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 .
Status of the Claims
Claims 1-18 are pending in a Response dated 03/03/2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Claim Rejections - 35 USC § 101
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.
Claims 1-18 are not eligible subject matter under 35 USC 101.
The claimed invention is directed to a composition comprising isolated cannabidiol or its analogue in certain amounts without significantly more. However, instant claim 1 merely covers a naturally occurring cannabidiol or its analogue that has been separated from the plant, without adding elements that change its nature or function such as markedly different characteristics and/or, structural changes. Thus, this judicial exception is not integrated into a practical application. Further, the claimed additional ingredients embraces naturally occurring products: carrier and diluent including water and/or oil, steroid such as cholesterol, antibiotics such as garlic, honey, ginger, etc., antiseptic/antiacne/antifungal such as tea tree oil and/or aloe vera, etc., humectant such as glycerin or honey, UV absorbing agent such as zinc oxide, analgesic agent such as turmeric or ginger. In addition, their amounts are nothing more than a mere field of use and varies depending on the used ingredients including active ingredient, carrier, excipient, and the type of disorder or disease for the treatment or prevention. As a result, the claimed invention does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
In light of the foregoing, instant claims 1-18 are not eligible subject matter without markedly different features.
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 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.
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.
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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6, 9, 10 and 13 are rejected under 35 USC 103 as being obvious over Gardner (WO2018/085794A1, of record in parent application no. 17/728522) as evidenced by Helfrich et al., “Overview of skin aging and photoaging”, Dermatology Nursing, June 2008, vol. 20/no. 3, pp. 177-183 (of record in parent application no. 17/728522) in view of Wurzer (US2014/0271940A1, IDS of 4/21/2023 in parent application no. 17/728522).
Applicant claims including the below claim 1 filed 03/03/2025:
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Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Gardner discloses a topical composition for preventing and treating skin conditions and/or enhancing the appearance of skin comprising cannabinoids and skin protecting/enhancing ingredients (abstract) wherein protecting skin conditions and/or appearance includes protecting skin from damage such as external damage, skin aging, redness, dry skin, photo-sensitiveness, etc. ([0006], [0033], [0036], [0087] and claim 23 of prior art) wherein the cannabinoid includes cannabidiol (CBD), THC, CBN, CBC, CBG, CBE, iso-THC, CBL, CBT and other cannabinoids isolated from the cannabis plant ([0009] and claim 5 of prior art) and thus the used cannabidiol is seen isolated, and improving skin appearance means improvement of skin appearance caused by harmful effects of UV radiation, environmental, etc. Please note that it is well known that UV radiation gives skin with aging, wrinkles and pigmentation as evidenced by Helfrich et al., that skin aging, changes in pigmentation, sallowness, and deep wrinkling are result of sun exposure; and wherein the cannabinoid includes isolated cannabidiol (CBD), CBG, CBN, THC, CBL … analogues (claim 5 of prior art) wherein CBD has the same structure of instant claim 10 and the cannabinoid is used in an amount of about 0.01 to 25% ([0021]) or greater than 25% if more than one cannabinoid is included and please note that the claimed cannabinoid is class of compounds as supported by the instant specification ([0002]) and the cannabinoid contains about 0.1 to about 25% or greater than 25% (See [0022] and Table 1) which overlaps the instant range of about 0.01 to about 75% and is within the claimed range of about 0.5 to about 25%, and further, one or more cannabinoid can be present and thus, if single cannabidiol is present in about 0.1 to about 25% of the composition, total cannabidiol is present in amount of 100% and the composition is topically applied (abstract). MPEP 2144.05 states that [I]n 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) (instant claim 1 (in part), and claims 2, 3, 6 and 10); the composition further comprises pharmaceutical carrier such as water or fatty acids, excipients, etc. ([0008] and [0056]) (instant claim 4); the composition further comprises UV stabilizer ([0051]-[0053]), sterol ([0056]) such as hydrocortisone and ketoconazole, humectant ([0060]), analgesics ([0064]), preservatives (=antiseptic) ([0063]), erythromycin which reads on the claimed antibiotics, benzoyl peroxide or zinc pyrithione which reads on the claimed anti-acne agent and ketoconazole which reads on the claimed antifungal agent ([0058]), etc. (instant claim 5); the composition is provided in the form of e.g., spray, lotion, cream, gel or emulsion ([0020]) which reads on the claimed formulation type (instant claim 9); the antiseptic (=preservative) is used in an amount of 1% ([0105]) which is within the claimed range of about 0.01 to about 5% (instant claim 13); and the at least skin protecting/enhancing agent is used in an amount of about 0.01 to about 50% or about 2 to about 18% ([0023]-[0024] and claim 14 of prior art).
However, Garner does not expressly teach isolated cannabidiol or its analogue having the claimed formula I structure of instant claims 1 and 10. The deficiency is cured by Wurzer.
Wurzer teaches a composition comprising concentrates obtained from extraction from Cannabis, preferably isolated cannabinoid for supporting healthy skin and reducing blemishes ([0045]-[0046] and [0056]); the concentrates comprises a total cannabinoid fraction of from about 45% to 98% of the total cannabinoid concentrates ([0016]) which overlaps the instant range of about 90 to about 100% of total cannabinoids. MPEP 2144.05 states that [I]n 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). (instant claim 1– total cannabinoid amount); and the cannabinoid includes cannabidiol (CBD), its derivatives ([0013]) and CBD has the following structural formula found in [0049], CBD-C5, CBDM (cannabidiol monomethyl ether-C5), CBD-C4, CBDV (cannabidivarin)-C3, CBDA (cannabidiolic acid)-C5, CBDVA (cannabidivarinic acid)-C3, all of these compounds are within the scope of claimed formula I(instant claim 10).
It would be obvious to provide higher amounts of isolated cannabinoid or its analogue of Wurzer to the composition of Garner to enhance intended efficacy for e.g., improving or lightening skin tone because isolated cannabinoid or its analogue has highest purity without any other cannabinoids. Further, it would be obvious to further define cannabidiol or its analogue of Garner with specific structural formula of Wurzer and such definition would have yielded no more than the predictable results.
In light of the foregoing, instant claims 1-6, 9, 10 and 13 are obvious over Gardner in view of Wurzer.
Claims 7-8, 11, 12 and 14-18 are rejected under 35 USC 103 as being obvious over Gardner as evidenced by Helfrich et al., in view of Wurzer and further in view of Sekura et al. (US2015/0086494A1, IDS of 04/21/2023 in parent application no. 17/728522).
Although Gardner in view of Wurzer discloses topical emulsion/cream, Gardner did not expressly teach oil and water in approximately equal proportions of instant claim 7; oil-in-water cream or water-in-oil cream of instant claim 8. Further, Gardner teaches skin protecting/enhancing agents can be present in an amount of about 0.01 to 18% ([0023]-[0024]), and however, Gardner does not expressly teach the amounts of additional ingredients of claims 11-18. The deficiencies are cured by Sekura.
Sekura teaches a method of treating dermatological diseases comprising administering composition e.g., anti-acne agent which relates to skin by reducing redness ([0020]) by topically applying a composition comprising a cannabinoid, cannabidiol, cannabinoid analogues (abstract and claims 1 and 23 of prior art) and other ingredients including steroid ([0016]), antibiotic ([0017]), antiseptic ([0018]), antifungal ([0019]), anti-acne agent ([0020]), humectant ([0076]), UV-absorbing compound ([0022]), tocopherol antioxidants, methyl salicylate having analgesic properties and anti-inflammatory properties, beta-sitosterol having antiviral, antifungal, and anti-inflammatory properties ([0023] and [0045]),; and the topical composition is provided in W/O or O/W emulsion where the emulsion has oil and water in approximately equal proportions ([0081]) which could imply semi-solid emulsion in the absence of evidence to the contrary (instant claims 7 and 8); the steroid is used in an amount of 0.01 to 5% ([0071]) which is identical to the claimed range (instant claim 11); the antibiotic is used in an amount of 0.01 to 5% ([0072]) which is identical to the claimed range (instant claim 12); the antiseptic is used in an amount of 0.01 to 5% ([0073]) that is identical to the claimed range; the antifungal agent is used in an amount of0.01 to 5% ([0074]) that is identical to the claimed range (instant claim 14); the anti-acne agent is used in an amount of 0.01 to 5% ([0075]) that is identical to the claimed range (instant claim 15); the humectant agent is used in an amount of 0.01 to 5% ([0076]) that is identical to the claimed range (instant claim 16); the UV-absorbing agent is used in an amount of 0.01 to 5% ([0077]) that is identical to the claimed range (instant claim 17); and the analgesic agent is used in an amount of0.01 to 5% ([0078]) that is identical to the claimed range (instant claim 18).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to optimize the proportions of water and oil in W/O or O/W emulsion depending on the intended purpose, formulation type, etc., as taught by Sekura, devoid of criticality evidence.
Sekura teaches all the additional ingredients and same amounts as claimed. Thus, adding such ingredients with identical amounts to the composition of Gardner/Wurzer would have yielded no more than the predictable results of enhancing properties of the composition.
In light of the foregoing, claims 7, 8, 11, 12 and 14-18 are obvious over Gardner in view of Wurzer and further in view of Sekura.
Consequently, the Examiner concludes 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 references, 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 references, especially in the absence of evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of patent No. 11,337,905B2.
Although the claims at issue are not identical (instant composition vs. method of use of patent ‘905), they are not patentably distinct from each other because both claim sets require the same composition comprising same CBD or its analog ingredient and amount thereof. That is, patent ‘905 requires about 0.5 to about 25% Cannabis plant-isolated cannabidiol or its analog based on the total weight of the composition, and the isolated cannabidiol or cannabidiol analog is present in an amount of about 90 w/v% to about 100w/v% of the total cannabinoids in the composition. The difference between them is that patent ‘905 requires about 0.5-25% CBD based on the total weight of the composition, and about 90-100% CBD based on the total cannabinoid in the composition, and the instant claim requires overlapping amounts about 0.01-75% and about 80-about 100%. However, since the ranges of patent ‘905 overlap the instant ranges. MPEP 2144.05: “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).”
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter,
Conclusion
All claims examined are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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