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 .
Priority
The present application, filed August 15, 2023, claims priority to foreign priority application CN202211223837.3, filed October 8, 2022.
Status of the Application
Claims 1-16 are pending and examined on the merits herein.
Claim Interpretation
Claim 1 recites: “A composite solution for enhancing an induced disease resistance of lentinan (LNT) to a plant, comprising: an LNT-containing solution and an SPc-containing solution, wherein SPc is a dendritic macromolecule functionalized by an amino functional group and has a structural formula shown in formula I, wherein n = 1 to 100; and an induced disease resistance of the plant is at least one selected from the group consisting of an induced viral resistance of a tobacco plant, an induced viral resistance of a tomato plant, an induced viral resistance of a cucumber plant, and an induced viral resistance of a potato plant.
The limitation “for enhancing an induced disease resistance of lentinan (LNT) to a plant” is interpreted herein as an intended use of the composite solution of claim 1.
MPEP 2111.02 (II) states: “During examination, statements in the preamble reciting
the purpose or intended use of the claimed invention must be evaluated to determine whether or
not the recited purpose or intended use results in a structural difference (or, in the case of process
claims, manipulative difference) between the claimed invention and the prior art. If so, the
recitation serves to limit the claim. …To satisfy an intended use limitation which is limiting, a
prior art structure which is capable of performing the intended use as recited in the preamble
meets the claim.”
In this instance, because the intended use does not limit the composite solution of claim 1, claim 1 is considered satisfied by a solution that satisfies the structural requirements of the composite solution recited in claim 1.
Claim Objections
Claims 4, 11, and 15 are objected to because of the following informalities: Please amend claims 4, 11, and 15 to recite “a binding coefficient Ka of the SPc to the LNT is 5.099 x 105 M-1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 9, and 13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 depends from claim 1 and requires: “the induced disease resistance of
the plant is at least one selected from the group consisting of an induced tobacco mosaic virus (TMV) resistance of the tobacco plant, an induced tomato chlorosis virus (ToCV) resistance of the tomato plant, an induced potato virus Y (PVY) resistance of the potato plant, and an induced cucumber mosaic virus (CMV) resistance of the cucumber plant.”
However, the induced disease resistance is interpreted as an intended use of the composite solution of claim 1 and does not limit the structure of the composite solution of claim 1. Therefore, claim 2, which further limits the intended use of the composite solution of claim 1, fails to further limit the subject matter of the claim upon which it depends.
Claim 9 depends from claim 6 and requires: “wherein in the composite solution, the
induced disease resistance of the plant is at least one selected from the group consisting of an
induced tobacco mosaic virus (TMV) resistance of the tobacco plant, an induced tomato
chlorosis virus (ToCV) resistance of the tomato plant, an induced potato virus Y (PVY)
resistance of the potato plant, and an induced cucumber mosaic virus (CMV) resistance of the
cucumber plant.”
Similarly, the induced disease resistance is interpreted in claim 6 as an intended use of the composite solution of claim 1 and does not limit the structure of the composite solution of claim 1. Because claim 6 is drawn to a method of making the composite solution of claim 1, and claim 9 further limits the intended use of the composite solution prepared by the method of claim 6, claim 9 fails to further limit the subject matter of the claim upon which it depends.
Finally, claim 13 recites: “wherein in the composite solution, the induced disease resistance of the plant is at least one selected from the group consisting of an induced tobacco mosaic virus (TMV) resistance of the tobacco plant, an induced tomato chlorosis virus (ToCV) resistance of the tomato plant, an induced potato virus Y (PVY) resistance of the potato plant, and an induced cucumber mosaic virus (CMV) resistance of the cucumber plant.”
Because the claim 13 appears to further limit the induced disease resistance in the composite solution, and not the induced disease of the LNT to the plant as recited in claim 8, claim 13 further limits the intended use of the composite solution of claim 1, and thus claim 13 fails to further limit the subject matter of the claim upon which it depends.
For claim 13, this rejection may be overcome by amending the claim to state: “The method according to claim 8, wherein the induced disease resistance of the LNT to the plant is at least one selected from the group consisting of…”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-5, 8, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (Wang, X.; et al. Chemical Engineering Journal 2021, vol. 417, 129327; cited in PTO-892) in view of Wei (Publication no. CN101851356A; cited in PTO-892), as evidenced by Li (Li, J.; et al. ACS Sustainable Chemistry and Engineering 2019, vol. 7, pp. 6316-6322; cited in PTO-892) and Sigma (Sigma catalog entry for Chitosan; cited in PTO-892).
Wang was available online March 15, 2021, and thus is eligible as prior art under 35 U.S.C. § 102(a)(1).
Wei was published in a language other than English. Although Wei was cited in the IDS received August 23, 2023, because Wei is cited in the rejection below, a full English language machine translation of Wei is included with this office action and cited in the PTO-892. Citations below refer to the attached English language machine translation.
Citations in Li below refer to both the journal article and supporting information. The document of Li attached to this office action includes both the journal article and supporting information as a single document.
Wang teaches a sustainable method for controlling plant diseases that involves using a star polymer (SPc) to deliver plant elicitors/botanical fungicides with a low production cost. Wang teaches that the SPc could be complexed with chitosan through hydrogen bond and Van der Waals forces, and the complexation of SPc with chitosan decreased chitosan particle size from 144.61 nm to 17.40 nm in an aqueous solution. Wang teaches the SPc could activate the endocytosis pathway of plants by a nano-delivery system to amplify the defense responses induced by the chitosan elicitor, and the nano-sized chitosan/SPc complexes exhibited enhanced control effects against potato late blight, which is considered one of the most destructive crop pathogens threatening global food security (p. 1, Abstract, lines 1-10).
Wang teaches that their SPc was constructed according to the method described by Li (p. 2, right column, section 2.1, lines 1-2), as cited above. As evidenced by Li, the SPc used by Wang has the same structure as the SPc shown in claim 1 (p. 6318, Scheme 1a). Li teaches their product has repeat units of 28, which is interpreted as equivalent to the subscript n as recited in present claim 1 as being 28 (document p. 11, Table S2). Therefore, the SPc product of Li, which is used by Wang, satisfies all limitations of the SPc product of claim 1.
Wang teaches preparation of the solution comprising chitosan and SPc (abbreviated as CSC by Wang) (p. 2, left column, final paragraph, line 3). Regarding preparation of the CSC solution, Wang teaches that the chitosan was dissolved in water and acetic acid mixture solution (with acetic acid fraction of 1%), and the SPc was dissolved in ddH2O solution to obtain a 0.2% chitosan and a 0.2% SPc solution. The 0.2% chitosan solution was mixed with the same volume of 0.2% SPc solution, and the mixture was incubated for 15 min at room temperature to prepare the 0.1% CSC solution. Wang teaches the chitosan particle could spontaneously bind with SPc into the CSC complex in an aqueous solution (p. 2, right column, section 2.1, lines 2-10). Because Li teaches that SPc was obtained as a white powder (p. 6317, left column, Synthesis of Star Polycation (SPc) section, lines 13-14), and because Sigma teaches chitosan is a powder (p. 3, Properties section), the concentrations taught by Wang above are interpreted as % wt/vol concentrations.
A 0.2% solution for each of chitosan and SPc would correspond to a concentration 2 mg/mL for each of the chitosan and SPc, which falls within the ranges recited in claims 3 and 14. In addition, the mass ratio of chitosan-containing solution to SPc-containing solution is 1:1. Finally, the concentration of chitosan and SPc in the 0.1% CSC would be 1 mg/mL, which corresponds to a concentration of 1000 mg/L. Therefore, the CSC composition taught by Wang satisfies the requirements of the composite solution recited in claims 3 and 14. The examiner notes that if the measurements of Wang are instead % wt/wt, the compositions comprising chitosan and SPc would have the same concentrations described above, because the density of an aqueous solution would be 1 g/mL.
Regarding the method of application of the CSC solution, Wang teaches that leaf surfaces of potted plants were sprayed with the formulations of chitosan (0.5 g/L), CSC (0.5 g/L), and SPc using a fine glass atomizer, and then spray inoculated one day later with a suspension of P. infestans (p. 3, left column, Section 2.6, lines 1-3). This method of applying the CSC to a plant, together with the method of preparing the CSC solution, satisfies the requirements of a) recited in claim 8. Wang teaches that administration of CSC reduced colonization of P. infestans (p. 5, right column, lines 2-3), as shown by the disease index and improved protection compared with administration of chitosan alone (p. 7, Figure 4B and 4C).
Wang concludes by stating that the SPc used in their method could activate the endocytosis pathway of plants by a nano-delivery system to up-regulate further gene expression related to pathogen defense, thereby amplifying the plant defense responses induced by chitosan elicitors. The SPc could be applied as a common adjuvant in the field, and the control effects of chitosan/SPc was significantly improved against potato late blight that is considered one of the most destructive crop pathogens (p. 12, left column, Section 5, lines 5-11) (emphasis added). Therefore, one of ordinary skill in the art would have recognized the method of Wang as effector for delivering an elicitor (chitosan) of the plant defense mechanisms.
Wang does not teach the composite solution of SPc and lentinan, as required by claim 1. In addition, Wang does not teach a method for enhancing the induced disease resistance of the LNT to the plant, as recited in claim 8.
Wei teaches a method of extraction of lentinan (document p. 3, lines 1-7) and the use of lentinan for agricultural purposes (document p. 8, [0008], lines 1-3). Wei teaches lentinan has an
inhibitory and killing effect on viruses, can enhance the disease resistance of plants, and at
the same time achieve the effects of increasing yield and improving plant quality (document p. 8, [0008], lines 1-3) (emphasis added). Wei teaches that lentinan can reduce the harm caused by viruses to plants and improve their disease resistance (document p. 9, [0009], lines 1-2). This is taken as an express teaching that lentinan can improve a plant’s disease resistance, specifically reducing the harm caused by viruses to plants.
Wei teaches that tomato viral diseases are currently the main diseases affecting tomatoes, and its main infecting viruses are tobacco mosaic virus (TMV) and cucumber mosaic virus (CMV) (document p. 26, [0044], lines 1-7).
Wei further teaches the antiviral effect of lentinan using the whole plant method (document p. 27, [0046]) in tobacco. Wei teaches that this method involved planting common tobacco plants, and when the plants have grown to 8 true leaves, retaining the 4th to 7th true leaves, inoculating the plant with 13.1 μg/mL tobacco mosaic virus and spraying the agent once every 7 days (document p. 28, [0047], lines 1-3). In this instance, the agent is interpreted as the lentinan solution taught by Wei (e.g., see p. 26, [0043], lines 1-2).
Wei teaches that fourteen days after application, uninoculated and newly grown leaves were collected to determine the inhibition rate of TMV by the pesticide (document p. 28, [0047], lines 5-7). Wei teaches quantification of TMV inhibition using an ELISA assay (document p. 29, [0049]), with the lentinan aqueous solution obtained in Example 1 having a significant inhibitory effect on TMV, with an EC50 of 121.3 mg/L (document p. 32, [0056]). Wei concludes that their results show that 1% lentinan can effectively inhibit TMV (document p. 33, [0060], lines 1-3). Therefore, in view of Wei, one of ordinary skill in the art would have recognized lentinan as having an antiviral effect on tobacco mosaic virus in tobacco plants.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to substitute chitosan in the CSC solution taught by Wang with lentinan. One of ordinary skill in the art would have been motivated to substitute chitosan in the CSC solution taught by Wang with lentinan because Wang teaches their SPc as improving the effect of chitosan as an elicitor of plant defense mechanisms, and because Wei teaches lentinan as inducing an antiviral effect of tobacco mosaic virus in tobacco plants.
In this instance, the rationale “use of a known technique to improve a similar method in the same way” would apply. Because Wang teaches their SPc polymer as improving the effect of chitosan for eliciting plant defense mechanisms, and Wei teaches that lentinan induces an antiviral effect on TMV in tobacco plants, one of ordinary skill in the art would have considered that SPc may similarly be used to improve the delivery of lentinan to plants, thus improving the anti-viral defense mechanisms in plants induced by lentinan.
Regarding the method of administering the composite solution recited in claim 8, because Wang teaches preparation of separate solutions comprising SPc and chitosan, mixing these solutions to form the CSC solution, and finally administering to a leaf surface, by practicing this method with lentinan in place of chitosan, one of ordinary skill in the art would satisfy the limitations of method a) of claim 8.
Regarding the binding coefficient Ka and the change in Gibbs free energy ΔG required by claims 4 and 15 and the properties of the spherical LNT/SPc complex of claims 5 and 16, these properties are believed to be necessarily present when preparing the composition solution of SPc and lentinan obvious over Wang in view of Wei.
As evidenced by the instant specification, the composition of SPc and lentinan prepared with equal mass of SPc and lentinan (p. 8, Example 1, [0059]), analogous to the composite composition of SPc and chitosan prepared by Wang, has a Ka of the SPc to the LNT of 5.099 x 105 M-1 and a Gibbs free energy AG is -38.29 kJ/mol (p. 9, [0064], lines 1-7), and that interaction occurred via hydrogen bonding. In addition, the composition of SPc and lentinan prepared with a mass ratio of LNT to SPc was 1:1 showed an average particle size of 141.79 ± 1.38 nm (p. 9, [0070], Table 1) and a contact angle of 82.67° (p. 10, [0073], lines 1-3).
MPEP 2112.01 (especially at I) citing In re Best, 562 F.2d 1252, 195 USPQ 430
(C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)
discusses the support of rejections wherein the prior art discloses subject matter which there is
reason to believe necessarily includes functions or characteristics that are newly recited or is
identical to an invention as instantly claimed. In such a situation, the burden is shifted to the applicants to show the invention of the applicant and the prior art are not the same or that the prior art invention does not necessarily possess the characteristics of the claimed invention. Therefore, because such a composition comprising a 1:1 ratio by mass of lentinan and SPc is obvious over Wang in view of Wei for the purposes of improving the induced disease resistance of lentinan in a plant, such a composition would necessarily possess the properties required by claims 4-5 and 15-16.
Therefore the invention taken as a whole is prima facie obvious.
Claims 6-7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (Wang, X.; et al. Chemical Engineering Journal 2021, vol. 417, 129327; cited in PTO-892) in view of Wei (Publication no. CN101851356A; cited in PTO-892), as evidenced by Li (Li, J.; et al. ACS Sustainable Chemistry and Engineering 2019, vol. 7, pp. 6316-6322; cited in PTO-892) and Sigma (Sigma catalog entry for Chitosan; cited in PTO-892) as applied to claims 1-5, 8, and 13-16 above, and further in view of Saisheng (Publication no. CN 1939334 A; cited in PTO-892) and Chen (Publication no. CN 112999241 A; cited in PTO-892).
Each of Saisheng and Chen were published in a language other than English. Both the original documents of Saisheng and Chen and English language machine translations are included with this office action and cited in the PTO-892). Citations below refer to the English language machine translation documents.
Wang and Wei teach as described in the above rejection under 35 U.S.C. § 103.
Wang and Wei do not teach the steps of subjecting a resulting mixed solution to an
ultrasonic treatment for a complete dissolution, and filtering a resulting mixture to obtain the
composite solution, as required by the preparation method of claim 6.
Saisheng teaches a method for preparing a lyophilized powder of lentinan as an injectable solution (document p. 3, lines 4-5). Saisheng teaches that this solution may be prepared by weighing the prescribed amount of lentinan and adding an appropriate amount of sterile water, heating the solution in a water bath until completely dissolved, filtering the solution through a 0.45 μm filter membrane, adsorbing with activated carbon, and filtering through a 0.22 μm filter membrane (document p. 32, lines 1-5). A 0.45 μm filter membrane is equivalent to a 450 nm filter membrane.
Chen teaches a method for preparing a lentinan nano-selenium composition (document p. 5, Description section, line 1). As part of this method, Chen that an aqueous solution of lentinan is prepared by dissolving lentinan (LNT) powder in water by ultrasonication and filtering (document p. 12, [0011]). Chen teaches that the conditions for ultrasound in step (1) are: frequency 40KHz, power 240W, temperature 20℃, and time 1 to 5 minutes (preferably 2 minutes) (document p. 15, [0017], lines 1-2), and the filtration in step (1) is performed using a sterile filter membrane, and preferably, filtration is performed sequentially using a 0.45 μm sterile filter membrane and/or a 0.22 μm sterile filter membrane (document p. 15, [0018], lines 1-3). As stated, a 0.45 μm filter membrane is equivalent to a 450 nm filter membrane.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to prepare the composite solution of claim 1 by dissolving the LNT to obtain the LNT-containing solution, and then mixing the LNT-containing
solution with the SPc-containing solution, as required by claim 6. One of ordinary skill in the art would have been motivated to dissolve the LNT to obtain the LNT-containing solution, and then mix the LNT-containing solution with the SPc-containing solution, as required by claim 6, because these are the same steps taught by Wang when preparing their CSC solution, and accordingly, when following the guidance of Wang to prepare a composition solution with lentinan and SPc, obvious over Wang in view of Wei as described in the above rejection, one of ordinary skill in the art would have considered following the steps taught by Wang for preparing the solution comprising chitosan and SPc.
Regarding the steps of subjecting resulting mixed solution to an ultrasonic treatment for a complete dissolution and filtering a resulting mixture to obtain the composite solution, as recited in claim 6, one of ordinary skill in the art would have contemplated subjecting a solution to ultrasonic treatment because each of Saisheng and Chen teach methods of enhancing the dissolution of lentinan – heating and ultrasonic treatment – and thus one of ordinary skill in the art would have considered each of these methods for the purposes of enhancing dissolution lentinan in the composite solution obvious over Wang in view of Wei. Moreover, one of ordinary skill in the art would have contemplated ultrasonic treatment for 1-5 minutes, including the 2 minutes suggested by Chen, which would satisfy the ultrasonic treatment time of claim 7.
Regarding the step of filtering the resulting mixture through a 450 nM filter membrane, in view of each of Saisheng and Chen teaching the filtering of a lentinan solution through 0.45 and 0.22 μM (450 nM and 220 nM) filters, one of ordinary skill in the art would have contemplated these same sterile filtration steps for the purposes of sterilizing the solution prior to administration to a plant, because the solution obvious over Wang in view of Wei is used for the purpose of inducing an antiviral response in a plant, and thus minimizing contamination and potential microorganisms that would induce additional stress in a plant may improve the efficacy of a method of using the solution obvious over Wang in view of Wei.
More generally, each of the steps of ultrasonic treatment and filtration are recognized by the prior art as effective for enhancing the dissolution of lentinan and sterilizing solutions comprising lentinan. Accordingly, one of ordinary skill in the art would have reasonably applied these methods when preparing the composite solution obvious over Wang in view of Wei. In this instance, the rationale “use of a known technique to improve similar methods in the same way” would apply. Because the steps of ultrasonic treatment and filtration are known in the prior art for enhancing dissolution and sterilizing solutions, one of ordinary skill in the art would have considered applying these methods when preparing the composition obvious over Wang in view of Wei with a reasonably expectation that said methods would be effective to enhance dissolution and sterilize the composite solution.
Regarding the limitations of claims 10-12, when following the guidance of Wang and Wei described in the above rejection under 35 U.S.C. § 103, one of ordinary skill in the art would have prepared a composition that necessarily includes the mass ratio and concentration of the composition solution of claim 10 and the properties recited in claims 11 and 12, as described in the above rejection. See MPEP 2112.01.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed.
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/B.M.B./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693
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