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 .
This action is in response to the amendment filed 08 April 2026.
Claim Status
In the reply filed on 08 April 2026, claims 17, 27 are withdrawn; claims 1-4, 7-9, and 12-16 are amended, claim 28 are newly added, and claims 18-27 have been cancelled. Therefore, claims 1-17, 27-28 are herein pending.
Election/Restrictions
Applicant previously elected without traverse of Group I, claims 1-16, drawn to a method of making sterile diploid organisms in the reply filed on 07 October 2025. The new claim 28 is within the scope of the elected invention.
Claims 17 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 1-16 and 28 are herein under current examination.
Modified Priority
This application was filed 03/22/2023 and is a 371 application of PCT/US2021/ 052374 filed on 09/28/2021, which claims benefit to the US provisional application 63084683 filed on 09/29/2020 is acknowledged. Thus, the earliest possible priority for the instant application is 09/29/2020.
Withdrawn of rejections
Examiner has amended claim 1 to exclusively include the limitation, wherein expression of the first and second markers results in a recessive sterile phenotype. In Kyrou describes making Anopheles gambiae mosquitoes with mutations in the doublesex gene- a sex-determination gene with sex-specific isoforms. Doublesex is not a gene required for fertility as claimed in claim 1. Furthermore, Kyrou, the first population includes a first marker inserted into the doublesex gene. The second population, however, does not include a second marker inserted into the doublesex gene. Therefore, Kyrou does not teach or fairly suggest the method of making sterile diploid organisms comprising mating a first population of single knock-in diploid organisms and a second population of single knock-in diploid organisms as required in amended claim 1. Therefore, the prior rejection of Claims 1-3, 5-6, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kyrou et al., (Nature Biotechnology, Vol. 36; 2018; pages 1062-1066; cited in IDS filed 03/22/2023; hereinafter “Kyrou”)) in view of Kmiec et al. (WO2018132390A1; cited in IDS filed 03/22/2023; hereinafter “Kmiec”) is withdrawn.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 08 April 2026 are acknowledged.
The rejection under 103 over Kyrou has been withdrawn in view of amendments to the claims. Applicant’s arguments are moot.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per MPEP 2163(I), "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Also, as per MPEP 2163.03(V), there is a presumption that an adequate written description of the claimed invention is present in the specification as filed.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Possession may be shown in a variety of ways, for example, possession may be shown by describing an actual reduction to practice of the claimed invention. A specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) ("[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim."); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) ("[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose."); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves). Alternatively, applicant may present that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
Specifically, the claim limitation at issue is the breadth of embodiments encompassing the components of the diploid organisms of claims 1-17 and 28.
Claims 1 and 4 generally recites method of making sterile diploid organisms comprising mating a first population of single knock-in diploid organisms and a second population of single knock-in diploid organisms. The broadest reasonable interpretation of this claim includes not only the use of a first and second population of single knock-in any diploid organisms, but also making sterile any diploid organisms. Claim 2 recites the diploid organism is an arthropod, specifically any insect or any arachnid.
Instant specification discloses “the population of heteroallelic sterile diploid organisms are biological control agents of a species different from the population targeted for population control. In this aspect, a self-limiting population of heteroallelic sterile diploid biological control agents can be released to reduce the target organism population. Thus, in an aspect, the heteroallelic sterile diploid organisms are biological control agents for the diploid organism population that is a different species than the heteroallelic sterile diploid organisms.” ([0060] of US20230354790A1). Therefore, the specification fails to identify the broadest reasonable interpretation of this claim includes not only the use of a first and second population of single knock-in any diploid organisms for making sterile any diploid organisms.
Claim 5 slightly limits the genus of the insect “the insect comprises an insect of the genus Drosophila, Stegomyia, Aedes, Anopheles, Lutzomyia, Brumptomia, Warileya, Phlebotomus, Sergentiomyia, Cochliomyia, Chrysomyia, Glossinia, Ceratitis, Homalodisca, or Culex.” Similarly, claim 6 limits the genus of the insect. Further, claims 10 and 28 limits the genus of gene required for fertility in the arthropod. However, claims 2, 5-6, 10 and 28 do not further limit the scope of any diploid organisms.
The disclosure as originally filed shows a clear reduction to practice of the invention (e.g., as per the Examples and Figures) for insect comprising Anopheles gambiae. In FIG. 2, the 3XP3 promoter is used to drive XFP (e.g., RFP and EYFP) expression. 3XP3 drives expression in the visual system across a wide range of insects and developmental stages, from larval to pupal to adult, as illustrated for Anopheles gambiae in FIG. 2. ([0071] of US20230354790A1). Therefore, it is apparent that Applicant was in possession of specific insect species of Anopheles gambiae the effective filing date.
However, as detailed in MPEP § 2163, besides an actual reduction to practice, Applicant may prove possession of the claimed invention by a showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention. Further, as per MPEP § 2163, “[f]or some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement.”
In the present case, the specification does little more than list of the diploid organism (e.g., an arthropod, specifically an insect or an arachnid). However, it is noted, in the prior art Kyrou et al. (Nature Biotech Vol. 36, 2018; cited in PTO892) discloses that that CRISPR–Cas9-targeted disruption of the intron 4–exon 5 boundary aimed at blocking the formation of functional AgdsxF did not affect male development or fertility, whereas females homozygous for the disrupted allele showed an intersex phenotype and complete sterility. A CRISPR–Cas9 gene drive construct targeting this same sequence spread rapidly in caged mosquitoes, reaching 100% prevalence within 7–11 generations while progressively reducing egg production to the point of total population collapse. Therefore, Kyrou describes making Anopheles gambiae mosquitoes with mutations in the doublesex gene- a sex-determination gene with sex-specific isoforms. Therefore, it is obvious that prior art does not support to identify the generic diploid organisms to characterize the genus of any arthropod, specifically any insect or any arachnid.
Accordingly, it concludes that the claimed genus of the generic diploid organisms to characterize the genus of any arthropod, specifically any insect or any arachnid doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claims 1 and 4 and dependent claims 2-3, 5-17 and 28
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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