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 .
Application Status
Claims 1-3, 5, 19, 21, 23, 35-41, 43, 46-48, 51, and 55 are pending and are examined on the merits herein.
Power of Attorney
It is noted that a Power of Attorney is not on record for the instant application. The Applicant is encouraged to file a Power of Attorney in the event that the Examiner needs to communicate with an authorized representative for the Applicant during the prosecution of the case.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 35. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
The recitation of (“an anti-IL-27antibody”) in line 3 of both claims is redundant and unnecessary.
Appropriate correction is required.
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 1-2, 35-39, 41, 43, 46-48, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill (WO 2019/183499 A1; PTO-892).
Regarding claims 1, 2, and 51, Hill teaches an isolated monoclonal antibody that specifically binds human IL-27, or antigen binding portion thereof, wherein the antibody or antigen binding portion thereof comprises heavy and light chain CDRs selected from the group consisting of: (i) heavy chain CDR1 consisting of N-GFTFXXXX-C (SEQ ID NO: 408), heavy chain CDR2 consisting of N-ISSSXXYI-C (SEQ ID NO: 409), and heavy chain CDR3 sequence set forth in SEQ ID NO: 163; and light chain CDR1, CDR2 and CDR3 sequences set forth in SEQ ID NOs: 169, 170 and 171, respectively (claim 4); wherein the heavy chain CDR1, CDR2 and CDR3 sequences are set forth in SEQ ID NOs: 161, 162 and 163, respectively, and the light chain CDR1, CDR2 and CDR3 sequences are set forth in SEQ ID NOs: 169, 170 and 171, respectively (claim 6). The SEQ ID NOs: 161-163 and 169-171 have 100% sequence identity to the instant claimed SEQ ID NOs: 5-7 and 13-15 respectively. Hill further teaches a method of stimulating an immune response, or treating a cancer in a subject, the method comprising administering to the subject an effective amount of the isolated monoclonal antibody, or antigen binding fragment, of any one claims 1-69 (claims 82-84), in combination with one or more additional therapeutic agents, wherein the agent is a PD-1 antagonist; specifically pembrolizumab (page 22, lines 16-30).
Regarding claims 35-37, Hill teaches the method comprising exposing a cell to an antibody, or antigen binding portion thereof, provided by the disclosure, concurrently with or sequentially to an anti-PD-1 antibody (page 103, lines 3-5). Concurrent administration necessitates that the administration is on the same day.
Regarding claim 38, Hill teaches that in some embodiments, the anti-IL-27 antibody, or antigen binding portion thereof, is administered first in time and the one or more additional therapeutics are administered second in time (page 103, lines 2-4).
Regarding claim 39, Hill teaches that in some embodiments the additional therapeutics are administered first in time and the anti-IL-27 antibody is administered second in time (page 102, lines 5-6).
Regarding claims 41, 43, and 46-48, Hill teaches an isolated monoclonal antibody that specifically binds to and antagonizes human IL-27, or antigen binding portion thereof, wherein the antibody or antigen binding portion thereof comprises heavy and light chain variable regions comprising amino acid sequences at least 90% identical to the amino acid sequences selected from the group consisting of: (vi) SEQ ID NO: 167 and 175, respectively (claim 55), SEQ ID NO: 167 has 100% sequence identity to the instant claimed SEQ ID NOs: 11, 21 and 25; and SEQ ID NO: 175 has 100% sequence identity to the instant claimed SEQ ID NOs: 19 and 23.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hill (WO 2019/183499 A1; PTO-892) as applied to claims 1-2, 35-39, 41, 43, 46-48, and 51 above, and further in view of Patnaik (ASCO Poster Abstract 2551; published online May 19, 2021; PTO-892).
The teachings of Hill regarding claims 1-2, 35-39, 41, 43, 46-48, and 51 are detailed above.
Regarding claim 3, Hill teaches a dose of 25 mg/kg demonstrate complete saturation of transfection derived IL-27 in vivo (page 151, lines 3-4), the instant specification defines “about” as +/- 10% which would maximize the instant claimed dose at 22mg/kg.
Regarding claim 5, Hill teaches IL-27 antibodies were dosed once weekly in an animal model of melanoma lung metastasis (page 146, Example 8).
Hill further teaches that the IL27 antibody corresponding to SEQ ID NOs: 167 and 175 is referred to as SFR388 (pages 170-173).
Hill does not teach the specific dosing range of the IL-27 antibody of 0.003 mg/kg to 20 mg/kg.
Patnaik teaches dosing of solid tumor hepatocellular carcinoma and renal carcinoma patients refractory to standard therapy (method) with 0.003 to 10 mg/kg SFR388 in a phase I clinical trial that was administered every 4 weeks (results). Patnaik further teaches that SRF388 is well tolerated at doses that achieve maximal inhibition of downstream pSTAT signaling (conclusions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the dosing and timing of SRF388 (anti-IL-27 antibody) as taught by Patnaik to the method of administration of an IL-27 antibody and pembrolizumab as taught by Hill. The ordinary artisan would have been motivated to do so because as Patnaik teaches the dose was well tolerated with maximal downstream pathway inhibition in hepatocellular carcinoma patients. The ordinary artisan has a reasonable expectation of success as Hill and Patnaik are the exact same IL-27 antibody being administered to treat cancer and Patnaik demonstrates human dose testing with safety and efficacy.
Claims 19, 21, 23, 40, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Hill (WO 2019/183499 A1; PTO-892) as applied to claims 1-2, 5, 35-39, 41, 43, 46-48, and 51 above, and further in view of Keytruda (FDA insert 2022; PTO-892).
The teachings of Hill regarding claims 1-2, 5, 35-39, 41, 43, 46-48, and 51 are detailed above.
Hill does not teach the dosing or timing of administration of Pembrolizumab.
Regarding claims 19 and 23, Keytruda teaches that pembrolizumab should be dosed at 2mg/kg every 3 weeks for pediatric melanoma patients (dosage and administration, page 2).
Regarding claim 21, Keytruda teaches that pembrolizumab should be administered at 200 mg every 3 weeks for adult melanoma patients and hepatocellular carcinoma patients (dose and administration; page 2).
Regarding claim 55, Keytruda further teaches that pembrolizumab is approved for use in melanoma patients following complete resection and hepatocellular carcinoma patients who have been preciously treated with sorafenib (indications and usage page 1).
Keytruda further teaches that in placebo-controlled trial in patients with completely resected stage IIB or IIC melanoma, patients were randomized to KEYTRUDA 200 mg or the pediatric (≥12 years old) dose of KEYTRUDA 2 mg/kg intravenously (up to a maximum of 200 mg) every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity that demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67). Keytruda further teaches that patients were randomized to KEYTRUDA 200 mg intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity and demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the dosing and timing of pembrolizumab as taught by Keytruda to the method of administration of an IL-27 antibody and pembrolizumab as taught by Hill. The ordinary artisan would have been motivated to do so because as Keytruda teaches pembrolizumab is an FDA approved treatment for melanoma after total resection with demonstrated clinical efficacy at the specified doses. The ordinary artisan has a reasonable expectation of success to administer pembrolizumab as the FDA recommends to melanoma patients or hepatocellular carcinoma patients at the specified doses and time intervals to achieve improved clinical results.
Further regarding claim 40 the ordinary artisan would have understood that sequential administration of IL-27 antibody every week with pembrolizumab every three weeks could be administered on separate days.
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 1-2, 19, 21, 23, 41, 43, 46-48, and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6, 10-12, and 15-18 of U.S. Patent No.11,332,524 B2 (PTO-892) in view of Keytruda (FDA insert revised 03/2022; PTO-892).
Regarding claims 1-2, the patented claims teach an isolated monoclonal antibody that specifically binds human IL-27, or antigen binding portion thereof, wherein the antibody or antigen binding portion thereof comprises heavy and light chain CDRs selected from the group consisting of: (i) heavy chain CDR1 consisting of N-GFTFXXXX-C (SEQ ID NO: 408), heavy chain CDR2 consisting of N-ISSSXXYI-C (SEQ ID NO: 409), and heavy chain CDR3 sequence set forth in SEQ ID NO: 163; and light chain CDR1, CDR2 and CDR3 sequences set forth in SEQ ID NOs: 169, 170 and 171, respectively (claim 1), wherein the heavy chain CDR1 comprises the amino acid sequence set forth in SEQ ID NO: 161, the heavy chain CDR2 comprises the amino acid sequence set forth in SEQ ID NO: 162, the heavy chain CDR3 comprises the amino acid sequence set forth in SEQ ID NO: 163 the light chain CDR1 comprises the amino acid sequence set forth in SEQ ID NO: 169, the light chain CDR2 comprises the amino acid sequence set forth in SEQ ID NO: 170, and the light chain CDR3 comprises the amino acid sequence set forth in SEQ ID NO: 171 (claims 4 and 15). SEQ ID NO: 408, 409 predict instant claimed sequences SEQ ID NOs: 5 and 6. SEQ ID NOs: 161-163 and 169-171 have 100% sequence identity to the instant claimed SEQ ID NOs: 5-7 and 13-15. The patented claims further teach the antibody or antigen binding portion thereof inhibits or reduces STAT1 and/or STAT3 phosphorylation in a cell, optionally wherein the cell is an immune cell or a cancer cell and the antibody or antigen binding portion thereof induces or enhances the PD-1-mediated secretion of one or more cytokines from a cell (claim 3), wherein the cell is an immune cell or a cancer cell (claim 6).
Regarding claims 41, 43, and 46-48, the patented claims teach wherein the heavy chain variable region comprises the amino acid sequence set forth in SEQ ID NO: 167, and the light chain variable region comprises the amino acid sequence set forth in SEQ ID NO: 175 (claims 10-12 and 16-18). SEQ ID NO: 167 has 100% sequence identity to the instant claimed SEQ ID NOs: 11, 21 and 25; and SEQ ID NO: 175 has 100% sequence identity to the instant claimed SEQ ID NOs: 19 and 23.
The patented claims do not teach combination treatment for cancer with pembrolizumab.
Regarding claims 1-2, Keytruda teaches that KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody (indications and usage page 1).
Regarding claims 19 and 23, Keytruda teaches that pembrolizumab should be dosed at 2mg/kg every 3 weeks for pediatric melanoma patients (dosage and administration, page 2).
Regarding claim 21, Keytruda teaches that pembrolizumab should be administered at 200 mg every 3 weeks for adult melanoma patients (dose and administration; page 2).
Regarding claim 55, Keytruda further teaches that pembrolizumab is approved for use in melanoma patients following complete resection (indications and usage page 1).
Keytruda further teaches that in placebo-controlled trial in patients with completely resected stage IIB or IIC melanoma, patients were randomized to KEYTRUDA 200 mg or the pediatric (≥12 years old) dose of KEYTRUDA 2 mg/kg intravenously (up to a maximum of 200 mg) every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity that demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67). Keytruda further teaches that patients were randomized to KEYTRUDA 200 mg intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity and demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67).
It would have been obvious to one of ordinary skill in the art to substitute pembrolizumab with the dosing and timing to treat cancer as taught by Keytruda in the method of enhancing PD-1 antibody activity with an IL-27 antibody as taught by the patented claims. The ordinary artisan would have been motivated to do so because as Keytruda teaches pembrolizumab is an FDA approved treatment for melanoma after total resection with demonstrated clinical efficacy at the specified doses and the patented claims teach that the IL-27 antibody enhances the PD-1-mediated secretion of one or more cytokines from a cell wherein the cell is a cancer cell. The ordinary artisan has a reasonable expectation of success to administer pembrolizumab as the FDA recommends to melanoma patients at the specified doses and time intervals to achieve improved clinical results in combination with an IL-27 antibody that will enhance the anti-PD-1 antibody effects in cancer cells.
Claims 1-3, 5, 19, 21, 23, 35-37, 40-41, 43, 46-48, 51, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 35, 40-41, 43, 45-48, and 51 of copending Application No.18/201,626 in view of Halmos (Lung Cancer. 2021 May;155:175-182; PTO-892) and Keytruda (FDA insert revised 03/2022; PTO-892).
Regarding claims 1-2, the copending claims teach a method of stimulating an immune response in a subject and a method of treating cancer in a subject, the method comprising administering to the subject (i) an antibody that binds human IL-27 or an antigen binding portion thereof ("an anti-IL-27 antibody"), (ii) atezolizumab, and (iii) bevacizumab; wherein the anti-IL-27 antibody comprises a heavy chain CDR1 comprising the amino acid sequence set forth in SEQ ID NO: 5, a heavy chain CDR2 comprising the amino acid sequence set forth in SEQ ID NO: 6, a heavy chain CDR3 comprising the amino acid sequence set forth in SEQ ID NO: 7, a light chain CDR1 comprising the amino acid sequence set forth in SEQ ID NO: 13, a light chain CDR2 comprising the amino acid sequence set forth in SEQ ID NO: 14, and a light chain CDR3 comprising the amino acid sequence set forth in SEQ ID NO: 15 (claims 1-2). SEQ ID NOs: 5-7 and 13-15 share 100% sequence identity to the instant claimed same SEQ ID NOs.
Regarding claim 3, the copending claims teach wherein the anti-IL-27 antibody is administered at a dose of at least about 0.003 mg/kg to at least about 20 mg/kg (claim 3).
Regarding claim 5, the copending claims teach wherein the antiIL-27 antibody is administered once about every week, once about every two weeks, once about every three weeks, once about every four weeks, once about every 6 weeks, once about every 8 weeks, or once about every 12 weeks (claim 5).
Regarding claims 35-37, the copending claims teach wherein the anti-IL-27 antibody, atezolizumab, and bevacizumab are administered on the same day.,_ concurrently, or sequentially (claim 35).
Regarding claim 40, the copending claims teach wherein (i) the anti-IL-27 antibody and (ii) atezolizumab and bevacizumab are administered on different days (claim 40).
Regarding claim 41, the copending claims teach wherein the anti-IL-27 antibody comprises a heavy chain variable region comprising an amino acid sequence that has at least about 85%, at least about 90%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, [[or]] at least about 99%, or at least 100% sequence identity to the amino acid sequence set forth in SEQ ID NO: 11 (claim 41 and 45). SEQ ID NO: 11 share 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 43, the copending claims teach wherein the anti-IL-27 antibody comprises a light chain variable region comprising an amino acid sequence that has at least about 85%, at least about 90%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, [[or]] at least about 99%, or at least 100% sequence identity to the amino acid sequence set forth in SEQ ID NO: 19 (claim 43 and 45). SEQ ID NO: 19 share 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 46, the copending claims teach wherein the anti-IL-27 antibody comprises a heavy chain comprising the amino acid sequence set forth in SEQ ID NO: 21 (claim 46). SEQ ID NO: 21 share 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 47, the copending claims teach wherein the anti-IL-27 antibody comprises a heavy chain comprising the amino acid sequence set forth in SEQ ID NO: 25 (claim 47). SEQ ID NO: 25 share 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 48, the copending claims teach wherein the anti-IL-27 antibody comprises a light chain comprising the amino acid sequence set forth in SEQ ID NO: 23 (claim 48). SEQ ID NO: 23 share 100% sequence identity to the instant claimed same SEQ ID NO.
Regarding claim 51, the copending claims teach wherein the subject is afflicted with a cancer (claim 51).
The copending claims do not teach use of pembrolizumab in the method or the dose or timing of administration of the pembrolizumab.
Halmos teaches that multiple immunotherapy and chemotherapy combinations are approved for the management of advanced NSCLC and that a matching-adjusted indirect comparison (MAIC) was conducted (abstract/ objective) and that the MAIC results showed a significantly better PFS for pembrolizumab + chemotherapy compared with atezolizumab + chemotherapy + bevacizumab (abstract/ conclusion).
Regarding claims 19 and 23, Keytruda teaches that pembrolizumab should be dosed at 2mg/kg every 3 weeks for pediatric melanoma patients (dosage and administration, page 2).
Regarding claim 21, Keytruda teaches that pembrolizumab should be administered at 200 mg every 3 weeks for adult NSCLC patients (dose and administration; page 2).
Regarding claim 55, Keytruda further teaches that pembrolizumab is approved for use in melanoma patients following complete resection and NSCLC patients after platinum containing chemotherapy (indications and usage page 1).
Keytruda further teaches that in placebo-controlled trial in patients with completely resected stage IIB or IIC melanoma, patients were randomized to KEYTRUDA 200 mg or the pediatric (≥12 years old) dose of KEYTRUDA 2 mg/kg intravenously (up to a maximum of 200 mg) every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity that demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67). Keytruda further teaches that patients were randomized to KEYTRUDA 200 mg intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity and demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67). Keytruda further teaches that NSCLC patients had significant improvement in OS versus chemotherapy as well as a statistically significant improvement in OS, PFS and ORR in patients randomized to KEYTRUDA in combination with carboplatin and either paclitaxel or paclitaxel protein-bound chemotherapy compared with patients randomized to placebo with carboplatin and either paclitaxel or paclitaxel protein-bound chemotherapy (pages 71-73).
It would have been obvious to one of ordinary skill in the art to substitute pembrolizumab as taught by Halmos, with the dosing and timing as taught by Keytruda in the method of treating cancer with an IL-27 antibody as taught by the copending claims. The ordinary artisan would have been motivated to do so because Halmos teaches that pembrolizumab was significantly better for NSCLC patients than atezolizumab and bevacizumab and Keytruda teaches that pembrolizumab is approved as a single agent or in combination with chemotherapy for NSCLC with demonstrated clinical efficacy at the determined dose and timing. Therefore the ordinary artisan would have a reasonable expectation of success to improve NSCLC patient clinical outcomes by substituting pembrolizumab for atezolizumab and bevacizumab in the method of treating cancer with an IL-27 antibody and a secondary therapeutic.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 19, 21, 23, and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No.18/307,850 in view of Keytruda (FDA insert revised 03/2022; PTO-892).
Regarding claim 1-2, the copending claims teach a method of enhancing one or more activities of an anti-PD-1 antibody, the method comprising exposing a cell to an antibody that specifically binds human IL-27, or antigen binding portion thereof, concurrently with or sequentially to an anti-PD-1 antibody, thereby to enhance one or more activities of the anti-PD1 antibody, wherein the antibody that specifically binds human IL-27, or antigen binding portion thereof, comprises heavy and light chain CDRs selected from the group consisting of: (i) heavy chain CDR1, CDR2 and CDR3 sequences set forth in SEQ ID NOs: 161, 162, ad 163, respectively, and light chain CDR1, CDR2 and CDR3 sequences set forth in SEQ ID NOs: 169, 170, and 171, respectively (claim 20), SEQ ID NOs: 161-163 and 169-171 have 100% sequence identity with the instant claimed SEQ ID NOs: 5-7 and 13-15 respectively.
The copending claims do not specifically claim pembrolizumab as the PD-1 antibody or specifically as a method to treat cancer.
Regarding claims 1-2, Keytruda teaches that KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody (indications and usage page 1).
Regarding claims 19 and 23, Keytruda teaches that pembrolizumab should be dosed at 2mg/kg every 3 weeks for pediatric melanoma patients (dosage and administration, page 2).
Regarding claim 21, Keytruda teaches that pembrolizumab should be administered at 200 mg every 3 weeks for adult melanoma patients (dose and administration; page 2).
Regarding claim 55, Keytruda further teaches that pembrolizumab is approved for use in melanoma patients following complete resection (indications and usage page 1).
Keytruda further teaches that in placebo-controlled trial in patients with completely resected stage IIB or IIC melanoma, patients were randomized to KEYTRUDA 200 mg or the pediatric (≥12 years old) dose of KEYTRUDA 2 mg/kg intravenously (up to a maximum of 200 mg) every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity that demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67). Keytruda further teaches that patients were randomized to KEYTRUDA 200 mg intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity and demonstrated a statistically significant improvement in RFS for patients randomized to the KEYTRUDA arm compared with placebo (page 67).
It would have been obvious to one of ordinary skill in the art to substitute pembrolizumab with the dosing and timing to treat cancer as taught by Keytruda in the method of enhancing PD-1 antibody activity with an IL-27 antibody as taught by the copending claims. The ordinary artisan would have been motivated to do so because as Keytruda teaches pembrolizumab is an FDA approved PD-1 antibody used for treatment of melanoma after total resection with demonstrated clinical efficacy at the specified doses and the copending claims teach that the IL-27 antibody will enhance the effects of an anti-PD-1 antibody. The ordinary artisan has a reasonable expectation of success to administer pembrolizumab as the FDA recommends to melanoma patients or hepatocellular carcinoma patients at the specified doses and time intervals to achieve improved clinical results in combination with an IL-27 antibody that will enhance the anti-PD-1 antibody effects.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643