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 5, 11 have been canceled. Claims 1-4, 6-10, 12-25 remain pending.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant's arguments filed 10-29-25 have been fully considered but they are not persuasive.
Election/Restrictions
Applicants elected Group I, claim 1-14, in the reply filed on 6-18-25 without traverse. Claims 15-25 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-4, 6-10, 12-14 are under consideration.
Claim Rejections - 35 USC § 101
The rejection of claims 1-6 under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism has been withdrawn in view of the amendment which limits the claims to non-human heterogametic species.
Claim Rejections - 35 USC § 112
Indefiniteness
Claims 1-4, 6-10, 12-14 remain 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.
The metes and bounds of a “conditional Y- [or X-]linked genetic lethal circuit” in claims 1 and 7 cannot be determined. The metes and bounds of a genetic lethal circuit cannot be determined because the phrase is not defined in the specification or the art at the time of filing. The metes and bounds of proteins or nucleic acids encoded by the “genetic circuit” cannot be determined. It cannot be determined when a genetic modification qualifies as a “circuit”. It cannot be determined when a “genetic circuit” is “conditional”. Accordingly, those of skill would not be able to determine when they were infringing on the claim.
The rejection regarding the metes and bounds of “pest species” in claim 4, 10, 14 has been withdrawn because the claims have been limited to insects.
The rejection regarding the metes and bounds of when a species in which “one sex has greater commercial value than the other sex” in claim 5 and 11 has been withdrawn because the claims have been canceled.
Written Description
Claims 1-4, 6-10, 12-14 remain 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.
The specification lacks written description for any genetically modified biological species as broadly encompassed by claims 1 and 7 other than insects. The claim encompasses any plant or animal. Animals encompass invertebrates, insects, fish, amphibians, reptiles, birds, and mammals. However, the specification is limited to genetically modified insects (Examples). The specification does not teach how to make/use genetically modified plants, invertebrates, fish, amphibians, reptiles, birds or mammals with a “conditional Y- or X-linked genetic lethal circuit”.
An adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for making it. What is required is a description of those “genetically modified” “non-human heterogametic biological species”. It is not sufficient to define a genetically modified “non-human heterogametic biological species” solely by its principal biological property, i.e. having a “conditional X- or Y-linked genetic lethal circuit”, because disclosure of no more than that, as in the instant case, is simply a wish to know the identity of any plant or animal that has a “conditional X- or Y-linked genetic lethal circuit”. Also, naming a type of material generically known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Thus, claiming all “genetically modified” “non-human heterogametic biological species” that achieve a result without defining what means will do is not in compliance with the description requirement. Rather, it is an attempt to preempt the future before it has arrived. Accordingly, the concept lacks written description other than insects.
Response to arguments
Applicants argue the rejection is flawed because the examiner does not provide technical authority to support the example in insects is inadequate to perform the method in any plant, invertebrate, fish, amphibian, reptile, bird, or mammal. Applicants’ argument is not persuasive. There is no correlative guidance in the specification or the art at the time of filing between making insects with conditional Y-linked and X-linked “genetic lethal circuits” and making any plant, invertebrate, fish, amphibian, reptile, bird, or mammal with conditional Y-linked and X-linked “genetic lethal circuits”. Applicants were not reasonably in possession of any plant, invertebrate, fish, amphibian, reptile, bird, or mammal with conditional Y-linked and X-linked “genetic lethal circuits”.
Claim Rejections - 35 USC § 102
Claims 1-4, 6-10, 12, 14 remain rejected under 35 U.S.C. 102a1 as being anticipated by Condon (Insect Biochem. Mol. Biol., Nov. 2007, Vol. 37, No. 11, pg 1168-1176).
Condon taught genetically modified Medflies whose genomes comprise an X chromosome comprising an exogenous nucleic acid sequence encoding a marker protein or conditional lethal proteins, and
genetically modified Medflies whose genomes comprise an Y chromosome comprising an exogenous nucleic acid sequence encoding a marker protein or conditional lethal proteins (abstract, Materials and Methods). “conditional” “lethal” DNA strategies are specifically discussed in the abstract, on pg 1169, col. 1, 1st full para), on pg 1169, col. 2, 2nd full para, and on pg 1174, col. 2, last 10 lines. Condon taught all the limitations of the “system” of claim 1.
The genetic modification in the X and Y chromosomes is the same (Materials and Methods; pg 1171, col. 2, para 3; pg 1169, col. 1, para 2) which is equivalent to the “lethal circuit” being “the same” as required in claim 2.
The genetic modification in the X and Y chromosomes is the same (Materials and Methods; pg 1170, col. 1, para 2; a “DsRed2 transformation” or “ZsYellow1 transformation”) which is equivalent to the “lethal circuit” being “different” as required in claim 3.
The Medfly is an insect as required in claim 4, 10, 14.
Claim 6 has been included because the transgene is only lethal to females.
Claim 7 has been included because Condon crossed the genetically modified Medflies twice and because the system of Condon selects males.
The genetic modification in the X and Y chromosomes is the same (Materials and Methods) which is equivalent to the “lethal circuit” being “the same” as required in claim 8.
The genetic modification in the X and Y chromosomes is the same (Materials and Methods; pg 1170, col. 1, para 2; a “DsRed2 transformation” or “ZsYellow1 transformation”) which is equivalent to the “lethal circuit” being “different” as required in claim 9.
Claim 12 has been included because the transgene is only lethal to females.
Response to arguments
Applicants argue Condon did not teach any specific constructs for conditional Y-linked and X-linked “genetic lethal circuits”. Applicants’ argument is not persuasive. “Molecular constructs” are on pg 1170, and the concept using “conditional lethal” cassettes was disclosed by Condon. This is all that is required to arrive at the claimed invention.
Claim Rejections - 35 USC § 103
Claims 1-4, 6-10, 12-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Condon (Insect Biochem. Mol. Biol., Nov. 2007, Vol. 37, No. 11, pg 1168-1176) in view of Alphey (20130298266).
Condon taught all the limitations of claims 1-4, 6-10, 12, 14 for reasons set forth above.
Condon did not teach irradiating the male Medflies with an X-ray as required in claim 13.
However, Alphey irradiated male insects with X-rays to sterilize them (paragraphs 4 and 7).
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make a system of genetically modified Medflies as described by Condon and irradiate males with an X-ray to sterilize them as described by Alphey. Those of ordinary skill in the art at the time of filing would have been motivated to prevent breeding of Medflies thereby curbing the spread of diseases carried by Medflies.
Response to arguments
Applicants argue Condon fails to teach the two strain system for reasons above. Applicants’ argument is not persuasive for reasons set forth above.
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.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638