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 .
Claims 17-20 are under examination.
Response to Applicants Arguments/Amendments
The examiner has carefully considered applicants arguments and amendments. In regards to the former 112(a) rejection, the applicant has presented convincing arguments that enough species of a pH responsive peptide that comprises between about 5 and about 20 histidine residues are present in the specification. Furthermore, the main important feature that must be conserved is the “between about 5 and about 20 histidine residues” which is required in the claims. Therefore, the 112(a) rejection is withdrawn. The claims have been amended to now include a protein kinase C (PKC) modulator. Therefore, the former art rejections are withdrawn and a new rejection is put forward. This amendment has also resulted in the withdraw of the Markush rejection because a protein kinase C (PKC) modulator is now included.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dixon (WO 2016207638) in view of Handumrongkul et al. “Distinct Sets of Cellular Genes Control the Expression of Transfected, Nuclear-Localized Genes” Molecular Therapy, Vol 5. No. 2, February 2002. Handumrongkul is disclosed in applicants’ IDS dated September 20, 2021.
Dixon discloses a composition/kit which can be used for transfection comprising a pH responsive peptide comprising between about 5 and about 20 histidine residues (Pages 8-10); a nucleic acid molecule for transfection (siRNA, modified messenger RNAs, microRNAs, DNA, PNA, LNA, or constructs thereof) (Page 16, 1st Paragraph) as in instant Claims 17 and 19.
Dixon does not teach the inclusion of a modulator of protein kinase C (PKC) and/or a histone deacetylase (HDAC) modulator. Handumrongkul teaches that phorbol myristic acid (PMA—a protein kinase C inhibitor) and/or a histone deacetylase (HDAC) inhibitor/modulator can be included in a transfection process (Abstract of Handumrongkul). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have included these components in any transfection composition kit and/or process. An artisan would have been motivated to have included a PMA (a protein kinase C inhibitor) and/or a HDAC inhibitor in such a transfection process/composition because such components make transfection more efficient and successful (Abstract and Page 187, left column of Handumrongkul). PMA increases the internalization of the gene delivery vector through a plasma membrane of the cell (Page 192, Discussion, 2nd Paragraph of Handumrongkul). Handumrongkul, states “Overall PMA (a protein kinase C modulator) and a HDAC inhibitor (modulator) appeared to increase transfection efficiency by regulating the expression of distinct classes of cellular genes that can control the expression of transfected genes present in the nucleus (Handumrongkul, Page 187, left column).” Because PMA (a protein kinase C inhibitor) and/or a HDAC inhibitor can improve transfection efficiency, there would be a high expectation for success (Abstract and Page 187, left column and pages 192-193 of Handumrongkul) as in instant Claims 17-20.
Dixon teaches a composition/kit that includes a pH responsive peptide and a nucleic acid molecule that can be transfected. Dixon does not teach including a HDAC inhibitor/modulator and/or a protein kinase C modulator to improve transfection. However, an artisan ordinarily skilled in the art would have been motivated to have used a HDAC inhibitor and a protein kinase C inhibitor (PMA) in order to improve the transcription and translation of nucleic acid introduced through transfection (Handumrongkul). Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be high educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in biology and transfection. Therefore, the level of ordinary skill in the art is high.
Response to Applicants Arguments
Applicants argue that Dixon does not teach or suggest that a histone deacetylase (HDAC) modulator be included in the pH medicated cell delivery vehicle. Dixon further does not teach any benefit to using a HDAC inhibitor.
The instant set of claims do not require that a histone deacetylase (HDAC) modulator be specifically included within an actual pH mediated cell delivery vehicle. The instant set of claims are so broad that they encompass the inclusion of HDAC inhibitors which are not contained within a specific structure. Furthermore, the limitation does not recite specifically a pH mediated cell delivery vehicle.
Applicants also argue that Dixon does not provide motivation for including a HDAC expression modulator. Eberwine did provide motivation because Eberwine taught that HDAC expression modulation improved transfection efficiency of the transfected nucleic acid. Furthermore, Handumrongkul, the new reference cited, teaches, “Overall PMA (a protein kinase C modulator) and a HDAC inhibitor (modulator) appeared to increase transfection efficiency by regulating the expression of distinct classes of cellular genes that can control the expression of transfected genes present in the nucleus (Handumrongkul, Page 187, left column).” Thus, the newly cited art also provides motivation for including such components into the claimed composition.
Additional arguments are put forward in which applicants argue the purpose of each of the components in the composition. However, the instant claims recite a composition comprising a modulator of protein kinase C (PKC), a pH responsive peptide comprising between about 5 and about 20 histidine residues, a molecule transfection, and a histone deacetylase (HDAC) modulator (dependent clam). The overall composition and each component can be used for any purpose. The clams are not method claims which involve the composition in a series of methods steps. The examiner feels that including more structure limitations to the composition would help to get around the prior art. An example would be to include a pH mediated cell delivery vehicle in the claims with specific interior and exterior structures included in the claim limitations.
Conclusion
All claims stand rejected.
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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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