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 .
Status of the Claims
Claims 1-23 are pending and examined.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 6-10, 19, 21, 22, and 23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hitchcock, (WO2018/227044 A1)(cited in ISR).
Hitchcock teaches a topical transdermal composition that can be delivered to treat pain and swelling. See par. 3. An analgesic gel with a solvent, and water is contemplated. See par. 5. The analgesic can be an NSAID, including ibuprofen, oxaprozin, naproxen, and others. See par. 10. The ibuprofen can be include in a range of 1% to 2%. See par. 14. DMSO can be included as well as chitosan as penetration enhanced. See par. 27. Chitosan and DMOS can be present in an amount of 0.1% to 10%. See par. 27. Glycerol can be a solvent and it can be used in a concentration of 0.1% to 10%. See par. 28. Lactic acid can be used in a concentration of 0.1% to 10% in an analgesic gel formulation. See par. 29. The lactic acid can be equivalent to chitosan powder used. See par. 30. De-ionized water can be included as well. See par. 32. Applicant to any tissue can be skin, mucous membranes, or buccal tissue. See par. 34. Example 1 provides an analgesic gel comprising: DMSO, ibuprofen, chitosan powder, lactic acid, glycerol, and de-ionized water. See par. 38.
As such, claims 1, 2, 6-10, 19, 21, 22, and 23 are anticipated by the prior art.
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.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hitchcock, (WO2018/227044 A1)(cited in ISR), in view of Niazi, (US2007/0141182), in view of Sinai et al., (US2018/0116998), and in view of Ozturk et al., (US2004/0265364), in view of Ray, II, et al., (US2013/0085171), and in view of Plakogiannis et al., (US2021/0346310).
Hitchcock teaches a topical transdermal composition that can be delivered to treat pain and swelling. See par. 3. An analgesic gel with a solvent, and water is contemplated. See par. 5. The analgesic can be an NSAID, including ibuprofen, oxaprozin, naproxen, and others. See par. 10. The ibuprofen can be include in a range of 1% to 2%. See par. 14. DMSO can be included as well as chitosan as penetration enhanced. See par. 27. Chitosan and DMOS can be present in an amount of 0.1% to 10%. See par. 27. Glycerol can be a solvent and it can be used in a concentration of 0.1% to 10%. See par. 28. Lactic acid can be used in a concentration of 0.1% to 10% in an analgesic gel formulation. See par. 29. The lactic acid can be equivalent to chitosan powder used. See par. 30. De-ionized water can be included as well. See par. 32. Applicant to any tissue can be skin, mucous membranes, or buccal tissue. See par. 34. Example 1 provides an analgesic gel comprising: DMSO, ibuprofen, chitosan powder, lactic acid, glycerol, and de-ionized water. See par. 38.
Hitchcock does not teach aspirin and cyclobenzaprine.
Niazi teaches a topical composition for treating pain comprising an NSAID in additional to a muscle relaxant including cyclobenzaprine. See prior art claim 1. Further, the composition can comprise ibuprofen, DMSO, and cyclobenzaprine. The concentrations can be 1-10%, 1-10%, and 0.1-10%, respectively. See prior art claim 12.
Sinai teaches a composition for topical administration that can be in the form of a gel. See par.’s 30 and 32. The composition comprises cannabidiol (CBD) or a derivative thereof. See par. 12. Additionally, the composition can be administered with an additional agent including cyclobenzaprine. See par. 73 and prior art claim 92.
Plakogiannis teaches topical compositions for treating pain that can comprise NSAIDs and CBD. See par. 71. The formulation can be in the form of a gel, e.g. See par. 85. An active agent can be from as low as 0.1% CBD and an additional agent including an NSAID, such as aspirin and/or ibuprofen. See prior art claims 1 and 22.
Ozturk teaches topical pain relieving compositions that include an analgesic. Including aspirin in an amount of 3-6%. See par. 13. Further, a composition can include cyclobenzaprine in an amount of 1-3% or 2-4%. See par.’s 11-13. See prior art claims 19, 23, 28, 32, and 39. The composition can be in the forms of a gel or other form. See par. 21.
Similarly, Ray, II, teaches topical compositions for treating pain and inflammation. The composition can comprise and NSAID and a muscle relaxant. See Abstract. Aspirin and derivatives can b e used in a concentration of as low as 0.01%. See par. 29. Further, cyclobenzaprine can be used in a concentration as low as 0.01%. See par. 45. A transdermal gel is contemplated as well. See par. 82, 84, and others.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed compositions and methods in view of the Hitchcock, Niazi, Sinai, Plakogiannis, Ozturk, and Ray, II. One would be motivated to do so because each of the claimed agents are taught to be included in compositions that are topically applied to a subject to ameliorate pain and/or inflammation. Further, the concentrations of teach component claimed is taught for use at a concentrations that overlaps the claimed concentrations. According to M.P.E.P. § 2144.05, “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).” The uses of NSAIDS, including ibuprofen and aspirin, as well as CBD, and cyclobenzaprine for ameliorating pain when administered topically at claimed concentrations is known in the art. According to M.P.E.P. § 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Even further, glycerol, DMSO, lactic acid, chitosan and/or chitosan powder, and water are each taught to be used in a topical formulation in an analgesic gel to alleviate pain. As such, there is a reasonable and predictable expectation of success in arriving at the claimed products and using those products by topically applying them to a claimed subject. There is no allegation of unexpected results.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628