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 05/18/2023 a 371 of PCT/AU2021/051383 filed on 11/19/2021.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed May 28, 2026 to the restriction requirement made on December 16, 2025.
Applicant's election with traverse of Group I in the reply filed on 5/28/26 is acknowledged. In response, Examiner respectfully reiterates in “a group of inventions claimed in an international application unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” is defined in PCT Rule 13.2 as meaning those features that define a contribution which each of the inventions, considered as a whole, makes over the prior art. The determination is made on the contents of the claims as interpreted in light of the description or drawings (if any).” The inventions listed as Groups I-II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features. In the instant case the process of preparing a pharmaceutical composition is disclosed by the prior art so there is no novel process as claimed, and therefore, there is a lack in unity (CN 110433133 A). Applicant' s arguments are not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 27-39 are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 8/18/23 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
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.
Claims 27-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over Du et al. (CN 110433133 A).
Du teaches a temperature sensitive gel for nasal delivery of cannabidiol for treating stress disorders (See Abstract). The composition is liquid at room temperature and becomes a gel when administered to the nose of the patient, because of a temperature dependent phase transition (See [0007]). Du further teaches compositions and methods to manufacture these compositions (See [0010]-[0022]). Example 1 discloses one embodiment, which comprises 2g poloxamer 188 and 12g poloxamer 407 with water. Then 1g of cannabidiol, 6mL 1,2-propandiol and 8mL Ethanol are added to form a temperature-sensitive gel composition for nasal delivery. Du also discloses the addition of glycerol monooleate (surfactant that isn't a poloxamer and/or poloxamine) in order to prepare the cannabidiol containing component of a similar composition to that of Example 1 (See [0016]-[0018] and Example 5). Finally, Du also teaches the inclusion of other bioadhesive components such as chitosan or carbomer (considered surfactants) (See [0020] and Examples 6-7).
Du do not explicitly state that the compositions comprise micelles, it is considered that the aqueous solution comprising poloxamers and a surfactant, that forms a thermo-responsive gel, obviously comprises a plurality of micelles as these structures self-assemble in water at the amounts included.
Furthermore, as Du describe an obvious products, it is considered that the disclosed compositions would possess the same (or at least very similar) physical characteristics, such as viscosity, gel strength or gelation temperature. Du differ from the claimed invention in that they do not explicitly disclose the amounts of the components defined by independent claims 1 and 18, nor the gelation temperature.
However, the differences are considered to amount to mere optimizations that the person skilled in the art would arrive at through routine experimentation. Du teaches very similar compositions comprising all the components of claim 1 which includes a thermoresponsive poloxamer, a surfactant and a cannabinoid composition comprising cannabidiol. The person skilled in the art would be well aware that by altering the amount of these components, in particular the poloxamer, the properties of the thermoresponsive sol-gel can be predictably manipulated. Thus, in attempting to find an alternative sol-gel for cannabinoid delivery the the person skilled in the art would arrive at the claimed invention through routine experimentation.
Claims 27-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over Xie et al. (Wo2020206258 A1).
Xie discloses a cannabidiol (CBD) pharmaccutical composition (See Abstract). Xie further discloses the composition is an aqucous, micellar pharmaceutical composition comprising a cannabidiol compound (See Abstract). Xie further discloses the well known mechanism of action and uses of CBD (See [003]-[005]). Claim 1 discloses that the composition comprises a first surfactant and a second, different, surfactant. The first surfactant is preferably poloxamer 407 or poloxamer 188 and the second surfactant is preferably polysorbate 80 (See Claims 8, 12). Xie discloses a number of different embodiments and also how to prepare them (See Examples 1-42). More specifically, Poloxamer 407 is commonly used as the first surfactant, sometimes combined with Poloxamer 188, and the second surfactant is often either PEG 40 Hydrogenated castor oil (See Examples 1,3, 22 and 28), Solutol HS-15 (See Example 2 and 27), PEG 35 castor oil (See Examples 4 and 29) or Polysorbate 80 (See Examples 16-21, 23-26, 32 and 38 ). Alternatively, the second surfactant can also be a combination of these (See Examples 5-8, 13-15, 34-37 and 39). These examples often comprise 0.1-15% wt CBD, 2-10% wt poloxamer, 5-15% wt second surfactant and therefore disclose compositions which will inherently have thermoresponsive sol-gel properties. Xie also discloses methods of making the aqueous compositions comprising the steps of: mixing CBD, the first surfactant of poloxamer 407, water and an organic solvent; removing the organic solvent; and mixing in the second surfactant (Examples 1-42).
Xie do not explicitly state that the compositions comprise micelles, it is considered that the aqueous solution comprising poloxamers and a surfactant, that forms a thermo-responsive gel, obviously comprises a plurality of micelles as these structures self-assemble in water at the amounts included.
Furthermore, as Xie describe an obvious products, it is considered that the disclosed compositions would possess the same (or at least very similar) physical characteristics, such as viscosity, gel strength or gelation temperature. Xie differ from the claimed invention in that they do not explicitly disclose the amounts of the components defined by independent claims 1 and 18, nor the gelation temperature.
However, the differences are considered to amount to mere optimizations that the person skilled in the art would arrive at through routine experimentation. Xie disclose very similar compositions comprising all the components of claim 1 which includes a thermoresponsive poloxamer, a surfactant and a cannabinoid composition comprising cannabidiol. The person skilled in the art would be well aware that by altering the amount of these components, in particular the poloxamer, the properties of the thermoresponsive sol-gel can be predictably manipulated. Thus, in attempting to find an alternative sol-gel for cannabinoid delivery the PSA would arrive at the claimed invention through routine experimentation.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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:/Awww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Asltrum-Acevedo, can be reached on (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
Prosecution Insights