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 .
Claim Status
Claims 1, 3-5, 9-14, 16, 19, 22-26 are pending. Claims 2, 6-8, 15, 17-18, 20-21 are canceled.
Claims 1, 3-5, 9-14, 16, 19, 22-26 are being examined on the merits in this office action.
Claim Rejections - 35 USC § 103 – Maintained and updated
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 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.
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.
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.
Claims 1, 3-5, 9-14, 16, 19, 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0302494A1 (hereinafter “the ‘494 publication”) in view of JP2005/053867 A (hereinafter “the ‘867 publication”).
This rejection is based in part on the English language machine translation of the JP2005/053867 publication provided by google patent and all citations are to the English language translation.
‘494 teaches a composition comprising a synergistic fungicidal combination of a polyene fungicide and at least one lipopeptide (Abstract; claim 1) and wherein the at least one lipopeptide is selected from the group consisting of iturin-type compounds, surfactin-type compounds, fengycin-type compounds and fusaricidins (claim 2). ‘494 teaches that the composition comprises 0.005 g/L to 100 g/L each of the polyene fungicide and the non-ribosomal protein(s), such as a lipopeptide [0056]. Examiner notes that that the composition therefore includes 0.005 g/L to 100 g/L lipopeptide. ‘494 teaches that the composition comprises a solubilizer to ensure good solubilization and/or dissolution of the active ingredients such as the fungicide and/or lipopeptide and that the solubilizer to maintain the composition as a stable or homogeneous solution or dispersion [0072]. ‘494 teaches examples of solubilizes including propylene glycol which is an example of a non-ionic surfactant. ‘494 teaches that the solubilizer can be in a weight ratio of about 5%, 2%, 1% or even less or about 5% to about 25% by weight [0075]. ‘494 teaches that iturin-type compounds, including iturin A2, iturin A3, A4, or A5, iturin A6, iturin A7; fengycin-type compounds, including pilpastatin A1, plipastatin A2, plipastatin B1, plipastatin B2, agrastatin A, agrastatin B, fengycin A, fengycin B; surfactin A1, A2, or A3, surfactin B1 or B2 and surfactin C1 or C2 [0078]. ‘494 further teaches that at least one lipopeptide is one or more fengycin-type compounds (claims 4, 7, 15-16). ‘494 teaches that the composition comprises 0.005 g/L to 100 g/L each of the polyene fungicide and the non-ribosomal protein(s), such as a lipopeptide [0056], therefore, fengycin can also be in the concentration of 0.005 g/L to 100 g/L. Examine notes that fengycin is a type of anionic surfactant. Since the ‘494 publication does not explicitly disclose that the composition was heated, the examiner infers that the composition was made at room temperature (i.e., 25 °C), which, therefore, reads on and is encompassed by the instant temperature range of 4-40 degrees. Examiner notes that ‘494 teaches that the composition includes 0.005 g/L to 100 g/L lipopeptide.
‘494 does not teach the composition comprising oil surfactants and does not teach a method that further comprises the dehydrating the solution as recited in claim 12.
‘867 teaches a dandruff suppressing composition comprising iturin type peptide in an amount of 0.005% by mass to 2.0% (claim 6) and surfactants (claim 4). In other embodiments, ‘867 teaches that the composition was prepared by adding 5% of the iturin peptide (p. 4, Example 5), which is about 50g/L.
5% w/w = 5% w/v = 50mg/ml = 50g/L.
‘867 further teaches that the composition comprises a solubilizing agent, which can be a surfactant (claim 4) used prevents aggregation and precipitation (p. 4) and that the surfactant comprises non-ionic surfactants such as alcohol fatty acid esters, ethylene glycol fatty acid esters, polyglycerin fatty acid esters, and sucrose fatty acid esters, and tetraalkylammonium salts (p. 3, para. 3, line 6-7). ‘867 teaches that the solubilizing agent which includes a surfactant is in the composition in the amount of 0.005- 90% by mass and more preferably 1.0 to 70% by mass (claim 7 and page 3, 3rd paragraph, line 3-4) (10g/L – 700g/L). This encompasses the instant amounts of 2-40 g/L. With regards to temperature, ‘867 teaches embodiments where ‘867 discloses other embodiments where a predetermined amount of iturin-based peptide was added to an aqueous solution mixed with components other than iturin-based peptide and dissolved at room temperature (Example 8 on page 4). ‘867 teaches that the solubilizing agent prevents aggregation and precipitation and stability is increased (page 4, Example 4). This reads on the instant homogenous and stable composition. ‘867 teaches that in other embodiments, the composition may comprise surfactants from the oil family such as olive squalane, rice squalane, rice germ oil, jojoba oil, castor oil, safflower oil, olive oil, macadamia nut oil, sunflower oil and other vegetable oils and beeswax (p. 3, para. 7, line 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of ‘494 and include surfactants oil surfactants such as those taught by the ‘867 publication because ‘867 teaches that the composition comprises solubilizing agents such as surfactants which prevents aggregation and precipitation (page 4, Example 4). One of ordinary skill in the art would therefore be motivated and would have had a reasonable expectation of success in preparing such a composition that includes the surfactants of ‘867 because it provided increased stability (page 4, Example 4). The disclosures render obvious claims 1, 11, and 14.
Regarding claim 3, ‘494 teaches the composition wherein the at least one lipopeptide is selected from the group consisting of iturin-type compounds, surfactin-type compounds, fengycin-type compounds including pilpastatin A1, plipastatin A2, plipastatin B1, plipastatin B2, (claims 2, 4, 7, 15-16; [0007, 0009, 0010, 0078]).
Regarding claim 4, ‘494 teaches the composition comprising gums, arabic and xanthum [0050, 0065], and guar gum [0066].
Regarding claim 5, ‘867 teaches that in other embodiments, the composition may comprise surfactants from the oil family such as olive squalane, rice squalane, rice germ oil, jojoba oil, castor oil, safflower oil, olive oil, macadamia nut oil, sunflower oil and other vegetable oils and beeswax (p. 3, para. 7, line 6-7).
Regarding claims 9-10, ‘867 teaches that the composition may comprise 2% (claim 6) and in other embodiments, the composition comprises 5% (example 5) iturin peptide which is about 20g/l and 50g/l respectively. ‘867 teaches that the solubilizing agent such as a surfactant is in the composition in the amount of 0.005- 90% by mass and more preferably 1.0 to 70% by mass (claim 7 and page 3, 3rd paragraph, line 3-4) and that the surfactants include nonionic surfactants, amphoteric surfactants, cationic surfactants, anionic surfactants. ‘867 further teaches that the surfactant is from the oil family such as olive squalane, rice squalane, rice germ oil, jojoba oil, castor oil, safflower oil, olive oil, macadamia nut oil, sunflower oil and other vegetable oils and beeswax (p. 3, para. 7, line 6-7). ‘867 also teaches solubilizers comprises polyglycerin fatty acid esters (page 3, para. 2, line 9). In addition, ‘867 teaches that the composition comprises one or more surfactant (solubilizer) (claim 4). It would therefore be obvious for one of ordinary skill in the art to include surfactants from the oil family such as vegetable oil in the amounts disclosed by ‘867, which incorporate the instant amount.
Regarding claim 12, ‘494 teaches a composition in the form of powder [0061-0062]. This reads on a composition that is dehydrated rendering obvious claim 12.
Regarding claim 13, ‘494 teaches that the compositions may be used to control fungal phytopathogens, post-harvest fungal pathogens, fungal pathogens of food or feed and human fungal pathogens [0012] which reads on agri-food.
Regarding claims 16 and 19, ‘494 teaches that Iturin-type compounds that are suitable for the present invention include one or more of the following compounds: bacillomycin D, bacillyomycin F, bacillomycin L, bacillomycin LC (also known as bacillopeptin), mycosubtilin, iturin A, iturin AL, and iturin C [0008, 0034].
Regarding claims 22-24, ‘867 further teaches that the surfactant is from the oil family such as olive squalane, rice squalane, rice germ oil, jojoba oil, castor oil, safflower oil, olive oil, macadamia nut oil, sunflower oil and other vegetable oils and beeswax (p. 3, para. 7, line 6-7). ‘867 also teaches solubilizers comprises polyglycerin fatty acid esters (page 3, para. 2, line 9). In addition, ‘867 teaches that the composition comprises one or more surfactant (solubilizer) (claim 4). It would therefore be obvious for one of ordinary skill in the art to include surfactants from the oil family such as vegetable oil in the amounts disclosed by ‘867, which incorporate the instant amount. ‘867 further teaches that the composition comprises a solubilizing agent, which can be a surfactant (claim 4) used prevents aggregation and precipitation (p. 4) and that the surfactant comprises non-ionic surfactants such as alcohol fatty acid esters, ethylene glycol fatty acid esters, polyglycerin fatty acid esters, and sucrose fatty acid esters, and tetraalkylammonium salts (p. 3, para. 3, line 6-7). ‘867 teaches that the solubilizing agent which includes a surfactant is in the composition in the amount of 0.005- 90% by mass and more preferably 1.0 to 70% by mass (claim 7 and page 3, 3rd paragraph, line 3-4) (10g/L – 700g/L). This encompasses the instant amounts.
Regarding claims 25, ‘494 teaches the surfactin-type compounds are composed of seven amino acids [0036-0037].
Regarding claims 26, ‘867 further teaches that the surfactant is from the oil family such as olive squalane, rice squalane, rice germ oil, jojoba oil, castor oil, safflower oil, olive oil, macadamia nut oil, sunflower oil and other vegetable oils and beeswax (p. 3, para. 7, line 6-7). ‘867 also teaches solubilizers comprises polyglycerin fatty acid esters (page 3, para. 2, line 9). In addition, ‘867 teaches that the composition comprises one or more surfactant (solubilizer) (claim 4). It would therefore be obvious for one of ordinary skill in the art to include surfactants from the oil family such as vegetable oil in the amounts disclosed by ‘867, which incorporate the instant amount. ‘867 further teaches that the composition comprises a solubilizing agent, which can be a surfactant (claim 4) used prevents aggregation and precipitation (p. 4) and that the surfactant comprises non-ionic surfactants such as alcohol fatty acid esters, ethylene glycol fatty acid esters, polyglycerin fatty acid esters, and sucrose fatty acid esters, and tetraalkylammonium salts (p. 3, para. 3, line 6-7). ‘867 teaches that the solubilizing agent which includes a surfactant is in the composition in the amount of 0.005- 90% by mass and more preferably 1.0 to 70% by mass (claim 7 and page 3, 3rd paragraph, line 3-4) (10g/L – 700g/L). Further, ‘494 teaches the surfactin-type compounds are composed of seven amino acids [0036-0037].
Response to Arguments
Applicant's arguments filed 05/14/2025 have been fully considered but they are not persuasive.
Applicant arguments
Applicant argues unexpected synergistic results in stability and solubility when an anionic surfactant is used in combination with a non-ionic or oil surfactant. Applicant argues that the composition #13 included 4% surfactin and 0.2% fatty alcohol oxalkylate surfactant and showed a maximum soluble concentration of about 110 mg/L. Applicant argues that composition # 9 included 4% surfactin and had a soluble concentration of 30mg/L and argues the data of Fig 2. Applicant further argues that the cited reference does not provide any working examples showing solubility and stability. Applicant argues that Kitaguni does teach or suggest an anionic surfactant. Applicant argues that ‘494 does not teach using polyglycoside based surfactant and does not teach using fatty alcohol oxalkylate surfactant (Pages 1-13 of the Arguments).
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that the obviousness rejection is based on the combined teachings of ‘494 and ‘867. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). ‘494 teaches a composition that comprises iturinic lipopeptide and several surfactants; non-ionic and anionic surfactants. Further, ‘494 teaches that the lipopeptide in concentrations including the instant concentration ranges. ‘494 teaches that the surfactants or solubilizer ensure good solubilization and/or dissolution of the active ingredients such as the fungicide and/or lipopeptide and that the solubilizer to maintain the composition as a stable or homogeneous solution or dispersion [0072]. Examiner used the secondary reference ‘867 to teach a similar composition that comprises high concentrations of lipopeptides (50g/L) that comprises oil surfactants. ‘867 further teaches that the surfactant prevents aggregation and precipitation and stability is increased (page 4, Example 4). This reads on the instant homogenous and stable composition. Examiner notes that the instant invention is not drawn to solubilization or stabilization of iturinic lipopeptide, rather the invention is drawn to a composition that comprises lipopeptide and surfactants. Such a composition has been rendered obvious by the ‘494 and ‘867 reference.
Regarding the argument that the cited reference do not teach adding anionic surfactant or does not teach using polyglycoside based surfactant and does not teach using fatty alcohol oxalkylate surfactant, Examiner notes that ‘867 teaches that the surfactant is from the oil family such as olive squalane, rice squalane, rice germ oil, jojoba oil, castor oil, safflower oil, olive oil, macadamia nut oil, sunflower oil and other vegetable oils and beeswax (p. 3, para. 7, line 6-7). ‘867 also teaches solubilizers comprises polyglycerin fatty acid esters (page 3, para. 2, line 9). In addition, ‘867 teaches that the composition comprises one or more surfactant (solubilizer) (claim 4). It would therefore be obvious for one of ordinary skill in the art to include surfactants from the oil family such as vegetable oil in the amounts disclosed by ‘867, which incorporate the instant amount. ‘867 further teaches that the composition comprises a solubilizing agent, which can be a surfactant (claim 4) used prevents aggregation and precipitation (p. 4) and that the surfactant comprises non-ionic surfactants such as alcohol fatty acid esters, ethylene glycol fatty acid esters, polyglycerin fatty acid esters, and sucrose fatty acid esters, and tetraalkylammonium salts (p. 3, para. 3, line 6-7). ‘867 teaches that the solubilizing agent which includes a surfactant is in the composition in the amount of 0.005- 90% by mass and more preferably 1.0 to 70% by mass (claim 7 and page 3, 3rd paragraph, line 3-4) (10g/L – 700g/L). This encompasses the instant amounts.
With regards to the argument of unexpected synergistic results, Examiner notes that such arguments need to be commensurate in scope with the claimed invention. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” See MPEP 716.02(d). In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). Examiner notes that Applicant argues the composition # 13 displayed superior results than the other compositions shown in Fig. 2. From an examination of the Specification, the composition # 13 comprises 42 g/L, a concentration not recited in the instant claims and is thus not commensurate in scope with present claim 1 because claim 1 does not encompass the concentrations of composition # 13. Further, Examiner adds that from instant disclosure, composition 13 displayed superior results than the other compositions shown in Fig. 2. However, composition 13 comprises 30mg/l iturinic lipopeptide mycosubtilin and non-ionic surfactant of 0.2% fatty alcohol oxalkylate and 4% surfactin. Examiner notes that independent claim 1 broadly recites a composition that comprises iturinic lipopeptides, anionic surfactant and a non-ionic surfactant. Such a composition is taught by the cited references thus rendering obvious the instant claims. The arguments are unpersuasive. Examiner notes that a composition that comprises iturinic lipopeptides, anionic surfactant and a non-ionic surfactant is known in the art and the surfactants are known to be added in the composition as a solubilizer to maintain the composition as a stable or homogeneous solution. One of ordinary skill in the art would be motivated to try different types of anionic and non-ionic surfactants in the composition and would have achieved a reasonable expectation of success. Examiner notes that when the teachings of the cited references are combined, the instant invention is obvious.
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/ Examiner, Art Unit 1654
/LI N KOMATSU/Primary Examiner, Art Unit 1658