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 .
Claims 1-2, 4-11, 14-15, 17-24, are pending in this application.
Claim 3, 12-13, 16, are deleted.
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 4, 17, are rejected under 35 U.S.C. 101 because the claimed inventions lack patentable utility. The claims are drawn to treating none-specific medical condition. Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-11, 14-15, 17-24, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims lack adequate support in the specification. There is no disclosure how to extract plant-based cannabidiol and THC, how to make synthetic cannabidiol and THC and how to make their thin film freezing (TFF) dry powders. There is no incorporation-by-reference of US publications where the enablements can be found. The specification disclose what is done instead of how it is done. There are no assays establishing nexus between the composition and each disease.
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 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 1-2, 4-11, 14-15, 17-24, 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Comprising, e.g. claim 1, line 1; or claim 4, line 2; implies the claims have other cannabis not cited in the claims. Therefore, they are indefinite. Applicant must deleted the term in every occurrence.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 14-15, are rejected under 35 U.S.C. 102(a) as anticipated by Willinsky, US 2018/0000727 A1, which teaches an inhaler for the delivery of solid particles composition comprising cannabis: plant extracts and synthetics. See the entire document, particularly the title, abstract and the claims.
The claims cite intended use of the inhaler: housing and dispensing dry powder composition made by TFF. Under the US patent practice intended use is not a limitation of a product or compound. In re Hack, 114USPQ 161 (CCPA, 1957); In re Craig, 90 USPQ 33 (CCPA, 1951); In re Brenner, 82 USPQ 49 (CCPA, 1949).
Claims 1-2, 14-15, are rejected under 35 U.S.C. 102(a) as anticipated by Kinsey et al., US2017/0216538.
Kinsey et al., teaches a dry powder inhaler set forth below useful for local and systemic delivery of active compositions through the pulmonary tract and lungs. See the entire document, particularly the title and abstract.
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The claims cite intended use of the inhaler: housing and dispensing dry powder composition made by TFF. Under the US patent practice intended use is not a limitation of a product or compound. In re Hack, 114USPQ 161 (CCPA, 1957); In re Craig, 90 USPQ 33 (CCPA, 1951); In re Brenner, 82 USPQ 49 (CCPA, 1949).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-2, 4-11, 14-15, 17-24, rejected under 35 U.S.C. 103(a) as being unpatentable over NIH, Nat Lib Med (2017) Nat Aca Press, p. 1-41 [NIH]; in view of Willinsky, US 2018/0000727 A1; and Engstrom et al., Pharm Res (2008) vol 25(6): 1334-46.
NIH teaches treating the instant disorders with cannabis or cannabinoids. The prior art teaches combination therapy, e.g. nabiximols (plant extracts) as oromucosal spray, and synthetic THC, e.g. nabilone. See the entire document, particularly pages 1-3.
The prior art does not teach dry powder made by TFF in inhaler. However, the claims are obvious in view of Willinsky, and Engstrom et al.
Willinsky teaches as set forth above under anticipatory rejection. The prior art teaches inhaler delivery of solid particles composition improves stability, pharmacodynamics, avoids over or under dosing and misuse. See the entire document, particularly the title, abstract, pages 1-2 and claims.
Engstrom et al., teaches the advantages of particles produced by TFF and the process thereof. See the entire document, particularly the abstract, and introduction.
A POSA having known the advantages of inhaler delivery of dry particle and how to do it by TFF, would have been motivated to do so at the time the invention was made, with reasonable expectation of success.
As held in KSR Int. Co. v. Teleflex Inc, 550 U.S. 82 USPQ2d 1385 (2007), “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. For the same reason 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 his or her skill.”
In the instant, it is not beyond the ordinary skill of a Scientist to use conventional technique, e.g. Engstrom et al., in making the instant invention. It’s deemed invention of reasoning, not of creativity, KSR, supra.
Therefore, the claims are not allowable over the combination of the prior arts and knowledge well-known in the art.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/ Primary Examiner, Art Unit 1625
May 19, 2025