Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, crotonic acid, SEQ ID NO: 1 (defensin), sunflower lecithin (surfactant) and propylene glycol in the reply filed on 6/10/2026 is acknowledged.
Claims 24-28 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/10/2026.
Status of the Claims
Claims 18-30 are pending in this application.
Claims 24-28 and 30 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 18-23 and 29 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claim 19 is objected to because of the following informalities: The claim should be amended to replace each instance of “SEQ.ID.NO:” with “SEQ ID NO:”. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995); See also MPEP § 608.01(m). Appropriate correction is required.
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.
Claims 18, 20-23 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Turovets et al. (WO 2015/195677) in view of Wolf et al. (DE 19841794A1).
With respect to claims 18 and 29, Turovets et al. teach a topical cosmetic formulation, comprising a cosmetically acceptable carrier in combination with a first defensin (claim 1), wherein the first defensin is encapsulated in a liposome (claim 10).
Turovets et al. also teach that the liposomal formulations have the ability to induce hair growth and enhanced wound healing (paras [0004], [0006] and [0032]).
Turovets et al. do not teach that the formulation further comprises a fatty acid selected from crotonic acid, pelargonic acid and caproleic acid.
Wolf et al. teach that “[t]he cosmetic and/or dermatological formulations according to the invention may be composed as usual and for the treatment of the skin and/or the hair (page 9, 12th para).
Wolf et al. further teach that the fatty acids of the formulation are antimicrobial (page 5, 8th para).
Wolf et al. also teach an exemplary composition comprising pelargonic acid as a hair care product and a gel comprising liposomes (Examples 10 and 14 on page 12).
It would have been obvious to one of ordinary skill in the art to include pelargonic acid in the cosmetic formulation of Turovets et al. because Wolf et al. teach antimicrobial formulations for the treatment of the hair comprising liposomes and pelargonic acid.
With respect to claim 22, Turovets et al. teach that the formulation further comprises surfactants such as phosphatidylcholine, phosphatidylethanolamine, phosphatidic acid, phosphatidylserine, phosphoinositides, lecithin, Helianthus Annuus (Sunflower) Seed Oil (which comprises the elected species sunflower lecithin) (paras [0031] and [0038]-[0039]).
With respect to claims 20-21 and 23, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum amounts of defensin, fatty acid and surfactants by normal optimization procedures known in the pharmaceutical art.
Claims 18-23 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (WO 2009/094719) in view of Chadeganipour et al. (Mycoses. 2001 May; 44(3-4): 109-12).
With respect to claim 18, Anderson et al. teach a system for protecting a plant from a disease caused by a given susceptible fungus, comprising a first component and a second component, each of said first and second components being an inhibitor of a given susceptible fungus, the first component being a plant defensin which is not in nature expressed by said plant, the second component being a chemical fungicide, the defensin and the fungicide in combination being synergistic with respect to inhibition of the fungus when combined in contact with the fungus (claim 1).
Anderson et al. also teach that “[A]ntifungal formulations include aqueous solutions of the active compounds in water-soluble form. Additionally, suspensions of the active compounds may be prepared as appropriate oily suspensions. Suitable lipophilic solvents or vehicles include fatty oils such as sesame oil, or synthetic fatty acid esters, such as ethyl oleate or triglycerides, or liposomes”.
Anderson et al. do not teach the formulation comprises a fatty acid.
Chadeganipour et al. teach that pelargonic acid has antifungal activity against Microsporum gypseum (abstract).
The MPEP 2144.06 states that "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 them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that liposomes comprising defensins and pelargonic acid are effective agricultural antifungals, it would have been obvious to combine the two c with the expectation that such a combination would be effective in inhibiting fungal growth in agriculture. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 19, Anderson et al. teach that the defensin is RsAFP1, RsAFP2, etc. (para [008]).
With respect to claims 22 and 29, Anderson et al. teach that “[T\he fungicide of interest can be applied to the plants to be protected or treated in the form of a composition with carriers, surfactants, adjuvants or other application-promoting chemicals customarily employed in formulation technology” (para [0052]).
With respect to claims 20-21 and 23, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum amounts of defensin, fatty acid and surfactants by normal optimization procedures known in the pharmaceutical art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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