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 .
Summary
Receipt of Applicant’s Preliminary/Remarks and Amendments filed on 01/18/2024 is acknowledged. Claims 1-14 are pending and under examination in this application.
Priority
The current application filed on 01/18/2024 is a 371 of PCT/EP2022/070480 filed 07/21/2022, which in turn claims priority to patent application IT102021000019568 filed on 07/22/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/18/2024 are in compliance with the provisions of 37 CFR 1.98. Accordingly, the information disclosure statements has been considered by the examiner. Signed copies have been attached to this office action.
Claim Objections
Claims 11, 12 and 14 are objected to because of the following informalities: claim 11 status identifier is “Ameded” should be “Amended”; claim 12 recites “papapya” in line 3, which the correct spelling should be “papaya” referring to the tropical plant; and claim 14 recites endothepic in line 2, which Examiner interprets applicant to mean “endotherapeutic”. 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.
Claim 1 is 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.
Claim 1 recites "at least one bioactive compound selected from the group consisting of: an aromatic plant extract and/or an active substance thereof, a metal ion, and a carboxylic acid." The use of "and/or" within a Markush group introduces ambiguity as to whether the claim requires both the aromatic plant extract and an active substance thereof, or one of them, thereby rendering the scope of this limitation unclear. See MPEP § 2173.05(e). It is suggested that Applicant should revise to remove the internal "and/or" from the Markush group. Additionally, claim 1 recites "a phytotherapeutic agent" both at the beginning and end of the preamble/body in a manner that is grammatically ambiguous following amendment. Applicant should clarify whether the preamble "use of a phytotherapeutic composition" language is fully replaced by the amended method language. Appropriate correction is required.
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.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Manfredini (US 2018/0132485 A1) in view of Piva (US 2021/0337808 A1 with priority date of May 18, 2015), Landi (Carbonated hydroxyapatite as bone substitute) cited in IDS file 1/18/2024), Morgunov (Application of organic acids for plant protection against phytopathogens) and further in view of Acimovic (Choosing an Adequate Pesticide Delivery System for Managing Pathogens with Difficult Biologies: Case Studies on Diplodia corticola, Venturia inaequalis and Erwinia amylovora).
Manfredini teaches subject matter comprising substituted hydroxyapatite carrier, corresponding to the formula: Ca ( 10 - x ) M ( PO4 ) ( 6 - v ( CO3 ) ( OH ) 2 in which: M is chosen from Cu, Mg, Zn, Pb, Cd, Ba, K, Mn, Mo, Fe, Ag, B, Se or a combination of at least two of such elements; - x is comprised between 0 and 2, preferably between 0 and 1, more preferably between 0 and 0. 8, even more preferably between 0. 02 and 0.05; y is comprised between 0 and 2, preferably between 0 and 1, more preferably between 0.002 and 0. 030, with the proviso that x and y are never equal to 0 at the same time. The substituted hydroxyapatite is a carrier of a bioactive substance chosen among a metal ion selected from Mn, Mg, K, Fe, B, Mo, Se and/or an extract of vegetal origin. The invention relates also to the use of the carrier for the delivery of such a bioactive substance to plants in order to achieve the phytosanitary and/or nutritional treatment of the plant (abstract).
Regarding claims 1-9, 12 and 13, as noted above, Manfredini teaches hydroxyapatite carrier of formula Ca{rn-x)Mx(PO4){6-y)(CO3)y(OH)2 in which M is chosen from Cu, Mg, Zn, Pb, Cd, Ba; K, Mn, Mo, Fe, Ag, B; x is comprised between O and 2, y too. The hydroxyapatite is a carrier of a substance that can be a metal ion or an extract of vegetal origin. The function of the hydroxyapatite is the phytosanitary treatment of the plant. The carbonate substitute in the phosphate or hydroxyl site and the metal in the calcium site. Greenhouse tests were carried out on Plasmopara viticola. The content of the carbonate is 1 to 20% by weight. The carrier has a size of the particles that should be 0.5 to 5 microns (¶ 0183-¶ 0196; claims 1-4). Moreover, Manfredini discloses The carbonate substitution, but also the metal ion substitution, has the advantage to lower the crystallinity degree of hydroxyapatite, which thus becomes more amorphous (¶ 0026), with crystallinity degree comprised between 25 and 75%, preferably between 25 and 40%. Preferably, the hydroxyapatite carrier is in the form of particles smaller than 2 μm, preferably sized between 0.2 and 0.9 μm (¶ 0056); and bioactive substances adsorbed on the hydroxyapatite carrier of the invention are chosen among metal ions such as Mn, Mg, K, Fe, B, Mo, Se (acting as fertilizers and nutritional elements), and extracts of vegetal origin, such as extracts of Abies sibirica...Zingiber officinale (¶ 0058, claim 1); and plants comprising fruits (olive), flax, corn, coconut palm and grape vine (¶ 0006-¶0010, and claim 6); and Method for treating or preventing plant diseases in plants with a carrier loaded with at least one bioactive substance (claim 6), and in controlling the growth of the fungi in the long-term period, without destroying the fungal cell (as some synthetic fungicide act) but interfering with its fertility in the time (¶ 0182).
Piva teaches a carrier loaded with bioactive substances, wherein the carrier is carbonate substituted hydroxyapatite and the bioactive substances are an ion and a plant extract, wherein said ion is selected from the group consisting of Cu, Zn and a combination thereof, and wherein the plant extract consists of mint extract, rosemary extract, Ocimum basilicum extract, lemon extract, garlic extract, clove; extract, thyme extract and Cinnamon extract (abstract).
Regarding claims 1-9, 12 and 13, Piva teaches the use of substituted hydroxyapatite as a carrier of (i.e., loaded with) bioactive substances intended for treating vascular diseases, in particular grapevine yellows, bacterial canker in kiwifruit, olive quick decline syndrome and citrus bacterial canker disease (¶ 0020), and the substituted hydroxyapatite is substituted with at least one ion selected from carbonate ion or metal ion, Mg...Se, and the hydroxyapatite is substituted with carbonate ions only (¶ 0021), wherein the carrier is loaded with bioactive substances such as the metal ions Cu, Zn and plant extracts such as from rosemary, lemon, clove, garlic, thyme, cinnamon, Abies sibirica...Zingiber officinale (¶ 0024). Moreover, Piva discloses the substituted hydroxyapatite carrier of the invention has the following formula: Ca (10 - x) M_ ( PO4) (6-7) (CO3), (OH) 2, where: M is chosen from Mg, Zn, Pb, Cd, Ba, K, Mn, Cu, Mo, Fe, Ag, B and Se or a combination of at least two of such elements; x is comprised between 0 and 2, preferably between 0 and 1, more preferably between 0 and 0.8,even more preferably between 0.02 and 0.05; and y is comprised between 0 and 2, preferably between 0 and 1, more preferably between 0.002 and 0.030 (¶ 0058-¶ 0062), and the hydroxyapatite included in the above formula can be substituted with carbon ions only or metal ions only or a mixture of carbonate and metal ions (¶ 0063), and the carbonate substitution can occupy site B (PO4- phosphate ions ) as per general formulae above and/or site A (OH hydroxyl ions) of the hydroxyapatite. The ratio of substitution on site A/substitution on site B is comprised between 0.10 and 0.60 and even more preferably the ratio is comprised between 0.20 and 0.40 (¶ 0065), and crystallinity degree comprised between 25 and 75 %, preferably between 25 and 40 %. Preferably, the hydroxyapatite carrier is in the form of particles smaller than 2 um, preferably sized between 0.2 and 0.9 um (¶ 0069). Furthermore, Piva discloses the copper is adsorbed on a carbonate substituted hydroxyapatite in an amount of 20 to 80% by weight, the zinc 5 to 30%. Plant extracts in a percentage dependent on the extract (¶ 0105). The particles penetrate the xylem through the natural openings of the plants, they decompose when they meet a pathogen and act against it (¶ 0070-0085, ¶ 0095-¶ 0096).
Landi teaches B-carbonate apatite (CHA) powder was synthesized starting from calcium nitrate tetrahydrate, diammonium hydrogen phosphate and sodium hydrogen carbonate. The powder was fully characterized in terms of phase purity, stoichiometry, morphology, specific surface area and particle size distribution (abstract).
Regarding claims 1 and 5, Landi teaches The presence of B-carbonate in the apatite lattice was shown to cause a decrease in crystallinity and an increase in solubility in both in vitro and in vivo tests (page 2931, left column last ¶), The degree of crystallinity of the powder was about 72±5%, evaluated by an XRD method elsewhere proposed (page 2933, right column, 1st ¶). Moreover, Landi confirms synthesis procedures and XRD crystallinity characterization of carbonate-substituted hydroxyapatite (CsHAp) within the substitution range claimed, further establishing the general knowledge in the art regarding CsHAp preparation and physicochemical parameters.
Morgunov the basic tendency in the field of plant protection concerns with reducing the use of pesticides and their replacement by environmentally acceptable biological preparations. The most promising approach to plant protection is application of microbial metabolites. In the last years, bactericidal, fungicidal, and nematodocidal activities were revealed for citric, succinic, α-ketoglutaric, palmitoleic, and other organic
acids. It was shown that application of carboxylic acids resulted in acceleration of plant development and the yield increase (abstract).
Regarding claim 10, Morgunov expressly teach that bactericidal, fungicidal, and nematodocidal activities have been demonstrated for citric, succinic, α-ketoglutaric, palmitoleic, and other organic acids, and that application of carboxylic acids resulted in acceleration of plant development and yield increase and also teaches the use of arachidonic acid as an inductor of protective functions in plants (page 922-928). Therefore, the limitations is directly taught and Citric acid is a hydroxy carboxylic acid (C3–C8 class), palmitoleic acid is a C9–C22 unsaturated fatty acid, and arachidonic acid is a C20 polyunsaturated fatty acid are all squarely within the chemical classes recited in claim 10.
Regarding claim 11, Morgunov teaches that arachidonic acid (ARA) is effective at very low concentrations as an elicitor (abstract, and page 923 right column, ¶ 4) and concentrations of ARA (0.001, 0.01, and 0.1 μg ml−1) (page 932, right column, 1st 2 lines), thus it is consistent with the low end of the claimed ratio (0.01) while other organic acids are effective at higher concentrations, bracketing the claimed range and therefore, optimization of this ratio is routine experimentation.
Neither Manfredini, Piva, Landi or Morgunov specifically teach injection in the xylem and dilution with water.
Acimovic teaches as practical management options for this and other vascular tissue pathogens of trees are limited, we evaluated efficacy of several trunk injected fungicides in control of D. corticola and compared it with the efficacy of trunk injection of similar compounds for control of Venturia inaequalis and Erwinia amylovora, as two well-studied apple tree pathogens with different or partially similar lifestyles to D. corticola, respectively (abstract).
Regarding claims 12, 13 and14, Acimovic expressly teach: (i) a method of endotherapeutic treatment of a plant comprising administering a phytotherapeutic composition directly into the xylem of a tree trunk (page 2, last ¶); (ii) the use of copper and zinc salts (metal ions) as active agents in such compositions (page 21; (iii) the application of said compositions via xylem injection for controlling fungal diseases, bacterial diseases, and insect infestations of tree crops, citrus trees, fruit crops, and vine crops (page 4, ¶ 2-3) encompassing the same plant categories recited in claim 12; and (iv) specifically targeting pathogens such as Erwinia amylovora (bacterial disease) and Venturia inaequalis (fungal disease) (page 4, ¶ 2-3) diseases encompassed by claim 13. Moreover, Acimovic discloses dilution with water prior to (page 15, ¶ 1, Table 3, page 21 ¶ 3, and page 22, last 2 lines).
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to formulate a composition comprising a carbonate substituted hydroxyapatite of Manfredini and Piva to plant protection and endotherapy. A person having ordinary skill in the art (PHOSITA) with knowledge of both agricultural chemistry/nano-carrier technology and plant protection/endotherapeutic and phytotherapeutic agents would have been motivated to combine the teachings in Manfredini and Piva with the confirmed crystallinity characterization of carbonate-substituted hydroxyapatite (CsHAp) within the substitution range (25-59%) in order to control the dissolution rate of hydroxyapatite, and is well established in biomedical hydroxyapatite literature as taught by Landi. A PHOSITA seeking to formulate an effective phytotherapeutic composition for plant endotherapy would have been motivated to incorporate carboxylic acids taught by Morgunov, specifically citric acid, palmitoleic acid, or arachidonic acid, given their known bactericidal, fungicidal, and plant-stimulating properties documented in that reference. Combining these known bioactive carboxylic acids with the CsHAp carrier of Manfredini and Piva and the endotherapy method of Acimovic yields the method of claims. Acimovic expressly discloses a method of endotherapeutic treatment of a plant comprising administering a phytotherapeutic composition directly into the xylem of a tree trunk with the use of copper salts (metal ions) as active agents in such compositions, with application via xylem injection from controlling fungal diseases, bacterial diseases and insect infestations of tree crops, citrus trees, fruit crops and vine crops. All the references share the common goal of reducing pesticide load on the environment while maintaining or improving efficacy of active ingredients delivered to plants. A PHOSITA would have had a reasonable expectation of success in formulating carbonate-substituted hydroxyapatite in aqueous composition having particle sizes compatible with movement through xylem vessels (typically >10 microns in diameter for most trees), and the pH-responsive dissolution of (CsHAp) in the slightly acidic xylem would provide controlled release of associated active compounds. Moreover, the combination of copper/zinc metal ions as bioactive compounds in a (CsHAp) fungicidal trunk injection was taught by Acimovic. Thus, combination is therefore no more than the use of a known carrier (CsHAp) with known active agents (Cu/Zn metal ions) delivered by a known route (xylem injection) with predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE MACH whose telephone number is (571)272-2755. The examiner can normally be reached 0800 - 1700 M-F.
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/ANDRE MACH/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615