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 .
DETAILED ACTION
This action is in response to papers filed October 27, 2025. Applicant’s reply to the restriction/election requirement of September 11, 2025 has been entered. Claims 1-23 have been canceled. Claims 24-48 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/EP2021/080707, filed November 5, 2021 under 35 U.S.C. 365(c), is hereby acknowledged.
Acknowledgment is also made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of Italian Patent Application No. IT 102020-000026575, filed in the Italian Republic on November 6, 2020, has been received as required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group I, claims 24-28 and 30-41, is acknowledged. Applicant’s elections of i) “Chrysanthemum cinerariaefolium” as the species of plant species from which the extract is obtained, ii) “pyrethrin I” as the species of active compound, iii) “organic solvent extract” as the species of extract, iv) “metal ion” as the species of bioactive compound, v) “zinc” as the species of metal ion, and vi) “controlling insects” as the species of method are all also acknowledged.
The traversal is on the following grounds:
1. “it is well known to the skilled person that a Chrysanthemum…extract contains, as an active substance, at least one…pyrethrin” and “claim 29 depends on claim 24 and, therefore, should be included in Group I”.
2. “the Applicant has surprisingly found out that the carbonated hydroxyapatite of formula (I) improves the photostability of Chrysanthemum…extract, in particular pyrethrum extract as well as of pyrethrins”, “provides a beneficial fertilizing effect on the plants treated with the photostable composition”, and “actively contributed to limiting the environmental impact connected with the cultivation of the treated plants”.
3. “even if the carbonated hydroxyapatite of formula (I) is known from Benataya, the present invention resides in a novel and inventive combination of ingredients, which provides unexpected technical effects”.
These grounds are found persuasive-in-part because:
1. Applicant’s argument with respect to claim 29 is found persuasive. Claim 29, therefore, is being rejoined to Group I and presently examined.
2. Applicant’s arguments with respect to the alleged “unexpected results” somehow overcoming the finding of a lack of unity a posteriori are not found persuasive.
3. As noted in the restriction/election requirement, the special technical feature common to Groups I-IV is specifically “a carbonate substituted hydroxyapatite of formula (I)”. As further noted in the restriction/election requirement, this common technical feature is disclosed in the prior art. This is sufficient to establish a lack of unity a posteriori, and a lack of unity cannot be overcome by a showing of unexpected results.
Accordingly, claims 32-34 and 39-48 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. The restriction requirement is still deemed proper, maintained, and is hereby made FINAL.
Applicant timely traversed the restriction (election) requirement in the reply filed on September 11, 2025. Claims 24-31 and 35-38 are currently under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The phrase “the invention relates to” should be deleted. Further, the phrase “to a to novel” is in improper English grammatical form.
2. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art (i.e. “novel”).
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 24-29, 31, and 35-37 are objected to because of the following:
i) In claims 24-27 and 35, the expression “carbonate substituted hydroxyapatite” should have a hyphen between “carbonate” and “substituted”.
ii) In claim 27, there should be a comma between “hydroxyapatite” and “of said at least one vegetal extract”.
iii) In claims 28, 29, 31, 36, and 37, there is an extraneous colon within the Markush group following “consisting of”.
iv) In claim 28, the recited species names, e.g. “Chrysanthemum cinerariaefolium”, should all be italicized.
v) In claim 31, the expression “a aromatic plant extract” is in improper English grammatical form. Further, the expression “a C3-C8 saturated acid” appears to be a typographical error for the intended expression “a C3-C8 saturated fatty acid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 24-31 and 35-38 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.
Claim 24 is directed to a composition comprising “a carbonate-substituted hydroxyapatite” with the recited formula (I), i.e. Ca(10-y/2)(PO4)(6-y)(CO3)y(OH)2. Hydroxyapatite is generally known in the art to have the formula Ca10(PO4)6(OH)2. It is well known in the art that carbonate ions can replace phosphate ions, and that this substitution lowers crystallinity and increases solubility, often requiring charge compensation via calcium or hydroxyl vacancies, which is reflected in formula (I). However, claim 24 provides that y can be 0.01-2. In other words, the number of carbonates can be 0.01-2. This appears to be incongruous. One of ordinary skill in the art thus cannot definitively ascertain how there can be a “carbonate-substituted hydroxyapatite” without at least 1 carbonate present, which replaces at least one phosphate.
Claims 29, 31, 36, and 37 are in improper Markush format and thus one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter. Applicant is advised that a proper Markush claim has the general format “selected from the group consisting of A, B, C, and D”, not “selected from the group consisting of A, B, C, or D”, not “selected from the group consisting of A, B, C, D”, and not “selected from the group consisting of A, B, C, or D selected from the group consisting of E, F or G, or H”.
Claim 31 stipulates that the carboxylic acid is selected from the group consisting of a C9-C22 saturated or unsaturated fatty acid, a C3-C8 saturated acid, a salt thereof, or a derivative thereof”. The “derivative thereof” is not defined by the claim or the specification, and one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “a derivative thereof”.
Claims 36 and 37 stipulate in a wherein clause that the metal ion is selected from those recited. However, the list includes “B”, i.e. boron, which is generally not recognized as a metal.
Claims 25-31 and 35-38 are (also) indefinite for depending from an indefinite claim.
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 24-31 and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Manfredini et al. (U.S. Patent Application Pub. No. 2018/0132485), in view of Layton (Bug-Wise [online]; 2010).
Applicant Claims
Applicant’s elected subject matter is directed to a composition comprising a carbonate-substituted hydroxyapatite of formula (I), an extract of Chrysanthemum cinerariaefolium, and zinc ion; wherein the composition comprises 2-60 wt% of the carbonate-substituted hydroxyapatite; wherein the extract of Chrysanthemum cinerariaefolium and zinc ion are present in the amounts of 0.01-50 wt% and 0.01-15 wt%, respectively, with respect to the weight of the carbonate-substituted hydroxyapatite; and wherein the carbonate-substituted hydroxyapatite has a crystallinity degree of 25-59%.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Manfredini et al. disclose a composition comprising a carbonate-substituted hydroxyapatite e.g. of formula (I), a vegetable extract with e.g. insecticide properties, and zinc ion; wherein the composition comprises preferably 6-60 wt% of the carbonate-substituted hydroxyapatite; and wherein the carbonate-substituted hydroxyapatite has a crystallinity degree preferably of 25-40% (abstract; paragraphs 0007, 0008, 0017, 0022, 0023, 0026, 0041, 0047-0053, 0056, 0076, 0079, 0110, 0112).
Layton discloses that pyrethrum is a botanical extract of Chrysanthemum cinerariaefolium (i.e. a vegetable extract) with insecticide properties comprising the active agents e.g. pyrethrin I and pyrethrin II, with low mammalian toxicity, and which is popular and readily available.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Manfredini et al. do not explicitly disclose that the vegetable extract with e.g. insecticidal properties is pyrethrum extract of Chrysanthemum cinerariaefolium. This deficiency is cured by the teachings of Layton.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Manfredini et al. and Layton, outlined supra, to devise Applicant’s claimed composition.
Manfredini et al. disclose a composition comprising a carbonate-substituted hydroxyapatite e.g. of formula (I), a vegetable extract with e.g. insecticide properties, and zinc ion; wherein the composition comprises preferably 6-60 wt% of the carbonate-substituted hydroxyapatite; and wherein the carbonate-substituted hydroxyapatite has a crystallinity degree preferably of 25-40%. Since Layton discloses that pyrethrum is a botanical extract of Chrysanthemum cinerariaefolium (i.e. a vegetable extract) with insecticide properties comprising the active agents e.g. pyrethrin I and pyrethrin II, which is popular, readily available, and has low mammalian toxicity; one of ordinary skill in the art would thus be motivated to employ pyrethrum as the vegetal extract in the Manfredini et al. composition, with the reasonable expectation that the resulting composition can be applied to plants and protect the plants from pest insects without posing a toxicity danger to mammals.
Manfredini et al. provide that the hydroxyapatite carrier has the formula Ca(10-x)Mx(PO4)(6-y)(CO3)y(OH)2, wherein M can be Zn, x can be e.g. 2, and y can be e.g. 1. In this case, zinc is present in the amount of about 13% with respect to the weight of the carbonate-substituted hydroxyapatite.
Manfredini et al. further appear to provide in the examples that the vegetal extract can be present in the amount of 30 g/kg of formulation, in which the formulation contains the carbonate-substituted hydroxyapatite and water (see e.g. paragraph 0110). Assuming all the vegetal extract is loaded in the carbonate-substituted hydroxyapatite, and in the case in which the carbonate-substituted hydroxyapatite represents 10% of the formulation, the formulation as a whole contains about 3% of vegetal extract, and since all of this is loaded in the carbonate-substituted hydroxyapatite, the vegetal extract is present in the amount of about 30% by weight of the carbonate-substituted hydroxyapatite.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617