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 .
Applicant’s amendment and response to restriction requirement of 7/11/25 are entered.
Claims 44-48, 51, and 59 are amended.
Claim 63 is newly presented.
Claims 44-63 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, as in present Claims 44-47 and 63, in the reply filed on 7/11/25 is acknowledged.
Applicant’s election of the species of P. Aeruginosa, and FtsZ gene in the reply filed on 7/11/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 48-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/11/25.
Claims 44-47 and 63 are considered with respect to the elected species, however, if non-elected species are realized during prosecution, those rejections will be made, regardless of the species election, in the interest of compact prosecution.
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 (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.
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.
Claim(s) 44-47 and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghosal, et al. (2012) “Potent antibacterial antisense peptide-peptide nucleic acid conjugates against Pseudomonas aeruginosa”, Nucleic Acid Therapeutics, 22(5): 323-34; Gong, et al. (April 2014) “siRNA-mediated gene silencing of MexB from the MexA-MexB-OprM efflux pump in Pseudomonas aeruginosa”, BMB Reports Online, 47(4): 203-08 (NPL reference 16, IDS of 5/14/24) and Bai, et al. (2012) “Antisense inhibition of gene expression and growth in gram-negative bacteria by cell-penetrating peptide conjugates of peptide nucleic acids targeted to rpoD gene”, Biomaterials, 33: 659-67.
Ghosal teaches the use of antisense peptide nucleic acid conjugates for knocking down the ftsZ gene in Pseudomonas aeruginosa (ABSTRACT). However, Ghosal does not teach the delivery of dsRNA of 15-30 base pairs in length, for effecting the same.
On the other hand, Gong teaches silencing of the MexB of P. aeruginosa, by 21 bp siRNA duplexes against the MexB gene (ABSTRACT). However, Gong does not teach the use of vesicles outside of cells, containing the siRNA, as Gong teaches the use of plasmids to grow the siRNA in the bacteria (DISCUSSION, paragraph 4).
Bai teaches that PNAs can be delivered to gram-negative bacteria, to inhibit expression of a gene, when conjugated to the nucleic acid (e.g., TITLE; MATERIALS AND METHODS, section 2.3).
Given the teachings of Gong and Bai, it would have been obvious to deliver siRNA in conjugated to cell-penetrating peptides to to P. Aeruginosa. The Artisan would do so to silence the MexB gene in the bacteria, as taught by Gong. The Artisan would expect success, as the components are utilized for Art-recognized purposes.
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 (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.
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.
Claim(s) 44-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong, et al. (April 2014) “siRNA-mediated gene silencing of MexB from the MexA-MexB-OprM efflux pump in Pseudomonas aeruginosa”, BMB Reports Online, 47(4): 203-08 (NPL reference 16, IDS of 5/14/24) and Bai, et al. (2012) “Antisense inhibition of gene expression and growth in gram-negative bacteria by cell-penetrating peptide conjugates of peptide nucleic acids targeted to rpoD gene”, Biomaterials, 33: 659-67.
Gong teaches silencing of the MexB of P. aeruginosa, by 21 bp siRNA duplexes against the MexB gene (ABSTRACT). However, Gong does not teach the use of vesicles outside of cells, containing the siRNA, as Gong teaches the use of plasmids to grow the siRNA in the bacteria (DISCUSSION, paragraph 4).
Bai teaches that PNAs can be delivered to gram-negative bacteria, to inhibit expression of a gene, when conjugated to the nucleic acid (e.g., TITLE; MATERIALS AND METHODS, section 2.3).
Given the teachings of Gong and Bai, it would have been obvious to deliver siRNA in conjugated to cell-penetrating peptides to to P. Aeruginosa. The Artisan would do so to silence the MexB gene in the bacteria, as taught by Gong. The Artisan would expect success, as the components are utilized for Art-recognized purposes.
Claim(s) 44-47 and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong, et al. (April 2014) “siRNA-mediated gene silencing of MexB from the MexA-MexB-OprM efflux pump in Pseudomonas aeruginosa”, BMB Reports Online, 47(4): 203-08 (NPL reference 16, IDS of 5/14/24) and Bai, et al. (2012) “Antisense inhibition of gene expression and growth in gram-negative bacteria by cell-penetrating peptide conjugates of peptide nucleic acids targeted to rpoD gene”, Biomaterials, 33: 659-67, as applied to claims 44-47, above, and further in view of Lopez, et al. (28 November 2017) “Dynamics of Intact MexAB-OprM Efflux Pump: Focusing on the MexA-OprM Interface”, Scientific Reports, 7: Article 16521 (17 pages).
As shown above, the base claims are obviated by the base Art, however the aspect of targeting the MexB gene is not taught by the Art presented.
On the other hand, Lopez teaches that MexB is a critical member of the complex for the pump (e.g., p. 1, last paragraph).
Thus, at the time of invention, it would have been obvious to further modify the invention, to utilize siRNA to the MexB gene. The Artisan would do so to shut down the pump, similar to the way it is done by Gong. The Artisan would expect success, as it is taught by Lopez that MexB is another critical member to the pump, and thus, silencing it, would also have the same effect on the cells as silencing MexA.
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 (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.
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.
Claim(s) 44-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong, et al. (April 2014) “siRNA-mediated gene silencing of MexB from the MexA-MexB-OprM efflux pump in Pseudomonas aeruginosa”, BMB Reports Online, 47(4): 203-08 (NPL reference 16, IDS of 5/14/24) and Perche, et al. (30 April 2019) “Cardiolipin-Based Lipopolyplex Platform for the Delivery of Diverse Nucleic Acids into Gram-Negative Bacteria”, Pharmaceuticals, 12(2): Article 18 (12 pages).
Gong teaches silencing of the MexB of P. aeruginosa, by 21 bp siRNA duplexes against the MexB gene (ABSTRACT). However, Gong does not teach the use of vesicles outside of cells, containing the siRNA, as Gong teaches the use of plasmids to grow the siRNA in the bacteria (DISCUSSION, paragraph 4).
On the other hand, Perche teaches the delivery liposomes comprising RNA or DNA, to P. Aeruginosa (Figure 1, Table 1, and Figure 3).
Given the teachings of Gong and Perche, it would have been obvious to deliver siRNA in liposomes to P. Aeruginosa. The Artisan would do so to silence the MexB gene in the bacteria, as taught by Gong. The Artisan would expect success, as the components are utilized for Art-recognized purposes.
Claim(s) 44-47 and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong, et al. (April 2014) “siRNA-mediated gene silencing of MexB from the MexA-MexB-OprM efflux pump in Pseudomonas aeruginosa”, BMB Reports Online, 47(4): 203-08 (NPL reference 16, IDS of 5/14/24) and Perche, et al. (30 April 2019) “Cardiolipin-Based Lipopolyplex Platform for the Delivery of Diverse Nucleic Acids into Gram-Negative Bacteria”, Pharmaceuticals, 12(2): Article 18 (12 pages), as applied to claims 44-47, above, and further in view of Lopez, et al. (28 November 2017) “Dynamics of Intact MexAB-OprM Efflux Pump: Focusing on the MexA-OprM Interface”, Scientific Reports, 7: Article 16521 (17 pages).
As shown above, the base claims are obviated by the base Art, however the aspect of targeting the MexB gene is not taught by the Art presented.
On the other hand, Lopez teaches that MexB is a critical member of the complex for the pump (e.g., p. 1, last paragraph).
Thus, at the time of invention, it would have been obvious to further modify the invention, to utilize siRNA to the MexB gene. The Artisan would do so to shut down the pump, similar to the way it is done by Gong. The Artisan would expect success, as it is taught by Lopez that MexB is another critical member to the pump, and thus, silencing it, would also have the same effect on the cells as silencing MexA.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638