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 Status
Claims 7-9 and 11-12 are currently amended, claims 17-25 are new, claims 7-9, 11-12, and 17-25 have been considered on their merits.
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.
Claims 11-12, 19, 22, and 25 are 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 11(b) recites “wherein the physiological and/or anatomical features of the fish are characteristic of a fish that has developed from a zygote which was lacking in maternally-derived mRNA encoded by the germ cell survival factor gene”, the physiological and/or anatomical features are undefined, thus rendering the scope of the claim unclear. The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds". See, e.g., the following decisions: In re Hammack, 427 F 2d. 1378, 1382, 166 USPQ 204, 208 (CCPA 1970); In re Venezia 530 F 2d. 956, 958, 189 USPQ 149, 151 (CCPA 1976); In re Goffe, 526 F 2d. 1393, 1397, 188 USPQ 131, 135 (CCPA 1975); In re Watson, 517 F 2d. 465, 477, 186 USPQ 11, 20 (CCPA 1975); In re Knowlton 481 F 2d. 1357, 1366, 178 USPQ 486, 492 (CCPA 1973).
It is also unclear if the limitations of claim 12 are directed to the physiological and/or anatomical features referenced in claim 11. If this is the case, it is suggested to direct the claim language of claim 12 to specify which aspects of claim 11 are further limited by claim 12.
Claims 12, 19, 22, and 25, which depend from claim 11, do not clarify the metes and bounds of claim 11, thus are rejected for the same reason.
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.
Claims 7-9, 11-12, and 18-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lauth et al. (WO2020033940, published 13 February 2020, IDS ref).
Regarding claims 7-8 and 12, Lauth et al. teach a method of generating a sterile sex-determined fish, comprising breeding a fertile homozygous mutated female fish having at least a first mutation and a second mutation with a fertile homozygous mutated male fish having at least the first mutation and the second mutation to produce the sterile sex-determined fish (Abstract).
Lauth et al. teach fertility rescue may comprise germline stem cell transplantation (para. [0018]). Lauth et al. teach germline stem cell transplantation comprise the steps of obtaining a germline stem cell from a sterile homozygous male fish having at least the first mutation and the second mutation or a germline stem cell from a sterile homozygous female fish having at least the first mutation and the second mutation; and transplanting the germline stem cell into a germ cell-less recipient male fish or into a germ cell-less recipient female fish (para. [0019]). Lauth et al. teach the germ cell-less recipient male fish and the germ cell less recipient female fish may be homozygous for a null mutation of the piwi-like (piwil) gene (para. [0019]). The fish which is homozygous for a null mutation of the piwil gene reads as a fish whose cell genome comprise mutations in a germ cell survival factor gene, wherein the mutations render all copies of the germ cell survival factor gene or gene product in the fish non-functional, wherein the germ cell survival gene is piwil gene (claim 7(a)). The fertility rescue via germline stem cell transplantation reads as a fish which has gonads which are capable of producing viable sperm or eggs (claim 7(b) and claim 8).
Lauth et al. teach the germline stem cell transplantation may comprise the steps of: obtaining a spermatogonial stem cell from a sterile homozygous male fish having at least the first mutation and the second mutation or a oogonial stem cell from a sterile homozygous female fish having at least the first mutation and the second mutation; and transplanting the spermatogonial stem cell into a testis of a germ cell-less fertile male fish or the oogonial stem cell into an ovary of a germ cell-less fertile female fish (para. [0020]). The fish with testis or ovary read as sexually-mature fish (claim 7, preamble). The germ cell-less fertile male fish and the germ cell-less fertile female fish may be homozygous for the mutation of the piwil gene (para. [0020]). The germ cell-less fertile female and male fish reads as a sterile fish wherein the fish has no germ cells (claim 12).
Regarding claims 9, 11, and 18-19, Lauth et al. teach a method of making a fertile homozygous mutated fish which generates a sterile sex-determined fish comprising the steps of: breeding (i) a fertile hemizygous mutated female fish having at least a first mutation and a second mutation with (ii) a fertile hemizygous mutated male fish having at least the first mutation and the second mutation; selecting a progenitor that is homozygous by genotypic selection; and rescuing the fertility of the homozygous progenitor, wherein the first mutation disrupts one or more genes that specify sexual differentiation, and wherein the second mutation disrupts one or more genes that specify gamete function (para. [0041]) (claim 18 and claim 19). Generating a sterile sex-determined fish reads as a fish zygote and a sterile fish, with a non-functional piwil gene (claim 9(a) and claim 11(a)) and wherein the zygote does not comprise functional protein encoded by the germ cell survival factor gene (claim 9(b)).
Claim 11(b) does not define the physiological and/or anatomical features of a fish lacking in maternally-derived mRNA encoded by the germ cell survival factor gene, therefore, the claim limitation is interpreted as a fish developed from a zygote lacking in maternally-derived mRNA encoded by the germ cell survival factor gene. The zygote does not comprise functional protein encoded by the germ cell survival factor gene reads on claim 11(b), as a fish developed from a zygote lacking in maternally-derived mRNA encoded by the germ cell survival factor gene.
Regarding claims 20-22, Lauth et al. teach a fish refers to any gill-bearing craniate animal that lacks limbs with digits, to include salmon which reads on the family Salmonidae (para. [0084]).
Thus, the reference anticipates the subject matter of claims 7-9, 11-12, and 18-22.
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.
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lauth et al. (WO2020033940, published 13 February 2020, IDS ref.) as applied to claims 7-9, 11-12, and 18-22 above, and further in view of Kleppe et al. (Gene 560, 217-225, published 07 February 2015, IDS ref.).
Lauth et al. anticipate the subject matter of claims 7-9, 11-12, and 18-22, and thus, render them obvious.
Regarding claims 23-25, Lauth et al. is silent to the piwil1 gene specifically.
Kleppe et al. teach piwil1 is only expressed in the testis and ovary of Atlantic salmon (Fig. 3). Kleppe et al. teach mutations of piwi proteins, as shown in zebrafish with piwi11 mutations, cause progressive loss of germ cells (p. 218, Introduction). Kleppe et al. teach piwil1 expression is confined to germ cells of the testis and ovary in juvenile salmon, with no expression in other tissues, suggesting a crucial role for piwil1 in gametogenesis in salmon (p. 224, Discussion, 1st column). Kleppe et al. teach the salmon genome posses a single copy of the piwil1 gene (p. 224, 1st column).
Therefore, it would have been obvious to one of ordinary skill in the art to mutate the piwil1 gene taught by Kleppe et al. in the method of Lauth et al. with a reasonable expectation of success because Kleppe et al. suggest piwil1 plays a crucial role in gametogenesis in salmon. One would have been motivated to mutate the piwil1 gene taught by Kleppe et al. in the method of Lauth et al. because Lauth et al. teach the germ cell-less recipient male fish and the germ cell less recipient female fish may be homozygous for a null mutation of the piwi-like (piwil) gene (para. [0019])
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lauth et al. (WO2020033940, published 13 February 2020, IDS ref.) as applied to claims 7-9, 11-12, and 18-22 above.
Lauth et al. anticipate the subject matter of claims 7-9, 11-12, and 18-22, and thus, render them obvious.
Regarding claim 17, Lauth et al. is silent to the number of mutations in the piwil gene.
However, Lauth et al. teach testes dissected from 4 months old dnd1 Knockout and wild type aged match control wherein the relative expression level of vasa, a germ cell specific gene is reduced to undetectable level in testis from dnd1 KO fish but strongly expressed in wild type testis (para. [0059] and Fig. 16). A knockout of the dnd1 gene, a germ cell survival factor gene, reads as 3-20 mutations as there could be any number of nucleotide deletions in a knockout and each missing nucleotide reads as an individual mutation.
It would have been obvious to one of ordinary skill in the art to substitute piwil for dnd1 with a reasonable expectation of success because both genes are germ cell survival factor genes. One would be motivated to substitute piwil for dnd1 because knockout of either gene would result in a non-functional gene.
Additionally, the number of mutations would be obvious because the claim uses the term mutations very broadly and the number of mutations would be a design choice, as the end result is a non-functional gene or gene product. MPEP § 2144.04(VI)(C) states rearrangement of parts is an obvious matter of design choice absent evidence to the contrary.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631