28!24!6Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, 8-19, 28, and 30 and species: serum concentration of 100 μg/mL or greater in the reply filed 11/18/2025 is acknowledged.
Claims 31-32 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 11/18/2025. Upon further consideration, the examiner is withdrawing the species requirement regarding the product. Claim 2 is now under examination.
Claims 1-6, 8-19, 28, and 30 are now under consideration in the instant Office Action.
Claim Objections
Claim 5 is objected to because of the following informalities: the word comprising is misspelled as “comprnsing”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the terminology “25C” is not a sufficient way of referring to 25 degrees Celsius. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Instant claim 19 recites the term “preferably”. This term renders the claim indefinite as it is unclear if the limitations recited after “preferably” are encompassed within the invention or not. For the purposes of examination, the instant claims will be interpreted without the optional limitations as they are not required or claimed as necessary to the invention.
Instant claim 19 refers to a “baseline” for several intended effects of the method when used on a patient. It is unclear what the “baseline” is as Applicant has not properly defined it as a comparative value.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-19, 28, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Payton et al. (WO 2019/231983 A1, in IDS filed 07/25/2023).
Payton et al. teaches a method of treating a human pediatric patient with Paroxysmal Nocturnal Hemoglobinuria (PNH), the method comprising administering to the patient an effective amount of an anti-C5 antibody or antigen binding fragment thereof, comprising CDR1, CDR2 and CDR3 heavy chain sequences as set forth in SEQ ID NOs: l9, 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, is administered: (a) once on Day 1 at a dose of 600 mg to a patient weighing > 5 to < 10 kg, 600 mg to a patient weighing > 10 to < 20 kg, 900 mg to a patient weighing > 20 to < 30 kg, 1200 mg to a patient weighing > 30 to < 40 kg, 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 and every four weeks thereafter at a dose of 300 mg to a patient weighing > 5 to < 10 kg or 600 mg to a patient weighing > 10 to < 20 kg; or on Day 15 and every eight weeks thereafter at a dose of 2100 mg to a patient weighing > 20 to < 30 kg, 2700 mg to a patient weighing > 30 to < 40 kg, 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, see Payton’s claim 1 and 3-5. The instantly claimed sequences are 100% match to the sequences of Payton et al., including the sequence identity numbers. This meets the limitations of instant claims 1 and 8-14 wherein the antibody, method of use, and dosage requirements are taught.
Payton et al. teaches the administration of the antibody “with a frequency to maintain about 175 micrograms of antibody per milliliter of the patient’s blood”, see page 7. Payton et al. also teaches the intravenous administration of said antibody for a total of 26 weeks, see claims 17-18. This meets the limitations of instant claims 15-18 and 28 wherein the serum concentration and method of administration of the antibody are taught.
Payton et al. also teaches modifications to the Fc region, wherein “a variant human Fc constant region that binds to human neonatal Fc receptor (FcRn), wherein the variant human Fc constant region comprises Met429Leu and Asn435Ser substitutions at residues corresponding to methionine 428 and asparagine 434 of a native human IgG Fc constant region, each in EU numbering”, see reference’s claim 2. Payton et al. also teaches the sequences for the heavy and light chain regions in claims 3-5, wherein 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, a heavy chain constant region set forth in SEQ ID NO: 13, and a heavy chain polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 14 and a light chain polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 11. The instantly claimed sequences are 100% match to the sequences of Payton et al., including the sequence identity numbers. Payton et al. disclose some of the binding characteristics of the antibody, stating “the anti-C5 antibody binds to human C5 at pH 7.4 and 25C with an affinity dissociation constant (KD) that is in the range 0.1 nM < KD < 1 nM”, see reference’s claim 6. This meets the limitations of instant claim 2 wherein the same modifications to the Fc constant region are made, instant claims 3-5 wherein the same sequences are taught for the claimed antibody, and instant claim 6 wherein the pH and affinity dissociation constants are the same.
Payton et al. teaches the intended results of the method, wherein “the efficacy of the treatment methods provided herein can be assessed using any suitable means. In one embodiment, for a pediatric PNH patient, the treatment produces at least one therapeutic effect selected from the group consisting of: a reduction or cessation in fatigue, abdominal pain, dyspnea, dysphagia and chest pain compared to baseline. In another embodiment, the treatment results in terminal complement inhibition. In another embodiment, the treatment results in a reduction of hemolysis as assessed by lactate dehydrogenase (LDH) levels compared to baseline. In another embodiment, the treatment produces a shift toward normal levels of at least one hemolysis-related hematologic biomarker selected, for example, from the group consisting of: free hemoglobin, haptoglobin, reticulocyte count, PNH red blood cell (RBC) clone and D-dimer. In another embodiment, the treatment produces a reduction in the need for blood transfusions compared to baseline”, see pages 7-8. This meets the limitations of instant claim 19 wherein the methods as taught result in the same intended effects. Payton et al. also discloses previous treatments for target populations wherein “the patient has previously been treated with eculizumab and Day 1 (e.g., of the administration cycle) is two weeks or more from the patient’s last dose of eculizumab”, see reference’s claim 27. This meets the limitations of instant claim 30 wherein the patient has been previously treated with eculizumab and the first day of treatment is two weeks or more from the patient’s last dose.
Therefore, the teachings of Payton et al. anticipate claims 1-6, 8-19, 28, and 30.
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 1-6, 8-19, 28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-12 of U.S. Patent No. 12,404,320 B2, hereinafter ‘320. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims either anticipate or are obvious variants over the instant claims.
‘320’s claims recite a method of treating a human pediatric patient with paroxysmal nocturnal hemoglobinuria (PNH) comprising administering an anti-C5 antibody or antigen binding fragment thereof. The anti-C5 antibody comprises (a) a variant human Fc constant region comprising M429L and N435S mutations corresponding to M428 and N434 of native human IgG Fc constant region in EU numbering (b) a VH and VL chain pair of SEQ ID NOs: 12 and 8, (c) a heavy chain constant region of SEQ ID NO: 13, corresponding to SEQ ID NO: 13 of the instant claims, and/or (d) a VH and VL chain pair of SEQ ID NOs: 14 and 11, corresponding to SEQ ID NOs: 14 and 11 of the instant claims (reference’s claims 1-2). ‘320’s claims further recite the dosing regimen of the instantly claimed invention (reference’s claims 4-9, 11). Further, the patient has previously been treated with eculizumab and Day 1 of the treatment is two weeks or more from the patient’s last dose of eculizumab (reference’s claim 12). The anti-C5 antibody is also formulated for intravenous administration (reference’s claim 17). Further recited is a kit comprising (i) a dose of the anti-C5 antibody and instructions for use (reference’s claim 1). Lastly, the anti-C5 antibody has the functional properties recited in instant claims 19 (reference’s claim 10).
Thus, the claims of ‘320 meet the limitations of the instant claims.
Claims 1-6, 8-19, 28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-12 of U.S. Patent No. 12,128,101 B2, hereinafter ‘101. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims either anticipate or are obvious variants over the instant claims.
‘101’s claims recite a method of treating a human pediatric patient with paroxysmal nocturnal hemoglobinuria (PNH) comprising administering an anti-C5 antibody or antigen binding fragment thereof. The anti-C5 antibody comprises (a) a variant human Fc constant region comprising M429L and N435S mutations corresponding to M428 and N434 of native human IgG Fc constant region in EU numbering (b) a VH and VL chain pair of SEQ ID NOs: 12 and 8, (c) a heavy chain constant region of SEQ ID NO: 13, corresponding to SEQ ID NO: 13 of the instant claims, and/or (d) a VH and VL chain pair of SEQ ID NOs: 14 and 11, corresponding to SEQ ID NOs: 14 and 11 of the instant claims (reference’s claims 1-2 and 6). ‘101’s claims further recite the dosing regimen of the instantly claimed invention (reference’s claims 1-2, 5, 8, 11-12). Further, the patient has previously been treated with eculizumab and Day 1 of the treatment is two weeks or more from the patient’s last dose of eculizumab (reference’s claim 3-5). The anti-C5 antibody is also formulated for intravenous administration (reference’s claim 10). Lastly, the anti-C5 antibody has the functional properties recited in instant claims 19 (reference’s claim 12).
Thus, the claims of ‘101 meet the limitations of the instant claims.
Claims 1-6, 8-19, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-12, 15 of U.S. Patent No. 11,365,241 B2, hereinafter ‘241, in view of Payton et al. (WO 2019/231983 A1, in IDS filed 07/25/2023).
‘241’s claims recite a stable aqueous solution comprising an anti-C5 antibody or antigen binding fragment thereof comprising the HCDRs of SEQ ID NOs: 19, 18, and 3, corresponding to SEQ ID NOs: 19, 18, and 3 of the instant claims, and the LCDRs of SEQ ID NOs: 4, 5, and 6, corresponding to SEQ ID NOs: 4, 5, and 6 of the instant claims (reference’s claim 1). The anti-C5 antibody comprises a variant human Fc constant region comprising M429L and N435S mutations corresponding to M428 and N434 of native human IgG Fc constant region in EU numbering (reference’s claim 6). The anti-C5 antibody can comprises 1) a VH and VL chain pair of SEQ ID NOs: 12 and 8, (2) a heavy chain constant region of SEQ ID NO: 13, corresponding to SEQ ID NO: 13 of the instant claims, or 3) a VH and VL chain pair of SEQ ID NOs: 14 and 11, corresponding to SEQ ID NOs: 14 and 11 of the instant claims (reference’s claims 7-9). Per the instant claims, the minimal structure required for an anti-C5 antibody 1) to bind to human C5 at pH 7.4 and 25 C with an affinity dissociation constant of 0.1 nM ≤ Kd ≤ 1 nM or 2) to bind to human C5 at pH 6.0 and 25C with a Kd > 10 nM or 3) to be safe, tolerable, efficacious, and sufficiently non-immunogenic in pediatric PNH patients after multiple IV doses includes having the HCDRs of SEQ ID NOs: 19, 18, and 3 and the LCDRs of SEQ ID NOs: 4, 5, and 6; As such, the anti-C5 antibody disclosed by the co-pending claims necessarily has the functional properties recited in the instant claims.
The reference’s claims do not recite a method of treating a pediatric human patient suffering from PNH nor the specific dosages or frequency of dosages of the anti-C5 antibody administered as recited in the instant claims.
However, Payton et al. discloses the same antibody as instantly claimed that are used in the same methods of treating paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients. See above for teachings regarding Payton et al.
It would have been obvious to one of ordinary skill in the art to modify the method of treating paroxysmal nocturnal hemoglobinuria (PNH) in a subject comprising administering an anti-C5 antibody to the subject as disclosed by ‘241 such that the subject is a pediatric patient and the anti-C5 antibody is substituted with the anti-C5 antibody of the issued claims. One of ordinary skill in the art would have been motivated to do so 1) pediatric subjects with PNH have a high rate of bone marrow failure, are susceptible to bone marrow cytogenetic abnormalities, and have similar rates of thrombotic events compared to adult patients and are thus in need of therapeutic intervention and 2) an anti-C5 antibody can be used to effectively treat PNH in a pediatric patient. It would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dose of the anti-C5 antibody administered as well as dosage frequency to effectively treat PNH in a pediatric patient. Moreover, the wherein clauses of instant claim 19 do not require a practitioner to measure any of the serum trough concentrations of the anti-C5 antibody nor any of the clinical endpoints of instant claim 19. Thus, the wherein clauses of instant claim 19 recite expected results/outcomes of the claimed treatment and do not add patentable weight to the claims. Therefore, one of ordinary skill in the art would expect that the anti-C5 antibody of the issued claims can be used to effectively treat PNH in a pediatric patient.
Claims 1-6, 8-19, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,079,949 B1, hereinafter ‘949, in view of Payton et al. (WO 2019/231983 A1, in IDS filed 07/25/2023).
‘949’s claims recite an anti-C5 antibody or antigen binding fragment thereof that binds to complement component human C5 and inhibits the cleavage of C5 into fragments C5a and C5b, comprising 1) the HCDRs of SEQ ID NOs: 23, 18, and 3, corresponding to SEQ ID NOs: 19, 18, and 3 of the instant claims, and the LCDRs of SEQ ID NOs: 4, 5, and 6, corresponding to SEQ ID NOs: 4, 5, and 6 of the instant claims; and 2) a variant human Fc constant region comprising M429L and N435S mutations corresponding to M428 and N434 of native human IgG Fc constant region in EU numbering (reference’s claim 1). The anti-C5 antibody can comprises 1) a VH and VL chain pair of SEQ ID NOs: 12 and 8, (2) a heavy chain constant region of SEQ ID NO: 13, corresponding to SEQ ID NO: 13 of the instant claims, or 3) a VH and VL chain pair of SEQ ID NOs: 14 and 11, corresponding to SEQ ID NOs: 14 and 11 of the instant claims (reference’s claims 2-4). Per the instant claims, the minimal structure required for an anti-C5 antibody 1) to bind to human C5 at pH 7.4 and 25 C with an affinity dissociation constant of 0.1 nM ≤ Kd ≤ 1nM or 2) to bind to human C5 at pH 6.0 and 25C with a Kd > 10 nM or 3) to be safe, tolerable, efficacious, and sufficiently non-immunogenic in pediatric PNH patients after multiple IV doses includes having the HCDRs of SEQ ID NOs: 19, 18, and 3 and the LCDRs of SEQ ID NOs: 4, 5, and 6;. As such, the anti-C5 antibody disclosed by the co-pending claims necessarily has the functional properties recited in the instant claims.
‘949’s claims do not recite a method of treating a pediatric human patient suffering from PNH nor the specific dosages or frequency of dosages of the anti-C5 antibody administered as recited in the instant claims.
However, Payton et al. discloses the same antibody as instantly claimed that are used in the same methods of treating paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients. See above for teachings regarding Payton et al.
It would have been obvious to one of ordinary skill in the art to modify the method of treating paroxysmal nocturnal hemoglobinuria (PNH) in a subject comprising administering an anti-C5 antibody to the subject as disclosed by ‘241 such that the subject is a pediatric patient and the anti-C5 antibody is substituted with the anti-C5 antibody of the issued claims. One of ordinary skill in the art would have been motivated to do so 1) pediatric subjects with PNH have a high rate of bone marrow failure, are susceptible to bone marrow cytogenetic abnormalities, and have similar rates of thrombotic events compared to adult patients and are thus in need of therapeutic intervention and 2) an anti-C5 antibody can be used to effectively treat PNH in a pediatric patient. It would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dose of the anti-C5 antibody administered as well as dosage frequency to effectively treat PNH in a pediatric patient. Moreover, the wherein clauses of instant claim 19 do not require a practitioner to measure any of the serum trough concentrations of the anti-C5 antibody nor any of the clinical endpoints of instant claim 19. Thus, the wherein clauses of instant claim 19 recite expected results/outcomes of the claimed treatment and do not add patentable weight to the claims. Therefore, one of ordinary skill in the art would expect that the anti-C5 antibody of the issued claims can be used to effectively treat PNH in a pediatric patient.
Claims 1-6, 8-19, 28, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-11, 13-30 of copending Application No. 17/612,368, hereinafter ‘368.
This is a provisional nonstatutory double patenting rejection.
‘368’s claims recite a method of treating a patient with vitiligo or paroxysmal nocturnal hemoglobinuria comprising administering an anti-C5 antibody or antigen binding fragment thereof. The anti-C5 antibody comprises (a) a variant human Fc constant region comprising M429L and N435S mutations corresponding to M428 and N434 of native human IgG Fc constant region in EU numbering (b) a VH and VL chain pair of SEQ ID NOs: 12 and 8, (c) a heavy chain constant region of SEQ ID NO: 13, corresponding to SEQ ID NO: 13 of the instant claims, and/or (d) a VH and VL chain pair of SEQ ID NOs: 14 and 11, corresponding to SEQ ID NOs: 14 and 11 of the instant claims (reference’s claims 1, 5-11). ‘368’s claims further recite the dosing regimen of the instantly claimed invention (reference’s claims 14-26). Further, the patient has previously been treated with eculizumab and Day 1 of the treatment is two weeks or more from the patient’s last dose of eculizumab (reference’s claim 28-30). The anti-C5 antibody is also formulated for intravenous administration (reference’s claim 27).
Claims 1-6, 8-19, 28, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 20-23, and 46 of copending Application No. 17/424,794, hereinafter ‘794, in view of Payton et al. (WO 2019/231983 A1, in IDS filed 07/25/2023).
This is a provisional nonstatutory double patenting rejection.
‘241’s claims recite a stable aqueous solution comprising an anti-C5 antibody or antigen binding fragment thereof comprising the HCDRs of SEQ ID NOs: 19, 18, and 3, corresponding to SEQ ID NOs: 19, 18, and 3 of the instant claims, and the LCDRs of SEQ ID NOs: 4, 5, and 6, corresponding to SEQ ID NOs: 4, 5, and 6 of the instant claims (reference’s claim 1). The anti-C5 antibody comprises a variant human Fc constant region comprising M429L and N435S mutations corresponding to M428 and N434 of native human IgG Fc constant region in EU numbering (reference’s claim 6). The anti-C5 antibody can comprises 1) a VH and VL chain pair of SEQ ID NOs: 12 and 8, (2) a heavy chain constant region of SEQ ID NO: 13, corresponding to SEQ ID NO: 13 of the instant claims, or 3) a VH and VL chain pair of SEQ ID NOs: 14 and 11, corresponding to SEQ ID NOs: 14 and 11 of the instant claims (reference’s claims 7-9). Per the instant claims, the minimal structure required for an anti-C5 antibody 1) to bind to human C5 at pH 7.4 and 25 C with an affinity dissociation constant of 0.1 nM ≤ Kd ≤ 1 nM or 2) to bind to human C5 at pH 6.0 and 25C with a Kd > 10 nM or 3) to be safe, tolerable, efficacious, and sufficiently non-immunogenic in pediatric PNH patients after multiple IV doses includes having the HCDRs of SEQ ID NOs: 19, 18, and 3 and the LCDRs of SEQ ID NOs: 4, 5, and 6; As such, the anti-C5 antibody disclosed by the co-pending claims necessarily has the functional properties recited in the instant claims.
The reference’s claims do not recite a method of treating a pediatric human patient suffering from PNH nor the specific dosages or frequency of dosages of the anti-C5 antibody administered as recited in the instant claims.
However, Payton et al. discloses the same antibody as instantly claimed that are used in the same methods of treating paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients. See above for teachings regarding Payton et al.
It would have been obvious to one of ordinary skill in the art to modify the method of treating paroxysmal nocturnal hemoglobinuria (PNH) in a subject comprising administering an anti-C5 antibody to the subject as disclosed by ‘241 such that the subject is a pediatric patient and the anti-C5 antibody is substituted with the anti-C5 antibody of the issued claims. One of ordinary skill in the art would have been motivated to do so 1) pediatric subjects with PNH have a high rate of bone marrow failure, are susceptible to bone marrow cytogenetic abnormalities, and have similar rates of thrombotic events compared to adult patients and are thus in need of therapeutic intervention and 2) an anti-C5 antibody can be used to effectively treat PNH in a pediatric patient. It would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dose of the anti-C5 antibody administered as well as dosage frequency to effectively treat PNH in a pediatric patient. Moreover, the wherein clauses of instant claim 19 do not require a practitioner to measure any of the serum trough concentrations of the anti-C5 antibody nor any of the clinical endpoints of instant claim 19. Thus, the wherein clauses of instant claim 19 recite expected results/outcomes of the claimed treatment and do not add patentable weight to the claims. Therefore, one of ordinary skill in the art would expect that the anti-C5 antibody of the issued claims can be used to effectively treat PNH in a pediatric patient.
Claims 1-6, 8-19, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-33, 38-45, 48-49, and 51 of copending Application No. 17/738,131, hereinafter ‘131, in view of Payton et al. (WO 2019/231983 A1, in IDS filed 07/25/2023).
This is a provisional nonstatutory double patenting rejection.
‘131’s claims recite a method of treating a human patient with a complement-mediated condition comprising intravenously or subcutaneously administering to the patient a stable aqueous solution comprising an anti-C5 antibody or antigen binding fragment can comprise 1) a VH and VL chain pair of SEQ ID NOs: 12 and 8 or SEQ ID NOs: 14 and 11, corresponding to SEQ ID NOs: 12 and 8 and SEQ ID NOs: 14 and 11of the instant claims (co-pending claims 39 and 41). In other embodiments, the anti-C5 antibody comprises a heavy chain constant region of SEQ ID NO: 13, corresponding to SEQ ID NO: 13 of the instant claims (co-pending claim 40). The antibody of the copending claims is used to treat complement-mediated conditions, wherein paroxysmal nocturnal hemoglobinuria (PNH) is listed (co-pending claims 32, 33, 49, 51). The anti-C5 antibody can further comprises a variant human Fc constant region comprising M429L and N435S mutations corresponding to M428 and N434 of native human IgG Fc constant region in EU numbering (co-pending claim 38). The anti-C5 antibody per the instant claims, the minimal structure required for an anti-C5 antibody 1) to bind to human C5 at pH 7.4 and 25 C with an affinity dissociation constant of 0.1 nM ≤ Kd ≤ 1nM or 2) to bind to human C5 at pH 6.0 and 25C with a Kd > 10 nM or 3) to be safe, tolerable, efficacious, and sufficiently non-immunogenic in pediatric PNH patients after multiple IV doses includes having the HCDRs of SEQ ID NOs: 19, 18, and 3 and the LCDRs of SEQ ID NOs: 4, 5, and 6;. As such, the anti-C5 antibody disclosed by co-pending claims necessarily has the functional properties recited in the instant claims.
The co-pending claims do not recite a method of treating a pediatric human patient suffering from PNH nor the specific dosages or frequency of dosages of the anti-C5 antibody administered as recited in the instant claims.
However, Payton et al. discloses the same antibody as instantly claimed that are used in the same methods of treating paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients. See above for teachings regarding Payton et al.
It would have been obvious to one of ordinary skill in the art to modify the method of treating paroxysmal nocturnal hemoglobinuria (PNH) in a subject comprising administering an anti-C5 antibody to the subject as disclosed by ‘131 such that the subject is a pediatric patient and the anti-C5 antibody is substituted with the anti-C5 antibody of the issued claims. One of ordinary skill in the art would have been motivated to do so 1) pediatric subjects with PNH have a high rate of bone marrow failure, are susceptible to bone marrow cytogenetic abnormalities, and have similar rates of thrombotic events compared to adult patients and are thus in need of therapeutic intervention and 2) an anti-C5 antibody can be used to effectively treat PNH in a pediatric patient. It would have been prima facie obvious to one of ordinary skill in the art to determine by routine experimentation the optimum dose of the anti-C5 antibody administered as well as dosage frequency to effectively treat PNH in a pediatric patient. Further, the antibodies of the instant claims and copending application share the same structures and reasonably, the same functions. As such, the antibody is expected to perform the same binding function across a variety of disease states. Moreover, the wherein clauses of instant claim 19 do not require a practitioner to measure any of the serum trough concentrations of the anti-C5 antibody nor any of the clinical endpoints of instant claim 19. Thus, the wherein clauses of instant claim 19 recite expected results/outcomes of the claimed treatment and do not add patentable weight to the claims. Therefore, one of ordinary skill in the art would expect that the anti-C5 antibody of the issued claims can be used to effectively treat PNH in a pediatric patient.
Conclusion
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675