DETAILED ACTION
Status of Application
The claim set filed 4/30/2025 is acknowledged.
Claims 4-6, 8, 9, 21, 23-26, 30, and 32 are cancelled.
Claims 1-3, 7, 10-20, 22, 27-29, and 31 are under consideration
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) filed on 4/3/2024 and 10/01/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 12, 13, and 17 are indefinite because the claim contains the trademark “Tween®”. Generally, trademarks are not appropriate claim language because the mark identifies the product but not its composition. The composition of trademarked products can change with no notice. In the interested of compact prosecution the examiner interprets the phrase as the generic of “Tween®” which is polysorbate.
Claim 12 is indefinite because the claim contains the trademark “Span®”. Generally, trademarks are not appropriate claim language because the mark identifies the product but not its composition. The composition of trademarked products can change with no notice. In the interested of compact prosecution the examiner interprets the phrase as the generic of “Tween®” which is polysorbate.
Claims 14-15 are included in this rejection because they do not correct the defect for which the claim from which they depend was rejected.
Appropriate correction is required.
Claim Rejections - 35 USC §102/103
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
on sale or otherwise available to the public before the effective filing date of the claimed
invention.
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 1-3, 7, 10-20, and 27-29 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Danek et al. (US20210113783A1) hereinafter Danek.
Anticipation
Regarding claims 1-3, 7, 10-20, and 27-29, Danek is drawn to an electronic device includes a mouthpiece, a bladder, and a mesh assembly having a mesh material and a piezoelectric material. The mesh material is in contact with a liquid of the bladder. The mouthpiece, the bladder, and the mesh assembly are located in-line along a longitudinal axis of the device between opposite longitudinal ends of the device, with the mesh assembly extending between and separating the mouthpiece and the bladder. A liquid-filled cartridge also is disclosed for use with an electronic device for delivery of a substance into a body through respiration includes a liquid container; and a liquid contained within the container for aerosolizing and inhaling by a person using the electronic device. The liquid includes a plurality of nanoparticles in a nanoemulsion, the nanoparticles including the encapsulation of the substance to be delivered into the body through respiration. The nanoemulsion preferably is produced using a microfluidizing machine (abstract).
Danek discloses using an electronic device of the present invention to produce an aerosol for inhalation by a person using such electronic device [0023]. Danek discloses a liquid-filled cartridge for use with an electronic device for delivery of a substance into a body through respiration comprises: a liquid container; and (b) a liquid contained within the container for aerosolizing and inhaling by a person using the electronic device, the liquid comprising a plurality of nanoparticles in a nanoemulsion, each nanoparticle comprising an encapsulation of the substance to be delivered into the body through respiration [0025]. Danek discloses the liquid is an oil-in-water nanoemulsion [0026]. Danek discloses the encapsulated substance comprises cannabidiol [0032].
Danek discloses wherein the nanoparticles are suspended within an aqueous solution. The aqueous solution preferably comprises a saline; the aqueous solution preferably comprises sodium chloride; and, the nanoparticles preferably are suspended within an aqueous solution of 0.9% sodium chloride [0036]. Danek discloses surfactants include, but are not limited to: high purity polyoxyethylene sorbitan monooleate (also known by its trade name, SUPER REFINED® Polysorbate 80); polyoxyethylene sorbitan monooleate; (also known by its trade name, TWEEN® Polysorbate 80 [0302].
Danek discloses the encapsulated molecules are chemically bonded to other molecules in a conjugated system. Establishing a conjugated system with chemical bonds between the active ingredient molecules and other molecules facilitates more efficient encapsulation of the active ingredients via the techniques described herein. In some contemplated embodiments, then THC/CBD molecules are chemically bonded with molecules of stearic acid and/or oleic acid [0309].
Danek discloses the electronic device comprises a vibrating mesh nebulizer coupled [0291]. Danek discloses CBD interact with different receptors in the human brain [0296].
Danek discloses with preferred embodiments of aspects and features of the invention, nanoparticles preferably have a dimension of between about 50 and about 200 nanometers [0219]. Danek discloses the final liquid mixture has a PDI value measuring less than 0.3. The PDI value provides a measurement of the broadness of size distribution. A low PDI value is indicative of a high level of particle size uniformity in a mixture. In accordance with contemplated embodiments of the invention, the PDI value is 0.3 or less, which is believed to indicate a liquid mixture with increased stability and enhanced shelf-life [0306].
Obviousness
Danek does not explicitly disclose each of the components of the composition in one single embodiment for an anticipation rejection.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Danek, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Danek discloses all the required components and Danek discloses the an oil-in-water nanoemulsion [0026], comprising cannabidiol [0032], delivered into the body through respiration [0025]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
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 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 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.
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.
Claims 22 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Danek et al. (US20210113783A1) hereinafter Danek as applied to claims 1-3, 7, 10-20, 22, 27-29 above in view of Agarwal (WO2021062481A1).
The teachings of Danek are disclosed above.
Regarding claims 22 and 31, Danek does not explicitly disclose the presence of isoflurane or a method for the treatment of TBI.
However, Agarwal is drawn to methods and compositions comprising cannabidiol (CBD) and a volatile anaesthetic, particularly isoflurane, useful for treating or preventing traumatic brain injury (TBI) (abstract).
Agarwal discloses a method for the treatment or prevention of traumatic brain injury (TBI) comprising administering to a subject in need thereof a loading dose comprising an effective amount of cannabidiol (CBD) [0005].
Agarwal discloses administration of cannabidiol (CBD) and a volatile anaesthetic, e.g., isoflurane, can synergise to protect the brain from secondary immune-mediated damage associated with traumatic brain injury (TBI), thereby providing a neuroprotective effect following head injury. This finding has been reduced to practice in a method for the treatment or prevention of TBI [0015].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Danek, wherein the composition comprises isoflurane for the treatment of TBI, as previously disclosed by the teachings of Agarwal, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Danek and Agarwal are both in the field of cannabidiol nanoparticle inhalation compositions and Agarwal discloses administration of cannabidiol (CBD) and a volatile anaesthetic, e.g., isoflurane, can synergise to protect the brain from secondary immune-mediated damage associated with traumatic brain injury (TBI), thereby providing a neuroprotective effect following head injury. This finding has been reduced to practice in a method for the treatment or prevention of TBI [0015]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
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 at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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