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 .
DETAILED ACTION
Election/Restrictions
Claims 1-20 are pending.
Applicant's election with traverse of Group I, species CD59 polypeptide, SEQ ID NO: 1, TIMP1, SEQ ID NO: 11, in the reply filed on 9/9/26 is acknowledged. The traversal is on the ground(s) that searching for all the invention groups is not a burden. This is not found persuasive because as indicated in the previous office action, the inventions of Group I-III are three distinct inventions for the reason of the record. They have different electronic resources and search queries, and searching for one subject matter will not necessarily lead to another. Applicant is reminded of the extensive literature search in biotechnology which is not co-extensive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-5, 7-9, 13-17, 19, and 20 are withdrawn.
Claims 1, 2, 6, 10-12, and 18 are examined on the merits.
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, 6, and 18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sims et al (JP H1057054 A), as evidenced by Halperin (US 20050032128 A1)*
Sims et al teach a method of expressing human complement-inhibiting proteins (thus claim 1 is met), particularly human CD59 (thus claim 18 is met) or functionally equivalent polypeptides (thus CD59 polypeptide, thus claim 2 is met), in mammalian cells [0151].
As evidenced by Halperin, A CD59 sequence is provided herein as SEQ ID NO:5, which represents non-glycated CD59 [0029], which is 100% query match (thus at least 80%) with the amino acid sequence SEQ ID No. 1 in claim 6, thus claim 6 is met.
Therefore, the reference is deemed to anticipate the instant claim above.
*This reference is cited merely to relay an intrinsic property and is not used in the basis for rejection per se.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 2, 6, 10-12, and 18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Regev et al (US 20200347456 A1), as evidenced by Halperin (US 20050032128 A1)*, and Rose et al (US 2003/0175686 A1)*.
Regev et al teach In another aspect, the present invention provides for a method of detecting an immunotherapy resistance (ITR) gene signature in a tumor comprising, detecting in tumor cells obtained from a subject in need thereof the expression or activity of a malignant cell gene signature comprising [0038]: e) one or more genes or polypeptides (thus the claimed polypeptide) selected from the group consisting of TM4SF1, ANXA1, MT2A, SERPINA3, EMP1, MIA, ITGA3, CDH19, CTSB, SERPINE2, MFI2, APOC2, ITGB8, S100A6, NNMT, SLC5A3, SEMA3B, TSC22D3, ITGB3, MATN2, CRYAB, PERP, CSPG4, SGCE, CD9, A2M, FGFR1, CST3, DDR1, CD59 (thus the claimed CD59 polypeptide), DPYSL2, KCNN4, SLC26A2, CD151, SLC39A14, AHNAK, ATP1A1, PROS1, TIMP1 (thus the claimed TIMP1 polypeptide, claims 10, 11, and 18 are met) [0043].
As evidenced by Halperin, A CD59 sequence is provided herein as SEQ ID NO:5, which represents non-glycated CD59 [0029], which is 100% query match (thus at least 80%) with the amino acid sequence SEQ ID No. 1 in claim 6, thus claim 6 is met.
As evidenced by Rose et al, FIG. 2 shows corresponding amino acid sequence (SEQ ID NO: 4) for human tissue inhibitor of metalloproteinases-1 (TIMP-1) available from Genbank accession NM.sub.—003254, which is 100% query match (thus at least 80%) with the amino acid sequence SEQ ID No. 11 in claim 12, thus claim 12 is met.
Regev et al do not teach CD59 peptide and TIMP1 polypeptide in one composition.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have both CD59 polypeptide and TIMP1 polypeptide all together since Regev et al teach the expression or activity of a malignant cell gene signature comprising one or more genes or polypeptides selected from the group consisting of CD59 and TIMP1, etc.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
*This reference is cited merely to relay an intrinsic property and is not used in the basis for rejection per se.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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