma therapies (see particularly the first paragraph of the section titled “Treatment and evolution” on page 453). Huerta et al. teach that “As a whole, our study illustrates the complete efficacy of eculizumab to treat p-aHUS in 13 p-aHUS patients (2 were treated twice), without any adverse situations reported in any of them.” (see particularly the last sentence of the paragraph bridging pages 456 and 457).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while Huerta et al. teach that anti-C5 antibodies had complete efficacy in treating p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patients of Huerta et al.
Claims 1, 3, 5-8, 18, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,584,164 in view of De Sousa Amorim et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating atypical hemolytic uremic syndrome (aHUS) (see all issued claims). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
De Sousa Amorim et al. disclose treatment of a 41 year old woman suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections). Specifically, the woman was initially treated by plasmapheresis for five days which failed to improve renal function (see particularly the left column of page 642). At that time the woman was started on eculizumab, PE was discontinued, and four days later renal function improved (see particularly the right column of page 642). A renal biopsy confirmed the presence of thrombotic microangiopathy (TMA), with a follow up renal biopsy nine months later showing no signs of TMA prior to discontinuation of eculizumab therapy (ibid). They further report that multiple clinicians have successfully administered eculizumab to treat p-aHUS patients, specifically revert complement activation and induce remission (see particularly the left column of page 645 and Table I).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while De Sousa Amorim et al. specifically teach that anti-C5 antibodies revert complement activation and induce remission in p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patient of De Sousa Amorim et al. as well as all of those patients summarized in the data of Table I of De Sousa Amorim.
Claims 1, 3, 5-8, 18, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,584,164 in view of Huerta et al.
The issued claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating atypical hemolytic uremic syndrome (aHUS) (see all issued claims). These teachings differ from the instant claimed invention in that the issued claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
Huerta et al. disclose treatment of 10 women suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections as well as Table 1). Notably they disclose that plasmapheresis was unsuccessful in the majority of patients in contrast to the excellent responses to eculizumab in all patients thus treated (see particularly the fourth paragraph of the right column of page 456). Indeed, they report that eculizumab treatment was successful with normalization of all hematologic parameters and preservation of renal function in all 10 patients (see particularly the bottom of the right column of page 456 and Figure 2). They report that in 9 of the 10 women treated with eculizumab, the decision to begin eculizumab administration was made because of a lack of clinical response to plasma therapies (see particularly the first paragraph of the section titled “Treatment and evolution” on page 453). Huerta et al. teach that “As a whole, our study illustrates the complete efficacy of eculizumab to treat p-aHUS in 13 p-aHUS patients (2 were treated twice), without any adverse situations reported in any of them.” (see particularly the last sentence of the paragraph bridging pages 456 and 457).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the issued claims on p-aHUS patients. This is because the issued claims indicate their methods are generically useful in treating all forms of aHUS while Huerta et al. teach that anti-C5 antibodies had complete efficacy in treating p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patients of Huerta et al.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15, 18, 19, 27-34, 36, and 37 of copending Application No. 18/272,906 in view of De Sousa Amorim et al.
The copending claims recite the administration of anti-C5 antibodies comprising the same biological sequences as those recited in the instant claims to human patients to treat complement mediated TMA (thrombotic microangiopathy) including antibodies comprising the Fc mutations as recited in the instant claims (see all copending claims, and in particular compare instant claims 1-3 and 5 to copending claims 1-5 respectively). Dosing information concerning mass of drug per weight of patent as well as timing intervals are the same when comparing the instant and copending claims (compare in particular instant claim 9 to copending claim 9 as well as instant claim 11 to copending claims 12-14). Intended results of such administrations, such as reductions in free serum C5 concentration as well as terminal complement inhibition track when comparing the instant and copending applications (for example, compare instant claims 16 to copending claim 15 and instant claim 18 to copending claim 19). The copending claims differ from the instant claimed invention in that the copending claims do not teach that p-aHUS is a complement mediated thrombotic microangiopathy.
De Sousa Amorim et al. disclose treatment of a 41 year old woman suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections). Specifically, the woman was initially treated by plasmapheresis for five days which failed to improve renal function (see particularly the left column of page 642). At that time the woman was started on eculizumab, PE was discontinued, and four days later renal function improved (see particularly the right column of page 642). A renal biopsy confirmed the presence of thrombotic microangiopathy (TMA), with a follow up renal biopsy nine months later showing no signs of TMA prior to discontinuation of eculizumab therapy (ibid). They further report that multiple clinicians have successfully administered eculizumab to treat p-aHUS patients, specifically revert complement activation and induce remission (see particularly the left column of page 645 and Table I).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of the copending claims on p-aHUS patients. This is because De Sousa Amorim et al. teach that p-aHUS is a disease having TMA that can be successfully treated by administration of anti-C5 antibodies. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patient of De Sous Amorim et al. in addition to the teachings of the copending claims that administration of anti-C5 antibodies is applicable to all disorders involving microangiopathic hemolytic anemia.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-15, 18, 19, 27-34, 36, and 37 of copending Application No. 18/272,906 in view of Huerta et al.
The copending claims recite the administration of anti-C5 antibodies comprising the same biological sequences as those recited in the instant claims to human patients to treat complement mediated TMA (thrombotic microangiopathy) including antibodies comprising the Fc mutations as recited in the instant claims (see all copending claims, and in particular compare instant claims 1-3 and 5 to copending claims 1-5 respectively). Dosing information concerning mass of drug per weight of patent as well as timing intervals are the same when comparing the instant and copending claims (compare in particular instant claim 9 to copending claim 9 as well as instant claim 11 to copending claims 12-14). Intended results of such administrations, such as reductions in free serum C5 concentration as well as terminal complement inhibition track when comparing the instant and copending applications (for example, compare instant claims 16 to copending claim 15 and instant claim 18 to copending claim 19). The copending claims differ from the instant claimed invention in that the copending claims do not teach that p-aHUS is a complement mediated thrombotic microangiopathy.
Huerta et al. disclose treatment of 10 women suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections as well as Table 1). Notably they disclose that plasmapheresis was unsuccessful in the majority of patients in contrast to the excellent responses to eculizumab in all patients thus treated (see particularly the fourth paragraph of the right column of page 456). Indeed, they report that eculizumab treatment was successful with normalization of all hematologic parameters and preservation of renal function in all 10 patients (see particularly the bottom of the right column of page 456 and Figure 2). They report that in 9 of the 10 women treated with eculizumab, the decision to begin eculizumab administration was made because of a lack of clinical response to plasma therapies (see particularly the first paragraph of the section titled “Treatment and evolution” on page 453). Huerta et al. teach that “As a whole, our study illustrates the complete efficacy of eculizumab to treat p-aHUS in 13 p-aHUS patients (2 were treated twice), without any adverse situations reported in any of them.” (see particularly the last sentence of the paragraph bridging pages 456 and 457).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of the copending claims on p-aHUS patients. This is because Huerta et al. teach that anti-C5 antibodies had complete efficacy in treating p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patients of Huerta et al.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5-11, 14, 16-18, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60-79 of copending Application No. 19/014,677 in view of De Sousa Amorim et al.
The copending claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating complement-associated conditions (see all copending claims, particularly claim 75). Disorders recited as being “complement-associated” include atypical hemolytic uremic syndrome (aHUS), HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count, a complication of pregnancy), spontaneous fetal loss, and recurrent fetal loss (see particularly claims 61 and 62). Doses of antibody based upon a patient’s body weight as well as timing of administrations track the limitations recited in the instant claims (for example compare copending claim 60 to instant claim 11). The copending claims recite various clinical effects of the claimed administration methods, many of which are the same as those presently claimed including terminal complement inhibition (compare copending claim 74 to instant claim 18 for example). These teachings differ from the instant claimed invention in that the copending claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
Huerta et al. disclose treatment of 10 women suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections as well as Table 1). Notably they disclose that plasmapheresis was unsuccessful in the majority of patients in contrast to the excellent responses to eculizumab in all patients thus treated (see particularly the fourth paragraph of the right column of page 456). Indeed, they report that eculizumab treatment was successful with normalization of all hematologic parameters and preservation of renal function in all 10 patients (see particularly the bottom of the right column of page 456 and Figure 2). They report that in 9 of the 10 women treated with eculizumab, the decision to begin eculizumab administration was made because of a lack of clinical response to plasma therapies (see particularly the first paragraph of the section titled “Treatment and evolution” on page 453). Huerta et al. teach that “As a whole, our study illustrates the complete efficacy of eculizumab to treat p-aHUS in 13 p-aHUS patients (2 were treated twice), without any adverse situations reported in any of them.” (see particularly the last sentence of the paragraph bridging pages 456 and 457).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the copending claims on p-aHUS patients. This is because the copending claims indicate their methods are generically useful in treating all forms of aHUS while De Sousa Amorim et al. teach p-aHUS is a disease that can be successfully treated by administration of anti-C5 antibodies. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patient of De Sousa Amorim et al. as well as all of those patients summarized in the data of Table I of De Sousa Amorim.
This is a provisional nonstatutory double patenting rejection
Claims 1-3, 5-11, 14, 16-18, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60-79 of copending Application No. 19/014,677 in view of Huerta et al.
The copending claims recite methods of administering anti-C5 antibodies comprising biological sequences matching those of the instant claims for the purpose of treating complement-associated conditions (see all copending claims, particularly claim 75). Disorders recited as being “complement-associated” include atypical hemolytic uremic syndrome (aHUS), HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count, a complication of pregnancy), spontaneous fetal loss, and recurrent fetal loss (see particularly claims 61 and 62). Doses of antibody based upon a patient’s body weight as well as timing of administrations track the limitations recited in the instant claims (for example compare copending claim 60 to instant claim 11). The copending claims recite various clinical effects of the claimed administration methods, many of which are the same as those presently claimed including terminal complement inhibition (compare copending claim 74 to instant claim 18 for example). These teachings differ from the instant claimed invention in that the copending claims recite treating aHUS generically and do not appear to specify the subgenus of pregnancy-associated atypical hemolytic uremic syndrome (p-aHUS).
De Sousa Amorim et al. disclose treatment of a 41 year old woman suffering from p-aHUS with the anti-C5 antibody eculizumab (see entire document, particularly the abstract and discussion sections). Specifically, the woman was initially treated by plasmapheresis for five days which failed to improve renal function (see particularly the left column of page 642). At that time the woman was started on eculizumab, PE was discontinued, and four days later renal function improved (see particularly the right column of page 642). A renal biopsy confirmed the presence of thrombotic microangiopathy (TMA), with a follow up renal biopsy nine months later showing no signs of TMA prior to discontinuation of eculizumab therapy (ibid). They further report that multiple clinicians have successfully administered eculizumab to treat p-aHUS patients, specifically revert complement activation and induce remission (see particularly the left column of page 645 and Table I).
Therefore, it would have been obvious to an artisan at the time of filing to practice the methods of treating aHUS as recited in the copending claims on p-aHUS patients. This is because the copending claims indicate their methods are generically useful in treating all forms of aHUS while Huerta et al. teach that anti-C5 antibodies had complete efficacy in treating p-aHUS patients. Artisans would have a reasonable expectation of success in doing so given the favorable response to anti-C5 treatment in the p-aHUS patients of Huerta et al.
This is a provisional nonstatutory double patenting rejection
No claims are allowable.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641