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
In the reply filed on 24 July 2026, claims 17 and 27 are withdrawn; claim 1 is amended, and claims 18-26 have been cancelled.
Therefore, claims 1-17, 28 are herein pending.
Election/Restrictions
Applicant previously elected without traverse of Group I, claims 1-16, and 28 drawn to a method of making sterile diploid organisms in the reply filed on 07 October 2025.
Claims 17 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Examiner noticed that withdrawn claim 27 has no claim description that filed on 24 July 2026.
This application is in condition for allowance except for the presence of claims 17 and 27 directed to inventions non-elected without traverse. Accordingly, claims 17 and 27 have been cancelled (see examiner’s amendment to claims ¶ below).
Therefore, claims 1-16 and 28 are herein under current examination.
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.
Information Disclosure Statement
Applicant has filed Information Disclosure Statements on 24 July 2026 that have been considered. The signed and initialed PTO Forms 1449 are mailed with this action.
Maintained 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 maintained rejection 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. This rejection is maintained for reasons of record and further explained below.
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 the first and second population of single knock-in any diploid organisms but also making any diploid organisms sterile. 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 limit 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 identifying 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 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.
RESPONSE TO ARGUMENTS
Applicant's arguments and Rule 1.132 Declaration filed on 24 July 2026 are acknowledged.
Applicant argues in the Declaration, section 3 and 4 that the published peer-reviewed journal article (Laursen et al., "Humidity sensors that alert mosquitoes to nearby hosts and egg laying sites", Neuron, 2023, 111(6): 874-88), in which IR93a gene knock-ins were made in in Anopheles gambiae and Ae. Aegypti. Inventor Garrity concluded "While the knockin method was used to disrupt Ir9 3a, one of skill in the art would understand that the method shown in Figure 2 is not limited to Ir93a or the specific hosts as the Figures, as with the patent application, demonstrate a general strategy for distinguishably marked knock-in pairs (DMKPs)." Therefore, applicant concluded "The DMKP method has therefore been successfully demonstrated in three insect species separated by -250 million years of evolution (An. gambiae, Ae. aegypti, D. melanogaster) . Further, given that the method is based on the rules of Mendelian inheritance, one of ordinary skill in the art would recognize that the method will work in all diploid species that are comprised of males and females. In view of this, Applicant believe that the scope of the claims is much broader than that asserted by the Examiner and should not be limited to Anopheles gambiae." See remark p. 13 and Declaration, section 3 and 4 filed 24 July 2026.
Applicant arguments have been fully considered but they are not persuasive. Applicant relies on the Garrity Declaration filed 24 July 2026 and the subsequently published Laursen et al. (2023) article to assert that the distinguishably marked knock-in pair (DMKP) method is not limited to Anopheles gambiae and that successful implementation in An. gambiae, Aedes aegypti, and Drosophila melanogaster demonstrates that the method is generally applicable to diploid species comprising males and females. However, the relevant inquiry for written description is whether the disclosure as originally filed reasonably conveys to a person of ordinary skill in the art that the inventor was in possession of the full scope of the presently claimed genus as of the effective filing date. Evidence arising after the effective filing date may be considered for limited purposes, but it cannot establish possession of subject matter that was not adequately described in the application as originally filed (see MPEP 2163.02).
The instant Specification provides working disclosure directed to particular insect systems. For example, Figure 2 describes use of the 3XP3 promoter to drive XFP expression and illustrates the DMKP strategy in Anopheles gambiae. See ¶ [0071] of US 2023/0354790 A1. The Specification additionally describes implementation in Drosophila melanogaster, including XFP-marked disruptions of zpg (zero population growth), a gene required for fertility, and reports sterility of the resulting mutant flies. See ¶ [0065] and Fig. 3B.
In contrast, the additional Aedes aegypti implementation relied upon by Applicant is reported in Laursen et al. (2023), after the September 29, 2020, effective filing date. Although this later work may provide evidence concerning subsequent implementation of the methodology in another insect species, it does not, by itself, demonstrate that the Specification as filed reasonably conveyed possession of a genus extending to all diploid species comprising males and females. Moreover, Applicant’s reliance on Mendelian inheritance does not adequately address whether the disclosed DMKP methodology including generation of the required knock-ins, expression and distinguishability of the markers, reproductive compatibility and transmission of the engineered alleles was sufficiently described across the entire breadth of the claimed genus. The Specification’s working examples involving An. gambiae and D. melanogaster do not, without further disclosure of representative species or common identifying characteristics demonstrating applicability across the claimed genus, reasonably convey possession of the full scope encompassing all diploid male-and-female species (e.g., human). Accordingly, the Specification reasonably demonstrates possession of the disclosed insect embodiments, including Anopheles gambiae and Drosophila melanogaster, but does not reasonably convey possession, as of the effective filing date, of the substantially broader genus encompassing all diploid species comprising males and females. Therefore, Applicant’s Declaration and the post-filing Laursen et al. publication do not overcome the written description rejection.
Conclusion
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). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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 extension fee 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 date of this final action.
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).
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.
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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