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 election without traverse of Group I, claims 1-12, 19-25, and 31, in the reply filed on 05/25/2026 is acknowledged.
Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/25/2026.
Applicant is reminded of the manner of making amendments in application under 37 CFR 1.121. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The text of all pending claims under examination and withdrawn claims must be submitted each time any claim is amended. The text of pending claims not being currently amended, including withdrawn claims, must be presented in clean version, i.e., without any markings. See MPEP 714(c) and 714 C.(C).
Claim Status
Claims 1-12, 14-25, and 31, are pending.
Claims 14-18 are withdrawn.
Claim Interpretation
The examiner is interpreting “glycerophospholipids” as recited in claim 1 to have the same meaning as “one or more glycerophospholipids,” which is consistent with its use in claim 6.
The examiner best understands the term “pharmaceutical quality” as recited in claim 8 as wherein the solvents are suitable for the intended use of pharmaceutical compositions.
Claim Objections
Claim 5 is objected to because of the following informalities: the first time an abbreviated term is used, it should be preceded by the full name (e.g., epigallocatechin gallate (EGCG)). Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the claim recites “wherein the aqueous medium comprises an aqueous alkali metal salt dissolved in a mildly acidic aqueous solution,” and the “aqueous” limitation in aqueous alkali metal salt is redundant where the claim already recites that it is an aqueous solution with the alkali metal salt dissolved therein, and should be removed. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the claim recites “wherein the alkali metal salt comprises an alkali metal cation selected from…, calcium, and an inorganic or organic anion comprising chloride, sulfate, phosphate, acetate or citrate,” where “and” is missing just before calcium, as it appears Applicant is reciting the alkali metal salt comprises an alkali metal cation and an inorganic or organic anion. Appropriate correction is required.
Claims 20-25, and 31, are objected to because of the following informalities: a comma is missing following “the final composition of claim 19”. Appropriate correction is required.
Claim Rejections - 35 USC § 101 / § 112- Hybrid Claim
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 31 is rejected under 35 U.S.C. 101 because the claimed invention is not directed to a single statutory class. The claims are directed to neither a “process” nor a “machine”, but rather embraces or overlaps two different statutory categories of invention set forth under that statute, which is drafted so as to set forth the statutory classes of invention in the alternative only. See Ex parte Lyell, 17 USPQ2d 1548, 1551 (Bd. Pat. App. & Inter. 1990).
In the present instance, claim 31 recites the “use” of the final composition of claim 19 for treating a skin disorder by administering a therapeutic amount of the composition to a human being in need thereof, which is neither a “process” nor a “machine”.
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
Claim 31 is also rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
A single claim which recites both a product and method steps of using that product is indefinite under 35 USC 112, second paragraph. See Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990).
Note, for purposes of examination, the claimed limitations directed to active steps will be interpreted as intended use limitations or product by process limitations.
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 1-12, 19-25, and 31, 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 1 recites that the “lipid membrane bilayers of spherical vesicles comprise glycerophospholipids… and an aqueous medium,” and it is unclear how the aqueous medium can be present within the membrane bilayer, as suggested by the limitation, as the membrane bilayer is hydrophobic due to the nature of the hydrophobic tails that make up the bilayer. The examiner is interpreting the limitation as wherein the liposomal polyphenol composition further comprises an aqueous medium, rather than the membrane bilayer comprises the aqueous medium.
The term “high purity” in claims 1 and 2 is a relative term which renders the claims indefinite. The term “high purity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is required for the polyphenol to be considered “high purity”.
Claim 5 recites “wherein each lipophilic and glycoside free polyphenol is optimally encapsulated within the lipid membrane,” and it is unclear how the polyphenols are to be encapsulated in order to be “optimally encapsulated.” For purposes of examination, the claim is interpreted as simply “encapsulated.”
The term “mostly spherical” in claim 5 is a relative term which renders the claims indefinite. The term “mostly spherical” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, it is not clear how spherical or what amount of the total spherical liposomes are required to be considered “mostly spherical”.
The term “lower molar mass category” in claim 5 is a relative term which renders the claims indefinite. The term “lower molar mass category” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, it is not clear what the molar mass has to be lower than, and what molar mass reads on a “lower molar mass category.”
Claim 5 recites “about 2.5 microns for encapsulated polyphenols in the lower molar mass category including quercetin and cannabidiol with molar masses of 302 and 314 grams per mole respectively,” and it is unclear if quercetin and cannabidiol are simply included as an example of a polyphenol of lower mass category, or if one or both are required components. Where the working embodiments from the instant specification appear to comprise quercetin or cannabidiol, not both, the examiner is interpreting the limitation as “about 2.5 micron for encapsulated polyphenols comprising quercetin or cannabidiol with molar masses of 302 and 314 grams per mole respectively.”
The term “upper molar mass category” in claim 5 is a relative term which renders the claims indefinite. The term “upper molar mass category” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, it is not clear what the molar mass has to be higher than, and what molar mass reads on a “upper molar mass category.”
Claim 5 recites “about 5 microns for encapsulated polyphenols in the upper molar mass category including EGCG with a molar mass of 458 grams per mole,” and it is unclear if EGCG is simply included as an example of a polyphenol of lower mass category or if it is a required component. For purposes of examination, the examiner is interpreting the limitation as “about 5 microns for encapsulated polyphenols comprising EGCG with a molar mass of 458 grams per mole.”
Claim 10 recites a list of alkali metal cations, however, magnesium and calcium are not alkali cations, and are instead alkaline earth metals that form divalent cations. Accordingly, it is unclear how magnesium and calcium can be alkali metal cations, let alone form alkali metal salts.
Claim 11 recites “wherein the alkali metal salt is magnesium chloride”, and as discussed above, magnesium is not an alkali metal, and it is unclear how magnesium chloride can be considered an alkali metal salt.
Claims 20-25 recite a concentration in terms of a percentage, and it is unclear if the concentration is a wt%, vol%, mol%, etc. For purposes of examination, the claims are interpreted as a wt%.
Claim 21 recites the limitation "the one or more lipophilic flavonoids" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 21 depends from claim 19 where a liposomal polyphenol composition of claim 1 is recited, but neither of claim 19 or claim 1 recite lipophilic flavonoids. For purposes of examination, the claim is interpreted as the one or more lipophilic, glycoside free, and high purity polyphenol ingredients.
Claim 22 recites the limitation "the one or more lipophilic cannabinoids" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 22 depends form claim 19, and neither of claim 19 or claim 1 recite one or more lipophilic cannabinoids.
Claim 23 recites the limitation "the one or more phosphatidylcholines" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 22 depends form claim 19, and neither of claim 19 or claim 1 recite one or more phosphatidylcholines.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6, 7, 19-21, 23-25, and 31, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Simmons (US 20150342843 A1), as evidenced by Fernandez et al (Antioxidants, 2020, 9(5), 440, pp. 1-20, hereinafter “Fernandez”) and Kolbina et al (Eur Jour Pharm Sci, 2017, 108, pp. 86-92, hereinafter “Kolbina”).
Simmons discloses topical aqueous liposome compositions containing phenolic agents that are capable of being used prevent and/or treat skin conditions (abs). In embodiments, the composition comprises Phospholipon 90H (hydrogenated soy phosphatidylcholine), Teavigo (epigallocatechin gallate), cholesterol, alcohol, and purified water (¶ 55). The liposomes are spherical vesicles wherein the membranes exist in a bilayer arrangement, wherein the membranes consist of the one or more phenolic agent, a glycerophospholipid, a skin-related lipid and a cosmetically acceptable solvent (claim 1). As evidenced by Fernandez, Teavigo is a natural green tea extract providing a purified source of the flavanol epigallocatechin gallate (abs, pg 3 3rd ¶). As evidenced by Kolbina, Phospholipon 90H is saturated phosphatidylcholine of stearic and palmitic acid (2.1). The liposome composition is formulated as a final composition in the form of a gel-cream in a cream base comprising purified water, with a pH of 4.50 (ex 1). The final composition comprises 15.000% of the liposomal composition, 0.190% of epigallocatechin gallate, 2.200% Phospholipon 90H, 0.012% cholesterol, and 2.000% alcohol (i.e., solvent) (ex 1). Simmons discloses all weights are given by percentages unless otherwise specified (¶ 38).
Regarding claim 1, Simmons discloses a liposomal polyphenol composition comprising epigallocatechin gallate (polyphenol) encapsulated in a lipid bilayer membrane comprising Phospholipon 90H (hydrogenated soy phosphatidylcholine, i.e., glycerophospholipid), cholesterol, alcohol (solvent), and purified water (aqueous medium), wherein the composition is capable of topical administration.
Regarding claim 2, Teavigo is epigallocatechin gallate derived from green tea and is a high purity flavonol, as evidenced by Fernandez.
Regarding claim 4, where epigallocatechin gallate has a fixed molecular formula, epigallocatechin gallate has a molar mass of 458 g/mol, as evidenced by instant claim 5.
Regarding claim 6, Phospholipon 90H is a phosphatidylcholine.
Regarding claim 7, where Phospholipon 90H is a saturated phosphatidylcholine comprising the fatty acid side chains stearic (C18) and palmitic acid (C16), the limitation is met.
Regarding claim 19, the final composition disclosed by Simmons comprises the liposomal polyphenol composition in the form of an gel-cream comprising an aqueous cream base having a pH of 4.50.
Regarding claim 20, the final composition disclosed by Simmons comprises the liposomal polyphenol composition at 15.000 wt% of the final composition, falling within the claimed range.
Regarding claim 21, the final composition disclosed by Simmons comprises epigallocatechin gallate at 0.190 wt%, falling within the claimed range.
Regarding claim 23, the final composition disclosed by Simmons comprises Phospholipon 90H at 2.200 wt%, falling within the claimed range.
Regarding claim 24, the final composition disclosed by Simmons comprises 0.012 wt% cholesterol, falling within the claimed range.
Regarding claim 25, the final composition disclosed by Simmons comprises 2.000 wt% alcohol (i.e., solvent), falling with the claimed range.
Regarding claim 31, where the final composition of claim 19 is anticipated above, and can be applied to the skin for treating skin conditions, it appears the final composition of Simmons would be capable of meeting the intended use limitation as instantly claimed.
Claims 1, 3-4, and 6-8, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sloat et al (WO 2020123407 A1, hereinafter “Sloat”), as evidenced by Avanti (Sunflower PC, retrieved 2026).
Sloat discloses liposomal compositions that are capable of topical administration, comprising cannabidiol (CBD), phosphatidylcholine, cholesterol, ethanol, water, etc. (¶¶ 134, ex 1, table 1). The CBD was high purity CBD (¶ 72). As evidenced by Avanti, sunflower phosphatidylcholine comprises saturated fatty acid chains comprising 16 and 18 carbon atoms. As evidenced by the instant specification, CBD is a flavonoid derived from the plant Cannabis sativa (¶ 4).
Regarding claim 1, Sloat discloses a liposomal polyphenol composition comprising purified cannabidiol (polyphenol), sunflower phosphatidylcholine (glycerophospholipid), cholesterol, ethanol (solvent), and purified water (aqueous medium), wherein the composition is capable of topical administration.
Where the liposomal polyphenol compositions comprises the same ingredients as instantly claimed, it appears that the cannabidiol would be present in the membrane layer, where cannabidiol is lipophilic, as evidenced by instant claim 5.
Regarding claim 3, Sloat discloses the cannabidiol is high purity.
Regarding the limitation of derived from industrial hemp and synthetic processes of claim 3, this limitation appears to be a product by process limitation, and where high purity cannabidiol is anticipated above, the limitation appears to be met.
Regarding claim 4, where cannabidiol has a fixed molecular formula, cannabidiol has a molar mass of 458 g/mol, as evidenced by instant claim 5.
Regarding claims 6 and 7, sunflower phosphatidylcholine anticipated above comprises saturated fatty acid chains comprising 16 and 18 carbon atoms.
Regarding claim 8, where the liposomal composition of Sloat comprises ethanol (i.e., ethyl alcohol), and are capable of being used to treat skin conditions, it appears the ethyl alcohol is suitable for pharmaceutical use.
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 3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons (US 20150342843 A1), in view of Sloat et al (WO 2020123407 A1, hereinafter “Sloat”).
Simmons is discussed above and further teaches the phenolic agents are anti-inflammatory agents, but does not teach wherein the polyphenols are cannabinoids.
Sloat teaches liposomal compositions that are suitable for topical application to the skin and can be used to treat inflammatory skin disorders, etc., where high purity cannabidiol was a suitable therapeutic agent (abs, ¶¶ 134, 136). Compositions comprising the liposomes are taught to comprise from 1 to 10% of cannabidiol (¶ 12).
Regarding claims 3 and 22, it would have been obvious to substitute high purity cannabidiol for epigallocatechin gallate of Simmons, where cannabidiol was a known therapeutic agent suitable for liposomal formulations, and where Simmons and Sloat are both directed to liposomal compositions containing anti-inflammatory phenolic agents that are capable of topical administration for treating skin disorders.
Regarding the limitation of derived from industrial hemp and synthetic processes, this limitation appears to be a product by process limitation, and where high purity cannabidiol is made obvious above, the limitation appears to be met.
Regarding the amount of cannabinoid of claim 22, it would have been obvious to formulate the compositions with an amount of cannabidiol ranging from 1 to 10%, as taught by Sloat, depending on desired therapeutic activity, applications, and treatments. 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 would have been well within the relative skills of the skilled artisan to have routinely adjusted the amount of cannabidiol in the formulations in order to achieve desired therapeutic activity, for desired treatments, applications, etc. 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Simmons (US 20150342843 A1), in view of Mezei (US 4897269).
Simmons is discussed above and further teaches the liposomes are unilamellar, oligolamellar or multilamellar, more preferably multilamellar vesicles. (¶ 35). The encapsulation of drugs into large multilamellar vesicles for topical application have significantly enhanced skin penetration properties over conventional topical products (¶ 12).
Simmons does not specifically teach the size of the liposomes.
Mazei teaches liposomal drug delivery compositions that can be used for topical application, where it was known to formulate spherical liposomes between 1 and 15 micron diameters (abs, col 8 ln 32-33, col 9 ln 3-4, col 9 ln 43-44). The liposomes are suitable for anti-inflammatory agents (col 6 ln 18). The activity of the bioactive ingredients may be localized at or near the site of application, i.e., skin, and because of their size, they are not taken up by the blood circulation (col 7 ln 14-20). In embodiments the liposomes comprise phosphatidylcholine, cholesterol, ethanol, propylene glycol, etc. (see examples).
It would have been obvious to formulate the liposomes of Simmons with liposomal particle diameters that were known to be suitable for topical application of anti-inflammatory agents, including between 1 and 15 microns, in order to formulate a composition wherein the active agent is localized at the site of application, as taught by Mazei. 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 would have been well within the relative skills of the skilled artisan to routinely adjust the liposomal diameter for desired applications, therapeutic activity, etc. 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Simmons (US 20150342843 A1).
Simmons is discussed above but and further teaches the solvent is selected from ethyl alcohol (¶ 39, claim 18). Propylene glycol may be included (¶ 40).
It would have been obvious to modify the liposomal polyphenol composition above by selecting ethyl alcohol as the solvent, as taught by Simmons.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Simmons (US 20150342843 A1), in view of Laudadio et al (Molecules, 2018, 23(2), 441, pp. 1-18, hereinafter “Laudadio”, cited on IDS dated 12/11/2023) and Istenic et al (J Sci Food Agric, 2016, 96, pp. 4623-4632, hereinafter “Istenic”), as evidenced by PubChem (Magnesium Chloride, retrieved 2026).
Simmons is discussed above and further teaches alkalizing agents including citrates and acetates can be included to adjust the pH in the range of 4.0 to 4.8 (¶¶ 43, 44). A minimal pH limit of 4.8 and appreciable overages need to be established in order to assure product shelf life of 24 months, and teaches the importance of acid inclusion and precise pH requirements for stabilizing phenolic containing agents (¶ 11).
Simmons does not teach the alkali metal salts dissolved in a mildly acidic aqueous solution as instantly claimed.
Laudadio teaches liposomal formulation for efficient encapsulation of epigallocatechin-3-gallate (EGCG), where it was known the encapsulate EGCG in the presence of magnesium chloride, where magnesium chloride improves the insertion degree of EGCG molecules respect to the liposomes without divalent salts (abs). The inclusion of magnesium chloride avoids time-consuming separation steps of unentrapped active principle and is particularly suitable for EGCG delivery applications (abs). It was also known that Mg2+ improves penetration of drugs carried by the liposomes inside the cells (pg 2 2nd ¶). The inclusion of Mg2+ salts obtained the maximum percentage of encapsulated catechin (pg 2 3rd ¶). As evidenced by PubChem, magnesium chloride is highly water soluble.
Laudadio does not teach wherein the magnesium chloride is dissolved in acetic acid or citric acid.
Istenic teaches encapsulation of epigallocatechin gallate, wherein it was known to include citric acid in the water phase for preparation of liposomes, since epigallocatechin gallate is most stable in solutions with acidic pH (pg 4624 1st col 3rd ¶). In other embodiments, acetic acid was used (pg 4624).
It would have been obvious to modify the composition of Simmons by further including magnesium chloride, where it was known to enhance encapsulation of epigallocatechin gallate and improve penetration of drugs carried by liposomes inside cells, as taught by Laudadio.
Regarding the mildly acidic aqueous solution, where Simmons teaches an acidic pH is important for stabilizing the polyphenol, and teaches the inclusion of ascorbic acid, it would have been obvious for the skilled artisan to select from other known acids known to be suitable for liposomal compositions comprising epigallocatechin gallate, including citric acid or acetic acid, where these acids were known to provide optimal pH for optimal stability of EGCG for liposomal formulations, as taught by Istenic. Further, it upon adding citric or acetic acid to the aqueous medium, it would be reasonably expected that magnesium chloride would dissolve as magnesium chloride is highly water soluble.
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 1-12, 19-25, and 31, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,775,789 B2, hereinafter ‘789, in view of Sloat et al (WO 2020123407 A1, hereinafter “Sloat”), Laudadio et al (Molecules, 2018, 23(2), 441, pp. 1-18, hereinafter “Laudadio”) and Istenic et al (J Sci Food Agric, 2016, 96, pp. 4623-4632, hereinafter “Istenic”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘789 disclose a topical composition comprising an aqueous liposome concentrate composition comprising one or more alcohol solvents, one or more phenolic anti-inflammatory agents, one or more glycerophospholipids, and one or more of cholesterol, an aqueous medium, etc. The one or more phenolic compounds comprise green tea catechin, quercetin, epigallocatechin gallate, etc. The one or more alcohol solvents is ethyl alcohol. The liposomes are spherical vesicles. Comprising multilamellar membranes. Also disclosed is an aqueous base having a pH between 4.2 and 4.6. The liposomal composition is present at a concentration of 5-40 wt% of the total composition. The base is in the form of a suspension, a gel, a cream, or a lotion. The one or more phenolic anti-inflammatory agents are present in a concentration of about 0.1 to about 5.0%. The one or more glycerophospholipids are present at a concentration of about 1 to about 4%. The one or more skin related lipids (i.e., cholesterol) are present at a concentration of about 0.001 to about 0.1%. The solvent ethyl alcohol is present at a concentration of about 0.5 to about 3%. Also disclosed is a method for reducing inflammatory skin conditions comprising administering an effective amount of the topical composition to a subject in need thereof.
The claims of ‘789 are different insofar as they do not disclose wherein the polyphenol is cannabidiol, nor wherein the compositions further comprise a metal salt dissolved in a mildly acidic aqueous solution as instantly claimed.
Sloat, Laudadio, and Istenic are discussed above.
It would have been obvious to modify the claims of ‘780 for the same reasons discussed above.
It would have been obvious to substitute cannabidiol for the phenolic compounds of ‘789, and in known amounts, for the same reasons discussed above by Sloat.
It would have been obvious to further include a metal salt dissolved in a mildly acidic aqueous solution, such as magnesium chloride in citric acid or acetic acid, as taught by Laudadio and Istenic, for the same reasons discussed above.
Regarding the amount of each component of the final composition, it would have been obvious to select from within the disclosed ranges of ‘789, thereby overlapping or falling within the instantly claimed ranges.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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