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 .
Preliminary Claims filed November 27, 2023 are entered.
Claims 1-13, 16-17, 20-22 are pending. Claims 14-15, 18-19 are canceled.
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.
Claims 1-13, 16-17, 20-22 are 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.
Claims 1 and 12 recite the term “flexible linker” which is confusing and ambiguous because the metes and bounds of the term is not clear. The terms encompass a relative term whose boundaries are not clear. Claims 1-13, 16-17, 20-22 encompass the term.
Claim 3 recite the term “wild type” which is ambiguous because the metes and bounds of the term is not clear. It is not clear whether the wild type refers to a specific species of human TRAIL with specific structure or any human TRAIL which would be found in the wild whose structure is known or not known. Furthermore it is not clear whether the wild type encompasses any structural changes to the human TRAIL structure since the difference in structure of human TRAIL which would be considered wild type functionally is not clear.
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.
Claim(s) 1-6, 8, 10-13, 20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Levin et al. (US 2013/0095102)
Levin disclose a fusion protein comprising dimer cytokine linked by linker such as GGGSG wherein the cytokines are TRAIL or Fas to form a homodimer or heterodimer (columns 10-16, 31, 41-42, 58, 60-63, 65-66, 75, 84-89, 159, 176, 189). The TRAIL inherently forms a trimer and hexamer. The linker is a flexible linker which allows the proteins to conform to inherently bind into a trimer or hexamer. Thef soluble TRAIL inherently comprises the extracellular domain which comprises the claimed residues and sequence. The fusion protein inherently exhibits improved biological activity compared to wild type TRAIL. Levin disclose the pharmaceutical acceptable carrier for the fusion protein composition (paragraph 20, 113, 118, 120-124). Levin disclose the polynucleotide encoding the fusion protein (paragraph 18-19, 30-36).
Claim(s) 1-9, 12, 16, 20-22 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Lee (EP 3145530).
Lee disclose fusion polypeptide comprising TRAIL trimer linked by linker. The linker is soluble in solution inherently is flexible since the linker flexes with PEGylation (paragraph 19, 21, 27-32, 39-40,44-46, 48-55, 56, 57-64, 65, 66, 96-109; claim 5). The TRAIL inherently forms a trimer and hexamer. The fusion polypeptide increased the in vivo half-life and thus inherently have the improved biological activity compared to wild type. Lee’s human TRAIL comprises the same extracellular sequences (para 19). Lee disclose the fusion with Fc of IgGi (para 63). Lee disclose the polynucleotide encoding the fusion protein (para 67-71). Lee disclose the pharmaceutical composition comprising the TRAIL fusion and excipient (para 134-135). Lee teach the method of treating cancer with TRAIL fusion as chemotherapeutic agent (para 174).
Claim(s) 1-6, 8, 12, 16, 20-22 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Brin et al. (US 2018/0296690 is the PGPUB version of Almassy et al. (WO 2018/183671)).
Brin disclose nonameric TRAIL conjugate construct wherein three single chain TRAIL polypeptides are linked via a glycine-serince rich flexible linker (figure 1; SEQ ID NO: 217, Example 1; claims 1-21). SEQ ID NO: 217 has 97.6% sequence identity with claimed SEQ ID NO:2. Brin teach the method of treating lung cancer and myeloma with fusion protein of TRAIL (para 5, 15-18; Table E2, page 37). Brin discloses the polynucleotides encoding the conjugate (para 28, 54, 62). Brin disclose composition comprising pharmaceutically acceptable carrier or excipient with conjugate (para 29).
TRAIL inherently forms a trimer and hexamer. The fusion polypeptide increased the in vivo half-life and thus inherently have the improved biological activity compared to wild type. Brin’s human TRAIL comprises the same extracellular sequences.
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.
Claim(s) 1-13, 16, 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (US 2013/0095102) in view of Lee (EP 3145530).
Levin disclose a fusion protein comprising dimer cytokine linked by linker such as GGGSG wherein the cytokines are TRAIL or Fas to form a homodimer or heterodimer (columns 10-16, 31, 41-42, 58, 60-63, 65-66, 75, 84-89, 159, 176, 189). The TRAIL inherently forms a trimer and hexamer. The linker is a flexible linker which allows the proteins to conform to inherently bind into a trimer or hexamer. Thef soluble TRAIL inherently comprises the extracellular domain which comprises the claimed residues and sequence. The fusion protein inherently exhibits improved biological activity compared to wild type TRAIL. Levin disclose the pharmaceutical acceptable carrier for the fusion protein composition (paragraph 20, 113, 118, 120-124). Levin disclose the polynucleotide encoding the fusion protein (paragraph 18-19, 30-36). Levin does not disclose PEGylation of the fusion polypeptide. Levin does not disclose the fusion protein comprising IgG Fc or HSA. Levin does not teach the method of treatment of cancer.
Lee discloses fusion polypeptide comprising TRAIL trimer linked by linker. The linker is soluble in solution inherently is flexible since the linker flexes with PEGylation (paragraph 19, 21, 27-32, 39-40,44-46, 48-55, 56, 57-64, 65, 66, 96-109; claim 5). The TRAIL inherently forms a trimer and hexamer. The fusion polypeptide increased the in vivo half-life and thus inherently have the improved biological activity compared to wild type. Lee’s human TRAIL comprises the same extracellular sequences (para 19). Lee disclose the fusion with Fc of IgGi (para 63). Lee disclose the polynucleotide encoding the fusion protein (para 67-71). Lee disclose the pharmaceutical composition comprising the TRAIL fusion and excipient (para 134-135). Lee teach the method of treating cancer with TRAIL fusion as chemotherapeutic agent (para 174).
It would have been obvious to one of ordinary skill in the art at the time of the filing to incorporate the Pegylation and IgG Fc as taught by Lee into the fusion protein of Levin. One of ordinary skill in the art would be motivated to increase the half-life of the fusion protein with various technique because the monomer wild type is effectively eliminated from the body quickly.
It would be obvious for one of ordinary skill in the art at the time of filing to treat treat cancer as taught by Lee using the fusion protein pharmaceutical taught by Levin in view of Lee. One of ordinary skill in the art would be motivated to treat cancer because TRAIL targets cancer apoptosis and the increased extended life of the fusion protein would increase the apoptosis of cancer.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (US 2013/0095102) in view of Lee (EP 3145530) as applied to claims 1-13, 16, 20-22 above, and further in view of Brin et al. (US 2018/0296690 is the PGPUB version of Almassy et al. (WO 2018/183671)).
The teaching of Levin et al. (US 2013/0095102) in view of Lee (EP 3145530) are discussed above. Levin and Lee do not teach the lung cancer or myeloma treatment.
Brin disclose nonameric TRAIL conjugate construct wherein three single chain TRAIL polypeptides are linked via a glycine-serince rich flexible linker (figure 1; SEQ ID NO: 217, Example 1; claims 1-21). SEQ ID NO: 217 has 97.6% sequence identity with claimed SEQ ID NO:2. Brin teach the method of treating lung cancer and myeloma with fusion protein of TRAIL (para 5, 15-18; Table E2, page 37). Brin discloses the polynucleotides encoding the conjugate (para 28, 54, 62). Brin disclose composition comprising pharmaceutically acceptable carrier or excipient with conjugate (para 29).
TRAIL inherently forms a trimer and hexamer. The fusion polypeptide increased the in vivo half-life and thus inherently have the improved biological activity compared to wild type. Brin’s human TRAIL comprises the same extracellular sequences.
It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate treatment of lung cancer and myeloma as taught by Brin using the method of cancer treatment of Levin in view of Lee. One of ordinary skill in the art would be motivated to treat specific cancers because TRAIL targets cancer cells specifically over normal cells to apoptosis.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 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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/MICHAEL D PAK/Primary Examiner, Art Unit 1674
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