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 .
Election/Restrictions
2. Applicant’s election without traverse of single species of a solid tumor (melanoma) in the reply filed on September 3, 2025 is acknowledged.
3. Claims 1, 13-28, 33-35 and 40-56 are pending.
Claims 41 and 43, drawn to non-elected inventions and non-elected species are withdrawn from consideration.
Claims 2-12 and 29-32 have been cancelled.
Claims 21-28, 33, 40-46, 48, 49, 51, 52, 55 and 56 have been amended.
Claims 1, 13-28, 33-35, 40, 42 and 44-56 are examined on the merits with the species (solid tumor): melanoma.
Claim Objections
4. Claims 17, 19 and 20 are objected to because of the following informality: the claims do not end with a punctuation mark, a period denoting completion of the claim text. Hence, it is no clear if additional text is missing or the claim is complete.
Correction is required.
Claim Rejections - 35 USC § 103
4. 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.
5. Claim(s) 1, 13-28, 33-35, 40, 42 and 44-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al., WO 2017/079117 A1 (published 11 May 2017/ IDS reference C1 submitted May 2, 2022), and further in view of Inamdar et al., WO 2020/047087 A1 (effective priority date 29 August 2018/ IDS reference C3 submitted May 2, 2022). Brennan teaches the fusion protein (sequence 20) comprising the amino acid sequence set forth in SEQ ID NO: 5, see sequence alignment at close of rejection; and page 67, sequence 20. Brennan teaches the extracellular domain (ECD) of human cluster of differentiation 80 (CD80) comprises the amino acid sequence (sequence 5) set forth in SEQ ID NO: 1, see sequence alignment; and page 65, sequence 5. Brennan also teaches the fragment crystallizable (Fc) domain of human immunoglobulin G1 (IgGI) comprising the amino acid sequence (sequence 9) set forth in SEQ ID NO: 3, see sequence alignment at close of rejection; and page 66, sequence 9; and page 67, underlined amino acid residues within sequence 20. All three of Applicant’s sequences share 100% sequence similarity with Brennan’s sequences, see sequence alignments.
“[T]he fusion molecule comprises an Fc domain, such as an Fc domain comprising a sequence selected from SEQ ID NOs: 9…[which is the same as Applicant’s SEQ ID NO 3]. .. In some embodiments, the CD80 ECD fusion molecule comprises an amino acid sequence … SEQ ID NO: 20 [which is the same as Applicant’s SEQ ID NO: 5], ... In some embodiments, the CD80 ECD fusion molecule fusion partner is directly attached to the C-terminal amino acid of the CD80 ECD amino acid sequence or to the N- terminal amino acid of the mature CD80 ECD amino acid sequence. In some embodiments, the CD80 ECD fusion molecule may be attached to the CD80 ECD through a linker peptide, such as a GS linker.”, see section 006 spanning pages 2 and 3.
“In some embodiments, the CD80 ECD fusion molecule has a sialic acid content of 10-60 mol sialic acid (SA)/mol protein, such as 15-60 mol SA/mol protein.”, see page 3, 1st sentence in section 007; and section 00110 spanning pages 34 and 35.
These fusion molecules are implemented in “…methods of treating cancer in a subject comprising administering to the subject an effective amount of a CD80 ECD or CD80 ECD fusion protein or a composition from among the embodiments described above. In some embodiments, the cancer is a solid tumor.”, see section 0015 on page 5. “In some embodiments, the cancer is recurrent or progressive after a therapy selected from surgery, chemotherapy, radiation therapy, or a combination thereof.”, see page 6, lines 1 and 2; and page 10, last 3 lines.
Brennan used the murine melanoma cell line B16-F10, art known to be a highly metastatic cell and implemented in experiments for studying tumor growth and metastasis, see B16 tumor model segment beginning on page 63. “[T]reatment with murine CD80 ECD-Fc at 20 mol/mol SA…”, see page 64, section 00205. Hence, administration of taught disclosed therapeutic agents is recognized as within an advanced or metastatic stetting.
The “…fusion molecules may be administered in vivo by various routes, including…intravenous,”, see page 43, section 00150. “[A]n effective dose is administered more than once a month, such as, for example, every three weeks, every two weeks or every week. In some embodiments, an effective dose is administered once per 1, 2, 3, 4, or 5 weeks.”, see page 45, section 00155.
“Also provided herein are compositions comprising a CD80 ECD or CD80 ECD fusion molecule of any of the embodiments described above, and further comprising at least one pharmaceutically acceptable carrier. Some such compositions further comprise at least one additional therapeutic agent.”, see page 5, section 011. The said fusion protein can be administered “…in combination with other therapeutic agents, such as immune stimulating agents such as PD-1/PD-L1 inhibitors”… comprising nivolumab and pembrolizumab, see abstract; and pages 5-9. “In some cases, one or more doses of the PD-l/PD-L1 inhibitor are administered prior to administering the CD 80 ECD or CD 80 ECD fusion molecule. In some cases, the subject has received a complete course of immune stimulating agent, e.g., PD-l/PD-L1 inhibitor therapy prior to administration of the CD80 ECD or CD80 ECD fusion molecule.”, see page 6, section 0019. Given Brennan notes “[i]n some cases”, conversely, in other cases there are no doses or prior therapy of PD-1/PD-L1 antagonists.
Additional therapeutic agents that can be administered in combination with the said fusion protein includes anti-angiogenesis agents, “…antibodies to VEGF-A (e.g., bevacizumab (Avastin®)),… Sutent®/SU11248 (sunitinib malate),… Anti-angiogenesis agents also include native angiogenesis inhibitors, e.g., angiostatin, endostatin, etc. See,…Streit and Detmar (2003) Oncogene 22:3172- 3179 (e.g., Table 3 listing anti-angiogenic therapy in malignant melanoma)”, page 49, section 00162.
Brennan does not teach the taught ECD CD80 IgG1 is administered to the subject in the dosage of about 140 mg to about 1,260 mg. Nor does Brennan teach the malignant melanoma taught has a BRAF mutation and the subject has received prior therapy with a BRAF inhibitor, vemurafenib or dabrafenib. Brennan also does not teach the PD-1/PD-L1 inhibitors, atezolizumab, durvalumab, or avelumab and the anti-angiogenesis agent is sorafenib, pazopanib, axitinib, tivozanib, ramucirumab.
However, Inamdar teaches “…treating a solid tumor in a human patient administering to the patient about 0.07 mg to about 70 mg of a fusion protein comprising the ECD of human CD80 and the Fc domain of human IgG1.”, see page 2, section 0006.
“In certain aspects, the patient has not received prior therapy with a PD-1/PD-L1 antagonist. In certain aspects, the patient has received prior therapy with at least one PD- 1/PD-L1 antagonist selected from a PD-L1 antagonist and a PD-l antagonist. In certain aspects, the PD-1/PD-L1 antagonist is …atezolizumab, durvalumab, or avelumab. In certain aspects, the at least one PD-l/PD-l antagonist was administered in an advanced or metastatic setting.
“In certain aspects, the patient has received prior therapy with at least one anti-angiogenic agent. In certain aspects, the anti-angiogenic agent is… sorafenib, pazopanib, axitinib, tivozanib, ramucirumab…. In certain aspects, the at least one anti-angiogenic agent was administered in an advanced or metastatic setting.
In certain aspects, the patient (e.g., a patient with melanoma) has a BRAF mutation. In certain aspects, the patient has received prior therapy with at least one BRAF inhibitor. In certain aspects, the BRAF inhibitor is vemurafenib or dabrafenib. In certain aspects, the BRAF inhibitor was administered in an advanced or metastatic setting.
In certain aspects, the solid tumor is recurrent or progressive after a therapy selected from surgery, chemotherapy, radiation therapy, and a combination thereof.”, see sections 0014-0017 spanning pages 3 and 4.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the therapeutic ECD CD80 fusion protein at the dosages ranging from about 140 mg to about 1,260 mg because Inamdar teaches the fusion protein can be administered in that standard measured unit. One of ordinary skill in the art would have been motivated to arrive at the designated dosages in claims 1 and 13-20 given “various modifications of the invention in addition to those described will become apparent to those skilled in the art...”, as well as success by teachings well known in the art and noted herein that dosages of any pharmaceutical composition may be adjusted and optimized.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute and administer a PD-1/PD-L1 antagonist for another. One of ordinary skill in the art would have been motivated to because it is obvious to those skilled in the art to substitute one known equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the melanoma with a BRAF inhibitor given it is art known a high percentage of skin melanomas have a BRAF mutation and Inamdar plainly states the melanoma treated with the same therapeutic agent, ECD CD80 has a BRAF mutation, see abstract; page 4, section 0016; sections 0067 and 0071 spanning pages 16 and 17. One of ordinary skill in the art would have been motivated to treat this mutation with a BRAF inhibitor given a similar cohort has an overlapping treatment regimen, see Cohort 1b2 spanning pages 37 and 38.
RESULT 1 from 5.rag database. The human IgG1 Fc region, SEQ ID NO:9 is underlined herein.
BDW52843
(NOTE: this sequence has 10 duplicates in the database searched)
ID BDW52843 standard; protein; 440 AA.
DT 29-JUN-2017 (first entry)
XX
DE CD80-IgG1 Fc fusion protein, SEQ:20.
XX
KW CD80; Immunoglobulin G1; bladder cancer; breast tumor; cancer;
KW colorectal tumor; cytostatic; endometrioid carcinoma; fusion protein;
KW head and neck tumor; hepatocellular carcinoma; immunoglobulin gamma 1;
KW melanoma; non-small-cell lung cancer; ovary tumor; pancreas tumor;
KW protein therapy; recombinant protein; renal cell carcinoma;
KW squamous cell carcinoma; stomach tumor; therapeutic.
XX
OS Homo sapiens.
OS Synthetic.
XX
FH Key Location/Qualifiers
FT Region 1..208
FT /note= "CD80 protein"
FT Region 209..440
FT /note= "IgG1 protein"
XX
CC PN WO2017079117-A1.
XX
CC PD 11-MAY-2017.
XX
CC PF 01-NOV-2016; 2016WO-US059838.
XX
PR 02-NOV-2015; 2015US-0249836P.
PR 11-AUG-2016; 2016US-0373654P.
XX
CC PA (FIVE-) FIVE PRIME THERAPEUTICS INC.
XX
CC PI Brennan T, Bellovin D, Busha D, Sennino B;
XX
DR WPI; 2017-301449/39.
XX
CC PT New cluster of differentiation (CD)-80 extracellular domain (ECD) fusion
CC PT molecule comprising human CD80 ECD polypeptide and immunoglobulin-G1
CC PT fragment crystallizable domain and having specified amount of sialic
CC PT acid, used to treat cancer.
XX
CC PS Claim 45; SEQ ID NO 20; 94pp; English.
XX
CC The present invention relates to a novel cluster of differentiation (CD)-
CC 80 extracellular domain (ECD) fusion molecule useful for treating cancer
CC in a subject. The invention further claims: (1) a method for enhancing
CC the efficacy of CD80 ECD fusion protein in treating cancer in a subject;
CC (2) a method for treating cancer in a subject; (3) a CD80 ECD fusion
CC molecule comprising a human CD80 ECD polypeptide and a human IgG1 Fc
CC domain with L234F, L235E, and P331S amino acid substitutions; and (4) a
CC composition comprising the CD80 ECD fusion molecule. Cancer can be
CC colorectal cancer, breast cancer, gastric cancer, non-small cell lung
CC cancer, melanoma, squamous cell carcinoma of head and neck, ovarian
CC cancer, pancreatic cancer, renal cell carcinoma, hepatocellular
CC carcinoma, bladder cancer or endometrial cancer. The present sequence is
CC a CD80-IgG1 Fc fusion protein comprising human CD80 ECD fused with human
CC IgG1 Fc region, which is useful in preparing a pharmaceutical composition
CC for treating cancer in a subject.
XX
SQ Sequence 440 AA;
Query Match 100.0%; Score 2360; Length 440;
Best Local Similarity 100.0%;
Matches 440; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VIHVTKEVKEVATLSCGHNVSVEELAQTRIYWQKEKKMVLTMMSGDMNIWPEYKNRTIFD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 VIHVTKEVKEVATLSCGHNVSVEELAQTRIYWQKEKKMVLTMMSGDMNIWPEYKNRTIFD 60
Qy 61 ITNNLSIVILALRPSDEGTYECVVLKYEKDAFKREHLAEVTLSVKADFPTPSISDFEIPT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ITNNLSIVILALRPSDEGTYECVVLKYEKDAFKREHLAEVTLSVKADFPTPSISDFEIPT 120
Qy 121 SNIRRIICSTSGGFPEPHLSWLENGEELNAINTTVSQDPETELYAVSSKLDFNMTTNHSF 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SNIRRIICSTSGGFPEPHLSWLENGEELNAINTTVSQDPETELYAVSSKLDFNMTTNHSF 180
Qy 181 MCLIKYGHLRVNQTFNWNTTKQEHFPDNEPKSSDKTHTCPPCPAPELLGGPSVFLFPPKP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MCLIKYGHLRVNQTFNWNTTKQEHFPDNEPKSSDKTHTCPPCPAPELLGGPSVFLFPPKP 240
Qy 241 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLT 300
Qy 301 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTC 360
Qy 361 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 420
Qy 421 MHEALHNHYTQKSLSLSPGK 440
||||||||||||||||||||
Db 421 MHEALHNHYTQKSLSLSPGK 440
BDW52828 from 1.rag database.
ID BDW52828 standard; protein; 208 AA.
DT 29-JUN-2017 (first entry)
XX
DE Human CD80 ECD protein, SEQ:5.
XX
KW CD80; bladder cancer; breast tumor; cancer; colorectal tumor; cytostatic;
KW endometrioid carcinoma; head and neck tumor; hepatocellular carcinoma;
KW melanoma; non-small-cell lung cancer; ovary tumor; pancreas tumor;
KW protein therapy; recombinant protein; renal cell carcinoma;
KW squamous cell carcinoma; stomach tumor; therapeutic.
XX
OS Homo sapiens.
XX
FH Key Location/Qualifiers
FT Misc-difference 1..208
XX
CC PN WO2017079117-A1.
XX
CC PD 11-MAY-2017.
XX
CC PF 01-NOV-2016; 2016WO-US059838.
XX
PR 02-NOV-2015; 2015US-0249836P.
PR 11-AUG-2016; 2016US-0373654P.
XX
CC PA (FIVE-) FIVE PRIME THERAPEUTICS INC.
XX
CC PI Brennan T, Bellovin D, Busha D, Sennino B;
XX
DR WPI; 2017-301449/39.
XX
CC PT New cluster of differentiation (CD)-80 extracellular domain (ECD) fusion
CC PT molecule comprising human CD80 ECD polypeptide and immunoglobulin-G1
CC PT fragment crystallizable domain and having specified amount of sialic
CC PT acid, used to treat cancer.
XX
CC PS Claim 45; SEQ ID NO 5; 94pp; English.
XX
CC The present invention relates to a novel cluster of differentiation (CD)-
CC 80 extracellular domain (ECD) fusion molecule useful for treating cancer
CC in a subject. The invention further claims: (1) a method for enhancing
CC the efficacy of CD80 ECD fusion protein in treating cancer in a subject;
CC (2) a method for treating cancer in a subject; (3) a CD80 ECD fusion
CC molecule comprising a human CD80 ECD polypeptide and a human IgG1 Fc
CC domain with L234F, L235E, and P331S amino acid substitutions; and (4) a
CC composition comprising the CD80 ECD fusion molecule. Cancer can be
CC colorectal cancer, breast cancer, gastric cancer, non-small cell lung
CC cancer, melanoma, squamous cell carcinoma of head and neck, ovarian
CC cancer, pancreatic cancer, renal cell carcinoma, hepatocellular
CC carcinoma, bladder cancer or endometrial cancer. The present sequence is
CC a human CD80 ECD protein, which is useful in preparing a pharmaceutical
CC composition for treating cancer in a subject.
XX
SQ Sequence 208 AA;
BDW52832 from 3.rag database.
ID BDW52832 standard; protein; 232 AA.
DT 29-JUN-2017 (first entry)
XX
DE Human IgG1 Fc region, SEQ:9.
XX
KW Immunoglobulin G1; Immunoglobulin gamma 1; bladder cancer; breast tumor;
KW cancer; colorectal tumor; cytostatic; endometrioid carcinoma;
KW head and neck tumor; heavy chain constant region;
KW hepatocellular carcinoma; melanoma; non-small-cell lung cancer;
KW ovary tumor; pancreas tumor; protein therapy; recombinant protein;
KW renal cell carcinoma; squamous cell carcinoma; stomach tumor;
KW therapeutic.
XX
OS Homo sapiens.
XX
CC PN WO2017079117-A1.
XX
CC PD 11-MAY-2017.
XX
CC PF 01-NOV-2016; 2016WO-US059838.
XX
PR 02-NOV-2015; 2015US-0249836P.
PR 11-AUG-2016; 2016US-0373654P.
XX
CC PA (FIVE-) FIVE PRIME THERAPEUTICS INC.
XX
CC PI Brennan T, Bellovin D, Busha D, Sennino B;
XX
DR WPI; 2017-301449/39.
XX
CC PT New cluster of differentiation (CD)-80 extracellular domain (ECD) fusion
CC PT molecule comprising human CD80 ECD polypeptide and immunoglobulin-G1
CC PT fragment crystallizable domain and having specified amount of sialic
CC PT acid, used to treat cancer.
XX
CC PS Claim 44; SEQ ID NO 9; 94pp; English.
XX
CC The present invention relates to a novel cluster of differentiation (CD)-
CC 80 extracellular domain (ECD) fusion molecule useful for treating cancer
CC in a subject. The invention further claims: (1) a method for enhancing
CC the efficacy of CD80 ECD fusion protein in treating cancer in a subject;
CC (2) a method for treating cancer in a subject; (3) a CD80 ECD fusion
CC molecule comprising a human CD80 ECD polypeptide and a human IgG1 Fc
CC domain with L234F, L235E, and P331S amino acid substitutions; and (4) a
CC composition comprising the CD80 ECD fusion molecule. Cancer can be
CC colorectal cancer, breast cancer, gastric cancer, non-small cell lung
CC cancer, melanoma, squamous cell carcinoma of head and neck, ovarian
CC cancer, pancreatic cancer, renal cell carcinoma, hepatocellular
CC carcinoma, bladder cancer or endometrial cancer. The present sequence is
CC a human IgG1 Fc region, which is useful in preparing a pharmaceutical
CC composition for treating cancer in a subject.
XX
SQ Sequence 232 AA;
ALIGNMENT:
Query Match 100.0%; Score 1258; Length 232;
Best Local Similarity 100.0%;
Matches 232; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EPKSSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EPKSSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKF 60
Qy 61 NWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKT 120
Qy 121 ISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTP 180
Qy 181 PVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 232
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 232
Double Patenting
7. 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.
7. Claims 1, 13-28, 33-35, 40, 42 and 44-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10-14, 24, 25 and 35 of U.S. Patent No. 10,273,281 B2 (issued April 30, 2019) in view of Inamdar et al., WO 2020/047087 A1 (effective priority date 29 August 2018/ IDS reference C3 submitted May 2, 2022). Both sets of claims read on the extracellular domain (ECD) of human cluster of differentiation 80 (CD80) and the fragment crystallizable (Fc) domain of human immunoglobulin G1 (IgG1). The ECD CD80 fusion protein is one and the same, see sequence alignments at the close of the instant rejection.
Both sets of claims read on the said fusion protein comprising at least 15 molecules of sialic acid and the CD80 ECD fusion molecules are included with a pharmaceutically acceptable carrier. These sets of claims overlap in scope to the extent of implementing the same fusion protein as a therapeutic agent for the treatment of cancer.
The U.S. Patent No. 10,273,281 does not explicitly teach the method of treating the solid tumor that is melanoma with a BRAF mutation and the fusion protein within the quantity of milligrams, administered in the manner and with additional agents as cited in instant claims 21, 22, 45-51, 55 and 56.
However, Inamdar teaches “…treating a solid tumor in a human patient administering to the patient about 0.07 mg to about 70 mg of a fusion protein comprising the ECD of human CD80 and the Fc domain of human IgG1.”, see page 2, section 0006.
“In certain aspects, the patient has not received prior therapy with a PD-1/PD-L1 antagonist. In certain aspects, the patient has received prior therapy with at least one PD- 1/PD-L1 antagonist selected from a PD-L1 antagonist and a PD-l antagonist. In certain aspects, the PD-1/PD-L1 antagonist is …atezolizumab, durvalumab, or avelumab. In certain aspects, the at least one PD-l/PD-l antagonist was administered in an advanced or metastatic setting.
“In certain aspects, the patient has received prior therapy with at least one anti-angiogenic agent. In certain aspects, the anti-angiogenic agent is… sorafenib, pazopanib, axitinib, tivozanib, ramucirumab…. In certain aspects, the at least one anti-angiogenic agent was administered in an advanced or metastatic setting.
In certain aspects, the patient (e.g., a patient with melanoma) has a BRAF mutation. In certain aspects, the patient has received prior therapy with at least one BRAF inhibitor. In certain aspects, the BRAF inhibitor is vemurafenib or dabrafenib. In certain aspects, the BRAF inhibitor was administered in an advanced or metastatic setting.
In certain aspects, the solid tumor is recurrent or progressive after a therapy selected from surgery, chemotherapy, radiation therapy, and a combination thereof.”, see sections 0014-0017 spanning pages 3 and 4.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the therapeutic ECD CD80 fusion protein at the dosages ranging from about 140 mg to about 1,260 mg because Inamdar teaches the fusion protein can be administered that standard measured unit. One of ordinary skill in the art would have been motivated to arrive at the designated dosages in claims 1 and 13-20 given “various modifications of the invention in addition to those described will become apparent to those skilled in the art from the foregoing description and accompanying figures.”, as well as success by teachings well known in the art and noted herein that dosages of any pharmaceutical composition may be adjusted and optimized.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute and administer a PD-1/PD-L1 antagonist for another. One of ordinary skill in the art would have been motivated to because it is obvious to those skilled in the art to substitute one known equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the melanoma with a BRAF inhibitor given it is art known a high percentage of skin melanomas have a BRAF mutation and Inamdar plainly states the melanoma treated with the same therapeutic agent, ECD CD80 has a BRAF mutation, see abstract; page 4, section 0016; sections 0067 and 0071 spanning pages 16 and 17. One of ordinary skill in the art would have been motivated to treat this mutation with a BRAF inhibitor given a similar cohort has an overlapping treatment regimen, see Cohort 1b2 spanning pages 37 and 38.
RESULT 1 from 5.rai database.
US-15-340-238-20
(NOTE: this sequence has 10 duplicates in the database searched.
See complete list at the end of this report)
Sequence 20, US/15340238 and sequences 21, 18 and 19.
Patent No. 10273281
GENERAL INFORMATION
APPLICANT: FIVE PRIME THERAPEUTICS, INC.
TITLE OF INVENTION: CD80 EXTRACELLULAR DOMAIN POLYPEPTIDES AND THEIR USE IN CANCER
TITLE OF INVENTION: TREATMENT
FILE REFERENCE: 01134-0047-00US
CURRENT APPLICATION NUMBER: US/15/340,238
CURRENT FILING DATE: 2016-11-01
PRIOR APPLICATION NUMBER: US 62/249,836
PRIOR FILING DATE: 2015-11-02
PRIOR APPLICATION NUMBER: US 62/373,654
PRIOR FILING DATE: 2016-08-11
NUMBER OF SEQ ID NOS: 25
SEQ ID NO 20
LENGTH: 440
TYPE: PRT
ORGANISM: Homo sapiens
FEATURE:
NAME/KEY: MISC_FEATURE
LOCATION: (1)..(440)
OTHER INFORMATION: Human CD80 ECD Human Fc IgG1 WT
Query Match 100.0%; Score 2360; Length 440;
Best Local Similarity 100.0%;
Matches 440; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VIHVTKEVKEVATLSCGHNVSVEELAQTRIYWQKEKKMVLTMMSGDMNIWPEYKNRTIFD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 VIHVTKEVKEVATLSCGHNVSVEELAQTRIYWQKEKKMVLTMMSGDMNIWPEYKNRTIFD 60
Qy 61 ITNNLSIVILALRPSDEGTYECVVLKYEKDAFKREHLAEVTLSVKADFPTPSISDFEIPT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ITNNLSIVILALRPSDEGTYECVVLKYEKDAFKREHLAEVTLSVKADFPTPSISDFEIPT 120
Qy 121 SNIRRIICSTSGGFPEPHLSWLENGEELNAINTTVSQDPETELYAVSSKLDFNMTTNHSF 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SNIRRIICSTSGGFPEPHLSWLENGEELNAINTTVSQDPETELYAVSSKLDFNMTTNHSF 180
Qy 181 MCLIKYGHLRVNQTFNWNTTKQEHFPDNEPKSSDKTHTCPPCPAPELLGGPSVFLFPPKP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MCLIKYGHLRVNQTFNWNTTKQEHFPDNEPKSSDKTHTCPPCPAPELLGGPSVFLFPPKP 240
Qy 241 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 KDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLT 300
Qy 301 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTC 360
Qy 361 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSV 420
Qy 421 MHEALHNHYTQKSLSLSPGK 440
||||||||||||||||||||
Db 421 MHEALHNHYTQKSLSLSPGK 440
RESULT 19 from 1.rai database.
US-15-340-238-20
(NOTE: this sequence has 10 duplicates in the database searched.
See complete list at the end of this report)
Sequence 20, US/15340238
Patent No. 10273281
GENERAL INFORMATION
APPLICANT: FIVE PRIME THERAPEUTICS, INC.
TITLE OF INVENTION: CD80 EXTRACELLULAR DOMAIN POLYPEPTIDES AND THEIR USE IN CANCER
TITLE OF INVENTION: TREATMENT
FILE REFERENCE: 01134-0047-00US
CURRENT APPLICATION NUMBER: US/15/340,238
CURRENT FILING DATE: 2016-11-01
PRIOR APPLICATION NUMBER: US 62/249,836
PRIOR FILING DATE: 2015-11-02
PRIOR APPLICATION NUMBER: US 62/373,654
PRIOR FILING DATE: 2016-08-11
NUMBER OF SEQ ID NOS: 25
SEQ ID NO 20
LENGTH: 440
TYPE: PRT
ORGANISM: Homo sapiens
FEATURE:
NAME/KEY: MISC_FEATURE
LOCATION: (1)..(440)
OTHER INFORMATION: Human CD80 ECD Human Fc IgG1 WT
Query Match 100.0%; Score 1102; Length 440;
Best Local Similarity 100.0%;
Matches 208; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VIHVTKEVKEVATLSCGHNVSVEELAQTRIYWQKEKKMVLTMMSGDMNIWPEYKNRTIFD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 VIHVTKEVKEVATLSCGHNVSVEELAQTRIYWQKEKKMVLTMMSGDMNIWPEYKNRTIFD 60
Qy 61 ITNNLSIVILALRPSDEGTYECVVLKYEKDAFKREHLAEVTLSVKADFPTPSISDFEIPT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ITNNLSIVILALRPSDEGTYECVVLKYEKDAFKREHLAEVTLSVKADFPTPSISDFEIPT 120
Qy 121 SNIRRIICSTSGGFPEPHLSWLENGEELNAINTTVSQDPETELYAVSSKLDFNMTTNHSF 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SNIRRIICSTSGGFPEPHLSWLENGEELNAINTTVSQDPETELYAVSSKLDFNMTTNHSF 180
Qy 181 MCLIKYGHLRVNQTFNWNTTKQEHFPDN 208
||||||||||||||||||||||||||||
Db 181 MCLIKYGHLRVNQTFNWNTTKQEHFPDN 208
US-15-340-238-14 from 3.rai database.
Filing date in PALM: 2016-11-01
Sequence 14, US/15340238 and sequence 9
Patent No. 10273281
GENERAL INFORMATION
APPLICANT: FIVE PRIME THERAPEUTICS, INC.
TITLE OF INVENTION: CD80 EXTRACELLULAR DOMAIN POLYPEPTIDES AND THEIR USE IN CANCER
TITLE OF INVENTION: TREATMENT
FILE REFERENCE: 01134-0047-00US
CURRENT APPLICATION NUMBER: US/15/340,238
CURRENT FILING DATE: 2016-11-01
PRIOR APPLICATION NUMBER: US 62/249,836
PRIOR FILING DATE: 2015-11-02
PRIOR APPLICATION NUMBER: US 62/373,654
PRIOR FILING DATE: 2016-08-11
NUMBER OF SEQ ID NOS: 25
SEQ ID NO 14
LENGTH: 232
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Fc human IgG1
8. Claims 1, 13-28, 33-35, 40, 42 and 44-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-50, 52, 53, 55 and 58-69 of copending Application No. 17/904,928 (filed August 24, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on a method of treating a solid tumor, melanoma with a BRAF mutation comprising administering to the patient at an overlapping time frame, manner and dosage of a fusion protein comprising the extracellular domain (ECD) of human cluster of differentiation 80 (CD80) and the fragment crystallizable (Fc) domain of human immunoglobulin G1 (IgGI) with a PD-1/PD-L1 antagonist and/or a BRAF inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5.align database.
PNG
media_image1.png
354
1213
media_image1.png
Greyscale
1.align database.
PNG
media_image2.png
300
1118
media_image2.png
Greyscale
US-17-773-800-3 from 3.align150.rapm.
Filing date in PALM: 2022-05-02
Sequence 3, US/17773800
GENERAL INFORMATION
APPLICANT: FIVE PRIME THERAPEUTICS, INC.
TITLE OF INVENTION: CD80 EXTRACELLULAR DOMAIN FC FUSION PROTEIN DOSING REGIMENS
FILE REFERENCE: 3986.022PC01
CURRENT APPLICATION NUMBER: US/17/773,800
CURRENT FILING DATE: 2022-05-02
PRIOR APPLICATION NUMBER: US 62/930,334
PRIOR FILING DATE: 2019-11-04
NUMBER OF SEQ ID NOS: 7
SEQ ID NO 3
LENGTH: 232
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Fc human IgG1
Conclusion
9. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can normally be reached 8AM-8PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video
conferencing using a USPTO supplied web-based collaboration tool. To
schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the
Examiner’s supervisor, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information
about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
12 November 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643