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 .
Election/Restrictions
Applicant’s election without traverse of Group III, the subject matter of claim 7, in the reply filed on January 29th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election requirement is still deemed proper for the reasons of record and is therefore made FINAL.
Claims 1-7 are pending of which Claims 1-6 (Groups I and II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to (a) nonelected invention(s), there being no allowable generic or linking claim.
Pending claim 7 has been examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on May 20th, 2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date is September 6th, 2023.
Information Disclosure Statement
The information disclosure statement filed March 4th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the English translated portion of the document cited (KR-10-2305606-B1) has illegibility caused by text cut off on the right margin of the document and inadequate scanning resolution. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
A copy of KR-10-2305606-B1 has been provided by the examiner and cited on the PTO-892 form.
Drawings
The drawings were received on March 4th, 2024. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities: "dibutylhydroxytoluene (BHT) hexane and ethyl acetate" should be changed to "dibutylhydroxytoluene (BHT), hexane, and ethyl acetate", especially to distinguish that dibutylhydroxytoluene (BHT) and hexane are separate chemical species, not different parts of a single name of a single chemical species.
Appropriate correction is suggested.
The use of the terms Merck; JASCO; Vydac; Varian; Supelco; ATCC; Research Diets, Inc.; DMEM; BCS; Dex; and IBMX; which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 7 is objected to because of the following informalities: commas should be used to separate the members of the list of solvents in claim 7 step 3, as follows: dibutylhydroxytoluene (BHT), hexane, and ethyl acetate. Appropriate correction is suggested.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The terms “pyrogallol” (step 1), “potassium hydroxide” (step 1), and “sodium chloride” (step 3), are read as encompassing solutions of these compounds (instant specification, Example 1). The term “reaction” recited in claim 7 is understood as encompassing a saponification reaction (instant specification, Example 1).
Claim Rejections - 35 USC § 112
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.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the concentration of under reduced pressure to remove solvent comprising ethyl acetate (instant specification Example 1). Without this concentration step, ethyl acetate remains a component of the final extract composition. Ethyl acetate is broadly understood in the art as a saponifiable compound. Therefore, omitting the step of removing ethyl acetate would render the extract at least partly saponifiable, contradicting the preamble of claim 7, which describes the extract as unsaponifiable.
Claim 7 step 3 ends with the production of a supernatant, but it is unclear whether this supernatant is the extract recited in the preamble of claim 7. It is suggested to end the claim with obtaining a hemp seed unsaponifiable extract.
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 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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Montserrat-de la Paz et al. (Journal of Agricultural and Food Chemistry 2014, 62 (5), 1105–1110) and further in view of Yu et al. (Steroids 2018, 140, 196-201), Asahina et al. (US 4013731 A), Tuinstra et al. (US 20120107380 A1), Shibamoto et al. (US 20220387298 A1) .
Claim 7 recites “A method of preparing a hemp seed unsaponifiable extract having an anti-obesity activity, the method comprising: (1) adding a hemp seed, pyrogallol, and potassium hydroxide (KOH) to a reaction vessel and filling the reaction vessel with nitrogen; (2) causing a reaction in a water bath at a temperature in a range of 70°C to 80°C for 40 to 60 minutes and then cooling the resulting product; and (3) adding sodium chloride (NaCl) and an extraction solvent in which dibutylhydroxytoluene (BHT) hexane and ethyl acetate are mixed to the cooled product and shaking the resulting mixture to obtain a supernatant”. The terms “pyrogallol” (step 1), “potassium hydroxide” (step 1), and “sodium chloride” (step 3), are read as encompassing solutions of these compounds (instant specification, Example 1). The term “reaction” recited in claim 7 is understood as encompassing a saponification reaction (instant specification, Example 1).
Montserrat-de la Paz et al. uses the abbreviation “HSO” to refer to hempseed oil from Cannabis sativa (Introduction paragraphs 1 and 2) and recites the following “Sterols were isolated from the HSO [Hempseed oil; Introduction paragraph 2] unsaponifiable matter and represented a 15.18% from this fraction. The identification of the different phytosterols has been made by gas chromatography (GC) and GC–MS comparing their relative retention time (RRt) values and their MS fragments to literature values. Chromatographic analyses are shown in Figure 1 and Table 2. β-Sitosterol (1905.07 ± 59.27 mg/kg of oil) and campesterol (505.69 ± 32.04 mg/kg of oil) were predominant in the phytosterol fraction (2793.73 ± 124.32 mg/kg of oil)” (Results and Discussion, paragraph 4). At least one of the unsaponifiable compounds in hempseed oil, β-sitosterol, has been shown to inhibit cellular adipogenesis, as recited by Yu et al., where “Sit” is an abbreviation for β-sitosterol (Introduction , paragraph 1): “The inhibitory effects of these drugs on intracellular lipid accumulation in 3T3-L1 adipocytes are presented in Fig. 6. The oil contents of both Sit- and Sit-HP-β-CD complex-treated cells decreased when the dose concentration was increased, indicating that both Sit and Sit-HP-β CD complex caused the inhibition of adipogenesis” (Yu et al., subheading 3.5, paragraph 2). Yu et al. also recites “β-Sitosterol (Sit) has been used as a functional food additive. Among its many beneficial effects, this phytosterol plays a role in controlling obesity by inhibiting the adipogenesis process of pre-adipocytes” (Abstract). From Montserrat-de la Paz et al. and Yu et al., β-sitosterol is both a component of the unsaponifiable matter of hemp (Cannabis sativa) seed oil and participates in controlling obesity through its anti-adipogenic activity. Therefore, one of skill in the art would have been motivated to prepare a hemp seed unsaponifiable extract having an anti-obesity activity (instant claim 7).
Montserrat-de la Paz et al. recites a process of unsaponifiable extraction comprising the following steps: hempseed oil was combined with potassium hydroxide in ethanol/water (80:20, v/v) (Materials and Methods, Unsaponifiable Extraction; instant claim 7, step 1). The mixture was boiled and stirred for 1 hour (saponification), then cooled (Montserrat-de la Paz et al., Materials and Methods, Unsaponifiable Extraction; instant claim 7, step 2). The cooled mixture and combined with distilled water, then extracted with diethyl ether (Montserrat-de la Paz et al., Materials and Methods, Unsaponifiable Extraction; instant claim 7, step 3).
Although Montserrat-de la Paz et al. recites using hempseed oil, not hemp seed, as a starting material for an unsaponifiable extraction, hemp seed and hempseed oil are overlapping with hempseed materially encompassing hempseed oil. As presented above, β-sitosterol has been isolated from hempseed oil and participates in controlling obesity through its anti-adipogenic activity. Therefore, it would have been obvious to one of skill in the art to try using hemp seed as an alternative starting material to hempseed oil in the instantly claimed preparation of an unsaponifiable extract having anti-obesity activity (instant claim 7).
Although the use of pyrogallol with potassium hydroxide is not recited by Montserrat-de la Paz et al., Asahina et al. recites adding pyrogallol to the mixture containing fatty matter in a saponification reaction using an alkali such as potassium hydroxide (Background/Summary, paragraph (10); instant claim 7 step 1). Asahina et al. recites the purpose of adding the pyrogallol is to prevent oxidation of solanesol during saponification (Background/Summary, paragraph (10)). Therefore, it would have been obvious to one of skill in the art to add pyrogallol to avoid the oxidation of compounds in the reaction mixture (instant claim 7 step 1). It would have also been obvious to one of skill in the art to perform the reaction under a nitrogen atmosphere to exclude oxygen gas from the reaction vessel, helping to avoid the oxidation of organic compounds in the reaction mixture (instant claim 7 step 1). Tuinstra et al. recites heating a saponification reaction mixture to 60-70 °C and maintaining the mixture under nitrogen (Background/Summary, paragraph [0033]; instant claim 7 steps 1 and 2).
Although performing a reaction in a water bath is not explicitly recited by Montserrat-de la Paz et al., Tuinstra et al. recites using a water bath for regulating the temperature of the contents inside a reaction vessel (paragraph [0059]), where a water bath is broadly understood as an apparatus comprising water that surrounds an object, in this case a reaction vessel. Therefore, it would have been obvious to one of skill in the art to place a reaction vessel in water bath for temperature regulation (instant claim 7, step 2).
Regarding the solvent of the reaction (instant claim 7 steps 1 and 2); the “pyrogallol” and “potassium hydroxide” in instant claim 7 are read as encompassing solutions of these compounds in which the solvent is not explicitly defined (instant specification, example 1). Therefore, the ethanol/water mixture recited by Montserrat-de la Paz et al. (Materials and Methods, Unsaponifiable Extraction), is understood by the Examiner as a possible solvent for the reaction of instant claim 7.
Montserrat-de la Paz et al. does not explicitly recite combining aqueous sodium chloride (instant claim 7, step 3) with the post-saponification mixture with, instead reciting water. However, both water and aqueous sodium chloride are polar solvents able to dissolve polar and ionic species. Adding aqueous sodium chloride would provide dissolved ions able to electrostatically pair with polar and ionic chemical species in the post-saponification mixture. Therefore, adding aqueous sodium chloride, instead of water, would be obvious to try to optimize the separation of chemical species based on their polarity or ionic character (instant claim 7, step 3).
Montserrat-de la Paz et al. does not explicitly recite using a combination of dibutylhydroxytoluene, hexane, and ethyl acetate as a post-saponification extraction solvent (instant claim 7, step 3), instead reciting a single amphiphilic solvent species: diethyl ether. However, based on their chemical structures, one of skill in the art would recognize that dibutylhydroxytoluene, hexane, and ethyl acetate would combine to also produce a solvent with amphiphilic character. Dibutylhydroxytoluene is an antioxidant (Shibamoto et al., Background/Summary, paragraph [0032]), and therefore has utility for avoiding free radical damage to chemicals in the extract. Therefore, it would be obvious to one of skill in the art to try a combination of dibutylhydroxytoluene, hexane, and ethyl acetate as extraction solvent applied to a post-saponification mixture (instant claim 7, step 3).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655