DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 recites the composition of claim 1 “further comprising a long chain triglyceride (LCT) oil, an olive oil, a coconut oil, or a combination thereof”. However, claim 1 recites 5-50 wt% carrier oil, which “is long chain triglyceride (LCT) oil, medium chain triglyceride (MCT) oil, coconut oil, olive oil, or a combination thereof”, according to claim 4. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 10 recites the composition of claim 1 “further comprising a preservative”. However, claim 1 recites 0-0.2 wt% preservatives. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz et al (US 20200022386 A1) in view of Madwar et al (US 20200138730 A1).
Regarding claims 1 and 4-5, Schwarz teaches a nanoemulsion composition of biologically active components completely dissolved in the oil phase comprising 1-75 wt% of cannabis extract, 0.1-50 wt% of lipid components including olive oil, 0.1-90 wt% of surfactants [0014, 0046-0047, 0053, 0059, 0060]. The surfactants include a mixture of phospholipids and d-α-Tocopheryl polyethylene glycol 1000 succinate (TPGS) or polysorbates [0062].
The examiner submits that the 1-75 wt% of a cannabis component including cannabis extract overlaps the claimed f) 1-30 wt% cannabinoid extract. The 0.1-50 wt% of lipid components including olive oil overlaps the claimed b) 5-50 wt% carrier oil, as specified in claim 4. The d-α-Tocopheryl polyethylene glycol 1000 succinate (TPGS) is equivalent to the claimed vitamin E TPGS and reads on the claimed water-soluble emulsifier, as specified in claim 5. The phospholipids correspond to the claimed water insoluble lecithins as explained below.
In the same field of endeavor, Madwar teaches a cannabinoid emulsion composition [0019-0022]. The surfactants include a combination of small-molecule surfactant such as polysorbate and phospholipids such as phosphatidylethanolamine [0112]. The examiner submits that this surfactant system is identical to Schwarz’s surfactant system. Madwar specifies that the phospholipids include phosphatidylethanolamine.
It would have been obvious to one of ordinary skill in the art at the time of filing to select phosphatidylethanolamine as the phospholipid in Schwarz’s composition, as it is expressly disclosed as being useful in this capacity. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
The cited prior art does not expressly disclose the claimed 5-40 wt% of the phosphatidylethanolamine as the water insoluble lecithin and 10-50 wt% of TPGS as the water soluble emulsifier. Nevertheless, the obviousness analysis may “take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). For example, the analysis may “include recourse to logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference or expert opinion.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009). The Patent Trial and Appeal Board has held that mixing equivalent components in a 1:1 ratio represented no more than application of the “logic, judgment, and common sense available to the person of ordinary skill” in the art. Ex parte Swanzy, Appeal 2017-004875 at 8-9.
In this case, Schwarz discloses phosphatidylethanolamine and TPGS as equally suitable alternatives to one another and therefore recognizes the equivalence of the two components as the surfactants. It would have would have been prima facie obvious, using no more than ordinary creativity, logic, judgment, and common sense, to combine phosphatidylethanolamine and TPGS in equal amounts (i.e. in a 1:1 ratio) based on the fact that both are disclosed in parallel as being equally suitable for use in this capacity.
As discussed above, Schwarz teach 0.1-90 wt% of surfactants. Including phosphatidylethanolamine and TPGS in a 1:1 ratio to obtain this total amount of surfactants will result in a composition that includes 0.05-45 wt% of phosphatidylethanolamine, which overlaps the claimed a) 5-40 wt% of water insoluble lecithin; and 0.05-45 wt% of TPGS, which overlaps the claimed c) 10-50 wt% water soluble emulsifier.
Schwarz teaches that the composition can comprise preservatives [0066], meeting the claimed d) 0-0.2 wt% preservatives.
Schwarz teaches does not teach water in the composition. Thus, 0% of water is expected from Schwarz’s composition, meeting the claimed e) 0-2 wt% water.
The recited “wherein the cannabinoid nanoemulsion composition is kinetically stable; wherein kinetically stables means dilution of the cannabinoid nanoemulsion composition does not affect a range of particle sizes in the composition” is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present.
Regarding claim 2, Schwarz teaches phosphatidyl serine as the surfactants [0062].
Regarding claim 3, Schwarz teaches a mixture of surfactants include phospholipids [0062]. Madwar teaches that the phospholipids include phosphatidylserine, phosphatidylethanolamine and phosphatidylcholine [0112]. Therefore, the surfactants comprise a single lecithin or multiple lecithins.
Regarding claim 6, the recited “the Vitamin E TPGS is derived from a sunflower source or soy source” is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only to the structure implied by the steps. If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the product was made by a different process. See MPEP 2113(1). The product obtained through this process is the Vitamin E TPGS. Since the prior art teaches the same Vitamin E TPGS, the product-by-process limitation does not gain further patentable weight.
Regarding claim 7, Schwarz teaches olive oil as stated above.
Regarding claim 8, Schwarz teaches biologically active components including cannabis extracts as stated above. Madwar teaches that the actives include cannabis extracts as well as Vitamin E [0036].
It would have been obvious to one of ordinary skill in the art at the time of filing to select Vitamin E as an active ingredient in Schwarz’s composition, as it is expressly disclosed as being useful in this capacity. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
Schwarz also teaches additives [0066].
Madwar teaches glycerine as a viscosity modifier to improve the emulsion stability [0105]. It would have been obvious to one of ordinary skill in the art at the time of filing to add glycerine in Schwarz’s composition as an additive to improve the emulsion stability.
Regarding claim 9, Schwarz teaches tocopherols as a solubilizer [0049].
Regarding claim 11, the recited “the composition is infinitely dilutable in water” is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz in view of Madwar as applied to claim 1 above, and further in view of Faraci et al (US 20200037638).
Regarding claim 10, Schwarz teaches preservative as stated above. Schwarz is silent about the specific preservative.
In the same field of endeavor, Faraci teaches cannabinoid emulsions [Abstract] used in beverages [0151] and [0154] which may include preservatives such as sorbic acid, potassium sorbate, and sodium benzoate [0186]. It would have been obvious to one of ordinary skill in the art at the time of filing to select sorbic acid, potassium sorbate, and sodium benzoate as the preservative in Schwarz’s composition, as it is expressly disclosed by the prior art as being suitable for preservative use in the same type of application. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762