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 .
Claim Interpretation
Claims 11, 17, and 18 recite “AgCPB-3 or a variant thereof” as opposed to claim 9, which lacks the phrasing “or a variant thereof”. As AgCPB-3 and AgCPB-1 are both variants of the Anopheles gambiae carboxypeptidase B gene, any variant of the gene will be considered satisfactory regarding claims 11, 17, and 18.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5, 7, 11, 13, 22, 29, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hannon et al. (US 2009/0062228 A1)
Regarding claims 1 and 29: Hannon discloses a piRNA comprising a nucleotide sequence which hybridizes under physiologic conditions of a cell to cause down-regulation of transcription of the mRNA at the genomic level (0023) which selectively binds to Piwi or Aubergine proteins. (0037)
Regarding claim 2: Hannon discloses that the piRNA is about 25-50 nucleotides in length, reading on the range of about 20-50 nucleotides in length. (0018)
Regarding claim 3: Hannon discloses that in certain embodiments of the invention that the piRNAs are of the same or different sequences. (0038)
Regarding claim 4: Hannon discloses that in certain embodiments of the invention the piRNA comprises no more than 1 in 5 base pairs of nucleotide mismatches with respect to the target gene mRNA transcript. (0024)
Regarding claim 5: Hannon discloses that in certain embodiments, the piRNA has greater than 90% sequence identity between the piRNA and the portion of the target gene. (0064)
Regarding claim 7: Hannon discloses that the Piwi subclass of Argonaute proteins include insect proteins. (0108)
Regarding claim 11: Hannon discloses that the invention provides two Anopheles gambiae carboxypeptidase B nucleotide sequences or variants thereof. (57)
Regarding claim 13: It is known in the art that exonic regions are coding sequences retained in the translation process but intronic sequences are spliced out. As such, it is inherent that the piRNA is located within the intronic region of the nucleotide sequence encoding AgCPB-3.
Regarding claim 22: Hannon discloses that the piRNA comprises a 5’ uracil residue in certain embodiments of the invention. (0030)
Regarding claim 34: Following the discussions of claims 1 and 29 above, Hannon further discloses that the claimed invention may be used to silence target gene expression in a host cell including insect cells. (0060) As such, this would inherently cause a reduction of transmission of a disease as the host (such as a mosquito) would have target gene expression silenced, thereby preventing production of said disease.
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.
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.
Claim(s) 8-10, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hannon et al. (US 2009/0062228 A1) in view of Lavazec et al. (US 2005/0260219 A1)
The teachings of Hannon are discussed above. Hannon fails to teach use of sequences matching SEQ ID NOs. 1-10 or 12-15 or use of an Anopheles gambiae-specific gene.
Regarding claim 8: Lavazec teaches an invention which comprises compositions and vaccines containing the Anopheles gambiae carboxypeptidase B which is used to block Plasmodium development (0003) which aids in preventing the spread of plasmodium falciparum, the most deadly species of human malaria parasite. (0005)
Regarding claim 9: Lavazec teaches that the invention includes polynucleotides which hybridize to the target gene CPBAG1 (0075) which exhibit carboxypeptidase B activity. (0080)
Regarding claim 10: Lavazec teaches SEQ ID NO. 1 to be used in the claimed invention, which corresponds to a full length cDNA of CPBAG1 (0140) and matches the claimed SEQ ID NO: 10 by 98.5%, reading on the matching of SEQ ID NO: 10 by at least 75% as shown in the alignment chart pictured below:
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1004
448
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Greyscale
Regarding claim 20: Lavazec teaches that the invention may be administered orally by means of the transformation of plants used as a host feed for consumption. (0104)
Regarding claim 23: Lavazec teaches that the claimed invention may be used via integration into host cells, which is interpreted to mean both plant and animal cells. (0105)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Lavazec with the teachings of Hannon to incorporate the teachings of use of an Anopheles gambiae-specific gene. One would have had motivation and a reasonable expectation of success based on the teachings of Lavazec, who states that Anopheles gambiae carboxypeptidase B is used to block Plasmodium development, thereby leading to a prevention of the most deadly form of Malaria.
Claim(s) 14-15, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hannon et al. (US 2009/0062228 A1) in view of Lavazec et al. (US 2005/0260219 A1), Hoermann et al. (Converting endogenous genes of the malaria mosquito into simple non-autonomous gene drives for population replacement, 2021) and Bahia et al. (Exploring Anopheles gut bacteria for Plasmodium blocking activity, 2014)
The teachings of Hannon and Lavazec are discussed above. Both fail to teach use of a midgut lumen receptor blocking protein or use of a specific AgCP promoter.
Regarding claims 14-15 and 17-18: Bahia teaches that the malaria parasite undergoes a bottleneck in the midgut of the mosquito, wherein the majority of the ingested parasites are killed. (Pg 1, Introduction) Bahia teaches that isolates from the midgut display parasite-blocking mechanisms, and all but one isolate displayed interference with the infection process. (Pg 4-5, Results) While Bahia fails to teach a plasmid constructed from said isolates, one skilled in the art would be motivated by the teachings of Bahia that midgut protein isolates prohibit the malaria parasite lifecycle and be motivated to combine said teachings with the construct taught by Hannon via incorporation of a midgut lumen receptor blocking protein. However, Hoermann teaches use of three Anopheles gambiae promoters, including a carboxypeptidase promoter (pg 3, Results). Hoermann further teaches that when used via incorporation of midgut-specific loci into a malaria vector, anti-malaria effects were observed. (Pg 1, Abstract) While neither Bahia nor Hoermann specify that the nucleotide sequences are downstream of the AgCPB-3 variant, Lavazec specifies in claim 7 that the vector is operably linked to an inducible promoter. As claim 15 specifies use of any number of nucleotide sequences from 1-6, use of even one of the promoters taught by Hoermann satisfies this requirement.
Regarding claim 20: Hoermann teaches use of the construct as a source of Cas9 in both male and female germlines of mosquitos, inducing high rates of gene drive of the modified loci. (Pg 13, Results)
One skilled in the art would have clear motivation to incorporate the teachings of Hoermann and Bahia of an Anopheles gambiae promoter into the construct taught by Hannon and Lavazec as both Bahia and Hoermann teach that midgut receptor blocker isolates and promoters are effective anti-malaria management strategies. Furthermore, Hoermann clearly demonstrates the transformation of said polynucleotide into an Anopheles gambiae germline.
Allowable Subject Matter
Claims 6, 12, 13, 16, 19, and 21 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. All SEQ ID NOs identified in claims 6, 12, 16, 19, and 21 are free of the art and as claim 13 is further dependent from claim 12, claim 13 is free of the art as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/HANNA MARIE THUESON/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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