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
1. Claims 18-38 are pending.
2. Applicant's election with traverse of Group I claims 18-21 and 23 in the reply filed on 10/06/25 is acknowledged. Applicant traverse the Restriction Requirement on the grounds that the search of Groups I-VI together would not constitute a serious search burden on the examiner and that search of the claims of Group I would provide useful information for the claims of Group II -VI
This is not found persuasive because the MPEP 803 (August 2001) states that “For purposes of the initial requirement, a serious burden on the examiner may be prima facie shown if the examiner shows by appropriate explanation either separate classification, separate status in the art, or a different field of search”. The Restriction Requirement enunciated in the previous Office Action meets this criteria and therefore establishes that serious burden is placed on the examiner by the examination of more than one Group. The Inventions are distinct for reasons elaborated in paragraphs 3-5 of the previous Office Action and above
The requirement is still deemed proper and is therefore made FINAL.
Claims 22, 24-38 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 18-21 and 23 read on tumor specific neoantigeneic peptide, wherein said peptide is encoded by a part of ORF sequence from transcript associated with SF3B1 mutation are under consideration in the instant application.
3. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
4. 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.
5. 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.
6. Claims 18-21 and 23 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by or in the alternative, under 35 U.S.C. 103 as obvious over US Patent Application 20200291076
US Patent Application’076 teaches a cancer specific neoantigenic peptide, wherein said peptide is result of cancer-associated mutation in ORF of SF3B1. US patent Application’076 teaches that SF3B1 mutant tumor includes melanoma, breast cancer, carcinoma etc. US patent Application’076 teaches that said peptide are typicaly 15 to 30 amino acid long ( see entire document , paragraphs 0006, 0010, 0035, 0041, 0094 in particular).
It is noted that because the neoantigenic peptide is the results of cancer-associated mutation in ORF of SF3B1 it is not expressed in normal healthy cells.
Claim 23 is included because the claimed functional limitation would be inherent properties of the referenced cell composition. A cancer specific neoantigenic peptide is a neoantigenic peptide irrespective of its intended use. The terms “ vaccine or pharmaceutical composition” carries little patentable weight in the absence of evidence of structural difference.
Claim 19 is included because it would be conventional and within the skill of the art to : (i) identify an optimal size of cancer specific neoantigenic peptide . Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
The reference teaching anticipates or , the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
7. No claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644