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. DETAILED ACTION Status of Claims Claims 54-73 are pending. Election /Restrictions Applicants’ election of Group I, in the reply filed on 3 /2/20 26 is acknowledged. The election was made without traverse. Accordingly, c laims 69-73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 54-68 are under examination in the instant office action. Claim Ob jections Claims 54-68 are objected to because of the following informalities: typographical errors. It is advised to amend “Composition” in line 1 of claim 54 to -- A composition-- and “ Composition” in line 1 of claims 55-68 to -- The composition--. In claim 58, the word, “is”, is missing after “ratio” in line 1. In claim s 60 -62 , the acronym, “CB” in line 2 of claims 60 and 62 and line 3 of claim 61 , appears to be misspelled (see claim 59) . It should be corrected to -- CBL--. In claim 66, “%” is missing before “(w/w)” in line 2. In claim 67, closing parenthesi s , “)” is missing after “(CAS no. 8000-28-0” in line 6 . Also, the comma (,) before “including any combination(s)” in line 9 and “LLL” before “7-19% LLL ” in line 14 should be deleted. In addition, a full name of “VOC-CH should be given for clarification. In claim 68, “CO2” in the recitation of “critical CO2 extraction” in line 5, should corrected to be --CO 2 --. Claim Rejections - 35 USC § 112 (d) 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 35 U.S.C. 112 (pre-AIA), fourth paragraph: Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA)], 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. Claim 5 8 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA), 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 5 8 recites “ the CBN:CBD ratio is in the range of 5:1 to 1:1 , 4:1 to 1:1 , 3:1 to 1:1 , 2.5:1 to 1:1 , or around 2:1 ”. Thus, the range includes the ratio of 1:1, which is not greater than 1. However, claim 57 from which claim 5 8 is dependent recites that “the CBN:CBD ratio by weight is greater than 1 ”. As such, claim 58 fails to further limit the subject matter of claim 57 . Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements. 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 of this title, 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. 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. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 . Claims 54-6 7 are rejected under 35 U.S.C. 103 as being unpatentable over US 202 2/0401378 (hereafter, PERSAUD ) in view of US2021/0145910 (her e after, GORDON ) . PERSAUD teaches compositions comprising at least one purified cannabinoid or a derivative thereof, at least one functional fragrance , and at least one vitamin for improving sleep or treating insomnia and/or related sleep disorders , wherein the at least one purified cannabinoid is CBD , the functional fragrance is lavender oil , and the vitamin is vitamin E i n some embodiments (abstract , [0062], [0073] , [0114], and, claim 3 ) . PERSAUD further teaches that the composition comprise s CBD or a derivative thereof in an amount of about 1 wt %, about 2 wt %, about 3 wt %, about 5 wt %, about 6 wt %, about 7 wt %, about 8 wt %, about 9 wt % or about 10 wt % of the total weight of the composition ([0056]). The percentage range of CBD falls within or overlaps those claimed. PERSAUD further teaches that the functional fragrance useful in the compositions comprises between about 0.005 wt % and about 25 wt % lavender oil, or between about 0.01 wt % and about 10 wt % lavender oil, or between about 0.025 wt % and about 5 wt % lavender oil, or between about 0.3 wt % and about 5 wt % lavender oil, or between about 1 wt % and about 10 wt % lavender oil ([0074]). The percentage range of lavender oil falls within or overlaps those claimed. Lavender oil is an essential oil obtained by distillation from the flower spikes of certain species of lavender. Lavender oil has long been used as a perfume, for aromatherapy, and for skin applications for its relaxation, calming, anxiolytic, soothing and sedative effects ([0073]). PERSAUD further teaches that v itamins may be present in the compositions of the present disclosure in an amount ranging from between about 0.001 wt % and about 2 wt %, or between about 0.01 wt % and about 1 wt %, or between about 0.05 wt % and about 2 wt %, or between about 0.05 wt % and about 1 wt % and specifically discloses a composition comprising 0.01-1 wt % tocopherol ([0114] and [0194]) . The percentage range of the vitamin falls within or overlaps those claimed PERSAUD also teaches that t he compositions further comprise a carrier oil for protect ing from chemical degradation during storage and distribution, and/or increas ing bioavailability following application , which include hemp oil and sesame oil ( [0121], and [0122]) . T he weight ratio of the cannabinoid to carrier oil is about 5:1 or about 1:5 or the weight ratio of cannabinoid to carrier oil is about 1:1 ([0123]) . PERSAUD also teaches that t he compositions of the present technology may comprise an emollient such as sesame oil ([0119]). PERSAUD teaches that the compositions are suitable for nasal administration and compositions that are nasally administrable include spray s (nasal spray) ([0128] , [0148] , [0156], and claim 32-33 ). Also, PERSAUD teaches that the compositions comprise one or more of: CBD, THC, CBG, CBN , CBC, THCV, CBGA, CGCA, CBCA, THCA and CBDA ([0053]) . In addition, PERSAUD teaches that the expression “cannabinoid concentrate” includes one or more of cannabinoid distillate and cannabinoid isolate (e.g., crystalline CBD) ([0045]) . While PERSAUD teaches and suggests all the claimed components (i.e., hemp oil, CBD, CBN, lavender oil, sesame oil, and vitamin E), PERSAUD does not specifically discloses a specific embodiment comprising all the components. GORDON teaches a pharmaceutical composition comprising a Cannabis extract comprising Δ9-Tetrahydrocannabinol (THC), Cannabidiol (CBD), and Cannabinol (CBN) a nd optionally one or more pharmaceutically acceptable carriers, diluents, adjuvants, excipients or any combination thereof for treating sleep disorder (abstract). GORDON further teaches that t he ratio by weight of CBN:CBD may be from about 1:1 to about 10:1, for example from about 1:1 to about 5:1, about 1.5:1 to about 3:1 or about 2:1 ([0035]) . GORDON also teaches that liquid form preparations can be prepared by combining the Cannabis extract with one or more oils such as sesame oil , lavender, Lavender essential oil, Lavender Spike essential oil , and hemp oil ([0074]). The specific combination of features claimed is disclosed within the broad genera of taught by PERSAUD , but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec. , 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of variables, anticipation cannot be found. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex , 127 S.Ct . 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro , 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” ( Id. ). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex , 127 S.Ct . 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected hemp oil and sesame oil as carrier oil / emollient for preparing a liquid composition to arrive at compositions “yielding no more than one would expect from such an arrangement”. As stated above, PERSAUD already teaches and suggests a specific combination comprising CBD, lavender oil, and vitamin such as vitamin E and the use of hemp oil and sesame oil as suitable carrier oil/emollient for protecting from chemical degradation during storage and distribution, and/or increasing bioavailability following application . In addition, it was well known in the art to use hemp oil and sesame oil as carrier oil for a composition comprising CBD in the treatment of sleep as evidenced by GORDON. Thus, one of ordinary skill in the art would have been motivated to use hemp oil and sesame oil as carrier oil/ emollient for preparing a liquid composition comprising CBD since such combination has been suggested by prior art and the skilled artisan would have reasonably expected that they would work as suitable oil carriers for the CBD composition . As to the specific concentration range of the ingredients, the prior art teaches the range s of active ingredients such as CBD, lavender oil, and vitamin such as vitamin E, which fall within or overlap those 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. In re Wertheim , 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) . Also, it would have been obvious to make up the remaining percentages of the composition with carriers and other additives such as hemp oil and sesame oil . 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. “[W]here 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.” In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele , 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.) . See MPEP 2144.05 IIA. As to the ratio of CBN and CBD, PERSAUD already teaches the composition further comprising additional cannabinoid including CBD in addition to CBD. Also, Gordon teaches the combination of CBN and CBD in the treatment of sleep disorder and the ratio of CBN and CBD , which overlap those claimed. Thus, it would have been prima facie obvious to optimize the ratio of CBN and CBD for obtaining the best results of combinational use. The skilled artisan would have been capable of arriving at the claimed ratio through routine optimization based on the ratio disclosed in GORDON. As to claims 60-63, PERSAUD teaches that i n some implementations of these embodiments, the compositions may comprise a predominant cannabinoid and minimal or trace amounts of other cannabinoids ([0054]) For example, the composition of the present technology may comprise CBD as a predominant cannabinoid and trace amounts or minimal amounts of THC ([0054]). Thus, it would have been obvious to prepare a composition comprising no additional cannabinoids other than CBD or minimal or trace amounts of those cannabinoids as PERSAUD teaches and suggests. As to claim 65 and 66, they recite less than 0.1 % (w/v) sodium chloride and less than 1.0% (w/w) water, which encompass 0% or a negligible amount. The composition of the prior art does not require the presence of sodium chloride and water, thus meet the limitations. As to claim 67, the claims further recite characteristics of hemp oil, lavender oil and sesame oil . The prior art is silent about those characteristics. However, hemp oil, lavender oil and sesame oil taught by the prior art appear to be the same and have the same use as claimed . Thus, they necessarily have the same characteristics. Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]." Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over US2022 / 0401 3 78 (hereafter, PERSAUD ) in view of US2021/0145910 (hereafter, GORDON ) in further view of US2020/0078427 (hereafter, Rhodes ) . The teachings of PERSAUD and GORDON as applied supra are herein applied for the same teachings in their entirety. PERSAUD does not specifically teaches the use of CBD in a specific crystalline form such as needle-like crystals recited in claim 68. However, it was known in the art that CBD extracts can be used in a liquid, oil or crystalline form and s olvent-free CBD can be derived from cannabis or hemp plant parts by a super-critical CO 2 extraction process as evidenced by Rhodes ([0025]) . Rhodes further teaches that the s upercritical CO 2 extraction process yields an extract with greater than 99% purity that is free of solvent residues and e xtracts produced by CO 2 extraction are a white needle-like crystalline ([0027]). I t would have been prima facie obvious to use the CBD needle-like crystal of Rhodes for preparing ph armaceutical composition of PERSAUD because PERSAUD already teach and suggest the use of purified CBD such as crystalline CBD and the needle-like CBD crystal of Rhodes is taught to have a purity greater than 99% that is free of solvent residues . The skilled artisan would have been motivated to do so because it is common technical knowledge in the art of pharmaceutical formulation that various components to be formulated should preferably be as pure as possible for principal drug stability and reducing irritability or other side effects which may be caused by impurities. A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. ( In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, it is concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the reference s , it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the reference, especially in the absence of evidence to the contrary. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /BONG-SOOK BAEK/ Primary Examiner, Art Unit 1611