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 .
Priority
This application filed on 04/21/2023 is a Continuation of International Application No. PCT/US22/72831, filed on 06/08/2022.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/23/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
The Amendments and Applicant’s Arguments submitted on 02/04/2026 have been received and
have been carefully considered. Claim 1-5, 7-8, 10-13, 23-25 and 27 were cancelled, claims 6, 9, and 14-20 were previously cancelled, and claims 30-34 were added.
Claims 21-22, 26, and 28-34 are pending.
Withdrawn claim Rejections 35 U.S.C. 112(b)
Rejection to claim 26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to recite the units of measurement for the total concentration, is withdrawn in view of Applicant amendment filed on 02/04/2026 that amended claim 26 with “within a range of 9 µM to 11 µM.
Rejection Maintained/slightly Modified in view of the Amendment
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.
§ 103 Rejection over Persaud in view of Biro
Claims 21-22, 26, and 28-34 are rejected under 35 U.S.C. 103 as being unpatentable over A. Persaud (WO 2021/224693 A1, 11/11/2021, “Persaud” cited in the PTO-892 dated 11/14/2025) in view of T. Biro et al. (US Pg-Pub 2018/0263952 A1, 09/202018, “Biro” cited in the PTO-892 dated 11/14/2025) and J. Siurkus (US PG-PUB 2019/0167749 A1, 06/06/2019, “Siurkus” cited in the IDS dated 07/23/2023).
Persaud teaches a composition for treating inflammatory skin conditions comprising cannabinoid compounds and at least one cosmetic active ingredient. [0007]. Persaud teaches that the cannabinoid is selected from one or more of Cannabigerol-type (CBG), Cannabichromene-type (CBC), Cannabidiol-type (CBD), etc. [0046], particularly, the compositions of the present technology comprise one or more of: CBD, THC, CBG, CBN, CBC, THCV, CBGA, CGCA, CBCA, THCA and CBDA. [0047]. Persaud teaches that the cosmetic active ingredient is one or more of alpha hydroxy acid (AHA), Bakuchiol, Hydroxypinacolone Retinoate (HPR), or a combination thereof. [0009].
Persaud teaches that the active cosmetic ingredient useful in the compositions of the present technology is bakuchiol, an antioxidant, anti-inflammatory and anti-bacterial. “bakuchiol comparable with retinol clinically in its ability to improve photo-aging (wrinkles, hyperpigmentation).” Persaud explicitly teaches that “in some such embodiments, the composition of the present technology thus comprises CBD or a derivative thereof; and bakuchiol or a derivative thereof.” [0075]. Persaud teaches that the weight ratio of cannabinoid to the cosmetic active i.e., Bakuchiol, is 1:1, 1:2 etc. [0120].
Persaud teaches a combination of cannabinoid and cosmetic active ingredient (cannabis-infused cosmetic), wherein the combination treats skin inflammatory conditions and improve skin appearance. [0005], [0006]. Persaud teaches that the combination containing a predetermined quantity of active material (e.g., cannabinoid, active cosmetic ingredient) calculated to produce the desired therapeutic or cosmetic effect. [0199]. Persaud teaches that Test Composition C of CBD and BAK resulted in treating skin conditions and improve skin appearance. [0220], [0221], [0222]. Persaud teaches that combining CBD with active with active cosmetic ingredient e.g., BAK provides beneficial therapeutic and cosmetic effects. [0006]. Thus, Persaud implicitly teaches the synergistic and/or additive effects of the cannabinoids and Bakuchiol.
Persaud teaches an exemplary composition, Test Composition C:
The composition may include between about 0.5-10 wt.% CBD; 0.5-15 wt.% bakuchiol; about 10-40 wt.% caprylic/capric triglyceride; about 0.01-2 wt.% tocopherol; about 0.1-5 wt.% squalane; one or more essential oil; linalool; limonene; and geraniol; mixed with other suitable active cosmetic ingredients and non-medicinal cosmetic ingredients and aqua (water), as appropriate for the intended purpose i.e., a cream or a serum for use in skin care. [0210].
Persaud’s composition differs from instant claim 1 composition in that one of ordinary skill in the art would need to select CBG from the cannabinoid list and added to the above Test Composition C.
However, Biro and Siurkus provide one of ordinary skill in the art with the motivation to include CBG in Persaud’s composition.
Biro teaches the use of cannabinoids selected from cannabidiol (CBD), cannabidivarin (CBDV), cannabigerol (CBG), and tetrahydrocannabivarin (THCV) for the treatment inflammatory skin disease. [Abstract]. Biro teaches that most preferably the cannabinoid is cannabidiol acid (CBDA) or cannabigerol (CBG). [0043]. Biro teaches that administration of CBD, CBDA, and CBG resulted in a dose-dependent suppression of the elevated release of both IL6 and IL8. [0106]. Biro teaches that CBG is the only at given (mostly lower) concentrations, could significantly suppress the UVB-upregulated expressions of the cytokines. [0133]. Biro teaches in the conclusion of the studies: CBDA and CBG might be most effective at the reduction of inflammation in microbial infection-induced dermatitis, inflammation caused by UV light, and the most effective in the reduction of inflammation caused by SEB/TSLP. [0140], [0143] and [0145].
Siurkus teaches a topical composition comprising essential combination of synergistically acting Cannabidiol (CBD), Cannabidiolic acid (CBDA), Cannabivarin (CBV), and Cannabigerol (CBG), [0003], wherein the synergistic effect of the cannabinoids results in treating inflammation. [0018]. Based on Siurkus, the synergistic effect of cannabinoid mixture (i.e., CBD, CBG, CBC, CBN) is known in the art. [0012]. Siurkus teaches that the ratio between cannabinoids is not described as an essential to have a synergetic anti-inflammatory effect. [0015]. Siurkus describes that the synergistic anti-inflammation effect to the cannabinoid mixture resulted from selectivity of the cannabinoid toward specific target. [0007].
Therefore, one of ordinary skill in the art would have been motivated by Biro’s teachings to select CBG form Persaud’s list of cannabinoids and include it in the composition of CBD and PAK. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Persaud teaches a composition comprising CBD and BAK for treating skin inflammation and teaches that the composition can include CBG or other cannabinoids, and Biro teaches a composition for treating skin inflammation comprising CBD and CBG and teaches that CBG is the most effective cannabinoid in suppressing the UVB-upregulated expressions of the cytokines, the most effective at the reduction of inflammation in microbial infection-induced dermatitis and inflammation caused by SEB/TSLP. Therefore, one of ordinary skill in the art looking to treat skin inflammation would be greatly motivated to include CBG in Persaud’s CBD and BAK composition.
With regards to the concentration ratio of CBD: CBG: BAK of 1:1:1, one of ordinary skill in the art would have been motivated to have the concentration ratio of CBD: CBG: BAK is 1:1:1 because Persaud teaches that the molar concentration ratio of cannabinoid to the cosmetic active i.e., Bakuchiol, is 1:1, 1:2 etc. [0120], and teaches that the amount of CBD in the composition is 0.5-10 wt.% and bakuchiol is 0.5-15 wt.%. Persaud’s concentration range of CBD and BAK appears to be close or overlapped, and it’s overlapped with the claimed CBD molar concentration of 9-11. 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). "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) MPEP 2144.05. Moreover, Biro teaches that the concentration of CBD and CBG and the other cannabinoid in the composition equal to 0.3 µM or 3 µM (all equal amounts). [see Tables 1 and 2], which would motivate the ordinary skilled artisan to use equal concentrations of the cannabinoids and BAK and thus necessarily achieve a molar concentration ratio equal to 1:1:1. Furthermore MPEP 2144.05.II.A explains: "[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).” In line with MPEP 2144,05, Persaud teaches that “a suitable amount can be readily determined by one skilled in the art, for example, one skilled in the art can begin with a low amount that can be increased until reaching the desired result or effect, or one skilled in the art can begin with a high dosage that can be decreased until reaching a minimum dosage needed to achieve the desired result or effect.
With regards to the total concentration of CBD/CBG/BAK of 9-11 µM , one of ordinary skill in the art would have been motivated to have the total CBD/CBG/BAK molar concentration in a range of 9-11 µM i.e., 10 or 11 µM because Biro teaches that the concentration of CBD and CBG and the other cannabinoid in the composition equal to 3 µM (all equal amounts) [see Tables 1 and 2], Persaud teaches that the amount of CBD in the composition is 0.5-10 wt.% and bakuchiol is 0.5-15 wt.%, and combination of CBD, CBG, and BAK at 1:1:1 molar concentration of CBD/CBG/BAK is established above. Biro’s concentration of 3 µM resulted in total concentration of 9 µM which falls with the claimed molar concertation of claims 28 and 29. As explained in the MPEP 2144.05, a prima facie case of obviousness exists where the claimed ranges or amounts are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). 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). "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) MPEP 2144.05. Furthermore MPEP 2144.05.II.A explains: "[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).” In line with MPEP 2144,05, Persaud teaches that “a suitable amount can be readily determined by one skilled in the art, for example, one skilled in the art can begin with a low amount that can be increased until reaching the desired result or effect, or one skilled in the art can begin with a high dosage that can be decreased until reaching a minimum dosage needed to achieve the desired result or effect. Therefore, one would have been motivated to have a total molar concentration of CBD, CBG and BAK of 10 µM or 11 µM.
With regard to the additive anti-inflammatory effect, it would have been prima facie obvious to one of ordinary skill in the art to reasonably presume that the resulting combination of CBD, CBG, AND BAK taught by Persaud and Biro has a synergistic anti-inflammatory effect or an additive anti-inflammatory effect because Siurkus teaches that cannabinoids e.g., CBD and CBG has synergistic effect in treating inflammation and that the synergistic effect of cannabinoids mixture for treating inflammatory condition is well known in the art, and Persaud implicitly mention the additive effect of combining the cannabinoids and BAK. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112.
Therefore, claims 21, 28 and 29 are obvious over the combination of Persaud, Biro and Siurkus.
Claim 30 is met because Biro teaches that the cannabinoid composition suppresses the pro-inflammatory cytokines. [0099].
Claim 31 is met because Persaud’s Test composition C has antioxidant activity because its comprises CBD [0003], Bakuchiol [0075], tocopherol [0011], and essential oils [0094], all of which are defined by Persaud as antioxidant.
Claim 32 is met because Persaud teaches that the composition is for treating acne. [0007].
Claim 33 is met because Persaud teaches that in some embodiments the active cosmetic ingredient comprises alpha hydroxy acid (AHA) [0009].
Claim 34 is met because Persaud teaches the compositions of the present technology comprise one or more of: CBD, CBG, CBGA, and CBDA. [0047]. Biro also teaches CBD, CBDA, CBGA, CBGV were used. [0163].
Regarding claim 22, Siurkus teaches that cannabinoid compounds particularly CBD treated inflammation by inhibiting COX-2, and that CBD in vitro effects induced a dose-dependent suppression of COX-2. [0007]. Thus, one of ordinary skill in the art would have been motivated with reasonable expectation of success to test the effectiveness and the synergistic effect of the Persaud and Biro composition by measuring the inhibition of COX-2 in vitro.
With regard to claim 26, the combination of Persaud, Biro and Siurkus teaches a composition comprising CBD, CBG, and BAK at a molar concentration ratio of 1:1:1 and total CBD/CBG/BAK concentration of 9-11 µM. Claim 26 recites the composition has synergistic anti-inflammatory effect at first total concentration which appears to mean the sum of the concentration of CBD, CBG, and BAK, then the body of the claim recites that there is an additive anti-inflammatory effect when the concentration of CBD, CBG, and BAK is greater than the first total concentration. This limitation is met over the combination of Persaud, Biro and Siurkus for the following reasons. First, one of ordinary skill in the art would reasonably presume that the resulting combination of CBD, CBG, and BAK taught by Persaud and Biro has a synergistic anti-inflammatory effect or an additive anti-inflammatory effect because Siurkus teaches that cannabinoids e.g., CBD and CBG has synergistic effect in treating inflammation and that the synergistic effect of cannabinoids mixture for treating inflammatory condition is well known in the art, and Persaud implicitly mentions the additive effect of combining the cannabinoids and BAK. Second, Biro teaches that the concentration of CBD and CBG and the other cannabinoid in the composition equal to 0.3 µM or 3 µM (all equal amounts). [see Tables 1 and 2], which would motivate the ordinary skilled artisan to use equal concentrations of the cannabinoids and BAK and thus necessarily achieve equal molar concentration ratio of CBD, CBG, and BAK. Equal concentration of CBD, CBG, and BAK of 0.3 µM would result in total concentration of 0.9 µM. Equal concentration of CBD, CBG and BAK of 3 µM would result in a total concentration of 9 µM, which is greater than 0.9 µM. Since the prior art teaches total concentrations of CBD, CBG, and BAK of about 0.9 µM and greater than 0.9 µM, it would be reasonable to presume that this total concentration would produce a synergistic effect and additive effect, respectively, since the properties of a composition are inseparable. MEPEP 2112 (1). "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). And because Persaud, Biro and Siurkus teach a substantially identical composition as claimed, it is reasonable to presume that the resulting combination index is inherently less than 1. The burden is on Applicant(s) to show that this property is different from those taught by the prior art and to establish patentable differences. See MPEP 2112. Therefore, claim 26 is met be the combination of Persaud, Biro, and Siurkus.
Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed on 02/04/2026 is insufficient to overcome the rejection of claim 21-22, 26, and 28-34 based upon a specific reference applied under 35 U.S.C. 103 as set forth in the last Office action because:
The Declaration at a and b stated that: this specific combination of CBD:CBG:BAK of 1:1:1-within a very narrow total concentration window (e.g., 9 µM to 11 µM) exhibits a quantifiable synergistic anti-inflammatory effect (i.e., CI<1), which is concentration-dependent and diminishes at higher concentrations. This finding is unpredictable, and no teachings or guidance thereof can be derived from the existing technical combinations. According to Table 2 of the specification of the current application, different ratios of CBD: CBG (e.g., 2:1, 3:1, 5:1) result in significantly different levels of COX-2 inhibition, indicating that the ratio is crucial to the synergistic effect. The existing technology does not suggest that the molar concentration ratio of CBD, CBG, and BAK is 1:1:1, which is the optimal or expected molar concentration ratio with a synergistic effect.
Examiner response:
It appears that Applicant is attempting to show unexpected results. As provided in MPEP 716 (b), the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Applicant asserted that Table 2 shows that different ratios of CBD: CBG result in significantly different levels of COX-2 inhibition:
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Claim 1 directed to a composition of CBD:CBG:BAK at 1:1:1, however, Table 2 is showing an effect of CBD:CBG only, therefore, this results is not commensurate with the scope of the claimed composition. Also, the results of Table 2 are not commensurate in the scope with the claimed ratio of 1:1:1 as the ratios are 2:1, 3:1, or 5:1. As provided in MPEP 716 (d), “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." While these results shows that the inhibition of COX-2 differs greatly by altering the ratio, the results does not show unexpected inhibition with respect to the claimed composition of CBD:CBG:BAK at 1:1:1 ratio. The results of Table 2 shows that the COX-2 inhibition of the ratio of CBD:CBG at 5:1 is 73.60, 3:1 is 81.87% and 2:1 is 19.63%. Looking at these results of Table 2, one of ordinary skill in the art would not consider that a ratio of 1:1 will produce an unexpected inhibition because having more CBD amount with respect to CBG appears to be more favorable (see 2:1 ratio vs 3:1 and 5:1). As "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence, Applicant required to explain how the result of Table 2 could be extrapolated to show an unexpected inhibition of the equal amount of CBD:CBG:BAK.
Declaration at b stated that: Persaud discloses CBG as an optional ingredient, but does not in any way teach or suggest that the CBG can be combined with CBD and BAK in a ratio of 1:1:1.
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive when the teaching of Persaud is combined with Biro’s teachings. One of ordinary skill in the art would have been motivated by Biro’s teachings to select CBG form Persaud’s list of cannabinoids and include it in the composition of CBD and PAK. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Persaud teaches a composition comprising CBD and BAK for treating skin inflammation and teaches that the composition can include CBG or other cannabinoids, and Biro teaches a composition for treating skin inflammation comprising CBD and CBG and teaches that CBG is the most effective cannabinoid in suppressing the UVB-upregulated expressions of the cytokines, the most effective at the reduction of inflammation in microbial infection-induced dermatitis and inflammation caused by SEB/TSLP. Therefore, one of ordinary skill in the art looking to treat skin inflammation would be greatly motivated to include CBG in Persaud’s CBD and BAK composition.
Declaration at C stated that: Although Siurkus discloses the synergistic effect of cannabinoids (e.g., CBD and CBG), it does not disclose a ternary combination with BAK, nor does it suggest a synergistic effect in a specific concentration range (such as 9 µM-11 µM).
Examiner response:
In response to applicant's arguments against the references individually, 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). The combination of Persaud and Biro teaches the combination of CBD, CBG and BAK, and because Siurkus teaches that cannabinoids e.g., CBD and CBG has synergistic effect in treating inflammation and that the synergistic effect of cannabinoids mixture for treating inflammatory condition is well known in the art, and Persaud implicitly mention the additive effect of combining the cannabinoids and BAK, one of ordinary skill in the art to reasonably presume that the resulting combination of CBD, CBG, and BAK taught by Persaud and Biro has a synergistic anti-inflammatory effect or an additive anti-inflammatory effect. See MPEP 2112.
Declaration at C stated that: According to Table 3 and FIGs. 5 and 6 of the specification, the combination index (CI) of the claimed composition (referred to as "MIX") at 10 µM was 0.74, suggesting that MIX of CBD, CBG, and BAK had a synergistic anti-inflammatory effect on the COX-2 inhibition at 10 µM; the CI of MIX at 50 µM was 1.0, suggesting that MIX of CBD, CBG, and BAK had an additive anti-inflammatory effect on the COX-2 inhibition at 50 µM; and the CI of MIX at 2 µM was 1.16, suggesting that MIX of CBD, CBG, and BAK had a competitive anti-inflammatory effect on the COX-2 inhibition at 2 µM. It is therefore proven that the synergistic effect is concentration-dependent and only appears in a narrow range.
Examiner response:
The Applicant asserted that the claimed composition (MIX) had an additive effect on COX-2 inhibition, however, looking at Table 3, the MIX has an inhibition% of 50.0 at the claimed concentration and CBG has inhibition% of 51.9, whereas CBD and BAK have 42.0 and 45.0 respectively. based on the % inhibition in Table 3, there is no synergistic anti-inflammatory effect. In fact, the MIX has less %inhibition than the majority of the single components at both 50µM and 10µM. Thus, the additive effect of the claimed combination is not statistical and practical significance in comparison of the agent individually, for example CBG. As provided in MPEP 716 (b), the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Also, since the combination produces less effect than, for example, CBG, it is unclear if the effect is produced by CBG. Even if we consider that the effect of the combination is greater than the combined effect (Table 3), that difference is not statistical and practical significance. Table 3 and Fig. 6 do not show that the synergistic effect is concentration-dependent only in a narrow range because similar effect also show at concentration of 50 µM. Fig. 6 is reproduced below, shows that the inhibition effect of MIX is less than the effect of CBG and BAK:
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Fig. 6 does not show any type of synergistic effect at the 10µM and 50µM amounts. Also, in Fig. 6, it is impossible to evaluate the 5µM Mix COX inhibition % since it does not provide the individual COX inhibition % of CBD, CBG, and BAK. Regarding Fig. 5, it is impossible to determine whether or not the effects are synergistic at 25µM or 12.5µM since Fig 5 do not show the COX inhibition % of the CBD, CBG, and BAK individually. And the COX inhibition % of the 50µM MIX does not show a synergistic effect; or an additive effect. The 132 Declaration does not provide any additional data to show synergism, and the data provided in the spec is not limited to a total CBC/CBG/BAK molar concentration range of 9µM to 11µM, as instantly claimed.
Declaration at d: Persaud, Biro, and Siurkus, either alone or in combination, do not disclose “a molar concentration ratio of CBD, CBG, and BAK is 1:1:1”, let alone disclose synergistic effect is observed in a total CBD/CBG/BAK molar concentration range of 9 µM to 11 µM.”
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive for the reasons stated above. That is Biro teaches that the concentration of CBD and CBG and the other cannabinoid in the composition equal to 0.3 µM or 3 µM (all equal amounts). [see Tables 1 and 2], which would motivate the ordinary skilled artisan to use equal concentrations of the cannabinoids and BAK and thus necessarily achieve a molar concentration ratio equal to 1:1:1. Moreover, Persaud teaches that the molar concentration ratio of cannabinoid to the cosmetic active i.e., Bakuchiol, is 1:1, 1:2 etc. [0120], and teaches that the amount of CBD in the composition is 0.5-10 wt.% and bakuchiol is 0.5-15 wt.%. Persaud’s concentration range of CBD and BAK appears to be close or overlapped, and it’s overlapped with the claimed CBD molar concentration of 9-11µM, thus, a prima facie case of obviousness exists according to MPEP 2144.05. Furthermore MPEP 2144.05.II.A explains: "[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).” In line with MPEP 2144,05, Persaud teaches that “a suitable amount can be readily determined by one skilled in the art, for example, one skilled in the art can begin with a low amount that can be increased until reaching the desired result or effect, or one skilled in the art can begin with a high dosage that can be decreased until reaching a minimum dosage needed to achieve the desired result or effect. Furthermore, because Biro teaches that the concentration of CBD and CBG and the other cannabinoid in the composition equal to 3 µM (all equal amounts) [see Tables 1 and 2], one of ordinary skill in the art would have been motivated to have the concentration ratio of CBD: CBG: BAK is 1:1:1 in a total concentration range of 9-11 µM (3 µM of CBD, CBG, and BAK = 9 µM). Note that, A total concentration of 9 µM falls with the claimed total molar concertation. The asserted synergistic effect at this claimed ratio and total concentration is responded to at Declaration at C above.
Note: Applicant’s arguments are parallel to the Declaration a-d, which have been discussed and responded to above.
Conclusion
Claims 21-22, 26, and 28-34 are rejected. No claim is 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.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622
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