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 .
Priority
Acknowledgement is made of the Applicant’s claim of foreign priority to application GB2210435.0 filed 15 July 2022.
Claim Rejections - 35 USC § 112
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.
Claims 21-33 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 enablement requirement. While being enabling for treating plant diseases caused by Salmonella enterica and Moraxella bovis (Examples 1-4), the specification does not reasonably provide enablement for preventing any and all fruit-bearing plant diseases. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not reasonably provide enablement for prevention of any and all fruit-bearing plant diseases. The skilled artisan cannot envision the prevention of prevention of all diseases, for example, and the instant specification provides no evidence or data to support prevention. Prevention involves “attacking” the underlying cause of the disease; i.e., disrupting the mechanisms which give rise to it. The skilled artisan is aware that not all diseases have known causes or treatment methods at the time of the invention herein. For purposes of enablement, the specification must provide reasonable detail in order for those skilled in the art to carry out the invention. In this case, the specification must disclose a means of preventing any and all fruit-bearing plant diseases regardless of the underlying causes of the disease. The teachings of the specification do not enable a person of ordinary kill in the art to make and use the claimed method of prevention. Moreover, “[p]atent protection is granted only in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d at 1366, 42 USPQ2d at 1005 (Fed. Cir.), cert. denied, 118 S. Ct. 397 (1997), (“Tossing out the mere germ of an idea does not constitute an enabling disclosure”).
The test of enablement is whether one skilled in the art could make and use the
claimed invention from the disclosures in the application coupled with information known
in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d
1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a
single factor, but rather a conclusion reached by weighing many factors (See Ex parte
Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d
1400 (Fed. Cir. 1988). These factors include the following:
Scope or breadth of the claims
The claims are broader in scope than the enabling disclosure. The specification does not provide evidence or data that the instant composition can reasonably prevent any and all fruit-bearing plant diseases. The claims do not narrow or limit the diseases to be treated.
Nature of the invention
The nature of the invention is directed to a method of treating or preventing disease in a fruit-bearing plant comprising transferring a phage or immunogenic agent to a plant using a flying insect as the carrier.
Relative level of skill possessed by one of ordinary skill in the art
The relative level of skill possessed by one of ordinary skill in the art of medical research is relatively high, as a majority of lead investigators directing scientific research and development in this particular technological area possess an Ph.D. in a scientific discipline such as organic synthetic chemistry, polymer chemistry, medicinal chemistry, biochemistry, pharmacology, biology or the like.
State of, or the amount of knowledge in, the prior art
It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved.” Unpredictability in treating any and all fruit-bearing plant diseases generally is established by the following references:
Bayer (“https://www.bayer.com/en/news-stories/citrus-greening-solutions-for-farmers” 1 September 2025) teaches that citrus greening is a disease, caused by a bacterium, that is incurable (pg 1-2). Efforts to control the vector have also failed (pg 2).
Level or degree of predictability, or a lack thereof, in the art
The art teaches that at least one fruit-bearing plant disease, citrus greening, is both incurable and efforts to control the vector have failed. Therefore, the art recognizes that at least one disease is incurable and so-far unable to be controlled thus rendering preventing any and all fruit-bearing plant diseases as nearly impossible.
Amount of guidance or direction provided by the inventor
The Applicant was required to provide in the specification additional guidance and direction with respect to the use of the claimed subject matter in order for the application to be enabled with respect to the full scope of the claimed invention. However, the Applicant has not provided guidance on how to use their claimed invention to prevent any and all fruit-bearing plant diseases.
Presence or absence of working examples
The specification provides working embodiments with respect to treating plant diseases caused by Salmonella enterica and Moraxella bovis (Examples 1-4) however does not provide evidence for preventing any and all fruit-bearing plant diseases.
Quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure
One of ordinary skill in the art would have to conduct a myriad number of experiments comprising picking and choosing diseases and plants, administering the claimed invention, and testing for efficacy. The art teaches that citrus greening is one plant disease that is incurable an uncontrollable. Therefore, in view of the Wands factors discussed above, to prevent any and all fruit-bearing plant diseases, a person of skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 21-28 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (WO 2014/063070) in view of Grace et al. (Plant Pathology. 2021;70:1987–2004) in view of IPPC (https://www.ippc.int/es/news/olives-under-attack-in-italy/).
Gonzalez teaches methods and compositions for isolating a bacteriophage and for treatment of plant diseases caused by Xylella fastidiosa and Xanthomonas axonpodis comprising the use of a bacteriophage (pg 1, lns 20-23). Insect vectors such as glassy winged sharpshooter (GWSS) may spread disease caused by X. fastidiosa as well as phage which infect the disease-causing bacteria (pg 12, lns 15-18). Gonzalez took a suspension of phage or bacteria in sterilized water (pg 44, lns 28-30) and anchored cowpea cut stems (which produces a green bean-like fruit) in the suspension (pg 45, lns 27-29). The stems in suspension were exposed to GWSSs and it was determined that both phage and bacteria could be acquired by the GWSSs and further transferred to fresh cut cowpea stems (pg 46, lns 7-13).
Gonzalez does not teach a method of treating a fruit-bearing plant wherein the insect vector is a wasp, oriental fruit fly, olive fruit fly, bee, hover fly or blow fly.
Grace teaches that Xylella bacteria are causing ecological devastation in olive fruits and that there is an urgent need to tackle bacterial plant diseases (abstract). Specifically, Xylella fastidiosa causes olive quick decline syndrome, which can result in tree death (pg 1994, sec 3.5). There are currently no treatments to eradicate X. fastidiosa (id). Grace further teaches that phages are promising biocontrol agents that can be used to replace damaging copper pesticides and antibiotics (pg 1998, sec 6).
IPPC teaches that the olive fruit fly (Bactrocera oleae) is a threat to olive trees as it carries Xylella fastidiosa, which causes leaf scorch (pg 2).
It would have been prima facie obvious to modify the process of Gonzalez to use olive fruit flies as the vector insect instead of GWSS since both insects are taught as carrying Xylella fastidiosa. By modifying the insect vector, it would have also been obvious to modify the target plant species to the olive tree. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06). The resulting method would be a method of treating olive trees (fruit-bearing plants) comprising subjecting olive fruit flies to bacteriophage and plant stems. Upon feeding on the plant stems, it would have then been obvious to subject the olive fruit flies to fresh cut plant stems to transfer the bacteriophage, which is taught by Gonzalez as being done in cowpea stems. The plant stems are effectively an insect attractant, based on scent and visual cues, and also a nutrient source of plant sugars. The plants can comprise both leaves and flowers, thus providing two attractant substances. Gonzalez teaches that a bacteriophage or a bacteria can be used, thus it would have been obvious to use both together. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07). The bacteria of Gonzalez are an immunogenic agent that can, by definition, produce bacterial antigens. Therefore, the prior art renders obvious the method of instant claims 21-28 and 31-33.
Claims 21-33 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (WO 2014/063070) in view of Grace et al. (Plant Pathology. 2021;70:1987–2004) in view of IPPC (https://www.ippc.int/es/news/olives-under-attack-in-italy/) in view of Scott et al. (WO 03/093462).
Gonzalez, Grace, and IPPC, as applied supra, are herein applied in their entirety for the teaching of a method of treating olive trees by using olive fruit flies as a vector for transmitting bacteriophage effective against Xylella fastidiosa.
Gonzalez does not teach wherein the bacteriophage is stabilized or immobilized via its head.
Scott teaches a method for immobilizing and stabilizing bacteriophage, preferably to a solid phase substrate, for use as a bacteriostatic agent (pg 1, lns 1-7). Immobilization to the substrate can be done via the head groups of the bacteriophage (pg 5, lns 20-23). The immobilized and stabilized bacteriophages can be used in the prevention and treatment of viral or bacterial infections in plants (pg 4, lns 18-20). Scott teaches that bacteriophage are particularly unstable and difficult to store (pg 2, lns 25-27). Immobilization by older methods have disadvantages such as inefficiency, reversibility, and lack of viability of the bacteriophage (pg 2, ln 28- pg 3, ln 3). The method of Scott is designed to mitigate these disadvantages and provide bacteriophages that are stable and retain viral biological activity (pg 3, lns 4-13).
It would have been prima facie obvious to modify the method of Gonzalez in view of Grace and IPPC wherein the bacteriophage is immobilized via head group and/or stabilized to a solid substrate. Doing so would provide a stable and biologically effective form of the bacteriophage, as taught by Scott. The resulting method of Gonzalez would thus be improved by modifying the bacteriophage according to Scott, thus addressing instant claims 21-33.
Claims 34-35 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (WO 2014/063070) in view of Capinera (Encyclopedia of Entomology, 2nd Edition, Vol 1, 2008, pgs 1-4346).
Gonzalez teaches methods and compositions for isolating a bacteriophage and for treatment of plant diseases caused by Xylella fastidiosa and Xanthomonas axonpodis comprising the use of a bacteriophage (pg 1, lns 20-23). Insect vectors such as glassy winged sharpshooter (GWSS) may spread disease caused by X. fastidiosa as well as phage which infect the disease-causing bacteria (pg 12, lns 15-18). Gonzalez took a suspension of phage or bacteria in sterilized water (pg 44, lns 28-30) and anchored cowpea cut stems (which produces a green bean-like fruit) in the suspension (pg 45, lns 27-29). The stems in suspension were exposed to GWSSs and it was determined that both phage and bacteria could be acquired by the GWSSs and further transferred to fresh cut cowpea stems (pg 46, lns 7-13).
Gonzalez does not teach a composition comprising both the phage and a flying insect attractant selected from pheromones, volatile agents, odorous materials, and materials that can reflect or emit light or radiation.
Capinera teaches that GWSSs fly between plants feeding on xylem fluid (pg 1625, ¶3). The adults are attracted to the color yellow and plant volatiles to locate plants for feeding (id).
It would have been prima facie obvious to combine, in a composition or kit, the bacteriophage and/or bacteria components of the method of Gonzalez useful for treating plant diseases caused by Xylella fastidiosa, with an attractant that would attract vector insects to feed on the bacteriophage in order to carry out the method of Gonzalez. Since Capinera teaches that GWSS are attracted to yellow and plant volatiles, it would have been obvious to include either or both agents in the composition of Gonzalez, thus reading on instant claims 34-35 and 39-40.
Claims 34-35 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez et al. (WO 2014/063070) in view of Capinera (Encyclopedia of Entomology, 2nd Edition, Vol 1, 2008, pgs 1-4346) in view of Fisher (https://www.fishersci.com/us/en/browse/90168074/centrifuge-tubes; available 19 June 2020).
Gonzalez and Capinera, as applied supra, are herein applied in their entirety for the teaching of a composition comprising bacteriophage and/or bacteria components of the method of Gonzalez useful for treating plant diseases caused by Xylella fastidiosa, with an attractant that would attract vector insects. Gonzalez teaches incorporating the composition in a tube (pg 44, lns 28-30; pg 45, lns 27-30).
Gonzalez does not teach using a plastic substrate.
Fisher teaches that plastic centrifuge tubes were readily available at the time of the instant application, therefore, it would have been obvious to use a plastic centrifuge tube as the substrate for comprising the composition of Gonzalez, thus rendering obvious instant claims 37-38.
Allowable Subject Matter
Claims 36 and 41 require the flying insect to be a bee. The prior art does not teach or suggest using a bee vector with a phage and/or immunogenic agent which has activity against a bacterium associated with disease in a fruit-bearing plant wherein the bacterium is Ralstonia solanacearum, Xylella fastidiosa, Pseudomonas savastanoi, and/or Pseudomonas syringae. Claims 36 and 41 would be allowable it written as independent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613