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 .
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 18 and 21 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.
Claim 18 contains the trademark/trade name Transcutol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe diethylene glycol monoethyl ether and, accordingly, the identification/description is indefinite.
Claim 21 contains the trademark/trade name Span® 85. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe sorbitane trioleate and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-6, 8-15 and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Corr (WO2019021005, disclosed by applicant).
Corr discloses a pharmaceutical composition comprising at least one cannabinoid and a propellant component comprising HFA-152a as an inhalable pharmaceutical formulation, which meets the limitation of claim 19 (Abstract and p. 2, line 5). Corr discloses the cannabinoid is cannabidiol (p.8, lines 6-8). Corr discloses the composition further comprise muscarinic antagonist, such as tiotropium, ipratropium and aclidinium and ling acting beta-2 agonist selected from formoterol arformoterol and bambuterol (p.9, lines 2-7). Corr discloses the composition comprises a flavor, such as peppermint oil and a cough suppressant, such as menthol (p. 9, lines 27 and 28). Corr discloses the composition comprises a solvent ethanol and/or glycerol (reference claim 26). Corr discloses the composition comprises at least one surfactant comprising polyvinylpyrrolidone and oleic acid (p. 11, lines 2 and 3). Corr discloses formulations that do not comprise delta-9-tetrahydrocannabinol or corticosteroid.
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.
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.
Claim(s) 1-29 are rejected under 35 U.S.C. 103 as being unpatentable over Cifter et al. (EP2682099A1) in view of Corr (WO2019021005, disclosed by applicant).
Cifter et al. disclose a pharmaceutical composition for inhalation comprising a ling acting muscarinic antagonists in the form of a dry powder in admixture with a pharmaceutically acceptable carrier and its use in the treatment of respiratory condition selected from asthma, COPD and other obstructive airways diseases (Abstract). Cifter et al. disclose the composition comprises long and short-acting beta-2 agonist and muscarinic antagonist comprising tiotropium, glycopyrronium, ipratropium, arformoterol, bambuterol, pirbuterol and procaterol (p.5, para. [0036], [0039] and [0040]). Cifter et al. disclose the composition comprises the carrier lactose and mannitol ([0033]).
Cifter et al. differs from the instant claims insofar as they do not disclose a composition comprising at least one cannabinoid.
Corr discloses a pharmaceutical composition comprising at least one cannabinoid and a propellant component comprising HFA-152a as an inhalable pharmaceutical formulation, which meets the limitation of claim 19 (Abstract and p. 2, line 5). Corr discloses the cannabinoid is cannabidiol and treats COPD (p.8, lines 6-8). Corr discloses the composition further comprise muscarinic antagonist, such as tiotropium, ipratropium and aclidinium and ling acting beta-2 agonist selected from formoterol arformoterol and bambuterol (p.9, lines 2-7). Corr discloses the composition comprises a flavor, such as peppermint oil and a cough suppressant, such as menthol (p. 9, lines 27 and 28). Corr discloses the composition comprises a solvent ethanol and/or glycerol (reference claim 26). Corr discloses the composition comprises at least one surfactant comprising polyvinylpyrrolidone and oleic acid (p. 11, lines 2 and 3). Corr discloses formulations that do not comprise delta-9-tetrahydrocannabinol or corticosteroid.
It is prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. MPEP 2144.07. Therefore, it would have been obvious to have included cannabinoid in the formulation of Cifter, since they are known for treating COPD.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
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/NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612