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 .
This office action is in response to the amendment filed May 4th, 2026.
Claim 7 is pending and was examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objections or rejections not reiterated below are hereby withdrawn.
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.
Drawings
The drawings were received on March 4th, 2024. These drawings are acceptable.
Withdrawal of Objection and Rejections
Applicant’s arguments filed May 4th, 2026, with respect to the objection to the instant specification regarding a lack of commas between the terms dibutylhydroxytoluene (BHT), hexane, and ethyl acetate have been fully considered and are persuasive. The objection to specification regarding a lack of commas between the terms dibutylhydroxytoluene (BHT), hexane, and ethyl acetate has been withdrawn.
Applicant’s arguments, filed May 4th, 2026, with respect to the objection to claim 7 have been fully considered and are persuasive. The objection to claim 7 has been withdrawn. The applicant has amended claim 7 to add commas separating the terms dibutylhydroxytoluene (BHT), hexane, and ethyl acetate.
Applicant’s arguments, filed May 4th, 2026, with respect to the rejection of claim 7 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 7 under 35 U.S.C. 112(b) has been withdrawn. The applicant has amended claim 7 to recite recited the removal of the extraction solvent comprising ethyl acetate. The applicant has defined the steps to obtain the supernatant. The applicant concludes claim 7 with “to obtain the hemp seed unsaponifiable extract” defining the end result of the steps recited in claim 7.
Pending Objections and Rejections
Specification
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/Control Number: 18/594,709 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.
Generic terminology is missing for at least the following terms: DMEM, BCS, Dex, and IBMX.
The applicant is notified that the supplied copies of the instant specification lack paragraph numbers, even though paragraph numbers are referenced in the supplied document reciting amendments to the specification.
The disclosure is objected to because of the following informalities: it is unclear what two compounds are referred to in the ratio "85:15", recited in amended paragraph [0061]. It appears the applicant has a typographical error for not referring to 0.01% dibutylhydroxytoluene.
Appropriate correction is required.
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)
Applicant's arguments filed on May 4th, 2026 have been fully considered but they are not persuasive. The response to the applicant's arguments is recited below.
Upon further consideration, the use of a mixture comprising hexane and ethyl acetate (instant claim 7) instead of diethyl ether (Montserrat-de la Paz, Materials and Methods, Unsaponifiable Extraction) as an extraction solvent merely substitutes one amphiphilic solvent for another, with the predictable result of extracting amphiphilic compounds in both cases. Furthermore, one of skill in the art would have been motivated to combine a non-polar compound (hexane) and a polar compound (ethyl acetate) to adjust the polarity of the extraction solvent by adjusting the ratio of these two constituent compounds, over the course of routine optimization. One of skill in the art would have a reasonable expectation of success at adjusting these proportions by measuring the volumes of the constituent compounds using volumetric glassware, before combining them. One of skill in the art would have had a reasonable expectation of success at the routine optimization of solvent constituent proportions as further detailed below.
Instant claim 7 is distinguished from the cited references, as the cited references do not explicitly recite 0.01% (w/v) BHT, hexane, and ethyl acetate wherein the hexane and ethyl acetate are mixed in a volume ratio of 85:15. Instant claim 7 is distinguished from the cited references, as the cited references do not explicitly recite a water bath temperature of 75 °C. Instant claim 7 is distinguished from the cited references, as the cited references do not explicitly recite adding a 6% w/v pyrogallol solution and a 6% w/v potassium hydroxide solution to hemp seed (instant claim 7, step 1). Instant claim 7 is distinguished from the cited references, as the cited references do not explicitly recite adding a 2% w/v sodium chloride solution to the cooled product. However, these parameters are obvious to one of skill in the art over routine optimization. Volume ratios are adjustable through the use of volumetric glassware. Weight/volume percentages are adjustable through the use a scale instrument to measure the weight of the solute (or a balance, if weight is understood interchangeably with mass) and volumetric glassware to measure the volume of the solution. The temperature of a water bath is adjustable using a hotplate and a thermometer. One of skill in the art could have adjusted these parameters, producing different compositions. One of skill in the art could have compared the anti-obesity activities of these compositions by orally or intravenously administering the compositions to obese subject organisms periodically, and periodically measuring the body weights of the organisms before each administration of the composition. Therefore, the parameters recited above and in instant claim 7 would be obvious to one of skill in the art over routine optimization.
Dibutylhydroxytoluene (BHT) was known in the art as an antioxidant (Shibamoto, Background/Summary, paragraph [0032]), its antioxidant property makes it applicable to the instantly claimed extraction to avoid the chemical degradation of bioactive compounds, and adding dibutylhydroxytoluene would have yielded the predictable result of a composition in which the bioactive components extracted from hemp seed (claim 7, step 1) are less oxidized, and the extraction solvent, otherwise composed of hexane and ethyl acetate, is still amphiphilic.
Instant claim 7 is distinguished from the cited references in that the cited references do not describe using the techniques of concentrating under reduced pressure and freeze-drying to obtain a hemp seed unsaponifiable extract. However, both concentrating under reduced pressure and freeze-drying are known in the art as solvent removal techniques, and one of skill in the art would have been motivated to use either or both of these techniques to decrease the mass and volume of the extract for easier storage and transportation. One of skill in the art would have a reasonable expectation of success of concentrating an extract under reduced pressure by temporary enclosing the extract in vacuum chamber and one of skill in the art would have had a reasonable expectation of success at freeze drying the extract by using a lyophilizer instrument.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the rejection of instant claim 7 under 35 U.S.C 103 is based on knowledge within the level of ordinary skill in the art before the effective filing date of the claimed invention, relying on the cited references and general knowledge of one of skill in the art before the effective filing date of the claimed invention.
In response to applicant's argument that Asahina, Tuinstra, Shibamoto, and Yu are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Asahina is relevant to performing saponification reactions while avoiding oxidative damage to chemical components of the reaction mixture; Tuinstra is relevant to adjusting the temperature of a saponification reaction; Yu is relevant to the anti-adipogenic activity of β-sitosterol, a component of the hempseed oil unsaponifiable fraction as disclosed by Monserrat-de la Paz (Table 2); Shibamoto is relevant to protecting chemical compositions from oxidative damage. Therefore, these references are all relevant to the problem of preparing an anti-obesity hemp seed unsaponifiable extract.
In response to applicant's arguments against the references individually, when reciting that when reciting that none of the cited references disclose or suggest that hemp seed unsaponifiable extract prepared by the claimed method - as a whole - exhibits any anti-obesity activity, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s arguments rely on language solely recited in preamble recitations in claim 7 when reciting that none of the cited references disclose or suggest that . When reading the preamble in the context of the entire claim, the recitation of anti-obesity activity is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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