DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/3/2026 has been entered.
Claims 1, 3-5, 8, 9, 11, 15-19, 21, 24 and 27-32 are pending. Claims 11, 15, 16, 18, 19, and 30-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Rejoinder as requested is dependent on allowance of the product claims. The claims are not currently allowable.
This application claims priority under 35 U.S.C. 371 to PCT/PT2019/050035 filed 10/9/2019 which claims priority to Portuguese Patent Application No. 115073, filed on 10/9/2018. A review of the priority document has demonstrated that the claims lack support. The Portuguese Patent Application No. 115073 does not teach restriction sites or yeast expression vectors or fungal host cells . These limitations form the basis for all of the pending claims. Hence, the priority date of the claims is 10/9/2019.
Response to Amendment
The amendments are sufficient to overcome the previous rejection under 35 USC 112, first.
Applicants arguments are sufficient to place claims 1, 3, 4 and 17 in condition for allowance.
Claim Rejections - 35 USC § 103
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 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.
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.
Claims 5, 8, 9, 21, 24, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Pinto, 2008, Dissertation, pages 1-174 in view of Parks et al (EUKARYOTIC CELL, Mar. 2008, p. 444–453). This is a new rejection based upon applicants amendment.
Pinto teaches at genetic construct for expression of polo protein wherein the constructs have sequences which consists of the nucleotide sequence of SEQ ID NO:1.This sequence is demarcated below as USE 1 wherein the demarcation below consists of SEQ ID NO:1. It is downstream of the protein of interest and provides the following sequence 1 aatttatttg tttttgcccc ttcccctt-28 as shown below as lod14/USE 1.
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Pinto places this sequence as shown above in an expression plasmid. Pinto does not teach that the plasmid expression vector is yeast or in fungal cells.
However, Park et al teach yeast systems, cells and vectors such as recited in claims 5, 8 and 9, for the analysis of polo wherein insertion of the construct below would be inserted into the vector of Park.
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As park teaches,
The initial findings showed that mutations in the Drosophila polo result in defects in bipolar spindle formation (26, 44). Subsequent studies in fission yeast also disclosed that loss of Plo1 function leads to a mitotic arrest as a result of a monopolar spindle. As Pinto teaches that USE 1 are auxiliary elements that can modulate the overall mRNA 3’end efficiency (see page 5, ¶3) this would be beneficial for the analysis provided for in Park et al. Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to study the function of the polo gene of Pinto et al using the system of cells and vectors of Park et al given that the effect of modifications and function can be monitored by regulation of spindle functions as set forth by Park et al.
As recited in claim 21, GFP is included by the construct of Pinto and as recited in claim 24, the host cell is Saccharomyces as taught by Parks. As recited in claims 28 and 29, the protein is an enzyme (polo, see Pinto).
Response to Arguments
Applicants have provided an affidavit demonstrating that iPLUS increases GFP-polo protein expression in Drosophila and mammals by 2-fold, in zebrafish by 1.3- fold, and in yeast by 114-fold, which they argue is evidence of unexpected superior results. The issue with the results is they are not commensurate with the claimed subject matter in that it is not clear that the expression system is a yeast expression plasmid vector and furthermore that the cells represent the genus of fungal host cells. As well, it is noted that in figure 4, the iPLUS that provides the 114-fold increase is a triplet of iPLUS.
MPEP 716.02
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.
Hence, the affidavit is not effective in overcoming the totality of the new rejection.
A review of the art suggests that the iPLUS sequence would be allowable if in a vector with a heterologous protein sequence.
Conclusion
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/MARIA MARVICH/ Primary Examiner, Art Unit 1631
