DETAILED ACTION
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 .
Priority
The instant application, filed on 07 December, 2023, is a 371 of PCT/US2022/032885 which was filed on 09 June, 2022 and claims domestic benefit to US provisional application no. 63/210,280, filed on 14 June, 2021.
Information Disclosure Statement
The five information disclosure statements (IDS) submitted on 11 June, 2024 have been considered by the examiner. It is noted that the following Non Patent Literature documents were not found and therefore not considered by the examiner:
Baldridge et al. Methods 19: 103-107 (1999).
Muyldermans et al., Trends Biochem Sci 26: 230-235 (2001).
Roberts et al., Advanced Drug Delivery Reviews 54: 459-476 (2002).
Status of Application, Amendments, and/or Claims
The response filed on 13 December, 2024 has been entered in full. These are the amended claims of the original claim set received on 07 December, 2023. In the amendment, claims 3-9, 19, 21, 22, 24, 48, 50-54,57, 58, and 61 are amended and claims 10-18, 20, 23, 25-47, 55, 56, 59, and 60 are cancelled. Therefore, claims 1-9, 19, 21, 22, 24, 48-54, 57, 58, and 61 are pending and are the subject of this Office Action.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(b)
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.
Claims 7 and 8 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 7 recites (e.g., 0.5nM) and claim 8 recites (e.g., 22nM) rendering the claims indefinite because it is unclear whether the example within the parenthesis is a limitation and/or a part of the present invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 8 are rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Both claims recite claim to a property of the antibody of claim 1 the property does not provide a any structural limitations to arrive at this property, nor any method limitations limit the scope of the claim and thus the claims are improperly dependent.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1-9, 19, 21, 22, 52, 57, 58, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Andrien Jr. et al. (US Pat No. 9,079,949, of record, hereafter Andrien) in view of Lee et al. (2019) Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naïve to complement inhibitors: the 301 study Blood 133 (6) 530-539 (of record , hereafter Lee), Tanaka et al. (2021) (published online 2020) The long-acting C5 inhibitor, ravulizumab, is efficacious and safe in pediatric patients with atypical hemolytic uremic syndrome previously treated with eculizumab Pediatric Nephrology 36:889-898 (hereafter Tanaka), and Gordon PA et al. (2012) Immunosuppressant and immunomodulatory treatment for dermatomyositis and polymyositis (Review) Cochrane Database of Systemic Reviews 8:CD003643 (of record, hereafter Gordon).
In regards to claims 1, 3, 4, 5, and 6 Andrien teaches the claimed sequences of instant claims. Andrien teaches an anti-C5 antibody which corresponds with the claimed sequences for the heavy chain of CDRs SEQ ID NOs: 19, 18, and 3 (SEQ ID NOs: 23, 19, and 3 of Andrien respectively/ Claim 1), the light chain CDRs of SEQ ID NOs: 4, 5, and 6 (SEQ ID NOs: 4, 5, and 6 of Andrien respectively/ Claim 1), the heavy chain variable region of SEQ ID NO: 12 (SEQ ID NO: 12 of Andrien/ Claim 2), the light chain variable region of SEQ ID NO: 8 (SEQ ID NO: 8 of Andrien/ Claim 2), the heavy chain constant region of SEQ ID NO:13 (SEQ ID NO: 13 of Andrien/ Claim 3), and the heavy and light chain polypeptides of SEQ ID NOs 14 and 11, respectively (SEQ ID NO 14 and 11 of Andrien/ Claim 4).
In regards to claim 3 Andrien teaches that this anti-C5 antibody (BNJ441) is an improved derivative of the antibody eculizumab wherein at position 8 of the heavy chain CDR2 the serine is substituted with a histidine, at position 2 of the heavy chain CDR1 the tyrosine is substituted with a histidine, and the substitutions Met-429-Leu and Asn-435-Ser (positions 428 and 434 under EU numbering) (col 64, lines 33-47 /brief descriptions of sequences) to enable extended dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
In regards to claims 7 and 8 Andrien teaches the anti-C5 antibody (BNJ441) has a dissociation constant KD of 0.491 nM at a pH of 7.4 (in the range of 0.1 nM ≤ KD ≤ 1nM) and a KD of 21.8 nM at a pH of 6.0 (KD ≥ 10 nM) (Table 9/ Claims 6 and 7 of Andrien).
In regards to claim 19 Andrien teaches maintaining a concentration of 100 μg/mL or more allows for complete terminal complement (C5) inhibition (col 69, lines 6-10).
Andrien fails to teaches the weight dependent administration of claims 1, 2, and 9, as well as the treatment of dermatomyositis with the anti-C5 antibody of claim 1. Andrien also fails to teach the intravenous administration of the antibody of claim 21, the patient being an adult human patient of claim 57, and the antibody being determined to be safe, tolerable, efficacious and sufficiently non-immunogenic after multiple IV doses in human patients of claim 61. Further, Andrien fails to teach the treatment resulting in one of the limitations listed (a-aa) of claim 22, the further administering one or more of the additional agent listed of claim 52, and the patient not having previously taken treatment a) - l) of claim 54.
Lee, however, in regards to claims 1, 2, and 9 teaches a dosing regimen in adults with paroxysmal nocturnal hemoglobinuria (PNH) in which a patients are treated with ”a loading dose (2400 mg for patients weighing <, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 kg to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter” (pg.531, col 1, lines 51-57).
In regards to claim 21, Lee teaches the intravenous delivery of ravulizumab (pg.531, col 1, lines 50-51).
In regards to claim 57, Lee teaches the human patient being an adult patient (pg.531, col 2, line 14).
In regards to claim 61, Lee teaches Ravulizumab was well tolerated in the study and had minimal side effects and only serious adverse side effects in 8.8% of the patients (Table 4). Further Ravulizumab was not discontinued by any patients and had no deaths (pg.535, col 2, lines 5-26).
Lee fails to teach the loading dose of 900mg, followed by a maintenance dose of 2100 mg two weeks (or day 15) later and then once every eight week thereafter to a patient weighing < 30 kg or a loading dose of 1200mg, followed by a maintenance dose of 2700mg two weeks later (or on day 15) and then once every eight weeks thereafter to a patient weighing ≥ 30 kg to < 40 kg, of claims 1, 2, and 9. Further Lee fails to teach the treatment of dermatomyositis with the anti-C5 antibody of claim 1, the treatment resulting in one of the limitations listed (a-aa) of claim 22, and further administering one or more of the additional agent listed of claim 52.
Tanaka, however, in regards to claims 1, 2, and 9, teaches a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis with the anti-C5 antibody of claim 1, the treatment resulting in one of the limitations listed (a-aa) of claim 22, and further administering one or more of the additional agent listed of claim 52.
Gordon , however, in regards to claim 1 teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling. Further in regards to claim 52 Gordon teaches that the study allowed for continued use of a stable dose of methotrexate or azathioprine (pg.22, Takada 2002 Methods Section).
In regards to claim 22 Gordon teaches a common metric used to measure benefit of treatment in dermatomyositis includes achieving the international myositis assessment and clinical studies group (IMACS) definition of improvement. This is a core set of measures which include the physician global disease activity, manual muscle testing (MMT), physical function assessment, laboratory assessment, and extramuscular disease complications (pg.3, col 2, lines 38-49). Improvement is defined as occurring if three of any of the six core set measure improves by 20% (pg.3, col 2, lines 38-49). Further Gordon teaches a study adapted the MMT to have an 8 point MRC scale (MMT-8) (pg.5, col 2, lines 33-37).
Claim 58 of the instant application recites claims to a kit comprising the anti-C5 antibody of claim 1, and instructions for using the antibody with the method of claim 1. The kit does not impart any further functional or structural limitations as compared to the method claims and thus is also obvious by the rejections outlined above.
Thus, Andrien discloses the sequences of the anti-C5 antibody of the instant application, the substitutions in the Fc region, the binding affinity dissociation constant at pH 7.4 and 6.0, and further highlights maintaining a concentration of 100 μg/mL or higher allows for complete terminal complement (C5) inhibition, Lee teaches a dosing regimen for intravenous of the anit-C5 antibody for adults that was well tolerated, and Tanaka teaches a dosing regimen for pediatric patient that was also well tolerated . Further Gordon teaches eculizumab )of which the anti-C5 antibody of the instant application is an improved version of) has shown success in treating dermatomyositis as well as highlights the common metric used to measure the benefit of treatments in the disease. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to try the combination of the teachings of Andrien with Lee and Tanaka’s weight based dosing regimens, and informed by Gordon demonstration of success in dermatomyositis with a reasonable expectation of success to develop a method of treatment for dermatomyositis which uses the improved anti-C5 antibody to treat a dermatomyositis which has shown response to a similar antibody with a weight based dosing mechanism in both adult and pediatric patients and is assessed on common metrics for a treatment which is well tolerated in patients who have not previously been exposed to complement inhibitors and has improved efficacy that is measurable on known metrics.
Claims 48, 49, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Andrien Jr. et al. in view of Lee et al., Tanaka et al., and Gordon PA et al. as applied to claim 1 above, and further in view of Oddis et al. (2013) Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis and Adult Polymyositis Arthritis & Rheumatism (65) 2: 314-324 (hereafter Oddis).
Andrien in view of Lee, Tanaka, and Gordon fails to teach the patient having a MMT-8 of ≤142/150 and two or more of the other assessments a) – e) prior to treatment of claim 48, the global disease activity score being based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary, and cardiac scales of the MDAAT of claim 49, and the muscles enzymes being selected from the group of claim 51.
Oddis however, teaches a method of evaluating a patient for enrollment into a study for the treatment of dermatomyositis or polymyositis requiring a score of <125 (of 150) on the MMT-8 in conjunction with 2 other abnormal CSMs, wherein the CSM needed to qualify for study entry in this trial consisted of 1 of the following 5 measures 1) patient’s/parent’s global assessment of disease activity by visual analog scale (VAS) with a minimum score of 2.0 cm (on scale of 10 cm, anchored at the ends and the midpoint); 2) physician’s global assessment of disease activity by VAS with a minimum score of 2.0 cm (on scale of 10 cm, anchored at the ends and the midpoint); 3) Health Assessment Questionnaire (HAQ) or Childhood HAQ (C-HAQ) disability index with a minimum value of 0.25; 4) elevated level of at least 1 (locally measured) muscle enzyme (creatine kinase, aldolase, lactate dehydrogenase, alanine aminotransferase, or aspartate aminotransferase AST) to a minimum of 1.3 times the upper limit of normal and 5) global extramuscular disease activity score with a minimum value of 1.0 cm (based on the investigator’s composite assessment of disease activity on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary, and cardiac scales of the Myositis Disease Activity Assessment Tool [MDAAT]), (pg.316, col 1, lines 4-28).
Thus, Andrien in view of Lee, Tanaka, and Gordon discloses a method of treatment for dermatomyositis which uses the improved anti-C5 antibody to treat a dermatomyositis which has shown response to a similar antibody with a weight based dosing mechanism in both adult and pediatric patients and is assessed on common metrics, and Oddis teaches a method of evaluating patient for enrollment in to a study for the treatment of dermatomyositis to ensure the patient had dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of Andrien in view of Lee, Tanaka, and Gordon with the teachings of Oddis with a reasonable expectation of success to develop a method wherein the patients are determined to have dermatomyositis by a variety of test to ensure disease presence.
Claims 24 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Andrien et al. in view of Lee et al., Tanaka et al., and Gordon et al. as applied to claims 1 and 22 above, and further in view of DeWane et al. (2020) Dermatomyositis: Clinical features and pathogenesis J Am Acad Dermatol 82 (2) 267-281 (hereafter DeWane).
Andrien in view of Lee, Tanaka, and Gordon fails to teach the specific autoantibodies of claim 24 and the patient has one or more of a) – e) prior to treatment of claim 50.
DeWane, however, in regards to claim 24 teaches NXP2 and MDA5 are dermatomyositis specific autoantibodies, and further teaches they are potentially helpful to dermatologist because they may facilitate diagnosis, in the absence of a biopsy and in atypical DM cases, they can impact prognosis and help guide management, and they allow for clinical studies to select patients based on serologies (pg.273, col 2, lines 2-19).
In regards to claim 50 DeWane teaches that biopsy is a way to determine muscle weakness to determine the presence of myopathy (pg.268, col 2, lines 31-37), and further highlight important characteristic findings in skin or muscle biopsies for determining the prognosis of dermatomyositis (pg. 268, col 2, line 48 – pg.270, col 2, line 4).
Thus, Andrien in view of Lee, Tanaka, and Gordon discloses a method of treatment for dermatomyositis which uses the improved anti-C5 antibody to treat a dermatomyositis which has shown response to a similar antibody with a weight based dosing mechanism in both adult and pediatric patients and is assessed on common metrics, and DeWane teaches that autoantibodies and skin and muscles biopsy are ways to determine the clinical prognosis and severity of dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of Andrien in view of Lee, Tanaka, and Gordon with the teachings of DeWane with a reasonable expectation of success to develop a method of treating dermatomyositis with a weight based administration method and further wherein biopsy or autoantigen expression is used to determine patient prognosis and severity and assess their suitability for the anti-C5 treatment.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Andrien et al. in view of Lee et al., Tanaka et al., and Gordon et al. as applied to claim 1 above, and further in view of Koler et al. (2001) Dermatomyositis American Family Physician 64 (9) 1565-1572 (hereafter Koler).
Andrien in view of Lee, Tanaka, and Gordon fails to teach the additional agent from a list of options a) – j) of claim 53.
Koler, however, teaches topical steroids (e) and antihistamines (a) are good agents for further control the erythematous and pruritic skin changes or control of sever pruritus, respectively (Table 8).
Thus, Andrien in view of Lee, Tanaka, and Gordon discloses a method of treatment for dermatomyositis which uses the improved anti-C5 antibody to treat a dermatomyositis which has shown response to a similar antibody with a weight based dosing mechanism in both adult and pediatric patients and is assessed on common metrics, and Koler teaches additional agent to treat specific symptoms of the disease. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of Andrien in view of Lee, Tanaka, and Gordon with the teachings of Koler with a reasonable expectation of success to develop a method of treating dermatomyositis with a weight based administration method and further with an additional agent which can treat specific symptoms of dermatomyositis for an improved treatment regimen for patients.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Andrien et al. in view of Lee et al., Tanaka et al., and Gordon et al. as applied to claim 1 above, and further in view of Waldman et al. (2020) Dermatomyositis: Diagnosis and treatment J Am Acad Dermatol 82(2) 283-296 (hereafter Waldman).
Lee teaches the patients included in the study are naïve to complement inhibitors to demonstrate the efficacy of ravulizumab in patients without prior treatment ().
Lee fails to teach the previous treatment which has not been administered being from the list of a) – l) treatments of claim 54.
Waldman however teaches that common and emerging treatment for dermatomyositis are Infliximab and Anakinra (Table III) as well as Rituximab (pg.291, col 2, line 9- pg.292, col 2, lines 17) and Intravenous immunoglobulin (pg.292, col 2, lines 18-25).
Thus, Andrien in view of Lee, Tanaka, and Gordon discloses a method of treatment for dermatomyositis which uses the improved anti-C5 antibody to treat a dermatomyositis which has shown response to a similar antibody with a weight based dosing mechanism in both complement inhibitor naïve adults and pediatric patients and is assessed on common metrics, and Waldman teaches other treatments of dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the teachings of Andrien in view of Lee, Tanaka, and Gordon with the teachings of Waldman with a reasonable expectation of success to develop a method of treating dermatomyositis with a weight based administration method and further wherein the patient has not been exposed to a previous treatment for dermatomyositis to determine the efficacy of the anti-C5 antibody in patients naïve to treatment.
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, 19, and 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 11-14, 16, 17, and 22 of U.S. Patent No. 12,617,846 in view of Lee et al. and Tanaka et al.
Claim 1 of the U.S. Patent recites claims to a method a treating a human patient with a complement- associated conditions (such as dermatomyositis) by subcutaneously co-administering to the patient a hyaluronidase and anti-C5 antibody. Further the claim recites the anti-C5 antibody has CDR1, CDR2, and CDR3 heavy chain sequences of SEQ ID NOs: 19, 18, and 3, respectively, and CDR1, CDR2, and CDR3 light chain sequences of SEQ ID NOs: 4, 5, and 6 respectively. SEQ ID NOs: 19, 18, and 3 of the patent are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. Therefore claim 1 of the patent significantly overlaps with instant application claim 1.
Claim 5 of the U.S. Patent recites claim to the anti-C5 antibody comprising a variant Fc constant region that binds to human FcRn with the substitutions Met-429-Leu and Asn-435-Ser. This significantly overlaps with instant claim 3.
Claim 11 of the U.S. Patent recites claim to the anti-C5 antibody comprises a heavy chain variable region of SEQ ID NO: 12 and a light chain variable region of SEQ ID NO: 8. SEQ ID NOs: 12 and 8 of the patent are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively. Therefore, patent claim 11 significantly overlaps with claim 4 of the instant application.
Claim 12 of U.S. Patent recites claim to the anti-C5 antibody comprises a heavy constant chain of SEQ ID NO: 13. SEQ ID NO: 13 of the patent is identical to SEQ ID NO: 13 of the instant application, therefore, claim 12 of the patent significantly overlaps with claim 5 of the instant application.
Claim 13 of the U.S. patent recites claim to the anti-C5 antibody comprises a heavy chain polypeptide of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the patent are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, patent claim 13 significantly overlaps with claim 6 of the instant application.
Claim 14 of the U.S. patent recites claim to the anti-C5 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 ≤ 1nM and/or binds to human C5 at pH 6.0 and 25 °C with a KD ≥ 10nM. This significantly overlaps with instant application claims 7 and 8.
Claim 16 of the U.S. patent recites claim to the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
Claim 17 of the U.S. patent recites the complement-associated condition is selected from a group of conditions which includes dermatomyositis. This significantly overlaps with instant application claim 1.
Claim 22 of the U.S. patent recites wherein the patient is an adult, this significantly overlaps with instant application claim 57.
The U.S. Patent fails to teach the dosing regimen of claims 1, 2, and 9 of the instant application. Lee, however, in regards to claims 1, 2, and 9 teaches a dosing regimen in adults treated with ravulizumab wherein ”a loading dose (2400 mg for patients weighing <, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 kg to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter” (pg.531, col 1, lines 51-57).
Lee fails to teach the loading dose of 900mg, followed by a maintenance dose of 2100 mg two weeks (or day 15) later and then once every eight week thereafter to a patient weighing < 30 kg or a loading dose of 1200mg, followed by a maintenance dose of 2700mg two weeks later (or on day 15) and then once every eight weeks thereafter to a patient weighing ≥ 30 kg to < 40 kg, of claims 1, 2, and 9.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Thus, the U.S. Patent discloses a method of treating a complement associated condition with the anti-C5 antibody of the instant application and further states the condition can be dermatomyositis which significantly encompasses the instant application, and Lee and Tanaka teach a weight based dosing regimen for adult and pediatric patients. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the U.S. Patent would have found it obvious to use the teachings of Lee and Tanaka to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method.
Claims 1-9, 19, 21, and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7, 8, and 12 of U.S. Patent No. 12,612,451 in view of Tanaka et al. and Gordon PA et al.
Claim 1 of the U.S. patent recites claim to a method for treating (NMSOD) in a human subject comprising administering an anti-C5 antibody which comprises CDR1, CDR2, and CDR3 heavy chain sequences of SEQ ID NOs: 19, 18, and 3, respectively, and CDR1, CDR2, and CDR3 light chain sequences of SEQ ID NOs: 4, 5, and 6 respectively and the Fc region comprises the amino acid sequence set forth in SEQ ID NO: 13. Further the administration cycle comprises (a) once on day 1 of the administration cycle at a dose of: 2400 mg to a patient weighing ≥ 40 to < 60 kg, 2700 mg to a patient weighing ≥ 60 to < 100 kg, or 3000 mg to a patient weighing ≥ 100 kg; and (b) on day 15 of the administration cycle and every eight weeks thereafter at a dose of 3000 mg to a patient weighing ≥ 40 to < 60 kg, 3300 mg to a patient weighing ≥ 60 to < 100 kg, or 3600 mg to a patient weighing ≥ 100 kg. SEQ ID NOs: 19, 18, and 3 of the U.S. patent are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the U.S. patent are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. SEQ ID NO: 13 of the U.S. patent is identical to SEQ ID NO: 13 of the instant application. Therefore claim 1 of the U.S. patent significantly overlaps with instant application claims 1, 2, and 9.
Claim 2 of the U.S. patent recites the antibody comprises a heavy chain variable region of SEQ ID NO: 12 and a light chain variable region of SEQ ID NO: 8, a heavy constant chain of SEQ ID NO: 13, or a heavy chain polypeptide of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 12, 8, 13, 14, and 11 of the U.S. patent are identical to SEQ ID NOs: 12, 8, 13, 14, and 11 of the instant application, respectively. Therefore, U.S. patent claim 2 significantly overlaps with claim 4 of the instant application.
Claim 3 of the U.S. patent recites the anti-C5 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 ≤ 1nM, or at pH 6.0 and 25 °C with a KD ≥ 10nM. This significantly overlaps with instant application claims 7 and 8.
Claim 7 of the U.S. patent which depends on claim 6 recites the addition of at least one immunosuppressive therapy (claim 6) selected from a group which includes Azathioprine and Methotrexate. This significantly overlaps with instant application claim 52.
Claim 8 of the U.S. patent recites claim to the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
Claim 12 of the U.S. patent recites the anti-C5 antibody is administered intravenously to the patient. This significantly overlaps with instant claim 21.
The U.S. patent fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application, and the treatment of dermatomyositis of instant claim 1.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the U.S. patent discloses a method of treating NMOSD with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients, and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka and Gordon to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method to treat dermatomyositis which further includes pediatric patients.
Claims 1-3, 7-9, and 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 8 of U.S. Patent No. 12,128,101 in view of Tanaka et al. and Gordon PA et al.
Claim 1 of the U.S. patent recites claim to a method of treating a human patient with paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome comprising administering an anti-C5 antibody which comprises CDR1, CDR2, and CDR3 heavy chain sequences of SEQ ID NOs: 19, 18, and 3, respectively, and CDR1, CDR2, and CDR3 light chain sequences of SEQ ID NOs: 4, 5, and 6 respectively and the Fc region comprises the amino acid sequence set forth in SEQ ID NO: 13. Further the administration cycle comprises (a) once on day 1 of the administration cycle at a dose of: 2400 mg to a patient weighing ≥ 40 to < 60 kg, 2700 mg to a patient weighing ≥ 60 to < 100 kg, or 3000 mg to a patient weighing ≥ 100 kg; and (b) on day 15 of the administration cycle and every eight weeks thereafter at a dose of 3000 mg to a patient weighing ≥ 40 to < 60 kg, 3300 mg to a patient weighing ≥ 60 to < 100 kg, or 3600 mg to a patient weighing ≥ 100 kg. SEQ ID NOs: 19, 18, and 3 of the U.S. patent are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the U.S. patent are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. Therefore claim 1 of the U.S. patent significantly overlaps with instant application claims 1, 2, and 9.
Claim 2 of the U.S. patent recites claim to a similar method to claim one but add the further limitation that the Fc constant region comprises Met-429-Leu and Ans-435-Ser substitutions. This significantly overlaps with instant applications claims 1-3 and 9.
Claim 7 of the U.S. patent recites the anti-C5 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 ≤ 1nM, or at pH 6.0 and 25 °C with a KD ≥ 10nM. This significantly overlaps with instant application claims 7 and 8.
Claim 8 of the U.S. patent recites the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
The U.S. patent fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application, and the treatment of dermatomyositis of instant claim 1.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the U.S. patent discloses a method of treating paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients, and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka and Gordon to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method to treat dermatomyositis which further includes pediatric patients.
Claim 1-9, and 58 rejected on the ground of nonstatutory double patenting as being unpatentable over the claims as listed below in table 1 of U.S. Patent Nos. 9,709,949; 9,107,861; 9,371,377; 9,663,574; 9,803,007; 10,227,400; 10,584,164; and 11,434,280 in view of Lee et al., Tanaka et al., and Gordon PA et al. These patent are part of a family which stem from parent application U.S. Patent No. 9,709,949 because of this the rejections have been grouped together for all the patents in the family.
Table 1: DP claim outline
U.S. Patent No:
Referred to as:
Patent Claims
Instant Application Claims
US 9,079,949
US ’949
1-4, 6, 7, 9-12, 16
1-9, 58
US 9,107,861
US ‘861
1-4, 6, 7, 11 -13, 16
1-9
US 9,371,377
US ‘377
1-5, 7, 8, 11-15, 17
1-9, 58
US 9,663,574
US ‘574
1-7, 10
1-9, 58
US 9,803,007
US ‘007
1-6
1-9
US 10,227,400
US ’400
1-6
1-9
US 10,584,164
US ‘164
1-6
1, 2, 7-9
US 11,434,280
US ‘280
1-4, 6, 16-18
1-3, 6-9
Patents US ’949 (claims 1 and 9), US ‘861 (claims 1 and 11), US ‘377 (claims 1, 2, 12, and 13), US ‘574 (claims 1 and 2), US ‘007 (claim 1), US ‘400 (claim 1), and US ‘164 (claims 1 and 2) all recite an isolated antibody or method of using said antibody comprising CDR1, CDR2, and CDR3 heavy chain sequences of SEQ ID NOs: 23, 19, and 3 respectively and CDR1, CDR2, and CDR3 light chain sequences of SEQ ID NOs: 4, 5, and 6, and further the FC constant region comprises Met-429-Leu and Asn-435-Ser substitutions. SEQ ID NO 23, 19, and 3 of the US patents are identical SEQ ID NOs: 19, 18, and 3 respectively and SEQ ID NO 4, 5, and 6 of the US patents are identical to SEQ ID NOs: 4, 5, and 6. These claims significantly overlaps with instant application claims 1 and 3.
Patents US ’949 (claims 2 and 10), US ‘861 (claims 2 and 12), US ‘377 (claims 3 and 14), US ‘574 (claim 3), US ‘007 (claim 2), and US ‘400 (claim 2) all recite the antibody comprises a heavy chain variable region of SEQ ID NO: 12 and a light chain variable region of SEQ ID NO: 8. SEQ ID NOs: 8 and 12 of the patents are identical to SEQ ID NOs: 8 and 12 of the instant application. These claims significantly overlap with instant application claim 4.
Patents US ’949 (claims 3 and 11), US ‘861 (claims 3 and 13), US ‘377 (claims 4 and 15), US ‘574 (claim 4), US ‘007 (claim 3), and US ‘400 (claim 3) all recite the antibody comprises a heavy chain constant region of SEQ ID NO: 13. SEQ ID NO: 13 of the patents is identical to SEQ ID NO: 13 of the instant application. These claims significantly overlap with the instant application claim 5.
Patents US ’949 (claims 4 and 12), US ‘861 (claims 4 and 16), US ‘377 (claim 5), US ‘574 (claim 5), US ‘007 (claim 4), and US ‘400 (claim 4) all recite the antibody comprises a heavy chain polypeptide of SEQ ID NO: 14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 11 and 14 of the patents are identical to SEQ ID NOs: 11 and 14 of the instant application. These claims significantly overlap with instant application claim 6.
Patents US ’949 (claims 6 and 7), US ‘861 (claims 6 and 7), US ‘377 (claims 7 and 8), US ‘574 (claims 6 and 7), US ‘007 (claim 5 and 6), US ‘400 (claim 5 and 6), US ‘164 (claims 3, 4, 5, and 6), and US’ 280 (claim 18) all recite 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 ≤ 1nM, or at pH 6.0 and 25 °C with a KD ≥ 10nM. This significantly overlaps with instant application claims 7 and 8.
Patents US ‘494 (claim 16), US ‘377 (claims 11 and 17), and US ‘574 (claim 10) all recite a kit comprising the antibody and instructions for use. This significantly overlaps with instant application claim 58.
Patent US’ 280 claims 1 and 17 recites an antibody of CDR with options for substitutions in which (XI), or BNJ44 encompass the antibody of the instant application.
The U.S. patents fail to teach the dosing regimen of claims 1, 2, and 9 of the instant application, and the treatment of dermatomyositis of claim 1 of the instant application.
Lee, however, in regards to claims 1, 2, and 9 teaches a dosing regimen in adults treated with ravulizumab wherein ”a loading dose (2400 mg for patients weighing <, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 kg to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter” (pg.531, col 1, lines 51-57).
Lee fails to teach the loading dose of 900mg, followed by a maintenance dose of 2100 mg two weeks (or day 15) later and then once every eight week thereafter to a patient weighing < 30 kg or a loading dose of 1200mg, followed by a maintenance dose of 2700mg two weeks later (or on day 15) and then once every eight weeks thereafter to a patient weighing ≥ 30 kg to < 40 kg, of claims 1, 2, and 9. Lee further fails to teach the treatment of dermatomyositis.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the U.S. patents disclose an antibody or method of treating a complement associated conditions with the anti-C5 antibody of the instant application and further states the condition can be dermatomyositis which significantly encompasses the instant application, Lee and Tanaka teach a weight based dosing regimen for adult and pediatric patients, and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Lee, Tanaka, and Gordon to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method of treatment for dermatomyositis including pediatric patient.
Double Patenting - Provisional
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 5, 6, 7, and 32 of copending Application No. 19/335,301 (claim set 03/11/2026) (reference application) in view of Lee at al. and Tanaka et al.
Claim 1 of the reference application recites claims to a method a treating a human patient with a complement- associated conditions (such as dermatomyositis) by subcutaneously co-administering to the patient a hyaluronidase and anti-C5 antibody. Further the claim recites the anti-C5 antibody has CDR1, CDR2, and CDR3 heavy chain sequences of SEQ ID NOs: 19, 18, and 3, respectively, and CDR1, CDR2, and CDR3 light chain sequences of SEQ ID NOs: 4, 5, and 6 respectively. SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. Therefore claim 1 of the reference application significantly overlaps with instant application claim 1.
Claim 2 of the reference claim recites claim to the anti-C5 antibody comprising a variant Fc constant region that binds to human FcRn with the substitutions Met-429-Leu and Asn-435-Ser. This significantly overlaps with instant claim 3.
Claim 3 of the reference application recites the anti-C5 antibody comprises a heavy chain variable region of SEQ ID NO: 12 and a light chain variable region of SEQ ID NO: 8. SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively. Therefore, reference claim 3 significantly overlaps with claim 4 of the instant application.
Claim 4 of the reference application recite the anti-C5 antibody comprises a heavy constant chain of SEQ ID NO: 13. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application, therefore, claim 4 of the reference application significantly overlaps with claim 5 of the instant application.
Claim 5 of the reference application recite the anti-C5 antibody comprises a heavy chain polypeptide of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, reference claim 5 significantly overlaps with claim 6 of the instant application.
Claim 6 of the reference application recites the anti-C5 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 ≤ 1nM. This significantly overlaps with instant application claim 7.
Claim 7 of the reference application recites the anti-C5 antibody binds to human C5 at pH 6.0 and 25 °C with a KD ≥ 10nM. This significantly overlaps with instant application claim 8.
Claim 32 of the instant application recites the complement-associated condition is selected from a group of conditions which includes dermatomyositis. This significantly overlaps with instant application claim 1.
The reference application fails to teach the dosing regimen of claims 1, 2, and 9 of the instant application.
Lee, however, in regards to claims 1, 2, and 9 teaches a dosing regimen in adults treated with ravulizumab wherein ”a loading dose (2400 mg for patients weighing <, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 kg to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter” (pg.531, col 1, lines 51-57).
Lee fails to teach the loading dose of 900mg, followed by a maintenance dose of 2100 mg two weeks (or day 15) later and then once every eight week thereafter to a patient weighing < 30 kg or a loading dose of 1200mg, followed by a maintenance dose of 2700mg two weeks later (or on day 15) and then once every eight weeks thereafter to a patient weighing ≥ 30 kg to < 40 kg, of claims 1, 2, and 9.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Thus, the reference application discloses a method of treating a complement associated condition with the anti-C5 antibody of the instant application and further states the condition can be dermatomyositis which significantly encompasses the instant application, and Lee and Tanaka teach a weight based dosing regimen for adult and pediatric patients. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Lee and Tanaka to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method.
This is a provisional nonstatutory double patenting rejection.
Claims 1-6, 9, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32, 33, 38-41, 48, 49, and 52 of copending Application No. 17/738,131 (claim set 02/25/2026) in view of Lee et al. and Tanaka et al.
Claims 32 and 33 of the reference application recites claims to a method a treating a human patient with a complement- associated conditions (such as dermatomyositis) by administering a stable aqueous solution wherein the solution comprises an anti-C5 antibody at a concentration of about 100 mg/mL, wherein the anti-C5 antibody comprises a heavy chain CDR1 comprising the amino acid sequence depicted in SEQ ID NO: 19, a heavy chain CDR2 comprising the amino acid sequence depicted in SEQ ID NO: 18, a heavy chain CDR3 comprising the amino acid sequence depicted in SEQ ID NO:3, a light chain CDR1 comprising the amino acid sequence depicted in SEQ ID NO:4, a light chain CDR2 comprising the amino acid sequence depicted in SEQ ID NO:5, and a light chain CDR3 comprising the amino acid sequence depicted in SEQ ID NO:6. SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. Therefore claims 32 and 33 of the reference application significantly overlaps with instant application claim 1.
Claim 38 of the reference claim recites claim to the anti-C5 antibody comprised a variant Fc constant region that binds to human FcRn with the substitutions Met-429-Leu and Asn-435-Ser. This significantly overlaps with instant claim 3.
Claim 39 of the reference application recites the anti-C5 antibody comprises a heavy chain variable region of SEQ ID NO: 12 and a light chain variable region of SEQ ID NO: 8. SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively. Therefore, reference claim 39 significantly overlaps with claim 4 of the instant application.
Claim 40 of the reference application recite the anti-C5 antibody comprises a heavy constant chain of SEQ ID NO: 13. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application, therefore, claim 40 of the reference application significantly overlaps with claim 5 of the instant application.
Claim 41 of the reference application recite the anti-C5 antibody comprises a heavy chain polypeptide of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, reference claim 41 significantly overlaps with claim 6 of the instant application.
Claim 48 of the reference application recites the solution is administered subcutaneously or intravenously to the patient. This significantly overlaps with instant application claim 21.
Claims 49 and 52 of the instant application recites the complement-associated condition is selected from a group of conditions which includes dermatomyositis. This significantly overlaps with instant application claim 1.
The reference application fails to teach the dosing regimen of claims 1, 2, and 9 of the instant application.
Lee, however, in regards to claims 1, 2, and 9 teaches a dosing regimen in adults treated with ravulizumab wherein ”a loading dose (2400 mg for patients weighing <, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 kg to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter” (pg.531, col 1, lines 51-57).
Lee fails to teach the loading dose of 900mg, followed by a maintenance dose of 2100 mg two weeks (or day 15) later and then once every eight week thereafter to a patient weighing < 30 kg or a loading dose of 1200mg, followed by a maintenance dose of 2700mg two weeks later (or on day 15) and then once every eight weeks thereafter to a patient weighing ≥ 30 kg to < 40 kg, of claims 1, 2, and 9.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Thus, the reference application discloses a method of treating a complement associated condition with the anti-C5 antibody of the instant application and further states the condition can be dermatomyositis which significantly encompasses the instant application, and Lee and Tanaka teach a weight based dosing regimen for adult and pediatric patients. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Lee and Tanaka to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method.
This is a provisional nonstatutory double patenting rejection.
Claims 1-6, 9, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-9, 24, 25, and 29 of copending Application No. 19/020,875 (claim set 01/14/2025) in view of Lee et al. and Tanaka et al.
Claims 1 and 2 of the reference application recite claim to stable aqueous solutions comprising an anti-C5 antibody at a concentration of about 100 mg/mL, wherein the anti-C5 antibody comprises a heavy chain CDR1 comprising the amino acid sequence depicted in SEQ ID NO: 19, a heavy chain CDR2 comprising the amino acid sequence depicted in SEQ ID NO: 18, a heavy chain CDR3 comprising the amino acid sequence depicted in SEQ ID NO:3, a light chain CDR1 comprising the amino acid sequence depicted in SEQ ID NO:4, a light chain CDR2 comprising the amino acid sequence depicted in SEQ ID NO:5, and a light chain CDR3 comprising the amino acid sequence depicted in SEQ ID NO:6. SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. Therefore claims 1 and 2 of the reference application encompass the anti-C5 antibody of the instant application claim 1.
Claim 6 of the reference claim recites claim to the anti-C5 antibody comprised a variant Fc constant region that binds to human FcRn with the substitutions Met-429-Leu and Asn-435-Ser. This encompasses the anti-C5 antibody of instant application claim 3.
Claim 7 of the reference application recites the anti-C5 antibody comprises a heavy chain variable region of SEQ ID NO: 12 and a light chain variable region of SEQ ID NO: 8. SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively. Therefore, reference claim 7 encompasses the anti-C5 antibody of instant application claim 4.
Claim 8 of the reference application recite the anti-C5 antibody comprises a heavy constant chain of SEQ ID NO: 13. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application, therefore, claim 8 of the reference application encompasses the anti-C5 antibody of instant application claim 5.
Claim 9 of the reference application recite the anti-C5 antibody comprises a heavy chain polypeptide of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, reference claim 9 encompasses the anti-c5 antibody of instant application claim 6.
Claim 24 of the reference application which depends on claims 1-21 recites claim to a method of treating a human patient with a complement-associated condition (such as dermatomyositis), and further reference claim 24 list complement associated diseases to be selected from which includes dermatomyositis. This significantly overlaps with instant claims 1-6 and 9.
Claim 29 of the reference application which depends on claim 24-26 teaches the solution if administered intravenously to the patient. This significantly overlaps with instant claim 21.
The reference application fails to teach the dosing regimen of claims 1, 2, and 9 of the instant application.
Lee, however, in regards to claims 1, 2, and 9 teaches a dosing regimen in adults treated with ravulizumab wherein ”a loading dose (2400 mg for patients weighing <, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 kg to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter” (pg.531, col 1, lines 51-57).
Lee fails to teach the loading dose of 900mg, followed by a maintenance dose of 2100 mg two weeks (or day 15) later and then once every eight week thereafter to a patient weighing < 30 kg or a loading dose of 1200mg, followed by a maintenance dose of 2700mg two weeks later (or on day 15) and then once every eight weeks thereafter to a patient weighing ≥ 30 kg to < 40 kg, of claims 1, 2, and 9.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Thus, the reference application discloses a method of treating a complement associated condition with the anti-C5 antibody of the instant application which significantly encompasses the instant application, and Lee and Tanaka teach a weight based dosing regimen for adult and pediatric patients. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Lee and Tanaka to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method.
This is a provisional nonstatutory double patenting rejection.
Claims 1-6, 9, 19, 21, and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-9, 13-15, 21, and 42 of copending Application No. 18/830,680 (claim set 01/10/2025) in view of Tanaka et al.
Claim 1 of the reference application recites claim to a method of treating a human patient with a complement-associated condition comprising administering an anti-C5 antibody comprising CDR1, CDR2, and CDR3 heavy chain sequences as set forth in SEQ ID NOs: 19, 18, and 3, respectively and CDR1, CDR2, and CDR3 light chain sequences as set forth in SEQ ID NOs:4, 5, and 6, respectively. Further the reference claim recites the anti-C5 antibody is administered (a) once on day 1 of the administration cycle at a dose of: 2400 mg to a patient weighing ≥ 40 to < 60 kg, 2700 mg to a patient weighing ≥ 60 to < 100 kg, or 3000 mg to a patient weighing ≥ 100 kg; and (b) on day 15 of the administration cycle and every eight weeks thereafter at a dose of 3000 mg to a patient weighing ≥ 40 to < 60 kg, 3300 mg to a patient weighing ≥ 60 to < 100 kg, or 3600 mg to a patient weighing ≥ 100 kg (reference claims 13 and 14 also recite this dosing regimen). SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. Therefore claims 32 and 33 of the reference application significantly overlaps with instant application claims 1, 2, and 9.
Claim 2 of the reference claim recites claim to the anti-C5 antibody comprised a variant Fc constant region that binds to human FcRn with the substitutions Met-429-Leu and Asn-435-Ser. This significantly overlaps with instant claim 3.
Claim 7 of the reference application recites the anti-C5 antibody comprises a heavy chain variable region of SEQ ID NO: 12 and a light chain variable region of SEQ ID NO: 8. SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively. Therefore, reference claim 7 significantly overlaps with claim 4 of the instant application.
Claim 8 of the reference application recite the anti-C5 antibody comprises a heavy constant chain of SEQ ID NO: 13. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application, therefore, claim 8 of the reference application significantly overlaps with claim 5 of the instant application.
Claim 9 of the reference application recite the anti-C5 antibody comprises a heavy chain polypeptide of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, reference claim 9 significantly overlaps with claim 6 of the instant application.
Claim 15 of the reference application recites the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
Claim 21 of the reference application recites the anti-C5 antibody is administered intravenously to the patient. This significantly overlaps with instant claim 21.
Claim 42 of the reference application recites claim to a kit comprising the anti-C5 antibody. This significantly overlap with instant application claim 58.
The reference application fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Thus, the reference application discloses a method of treating a complement associated condition with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method which further includes pediatric patients.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 6, 9, 19, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60, 61, 67-70, and 72 of copending Application No. 19/014,677 (claim set 01/09/2025) in view of Tanaka et al.
Claim 60 of the reference application recites claim to a method of treating a human patient with a complement-associated (such as dermatomyositis) condition the method comprising administering an anti-C5 antibody comprising a heavy chain polypeptide of SEQ ID NO: 14 and a light chain polypeptide sequence pf SEQ ID NO: 11. (it is noted that these sequences encompass the CDRs of the instant application) Further the reference claim recites the anti-C5 antibody is administered (a) once on day 1 of the administration cycle at a dose of: 2400 mg to a patient weighing ˃ 40 to < 60 kg, 2700 mg to a patient weighing ˃ 60 to < 100 kg, or 3000 mg to a patient weighing ˃ 100 kg; and (b) on day 15 of the administration cycle and every eight weeks thereafter at a dose of 3000 mg to a patient weighing ˃ 40 to < 60 kg, 3300 mg to a patient weighing ˃ 60 to < 100 kg, or 3600 mg to a patient weighing ˃ 100 kg (reference claims 67-69 also recite this dosing regimen). SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, reference application claim 60 significantly overlap with instant application claims 1, 2, 6, and 9.
Claim 70 of the reference application recites the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
Claim 72 of the reference application recites the anti-C5 antibody is administered intravenously to the patient. This significantly overlaps with instant claim 21.
The reference application fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Thus, the reference application discloses a method of treating a complement associated condition with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method which further includes pediatric patients.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31, 34, 37, 46-48, and 50 of copending Application No. 19/014,615 (claim set 06/20/2026) in view of Lee et al. and Tanaka et al.
Claim 31 of the reference application recites claim to an antibody which inhibits the cleavages of C5 comprising CDR1, CDR2, and CDR3 heavy chain sequences as set forth in SEQ ID NOs: 1, 2, and 3 respectively and CDR1, CDR2, and CDR3 light chain sequences as set forth in SEQ ID NOs:4, 5, and 6, respectively. Further the claim the antibody has at least one amino acid substitution with a histidine from a list of options of which XI encompasses the CDRs of instant application claim 1.
Claim 34 of the reference application recites substitution in the CDRs that arrive at the CDRs of instant application claim 1.
Claim 37 of the reference application recites claim to the anti-C5 antibody comprises a variant Fc constant region that binds to human FcRn with the substitutions Met-429-Leu and Asn-435-Ser. This encompasses the anti-C5 antibody of instant application claim 3.
Claims 46 and 50 of the reference application which depend on claims 31 recites claim to a method of treating a human patient with a complement-associated condition and further lists the complement associated diseases to be selected from which includes dermatomyositis. This significantly overlaps with instant claims 1, 2, and 9.
Claim 47 of the reference application recites the antibody of claim 31 is selected from a group of which (a) is BNJ441 which is the antibody of the instant application. Further SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, reference claim 47 encompasses the antibody of instant application claim 6.
Claim 48 of the reference application recites the anti-C5 antibody binds to human C5 at pH 7.4 and 25 °C with an affinity dissociation constant KD that is KD ≤ 1nM and at pH 6.0 and 25 °C with a KD ≥ 10nM. This encompasses the antibody of instant claims 7 and 8.
The reference application fails to teach the dosing regimen of claims 1, 2, and 9 of the instant application.
Lee, however, in regards to claims 1, 2, and 9 teaches a dosing regimen in adults treated with ravulizumab wherein ”a loading dose (2400 mg for patients weighing <, 2700 mg for patients ≥60 kg to <100 kg, and 3000 mg for patients ≥100 kg) on day 1, followed by maintenance doses of ravulizumab (3000 mg for patients ≥40 to <60 kg, 3300 mg for patients ≥60 kg to <100 kg, and 3600 mg for patients ≥100 kg) on day 15 and every 8 weeks thereafter” (pg.531, col 1, lines 51-57).
Lee fails to teach the loading dose of 900mg, followed by a maintenance dose of 2100 mg two weeks (or day 15) later and then once every eight week thereafter to a patient weighing < 30 kg or a loading dose of 1200mg, followed by a maintenance dose of 2700mg two weeks later (or on day 15) and then once every eight weeks thereafter to a patient weighing ≥ 30 kg to < 40 kg, of claims 1, 2, and 9.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Thus, the reference application discloses a method of treating a complement associated condition with the anti-C5 antibody of the instant application and further states the condition can be dermatomyositis which significantly encompasses the instant application, and Lee and Tanaka teach a weight based dosing regimen for adult and pediatric patients. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Lee and Tanaka to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 19, 21, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 11, 13, 17, 20, and 24 of copending Application No. 18/861,494 in view of Tanaka et al. and Gordon PA et al.
Claim 1 of the reference application recites claim to a method of treating neuromyelitis optica spectrum disorder in a human subject comprising an antibody comprising CDR1, CDR2 and CDR3 heavy chain sequences as set forth in SEQ ID NOs:19, 18 and 3, respectively, and CDR1, CDR2 and CDR3 light chain sequences as set forth in SEQ ID NOs:4, 5 and 6, respectively, wherein the anti-C5 antibody or antigen binding fragment thereof comprises an Fc region comprising the amino acid sequence set forth in SEQ ID NO:13. SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application. This encompasses the antibody of instant claims 1 and 5.
Claim 2 of the reference patent recites the antibody comprises heavy chain variable region depicted in SEQ ID NO:12 and a light chain variable region depicted in SEQ ID NO:8, a heavy chain constant region depicted in SEQ ID NO:13, a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO:14 and a light chain polypeptide comprising the amino acid sequence of SEQ ID NO:11. SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively, and SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. This encompasses the antibody of instant claims 1 and 4-6.
Claim 5 of the reference patent recites 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 ≤ 1nM or at pH 6.0 and 25°C with a KD ≥ 10nM. This significantly overlaps with instant application claims 7 and 8.
Claim 11 of the reference patent recites the antibody is administered with without or with at least one immunosuppressive therapy, and further claim 13 of the reference application which depends on claim 11 provides a list of immunosuppressive therapies to select from. This significantly overlap with instant application claim 52.
Claim 17 of the reference application refers to a dosing regimen wherein the antibody is administered (a) once on day 1 of the administration cycle at a dose of: 2400 mg to a patient weighing ≥ 40 to < 60 kg, 2700 mg to a patient weighing ≥ 60 to < 100 kg, or 3000 mg to a patient weighing ≥ 100 kg; and (b) on day 15 of the administration cycle and every eight weeks thereafter at a dose of 3000 mg to a patient weighing ≥ 40 to < 60 kg, 3300 mg to a patient weighing ≥ 60 to < 100 kg, or 3600 mg to a patient weighing ≥ 100 kg. This significantly overlaps with instant application claims 1, 2, and 9.
Claim 20 of the reference application recites wherein the treatment maintains (i) a serum trough concentration of the antibody of 100 μg/mL or greater during the administration cycle. This significantly overlaps with instant application claim 19.
Claim 24 of the reference application recites the antibody is formulated for intravenous delivery which significantly overlaps with instant application claim 21.
The reference application fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application, and the treatment of dermatomyositis of instant claim 1.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the reference application discloses a method of treating neuromyelitis optica spectrum disorder with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients, and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka and Gordon to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method to treat dermatomyositis which further includes pediatric patients.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 6-9, 19, 21, and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43, 49, 50, 54, and 75 of copending Application No. 18/933,215 (claim set 04/18/2025) in view of Tanaka et al. and Gordon PA et al.
Claim 43 of the reference application recites a method for treating myasthenia gravis comprising administering an antibody of heavy chains polypeptide sequence of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. The claim further recites the administration cycle comprises (i) once on Day 1 at a loading dose of:(1) 2400 mg to a patient weighing ≥ 40 to < 60 kg, (2) 2700 mg to a patient weighing ≥ 60 to < 100 kg, or (3) 3000 mg to a patient weighing > 100 kg; and (ii) on Day 15 and every eight weeks thereafter at a maintenance dose of:(1) 3000 mg to a patient weighing ≥ 40 to< 60 kg,(2) 3300 mg to a patient weighing ≥ 60 to< 100 kg, or (3) 3600mg to a patient weighing > 100 kg where the antibody is delivered intravenously. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively, therefore reference claim 43 significantly overlaps with instant application claims 1, 2, 6, 9, and 21.
Claim 49 of the reference application recites the anti-C5 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 ≤ 1nM. This significantly overlaps with instant application claim 7.
Claim 50 of the reference application recites the anti-C5 antibody binds to human C5 at pH 6.0 and 25 °C with a KD ≥ 10nM. This significantly overlaps with instant application claim 8.
Claim 54 of the reference application recites wherein the treatment maintains a serum trough concentration of the antibody of 100 μg/mL or greater during the administration cycle. This significantly overlaps with instant application claim 19.
Claim 75 of the instant application recites a kit comprising the antibody and instructions of use. This significantly overlaps with instant application claim 58.
The reference application fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application, and the treatment of dermatomyositis of instant claim 1.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the reference application discloses a method of treating myasthenia gravis with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients, and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka and Gordon to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method to treat dermatomyositis which further includes pediatric patients.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 19, 21, and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 15, 17, 31, and 32 of copending Application No. 18/011,807 (claim set 06/16/2023) in view of Gordon PA et al.
Claim 1 and 32 of the reference application recites claim to an anti-C5 antibody and a method of treating pediatric patients with Paroxysmal Nocturnal Hemoglobinuria comprising the anti-C5 antibody comprising CDR1, CDR2, and CDr3 heavy chain sequences as set forth in SEQ ID NOs: 19, 18, and 3 respectively, and CDR1, CDR2, and CDR3 light chain sequences as set forth in SEQ ID NOs: 4, 5, and 6 respectively. Further the claim recites a dosing regimen of (a) once on a Day 1 at a dose of 600mg to a patient to a patient weighing ≥ 5 to < 10 kg, 600mg to a patient weighing ≥ 10 to < 20 kg, 900mg to a patient weighing ≥ 20 to < 30 kg, 1200mg to a patient ≥ 30 to < 40 kg, 2400 mg to patient weighing ≥ 40 to < 60 kg, 2700 mg to patient weighing ≥ 60 to < 100 kg, or 3000mg to a patient weighing ≥ 100 kg; and on Day 15 and every four weeks thereafter at a dose of 300 mg to a patient to a patient weighing ≥ 5 to < 10 kg, 600mg to a patient weighing ≥ 10 to < 20 kg; or on Day 15 and every eight weeks thereafter at a dose of 2100mg to a patient weighing ≥ 20 to < 30 kg, 2700mg to a patient ≥ 30 to < 40 kg, 3000 mg to patient weighing ≥ 40 to < 60 kg, 3300 mg to patient weighing ≥ 60 to < 100 kg, or 3600mg to a patient weighing ≥ 100 kg. SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application. Therefore, this claims significantly overlaps with instant application claims 1, 2, and 9.
Claim 2 of the reference application further states the antibody comprises a variant human Fc constant region comprises Met429Leu and Asn435Ser substitution residues corresponding to methionine 428 and asparagine 434 of a native human IgG Fc constant region according to EU numbering. This significantly overlaps with instant application claims 1 and 3.
Claim 3 of the reference application further states the anti-C5 antibody comprises a heavy chain variable region set forth in SEQ ID NO: 12 and a light chain variable region set forth in SEQ ID NO: 8. SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively. Therefore, reference claim 3 significantly overlaps with claim 4 of the instant application.
Claim 4 of the reference application recite the anti-C5 antibody comprises a heavy constant chain of SEQ ID NO: 13. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application, therefore, claim 4 of the reference application significantly overlaps with claim 5 of the instant application.
Claim 5 of the reference application recite the anti-C5 antibody comprises a heavy chain polypeptide of SEQ ID NO:14 and a light chain polypeptide of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. Therefore, reference claim 5 significantly overlaps with claim 6 of the instant application.
Claim 6 of the reference application recites the anti-C5 antibody binds to human C5 at pH 7.4 and 25 °C with an affinity dissociation constant KD that is in the range of 0.1 nM ≤ KD 1nM ≤ 1nM and/or at pH 6.0 and 25 °C with a KD ≥ 10nM. This encompasses the antibody of instant claims 7 and 8.
Claim 15 of the reference application recites the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
Claim 17 of the reference application recites the anti-C5 antibody is administered intravenously to the patient. This significantly overlaps with instant claim 21.
Claim 31 of the reference application recites claim to a kit containing the antibody and instructions this significantly overlaps with instant application claim 58.
The reference application fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the reference application discloses a method of treating Paroxysmal Nocturnal Hemoglobinuria with the anti-C5 antibody of the instant application which significantly encompasses the instant application and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Gordon to try the method of the instant application to treat dermatomyositis due to the success of the biosimilar in treating the disease with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 19, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14 of copending Application No. 17/784,025 (claim set 06/22/2026) in view of Tanaka et al. and Gordon PA et al.
Claim 1 of the reference application recites claim to a method of treating a human patient with post-partum pregnancy-associated atypical hemolytic uremic syndrome comprising an anti-C5 antibody comprises a heavy chain CDR1 having the amino acid sequence of SEQ ID NO. 19; a heavy chain CDR2 having the amino acid sequence of SEQ ID NO. 18; a heavy chain CDR3 having the amino acid sequence of SEQ ID NO. 3; a light chain CDR1 having the amino acid sequence of SEQ ID NO. 4; a light chain CDR2 having the amino acid sequence of SEQ ID NO. 5; and an light chain CDR3 having the amino acid sequence of SEQ ID NO. 6. SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. This significantly overlaps with instant application claim 1.
Claim 2 of the reference application recites claim to the antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO: 14. Further reference claim 5 recites antibody comprises a heavy chain having the amino acid sequence SEQ ID NO: 14 and a light chain having the amino acid sequence of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. This is significantly overlaps with instant application claim 6.
Claim 3 of the reference application recites claim to the antibody comprising a heavy chain variable region of SEQ ID NO:12 and a light chain of SEQ ID NO:8 and/or a heavy chain constant region of SEQ ID NO:13. SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively and SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application. This significantly overlaps with instant application claims 4 and 5.
Claim 6 of the reference application recites claim to the antibody binds to C5 at pH 7.4 and 25 °C with a KD that is in the range 0.1 nM ≤ KD ≤ 1nM, which significantly overlaps with instant application claim 7.
Claim 7 of the reference application recites the antibody binds to C5 at pH 6.0 and 25 °C with a KD ≥ 10 nM, which significantly overlaps with the instant application claim 8.
Claim 8 of the reference application recites the antibody is formulated for intravenous administration, which significantly overlaps with instant claim 21.
Claims 9 and 11 of the references application recites the antibody is delivered by the weight based dosing regimen comprising (i) once on Day 1 at a loading dose of:(1) 2400 mg to a patient weighing ≥ 40 to < 60 kg, (2) 2700 mg to a patient weighing ≥ 60 to < 100 kg, or (3) 3000 mg to a patient weighing > 100 kg; and (ii) on Day 15 and every eight weeks thereafter at a maintenance dose of:(1) 3000 mg to a patient weighing ≥ 40 to< 60 kg,(2) 3300 mg to a patient weighing ≥ 60 to< 100 kg, or (3) 3600mg to a patient weighing > 100 kg. This significantly overlaps with instant application claim 1, 2, and 9.
Claim 10 of the reference application further recites the antibody a variant human Fc constant region comprises Met429Leu and Asn435Ser substitution residues corresponding to methionine 428 and asparagine 434 of a native human IgG Fc constant region according to EU numbering. This significantly overlaps with instant application claims 1 and 3.
Claim 14 of the reference application recites the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
The reference application fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application, and the treatment of dermatomyositis of instant claim 1.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the reference application discloses a method of treating post-partum pregnancy-associated atypical hemolytic uremic syndrome with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients, and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka and Gordon to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method to treat dermatomyositis which further includes pediatric patients.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 19, 21, and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 15, and 37 of copending Application No. 18/272,906 in view of Tanaka et al. and Gordon PA et al.
Claim 1 of the reference application recites claim to a method of treating a human patient with complement-mediated TMA comprising an anti-C5 antibody comprises a heavy chain CDR1 having the amino acid sequence of SEQ ID NO. 19; a heavy chain CDR2 having the amino acid sequence of SEQ ID NO. 18; a heavy chain CDR3 having the amino acid sequence of SEQ ID NO. 3; a light chain CDR1 having the amino acid sequence of SEQ ID NO. 4; a light chain CDR2 having the amino acid sequence of SEQ ID NO. 5; and an light chain CDR3 having the amino acid sequence of SEQ ID NO. 6. SEQ ID NOs: 19, 18, and 3 of the reference application are identical to SEQ ID NOs: 19, 18, and 3 of the instant application, respectively. SEQ ID NOs: 4, 5, and 6 of the reference application are identical to SEQ ID NOs: 4, 5, and 6, of the instant application, respectively. This significantly overlaps with instant application claim 1.
Claim 2 of the reference application further recites the antibody a variant human Fc constant region comprises Met429Leu and Asn435Ser substitution residues corresponding to methionine 428 and asparagine 434 of a native human IgG Fc constant region according to EU numbering. This significantly overlaps with instant application claims 3.
Claim 3 of the reference application recites claim to the antibody comprising a heavy chain variable region of SEQ ID NO:12 and a light chain of SEQ ID NO:8 SEQ ID NOs: 12 and 8 of the reference application are identical to SEQ ID NOs: 12 and 8 of the instant application, respectively. This significantly overlaps with instant application claim 4
Claim 4 of the instant application recites the antibody comprises a heavy chain constant region of SEQ ID NO:13. SEQ ID NO: 13 of the reference application is identical to SEQ ID NO: 13 of the instant application. This significantly overlaps with instant application claim 5.
Claim 5 of the reference application recites antibody comprises a heavy chain having the amino acid sequence SEQ ID NO: 14 and a light chain having the amino acid sequence of SEQ ID NO: 11. SEQ ID NOs: 14 and 11 of the reference application are identical to SEQ ID NOs: 14 and 11 of the instant application, respectively. This is significantly overlaps with instant application claim 6.
Claim 6 of the reference application recites claim to the antibody binds to C5 at pH 7.4 and 25 °C with a KD that is in the range 0.1 nM ≤ KD ≤ 1nM, which significantly overlaps with instant application claim 7.
Claim 7 of the reference application recites the antibody binds to C5 at pH 6.0 and 25 °C with a KD ≥ 10 nM, which significantly overlaps with the instant application claim 8.
Claim 8 of the reference application recites the antibody is formulated for intravenous administration, which significantly overlaps with instant claim 21.
Claims 9 of the references application recites the antibody is delivered by the weight based dosing regimen comprising (i) once on Day 1 at a loading dose of:(1) 2400 mg to a patient weighing ≥ 40 to < 60 kg, (2) 2700 mg to a patient weighing ≥ 60 to < 100 kg, or (3) 3000 mg to a patient weighing > 100 kg; and (ii) on Day 15 and every eight weeks thereafter at a maintenance dose of:(1) 3000 mg to a patient weighing ≥ 40 to< 60 kg,(2) 3300 mg to a patient weighing ≥ 60 to< 100 kg, or (3) 3600mg to a patient weighing > 100 kg. This significantly overlaps with instant application claim 1, 2, and 9.
Claim 15 of the reference application recites the serum concentration is maintained at 100 μg/mL or greater during administration cycle. This significantly overlaps with instant application claim 19.
Claim 37 recites claim to a kit comprising the antibody and instructions for use which significantly overlaps with instant application claim 58.
The reference application fails to teach the dosing regimen for the smaller weight ranges of claims 1, 2, and 9 of the instant application, and the treatment of dermatomyositis of instant claim 1.
Tanaka, however, in regards to claims 1, 2, and 9, teaches treating pediatric patient with ravulizumab with a loading dose of 900mg followed by a 2100mg maintenance dose on day 15 and every 8 week thereafter for patients weighing ≥20kg to <30kg or a loading dose of 1200kg followed by a maintenance dose of 2700kg on day 15 and every 8 weeks thereafter for patients weighing ≥30kg to <40kg (Figure 1). Further Tanaka teaches this dosing regime is beneficial for pediatric treatment (pg.890, col 1, lines 46-51).
Tanaka fails to teach the treatment of dermatomyositis.
Gordon , however, teaches a clinical trial where the treatment of dermatomyositis with eculizumab (an anti-C5 antibody) showed success in treating the disease (Section: Characteristics of Studies, pg. 21-22, Takada 2002). The antibody of the instant application is an improved version of the antibody eculizumab as taught above by Andrien in order to extend dosing by reducing antibody clearance through target-mediated antibody clearance and increasing the efficiency of FcRn-mediated antibody recycling.
Thus, the reference application discloses a method of treating complement-mediated TMA with the anti-C5 antibody of the instant application which significantly encompasses the instant application, Tanaka teaches a weight based dosing regimen for pediatric patients, and Gordon teaches the success of a biosimilar anti-C5 antibody for treating dermatomyositis. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention in possession of the reference application would have found it obvious to use the teachings of Tanaka and Gordon to arrive at the method of the instant application with a reasonable expectation of success to develop a well-tolerated method to treat dermatomyositis which further includes pediatric patients.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/D.A.A/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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