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 Status
1. Claims 1 – 11, 13 – 15, and 17 – 26 remain pending. Claims 12, 16, and 27 – 30 have been cancelled. New claims 31 – 36 have been added and are pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I (claims 1 – 26) in the reply filed on 11/08/2024 is acknowledged.
3. Claims 27 – 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/08/2024.
Claims Under Consideration
4. Claims 1 – 11, 13 – 15, 17 – 26 and 31 – 36 are under consideration.
Priority
5. This application claims priority to US 62/831,293, filed April 9, 2019.
Claim Objections
6. The objections to claim 1 and 7 are withdrawn in view of Applicant’s amendment to these claims.
Withdrawn Claim Rejections
7. The rejections of claims 5, 11, 15, 20 and 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicant’s amendment to the claims.
8. The rejection of claims 12 and 16 under 35 U.S.C. 103 is rendered moot by Applicant’s cancellation of these claims.
9. The rejection of clams 1 – 8, 10 – 11, 13 – 15, 17 – 23, and 26 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to the claims.
10. The rejection of claim 9 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to the claims.
11. The rejection of claims 24 – 25 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
12. Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 recites “wherein the progenitor is a wild-type fish”. Claim 35 depends from claim 11 which depends from claim 8. Claim 8 recites “a progenitor of the female fish comprising the homozygous alteration”. It is unclear how the progenitor can be both of “comprising the homozygous alteration” and “a wild-type fish”.
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.
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.
13. Claim(s) 1 – 11, 13 – 15, 17 – 26, 31 – 32, 35, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlson (WO2014193583A2; Filed 04/29/2014, Published 12/04/2014), hereinafter Carlson in view of in view of Skugor (Škugor, Adrijana, et al. Marine biotechnology 16 (2014): 256-264; previously cited) hereinafter Skugor in view of Zohar (US-9999208-B2; Filed 11/14/2014, Published 06/19/2018; previously cited), hereinafter Zohar.
Regarding claim 1, Carlson teaches a method for the production of genetically and genomically sterile animals that allow for rapid dissemination of desirable genetic traits as well as for protection of the proprietary control and containment of the traits (Abstract; page 5, lines 13 – 16). Carlson teaches examples of the method using pigs but teaches the method may be used with fish (page 15, lines 32 – 34; page 21, lines 19 – 25). Carlson teaches founder animals can be homozygous for a genetic modification and teaches methods of gene editing for producing the sterile animal including TALEN homologous dependent recombination (HDR) (“gene-edited homozygous alteration”) and an animal line is established when a pool of animals has been created that can be reproduced including by assisted reproductive techniques (“fertilizing an egg with a sperm”) (page 33, lines 28 – 29; page 34, lines 1 – 3; page 41, Example 11 and 12). Carlson teaches the sterile animal is incapable of sexual reproduction and the animal may have one or more desired/high-value/novel/recombinant trait where the animal is bred (“fertilizing an egg with a sperm”) (page 34, lines 23 – 27). Carlson does not teach an egg with an alteration in the 3’-UTR edited using a targeting construct that disrupts the function of the 3’-UTR without disrupting the coding sequence of the gene of claim 1.
Regarding claim 3, Carlson teaches animals with disruption of genes in the daz family which when disrupted prevent or destroy formation of a gamete (page 10, lines 10 – 13). Carlson teaches in Example 11 and 12 knockout of dazl gene results in animals without gametes (page 41, lines 16 – 33; Figure 13). Carlson does not teach the homozygous alteration in the 3’-UTR is responsible for reduced gametes.
Regarding claim 4, Carlson teaches in vitro and in vivo fertilization for creating the sterile animal (page 28, lines 3 – 31). Carlson does not teach the female fish comprising the homozygous alteration.
Regarding claim 6, Carlson teaches the genetically modified animal is a sterile male (page 41, lines 16 – 33; Figure 1). Carlson does not teach the animal is a fish but teaches the method can be used with fish (page 15, lines 32 – 34; page 21, lines 19 – 25).
Regarding claim 7, Carlson teaches the gene is dazl (page 41, Example 11 and 12) and the disrupted gene may be vasa (page 10, lines 1- 9).
Regarding claim 8, Carlson teaches gene-editing in a fertilized or unfertilized egg wherein the egg is obtained from a progenitor (page 28, lines 3 – 34). Carlson teaches gene-editing for a pig but teaches the method can be used with fish (page 15, lines 32 – 34; page 21, lines 19 – 25). Carlson does not teach the progenitor comprises the homozygous alteration.
Regarding claim 9, Carlson teaches somatic cell nuclear transfer with a cell comprising a nucleic acid encoding the genetic disruption can be introduced into an enucleated oocyte where after producing an embryo by fusing and activating the oocyte, the embryo is transferred to the oviducts of a recipient female and recipient females are checked for pregnancy (page 29, lines 9 – 20). Carlson does not teach the cell comprises the homozygous alteration.
Regarding claim 10, Carlson teaches gene-editing comprises pronuclear microinjection (page 27, lines 14 – 16 and 25 – 26; page 28, lines 3 – 5).
Regarding claims 11 and 31, Carlson teaches founder animals can be homozygous for a genetic modification and teaches methods of gene editing for producing the sterile animal including TALEN homologous dependent recombination (HDR) and an animal line is established when a pool of animals has been created that can be reproduced including by assisted reproductive techniques (“at least one generation”) (page 33, lines 28 – 29; page 34, lines 1 – 3; page 41, Example 11 and 12).
Regarding claim 13, Carlson teaches the gene editing comprises CRISPR/Cas or TALEN (page 39, Examples 6 – 8; page 40, Examples 9 – 10; page 41, Example 11).
Regarding claim 14, Carlson teaches the gene editing system for creating deletions and insertions (page 2, lines 5 – 7; page 15, lines 15 – 22; page 21, lines 7 – 9; page 26, lines 27 – 30) but does not teach a deletion or insertion in the 3’-UTR.
Regarding claim 17, Carlson teaches gene editing methods plasmid homology templates (page 3, lines 15 – 19; page 38, lines 7 – 13; page 40, Example 10). Carlson does not teach homology to the gene’s 3’-UTR.
Regarding claim 18 and 19, Carlson teaches gene editing by CRISPR/Cas comprising guide RNA (page 39; Figure 5).
Regarding claim 26, Carlson teaches the sterile animal is incapable of sexual reproduction and the animal may have one or more desired/high-value/novel/recombinant trait where the animal is bred (“fertilizing an egg with a sperm”) (page 34, lines 23 – 27).
Regarding claims 35, Carlson teaches gene-editing in an animal that has not undergone gene-editing of a gene in gametogenesis to create founder animals (page 41, Example 7). Carlson teaches founder animals can be homozygous for a genetic modification and teaches methods of gene editing for producing the sterile animal including TALEN homologous dependent recombination (HDR) and an animal line is established when a pool of animals has been created that can be reproduced including by assisted reproductive techniques (“at least one generation”)(page 33, lines 28 – 29; page 34, lines 1 – 3; page 41, Example 11 and 12).
Regarding claim 36, Carlson teaches in vitro fertilization by an animal that has not undergone gene-editing of a gene in gametogenesis (page 28, lines 3 – 31).
Carlson does not teach fertilizing an egg with an alteration in the 3’-UTR edited using a targeting construct that disrupts the function of the 3’-UTR without disrupting the coding sequence of the gene of claim 1 or “maternally-expressed mRNA” of claim 2 or “maintaining the fertilized egg under conditions suitable for development of the sterile fish into a fry” of claim 5 or “creates a premature truncation” of claim 15 and claim 32, or “non-homologous regions” of claim 20, or “zebrafish” of claim 23, or “further comprises an improved trait” of claim 24, or “faster growth” of claim 25. However, Carlson teaches the genetically sterile animal comprises a genomic disruption of a gene encoding a factor selectively involved in gametogenesis wherein the animal is sterile when homozygous for the disruption and the disruption prevents gametogenesis (Figure 1; page 6, lines 4 – 12 and 13 – 15). Carlson teaches in Figure 3A a gene for disruption of gametogenesis with expression controlled by microRNA binding to the 3’UTR (page 2, lines 27 – 28; Figure 3A). Carlson teaches the genetically sterile animal is a tool for dissemination of the donor’s genetics and mating the animal provides for a rapid spread of desirable traits (page 6, lines 29 – 31). Carlson teaches traditional livestock breeding is an expensive and time-consuming process that involves careful selection of genetic traits and lengthy waits for generational reproduction and variations of sexual reproduction present a considerable challenge in cultivating and passing on a desirable trait (page 5, lines 7 – 12).
Regarding an egg with an alteration in the 3’-UTR edited using a targeting construct that disrupts the function of the 3’-UTR without disrupting the coding sequence of the gene of claim 1 and “non-homologous regions” of claim 20, Skugor teaches a construct comprising a mutation in the 3’-UTR of nanos3 (claim 20) where the construct was injected into zebrafish embryos where the embryos showed lower expression of nanos3 in primordial germ cells (PGCs) indicating low stability of the RNA (page 260, left col. paragraph 2; page 262, left and right col.; Figure 6). Skugor does not teach fertilizing an egg with a 3-UTR alteration of claim 1.
Regarding claim 2, Skugor teaches the mutation is in nanos3 and nanos 3 is maternally inherited in zebrafish (page 263, left col. paragraph 2). Skugor teaches the mutation in nanos3 3’-UTR reduces the stability of the mRNA in PGCs (page 262, left and right col.). Skugor teaches PGCs migrate toward the future gonads to give rise to the gametes (page 265, right col. last paragraph ).
Regarding “premature truncation” of claim 15 and claim 32, Skugor teaches the construct comprises a truncation of the 3’-UTR in Figure 6b. Skugor teaches the mutation in nanos3 3’-UTR reduces the stability of the mRNA in PGCs (page 262, left and right col.).
Regarding claim 21 and 22, Skugor teaches the construct comprising the truncated 3’-UTR of nanos also comprises GFP (“exogenous gene” of claim 21 and “fluorescent protein” of claim 22) (Figure 6b).
Regarding claim 23, Skugor teaches zebrafish (page 260, left col. paragraph 2).
Skugor does not teach fertilizing an egg with a 3-UTR alteration of claim 1 or “maintaining the fertilized egg under conditions suitable for development of the sterile fish into a fry” of claim 5 or “further comprises an improved trait” of claim 24, or “faster growth” of claim 25. However, Skugor teaches the importance of aquaculture production is increasing with the declining global fish stocks but early sexual maturation in several farmed species reduces muscle growth and quality and escapees could have a negative impact on wild populations (Abstract; page 256, right col. paragraph 1). Skugor teaches a possible solution to these problems is the production of sterile fish by ablation of the PGCs (Abstract; page 256, right col. paragraph 1). Skugor teaches morpholino-mediated downregulation of the DnD which is a PGC-specific inhibitor of miRNA action abolished PGCs in zebrafish embryos (Abstract; page 257, left col. paragraph 1). Skugor teaches loss of DnD function in zebrafish or its target sequences made zebrafish nanos susceptible to miR-430-mediated degradation and resulted in the failure of PGC migration and survival (page 258, left col. paragraph 1; page 263, left col. last paragraph). Skugor teaches injection of morpholinos targeting dnd in fish embryos resulted in the disappearance of PGCs suggesting the requirement for Dnd in PGC-specific mRNA stabilization (page 258, right col. paragraph 2; page 259, right col. last paragraph ; Figure 4d,e; page 263, left col. last paragraph).
Regarding fertilizing an egg with a 3-UTR alteration of claim 1, Zohar teaches a method of producing sterile fish comprising disruption of primordial germ cell migration and/or development without detrimentally affecting other characteristics of a normal fish by contacting an unfertilized egg with an anti-sense Morpholino oligomer targeting dnd that renders progeny sterile and then fertilizing the egg in vitro (col. 1, lines 66 – 67; col. 2, lines 1 – 11; Figure 1; Figure 2). Zohar teaches in Figure 2 that the method causes disruption of PGC development including their differentiation such that adult fish have no fertile gonadal development relative to fish without treatment (col. 5, lines 48 – 50; Figure 2). Zohar teaches the dnd gene is expressed in PGCs and considered essential for normal migration and survival of PGCs (col. 6, lines 64 – 67; col. 7, lines 1 – 3 and lines 13 – 19). Zohar teaches the method is applicable to all fish species including zebrafish, carp species, trout species, salmon species, breams, basses, and catfish species (col. 13, lines 58 – 64).
Regarding claim 5, Zohar teaches the method produces adult infertile fish from embryos (col. 3, lines 38 – 44; Figure 2; col. 14, Example 2).
Regarding claims 24 and 25, Zohar teaches the reduced dnd expression (claim 24) resulting in sterilization of farmed fish enhances their growth rate by increasing the conversion of food energy to muscle growth instead of gonadal development (“faster growth” of claim 25) (col. 1, lines 45 – 48).
Zohar teaches optimization of aquaculture methods is increasingly necessary to maximize food production and minimize ecological impact, thereby achieving long-term environmental sustainability of seafood supplies (col. 1, lines 37 – 44). Zohar teaches sterile farmed fish will not be able to reproduce or inter-breed with wild population if they escape into the environment thus assisting with biological containment and preventing genetic contamination of wild populations (col. 1, lines 48 – 57). Zohar teaches the method allowed for efficiently inducing 100% sterility without affecting any other physiological characteristics of the fish (col. 14, lines 28 – 33).
It would have been obvious prior to the effective filing date of the invention as clamed for the person of ordinary skill in the art to combine the teachings of Carlson regarding a method of making a sterile animal comprising a homozygous gene-edited genomic disruption of a gene encoding a factor selectively involved in gametogenesis with the teachings of Skugor regarding a construct comprising a disruption of the 3’-UTR of nanos3 and knocking down dnd with morpholinos with the teachings of Zohar regarding a method of generating sterile fish comprising knocking down dnd with morpholinos to arrive at the claimed method where an egg from a female comprising a gene-edited homozygous alteration in the 3’-UTR of nanos3 is treated with dnd morpholinos and then is fertilized with a sperm to produce a sterile fish wherein a targeting construct for editing the 3’-UTR disrupt the function of the 3’-UTR without disrupting the coding sequence of nanos3. One would have been motivated to combine the teachings of Carlson, Skugor, and Zohar in a method to produce sterile fish that do not endanger wild fish populations as Skugor teaches commercial fish farming is hampered by early sexual maturation and environmental concerns about gene flow from escapees which could be solved by inducing sterilization of stock fish by ablation of the embryonic primordial germ cells and Zohar teaches optimization of aquaculture methods is increasingly necessary to maximize food production and minimize ecological impact, thereby achieving long-term environmental sustainability of seafood supplies. One would have a reasonable expectation of success in combining the teachings as Carlson teaches the method allows for rapid dissemination of desirable genetic traits as well as for protection of the proprietary control and containment of the traits and Skugor teaches the 3’-UTR disruption in nanos3 reduces stability of nanos3 mRNA in PGCs and Zohar teaches the method allowed for efficiently inducing 100% sterility without affecting any other physiological characteristics of the fish.
14. Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlson (WO2014193583A2; Filed 04/29/2014, Published 12/04/2014), hereinafter Carlson in view of in view of Skugor (Škugor, Adrijana, et al. Marine biotechnology 16 (2014): 256-264; previously cited) hereinafter Skugor in view of Zohar (US-9999208-B2; Filed 11/14/2014, Published 06/19/2018; previously cited), hereinafter Zohar as applied to claims 1 – 11, 13 – 15, 17 – 26, 31 – 32, 35, and 36 above, and further in view of Ilagan (Ilagan RP, et. al. FEBS J. 2010 Apr;277(8):1967-78), hereinafter Ilagan.
Carlson in view of Skugor and Zohar make obvious the limitations of claim 1 as set forth above.
Carlson teaches targeting gene editing to introduce EGFP into the chromosome of an animal (page 40, Example 9). Carlson teaches detection of EGFP for monitoring gene editing (page 41, paragraph 1).
Skugor teaches the ability of the 3’UTR of germ cell mRNAs to target the expression of GFP to the PGCs has been widely utilized not only for studying the PGC migration to the future gonad but also for cryopreservation and transplantation of PGCs in various fish species (page 257, left col. last paragraph). Skugor teaches the truncated 3’UTR of nanos3 was fused to GFP in the construct (page 257, right col. paragraph 2; Figure 6b). Skugor teaches use of GFP to monitor PGCs with DnD morpholinos (page 259, right col. last paragraph; Figure 4).
Ilagan teaches EGFP is a widely used variant of GFP and is brighter (page 2, paragraph 2).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to substitute GFP in the construct taught by Skugor with EGFP taught by Carlson and Ilagan to arrive at the claimed method where the targeting construct for editing the 3’-UTR of nanos3 disrupts the function of the 3’-UTR by truncation and comprises EGFP without disrupting the coding sequence of nanos3. One would have been motivated to make such a substitution as Ilagan teaches EGFP is brighter than GFP. One would have a reasonable expectation of success in carrying out the substitution as Carlson teaches gene editing to introduce EGFP into the chromosome where EGFP is used to monitor gene editing and Skugor teaches evaluating PGCs using GFP.
15. Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlson (WO2014193583A2; Filed 04/29/2014, Published 12/04/2014), hereinafter Carlson in view of in view of Skugor (Škugor, Adrijana, et al. Marine biotechnology 16 (2014): 256-264; previously cited) hereinafter Skugor in view of Zohar (US-9999208-B2; Filed 11/14/2014, Published 06/19/2018; previously cited), hereinafter Zohar as applied to claims 1 – 11, 13 – 15, 17 – 26, 31 – 32, 35, and 36 above, and further in view of Knaut (Knaut, Holger, et al. Current biology 12.6 (2002): 454-466.), hereinafter Knaut.
Carlson in view of Skugor and Zohar make obvious the limitations of claim 1 as set forth above.
Carlson teaches the vasa gene is essential for germ cell development (page 9, lines 29 – 33). Carlson teaches disruption of vasa expression results in female sterility and females homozygous for partial loss-of-function alleles produce eggs that can be fertilized but the resulting embryos lack germ cells (page 10, line 1 – 4). Carlson teaches an embodiment of animals with disrupted vasa genes (page 10, lines 8 – 9).
Skugor teaches vasa is maternally provided and later de novo transcribed in PGCs (page 257, left col. paragraph 1). Skugor teaches a region in the vasa 3’UTR sufficient for localizing maternal vasa mRNA to the germ plasm (page 257, right col. paragraph 1).
Zohar teaches the method may include morpholinos against vasa for producing sterile animals (col. 7, lines 4 – 12).
Carlson, Skugor, and Zohar do not teach alterations in the 3’UTR of vasa.
Knaut teaches constructs comprising vasa 3’UTR deletions that were introduced into zebrafish (Abstract; page 454, right col. last paragraph; page 455, left col. paragraph 1). Knaut teaches transgenic zebrafish that express vasa 3’UTR deletion constructs (page 460, left col. paragraph 1; Figure 3A). Knaut teaches the first 141 nucleotides of the 3’UTR of vasa do not localize to germ plasm in zebrafish during oogenesis (page 460, left col. paragraph 1; Figure 3).
It would have been obvious prior to the effective filing date of the invention as clamed for the person of ordinary skill in the art to combine the teachings of Carlson regarding a method of making a sterile animal comprising a homozygous gene-edited genomic disruption of a gene encoding a factor selectively involved in gametogenesis with the teachings of Skugor regarding a construct comprising a disruption of the 3’-UTR of nanos3 and knocking down dnd with morpholinos with the teachings of Zohar regarding a method of generating sterile fish comprising knocking down dnd with morpholinos with the teachings of Knaut regarding a vasa 3’UTR truncation that prevents vasa localization to germ plasm in zebrafish to arrive at the claimed method where an egg from a female comprising a gene-edited homozygous alteration in the 3’-UTR of nanos3 and in the 3’-UTR of vasa is treated with dnd morpholinos and then is fertilized with a sperm to produce a sterile fish wherein a targeting construct for editing the 3’-UTR disrupt the function of the 3’-UTR without disrupting the coding sequence of nanos3. One would have been motivated to combine the teachings of Carlson, Skugor, Zohar, and Knautin a method to produce sterile fish that do not endanger wild fish populations as Carlson teaches disruption of vasa expression results in female sterility and females homozygous for partial loss-of-function alleles produce eggs that can be fertilized but the resulting embryos lack germ cells and Skugor teaches commercial fish farming is hampered by early sexual maturation and environmental concerns about gene flow from escapees which could be solved by inducing sterilization of stock fish by ablation of the embryonic primordial germ cells and Zohar teaches optimization of aquaculture methods is increasingly necessary to maximize food production and minimize ecological impact, thereby achieving long-term environmental sustainability of seafood supplies. One would have a reasonable expectation of success in combining the teachings as Carlson teaches the method allows for rapid dissemination of desirable genetic traits as well as for protection of the proprietary control and containment of the traits and Skugor teaches the 3’-UTR disruption in nanos3 reduces stability of nanos3 mRNA in PGCs and Zohar teaches the method allowed for efficiently inducing 100% sterility without affecting any other physiological characteristics of the fish where the method may include knockdown of vasa and Knaut teaches the first 141 nucleotides of the 3’UTR of vasa do not localize to germ plasm in zebrafish during oogenesis.
Applicant Arguments/ Response to Arguments
16. Applicant Argues: On page 7 – 8, Applicant argues that Wargelius does not teach amended claim 1.
Response to Applicant: The previous rejections of the claims using the teachings of Wargelius have been withdrawn in view of the claim amendments. New rejections are set forth above using Skugor (previously cited) who teaches a truncation in the 3’UTR of nanos3 (Figure 6b). Skugor teaches the method of making the construct comprising amplifying regions of 3’UTR nanos3 and therefore does not teach disruption of the coding sequence of nanos3.
Conclusion
No claims 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.
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/Z.M.B./Examiner, Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632