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 Applicant’s amendment filed May 6, 2026 in reply to the First Office Action on the Merits mailed February 12, 2026. Claims 24-29, 31-37, and 39-42 have been amended; and claims 1-23 have been canceled. Claims 32-34 and 39-48 have been withdrawn. Claims 24-31 and 35-38 are under examination
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract, as now amended, introduces “methods of use”, but fails to inform the reader of the actual “use” or “uses”, and the key requisite active steps which are new to the art that define each of the methods.
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 29, 31, 36, and 37 are objected to because there is an extraneous colon within the Markush group following “consisting of”.
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 0.1-1.2. In other words, the number of carbonates can be 0.1-1.2. This appears to be incongruous. Applicant is in effect claiming a “carbonate-substituted hydroxyapatide” that can contain only 1/10 of a carbonate? One of ordinary skill in the art thus cannot definitively ascertain how there can in physical reality be a “carbonate-substituted hydroxyapatite” without at least 1 carbonate present, which replaces at least one phosphate.
Claim 31 is 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, or D selected from the group consisting of F or G, H, and I or J”. Indeed, one of ordinary skill in the art cannot begin to make heads or tails out of the metes and bounds of the claimed subject matter.
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.
Response to Arguments
Applicant's arguments filed May 6, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that “the cited references…fail to…teach or suggest…photostabilization of pyrethrum-based insecticides” and thus “a skilled person would have had no reasonable expectation of success that combining Manfredini’s delivery system with Layton’s pyrethrum extract would result in prolonged insecticidal activity under light exposure”; that a “carbonate-substituted hydroxyapatite of formula (I) having defined substitution and crystallinity ranges unexpectedly confers prolonged photostability to pyrethrum-based insecticides, maintaining biological activity for days after light exposure” while “pyrethrum extract without the claimed carbonate-substituted hydroxyapatite exhibit a rapid decline in insecticidal activity over the same time period”; and, moreover, “the carbonate-substituted hydroxyapatite of formula (I) also exerts a beneficial fertilizing effect on the plants…improving plant nutrition and vigor”.
The Examiner, however, would like to point out the following:
1. First, independent claim 24 is directed to a composition comprising a carbonate-substituted hydroxyapatite and an extract of a plant of the Chrysanthemum or Tanacetum genus. The claim says nothing at all about the carbonate-substituted hydroxyapatite having a specific degree of crystallinity, and also says nothing at all about pyrethrum insecticides generally or about any one of the pyrethrum insecticides in particular. Further, claim 24, nor any other claim, says anything about any required light exposure. Hence, it is entirely unclear why Applicant would even think that they should get a U.S. Patent based on “carbonate-substituted hydroxyapatite of formula (I) having defined substitution and crystallinity ranges unexpectedly conferring prolonged photostability to pyrethrum-based insecticides…after light exposure” when none of the claims require all of these elements.
2. The cited prior art need only disclose or render obvious the actual claimed composition itself. One of ordinary skill in the art, in view of the cited prior art, would arrive at the actual claimed composition itself with a reasonable expectation of success, and this is sufficient to preclude the patentability of the claimed composition, even if the cited prior art does not expressly disclose the photostability property, or even knew about it. Indeed, one of ordinary skill in the art would arrive at a composition that includes the combination of a carbonate-substituted hydroxyapatite with the claimed substitution and crystallinity, an extract of Chrysanthemum cinerariaefolium (i.e. a vegetable extract) with insecticide properties comprising the active agents e.g. pyrethrin I and pyrethrin II, and zinc. Since the composition one of ordinary skill in the art would thus arrive at is the same as the claimed composition, the properties must be the same as well, including the photostability, even if the cited prior art does not expressly disclose it. Indeed, in general terms, Applicant cannot expect only their composition comprising A, B, and C can exhibit photostability, but for another having the very same composition comprising A, B, and C, the photostability is not there because they did not expressly document it. On the contrary, the photostability is there in either case, since, as Applicant points out, “carbonate-substituted hydroxyapatite of formula (I) having defined substitution and crystallinity ranges confers prolonged photostability to pyrethrum-based insecticides”.
3. Regarding Applicant’s assertion that “the carbonate-substituted hydroxyapatite of formula (I) exerts a beneficial fertilizing effect on the plants…improving plant nutrition and vigor”, it is noted that Manfredini, the cited primary reference, provides for the carbonate-substituted hydroxyapatite as a requisite constituent, and is applying their composition to treat plants. Hence, Applicant is merely describing a property of the Manfredini composition itself, and this property is thus simply not going to serve as the basis for patentability of the presently claimed composition by any stretch of the imagination.
4. Regarding Applicant’s assertion that “carbonate-substituted hydroxyapatite of formula (I) having defined substitution and crystallinity ranges unexpectedly confers prolonged photostability to pyrethrum-based insecticides, maintaining biological activity for days after light exposure” while “pyrethrum extract without the claimed carbonate-substituted hydroxyapatite exhibit a rapid decline in insecticidal activity over the same time period”, it is noted that Manfredini, the cited primary reference, expressly teaches the combination of a carbonate-substituted hydroxyapatite e.g. of formula (I) with a crystallinity degree preferably of 25-40%, a vegetable extract with e.g. insecticide properties, and zinc ion. 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 defined benefits. Hence, it would no doubt be obvious to employ Layton’s pyrethrum as the extract with insecticidal properties in Manfredini.
5. Hence, the prior art rejection is not simply based on combining a reference that discloses a carbonate-substituted hydroxyapatite alone and another reference that discloses pyrethrum extract alone, and haphazardly combining them together. On the contrary, Manfredini, the cited primary reference, teaches that the carbonate-substituted hydroxyapatite and the plant extract with insecticidal properties should in fact be combined, and it would thus be obvious to do so, including in particular for pyrethrum extract. Applicant’s comparative data showing the combination of the carbonate-substituted hydroxyapatite with the plant extract having insecticidal properties, in this case pyrethrum, is superior to pyrethrum alone is undercut by the fact that, again, Manfredini, the cited primary reference, teaches that the carbonate-substituted hydroxyapatite and the plant extract with insecticidal properties should in fact be combined. Hence, even if Applicant has documented an advantage of the combination over the pyrethrum alone, it must be recognized that Manfredini teaches and motivates the combination. Therefore, in weighing the evidence of prima facie obviousness against the evidence of “unexpected results”, the scales tip in favor of the former.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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