DETAILED ACTION
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 applicant’s remarks filed December 4, 2025. Claim 36 has been cancelled. Claims 48-54 are withdrawn. Claims 35-47 are pending and stand rejected.
Election/Restrictions
Applicant's election with traverse of 48-54 in the reply filed on September 24, 2024 is acknowledged. The traversal is on the grounds that LLAMAS does not disclose the shared special technical feature of a (+)-cannabidiol. This is not found persuasive because as noted in the article Applicants cited (Chesney et al.) synthetic cannabidiol contains both enantiomer forms. Therefore the synthetic cannabidiol disclosed by Llamas comprises (+)-cannabidiol.
The requirement is still deemed proper and is therefore made FINAL.
Claims 48-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected article and method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 24, 2024.
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, 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.
Claims 35-47 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150181924 A1 (hereinafter LLAMAS) in view of “An overview on medicinal chemistry of synthetic and natural derivatives of Cannabidiol” (hereinafter MORALES).
Regarding claim 35, LLAMAS discloses a cannabidiol liquid composition for use in an electronic cigarette smoking device (abstract). LLAMA discloses an aerosolizable material comprising cannabidiol (¶25) and at least one carrier constituent (¶21, ¶28).
LLAMAS teaches that the cannabidiol is a cannabinoid that can include ANY compound that reacts with a cannabinoid receptor and provides a long list, though not limited to, in ¶25. This list includes (+)- cannabidiols, including natural and synthetic cannabidiol (¶29-¶30). Further LLAMAS discloses that the cannabidiol in the disclosure includes cannabidiol and cannabidiol derivatives.
LLAMAS does not specifically state (+)- stereochemical cannabidiols. However the synthetic cannabidiols and use of the word “any” is an open list. MORALES teaches uses for cannabidiol for beneficial neuroprotective, antiepileptic, anxiolytic, antipsychotic, and anti-inflammatory purposes (abstract). MORALES teaches that the CBD scaffold is interesting for medical chemists and provides an overview of synthetic CBD derivatives (abstract, emphasis added). MORALES teaches that different structures of natural and synthetic CBD derivatives are associated with different biological targets (highlighted portion page 5). MORALES teaches that synthetic approaches for CBD have resulted in compounds that show binding affinities for CB1 and CB2 receptors (page 20). MORALES teaches that the (+)- CBD have shown anti-inflammatory potential in inflammatory and autoimmune diseases (page 22). In view of the teachings of MORALES that synthetic cannabidiols include (+)- cannabidiols, 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 modified LLAMAS to include (+)-cannabidiols as taught in MORALES. A person of ordinary skill in the art would obviously include (+)-cannabidiol because doing so would target different receptors and provide targeted relief to inflammation and autoimmune diseases.
LLAMAS further teaches wherein at least 55% of the cannabidiol present in the aerosolizable material is present in the form of (+)-cannabidiol. The synthetic cannabidiols ranges taught in LLAMAS (¶34) include the (+)-cannabidiol as taught in MORALES to treat targeted conditions. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to provide at least 55% of the cannabidiol in the form of (+)-cannabidiol because doing so would treat the targeted conditions. 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)
Regarding claim 36, LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS further discloses wherein at least 1 % of the cannabidiol present in the aerosolizable material is present in the form of ( + )-cannabidiol (¶34).
Regarding claim 37, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS further discloses wherein the carrier constituent comprises one or more of glycerol, propylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, erythritol, meso-Erythritol, ethyl vanillate, ethyl laurate, a diethyl suberate, triethyl citrate, triethylene glycol diacetate, triacetin, a diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, and propylene carbonate (¶31-¶33).
Regarding claim 38, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS further discloses wherein the carrier constituent comprises propylene glycol (¶31, claim 8), in an amount of at least 50%w/w based on the total weight of the aerosolizable material (¶36). LLAMA discloses that propylene glycol is a possible emulsifier (¶32) and that the emulsifier is present from about 10% to about 99.9% (¶36, ¶55).
Regarding claim 39, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS further discloses wherein the carrier constituent comprises glycerol (¶32), in an amount of at least 50%w/w based on the total weight of the aerosolizable material (¶36, ¶55). LLAMAS discloses the use of vegetable glycol which is the same as glycerol both having the chemical formula C3H8O3.
Regarding claim 40, modified LLAMAS discloses the aerosolizable material of claim 37 as discussed above. LLAMAS further discloses wherein the carrier constituent comprises both glycerol and propylene glycol (¶33). LLAMAS teaches the use of a combination of the emulsifiers, this would include both glycerol and propylene glycol (¶33).
Regarding claim 41, modified LLAMAS discloses the aerosolizable material of claim 40 as discussed above. LLAMAS further teaches 60 to 90% w/w propylene glycol; and 10 to 40% w/w glycerol. LLAMAS teaches that a combination of different emulsifiers may be used (¶33). LLAMAS teaches that the combinations result in a smoother feel, more smoke with each drag, and guard against separation (¶33). LLAMAS further teaches ranges for the emulsifiers (¶36). LLAMAS discloses that the value combination ratio of emulsifiers needs to be optimized to result in a smoother feel, more smoke with each drag, and guard against separation (¶33). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to move the percent ranges as a matter of routine optimization since it has been held that "[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) (MPEP 2144.05.II.A).
Regarding claim 42, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS further discloses wherein the cannabidiol is present in an amount of at least 5 mg/ml of aerosolizable material (¶34). 5 mg/ml can be converted to a percentage of 0.5%. Since LLAMAS discloses percentages much higher that 0.5%, the claim is anticipated.
Regarding claim 43, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS further teaches wherein the turbidity of the aerosolizable material is about 10 NTU (Nephelometric Turbidity Units) or less. Given that the aerosolizable material taught by LLAMAS are the same as those disclosed in the instant specification to result in a turbidity having the claimed 10 NTU or less, the NTU of the aerosolizable material taught by LLAMAS is expected inherently to be the same. Recitation of a newly disclosed property does not distinguish over a reference disclosure of the article or composition claims. General Electric v. Jewe Incandescent Lamp Co., 67 USPQ 155. Titanium Metal Corp. v. Banner, 227 USPQ 773. Applicant bears responsibility for proving that reference composition does not possess the characteristics recited in the claims. In re Fitzgerald, 205 USPQ 597, In re Best, 195 USPQ 430.
Regarding claim 44, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS teaches wherein the aerosolizable material is a liquid at about 25°C. LLAMAS discloses a liquid composition for use in an electronic cigarette device (abstract). LLAMAS discloses that heat must be applied to vaporize the composition (¶9, ¶28). A person of ordinary skill in the art would immediately recognize that the temperature of 25°C is an ambient temperature that an electronic cigarette would be stored while the formulation remained a liquid prior to applying heat.
Regarding claim 45, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS teaches the aerosolizable material of claim 35, comprising less than 12% w/w water. LLAMAS discloses that trace amounts of water may be present (¶40, ¶48, ¶50). Trace amounts would clearly be less than 12% w/w water. In the paragraph where the mint is added at a concentration of 5%, the trace amounts of water are disclosed (¶48). A person of ordinary skill in the art would immediately conclude that trace amounts is at least less than the 5%.
Regarding claim 46, modified LLAMAS discloses the aerosolizable material of claim 35 as discussed above. LLAMAS further discloses wherein the aerosolizable material further comprises one or more further constituents (¶21, ¶46).
Regarding claim 47, modified LLAMAS discloses the aerosolizable material of claim 36 as discussed above. LLAMAS further discloses wherein the one or more further constituents is an olfactory active constituent (¶21, ¶46).
Response to Arguments
Applicant’s arguments, filed December 4, with respect to the rejection(s) of claim(s) 35-47 under 35 USC 10 have been fully considered and are not persuasive.
Applicant argues, “While the Examiner accepts the fact that (+)-cannabidiol is not disclosed in Llamas, the Examiner argues that reference to "synthetic cannabidiols" and the use of the word "any" in relation to "any" compound that reacts with a cannabinoid receptor inevitably includes reference to (+)-cannabidiol. Paragraph [0025] of Llamas states that the word "cannabinoid" used in this description, claims, and other conjugations is used to mean any compound that interacts with a cannabinoid receptor and other cannabinoid mimetics. This disclosure by Llamas does not make technical sense, given noncannabinoid compounds, such as caryophyllene, falcarinol and diarylpyrazoles (e.g.SR141716A or AM251), interact with the cannabinoid receptors and so would be considered cannabinoids in accordance with the disclosure in Llamas. Obviously, these compounds are not cannabinoids and would not be considered as such by the skilled person, irrespective of the disclosure in Llamas.” While examiner does accept the fact LLAMAS does not anticipate the (+)-cannabidiol because that term is not in the written description, LLAMAS broadly teaches, “any compound that interacts with a cannabinoid receptor and other cannabinoid mimetics” (LLAMAS ¶25). The fact that applicant has identified components that are would be included that are not (+)-cannabidiol does not invalidate the broad teaching of LLAMAS to include (+)-cannabidiol. A prior art reference is not held to a standard of “make technical sense”. A prior art reference is relied upon for everything it would teach a person of ordinary skill in the art and here LLAMAS teaches a person of ordinary skill in the art to combine any compound that interacts with a cannabinoid receptor and other cannabinoid mimetics. As stated in the response to arguments of the office action sent September 5, 2025, though there is no specific disclosure of the (+)- enantiomer of CBD, that is not required to read upon the limitation where the prior art reference discloses more broadly, namely where LLAMAS says any known derivative of cannabidiol. However, in order to advance prosecution, a secondary reference has been added to MORALES that teaches the use of stereochemistry in CBD for targeted treatment of diseases. Additionally, the prior art is crowded with art that discloses use of enantiomers of CBD to treat conditions. For example see US 20020117175 A1 to KOTTAYIL that discloses enantiomers are used to treat many conditions, including anxiety (¶18-¶19), US 20050032881 A1 to GARZON that discloses that (+)- enantiomers are preferred because they do not possess the undesired psychotropic side effects (¶134), and US 20070060636 A1 to AVIV that also discloses that while the opposite enantiomeric synthetic series (3S,4S) was free of these undesirable effects [psychotropic activity] (¶5).
Further, as disclosed in the instant application, cannabidiol is obtained from industrial hemp extract with trace amount of THC.” (¶27). The (+)- enantiomer of CBD is in fact a cannabidiol derivative obtained from hemp. This is exactly what the instant application discloses in the PG Pub ¶57. Therefore, not only does LLAMAS disclose cannabidiols and their derivatives, of which the (+)- enantiomer of CBD is irrefutably one, but LLAMAS discloses an identical or substantially identical composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Applicant further argues, “preference is explicitly given to naturally derived CBD and provided as a part of hemp oil. This is an implicit disclosure of (-)-cannabidiol, given that (+)-cannabidiol cannot be naturally derived. The disclosure of Llamas in paragraph [0030] states that cannabidiol may be artificially synthesized and is substantially free from impurities. In turn, this may be taken to mean that (-)-cannabidiol may be artificially synthesized and is substantially free from impurities. However, it is abundantly clear that there is not a hint or suggestion that the specific (+)-cannabidiol enantiomer can be employed in the formulations described in Llamas.” Applicant is selectively pointing to an alleged preferred embodiment to argue against the complete teachings of a prior art reference. A preferred embodiment or alternate embodiment does not constitute a teaching away where the specification teaches more broadly. See MPEP 2123, II. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant argues, “The Examiner alleges, in point 12, that Llamas further teaches wherein at least 55% of the cannabidiol present in the aerosolizable material is present in the form of (+)-cannabidiol, based upon the disclosure in paragraph [0034]. Applicant submits that the Examiner may not have considered the amendment properly. The claims clearly refer to the amount of (+)-cannabidiol present in the cannabidiol component only, not the composition as a whole. Nevertheless, it is clear that Llamas describes cannabidiol concentrations present as a total amount by weight of the composition, not of the cannabidiol component. This is obvious, given that Llamas fails to disclose any concentrations for specific cannabidiol derivatives.” LLAMAS discloses a cannabidiol composition for use in an electronic cigarette (abstract). LLAMAS does not discloses the amount of cannabidiol in the liquid can be present by weight in a range from 0.1% to about 90%. It is already established, as explained above, that this cannabidiol is in the form of a (+)-cannabidiol, so given broadest reasonable interpretation the entirety (100%) of the liquid may be is present in the form of a (+)-cannabidiol. The entirety (100%) is at least 55% as recited in the claim or less as taught in the overlapping range taught in LLAMA ¶34.
Applicant argues, “The disclosure of Morales makes reference to cannabidiol enantiomers, derivatives, analogs etc, i.e., a plurality of derivatives and not any one cannabidiol enantiomer. Furthermore, it seems the Examiner has considered disclosure in Morales to HU-485 as being relevant to (+)-cannabidiol (see the emboldened sections above). HU-485 is a different compound than (+)-CBD. Applicant has not identified any other disclosures in Morales that could support the assertion made by the Examiner that (+)-cannabidiol has anti-inflammatory potential in inflammatory and autoimmune diseases models. The Examiner has failed to explain why a person of ordinary skill in the art would choose the (+)-cannabidiol enantiomer over any other cannabidiol derivative or even any other (+)- cannabidiol derivative.” LLAMAS discloses the use of cannabidiols very broadly. This encourages one of ordinary skill in the art to use any and all cannabidiols. MORALES teaches that the (+)- CBD have shown anti-inflammatory potential in inflammatory and autoimmune diseases (page 22). Therefore, a person of ordinary skill in the art would obviously choose a (+)-cannabidiol enantiomer to provide the advantages of that particular substance in light of the teaching of MORALES that different cannabidiols provide different advantages. This does not constitute a teaching away.
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 LLAMAS broadly teaches any cannabidiol. This would reasonably lead a person of ordinary skill in the art to the crowded cannabis art to use a (+)-cannabidiol because MORALES teaches this type of cannabidiol treats (+)- CBD have shown anti-inflammatory potential in inflammatory and autoimmune diseases (page 22).
Conclusion
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 STEPHANIE L MOORE whose telephone number is (313)446-6537. The examiner can normally be reached Mon - Thurs 9 am to 5 pm.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached on 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE LYNN MOORE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747