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
Applicant’s election without traverse of Group I, claims 1-9, 11-15, 18, 19, 27-34 and 36, in the reply filed on March 12, 2026 is acknowledged.
Applicant’s election without traverse of 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; is acknowledged.
Claims 10, 16, 17, 20-26, 35, and 38-40 were previously canceled.
Claims 1-9, 11-15, 18, 19, 27-34, 36 and 37 are pending.
Claims 31-33 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions or species, there being no allowable generic or linking claim.
Claims 1-9, 11-15, 18, 19, 27-30, 34 and 36 are pending and under consideration.
Priority
It is acknowledged that this application is the US National Stage Application of PCT/US2022/012739, filed on January 18, 2022, which claims the benefit of priority to U.S. Provisional Patent Appl. No. 63/140,488 filed, January 22, 2021. The priority date has been established as January 22, 2021, for the examined claims.
Information Disclosure Statement
The Information Disclosure Statements filed on 07/02/2024, 07/02/2024, 07/02/2024, 07/02/2024, 07/02/2024, 07/02/2024, 09/24/2024, 11/12/2024, 05/01/2024, and 03/12/2026 have been considered and entered by examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “complement-mediated TMA (CM-TMA)” should be “complement-mediated thrombotic microangiopathy (CM-TMA)”. Appropriate correction is required.
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.
Claims 1-9, 11-15, 18, 19, 27-30, 34 and 36 are 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.
Regarding claim 1, the phrase "particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 recites the limitation "the variant human Fc CH3 region" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 34, the phrase "(e.g. …)" at lines 3-4 renders the claim indefinite because it is unclear whether the limitation(s) in the parenthesis are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 34, the phrase "(dialysis)" at line 4 renders the claim indefinite because it is unclear whether the limitation(s) in the parenthesis are part of the claimed invention. See MPEP § 2173.05(d). In other words, it is unclear whether renal replacement therapy is limited to dialysis.
Regarding claim 36(f), the phrase "e.g., Shiga toxin-related hemolytic uremic syndrome (STEC-HUS)" renders the claim indefinite because it is unclear whether the limitation(s) following “e.g.” are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 36(g), the phrase "e.g., wherein the ADAMTS13 deficiency is attributed to ADAMTS13 activity of less than 5%" at line 4 renders the claim indefinite because it is unclear whether the limitation(s) following “e.g.” are part of the claimed invention. See MPEP § 2173.05(d). In other words, it is unclear whether renal replacement therapy is limited to dialysis.
Regarding claim 36(g), the phrase "ADAMTS13 activity of less than 5%" at line 4 renders the claim indefinite. It is unclear what reference value was used for comparing ADAMTS13 activity.
Claims 2-9, 11-15, 18, 19, and 27-30 are also rejected because these claims depend on the rejected claims directly or indirectly.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 34 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), as evidenced by the instant publication: US 2024/0092881 A1.
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).
Ortiz teaches kits comprising the antibody and instruction (page 63, lines 6-11). 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 shown below that ravulizumab (SEQ ID NO: 14) CH3 region comprises a methionine to leucine substitution at position 428 and an asparagine to serine substitution at position 434, according to EU numbering (substitutions are underlined):
>US-18-272-906-14
QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY
TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV
SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ
SSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPS
VFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNST
YRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMT
KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQE
GNVFSCSVLHEALHSHYTQKSLSLSLGK.
In addition, ravulizumab comprise a heavy chain variable region of SEQ ID NO: 12 and a Light chain variable region of SEQ ID NO: 8. Sequence alignments are shown below.
SEQ ID NO: 14 vs SEQ ID NO: 12
Query Match 27.4%; Score 657; DB 1; Length 122;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGASVKVSCKASGHIFSNYWIQWVRQAPGQGLEWMGEILPGSGHTEY 60
Qy 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TENFKDRVTMTRDTSTSTVYMELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTV 120
SEQ ID NO: 11 vs SEQ ID NO: 8
Query Match 50.2%; Score 557; DB 1; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQNVLNTPLTFGQGTKVEIK 107
Thus, ravulizumab read on the antibody of instant claims 1-5.
Ortiz teaches that ravulizumab selectively binds to human complement protein C5, inhibiting its cleavage to C5a and C5b during complement activation. This inhibition prevents the release of the proinflammatory mediator C5a and the formation of the cytolytic pore-forming membrane attack complex C5b-9 while preserving the proximal or early components of complement activation essential for the opsonization of microorganisms and clearance of immune complexes (the bridging paragraph of pages 27-28).
Ortiz teaches using anti-C5 antibody (e.g. ravulizumab) to treat a complement-associated condition, e.g. aHUS (page 38, para. 2, page 59, para. 3; claims 10, 24-26). As evidenced by the instant publication: US 2024/0092881 A1, aHUS is a complement-mediated TMA (CM-TMA) ([0119] of instant publication US 2024/0092881 A1).
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, 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 34, Ortiz teaches the method further comprising administering an antibiotics (page 86, Table 15; and page 92, lines 3-7).
Taken together Ortiz anticipates the instant claims 1-8 and 34.
Claims 1-9, 11-14, 18, 19, 27-28, 34, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), as evidenced by the instant publication: US 2024/0092881 A1.
Chung teaches treating aHUS with ravulizumab (Abstract and § Ravulizumab and aHUS). 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 that aHUS is considered as the primary TMA (page 331, col. 1) and is mediated by dysregulated or impaired complement pathway (the bridging paragraph of cols 1-2 on page 337).
Regarding claims 6 and 7, Chung teaches the same antibody as the instant claims, and these features are intrinsic features of the antibody ravulizumab.
Regarding claim 8, Chung teaches Ravulizumab (ultomiris) is administered intravenously (Table 1).
Regarding claims 9, 11-14, and 18, 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).
Regarding claim 19, Chung teaches that 53.6% patients achieve complete TMA (Table 1).
Regarding claims 27 and 28, Chung teaches that aHUS develops because of dysregulation of the alternative complement pathway, followed by constitutive activation of complement components (autoimmune trigger). Given Broadest Reasonable Interpretation, aHUS would read on instant claims 27 and 28.
Regarding claim 34, 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(f), Chung teaches that eligible patients who are absence of STEC-HUS (the bottom paragraph of col. 2, on page 338).
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 9, 11-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), as evidenced by the instant publication: US 2024/0092881 A1, as applied to claims 1-8 and 34 above.
Ortiz teaches method of claim 1 as set forth above. However, Ortiz does not teach the dosages and administration regimens as claimed.
Regarding claims 9, 11-14 and 18, Ortiz teaches dose and administration method (pages 96-97). 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). Thus, one of ordinary skill in the art would be able to reach claimed dosages and administration regimens as claimed.
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.
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), as evidenced by the instant publication: US 2024/0092881 A1, as applied to claims 1-9, 11-15, 18 and 34 above, and further in view of Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
Ortiz teaches method of claim 1 as set forth above. However, Ortiz does not teach that the CM-TMA is associated with a trigger, including autoimmune trigger (e.g. systemic sclerosis).
Rare Disease Insight teaches that aHUS is often caused by a combination of environmental and genetic factors. Genetic factors involve genes that code for proteins that help control the complement system (part of your body’s immune system). Environmental factors include certain medications (such as anticancer drugs), chronic diseases (e.g., systemic sclerosis and malignant hypertension), viral or bacterial infections, cancers, organ transplantation, and pregnancy (1st paragraph).
Jokiranta teaches that complement inhibition is effective in HUS patients with autoimmunity (e.g. scleroderma), systemic lupus erythematosus, or HIV infection and beneficial for aHUS and secondary HUS patients without mutations in complement proteins (page 2852, col. 2).
Jokiranta teaches complement activation is central in the pathogenesis of aHUS (1st paragraph of § Conclusions). And it is logical that therapeutic complement inhibition is effective in aHUS (2nd paragraph of § Conclusions).
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 combine the teachings of Oritz, Rare Disease Insight, and Jokiranta, and to treat aHUS triggered by an autoimmune trigger, e.g. systemic sclerosis) with anti-C5 antibody: Ravulizumab. A person of ordinary skill in the art would have had expectation of success because:1) aHUS can be triggered by various factors including system sclerosis, as taught by Rare Disease Insight; 2) complement activation is central in the pathogenesis of aHUS and complement inhibition can be effective for treating aHUS and secondary HUS, as taught by Jokiranta; 3) Ravulizumab is an anti-C5 antibody with complement inhibition activity and can be used in treating aHUS, as taught by Oritz. The motivation would have been to apply the method of Oritz to a suitable aHUS population.
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 1-9, 11-15, 18, 19, 27-30, 34 and 36 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 Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
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 1-9, 11-15, 18, 19, 27-30, 34 and 36 are anticipated by the prior art above as discussed in the 102 section, or are rendered obvious by the combined teachings of the prior art above as discussed in the 103 section. The 102 and 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 PNH or aHUS. 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 complement-mediated TMA (CM-TMA), particularly 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, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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 Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 Ortiz, Chung, Rare Disease Insight, and Jokiranta, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1-9, 11-15, 18, 19, 27-30, 34 and 36 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 Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
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 1-9, 11-15, 18, 19, 27-30, 34 and 36 are anticipated by the prior art above as discussed in the 102 section, or are rendered obvious by the combined teachings of the prior art above as discussed in the 103 section. The 102 and 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 complement-mediated TMA (CM-TMA), particularly 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, Ortiz, Chung, Rare Disease Insight, and Jokiranta are considered to be analogous to the present invention as they are in the same field of immunotherapy composition (anti-C5 antibody). Thus, it would have been obvious to one of ordinary skill in the art that the compounds disclosed in the claims of reference patents could be used in the method as disclosed by Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 Ortiz, Chung, Rare Disease Insight, and Jokiranta, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1-9, 11-15, 18, 19, 27-30, 34 and 36 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 Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
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 1-9, 11-15, 18, 19, 27-30, 34 and 36 are anticipated by the prior art above as discussed in the 102 section, or are rendered obvious by the combined teachings of the prior art above as discussed in the 103 section. The 102 and 103 has being incorporated here. The addition of the reference claims of the above listed reference applications support the obviousness.
The above-listed reference claims teach the anti-C5 antibody: Ravulizumab and/or the method of using the antibody to treating diseases. However, the claims of the listed applications do not explicitly disclose complement-mediated TMA (CM-TMA), particularly 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, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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 compounds disclosed in the claims of reference applications (or the methods disclosed in the claims of reference applications) could be used in the method (or be modified) as disclosed by Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1-9, 11-15, 18, 19, 27-30, 34 and 36 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 Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
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 complement-mediated TMA (CM-TMA), particularly 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. 101, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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 Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1-9, 11-15, 18, 19, 27-30, 34 and 36 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 Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
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 treating diseases. However, the claims of the listed applications do not explicitly disclose complement-mediated TMA (CM-TMA), particularly 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, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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. 012 could be modified as disclosed by Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, in order to expand the application of the antibody (e.g. Ravulizumab) and to treat suitable patients for the antibody.
Claims 1-9, 11-15, 18, 19, 27-30, 34 and 36 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 Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
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 4). 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 complement-mediated TMA (CM-TMA), particularly 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. 025, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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 Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, 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 1-9, 11-15, 18, 19, 27-30, 34 and 36 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 Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
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, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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 Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, 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 1-9, 11-15, 18, 19, 27-30, 34 and 36 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-19, 31 and 32 of copending Application No. 18/011,807 (hereinafter Appl. 807) in view of Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
The claims of Appl. 807 teach method of treating PNH with anti-C5 antibodies (claims 1 and 2), dosages (claims 56-14), formulation (claim 17), expected outcomes (claims 15, 16, 19).
The claims of Appl. 807 teach the anti-C5 antibody (claims 31, 32 and 5), in particular an 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. 807 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. 807 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 complement-mediated TMA (CM-TMA), particularly 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. 807, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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. 807 could be modified as disclosed by Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, 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 1-9, 11-15, 18, 19, 27-30, 34 and 36 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19, 35 and 38 of copending Application No. 18/018,936 (hereinafter Appl. 936) in view of Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
The claims of Appl. 936 teach method of treating HSCT-TMA with anti-C5 antibodies (claims 1 and 2), dosages (claims 1, 2, 6-14), 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 treating 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 complement-mediated TMA (CM-TMA), particularly 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. 936, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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 for complement-associated conditions. 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 Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, 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 1-9, 11-15, 18, 19, 27-30, 34 and 36 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19, 35 and 38 of copending Application No. 18/032, 959 (hereinafter Appl. 959) in view of Ortiz (Ortiz et al., WO 2019/023564 A1, Publication Date: 01/31/2019, cited in IDS of 07/02/2024, of record), Chung (Chung, Annals of Pharmacotherapy, 2021, vol. 55(3) 330-343, Publication Date: 07/25/2020, cited in IDS of 09/24/2024), Rare Disease Insight (downloaded from: https://checkrare.com/atypical-hemolytic-uremic-syndrome/, Publication Date: 02/04/2019) and Jokiranta (Jokiranta, Blood, Vol. 129, Number 21, 2847-2856, Publication Date: 05/25/2017).
The claims of Appl. 959 teach 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 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. 959, Ortiz, Chung, Rare Disease Insight, and Jokiranta 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 Ortiz or Chung, and to use the administration regimens taught by Chung, and to treat aHUS triggered by autoimmune conditions such as systemic sclerosis taught by Rare Disease Insight and Jokiranta, 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 applications or to modify the methods of the reference applications based on the teachings of Ortiz, Chung, Rare Disease Insight, and Jokiranta, 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/ Supervisory Patent Examiner, Art Unit 1642
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