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 .
Claims status
Applicants reply filed 11/12/2025 is acknowledged.
Claims 7 and 8 is/are cancelled. Claims 1-6, 9-15 is/are currently pending and is/are under examination.
Claim Objections - Withdrawn
Objections to claims 1 and 9 are withdrawn in light of claim amendments.
Objection to claim 8 is moot due to claim cancellation.
Claim Rejections - 35 USC § 112(b) - Withdrawn
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.
Rejection of Claims 5, 6, 8 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn and/or moot due to claim amendment/cancellation..
Claim Rejections - 35 USC § 112(d) - Moot
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Rejection of Claims 8 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is moot due to claim cancellation.
Claim Rejections - 35 USC § 112(a) – New Matter, Maintained
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claim 14 remains 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 claim(s) contains 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. 37 CFR 1.118 (a) states that “No amendment shall introduce new matter into the disclosure of an application after the filing date of the application”.
Claim 14, added in the claim amendment filed 10/4/2024, recites “wherein the repressible genetic mutation and the underdominant mutation are on the same chromosome”. In the remarks filed 10/4/2024, Applicant indicates that Figure 5, 6, associated figure legends on page 3 (lines 14-24) and generic description provided on page 10 (lines 10-16) provide support for the new claim. However, Figures 5 and 6 show the repressible genetic mutation on X-chromosome and underdominant mutation on chromosome 2 (not the same chromosome as recited). The disclosure on page 10 states “In one exemplary embodiment, the SSIMS organisms can be created using the model eukaryote, D. melanogaster. The exemplary SSIMS flies were created by combining two distinct genetic technologies together: engineered genetic incompatibility (e.g., synthetic incompatibility) and sex sorting (e.g., female lethality). In the exemplary embodiment, flies were created containing a female lethality system (FIG. 5) so that only male progeny are produced. In the exemplary embodiment, the flies also contained engineered genetic incompatibility (FIG. 6) to eliminate the production of viable progeny when crossed with wild-type individuals. The SSIMS flies produced contained both genetic systems, indicating that both genetic constructs were compatible with each other without any appreciable fitness cost (FIG. 7).” (emphasis added). Therefore, the disclosure on page 10 also points to a fly where in the mutations are on separate chromosomes. There is no explicit or implicit disclosure that provides supports for the new claim 14 that requires the two mutations to be on the same chromosome.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure [or point to case law supporting incorporation of such a limitation as in the instant case]” (emphasis added).
Claim Interpretation – Reiterated
Claim 5 and 6 limit the insect species of claim 1 to an invasive or a pest species. Since the features of “invasive” and “pest” are not inherent to an insect species but its relation to the ecology and/or societal belief, any insect species meets these limitations.
Claim Rejections - 35 USC § 103
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.
Rejection of Claim(s) 1, 2, 4-6, 9, 10, 12, 13 under 35 U.S.C. 103 as being unpatentable over Zabalou et al (PNAS, Volume 101, October 19, 2004; cited in IDS dated 1/6/2023) and Fu et al (Nature Biotech., Volume 25, March 2007; cited in IDS dated 1/6/2023) as evidenced by Mediterranean Fruit Fly (ref of record) is withdrawn because Zabalou does not teach a chromosomal homozygous underdominant genetic mutation.
Rejection of Claim(s) 14 and 15 under 35 U.S.C. 103 as being unpatentable over Zabalou et al (PNAS, Volume 101, October 19, 2004; cited in IDS dated 1/6/2023) and Fu et al (Nature Biotech., Volume 25, March 2007; cited in IDS dated 1/6/2023) as applied to claim 1 above, and further in view of Fish et al (NATURE PROTOCOLS, VOL.2, NO.10, 2007) is withdrawn because Zabalou does not teach a chromosomal homozygous underdominant genetic mutation required for amended claims 1 and 9.
Rejection of Claim(s) 1, 2, 4-6, 9, 10, 12-15 under 35 U.S.C. 103 as being unpatentable over Thomas et al (Insect Population Control Using a Dominant, Repressible, Lethal Genetic System. Science, Vol 287, 2000; cited in IDS 1/6/2023) and Waters et al (Rationally-engineered reproductive barriers using CRISPR & CRISPRa: an evaluation of the synthetic species concept in Drosophila melanogaster. Sci Rep, Volume 8:13125, September 3, 2018; cited in IDS 1/6/2023) is withdrawn in light of claim amendments. Teachings from Thomas and Waters pertaining to the newly added claim limitations are included in the new grounds of rejection below.
Rejection of Claim(s) 3, 11 under 35 U.S.C. 103 as being unpatentable over Thomas et al (Insect Population Control Using a Dominant, Repressible, Lethal Genetic System. Science, Vol 287, 2000; cited in IDS 1/6/2023) and Waters et al (Rationally-engineered reproductive barriers using CRISPR & CRISPRa: an evaluation of the synthetic species concept in Drosophila melanogaster. Sci Rep, Volume 8:13125, September 3, 2018; cited in IDS 1/6/2023) as applied to claims 1 and 9 above, and further in view of Michiels et al (A 14 bp promoter element directs the testis specificity of the Drosophila b2 tubulin gene. The EMBO Journal vol.8 no.5 pp.1 559- 1565, 1989) is withdrawn because it depends from now withdrawn rejection of claims 1 and 9.
Claim(s) 1, 2, 4-6, 9, 10, 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al (Science, Vol 287, 2000; ref of record) and Waters et al (Sci Rep, Volume 8:13125, September 3, 2018; ref of record).
Waters teaches a several strains of genetically modified Drosophila insect species comprising chromosomally integrated underdominant genetic mutations that causes the offspring of a mating between an individual with the genetic modification and a wild type individual to be non-viable (Figure 1, 6). Waters teaches both homozygous and heterozygous underdominant genetic mutations (Figure 6; see section “Homozygous Viable” wherein “Yes” indicates homozygous underdominant genetic mutations). The % Synthetic lethality is also shown in this table which ranges from 0-100% and in case of homozygous underdominant genetic mutations from 3.6-52.5%.
Since the underdominant mutation is introduced artificially, it results in “a synthetic incompatibility mutation” resulting in reproductive incompatibility between the genetically modified and wild type insects (as required by claim 4).
Regarding a method using their genetically modified insect species comprising an underdominant genetic mutation to control wild type populations such as claimed in claims 9 and 12, Waters tests several strains of genetically modified Drosophila insect species by crossing with wild type Drosophila to show that offspring of these mating are nonviable with the specific amount of lethality depending on the strain of the genetically modified Drosophila (Figure 6).
Thomas teaches genetically modified insect species comprising a chromosomal homozygous repressible genetic mutations that result in death of an individual of a specific sex in the absence of the repressor (Abstract; page 2474, col.3, para 3; Table 2). Thomas teaches a repressible genetic mutations that are female lethal because of the presence of female-specific promoter (Table 2, as required by claim 2).
Regarding a method using their genetically modified insect species comprising a chromosomal homozygous repressible female-lethal mutation to control wild type populations such as claimed in claims 9 and 10, Thomas tests two genetically modified Drosophila insect species by crossing with wild type Drosophila to show that, in the absence of the repressor, only male offspring are produced (Table 1 and 2).
Both Thomas and Waters teach Drosophila species that would be invasive in non-native habitats and considered pests when not desired (as required by claims 5 and 6).
The combination of prior art cited above under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007): Exemplary rationales that may support a conclusion of obviousness include are noted in MPEP 2143.
In the present situation, rationale A (Combining Prior Art Elements According to Known Methods To Yield Predictable Results) is applicable. MPEP 2143 guides that for rationale Office personnel must articulate the following:
(1) a finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference;
(2) a finding that one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately;
(3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
In the instant case:
The prior arts of Waters and Thomas include each element claimed and the only difference between the claimed invention and the prior art being the lack of actual combination of the elements.
Methods to generate genetically modified insects were known in the art. Both Thomas and Waters teach the method to design their specific genetic constructs and means to use these constructs to generate genetically modified insects. For example, Thomas teaches the generation of stable Drosophila line expressing female-promoter driver tTa using prior art methods (page 2474, right column, para 2-3) and crossing them with fly line comprising tet-responsive toxic gene (page 2475, left column, para 1). Similarly, Waters teaches generation of their construct, the generation of stable Drosophila line by site-specific or random genomic integration (Construction of transactivation vectors, Generation and analysis of single-vector transgenics). An ordinary artisan expects the constructs of Thomas and Waters to function independently even when combined in the same individual since they function via distinct mechanisms (i.e. each element merely performs the same function as it does separately). Based on Thomas’s teachings, an artisan expects Thomas’s construct to be active in response to the repressor such as in lab or rearing facility where the individuals would be provided the repressor. On the other hand, Waters construct is expected to remain ineffective in the genetically modified flies since they comprise a protective INDEL in the target region and only produce lethality when the genetically modified flies are mated with wild type populations, such as in the wild. Furthermore, based on Thomas’s teachings, viable offspring of individuals comprising both Water and Thomas’s constructs would only be males in the absence of the repressor, such as in the wild, because of the female-lethal mutation of Thomas (an intended result recited in claims 1, 9).
An ordinary artisan reasonably predicts that the combination of the teachings of Thomas and Waters would result in an system wherein individuals are genetically modified to comprise female-lethal and underdominant mutations. Such a combination is predicted to produce non-viable offsprings between individuals of the system and wild type population due to the presence of the underdominant mutations taught by Waters. Similarly, such a combination is predicted to produce non-viable offsprings of female sex between individuals of the system in the absence of the repressor due to the presence of the female-lethal mutations taught by Thomas. Further, an ordinary artisan would reasonably predict that the combination of the repressible female-specific lethal mutation and the underdominant mutation would result in a synergistic greater effect when compared to a method comprising only one of the mutation because the female-specific lethal mutation alone would result in reducing the population by only reducing females from the wild-type population while the underdominant mutation alone would only reduce the number of viable offspring of either sex from the mating between the individuals of the system and the wild individuals. Together, the combination would result in non-viable female offspring and reduction in viability of male offspring thus producing an expected synergistic outcome (as required for claim 13).
Regarding claim 14 and 15, Waters teaches generation of stable Drosophila line by site-specific or random genomic integration (Construction of transactivation vectors, Generation and analysis of single-vector transgenics). An ordinary artisan combining the constructs of Thomas and Waters would recognize that while site-specific integration would necessarily result in insertion of the constructs at a specific site on the same chromosome, random insertion method wherein Thomas and Waters constructs are delivered separately could result in the insertion of the constructs at a specific site on the same chromosome or different chromosomes.
Therefore, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR. Therefore, it would be obvious to a person of ordinary skill in the art to combine the female-specific lethality of Thomas with the underdominant mutation of Waters to yield a predictable result of system comprising individuals are genetically modified to comprise female-lethal and underdominant mutations and methods of using such a system.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Claim(s) 3, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al (Science, Vol 287, 2000; ref of record) and Waters et al (Sci Rep, Volume 8:13125, September 3, 2018; ref of record) as applied to claims 1 and 9 above, and further in view of Michiels et al (The EMBO Journal vol.8 no.5 pp.1 559- 1565, 1989; ref of record).
Thomas and Waters teach the system of claim 1 and method of use of claim 9. Although Thomas teaches the design of repressible sex-specific lethal genetic mutation, Thomas only exemplifies female-lethal construct. Thomas uses female-specific promoter (Yp3) to limit the expression of the toxic gene product (Ras64B) to female larvae (Table 1). Thomas does not teach a male-specific promoter that would result in a male-lethal mutation. Michiels teaches b2-tubulin promoter that is testis i.e. male-specific (Abstract). Michiels also teaches the minimum promoter sequence and its location in the b2-tubulin promoter that provides the specificity (Abstract).
The combination of prior art cited above under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007): Exemplary rationales that may support a conclusion of obviousness include are noted in MPEP 2143.
In the present situation, rationale B (Simple Substitution of One Known Element for Another To Obtain Predictable Results) is applicable. MPEP 2143 guides that for rationale Office personnel must articulate the following:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
(2) a finding that the substituted components and their functions were known in the art;
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
In the instant case:
Thomas teaches a female-lethal construct that comprises a female-specific promoter (yolk-protein 3 promoter) resulting in female-specific expression of toxic gene product. Thomas’s construct differs from the claimed male-lethal construct due to the lack of male-specific promoter.
Male-specific promoter, such as b2-tubulin promoter was taught by Michiels.
An ordinary artisan would substitute one promoter for another in a construct resulting in transgene expression based on the promoter. In the instant case, substitution of Thomas’s female-specific promoter with Michiels’ male-specific promoter would result in a male-lethal construct. Therefore, the viable offspring of a mating between two individuals of the system comprising a male-specific promoter would result in only female offsprings. The other recited outcomes due to the presence of Waters’ underdominant mutation (i.e. offspring of a mating between an individual of the system and a wild-type individual of the biological species are non-viable) would remain unaffected.
Therefore, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR. Therefore, it would be obvious to a person of ordinary skill in the art to substitute the female-specific promoter of Thomas with the male-lethal promoter to yield a predictable result of system comprising individuals are genetically modified to comprise male-lethal and underdominant mutations and methods of using such a system.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in
the art at the effective time of filing of the invention, especially in the absence of evidence to the
contrary.
Response to Arguments
Applicant's arguments filed 11/12/2025 regarding the U.S.C. 112a (New Matter) rejection of claim 14 have been fully considered but they are not persuasive.
Applicant reference MPEP 2163(II)(A)(3)(a) which is regarding determining written description support in original claims (page 6, last para). Based on this guidance that pertains to original claims, Applicant argue regarding the claim amendments filed 10/4/2024 that “Applicant need not provide "explicit or implicit disclosure" for subject matter that is conventional or well known in the art” (page 7, para 1). Applicant further allege that “the knowledge of one of ordinary skill in the art, when combined with Applicant's explicit disclosure that the embodiment illustrated in FIG. 6 is merely exemplary, provides precisely the implicit disclosure of the embodiment recited in claim 14 that the Office Action asserts is missing from Applicant's specification.” (page 7, para 2).
This is not persuasive because assessment of written description support for original claims is not the same as the assessment of written description support for new or amended claims. MPEP 2163(II)(A)(3)(a) identifies principles regarding compliance with written description support in original claims.
MPEP 2163(II)(B) is relevant in the instant case. It states “The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251 ) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed.”
MPEP 2163.06 provides specific guidance regarding Relationship of Written Description Requirement to New Matter stating that “If an applicant amends or attempts to amend the abstract, specification or drawings of an application, an issue of new matter will arise if the content of the amendment is not described in the application as filed.”
Guidance regarding how to determine if new claims are supported by original disclosure is provided in MPEP 2163(II)(A)(3)(b). It states regarding new claims that “each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure. When an explicit limitation in a claim "is not present in the written description whose benefit is sought it must be shown that a person of ordinary skill would have understood, at the time the patent application was filed, that the description requires that limitation." See also In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed. Cir. 1999) ("To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill."
MPEP 2163.07 provides specific examples of amendments that are supported by original disclosure: Rephrasing, Obvious Errors, Inherent Function/Theory/Advantage.
In the instant case, Applicant do not argue that the new limitation in claim 14 is explicitly supported. Contrary to Applicant’s argument that "explicit or implicit disclosure" for subject matter that is conventional or well known in the art is not required, MPEP 2163(II)(A)(3)(b) explicitly requires “express, implicit or inherent” support in new claims. Furthermore, based on the guidance regarding implicit and inherent disclosure, there is no evidence that an ordinary artisan would have understood that the invention as described required “the repressible genetic mutation and the underdominant mutation are on the same chromosome” as recited in claim 14. In other words, the new limitation is not implicit to the described embodiment of Figure 6 wherein the repressible genetic mutation and the underdominant mutation are on different chromosomes.
Applicant’s arguments with respect to the U.S.C. 103 rejection of claim(s) 1, 2, 4-6, 9, 10, 12-15 as being unpatentable in view of Thomas and Waters have been considered but are moot because the new ground of rejection necessitated by claim amendments.
Arguments pertinent to instant U.S.C. 103 rejection of claim(s) 1, 2, 4-6, 9, 10, 12-15 as being unpatentable in view of Thomas and Waters are addressed below.
Applicants argue that “Thomas and Waters, separately or together, fail to describe all the claimed elements of Applicant's claim 1 and claim 9 that can be combined to yield nothing more than predictable results to one of ordinary skill in the art.” (page 11, para 5).
In support, Applicant argue regarding Waters that “None of the strains developed in Waters was fully homozygous and demonstrated complete incompatibility (i.e., non-viable offspring) as recited in Applicant's claim1 and claim 9. Only one strain in Waters' Figure 6 produced 100% non-viable offspring when mated to wild type flies; however, this strain was itself not viable in the homozygous state. Indeed, none of the strains in Waters that were viable as homozygotes achieved complete incompatibility. The highest observed synthetic lethality rate was only 52.5% (Figure 6A).” Applicant allege that “Indeed, the data and discussion in Waters clearly demonstrates that even seemingly straightforward combinations of independent genetic elements do not provide predictable results (see Figure 3B and Figure 6; page 10, first full paragraph and page 10, third full paragraph). Waters highlights the well-known variability of these systems and stresses the need for additional tuning in order to achieve desired outcomes.” (page 12-13, bridging para; page 13, para 1)
This is not persuasive because the claim does not require 100% lethality. 52.5% lethality meets the limitation that “offspring of a mating between an individual of the system and a wild-type individual of the biological species are nonviable”. There is no requirement that every mating results in nonviable offspring. Furthermore, indeed data in Figure 3B and 6 of Waters show that different combinations of promoters driving Cas9-VP4 and gene targeted by the sgRNA show different result but nevertheless, Waters identifies specific strains that result in underdominant genetic mutation. Further “tuning” suggested by Waters is a routine desire of every artisan.
Of note, the claim does not any recite specific underdominant genetic mutation and the specification teaches only one.
Regarding the combination of Waters and Thomas, Applicant allege that “Waters and Thomas together aspire to propose a potential system that neither was able to achieve. While this may lead the person of skill in the art to try to make such a system, Applicant asserts that "obvious to try" is an appropriate standard for an obviousness rejection under 35 U.S.C. § 103 only when there are "a finite number of identified, predictable solutions." M.P.E.P. § 2141(III). The disclosure of Waters establishes that "a finite number of identified, predictable solutions existed." Applicant's claim 1 and claim 9 recite a system and method that accomplish what Waters, alone or in combination with Thomas, could not. At a minimum, the person of skill in the art cannot derive from the combination of Waters and Thomas the degree of success that is demonstrated in Applicant's claim 1 and claim 9.” (page 12, para 2)
In response, obvious to try rationale was not relied upon for the previous or instant U.S.C. 103 rejection. Waters and Thomas teach elements that are claimed and these elements are combinable using known methods of crossing Drosophila strains. An ordinary artisan expects that a strain comprising the genetic elements of Waters that result in the synthetic incompatibility and genetic elements of Thomas that result in female lethal mutation in the absence of the repressor would have features that arise from these independent genetic elements. There is no evidence of record that the genetic elements of Waters and Thomas are not combinable. See MPEP 2143(I) for guidance regarding rationale (A): Combining Prior Art Elements According to Known Methods To Yield Predictable Results.
Furthermore, the claims do not a “recite a system and method that accomplish what Waters, alone or in combination with Thomas, could not” since the claim does not recite any element that is patentably distinct from the elements taught by Waters and Thomas. Regarding the degree of success, none has been demonstrated in claim 1 and 9.
Of note, the degree of success of the one specific underdominant genetic mutation disclosed in the specification does not imply the same degree of success for any generic underdominant genetic mutation as presently claimed.
Applicant’s arguments with respect to the U.S.C. 103 rejection of claim(s) 3 and 11 as being unpatentable in view of Thomas and Waters in view of Michiels have been considered but are moot because the new ground of rejection necessitated by claim amendments.
Arguments pertinent to instant U.S.C. 103 rejection of claim(s) 1, 2, 4-6, 9, 10, 12-15 as being unpatentable in view of Thomas and Waters are addressed below.
Applicant argue “Applicant submits that the teaching of a male-specific promoter in Michiels fails to cure the deficiencies in the combination of Thomas and Waters described above with respect to the subject matter in Applicant's claim 1 and claim 9.” (page 13, para 2)
In response, arguments pertaining to the alleged deficiencies in the combination of Thomas and Waters were not persuasive. Therefore, this argument is also not persuasive.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATASHA DHAR whose telephone number is (571)272-1680. The examiner can normally be reached M-F 8am-4pm (EST).
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/MATASHA DHAR/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632