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 .
Election/Restrictions
Applicant's election with traverse of Group 1 (claims 1-5, 7 and 9) in the reply filed on 6/11/2026 is acknowledged. The traversal is on the ground(s) that the cited references do not teach or suggest the instantly claimed technical feature of a composition comprising citric acid and a naphthoquinone compound, and thus the technical feature qualifies as a “special technical feature.”
Examiner would first like to address Applicant’s assertion that because “neither reference teaches the shared composition of citric acid and a naphthoquinone, the Examiner's conclusion that it would have been obvious "to modify the teachings of CN'601 with that of Zmantar to arrive at the shared technical feature of the instant invention" rests on impermissible hindsight.” Neither reference was relied upon as teaching or disclosing both citric acid and naphthoquinone. As for the argument that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Applicant argues that the antibacterial activity of the CN'601 disinfectant is supplied by a guanidine disinfectant, and that the citric acid of the composition merely serves as a carrier system. This is not persuasive because a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01. There is no evidence that because the citric acid may serve as a carrier system, it does not provide any disinfectant properties. To the contrary, CN’601 teaches that the method for preparing the citric acid disinfectant solution comprises a step wherein “[t]he components other than guanidine disinfectant are mixed to obtain a primary disinfectant solution.”
Applicant also alleges that Zmantar only teaches juglone for the purpose of modifying the resistance of other antibacterial agents. This is not persuasive. Zmantar teaches the MBC (minimum bactericidal concentration) and MIC (minimum inhibitory concentration) of juglone, alone, dissolved in DMSO [Sections 2.3-2.4; Table 1]. Thus, Zmantar teaches that juglone alone has antibacterial effects.
Applicant states that Examiner’s reliance on In re Kerhoven is misplaced because “the cited references neither teach the claimed combination nor supply a composition that suggests it.” Kerkhoven states, "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.” As discussed above, the composition of CN’601 is taught to be a citric acid disinfectant and Zmantar teaches that juglone is a disinfectant. Applicant states that “[n]othing in either reference would lead a person of ordinary skill to select citric acid from the CN'601 formulation and combine it specifically with a naphthoquinone from Zmantar in order to form the claimed product.” However, combining equivalents known for the same purpose is sufficient to provide the motivation necessary to combine the composition of CN’601, which comprises citric acid, with juglone, as taught by Zmantar, in order to arrive at the claimed technical feature.
Applicant also argues that “Examiner's reliance on In re Aller is likewise misplaced, because the optimization rationale presupposes that "the general conditions of a claim are disclosed in the prior art," whereas the general condition at issue here, a composition comprising citric acid and a naphthoquinone, is not disclosed in either reference.” As stated above, neither reference was relied upon as teaching or disclosing a composition comprising both citric acid and naphthoquinone. The general principle in Aller is that optimization of parameters of a known result-effective variable, such as temperature or concentration, is normally obvious. MPEP 2144.05. Thus, the general condition at issue is the disclosure of concentrations/amounts of said result-effective ingredients, not the presence of both claimed ingredients in a single reference. The application of In re Aller does not preclude the combination of references to arrive at the instantly claimed invention.
Applicant cites experimental results as support that the claimed composition makes a contribution over the prior art. This is not persuasive. The assertion that the omission of naphthoquinone or substitution of citric acid reduces the disinfectant effect compared to that of the claimed composition amounts to a mere conclusory statement. Applicant has not explained why the results are significant and unexpected, nor demonstrated that the results are unexpected compared to the closest prior art.
Finally, Applicant argues that maintaining all groups in a single application would not impose any serious burden on examination. This is not found persuasive as search burden is not a criterion for consideration when making a restriction in a 371 application. The Examiner has demonstrated that the groups lack unity of invention, as such, restriction is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6, 8 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/11/2026.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 recites “wherein the inorganic salt comprises an alkali metal salt and/or an alkaline-earth metal salt.” Since the transitional phrase “comprises” indicates the named elements are essential, Examiner suggests amending the instant limitation to recite, for example, “comprises at least one selected from an alkali metal salt or an alkaline-earth metal salt ” for clarity. Accordingly, claim 5, which depends from claim 4, is being interpreted as merely narrowing the scope of claim 4 instead of imposing a requirement that both an alkali metal salt and an alkaline-earth metal salt must both be present. 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 1-5 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 1 recites “parts by weight”. This renders the claim indefinite because it is unclear on the face of the claim if the recited values are intended to express a ratio (for example, if citric acid is present in 20 parts and naphthoquinone compound is present in 1 part, this results in a composition that is 95.2% citric acid 4.76% naphthoquinone compound by weight) or a percentage, as in claims 7 and 9, which both recite “per hundred parts…in parts by weight”. For purposes of compact prosecution, if the prior art teaches values that read on either interpretation, it will be considered to meet the instant limitation.
Claims 2-5 depend from claim 1 and do not cure the deficiencies of claim 1. Therefore, claims 2-5 inherit the deficiencies of parent claim 1.
Claims 2 and 5 recite “comprises one or more of …. and.” This renders the scope of the claim indefinite because it is unclear which elements are required as part of the invention. "Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. MPEP 2111.03. In contrast, the use of “one or more of” suggests that only at least one of the listed elements needs to be present. Thus, “comprising and “one or more” are contradictory. For purposes of compact prosecution, the limitation will be interpreted to read as “comprises one or more of …. or”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural composition of matter without significantly more. The claims recite a disinfectant composition comprising a natural naphthoquinone compound, citric acid, an inorganic salt, a solvent, and water. The instant claim limitations are drawn to products of nature, namely naturally occurring naphthoquinone compounds which may be found in plants including black walnut, hickory, pecan, butternut [McCoy, Introduction] and plants of the genera Diospyros and Euclea [Mbaveng, Abstract], among others. Furthermore, citric acid is a naturally occurring compound found in citrus fruits and a metabolite found in all aerobic organisms [Pubchem], and inorganic salts and water are naturally occurring compounds that are ubiquitous in nearly all chemical processes and in the environment.
Extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in a particular solvent. While the claimed composition comprising the solvated extracted compounds may not itself be found in nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, a claim to a solvent extract would tie up and monopolize a subset of compounds that are naturally present in the plant and are simply soluble in the selected solvent. Thus, the instantly claimed composition of natural naphthoquinone and the additional compounds claimed does not amount to an exception of the judicial exception, because isolation or purification does not result in a product which is ‘markedly different’ from the naturally-occurring component. Thus, while extraction of the compounds with a solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Please note that in Myriad, excising DNA to isolate the DNA from its natural source did not constitute a product which was “markedly different” from the naturally occurring DNA even though the excised ends of the DNA were different in structure when compared to native DNA.
Regarding the claimed amounts, altering the concentration of the claimed ingredients does not appear to change its structure or function and therefore does not appear to result in a markedly distant characteristics for the composition.
Thus, the claims are drawn to mixtures of naturally occurring products. Therefore, the claims are drawn to judicial exceptions. There are no structural limitations in claims 1-5 and 7 in addition to the extract containing naturally occurring ingredients.
Claim Rejections - 35 USC § 103
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over CN111418601A (published 7/17/2020, cited on the 8/2/2024 IDS) in view of MD1918 (published 5/31/2002, cited on the 8/2/2024 IDS).
Regarding claims 1-2, CN’601 teaches a citric acid disinfectant solution comprising 30 to 50 parts citric acid [claim 1]. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). CN’601 does not explicitly teach a citric acid disinfectant composition comprising a naphthoquinone compound. MD1918 teaches a bactericidal and fungicidal (reads on disinfectant) composition comprising citric acid and 0.10% to 0.30% juglone as the active agent [column 2]. The invention of CN’601 is taught as addressing the need for skin surface disinfection with high safety for humans and animals [0004; 0008]. MD1918 teaches that juglone in the amount of 0.10% to 0.30% is suitable for dermatological application [claim 1; see also column 3 lines 4-9 ]. Combining equivalents known for the same purpose is prima facie obvious. MPEP 2144.06. Thus, it would be obvious for a skilled artisan to modify the composition of CN’601 with the teachings of MD1918 by adding juglone to arrive at the instantly claimed composition, as both are taught in the prior art as suitable for skin application in the taught amounts.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over CN111418601A (published 7/17/2020, cited on the 8/2/2024 IDS), in view of MD1918 (published 5/31/2002, cited on the 8/2/2024 IDS) as applied to claim 1 above, and further in view of CN102845486A (published 1/2/2013).
Regarding claims 3-5, neither CN’601 and nor MD1918 teach a citric acid disinfectant composition further comprising 0.1 to 1 part, per hundred parts, of an inorganic salt by weight. CN102845486A teaches an herbal disinfection composition comprising extracts of Eucalyptus grandis, dandelion, Phellodendron chinense, Cnidium monnieri, Sophora flavescens [0012], and 1% to 1.5% sodium chloride [0009; claim 2]. The disinfection composition is suitable for human skin and less irritating than traditional disinfectants [0006; 0012]. Similarly, the inventions of CN’601 and MD1918 are taught to be suitable for human skin disinfection [CN’601 para. 0004; 0008 and MD1918 claim 1]. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06. Assuming that the composition of claim 1 (made obvious over CN’601 and MD1918) and composition of CN’481 are combined in a 1:1 weight ratio, this would yield a resulting mixture comprising about 15 to 25 parts citric acid and 0.5 to 0.75 parts, per hundred parts, by weight, which overlaps with the instantly claimed amounts. Thus, it would be prima facie obvious to combine the disinfection composition of claim 1 with that of CN’486 to arrive at the instantly claimed composition. (As discussed above in the objection of claim 4, claim 5 is being interpreted as merely narrowing the scope of claim 4 instead of imposing a requirement that both an alkali metal salt and an alkaline-earth metal salt must both be present.)
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over CN111418601A (published 7/17/2020, cited on the 8/2/2024 IDS), in view of MD1918 (published 5/31/2002, cited on the 8/2/2024 IDS) and CN102845486A (published 1/2/2013), and further in view of MD1471 (published 5/31/2000, cited on the 8/2/2024 IDS).
Regarding claims 7 and 9, these claims recite limitations that have been previously addressed and made obvious. The analysis for these limitations will not be repeated herein. (See above rejections of claims 1 and 3 for discussion on the claimed amounts of citric acid, naphthoquinone, and inorganic salt. Additionally, as discussed in the rejections of claims 1 and 3, it would be prima facie obvious to combine the compositions of CN’601 with that of MD1918 and CN’486A as combining equivalents known for the same purpose. MPEP 2144.06.)
Claims 7 and 9 both recite the limitation wherein the composition comprises 1-5 parts of a cosolvent. CN’601 teaches that the citric acid disinfectant composition may comprise of 5 parts by weight of ethanol [0052]. Assuming that the composition of claim 1 (made obvious over CN’601 and MD1918) and composition CN’481 are combined in a 1:1 weight ratio, this would yield a resulting mixture comprising about 2.5 parts by weight of ethanol. A prima facie case of obviousness exists where the range disclosed in the prior art overlaps with the instantly claimed range. MPEP 2144.05
Claims 7 and 9 both recite the limitation wherein the composition comprises of deionized water. CN’601 teaches a composition comprising 50 to 80 parts water [claim 1]. This is not explicitly stated to be a remaining “balance” of water, however, differences in concentration will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP 2144.05. CN’601 also does not explicitly teach deionized water. MD1471 teaches a composition comprising juglone, citric acid, and deionized water [column 4 lines 4-21]. MD1471 also discloses that citric acid has the ability to strongly complex with ions present in non-distilled water [column 2]. This property of citric acid allows for the disinfectant solution of MD1471 to retain pharmacological activity regardless of whether the water used as a diluent in the composition is deionized or not. Thus, it would be obvious to choose deionized water as an ingredient in the claimed composition, as it would be obvious to select from one of two types of water taught to be suitable for use in such a disinfectant composition. Additionally, the chelating function of citric acid effectively deionizes the water of the composition. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. As evidenced by MD1471, the composition made obvious by combining CN’601, MD1918, and CN’486 would necessarily exhibit the same chelating effect wherein the ions are removed from the water of the composition (i.e. reads on deionized water), through complexation with citric acid.
Regarding claim 9, this claim recites the limitation wherein the composition comprises 1-3 parts, per hundred parts, of a thickener. MD1918 teaches that the disinfectant composition gel comprises of 3% to 4% methylcellulose as a thickener [column 3, lines 26-31].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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