FINAL 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 .
Status of Claims
Receipt is acknowledged of the claim amendments filed on 30 March 2026.
Claim 1 has been amended.
Claims 12-20 are cancelled.
Claims 6-7 remains withdrawn from consideration.
Claim 21 has been added.
Claims 1-5, 8-11 and 21 are examined herein to the extent that the first component is a plant and the fatty amine portion of the inclusion complex is hexadecylammonium chloride, e.g., applicant's elected species.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The instant specification does not provide a definition for a “composition”. The specification does indicate that the inclusion complex can exist separate from or be coated on the instantly claimed plants, fruit or vegetable. Therefore the composition in claim 1 is interpreted as reading on a composition comprising a plant, fruit or vegetable and a fatty-amine polysaccharide inclusion complex that are separate from one another as well as being attached to the plant, fruit or vegetable.
Rejections Withdrawn
The rejection of claims 1-5 and 8-11 under U.S.C. 112(b), as being indefinite, is withdrawn in view of the claim amendments filed on 30 March 2026.
Rejections Maintained and Newly Made to Newly Added Claim
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 8-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature that does not have markedly different characteristics from what occurs in nature. Claims 1-5 and 8-11 reads on a composition that comprises a plant, fruit or vegetable (e.g., natural product) and a fatty-amine polysaccharide inclusion complex that are separate from each other. Therefore, the plant, fruit or vegetable is structurally and functionally identical to natural occurring plant, fruit or vegetable and do not have markedly different characteristics from what occurs in nature (e.g., the fatty-amine polysaccharide inclusion complex is separate from the plant, fruit or vegetable). Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: NO), the claims do not qualify as eligible subject matter, and is rejected under 35 U.S.C § 101. See MPEP 2106.04. It is also noted that the dependent claims are drawn to chemical components of the inclusion complex that encompass well understood, routine and conventional features as described in the prior art recited in the specification e.g. paragraph [0006] as well as in the prior art recited below in the 103 rejection. As such the dependent claims fail to add “significantly” more than the nature-based ineligible subject matter.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-5 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over MARUHASHI (DE3939721 A1, publication date of 07 June 1990) in view of FANTA (“Films prepared from poly(vinyl alcohol) and amylose–fatty acid salt inclusion complexes with increased surface hydrophobicity and high elongation”, Starch/Sträke, 68, 874-884, publication date of 15 January 2016; cited in IDS filed 12/22/2022) LE (US 2017/0072069 A1, publication date of 16 March 2017) and BUFFET-BATAILLON (“Emergence of resistance to antibacterial agents: the role of quaternary ammonium compounds—a critical review”, International Journal of Antimicrobial Agents, 39, 381-389, 2012).
Maruhashi is primarily directed towards a composition comprising a polyvinyl alcohol and a starch film (see entire English translation of the foreign patent publication).
Regarding claim 1, Maruhashi discloses a polyvinyl alcohol starch film used for agricultural including a film to protect root of plants (page 2, second paragraph of the English translation). Maruhashi discloses that the composition can include a germicide (page 4, third paragraph of the English translation).
Regarding claim 21, Maruhashi discloses that additives can be added if necessary, including plasticizer (page 4, third paragraph of the English translation). Therefore, plasticizers are only included as desired and it would have been prima facie obvious to not include the plasticizer if properties of the plasticizers are not desired. See In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient).
Maruhashi does not specifically teach that the starch is a fatty-amine polysaccharide inclusion complex, wherein the fatty-amine component is hexadecylammonium chloride (e.g., Applicant elected species). The deficiencies is made up for by the teachings of Fanta, Le and Buffet-Bataillon.
Fanta is primarily directed towards films prepared from poly(vinyl alcohol) and amylose-fatty acid salt inclusion complexes with increased surface hydrophobicity relative to PVOH control (abstract).
Regarding claims 1-2, Fanta teaches starch-PVOH films have been prepared but the combination of insolubility and retrogradation of starch results in a deterioration of the film’s tensile properties (page 875, first column second paragraph). Fanta teaches that using a method that comprises heating aqueous dispersions of granular starch at atmospheric pressure, the process of steam jet cooking at high temperature and pressure produces solutions of starch in which both the amylose and amylopectin components are completely dissolved. In the presence of complex-forming ligands, such as fatty acids and their carboxylic acid salts, the dissolved amylose in these hot, jet-cooked solutions adopts a helical conformation which enables the hydrophobic carbon chain of the fatty acid or fatty acid salt to be complexed within the hydrophobic central cavity formed by the amylose helix. Whereas amylose inclusion complexes prepared from high amylose corn starch and water insoluble fatty acids are insoluble and precipitate from the cooled solutions, complexes formed from water-soluble sodium salts of fatty acids are water soluble, and the complexes can be dried and then re-dissolved by heating in water. Unlike solutions of starch where the amylose component has not been complexed with a water-soluble ligand, these amylose–fatty acid salt complexes do not retrograde and precipitate from the cooled solutions used for film casting (page 875, second column, first paragraph). Fanta teaches fatty acids with carbon chain lengths of including C16 (page 875, second column, second paragraph). Fanta teaches the highest retention of TS (e.g., tensile strength) observed with the chain length C16 complex films (page 879, second column, first paragraph). Fanta teaches that in contrast to PVOH composite films prepared from uncomplexed starch, incorporation of the amylose complexes yields films with less reduction of tensile properties and improved %E (e.g., percent elongation) (page 883, first column, third paragraph). Fanta teaches amylose-fatty acid salt complexes can be produced easily, economically, and in large quantities by steam jet cooking. Fanta teaches that amylose-fatty acid salt complexes when used in PVOH composite films will provide benefits of enhanced biodegradability, %E (e.g., percent elongation), and surface hydrophobicity (page 883, paragraph bridging the first and second column).
Le is primarily directed towards a composition comprising starch and a bioactive agent forming an inclusion complex, wherein the bioactive agent is within the helix of the starch (abstract).
Regarding claim 1, Le teaches a bioactive forming an inclusion complex with a starch and the bioactive is within the helix of the starch (paragraph [0016]). Le teaches that the bioactive includes a quaternary ammonium compound (paragraph [0057]). Le teaches that for agricultural applications the bioactive can be a biocides, antibacterial or antiviral agents, particularly quaternary ammonium compounds (paragraph [0252]).
Buffet-Bataillon is primarily directed towards a review of quaternary ammonium compounds and the emergence of resistance to antibacterial agents (abstract).
Regarding claims 1, 3-5 and 8, Buffet-Bataillon teaches that common quaternary ammonium compounds include chlorine salts of cetrimonium (e.g., hexadecylammonium chloride) with a chain length of 16 alkyls (page 382, first column, second paragraph).
Regarding claim 9, Fanta teaches that preparation of amylose-fatty acid salt complex comprises using steam jet cooking a starch solution and adding a hot solution of fatty acid salts to hot starch dispersion, wherein the weight of the fatty acid salt is equal to 7.5% of the calculated weight of the amylose (e.g., polysaccharide portion) (page 876, first column, second paragraph).
Regarding claims 10-11, Maruhashi discloses a polyvinyl alcohol starch film used for agricultural including a film to protect root of plants (page 2, second paragraph of the English translation).
Regarding claims 10-11, Fanta teaches starch-PVOH films have been prepared but the combination of insolubility and retrogradation of starch results in a deterioration of the film’s tensile properties (page 875, first column second paragraph). Fanta teaches that in contrast to PVOH composite films prepared from uncomplexed starch, incorporation of the amylose complexes yields films with less reduction of tensile properties and improved %E (e.g., percent elongation) (page 883, first column, third paragraph).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a plant with the roots of the plant containing a protective film comprising polyvinyl alcohol (e.g., film-forming agent) and an inclusion complex of amylose and chlorine salt of cetrimonium (e.g., hexadecylammonium chloride). The person of ordinary skill in the art would have been motivated to make those modifications to: 1) obtain a film with enhanced including tensile strength, biodegradability and percent elongation by including amylose complex with polyvinyl alcohol as the film; and 2) obtain polyvinyl alcohol with amylose complex film that has an additional property of antibacterial effect without adding additional antimicrobial agents by complexing the amylose with quaternary ammonium, which can be complexed with a starch, including chlorine salt of cetrimonium (e.g., hexadecylammonium chloride/fatty-amine) that has a chain length of 16 alkyls similar to the palmitic acid taught in Fanta. The person of ordinary skill in the art would have reasonably expected success because Maruhashi discloses a polyvinyl alcohol starch film used for agricultural including a film to protect root of plants (page 2, second paragraph of the English translation). Maruhashi discloses that the composition can include a germicide (page 4, third paragraph of the English translation). Fanta teaches starch-PVOH films have been prepared but the combination of insolubility and retrogradation of starch results in a deterioration of the film’s tensile properties (page 875, first column second paragraph). Fanta teaches that unlike solutions of starch where the amylose component has not been complexed with a water-soluble ligand, these amylose–fatty acid salt complexes do not retrograde and precipitate from the cooled solutions used for film casting (page 875, second column, first paragraph). Fanta teaches fatty acids with carbon chain lengths of including C16 (page 875, second column, second paragraph). Fanta teaches the highest retention of TS (e.g., tensile strength) observed with the chain length C16 complex films (page 879, second column, first paragraph). Fanta teaches that in contrast to PVOH composite films prepared from uncomplexed starch, incorporation of the amylose complexes yields films with less reduction of tensile properties and improved %E (e.g., percent elongation) (page 883, first column, third paragraph). Fanta teaches amylose-fatty acid salt complexes can be produced easily, economically, and in large quantities by steam jet cooking. Fanta teaches that amylose-fatty acid salt complexes when used in PVOH composite films will provide benefits of enhanced biodegradability, %E (e.g., percent elongation), and surface hydrophobicity (page 883, paragraph bridging the first and second column). Le teaches a bioactive forming an inclusion complex with a starch and the bioactive is within the helix of the starch (paragraph [0016]). Le teaches that the bioactive includes a quaternary ammonium compound (paragraph [0057]). Le teaches that for agricultural applications the bioactive can be a biocides, antibacterial or antiviral agents, particularly quaternary ammonium compounds (paragraph [0252]). Buffet-Bataillon teaches that common quaternary ammonium compounds include chlorine salts of cetrimonium (e.g., hexadecylammonium chloride) with a chain length of 16 alkyls (page 382, first column, second paragraph).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues on page 6 that the Examiner improperly added a limitation to the claims that is not present, specifically, a plasticizer or film-forming agent. Applicant argues that the instant claims do not require PVOH or any film-forming agent.
Applicant's arguments filed on 30 March 2026 have been fully considered but they are not persuasive. In response, Applicant is reminded that the transitional phrase "comprising", in claim 11, indicates that the claim is open-ended and allows for additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). Maruhashi in view of Fanta, Le and Buffet-Bataillon render prima facie obvious a composition comprising PVOH (e.g., film-forming agent). Since the claim is open-ended, it allows for the inclusion of unspecified ingredients (e.g., film-forming agent) even in major amounts. See Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948).
Applicant argues on page 7 that the Examiner fails to cite that the instant application demonstrates that the incorporation of amylose complexes decreases PVOH tensile strength in all formulations and points to Figure 4 and the accompanying text. Applicant, additionally, argues that incorporation increased the stiffness and rigidity of the films, as evidenced by the increase in the Young’s modulus of the polymer blends and points to Figure 5 and accompanying text. Applicant argues that incorporating inclusion complexes into polymer blends alter the physical properties and would not have provided a reasonable expectation of success in using the inclusion complexes on plant, fruit or vegetable.
In response, Fanta teaches that the tensile properties of the PVOH composite films can be equivalent to PVOH control by using specific amounts of respective fatty acid salt complex (page 879, first column first paragraph). Fanta teaches that the Young’s modulus of PVOH composite films have no significant increase when the fatty acid complexes were incorporated at levels up to 30% (page 879, second column, second paragraph). Thus, from the teachings of Fanta, one of ordinary skill in the art would optimize the amount of the amylose-fatty acid salt inclusion complexes in order to obtain films with equivalent tensile properties to PVOH control and include amounts of only up to 30% to avoid increase in Young’s modulus of the film.
Applicant argues that Fanta does not teach agriculture applications and contradicts the assertion that one of skill in the art would recognize the potential of the compositions of Fanta to be used in agricultural settings.
In response, Maruhashi discloses a polyvinyl alcohol starch film used for agricultural including a film to protect root of plants (page 2, second paragraph of the English translation). Maruhashi discloses that the film is able to stretch and has water resistance and degradability (page 7, fifth paragraph of the English translation). Fanta teaches a film of a poly(vinyl alcohol) and water-soluble amylose-inclusion complexes were prepared from high amylose corn starch and C12, C16 or C18 fatty acid salt has increased surface hydrophobicity, enhanced biodegradability, can have the same tensile strength as PVOH alone and the same Young’s modulus (e.g., flexibility) as PVOH alone (page 879, first column, first paragraph; page 880, second column, second paragraph; page 882, first column, second paragraph; page 883, paragraph bridging the first a second column). Thus, it would have been prima facie obvious for one of ordinary skill in the art to substitute in the amylose fatty acid inclusion complex of Fanta as the starch in the film including PVOH for protecting root of plants of Maruhashi to obtain a film with enhancements including hydrophobicity, biodegradability, tensile strength and Young’s modulus.
Applicant argues on page 8 that Maruhashi does not mention QACs and Fanta does not teach using quaternary ammonium complexes as antimicrobials. Applicant argues that Le and Buffet-Bataillon deal with very different versions of quaternary ammonium compounds from those taught by Fanta. Applicant argues that Le teaches inclusion complex that are chemically distinct from the PVOH films of Maruhashi and the inclusion complexes taught by Fanta. Applicant argues that the Examiner has not provided any rationale for why the skilled artisan would consider these different starches to be interchangeable, or even functionally equivalent. Applicant argues that Buffet-Bataillon is a review article of quaternary ammonium compounds and only discloses naked Hex-Am and not inclusion complexes like Fanta and Le. Applicant argues that as evidenced by the record, anti-microbial activity of claimed complexes are a feature of the inclusion complex. Applicant argues that evidence from the scientific literature demonstrates that hexadecylammonium chloride, when in inclusion complexes, has altered activity against microbes compared to naked Hex-Am. Applicant argues on page 9 that it was demonstrated in the Hay et al. 2020 reference, that N-1-Hexadecyl ammonium chloride alone, without complexation, has poor antimicrobial ability over all, an no activity against certain bacteria, however, when Hex-Am inclusion complex was tested, it gained antimicrobial activity against each of the species of bacteria that Hex-Am alone had not activity against. Applicant argues that inclusion complex formation is demonstrated as essential for the antimicrobial function of the claimed compositions with respect to a broad variety of pathogens.
In response, Maruhashi discloses a polyvinyl alcohol starch film used for agricultural including a film to protect root of plants (page 2, second paragraph of the English translation). Maruhashi discloses that the composition can include a germicide (page 4, third paragraph of the English translation). Fanta teaches starch-PVOH films have been prepared but the combination of insolubility and retrogradation of starch results in a deterioration of the film’s tensile properties (page 875, first column second paragraph). Fanta teaches that unlike solutions of starch where the amylose component has not been complexed with a water-soluble ligand, these amylose–fatty acid salt complexes do not retrograde and precipitate from the cooled solutions used for film casting (page 875, second column, first paragraph). Fanta teaches fatty acids with carbon chain lengths of including C16 (page 875, second column, second paragraph). Fanta teaches the highest retention of TS (e.g., tensile strength) observed with the chain length C16 complex films (page 879, second column, first paragraph). Fanta teaches that in contrast to PVOH composite films prepared from uncomplexed starch, incorporation of the amylose complexes yields films with less reduction of tensile properties and improved %E (e.g., percent elongation) (page 883, first column, third paragraph). Fanta teaches amylose-fatty acid salt complexes can be produced easily, economically, and in large quantities by steam jet cooking. Fanta teaches that amylose-fatty acid salt complexes when used in PVOH composite films will provide benefits of enhanced biodegradability, %E (e.g., percent elongation), and surface hydrophobicity (page 883, paragraph bridging the first and second column). Le teaches a bioactive forming an inclusion complex with a starch and the bioactive is within the helix of the starch (paragraph [0016]). Le teaches that the bioactive includes a quaternary ammonium compound (paragraph [0057]). Le teaches that for agricultural applications the bioactive can be a biocides, antibacterial or antiviral agents, particularly quaternary ammonium compounds (paragraph [0252]). Buffet-Bataillon teaches that common quaternary ammonium compounds include chlorine salts of cetrimonium (e.g., hexadecylammonium chloride) with a chain length of 16 alkyls (page 382, first column, second paragraph). Therefore, in light of the disclosure of Maruhashi and the teachings of Fanta, Le and Buffet-Bataillon, it would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a plant with the roots of the plant containing a protective film comprising polyvinyl alcohol (e.g., film-forming agent) and an inclusion complex of amylose and chlorine salt of cetrimonium (e.g., hexadecylammonium chloride). The person of ordinary skill in the art would have been motivated to make those modifications to: 1) obtain a film with enhanced including tensile strength, biodegradability and percent elongation by including amylose complex with polyvinyl alcohol as the film; and 2) obtain polyvinyl alcohol with amylose complex film that has an additional property of antibacterial effect without adding additional antimicrobial agents by complexing the amylose with antibacterial and included quaternary ammonium as the antibacterial, which can be complexed with a starch and provide antibacterial even towards bacteria that are resistant towards antibacterial agents, including chlorine salt of cetrimonium (e.g., hexadecylammonium chloride/fatty-amine) that has a chain length of 16 alkyls similar to the palmitic acid taught in Fanta.
Additionally, Le teaches that including complex with a bioactive agent, including quaternary ammonium compounds as antibacterial, improves the solubility and availability of the bioactive agent (paragraphs [0241] and [0252]). Therefore, it is expected from the teachings of Le that the activity of the bioactive agent, including quaternary ammonium compounds as antibacterial, is improved by the inclusion complex.
Thus, for the reasons of record and for the reasons presented above claims 1-5, 8-11 and 21 are rejected under 35 U.S.C. § 101 and 35 U.S.C. § 103(a).
Conclusion and Correspondence
No claims are allowed.
THIS ACTION IS MADE FINAL.
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 extension fee 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 date of this final action.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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