DETAILED ACTION
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 .
This action is in response to papers filed 12/02/2025.
Applicant’s election without traverse of Group III and SEQ ID NO. 4 and 5 in the reply filed on 6/25/2025 is acknowledged.
Claims 19-22 have been cancelled. Claims 1-18 and 23 are pending. Claims 1-16 are withdrawn as being drawn to a nonelected invention.
The following rejections made in the previous office action are maintained necessitated by amendment.
This action is FINAL.
Withdrawn Rejections
The 35 USC 112b, 35 USC 101 rejection made in the previous office action is withdrawn based upon amendments to the claims.
Claim Rejections - 35 USC § 103
9. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
10. 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.
11. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
12. Claim(s) 17-18, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (Carcinogenesis 2010 Vol 31 p. 1552-1560) in view of Li et al. (Bioinformatics 2002 Vol. 18 p 1427-1431).
With regard to claim 17, Ma et al. teaches primers for PDX1 (p. 1554). Ma et al. the target of PDX1 is the same as the gene used (see claim 23 and specification). Ma et al. teaches that these primers are used to amplify amplicons with CpG sites (p. 1554). However, Ma et al. does not teach primers that specifically form an amplicon with a length of 90bp to 170bp, comprising 6 to 9 CpGs and have a melting temperature of 53 to 62°C.
Ma et al. teaches primers of PDX1 that are considered MSP primers (p. 1554).
With regard to claim17 and 23, Ma et al. teaches primers for PDX1 (p. 1554). Ma et al. the target of PDX1 is the same as the gene used (see claim 23 and specification). Ma et al. teaches that these primers are used to amplify amplicons with CpG sites (p. 1554). However, Ma et al does not teach specially the claimed structures of SEQ ID NO. 4 and 5, but rather the PDX1 gene which would encompassed the claimed structure.
With regard to claims 17 and 23, Ma et al. teaches PDX1 and detecting targets within PDX1 for MSP primers. The amount of CpGs within the target does not affect the primers, but rather are dependent on an amplicon that is not claimed. With regard to the melting temperatures the design of primers for methylation analysis are well known. Li et al. teaches design constraints for methylation PCRs. Li teaches designing constraints for melting temperatures of the primer (p 1428 General primer selection criteria). Li et al. teaches that the melting temperatures must be such that the amplicon can be detected (figure 1) and therefore a close melting temperature should be used in the design (claim 19). Furhtermore Li et al. teaches primer lengths including primers that are more than 20 bp and less than 35 bp (p. 1429 2nd column) (claim 18).
Designing primers to amplify and detect methylation to specific targets, which are equivalents to those taught in the art is routine experimentation. The prior art teaches the parameters and objectives involved in the selection of oligonucleotides that function as primers, see Li et al. The prior art is replete with guidance and information necessary to permit the ordinary artisan in the field of nucleic acid detection to design primers to amplify and detect CpG sites. As discussed above, the ordinary artisan would be motivated to have designed and tested oligonucleotides from the PDX1 region to obtain additional oligonucleotides that function to detect influenza and identify oligonucleotides with improved properties for such detection. Thus, for the reasons provided above, the ordinary artisan would have designed additional oligonucleotides using the teachings in the art at the time the invention was made including oligonucleotides that comprise and amplify targets of PDX1 including SEQ ID No. 4 and 5. As such the recited primers are obvious over the cited prior art, absent secondary consideration
Response to Arguments
The reply traverses the rejection. A summary of the arguetmsn is provided below with response to arguments following. The reply asserts that Ma and Li do not provide specific information regarding the actual primer sequence, number of CpG sits and amplicon length for the specific gene of PDX1 (p. 9). The reply asserts that Ma targets a different cancer type and region of PDX1 than the claimed invention (p. 10). The reply asserts that the primer design strategy for detecting intragenic methaytlion is different form those of Ma (p. 11). The reply asserts that further Li et al. teaches that CpG sites within primers should be avoided (p. 11).
These arguments have been fully reviewed but have not been found persuasive.
It is noted that the claims are drawn to primer structure and do not require a particular region for the target, except claim 24. As noted above the target of PDX1 is well known and absent secondary considerations equivalents of SEQ ID NO. 24 or 25 would be well within the skill of the ordinary artisan in view of the known target structure. Further, the claims are drawn to a primer structure and as such the limitation of particular cancers is not relevant to the structure claimed. Finally it is noted that although Li et al. does not teach the CpG sites, in combination with Ma et al it would obvious to design any number of primer pairs including ones which include the CpG sites dependent on the target regions to amplify.
Conclusion
13. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682