DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 5/21/2026.
Claims 1-20 are pending.
This application claims priority to U.S.. provisional 63/432,946 filed 12/15/2022.
Election/Restrictions
Applicant’s election of Group I (Claims 1-18, drawn to a method for rearing a genetically modified fly population to produce at least a first target compound) in the reply filed on 5/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (VEGF-C), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/21/2026.
Claim Objections
Claims 1, 4, 5. 10 and 15 are objected to because of the following informalities: in claim 1, line 6, the term “facing” appears to be repeated following and without completion at line 6. It should be deleted as well as the accompanying “and”.
For consistency in claim 1, line 28, “the target compound” should be referenced as –the first target compound--.
Claim 4 refers to “expression of the promoter sequence configured to trigger expression of the target sequence. Promoters work by mediating expression and the language in claim 4 is not proper. The promoter expressed does not trigger expression of the target sequence. Claim 13 similarly refers to the promoter in awkward terms wherein the target sequence is “configured to express responsive to expression of the first promoter sequence”. The target sequence is operably linked to a promoter and this is all that is required.
Claim 5 mixes the terminology between “the treatment chamber” instead of “treatment module” wherein one or the other should be used the same throughout. In line 11, the article “the” should be inserted prior to “expression promoter sequence”.
Claim 10, line 25 recites “third second tray” which appears inadvertent and should be “the third tray”.
In claim 15, the article “the” is missing prior to “first array of cage slots” in line 3. This is true of line 9 and 12.
Appropriate correction is required.
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 1-18 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.
Overall, the claims are confusing and resist using consistent jargon or numerical ascension properly when referring to subsequent cages, periods, fixed durations. Repetition of components previously recited and not always in consistent terms makes for large and jumbled claims. The following are specific instances of unclear language that meets the criteria of 112b.
The dependent claims are included in the rejection because they fail to address or clarify the basis of the rejection as discussed in detail for the independent claims.
Claim 1 recites “inverted” and “upright” configuration as opposing configurations. However, the term “inverted” is relative one not defined by the claim, no single set of conditions is recognized by the art as being “inverted” and because the specification does not provide a standard for ascertaining the requisite degree, the metes and bounds of this claim cannot be established.
Claim 1, line 18 refers to “the first container” wherein there is a first container in the first set of cages and one that has been decoupled. When referring to terms it is important to reference with as much clarity as possible when there are multiple references to the same or similar limitations. In this case, it would be remedial to refer to –the decoupled first container--. Or –the first container comprising the deposited first population of eggs--. This same situation arises in claim 3, line 19.
Claim 1, line 26 refers to “a first treatment period” but there is no indication of what the treatment is. This makes unclear if a step is missing.
Claim 1, lines 27-28 refer to “locating the second cage in a treatment module configured to promote generation of the target compound in fly larvae”. However, at this point, the second cages are in the incubation module unless by locating applicants mean that it is transferred to a treatment module. It is also unclear how the cage and/or treatment module can be configured to promote generation of the target compound. Modules are by definition either a unit of a set. It is not in itself something that could be configured to generate the target compound. This is also recited in claims 5, 6 and 8 (fourth cage).
Claim 1 refers to second cages configured to promote generation of the target compound in fly larvae. However, it is not clear from the disclosure or the claim how to configure a cage to promote generation of the target compound.
Claims 1, 3, 8, 10 and 13, refer to fixed duration wherein the term “fixed is a relative term not defined by the claim, no single set of conditions is recognized by the art as being “” and because the specification does not provide a standard for ascertaining the requisite degree, the metes and bounds of this claim cannot be established. Claim 15 refers to “target durations” which references the same durations wherein the term “target” is unclear as it is not clear who or how the target is determined.
The term “global” in claim 3 describing a global duration is unclear. It is a relative term and the metes and bounds of what constitutes the boundaries under which the duration is global is not set forth which makes unclear what the duration is. This is true of claim 15, line
Claim 3 recites “a second cycle”, however, there is no recitation of a first cycle and hence it is not clear to what this cycle is second to is unclear.
Claim 3 refers to “the third fixed duration” in line 25, wherein there are two uses of this duration and while it might be able to figure out which claim 3 refences, claims must be as complete as possible to negate issues of lack of clarity. This is true of the recitation of “the second population of larvae” in line 28-29 wherein this recitation lacks antecedent basis.
Claim 3, line 41 recites “the third cage”. However, the antecedent basis of this recitation is unclear as claim 3 refers to three sets of third cages, the first is the second container with the first tray and the other is the second container with a 3rd tray and the third is the second container with a 4th tray. Hence, when referring to “the third cage” lacks proper antecedent basis.
The recitation of “the promoter sequence associated with a first stressor” in claim 5 lacks antecedent basis.
In claim 8, line 10, the claim refers to a second cage that is comprised of a second container coupled to a third tray. However, claim 1 recites a second cage comprising a first container and a second try that forms the second cage. Hence, reference to a second cage is confusing and lacks proper antecedent basis.
The recitation of “the fourth cage in the treatment chamber” in claim 8, line 25, lacks antecedent basis as the 4th cage is never listed as being in the treatment chamber (module). Furthermore, in line 28, there is no first amount of the second target compound” such that “a second amount” has proper antecedent basis. This makes unclear if there is a first amount that was supposed to be extracted.
The recitation of “to form the first cage arranged in the inverted configuration” in claim 10, line 10, lacks antecedent basis as the first cage of claim 1, is the first container and first tray. Claim 10 recites that the first cage is a second container and a first tray.
Claim 10, line 15 recites that the sixth time succeeds the fourth time and in this step, the second container is decoupled from the first tray. However, it is not until the fifth time that the container is coupled to the tray. It appears that the sixth time should succeed the fifth time. This is true of claim 10, line 34 wherein the 7th time succeeds the 4th time.
Claim 10, line 29 recites “the second set of conditions configured to promote transformation of the second population of eggs into a third population of larvae” which technically does not have antecedent basis. The second set of conditions is not previously indicated as configured to promoter transformation of the second population of eggs. If the claim is limited to simply “the second set of conditions” this will provide adequate antecedent basis.
The recitation of “the third cage in the treatment chamber” in claim 10, line 31, lacks antecedent basis as the 3rd cage is never listed as being in the treatment chamber (module).
Claim 11 is vague in reciting “standard”. The term “standard” is a relative one not defined by the claim, no single set of conditions is recognized by the art as being “standard” and because the specification does not provide a standard for ascertaining the requisite degree, the metes and bounds of this claim cannot be established.
Claim 15 refers to module “defining” cage slots. This term is unclear as it is not clear how a module defines properties.
Claim 15 refers to a 5th time succeeding the first time by the second target duration. However, the 5th time appears to require steps from the 2nd-4th times and it is not clear how the fifth time can follow the first time.
Claim 17 is unclear as it is discussing a 5th set of cages but then it turns to the first set of cages in line 5. It is unclear if the process started in the fifth set of cages is switched to the first set of cages and if so how. As well, in line 11, the claims refer to a third treatment module but there is no reference to a second treatment module. Given the lengthy and complicated nature of the claims, these issues lead to a lack of cohesiveness of the method.
Claim observations
It is noted that in claim 3, the incubation period is of a third fixed period which does not match that the incubation period of claim 1 was of a second fixed duration. It is unclear if this is intentional or not. As well, claim 3, sets up a 3rd cage with a first population of flies but the cage is not subjected to the first set of conditions that leads to deposition of eggs as set forth in claim 1. This is true of claim 8 which has deposited eggs but no inclusion of conditions that lead to the production.
Claim 4 refers to genetically modifying the first population. However, the flies have already been genetically modified and this appears to be describing the step that led to the modification.
Claim Rejections - 35 USC § 112, first paragraph
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.
Claims 1-18 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims refer to a number of durations and conditions. Claim 1 refers to “fixed durations” and a set of conditions configured to promote deposition of fly eggs in the cages (first set), to promote transformation of fly eggs to fly larvae (second set) and promote generation of the target compound (third set). Claim 1, lines 27-28 refer to “locating the second cage in a treatment module configured to promote generation of the target compound in fly larvae”. Modules are by definition either a unit of a set. It is not in itself something that could be configured to generate the target compound. Hence, the structure of this cage and/or module to promote target compound is of issue. Claim 15, similar to claim 1, comprises target durations that fall under global durations and as well comprise a number of environmental conditions that are designed to lead to deposition of eggs, transformation of eggs into larvae and larvae into flies as well as produce a target compound. Claim 2 recites a bit more specifically that these conditions are generically “a temperature” and “a relative humidity” with target deviations. In claim 6 these are referred to a first stressor that is at a first and second dosage wherein claim 7 recites that these are target temperature range. Claim 12 recites that these are target air temperatures defined by the first set of conditions or second set of conditions. Each of these properties are conditions that are recited in generic terms and hence Structural features that could distinguish the elements above of the claimed genus from others not encompassed by the genus are missing from the disclosure. In this case, there are specific elements referenced but the claims reference these structures with broad generic functional terms that represent a large and diverse genus of elements. Looking to the disclosure, these elements have a limited description which means that the genus as claimed is not sufficiently described.
The number of embodiments disclosed in the specification must be commensurate with the magnitude of the claimed genus, particularly if the genus is to cover species that are not known in the prior art. Considering the “fixed duration” the term fixed means that it is set, however duration is a broad term with no set range. Therefore, the claims lack the guidance necessary to Considering conditions to promote deposition of fly eggs in the cages (first set), to promote transformation of fly eggs to fly larvae (second set) and promote generation of the target compound (third set), the conditions environmental or not are a huge set of elements.
[0046] In one implementation, the system 100 can define a rearing schedule—configured to maximize production of the target compound—including: an egg-laying period, of a first target duration (e.g., 8 hours, 12 hours, 24 hours), during which a fly population—contained in a feeder cage 150 in the feeder module 110—consumes foodstuff applied to a surface of the feeder cage 150 and deposits eggs onto this surface; an incubation period, of a second target duration (e.g., 2 days, 3 days, 5 days), during which larvae—contained in an incubator cage 152 in the incubator module 120—emerge from eggs extracted from the feeder cage 150 and mature into fully-developed larvae, the second target duration exceeding the first target duration; a treatment period, of a third target duration (e.g., 4 hours, 8 hours, 12 hours, 24 hours), during which larvae—contained in the incubator cage 152 in a heat-shock chamber—are subjected to heat-shock according to a heat-shock protocol configured to induce production of the target compound in larvae.
As to deposition of eggs in the feeder module, the claims refer simply in claim 1 to “a first set of conditions configured to promote deposition of fly eggs by adult flies”. Claim 2 is a little more limiting by indicating that this involves temperature and humidity. However, these claims refer to target deviations in one case of 25 degrees Celsius and 70% humidity. These rather broad boundaries
[[0071]] Adult flies in the feeder population—which generally seek moist, decaying organic material for deposition of eggs—may thus fly or crawl from the lower cage region to the upper cage region to concurrently consume foodstuff and deposit eggs in the food layer.
In ¶0087, this is provided “a target humidity of approximately (e.g., within five percent) 70 percent relative humidity; and a target temperature of approximately (e.g., within five percent) 25 degrees Celsius”. Otherwise, there is not a single other disclosure of conditions such that a person of skill in the art would know how to proceed with the method. As to conditions for incubation such that the eggs transform into larvae, the conditions are the same as for above.
[[0095]] For example, throughout the fixed duration of the incubation period, the incubator cage 152 can be exposed to: humidities within a target humidity range of approximately (e.g., within five percent) 70 percent relative humidity to 85 percent relative humidity; an initial incubator temperature of approximately 25 degrees Celsius at an initial time of the incubation period; a final incubator temperature of approximately 27 degrees Celsius at a final time of the incubation period; and a temperature ramp of approximately 2 degrees Celsius—from the initial incubator temperature at the initial time to the final incubator temperature at the final time—during the incubation period.
Finally, for the treatment modules, the set of conditions necessary for “generation of the target compound”, the disclosure only details heat shock or “stressor”.
[[0027]] The promoter sequence can be associated with a particular stressor (e.g., heat-shock, cold-shock, nutrient-deprivation, dehydration, UV exposure), such that application of the particular stressor to the fly population activates expression of the promoter sequence.
This then leads to what the target compound is as well as what genetically modified means. IN fact, based upon the disclosure, the flies are genetically modified to express a target molecule that is able to be induced by the third set of conditions by being limited to a modification in which the fly comprise a sequence encoding the target compound under control of a regulatory sequence that is activated by a stessor including heat-shock, cold-shock, nutrient-deprivation, dehydration and UV exposure. Here, the specification describes only genetic modification thus- genetic modification to express the target under a stress induced promoter but, the claims recite the construct in generic terms. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is needed. Since the disclosure fails to describe common attributes or characteristics that identify members of the genera, and because the genera are highly variant. Finally, the target compound is linked to a reporter but the reporter must have a detectable signal wherein this is used to create an image i.e. in Claim 13 which is then used to determine the amount of target compound is estimated “based on a set of features extracted from the image”. This can only results from a reporter that emits an optical signal.
To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art).
Closest art
A rearing system overlapping the properties of that recited in the claims is provided by Marchant et al DK 3171693. The system has conditions and durations for raising flies to deposit eggs, for eggs to become larvae. The system allows production of compounds (see ¶0002).
[0001] Aspects of the invention relate to systems and conditions adapted to enclose and continuously culture insects through various stages of an insect life cycle, particularly flying insects that lay eggs to produce larvae. Mechanized systems are provided that are adapted for the large scale production of insect larvae, which may be used in linked bioconversion systems, for example systems designed to convert organic waste materials into valuable outputs
[[0007]] The mating chamber is adapted to house male and female adult insects that mate to produce insect eggs. The eggs may then be transferred from the mating chamber to the bioconversion unit for rearing, where insect larvae are cultured to produce matured larvae. The mature larvae may in turn be transferred to the mating chamber, to eclose to produce a subsequent generation of egg-laying adult insects
[0033] In order to maximize hatching success, egg laying substrate may be suspended above a source of neonate feed and incubated in a humid (such as >90% RH) and warm (30-35C) environment.
[0034] During a second phase of neonate incubation (Incubation II), egg laying substrate is removed from the trays and a second feeding is provided.
The difference is the lack of genetically modified flies but also the specification of inverted and upright positions of the cages.
Conclusion
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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