DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. The amendments filed 04/24/2023 have been acknowledged. Claims 1, and 3-15 are amended. Claim 2 is cancelled. Claims 1 and 3-15 are pending.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 04/24/2023 is in compliance with the provisions of 37 CFR 1.91. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
4. Claims 5 and 11 are objected to because of the following informalities: the claims recite “PD-1” and “NK” which contain acronyms and/or abbreviations that should be spelled out upon first occurrence.
Appropriate correction is required.
5. Claims 3, 4, 5, 7, 8, and 12 are objected to because of the following informalities:
The word “whereas” recited in claims 3 and 12 appears to be a typographical error.
The phrase “ for the use of any one of claim 1” recited in claims 4, 5, 7, and 8 is grammatically incorrect.
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.
6. Claims 12, 13, and 14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is a product claim that directs to the IL-15/IL-15Ra complex. Claims 12, 13 and 14 claim both the IL-15/Il-15Ra complex and the method steps of using the complex.
See MPEP 2173.05(p):
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to "[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data" was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited "an input means" and required a user to use the input means was found to be indefinite because it was unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means."); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
In contrast, when a claim recites a product and additional limitations which focus on the capabilities of the system, not the specific actions or functions performed by the user, the claim may be definite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See Mastermine Software, Inc. v. Microsoft Corp., 874 F.3d 1307, 124 USPQ2d 1618 (Fed. Cir. 2017).
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.
7. Claims 1, and 3-15 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Margolin, et al. (Phase I Trial of ALT-803, A Novel Recombinant IL15 Complex, in Patients with Advanced Solid Tumors. Clin Cancer Res 15 November 2018; 24 (22): 5552–5561. https://doi.org/10.1158/1078-0432.CCR-18-0945).
Margolin, et al. teach ALT-803, which is a complex containing two molecules of an optimized amino acid–substituted IL15, two molecules of the IL15α receptor “sushi” domain fused to a dimeric human IgG1 Fc that confers stability and prolongs the half-life of the overall complex (IL15N72D:IL15RαSu/IgG1 Fc complex), to treat cancer in human patients, including squamous cell carcinoma, as recited by instant claims 1 and 3-15. Margolin, et al. teach that the primary objective of the clinical trial was to identify an optimal dose of ALT-803 (IL-15/Il-15Ra complex) and did not administer an immune checkpoint inhibitor and did not administer a PD-1 antagonist, as recited by instant claims 4-6. Margolin, et al. both intravenous and subcutaneous ALT-803 led to increases in circulating NK cells, with the greatest fold increases occurring in the CD56bright NK cell subpopulation, as recited by instant claim 11. Margolin, et al. teach the effects of ALT-803 administered intravenously (0.3–6 μg/kg/dose) or subcutaneously (6–20 μg/kg/dose), as recited in instant claim 14. The claim recites “for use in the treatment of non-melanoma skin cancer in a human patient, wherein the non-melanoma skin cancer in skin squamous cell carcinoma”. With respect to this limitation , it should be remembered that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
8. Claims 1, and 3-15 are rejected under 35 U.S.C. 102(a)(1)as being unpatentable over Lewis, et al. (WO2018134784, filed January 19, 2018).
Lewis, at al. teach a method of treating a cancer in a subject, the method comprising administering to the subject, at least one does of Interleukin-15/interleukin-15 reception alpha, as recited by instant claims 1, and 3-15, and in combination with an anti PD-1 antibody molecule. Subject is not defined in the in the disclosure, however, a person have ordinary skill in the art can reasonably interpret this to include human patients and the term cancer is defined in the discloser as to include all types of cancerous growths or oncogenic processes, metastatic tissues or malignantly transformed cells, tissues, or organs, irrespective of histopathologic type or stage of invasiveness (paragraph 215) including squamous cell carcinoma (paragraph 39). Lewis, et al. also teach that in an embodiment, the subject has a cancer that is historically resistant to treatment with an anti-PD-1 antibody molecule (paragraph 48), further teach different groups, one being patients with historically anti-PD-1 resistant cancers (paragraph 300), This meets the limitations of instant claims 1, 3, and 7-9.
Lewis, et al. teach the administration of a combination of an IL-15/IL-15Ra complex and an anti-PD-1 antibody molecule to a subject with cancer in accordance with the methods described herein inhibits or reduces the growth of a tumor by at least 30%, 50% and 95%, as recited by instant claim 10. Lewis, et al. teach that IL-15 plays a pivotal role in modulating the activity of both the innate and adaptive immune system such as induction of natural killer (NK) cell proliferation (paragraph 3) and further teach the IL-15 mediated immune function is NK cell proliferation (paragraph 121), as recited in instant claim 11. Lewis, et al. teach in specific embodiments, each dose is administered at least 1, 2, 3, 4, 5, 6 or more times over a 5 to 7 day, 5 to 10 day, 7 to 12 day, 7 to 14 day, 7 to 21 day or 14 to 21 day period of time (paragraph 196) and the regimen can be repeated in certain embodiment for at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 7 months, at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 1 year or more (paragraph 28), as recited in instant claims 12 and 13. Lewis, et al. teach the dose of IL-15/IL-15Ra complex is 1 ug/kg, followed by escalating doses of 2, 4, and 8 ug/kg, which fall into the ranges recited in instant claim 14. The claim recites “for use in the treatment of non-melanoma skin cancer in a human patient, wherein the non-melanoma skin cancer in skin squamous cell carcinoma”. With respect to this limitation , it should be remembered that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
9. Claim 15 is are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable over Yeung, et al (U.S. Patent No: 11,059,876 B2, issued July 13, 2021; Prior Publication issues August 29, 2019).
Yeung, et al. teach interleukin 15 (IL-15) variants and fusions protein comprising thereof (summary of invention). Yeung, et al. teach IL-15 variants and the IL-15 fusions proteins of the present invention are useful for therapeutic treatment methods and diagnostic treatment methods for squamous cell head and neck cancer. Yeung, et al. teach SEQ ID NO: 8 and 67 which are 100% identical to instant SEQ ID NO: 4, 6, and 9.
Yeung, et al. SEQ ID NO: 67 is 100% identical to instant SEQ ID NO: 4.
US-16-286-158-67
Query Match 100.0%; Score 581; Length 671;
Best Local Similarity 100.0%;
Matches 114; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NWVNVISDLKKIEDLIQSMHIDATLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIH 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 558 NWVNVISDLKKIEDLIQSMHIDATLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIH 617
Qy 61 DTVENLIILANNSLSSNGNVTESGCKECEELEEKNIKEFLQSFVHIVQMFINTS 114
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 618 DTVENLIILANNSLSSNGNVTESGCKECEELEEKNIKEFLQSFVHIVQMFINTS 671
Yeung, et al. SEQ ID NO: 8 is 100% identical to instant SEQ ID NO: 6.
US-16-286-158-8
Query Match 100.0%; Score 338; Length 241;
Best Local Similarity 100.0%;
Matches 61; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPSLK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3 CPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPSLK 62
Qy 61 C 61
|
Db 63 C 63
Yeung, et al. SEQ ID NO: 67 is 100% identical to instant SEQ ID NO: 9.
Query Match 100.0%; Score 1115; Length 671;
Best Local Similarity 100.0%;
Matches 211; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ITCPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 461 ITCPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPS 520
Qy 61 LKCIRDPALVHQRPAPPSGGSGGGGSGGGSGGGGSGGNWVNVISDLKKIEDLIQSMHIDA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 521 LKCIRDPALVHQRPAPPSGGSGGGGSGGGSGGGGSGGNWVNVISDLKKIEDLIQSMHIDA 580
Qy 121 TLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIHDTVENLIILANNSLSSNGNVTES 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 581 TLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIHDTVENLIILANNSLSSNGNVTES 640
Qy 181 GCKECEELEEKNIKEFLQSFVHIVQMFINTS 211
|||||||||||||||||||||||||||||||
Db 641 GCKECEELEEKNIKEFLQSFVHIVQMFINTS 671
Double Patenting
10. 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.
11. Claims 1, and 3-15 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18033773.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite an interleukin-15/interleukin-15 receptor alpha complex (IL-15/IL-15Ra). Although both sets of claims recite an intended use for the complex (i.e., for use in the treatment of non-melanoma skin cancer, specifically skin squamous cell carcinoma ('524) and for use in the treatment of squamous cell carcinoma ('773)) , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Both sets of claims recite the same complex, and there is no structural difference, and thus, the complex of the '773 claims would be able to perform the use recited in the instant claims ('524). As such, instant claims 1, and 3-15 are provisionally rejected.
Claim 1 of copending application ‘773 directs to an IL-15/IL-15Ra complex for the use of treatment of squamous cell carcinoma in a human patient, wherein the patient is resistant or refractory to at least one immune checkpoint inhibitor treatment, as recited by instant claims 1 and 3. Claim 4 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 1, wherein the IL-15/IL-15Ra complex is not administered in combination with an immune checkpoint inhibitor, as recited by instant claim 4. Claim 5 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 1, wherein the IL-15/IL-15Ra complex is not administered with a PD-1 antagonist, as recited by instant claim 5. Claim 6 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 1, wherein the IL-15/IL-15Ra complex is not administered in combination with the immune checkpoint inhibitor the patient is refractory or resistant to, preferably wherein the immune checkpoint inhibitor the patient is refractory to or resistant to and that is not administered in combination is a PD-1 antagonist, as recited by instant claim 6. Claim 7 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 1, wherein the IL-15/IL-15Ra complex is administered in combination with an immune checkpoint inhibitor, as recited by instant claim 7. Claim 8 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 1, wherein the IL-15/IL-15Ra complex is administered in combination with a PD-1 antagonist, as recited by instant claim 8. Claim 9 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 8, wherein the IL-15/IL-15Ra complex is administered in combination with the immune checkpoint inhibitor the patient is refractory or resistant to, preferably wherein the immune checkpoint inhibitor the patient is refractory to or resistant to and that is administered in combination is a PD-1 antagonist, as recited by instant claim 9. Claim 10 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 9, wherein the treatment of the cancer results in at least about 30% size reduction of the tumor present prior to the treatment, preferably about 30% size reduction within 16 weeks of the treatment, preferably about 50% size reduction within 16 weeks of the treatment, as recited by instant claim 10. Claim 11 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 10, wherein the response to the IL-15-IL-15Ra complex is mediated by the innate immune response medicated by NK cells, as recited in instant claim 11. Claim 12 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 11, whereas the IL-15/IL-15Ra complex is administered according to a cyclical administration regimen, wherein the cyclical administration regimen comprises:(a) a first period of x days during which the IL-15/IL-15Ra complex is administered at a daily dose on y consecutive days at the beginning of the first period followed by x-y days without administration of the IL-15/IL-15Ra complex ,wherein x is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or 21 days, preferably, 7 or 14 days, and y is 2, 3 or 4 days, preferably 2 or 3 days; (b) repeating the first period at least once; and (c) a second period of z days without administration of the IL-15/IL-15Ra complex, wherein z is 5,6,7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 28, 35, 42, 49, 56, 63 or 70 days, preferably 7, 14, 21 or 56 days, more preferably 7, 14 or 21 days, as recited by instant claim 12. Claim 13 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 12, wherein x is 7 days, y is 2, 3 or 4 days and z is 7 days, preferably wherein y is 2 days and z is 7 days, as recited in instant claim 13. Claim 14 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 1, wherein the daily dose of the IL-15/IL-15Ra complex is 0.1 ug/kg to 50 ug/kg, preferably 0.25 ug/kg to 25 ug/kg, more preferably 0.6 ug/kg to 12 ug/kg and even more preferably 2 ug/kg to 12 ug/kg, preferably 3 ug/kg to 20 ug/kg, more preferably 6 to 12 ug/kg, as recited in instant claim 14. Claim 15 of copending application ‘773 directs to the IL-15/IL-15Ra complex for the use of claim 14, wherein the IL-15/IL-15Ra complex a fusion protein comprising the human IL-15Ra sushi domain or derivative thereof, a flexible linker and the human IL-15 or derivative thereof, preferably wherein the human IL-15Ra sushi domain comprises the sequence of SEQ ID NO: 6, and wherein the human IL-15 comprises the sequence of SEQ ID NO: 4, more preferably wherein the IL- 15/IL-15Ra complex is SEQ ID NO: 9, as recited in instant claim 15.
Copending application ‘773 SEQ ID NO: 6 is 100% match with instant SEQ ID NO: 6.
US-18-033-773-6
Query Match 100.0%; Score 338; DB 1; Length 61;
Best Local Similarity 100.0%;
Matches 61; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPSLK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPSLK 60
Qy 61 C 61
|
Db 61 C 61
Copending application ‘773 SEQ ID NO: 4 is 100% match with instant SEQ ID NO: 4.
US-18-033-773-4
Query Match 100.0%; Score 581; DB 1; Length 114;
Best Local Similarity 100.0%;
Matches 114; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NWVNVISDLKKIEDLIQSMHIDATLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIH 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 NWVNVISDLKKIEDLIQSMHIDATLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIH 60
Qy 61 DTVENLIILANNSLSSNGNVTESGCKECEELEEKNIKEFLQSFVHIVQMFINTS 114
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DTVENLIILANNSLSSNGNVTESGCKECEELEEKNIKEFLQSFVHIVQMFINTS 114
Copending application ‘773 SEQ ID NO: 9 is 100% match with instant SEQ ID NO: 9.
US-18-033-773-9
Query Match 100.0%; Score 1115; DB 1; Length 211;
Best Local Similarity 100.0%;
Matches 211; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ITCPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ITCPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPS 60
Qy 61 LKCIRDPALVHQRPAPPSGGSGGGGSGGGSGGGGSGGNWVNVISDLKKIEDLIQSMHIDA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LKCIRDPALVHQRPAPPSGGSGGGGSGGGSGGGGSGGNWVNVISDLKKIEDLIQSMHIDA 120
Qy 121 TLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIHDTVENLIILANNSLSSNGNVTES 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIHDTVENLIILANNSLSSNGNVTES 180
Qy 181 GCKECEELEEKNIKEFLQSFVHIVQMFINTS 211
|||||||||||||||||||||||||||||||
Db 181 GCKECEELEEKNIKEFLQSFVHIVQMFINTS 211
12. Claims 1, and 3-15 are provisionally rejected on the grounds of anticipatory nonstatutory double patenting as being unpatentable over claims 42-52 of Copending Application No. 17612432.
Both sets of claims recite an interleukin-15/interleukin-15 receptor alpha complex (IL-15/IL-15Ra). As such, instant claims 1, and 3-15 are provisionally rejected on the grounds of non-statutory double patent.
Copending application ‘432 teaches a method of treating or managing cancer or infectious disease comprising administering an interleukin-2/interleukin 15 receptor By (IL-2/IL15RBy) agonist to a human patient, in which the agonist is defined further in the same claim as interleukin 15 (IL-15)/interleukin-15 receptor alpha (IL-15Ra) complex (claim 42). Copending application ‘432 further limits the agonist in claim 49 to be an interleukin-15 (IL-15)/interleukin-15 receptor alpha (IL-15Ra) complex. Copending application ‘432 does not further define cancer in the claims, however, the specification states head and neck squamous cell carcinoma are preferred cancer indications.
Copending application ‘432 teaches from claims 42-49, that the IL-2/IL15RBy agonist which is the IL-15/Il-15Ra complex is not administered with an immune checkpoint inhibitor or in combination with PD-1 antagonist as claim 42 was a method of treating cancer with only IL-2/IL15RBy agonist which is the IL-15/Il-15Ra complex, as recited by instant claims 4-6.
Copending application ‘432 goes on to limit claim 42 by administering a therapeutic agent in combination with the IL-2/IL15RBy agonist which is the IL-15/Il-15Ra complex (claim 51), and that therapeutic agent being an immune checkpoint inhibitor comprising from an anti-PD-1 antibody (claim 52), as recited by instant claims 7-8.
Copending application ‘432 teaches the administering of the IL-2/IL15RBy agonist which is the IL-15/Il-15Ra complex using a cyclical administration regimen, wherein the cyclical administration regimen comprises: (a) a first period of x days during which the IL-2/IL-15Rβγ agonist which is the IL-15/Il-15Ra complex, is administered at a daily dose on y consecutive days at the beginning of the first period followed by x-y days without administration of the IL-2/IL-15Rβγ agonist, wherein x is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or 21 days, and y is 2, 3 or 4 days; (b) repeating the first period at least once; and (c) a second period of z days without administration of the IL-2/IL-15Rβγ agonist which is the IL-15/Il-15Ra complex, wherein z is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 28, 35, 42, 49, 56, 63 or 70 days (claim 42). Wherein x is 7 days, y is 2, 3 or 4 days and z is 7 days (claim 43). This recites the limitations of instant claims 12 and 13.
Copending application ‘432 teaches the daily dose is 0.1 ug/kg to 50 ug/kg (claim 44), as recited by instant claim 14. Copending application ‘432 further teaches the human IL-15Rα sushi domain comprises the sequence of SEQ ID NO: 6, the human IL-15 comprises the sequence of SEQ ID NO: 4, and the IL-15/IL-15Rα complex comprises the sequence of SEQ ID NO: 9, as recited by instant claim 15. SEQ ID NO: 6, 4, and 9 are duplicates of instant claims SEQ ID NO: 6, 4, and 9.
Copending application ‘432 SEQ ID NO: 6 is 100% match with instant SEQ ID NO: 6.
RESULT 1
US-17-612-432-6
Query Match 100.0%; Score 338; DB 1; Length 61;
Best Local Similarity 100.0%;
Matches 61; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPSLK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPSLK 60
Qy 61 C 61
|
Db 61 C 61
Copending application ‘432 SEQ ID NO: 4 is 100% match with instant SEQ ID NO: 4
RESULT 1
US-17-612-432-4
Query Match 100.0%; Score 581; DB 1; Length 114;
Best Local Similarity 100.0%;
Matches 114; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NWVNVISDLKKIEDLIQSMHIDATLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIH 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 NWVNVISDLKKIEDLIQSMHIDATLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIH 60
Qy 61 DTVENLIILANNSLSSNGNVTESGCKECEELEEKNIKEFLQSFVHIVQMFINTS 114
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DTVENLIILANNSLSSNGNVTESGCKECEELEEKNIKEFLQSFVHIVQMFINTS 114
Copending application ‘432 SEQ ID NO: 9 is 100% match with instant SEQ ID NO: 9
RESULT 1
US-17-612-432-9
Query Match 100.0%; Score 1115; DB 1; Length 211;
Best Local Similarity 100.0%;
Matches 211; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ITCPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ITCPPPMSVEHADIWVKSYSLYSRERYICNSGFKRKAGTSSLTECVLNKATNVAHWTTPS 60
Qy 61 LKCIRDPALVHQRPAPPSGGSGGGGSGGGSGGGGSGGNWVNVISDLKKIEDLIQSMHIDA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LKCIRDPALVHQRPAPPSGGSGGGGSGGGSGGGGSGGNWVNVISDLKKIEDLIQSMHIDA 120
Qy 121 TLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIHDTVENLIILANNSLSSNGNVTES 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TLYTESDVHPSCKVTAMKCFLLELQVISLESGDASIHDTVENLIILANNSLSSNGNVTES 180
Qy 181 GCKECEELEEKNIKEFLQSFVHIVQMFINTS 211
|||||||||||||||||||||||||||||||
Db 181 GCKECEELEEKNIKEFLQSFVHIVQMFINTS 211
Conclusion
13. No claims allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SYED J ABBAS/
Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
Prosecution Insights