Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed August 18, 2026 in response to the Office Action of May 18, 2026 is acknowledged and has been entered.
Claims 1, 31, 32, 34, and 36 have been amended.
Claims 2, 9, 27, and 37 have been cancelled.
Claims 41-44 have been added.
Claims 1, 3-8, 11-15, 18, 19, 28-34, 36, and 41-44 are pending.
It is noted that Applicant elected species: 1) autoimmune trigger as the specific trigger; 2) the patient is not a patient who has developed TMA due to hematopoietic stem cell transplantation (HSCT-TMA) as the specific CM-TMA patient in the reply of March 12, 2026.
Claims 31-33, 37 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are currently under consideration as drawn to the elected invention.
In view of Applicant’s amendment of claim 1, the claim objection set forth in the previous Office Action is hereby withdrawn.
In view of amendments on claims 1, 34, and 36 and cancellation of claim 2, 112(b) rejections set forth in the previous Office Action are hereby withdrawn.
Amended claim 1 further limits CM-TMA to CM-TMA associated with a trigger and adds limitations of original claim 9, thus, 102 and 103 rejections set forth in the previous Office Action are hereby withdrawn.
In view of the claim amendments, the Double Patenting rejections set forth in the previous Office Action are hereby withdrawn.
NEW REJECTIONS
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.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18, which depends on claim 1, recites “wherein the anti-C5 antibody or antigen binding fragment thereof, is administered at a dose of 2700 mg, 3000 mg, 3300 mg, or 3600 mg every eight weeks up to two years”. Claim 1 recites “wherein the anti-C5 antibody or antigen binding fragment thereof, is administered to the patient: … (b) on Day 15 and every eight weeks thereafter …”. It is unclear whether the administering step of claim 18 is part of the step claim 1(b), or an additional step besides claim 1 (b).
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), in view of Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
Jacobs teaches that eculizumab is a humanized monoclonal antibody to complement protein C5 (page 2, col. 1, para. 3).
Jacobs teaches that eculizumab has been shown to be effective in both patients with primary aHUS and also in a number of patients with secondary TMA (page 2, col. 2, para. 2).
Jacobs teaches that in secondary TMA, there is emerging evidence for a pathogenic role for complement pathway, see page 2, col. 2, para. 2.
Jacobs teaches various triggers for secondary TMA, see Table 2.
Jacobs teaches that secondary TMA may have no known complement mutation, but rather due to hyperactivation of the complement cascade (page 8, col. 2, para. 2).
Jacobs teaches that eculizumab shows effectiveness to many types of secondary TMA associated with different triggers, including influenza B, Shigella flexneri, Enterococcus raffinosus, cytomegalovirus, clostridium difficile, varicella, cancer/chemotherapy, sickle cell disease, cobalamin C deficiency, calcineurin inhibitor usage, diabetes, hematopoietic stem cell transplant, malignant hypertension (Table 2).
Jacobs teaches as set forth above. Jacobs does not teach the anti-C5 antibody, or the administration regimen as instantly claimed.
Chung teaches ravulizumab is a long-acting complement inhibitor (Abstract).
Chung teaches that eculizumab and ravulizumab are both C5 inhibitors and binds with high affinity to C5, thereby inhibiting cleavage of the latter to C5a and C5b, with resultant inhibition of the terminal complement pathway (see description of Fig. 3).
Chung teaches that ravulizumab is developed by re-engineering eculizumab into a longer acting molecule, thereby requiring less frequent infusions than eculizumab. And it is approved for treating aHUS in 2019 (page 338, col. 2, paras. 1-3).
As evidenced by the instant publication US 2024/0092881 A1, ravulizumab comprises heavy chain of SEQ ID NO: 14 and light chain of SEQ ID NO: 11 ([0008]). As set forth above, ravulizumab reads on the antibodies of claims 1-5.
Chung teaches patients received ravulizumab as a weight-based loading dose on day 1, followed by weight-based maintenance dose on day 15, and every 8 weeks in a 26-week period (page 338, the bottom paragraph of col. 2). Table 1 teaches weight-based loading dose and maintenance dose:
• 30-39 kg: 1200 mg IV/2700 mg IV
• 40-59 kg: 2400 mg IV/3000 mg IV
• 60-99 kg: 2700 mg IV/3300 mg IV
• ≥100 kg: 3000 mg IV/3600 mg IV
In addition, it is noted that optimum suitable ranges may be obtained by routine experimentation, absent a showing of criticality or unexpected results. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A).
Ortiz teaches anti-C5 antibody: ravulizumab also known as antibody BNJ441 and ALXN210 (page 2, § Summary).
Ortiz teaches that the antibody can be used to treat complement-mediated TMA (page 60, lines 21-23).
It would have prima facie been obvious to one of ordinarily skilled in the art before the effective filing date of the claimed invention to use an anti-C5 antibody eculizumab to treat CM-TMA associated with a trigger (secondary TMA) as taught by Jacobs, and to substitute eculizumab with ravulizumab and use the administration regimen taught by Chung and Ortiz. One of ordinary skill in the art would have had a reasonable expectation to reach the claimed method because Jacobs, Chung and Oritz teach: 1) trigger associated TMA is also related to hyper activation of complement pathway; 2) anti-C5 antibody can lead to terminal complement inhibition; 3) eculizumab is effective to treat CM-TMA associated with a trigger such as lupus nephritis; 4) both eculizumab and ravulizumab are anti-C5 antibody and ravulizumab is a re-engineered eculizumab; 5) ravulizumab is a longer acting molecule, thereby requiring less frequent infusions than eculizumab; 6) ravulizumab is approved for treating human with TMA; 7) the administration regimen has been used in clinical settings. The motivation would have been to develop a better treatment for CM-TMA associated with a trigger (such as infection or chronic disease), and to expand the application of ravulizumab.
Regarding claims 6 and 7, Ortiz teach: the antibody binds to human C5 at pH 7.4 and 25°C with an affinity dissociation constant (KD) that is in the range 0.1 nM ≤ KD ≤ 1 nM. In another embodiment, the antibody binds to human C5 at pH 6.0 and 25°C with a KD ≥ 10 nM (page 4, lines 25-30). In addition, these features are intrinsic features of the antibody ravulizumab.
Regarding claim 8, Chung teaches ravulizumab (ultomiris) is administered intravenously (Table 1). Ortiz teaches that the antibody is formulated for intravenous administration (page 14, lines 4-5; and Example 2, page 81, lines 10-11).
Regarding claim 15, Oritz teaches that cohort 2 received a single 400 mg dose of ALXN1210 intravenously (page 81, lines 10-11). Administration of a single dose of ALXN1210IV 400 mg resulted in an immediate and nearly complete inhibition of free C5 (≥ 99%) through Day8 following IV administration (page 112, lines 17-18). Concentration can reach to 134 ug/ml within one hour (Table 21). Half-life of the antibody is about 30 days (page 114, lines 12-14). Based on these pharmacokinetic parameters, one of ordinary skill in the art would have expected that the dosages and administration of regimens (e.g. 2400 mg at Day1 and on Day 15 and every eight weeks thereafter at a dose of 3000 mg) “wherein the treatment maintains a serum trough concentration of the anti-C5 antibody of 100 ug/ml or greater during the treatment and/or wherein the treatment reduces free C5 concentration by greater than 99% throughout the treatment period”. Eight weeks is shorter than 2 half-life time of the antibody, thus, 3000 mg after eight weeks would still have more than 750 mg in the human body which would lead to a concentration of the anti-C5 antibody (ALXN1210) of 100 ug/ml or greater and/or reduces free C5 concentration by greater than 99% throughout the treatment period.
Regarding claim 19, Chung teaches that ravulizumab leads to inhibition of the terminal complement pathway (see description of Fig. 3). In addition, treatment results recited are merely intended results of the method steps positively recited. The court noted (quoting Minton v. Nat'/ Ass'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."' Id. Therefore, the results of claim 19 are given no weight. Because the references teach the same treatment, the same treatment would achieve the same treatment results.
Rgearding claims 28-30, Jacobs teaches CM-TMA associated with trigger diabetes, and malignant hypertension (Table 2). In addition, Jacobs teaches CM-TMA associated with chronic diseases including systemic lupus erythematosus (SLE). A systematic review and three recent case reports have shown success of anti-complement treatment with eculizumab in cases of SLE with TMA, cases of SLE and lupus nephritis, and cases of SLE and anti-phospholipid syndrome (page 6, the bottom paragraph of col. 1).
Regarding claims 34, Jacobs teaches that the treatment comprises supportive management, e.g. renal replacement therapy (Fig. 1). Chung teaches patients also receive TPE (therapeutic plasma exchange) or plasma infusion (page 339, col. 1, para. 1). Both TPE and plasma infusion read on transfusion support.
Regarding claim 36, Jacobs teaches many types of secondary CM-TMA which is not associated with hematopoietic stem cell transplant (Table 2).
Rgearding claim 41, Chung teaches patients also treated with antibiotic prophylaxis with ciprofloxacin or penicillin V or a macrolide (page 339, col. 2, para. 4).
Regarding claim 42, Jacob teaches that in patients who receive eculizumab, clinical benefits include those of discontinuation of TPE, hemodialysis. However, such clinical benefit has not been demonstrated in ravulizumab. One of ordinary skill in the art would continue hemodialysis for patients under ravulizumab treatment, particularly for patients with damage in kidney.
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.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of the U.S. Patent Nos. listed below in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
Patent No.
Appl. No.
Brief Description of the Invention
Pertinent Claims
9079949
14/641,026
Anti-C5 antibodies
1-4, 6-8,
9107861
14/727,313
Treating aHUS with anti-C5 antibody
1-4, 6-8, 10, 16, 18
9371377
14/923,879
Anti-C5 antibodies
1-5, 7-9
9663574
15/160,364
Anti-C5 antibodies
1-8
9803007
15/492,622
Treating PNH with anti-C5 antibody
1-7
10227400
15/708,658
Treating aHUS with anti-C5 antibody
1-7
10584164
16/246,842
Treating aHUS with anti-C5 antibody
1, 3, 5, 7
11434280
16/750,173
Anti-C5 antibodies
1, 17, 18
It is noted that all the listed patents share the same parent Application No.:14/641,026 (Patent No.: 9079949), thus, the sequence lists of these patents are the same. It is also noted that all the listed patents are cited in IDS of 07/02/2024
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rendered obvious by the combined teachings of the prior art above as discussed in the 103 section. The 103 has being incorporated here. The addition of the patented claims of the above listed reference patent support the obviousness.
It is specifically noted that all of the above-listed reference patents are drawn to anti-C5 antibodies or the method of using anti-C5 antibody to treat CM-TMA. The claims of these patent disclose the specific anti-C5 antibody comprising a heavy chain of SEQ ID NO: 14 and a light chain of SEQ ID NO: 11. As shown below, SEQ ID NO: 14 and 11 of these patents are the same as SEQ ID NO: 14 and 11 of the instant application.
SEQ ID NO: 14 alignment:
Query Match 100.0%; Score 2399; Length 448;
Best Local Similarity 100.0%;
Matches 448; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
Qy 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
Qy 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
Qy 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
Qy 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
Qy 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
Qy 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
Qy 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
||||||||||||||||||||||||||||
Db 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
SEQ ID NO:11 alignment:
Query Match 100.0%; Score 1110; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Thus, the above-listed patented claims teach the anti-C5 antibody: Ravulizumab and/or the method of using the antibody to treating diseases. However, the claims of the listed patents do not explicitly disclose CM-TMA associated with a trigger, or administration regimens, or triggers, or additional best supportive care. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 103 section.
The above-listed reference patents, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that the compounds disclosed in the claims of reference patents (or the methods disclosed in the claims of reference patents) could be used in the method (or be modified) as disclosed by Jacobs, Chung, and Ortiz, and to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz as delineated in the 103 rejection above, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of the U.S. Patent Nos. listed below in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
Patent No.
Appl. No.
Brief Description of the Invention
Pertinent Claims
11365241
16/633,930
Anti-C5 antibodies, including ravulizumab
1, 2, 9, 10, 15
12012448
18/086,031
Anti-C5 antibodies, including ravulizumab
1, 4, 5
It is noted that all the listed patents share the same parent Application No.:16/633,930 (Patent No.: 11365241), thus, the sequence lists of these patents are the same. It is also noted that Pat. 11,365,241 is cited in IDS of 07/02/2024, and Pat. 12,012,448 is cited in IDS of 05/01/2025.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rendered obvious by the combined teachings of the prior art above as discussed in the 103 section. The 103 has being incorporated here. The addition of the patented claims of the above listed reference patent support the obviousness.
It is specifically noted that all of the above-listed reference patents are drawn to anti-C5 antibodies, including ravulizumab. As set forth above, ravulizumab reads on the antibody of instant claims.
Thus, the above-listed patented claims teach the anti-C5 antibody: Ravulizumab. However, the claims of the listed patents do not explicitly disclose treating CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 103 sections.
The above-listed reference patents, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that the compounds disclosed in the claims of reference patents (or the methods disclosed in the claims of reference patents) could be used in the method (or be modified) as disclosed by Jacobs, Chung, and Ortiz, and to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the pertinent claims of the U.S. Application Nos. listed below in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
Appl. No.
Brief Description of the Invention
Pertinent Claims
17/738,131
Treating compliment conditions with anti-C5 antibody, e.g. ravulizumab
32, 33, 42
19/020,875
Anti-C5 antibodies, including ravulizumab and method of treating compliment conditions with anti-C5 antibody
35, 52
It is noted that all the listed Applications share the same parent Application No.:16/633,930 (Patent No.: 11365241).
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rendered obvious by the combined teachings of the prior art above as discussed in the 103 section. The 103 has being incorporated here. The addition of the patented claims of the above listed reference patent support the obviousness.
The above-listed reference claims teach the anti-C5 antibody: Ravulizumab and/or the method of using the antibody to treat diseases. However, the claims of the listed applications do not explicitly disclose CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 102 and 103 sections.
The above-listed reference patents, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that the compounds disclosed in the claims of reference patents (or the methods disclosed in the claims of reference patents) could be used in the method (or be modified) as disclosed by Jacobs, Chung, and Ortiz, and to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-12 of U.S. Patent No. 12,128, 101 (hereinafter Pat. 101, Appl. No. 16/757,512, cited in IDS of 05/01/2025) in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
The claims of Pat. 101 teach method of treating PNH or aHUS with anti-C5 antibodies (claim 1).
The claims of Pat. 101 teach the anti-C5 antibody comprising a heavy chain of SEQ ID NO: 14 and a light chain of SEQ ID NO: 11 (claim 6). As shown below, SEQ ID NO: 14 and 11 of Pat. 101 are the same as SEQ ID NO: 14 and 11 of the instant application.
SEQ ID NO: 14 alignment:
Query Match 100.0%; Score 2399; Length 448;
Best Local Similarity 100.0%;
Matches 448; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
Qy 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
Qy 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
Qy 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
Qy 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
Qy 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
Qy 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
Qy 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
||||||||||||||||||||||||||||
Db 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
SEQ ID NO:11 alignment:
Query Match 100.0%; Score 1110; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Thus, the above-listed patented claims teach the anti-C5 antibody: Ravulizumab and the method of using the antibody to treating diseases.
The claims of Pat. 101 disclose the anti-C5 antibody: Ravulizumab and the method of using the antibody to treating diseases. However, the claims of the listed applications do not explicitly disclose CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 103 sections.
The claims of Pat. 101, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art that the methods disclosed in the claims of Pat. 101 could be modified as disclosed by Jacobs, Chung and Ortiz, and to use the administration regimens taught by Chung, and to treat to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,460,012 (hereinafter Pat. 012, Appl. No. 17/057,898) in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
The claims of Pat. 012 teach method of treating aHUS with anti-C5 antibodies (claim 1), dosages (claims 2-8), formulation (claim 9).
The claims of Pat. 012 teach the anti-C5 antibody comprising a heavy chain of SEQ ID NO: 14 and a light chain of SEQ ID NO: 11 (claim 13), and ravulizumab (claim 15). As set forth above, Ravulizumab reads on the antibody of instant claims.
The claims of Pat. 012 disclose the anti-C5 antibody: Ravulizumab and the method of using the antibody to treat diseases. However, the claims of the listed applications do not explicitly disclose CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 102 and 103 sections.
The claims of Pat. 012, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art that the methods disclosed in the claims of Pat. 102 could be modified as disclosed by Jacobs, Chung and Ortiz, and to use the administration regimens taught by Chung, and to treat to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6-9, 14, 16, and 18 of copending Application No. 17/784,025 (hereinafter Appl. 025) in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
The claims of Appl. 025 teach method of treating aHUS with anti-C5 antibodies (claim 1), dosages (claims 9, 11), formulation (claim 8), expected outcomes (claims 14, 16, 18).
The claims of Appl. 025 teach the anti-C5 antibody comprising a heavy chain of SEQ ID NO: 14 and a light chain of SEQ ID NO: 11 (claim 5). As shown below, SEQ ID NO: 14 and 11 of Appl. 025 are the same as SEQ ID NO: 14 and 11 of the instant application.
SEQ ID NO: 14 alignment:
Query Match 100.0%; Score 2399; Length 448;
Best Local Similarity 100.0%;
Matches 448; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
Qy 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
Qy 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
Qy 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
Qy 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
Qy 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
Qy 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
Qy 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
||||||||||||||||||||||||||||
Db 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
SEQ ID NO:11 alignment:
Query Match 100.0%; Score 1110; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Thus, the above-listed claims teach the anti-C5 antibody: Ravulizumab and the method of using the antibody to treating diseases.
The claims of Appl. 025 disclose the same anti-C5 antibody as the instantly claimed and the method of using the antibody to treating diseases. However, the claims of the listed applications do not explicitly disclose CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 103 sections.
The claims of Appl. 025, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art that the methods disclosed in the claims of Appl. 025 could be modified as disclosed by Jacobs, Chung and Ortiz, and to use the administration regimens taught by Chung, and to treat to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 12-15, and 17-19 of copending Application No. 18/011,698 (hereinafter Appl. 698) in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
The claims of Appl. 698 teach method of treating complement-associated condition (e.g. aHUS) with anti-C5 antibodies: ravulizumab (claims 1 and 18), dosages (claims 5, 7 and 9), formulation (claim 8), expected outcomes (claims 17, 19).
The claims of Appl. 698 disclose the anti-C5 antibody: Ravulizumab and the method of using the antibody to treating diseases. However, the claims of the listed applications do not explicitly disclose CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 102 and 103 sections.
The claims of Appl. 698, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art that the methods disclosed in the claims of Appl. 698 could be modified as disclosed by Jacobs, Chung and Ortiz, and to use the administration regimens taught by Chung, and to treat to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-17, 19, 35 and 38 of copending Application No. 18/018,936 (hereinafter Appl. 936) in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
The claims of Appl. 936 teach method of treating HSCT-TMA with anti-C5 antibodies (claims 1 and 2), dosages (claims 1, 2, 6, 7, 10-14), formulation (claim 17), expected outcomes (claims 15, 16, 19).
The claims of Appl. 936 teach the anti-C5 antibody comprising a heavy chain of SEQ ID NO: 14 and a light chain of SEQ ID NO: 11 (claim 5). As shown below, SEQ ID NO: 14 and 11 of Appl. 936 are the same as SEQ ID NO: 14 and 11 of the instant application.
SEQ ID NO: 14 alignment:
Query Match 100.0%; Score 2399; Length 448;
Best Local Similarity 100.0%;
Matches 448; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
Qy 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
Qy 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
Qy 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS 240
Qy 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST 300
Qy 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT 360
Qy 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE 420
Qy 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
||||||||||||||||||||||||||||
Db 421 GNVFSCSVLHEALHSHYTQKSLSLSLGK 448
SEQ ID NO:11 alignment:
Query Match 100.0%; Score 1110; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Thus, the above-listed claims teach the anti-C5 antibody: Ravulizumab and the method of using the antibody to treat diseases.
The claims of Appl. 936 disclose the same anti-C5 antibody as the instantly claimed and the method of using the antibody to treating diseases. However, the claims of the listed applications do not explicitly disclose CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 103 section.
The claims of Appl. 936, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art that the methods disclosed in the claims of Appl. 936 could be modified as disclosed by Jacobs, Chung and Ortiz, and to use the administration regimens taught by Chung, and to treat to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-8, 11-15, 18, 19, 28-30, 34, 36, 41, 42, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19, and 28 of copending Application No. 18/032, 959 (hereinafter Appl. 959) in view of Jacobs (Jacobs et al., Current Pediatrics Reports (2019) 7:1-11, Publication Date: 02/13/2019), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024, of record) and Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record).
The claims of Appl. 959 teach a method of treating complement-mediated disorder (e.g. aHUS) with two anti-C5 antibodies (claims 1, 2, 27), dosages (claims 22, 25), formulation (claim 17), and wherein the first antibody can be ravulizumab (claim 28 and claim 23 (c)).
The claims of Appl. 959 disclose the anti-C5 antibody: Ravulizumab and the method of using the antibody to treat diseases. However, the claims of the listed applications do not explicitly disclose CM-TMA with a trigger, or administration regimens, or triggers, or additional best supportive care, or specific patient population of the instant invention. These deficiencies are addressed by the cited references, as provided by the teachings specified in the 103 section.
The claims of Appl. 959, Jacobs, Chung, and Ortiz are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody) and the method of using the composition for treatment. Thus, it would have been obvious to one of ordinary skill in the art that the methods disclosed in the claims of Appl. 959 could be modified as disclosed by Jacobs, Chung and Ortiz, and to use the administration regimens taught by Chung, and to treat to use the administration regimens taught by Chung, and to treat CM-TMA associated with a trigger, e.g. lupus nephritis, because combining prior art elements according to known methods would be expected to yield predictable results. Based on the above, one of ordinary skill could therefore arrive at the methods of the instant claims. One of ordinary skill in the art would be motivated to use the antibodies of the reference patents or to modify the methods of the reference patents based on the teachings of Jacobs, Chung, and Ortiz, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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/CHENG LU/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/ Supervisory Patent Examiner, Art Unit 1642
