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 .
Applicant’s arguments, filed 12/05/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-5, 9, and 12-27, are pending and under examination.
Claim Rejections - 35 USC § 112(a) or pre-AIA 1st ¶
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 9, and 12-27, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 17 recite “wherein the organogelator comprises… glyceryl monocaprylocaprate.” This limitation does not appear to be supported by the instant specification. While glyceryl monocaprylocaprate has support as a solvent in the instant specification (see for example ¶ 23 of the instant specification), there does not appear to be support for glyceryl monocaprylocaprate as an organogelator. The examiner noes that while mono- and di- glycerides are disclosed as organogelators, the instant specification recites that these organogelators have a chain length of greater than C10 (see ¶ 21 of the instant specification), which does not appear to be representative of glyceryl monocaprylocaprate. Accordingly, glyceryl monocaprylocaprate as an organogelator appears to be new matter. Additionally, claims 2-5, 9, and 12-27, are also rejected for the same reasons for depending upon rejected claim 1.
Claim 18 recites cholesterol in an amount of “about 20-25 wt%, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification, where there are no wt% ranges disclosed for cholesterol. Various embodiments disclosed in the instant specification comprise cholesterol at 20, 22, and 25 wt%, used in combination with other components at specific weight ratios, however, the full range as instantly claimed does not appear to have support. Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc. Accordingly, the limitations appear to be new matter.
Claim 19 recites glyceryl monocaprylocaprate present in an amount of “about 35-66 wt%, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification, where there are no wt% ranges disclosed for glyceryl monocaprylocaprate. Various embodiments disclosed in the instant specification comprise 36 wt%, 48 wt%, 52 wt%, 54 wt%, 60 wt%, 63 wt%, etc., used in combination with other components at specific weight ratios, however, the full range as instantly claimed does not appear to have support. Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc. Accordingly, the limitations appear to be new matter.
Claim 20 recites hydrogenated castor oil present in an amount of “about 10-12 wt%, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification, where there appear to be no wt% ranges for the hydrogenated castor oil. While there are embodiments comprising 10, 11, and 12 wt% hydrogenated castor oil, used with specific ratios of other components, the term “about” is not disclosed with the wt%. Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc. Accordingly, the limitations appear to be new matter.
Claim 22 recites mono- and di- glycerides present in an amount of “about 12-15 wt%, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification, where there are appear to be no wt% ranges disclosed for mono- and di- glycerides. Various embodiments disclosed in the instant specification comprise 12 and 15 wt%, etc., used in combination with other components at specific weight ratios, however, the full range as instantly claimed does not appear to have support. Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc. Accordingly, the limitations appear to be new matter.
Claim 24 recites soybean oil is present in an amount of “about 14-60 wt%, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification, where there do not appear to be wt% ranges disclosed for soybean oil. Various embodiments disclose soybean oil at, for example, 18 wt%, 30 wt%, 31 wt%, etc., used in combination with other components at specific weight ratios, however, the full range as instantly claimed does not appear to have support. The examiner notes that the instant specification discloses a weight ratio of organogelator to solvent generally, but these ratios appear to be in relation to each other and are not representative of the wt% based on the total weight of the composition. Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc. Accordingly, the limitations appear to be new matter.
Claim 25 recites oleic acid is present in an amount of “about 15-45 wt%, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification, where there do not appear to be wt% ranges disclosed for oleic acid. Various embodiments disclose oleic acid at, for example, 15 wt%, 29 wt%, 30 wt%, 45 wt%, etc., used in specific ratios with other components, such as those disclosed in table 4, however, the full range as instantly claimed does not appear to have support. Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc. Accordingly, the limitations appear to be new matter.
Claim 26 recites “about 25 wt% cholesterol,” “about 15 wt% mono- and di- glycerides,” “about 15-45 wt% soybean oil,” and “about 15-45 wt% oleic acid, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification.
Regarding cholesterol, while embodiments are disclosed with 25 wt% cholesterol, and are used in specific ratios with other components, for example 25 wt% cholesterol, 15 wt% mono- and di- glycerides, 31 wt% soybean oil, and 29 wt% oleic acid (see table 4). There also does not appear to be no support for “about 25 wt%”
Regarding mono- and di- glycerides, while embodiments are disclosed with 15 wt% mono- and di- glycerides, these amounts are used in specific ratios with other components, such as in table 4. Further, there appears to be no support for “about 15 wt%”.
Regarding soybean oil, while embodiments within the claimed ranges are disclosed, as discussed above, these amounts are used in specific ratios with other components, such as those in table 4. Further, there does not appear to be support for the full range of “about 15-45 wt% soybean oil.”
Regarding oleic acid, while embodiments within the claimed range are disclosed, as discussed above, these amounts are used in specific ratios with other components, such as in table 4. Further, there does not appear to be support for the full range of “about 15-45 wt% oleic acid.”
Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc.
Accordingly, the limitations appear to be new matter.
Claim 27 recites “about 20 wt% cholesterol,” “about 10 wt% hydrogenated castor oil,” “about 35-56 wt% glyceryl monocaprylocaprate,” and “about 14-35 wt% soybean oil, based on the total weight of the organogel composition”. The full range of this limitation does not appear to be supported by the instant specification.
Regarding cholesterol, while embodiments are disclosed with 25 wt% cholesterol are disclosed in the instant specification, the 25 wt% cholesterol was used in specific weight ratios with other components, for example 20 wt% cholesterol, 10 wt% hydrogenated castor oil, 52 wt% glyceryl monocaprylocaprate, and 18 wt% soybean oil (see table 4). Further, there also does not appear to be support for “about 10 wt%”., and are used in specific ratios with other components, there appears to be no support for “about 20 wt%”.
Regarding hydrogenated castor oil, while embodiments comprising 10 wt% are disclosed in the instant specification, the 10 wt% hydrogenated castor oil was used in specific weight ratios with other components, such as those in table 4. Further, there also does not appear to be support for “about 10 wt%”.
Regarding glyceryl monocaprylocaprate, while various embodiments comprising glyceryl monocaprylocaprate with different weight ratios are discussed in the instant specification, there does not appear to be support for the full range for the same reasons discussed above. Additionally, glyceryl monocaprylocaprate was used in specific weight ratios with other components, such as those of table 4.
Further, “based on the total weight of the organogel composition” appears to be new matter where the ratios recited in the instant embodiments appear to be based on the total weight of the organogel matrix, not the total weight of the organogel composition, which would also include the active agent, etc. Accordingly, the limitations appear to be new matter.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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 26 and 27 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 26 recites the composition according to claim 1 comprising about 25 wt% cholesterol, about 15 wt% mono- and di- glycerides, about 15-45 wt% soybean oil, and about 15-45 wt% oleic acid. If, for example, the organogel composition comprised 25 wt% cholesterol, 15 or 45 wt% mono- and di- glycerides, 15 wt% soybean oil, and 15 or 45 wt% oleic acid, totaling 100%, it is unclear how the organogel composition can also comprise the solid particles of a water-soluble antimicrobial or anti-infective agent, as required by claim 1. For purposes of examination, the weight percentages are interpreted to be the weight percentages based on the total weight of the organogel matrix, rather than the organogel composition.
Claim 26 recites the composition according to claim 1 comprising about 20 wt% cholesterol, about 10 wt% hydrogenated castor oil, about 35-56 wt% glyceryl monocaprylocaprate, and about 45-35 wt% soybean oil. If, for example, the organogel composition comprised 25 wt% cholesterol, 10 wt% hydrogenated castor oil, 35 or 56 wt% glyceryl monocaprylocaprate, and 14 or 35 wt% soybean oil, totaling 100%, it is unclear how the organogel composition can also comprise the solid particles of a water-soluble antimicrobial or anti-infective agent, as required by claim 1. For purposes of examination, the weight percentages are interpreted to be the weight percentages based on the total weight of the organogel matrix, rather than the organogel composition.
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.
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, 9, 12-16, 21, and 22, are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), in view of Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), as evidenced by Gibbons et al (Jour Exotic Med, 2014, 23, pp. 21-38) and Pramar et al (Int J Pharm Compd., 2021, 25(2): 169-175).
Singh et al teaches organogel matrix compositions for topical delivery of antimicrobials, wherein the organogels comprise sorbitan monostearate as the organogelator and sesame oil as the organic phase (pg 294 1st col 2nd ¶, table 1). Suitable common organogelators include monoacylglycerols, diacylglycerols, triacylglycerols, fatty acids, fatty alcohols, waxes, wax esters, and sorbitan monostearate (pg 293 2nd col 3rd ¶). Suitable oils include sesame oil, soybean oil, etc. (pg 293 2nd col 3rd ¶). In embodiments, the antimicrobial agent was metronidazole (abs, table II). As evidenced by Pramar et, metronidazole is a solid (pg 2 3rd ¶). As evidenced by Gibbons et al, metronidazole is water soluble (10 mg/mL at 25 deg C) (pg 27 2nd col). The organogels have a melting point measured by differential scanning calorimetry (DSC) in the range of 49-54 deg C, where the higher melting points with higher organogelator fractions indicated higher thermal stability (pg 300 1st col last ¶). Gels are semi-solid and the organogels were disclosed as being gels at room temperature (25 deg C) (pg 293 1st col 1st ¶, pg 294 2nd col 1st ¶). The organogelator comprised from 5% to 22% w/w (pg 294 2nd col 1st ¶, table II). The melting points of the organogels increased with the increase in gelator concentration (pg 300 1st col last ¶). In embodiments, the oil ranges from 77-95 wt% (tables I, II).
Singh et al do not teach the claimed combination of organogelators and solvents, nor an embodiment comprising the claimed combination in the claimed amounts by weight.
Ghan et al teach glycerol monostearate was a known organogelator for organogels (abs, pg 387 1st col 1st ¶). Glycerol monostearate comprises various quantities of mono- and di- glycerides and has carbon chain length of 18 (pg 397 1st col 1st ¶, table 2). The properties of an organogel is strongly affected by the molecular structure of the organogelators and it is possible to modify the properties by adjusting the concentration or organogelators used (conclusions). Mixing organogelators can be used to optimize organogel formulations to tailor the physical properties of the organogel according to desired characteristics (conclusions). The melting point of glycerol monostearate is 58-59 deg C (table 1).
Ghan et al do not teach cholesterol.
Pickering et al teach cholesterol was a known gelator for organogels, and it was known to use cholesterol in combination with other gelators, such as triglycerol monostearate, where the addition of cholesterol controls the release rate of actives within the organogels (pg 16 ln 24-25, pg 47 ln 2, example 19, claim 2). Pickering et al further teach it was known to formulate organogels for controlled release of an active that release various drug percentages over the course of hours, days, etc. (pg 46).
Crandall teaches cholesterol was known to increase stability and penetration of organogels, where increased penetration permits transdermal delivery of molecules, such as antifungal agents, antibiotics, antibacterial drugs, etc., after topical application (pg 4 ln 10-14, pg 11 ln 22-24, pg 38 ln 1-4).
Regarding the active agent of claim 1, the organogel compositions disclosed by Singh et al comprise metronidazole (solid water-soluble antimicrobial agent), thereby meeting the claimed limitation.
Regarding the organogelator of claim 1, it would have been obvious to modify the organogel of Singh et al, by using other known organogelators suitable for organogel formulations, such as glycerol monostearate, which comprises a mono- and di- glyceride blend, as taught by Ghan et al. Further, the skilled artisan would have a reasonable expectation of success in using glycerol monostearate in the compositions of Singh et al, where Singh et al teach suitable organogelators include monoacylglycerols, diacylglycerols, and triacylglycerols, which are present in glycerol monostearate as taught by Ghan et al above.
Further, it would have been obvious to modify the combination of Singh et al and Ghan et al by further including cholesterol, where cholesterol was a known co-gelator for organogels and can be used to control the release rate of actives from organogel formulations, as taught by Pickering et al. Additional motivation for including cholesterol is provide by Crandall, where it was known that cholesterol increases stability of organogels and improves penetration of molecules after topical application.
Regarding the solvent of claim 1, it would have been obvious to substitute the sesame oil from the working examples of Singh et al with soybean oil, which were known oils suitable for organogel compositions, as taught by Singh et al.
Regarding the melting point peak of claims 1-3, where the organogel composition made obvious above comprises the same components as instantly claimed, it appears that the melting point peak would be inherent to the components of the composition itself, and therefore would be expected to fall within the claimed ranges. See MPEP 2112(II) and (III).
Regarding the intended use limitation of application to an open-wound site in a non-sterile environment of claim 1, where the organogel compositions of Singh et al can be used for topical delivery of antimicrobial agents, the organogels made obvious above appear to be capable of being applied to an open-wound site as instantly claimed.
Regarding “biocompatible,” where the organogelator and organic solvent can be used for topical applications to skin, the organogelator and organic solvent read on being biocompatible.
Regarding claim 4 and 5, where the organogel compositions disclosed by Singh et al were gels (semi-solid state) at room temperature (25 deg C), and teaches mono- and di- acyl glycerides and soybean oil were known suitable components, it would be reasonably expected that the formulations would define a semi-solid state within the temperature ranges instantly claimed. Further, where the organogel composition made obvious above comprises the same components as instantly claimed, it appears temperatures at which the composition defines a semi-solid state is inherent to the components of the composition itself, and therefore would be expected to fall within the claimed ranges. See MPEP 2112(II) and (III).
Regarding claim 9, it would have been obvious to formulate the organogel composition made obvious above with an organogelator content of less than 50 wt% of the organogel matrix, as taught by Singh et al.
Regarding claim 12, where the organogel composition of instant claim 1 is made obvious above, comprising the same components instantly claimed, the ability for the organogel to adhere to deep tissues is inherent to the organogel itself. See MPEP 2112(II). Further, it would have been reasonably expected that where Singh et al teach the organogel compositions can be applied topically, that the organogels would be capable of adhering to a desired surface, such as deep tissues as instantly claimed.
Regarding claims 13-16, where the organogel composition made obvious by the combination above comprises a water-soluble antimicrobial agent and an organogel matrix comprising cholesterol and a mono- diglyceride blend of claim 1, and within the claimed amounts of organogel matrix, the functional limitations of an in vitro elution profile at a thickness of approximately 0.5 mm appears to be inherent to the compositions itself, where the organogels made obvious above are substantially the same as those instantly claimed. See MPEP 2113(II) and (III).
Purely arguendo, if the in vitro elution profile is somehow not inherent to the composition made obvious above, it would have been obvious for the skilled artisan to optimize the release rate of the organogels in order to achieve desired release rate of the antimicrobial active agent that fall within the claimed ranges, where these release rates were known from Pickering et al. It would have been well within the relative skills of the skilled artisan to adjust the release properties of the organogels such as by varying the concentration of organogelators, as taught by Singh et al, and adding release control agents, as taught by Pickering et al, where the references are directed to organogel compositions for controlled release of an active agent.
Regarding claim 21, the organogelator made obvious above comprises glyceryl monostearate and cholesterol, thereby meeting the claimed limitation.
Regarding claim 22, the where the organogelators in the composition made obvious above range from 5% to 22% w/w, as taught by Singh et al, it would have been obvious to formulate the organogel compositions comprising the mono- and di-glycerides within that range, overlapping the ranges instantly claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), and Crandall (WO 1998003641 A1), as applied to claims 1-5, 9, 12-16, 21, and 22 above, and further in view of Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647).
Singh et al, Ghan et al, Pickering et al, and Crandall are discussed above, and purely arguendo, if somehow the combination above would not have been expected to define a semi-solid state within the temperatures of claims 4 and 5, the following applies.
Hwang et al teach it was known to formulate organogels comprising soybean oil (plant-derived oil) and organogelators with a melting point from about 47 to about 65 deg C, with increased gelator content (abs, table 2, fig 1). The melting point was affected by the average chain length of the wax esters (organogelators), and the amount of gelator used (pg 644 1st col 1st ¶, pg 645 2nd col). The texture and firmness of the organogels were also controlled by controlling the amount of gelling agent (abs). The organogelators tested were waxes, such as hydrogenated vegetable oils including hydrogenated castor oil, sunflower wax, etc. (abs, table 1, pg 643 1st col last ¶). In embodiments, the organogelators were tested up to 10 wt% (pg 645 1st col).
Purely arguendo, if the compositions made obvious above would somehow not be expected to define a semi-solid state at the temperatures of claims 4 and 5, it would have been obvious to formulate the organogel composition with a known melting point peak suitable for organogels, such as from about 47 to about 65 deg C, as taught by Hwang et al, in order to achieve desired release profiles, properties, etc., depending on the intended use of the formulations. Where a melting point peak ranging from about 47 to about 65 deg C is made obvious, it would be expected that below the melting point temperature, the organogels would define a semi-solid state (i.e., gel), overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claims 23 and 25, are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), and Crandall (WO 1998003641 A1), as applied to claims 1-5, 9, 12-16, 21, and 22 above, and further in view of Mujawar et al (IJPCBS, 2014, 4(3), pp. 758-773).
Singh et al are discussed above and further teach the organogel formulations are designed for topical applications as an anatomical and biological barrier for drug penetration, and my organic substances work as penetration enhancers (pg 293 2nd col 2nd ¶).
Singh et al, Ghan et al, Pickering et al, and Crandall are discussed above but do not teach the inclusion of oleic acid.
Mujawar et al teach organogel compositions where it was known to include oleic acid as an absorption enhancer at 10 wt% (pg 770 1st col 1st ¶).
Regarding claim 23, where Singh et al teach the organogel compositions are designed for drug penetration, and mentions penetration enhancers, it would have been obvious to modify the combination made obvious above by further including oleic acid, a known penetration enhancer, in order to increase the penetration of the antimicrobial actives.
Regarding the amount of oleic acid of claim 25, it would have been well within the relative skills of the skilled artisan to routinely optimize the amount of oleic acid by starting with 10 wt%, as taught by Mujawar et al, and adjusting up from there in order to achieve desired drug penetration for specific active ingredients. Generally, 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. Where 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. See MPEP 2144.05(II)(A).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), and Crandall (WO 1998003641 A1), as applied to claims 1-5, 9, 12-16, 21, and 22 above, and further in view of Vergnault et al (US 20170319698 A1).
Singh et al, Ghan et al, Pickering et al, and Crandall are discussed above but do not specifically teach the amount of soybean oil of claim 24.
Vergnault et al teach organogel compositions were it was known to include oils, such as soybean oil, in an amount from 15-90 wt% (abs, ¶ 41).
It would have been obvious to modify the organogel composition made obvious above by including known amounts of oils, such as soybean oils, used in organogel compositions, such as from 15-90 wt%, as taught by Vergnault et al, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claims 1-5, 9, 12-16, 21, and 22, are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), in view of Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), and Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647).
Singh et al, Ghan et al, Pickering et al, and Crandall are discussed above, and purely arguendo, if the melting point peak is not inherent, the following applies. Further, if somehow the combination above would not have been expected to define a semi-solid state within the temperatures of claims 4 and 5, the following also applies.
Hwang et al are discussed above.
Purely arguendo, if the melting point peak is not inherent, it would have been obvious to formulate the organogel composition with a known melting point peak suitable for organogels, such as from about 47 to about 65 deg C, as taught by Hwang et al, in order to achieve desired release profiles, properties, etc., depending on the intended use of the formulations. The skilled artisan would have a reasonable expectation of success where Hwang et al teaches the melting point peak can be adjusted by adjusting the amount of organogelator, etc.
Purely arguendo, if the compositions made obvious above would somehow not be expected to define a semi-solid state at the temperatures of claims 4 and 5, where a melting point peak ranging from about 47 to about 65 deg C is made obvious above, it would be expected that below the melting point temperature, the organogels would define a semi-solid state, overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claims 1-5, 9, 12-16, 21, and 22, are rejected for the same reasons above as applied to each and every claimed limitation.
Claims 23 and 25, are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), and Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647), as applied to claims 1-5, 9, 12-16, 21, and 22 above, and further in view of Mujawar et al (IJPCBS, 2014, 4(3), pp. 758-773).
Singh et al, Ghan et al, Pickering et al, Crandall, and Huang et al, are discussed above but do not teach the inclusion of oleic acid.
Mujawar et al are discussed above.
Regarding claim 23, it would have been obvious to modify the combination made obvious above by further including oleic acid, a known penetration enhancer, for the same reasons discussed above.
Regarding the amount of oleic acid of claim 25, it would have been well within the relative skills of the skilled artisan to routinely optimize the amount of oleic acid by starting with 10 wt%, as taught by Mujawar et al, and adjusting up from there in order to achieve desired drug penetration for specific active ingredients, for the same reasons discussed above. See MPEP 2144.05(II)(A).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), and Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647), as applied to claims 1-5, 9, 12-16, 21, and 22 above, and further in view of Vergnault et al (US 20170319698 A1).
Singh et al, Ghan et al, Pickering et al, Crandall, and Hwang et al, are discussed above but do not specifically teach the amount of soybean oil of claim 24.
Vergnault et al are discussed above.
It would have been obvious to modify the organogel composition made obvious above by including known amounts of oils, such as soybean oils, used in organogel compositions, such as from 15-90 wt%, as taught by Vergnault et al, for the same reasons discussed above. See MPEP 2144.05(I).
Claims 1-5, 9, 12-17, and 20, are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), in view of Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647), and Thomas et al (WO 2019036770 A1).
Singh et al, Ghan et al, Pickering et al, and Crandall are discussed above but do not teach an embodiment comprising hydrogenated castor oil and glyceryl monocaprylocaprate, nor an embodiment comprising the claimed combination in the claimed amounts by weight.
Hwang et al are discussed above but do not teach glyceryl monocaprylocaprate.
Thomas et al teach antimicrobial compositions that may be in the form of a topical gel, where the compositions comprise a glycerolipid, an antimicrobial agent, and may further comprise an oil carrier (abs, ¶¶ 24, 139-141, claim 1). The glycerolipid includes Capmul MCM (glyceryl monocaprylocaprate, mono/diglycerides), and was known to act synergistically with an antibiotic or antiseptic (¶¶ 135, 277, 292, 302, table 2). The carrier may be soybean oil, etc. (¶ 141).
Regarding the active agent of claim 1, the organogel compositions disclosed by Singh et al comprise metronidazole (solid water-soluble antimicrobial agent), thereby meeting the claimed limitation.
Regarding the organogelator of claim 1, it would have been obvious to modify the organogel of Singh et al, by using other known organogelators suitable for organogel formulations comprising soybean oil, such as hydrogenated starch hydrolysate, as taught by Hwang et al, where mixtures of organogelators were known from Ghan et al to tailor the physical properties of the organogels according to desirable characteristics.
Where Singh et al teach mono- and diacylglycerols were known suitable organogelators, it would have been obvious to further include other known mono- and diacylglycerols suitable for antimicrobial concentrations that may be in the form of a gel comprising soybean oil, such as Capmul MCM (glyceryl monocaprylocaprate, mono/diglycerides).
It would have been obvious to modify the combination above by further including cholesterol, where cholesterol was a known co-gelator for organogels and can be used to control the release rate of actives from organogel formulations, as taught by Pickering et al. Additional motivation for including cholesterol is provide by Crandall, where it was known that cholesterol increases stability of organogels and improves penetration of molecules after topical application.
Regarding the solvent of claim 1, it would have been obvious to substitute the sesame oil from the working examples of Singh et al with soybean oil, which were known oils suitable for organogel compositions, as taught by Singh et al.
Regarding the intended use limitation of application to an open-wound site in a non-sterile environment of claim 1, where the organogel compositions of Singh et al can be used for topical delivery of antimicrobial agents, the organogels made obvious above appear to be capable of being applied to an open-wound site as instantly claimed.
Regarding “biocompatible,” where the organogelator and organic solvent can be used for topical applications to skin, the organogelator and organic solvent read on being biocompatible.
Regarding the melting point peak of claims 1-3, where the organogel composition made obvious above comprises the same components as instantly claimed, it appears that the melting point peak would be inherent to the components of the composition itself, and therefore would be expected to fall within the claimed ranges. See MPEP 2112(II) and (III).
Purely arguendo, even if not, where Hwang et al teach the melting point peak can be affected by the amount of gelator used, it would have been well within the relative skilled of the skilled artisan to routinely adjust the melting point peak of the formulations, depending on the desired properties, release properties, intended use of the organogels, etc. See MPEP 2144.05(II)(A).
Regarding claims 4 and 5, it would be reasonably expected that that the organogels made obvious above would define a semi-solid state (i.e., a gel), within the claimed ranges, were Singh et al teaches mono- and diacyl glycerides and soybean oil were suitable for organogels at room temperature, Hwang et al teaches organogels comprising soybean oil and hydrogenated castor oil may have a melting point from about 47 to about 65 deg C, and Pickering et al and Crandall teach cholesterol can control release rates of actives and the stability of the gels. See MPEP 2112(II) and (III).
Purely arguendo, if the compositions made obvious above would somehow not be expected to define a semi-solid state at the temperatures of claims 4 and 5, it would have been obvious to formulate the organogel composition with a known melting point peak suitable for organogels, such as from about 47 to about 65 deg C, as taught by Hwang et al, in order to achieve desired release profiles, properties, etc., depending on the intended use of the formulations. Where a melting point peak ranging from about 47 to about 65 deg C is made obvious, it would be expected that below the melting point temperature, the organogels would define a semi-solid state (i.e., gel), overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 9, it would have been obvious to formulate the organogel composition made obvious above with an organogelator content of less than 50 wt% of the organogel matrix, as taught by Singh et al.
Regarding claim 12, where the organogel composition as instantly claimed is made obvious above, and comprises the same components instantly claimed, the ability for the organogel to adhere to deep tissues appears to be inherent to the organogel itself. See MPEP 2112(II). Further, it would have been reasonably expected that where Singh et al teach the organogel compositions can be applied topically, that the organogels would be capable of adhering to a desired surface, such as deep tissues as instantly claimed.
Regarding claims 13-16, where the organogel composition made obvious by the combination above comprises a water-soluble antimicrobial agent and an organogel matrix comprising cholesterol, hydrogenated castor oil, glyceryl monocaprylocaprate, and soybean oil, and within the claimed amounts, the functional limitations of an in vitro elution profile at a thickness of approximately 0.5 mm appears to be inherent to the compositions itself, where the organogels made obvious above appear to be substantially the same as those instantly claimed. See MPEP 2113(II) and (III).
Purely arguendo, if the in vitro elution profile is somehow not inherent to the composition made obvious above, it would have been obvious for the skilled artisan to optimize the release rate of the organogels in order to achieve desired release rate of the antimicrobial active agent that fall within the claimed ranges, where these release rates were known from Pickering et al. It would have been well within the relative skills of the skilled artisan to adjust the release properties of the organogels such as by varying the concentration of organogelators, and adding release control agents, as taught by Pickering et al, where the references are directed to organogel compositions for controlled release of an active agent.
Regarding claim 17, the organogel composition made obvious above comprises cholesterol, hydrogenated castor oil, and glyceryl monocaprylocaprate, thereby meeting the claimed limitations.
Regarding claim 20, where hydrogenated castor oil is an organogelator, it would have been obvious to include hydrogenated castor oil within the ranges taught by Singh et al to be suitable for organogelators, such as from 5% to 22% w/w, overlapping the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647), and Thomas et al (WO 2019036770 A1), as applied to claims 1-5, 9, 12-17, and 20 above, and further in view of Mouri et al (WO 2015059193 A1).
Singh et al, Ghan et al, Pickering et al, Crandall, Hwang et al, and Thomas et al are discussed above but do not teach the amount of glyceryl monocaprylocaprate as instantly claimed.
Mouri et al teach organogel formulations where it was known to include acylglycerols in an amount from 30 to 49 wt%, relative to the total weight of the organogel (pg 2 ln 20-25).
Where glyceryl monocaprylocaprate are acylglycerols, it would have been obvious to modify the organogel composition made obvious above by including known amounts of acylglycerols used in organogel compositions, such as from 30-49 wt%, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claims 23 and 25, are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647), and Thomas et al (WO 2019036770 A1), as applied to claims 1-5, 9, 12-17, and 20 above, and further in view of Mujawar et al (IJPCBS, 2014, 4(3), pp. 758-773).
Singh et al, Ghan et al, Pickering et al, Crandall, Hwang et al, and Thomas et al, are discussed above but do not teach the inclusion of oleic acid.
Mujawar et al are discussed above.
Regarding claim 23, where Singh et al teach the organogel compositions are designed for drug penetration, and mentions penetration enhancers, it would have been obvious to modify the combination made obvious above by further including oleic acid, a known penetration enhancer, in order to increase the penetration of the antimicrobial actives.
Regarding the amount of oleic acid of claim 25, it would have been well within the relative skills of the skilled artisan to routinely optimize the amount of oleic acid by starting with 10 wt%, as taught by Mujawar et al, and adjusting up from there in order to achieve desired drug penetration for specific active ingredients. Generally, 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. Where 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. See MPEP 2144.05(II)(A).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647), and Thomas et al (WO 2019036770 A1), as applied to claims 1-5, 9, 12-17, and 20 above, and further in view of Vergnault et al (US 20170319698 A1).
Singh et al, Ghan et al, Pickering et al, Crandall, Hwang et al, and Thomas et al are discussed above but do not specifically teach the amount of soybean oil of claim 24.
Vergnault et al teach organogel compositions were it was known to include oils, such as soybean oil, in an amount from 15-90 wt% (abs, ¶ 41).
It would have been obvious to modify the organogel composition made obvious above by including known amounts of oils, such as soybean oils, used in organogel compositions, such as from 15-90 wt%, as taught by Vergnault et al, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 9, 12-17, 19-25, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 16/851,177 (reference application), hereinafter ‘177, in view of Singh et al (AAPS PharmSciTech, 2015, vol 16, no 2, pp. 293-305), Hwang et al (J Am Oil Chem Soc, 2012, 89:639-647), Ghan et al (Food Biophysics, 2020, 15:386-395), Pickering et al (WO 2018144991), Crandall (WO 1998003641 A1), Mujawar et al (IJPCBS, 2014, 4(3), pp. 758-773), Vergnault et al (US 20170319698 A1), Thomas et al (WO 2019036770 A1), and Mouri et al (WO 2015059193 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘177 disclose a method of delivering an active agent to a non-sterile open wound comprising hydrophilic anti-infective active agent within an organogel matrix comprising an organogelator and a biocompatible organic solvent (claim 1). The organogel matrix has a melting point above 37 deg C (claim 10). The fatty acid ester comprises one or more fatty acids, or salts or esters of fatty acids, and mixtures thereof, such as sorbitan monostearate (claims 14, 15). The biocompatible organic solvent is a plant or animal derived oil (claim 16). The active agent compress an antimicrobial agent, etc. (claim 20). The organogelator and biocompatible organic solvent are present in the organogel matrix in a ratio of about 10:90, etc. (claim 34).
The claims of ‘177 do not disclose wherein the organogelator are those of instantly claimed, soybean oil and optionally oleic acid as the organic solvent, the functional limitations of claims 13-16, nor the amounts of new claims 19, 20, 22, 24, and 25.
The references are discussed above.
Regarding the organogel, it would have been obvious to modify the claims of ‘177 by formulating an organogel composition comprising cholesterol, hydrogenated castor oil, glycerol monocaprylocaprate, soybean oil, and optionally oleic acid, for the same reasons discussed above by Singh et al, Pickering et al, Crandall, Hwang et al, and Thomas et al. Additionally, it would have been obvious to modify the claims of ‘177 by formulating an organogel composition comprising cholesterol, mono- and di- glycerides, soybean oil, and optionally oleic acid, for the same reasons discussed above by Singh et al, Pickering et al, Crandall, and Ghan et al.
Regarding the peak melting point, where the claims of ‘177 disclose the melting point is above 37 deg C, it would have been obvious to adjust the melting point within the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it was known from Singh et al and Hwang et al that organogels were known to be formulated within those ranges of instant claims 2 and 3, and would have been obvious for the reasons discussed above.
Regarding claims 4 and 5, where the melting point of the organogels are disclosed as being above 37 deg C, the organogels would be expected to be in gel state (i.e., semi-solid state) below 37 deg C, falling within the claimed ranges.
Regarding the functional limitations of claims 13-16, where the combination made obvious above is substantially the same as the organogel composition instantly claimed, it appears the functional limitations of an in vitro elution profile at a thickens of approximately 0.5 mm is inherent to the compositions itself, where the organogels are substantially the same as those instantly claimed. See MPEP 2113(II) and (III).
Even if not, it would have been obvious for the skilled artisan to adjust properties of the organogel in order to achieve desired in vitro elution profile, for the same reasons discussed above.
Regarding the amounts of the components, it would have been obvious to formulate the organogel compositors with known amounts of organogelators and solvent, for the same reasons discussed above by Singh et al, Mouri et al, Mujawar et al, and Vergnault et al, overlapping the instantly claimed ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Status of the Art
It appears that the prior art is silent regarding an organogel composition comprising cholesterol, and either (a) hydrogenated castor oil and glyceryl monocaprylocaprate, or (b) mono- and di-glycerides, and soybean oil and optionally oleic acid, wherein cholesterol is present at 20 wt%, 22 wt%, or 25 wt%, based on the total weight of the organogel composition. While the prior art provides teachings and motivation for including cholesterol to organogel compositions, as taught by Pickering et al and Crandall above, the prior art does not appear to teach or suggest amounts as high as 20 wt%, 22 wt%, or 25 wt%. For example, Mouri et al (WO 2015059193 A1) teaches organogel compositions comprising cosmetic or personal care substances, where it was known to include cholesterol, however, the total amount ranged from 0.825-4.5 wt% of the organogel, which is magnitudes of order less than 20, 22, and 25 wt%.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612