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 18, 20, and 76-86 are pending.
Claims 20 and 76 are withdrawn from consideration as directed to non-elected inventions.
Claims 18 and 77-86 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to kits containing two cannabinoid compositions in a pharmaceutically acceptable carrier or excipient, where one of the compositions has a higher viscosity than the other. Dependent claims narrow the identity of the cannabinoid to be present in the composition(s), require any of a variety of additional components be present in the compositions, or specify the physical form the composition is to take.
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.
Claims 18, 77, 79, 82, and 84-86 are rejected under 35 U.S.C. 103 as being unpatentable over Gunther (WO2018/060282), in view of Gullion (M. Gullion & S. Shah, Rationale for 24-Hour Management of Dry Eye Disease: A Review, 42 Cont. Lens Ant. Eye 147 (2019)).
Gunther describes kits containing compositions containing a cannabinoid receptor binding ligand for use in the treatment of keratoconjunctivitis sicca, or dry eye disease. (Abs., Pg.1, 8-10). Gunther indicates that the standard of care for the treatment of dry eye is eye drop formulations containing antiinflammatory agents per the requirements of Claim 84. (Pg.5). Gunther indicates that inflammation and microbial contamination can follow the onset of dry eye disease. (Pg.2). Particularly useful cannabinoid receptor binding ligands for use in these compositions is the cannabidiol of Claim 77 as well as the polyphenol epigallocatechin gallate (EGCG) of Claim 79. (Pg.11). Gunther indicates these active agents may be present in these compositions in concentrations of between 0.001-1% of the composition, a range overlapping and therefore rendering obvious the concentration limitations of the claims. (Pg.14), See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Gunther indicates these compositions advantageously take the form of liquids per the requirements of Claim 86, and may include antioxidants, alpha tocopherol, and preservatives. (Pg.19-20). While the particular concentrations of polyphenols or alpha tocopherols of Claims 79 and 82 are not recited, by indicating that these components are included to provide particular properties to the compositions containing them, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Gunther. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
Despite suggesting kits containing liquid ophthalmic solutions of cannabidiol combined with non-steroidal antiinflammatory agents, polyphenols, alpha tocopherols, antioxidants for use in the treatment of dry eye disease, Gunther does not suggest providing multiple compositions of differing viscosity in such a kit.
This is cured by the teachings of Gullion, which indicates that effective treatment of dry eye disease must be matched to the severity of the disease and to the environment eye are subjected to over a 24 hour period, with relatively nonviscous artificial tears to be used to moisturize the ocular surface and reduce damage to the corneal epithelium during the day, and a more viscous gel material for use at the right time to provide longer ocular retention time. (Abs.)
The skilled artisan would therefore be motivated to provide each of a relatively non-viscous artificial tear as well as a viscous gel in the kits of Gunther, because the skilled artisan would be aware that providing a kit for treatment of dry eye disease such as is suggested by Gunther would be improved, per the teachings of Gullion, by having a formulation suitable for each of daytime and nighttime use.
Claims 18, 77-80, and 82-86 are rejected under 35 U.S.C. 103 as being unpatentable over Gunther and Gullion as applied to claims 18, 77, 79, 82, and 84-86 above, and further in view of Dut Jasuja (Nakuleshwar Dut Jasuja, et al, A Review on Bioactive Compounds and Medicinal Uses of Commiphor mukul, 7 J Plant Sci. 113 (2012)).
Gunther and Gullion, discussed in greater detail above, suggest kits containing a non0viscous artificial tear and a viscous gel containing cannabidiol combined with non-steroidal antiinflammatory agents, polyphenols, alpha tocopherols, antioxidants for use in the treatment of dry eye disease.
Neither Gunther not Gullion indicates that additional agents such as alkaloids, sitosterol, linalool, or alpha terpeineol may be used in these compositions.
However, Dut Jasuja indicates that the alkaloids recited by Claim 83 are known to possess antimicrobial activity. (Pg.114). B-sitosterol of Claim 80 is known to possess antiinflammatory properties. (Pg.127). Each of the linalool and alpha terpeineol of Claim 78 are known to possess antimicrobial properties. (Pg.128). Because each of inflammation and microbial infection are known sequelae of dry eye disease, it would have been prima facie obvious to have included any of the antimicrobial alkaloids, linalool, and alpha terpeineol, or the antiinflammatory B-sitosterol in the dry eye treating compositions in the kit suggested by Gunther. This is because not only does Gunther invite the inclusion of useful excipients, but also establishes that inflammation and infection are known pathologies associated with dry eye disease. Incorporating agents known to be useful in the treatment of these pathologies appears to be the result of a recognition that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983). While the particular concentrations of terpenes or sitosterol of Claims 78 or 80 are not recited, by indicating that these components are included to provide particular properties to the compositions containing them, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Gunther. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
Claims 18 and 77-86 are rejected under 35 U.S.C. 103 as being unpatentable over Gunther, Gullion, and Dut Jasuja as applied to claims 18, 77-80, and 82-86 above, and further in view of Doroudian (U.S. PGPub. 2018/0360757).
Gunther, Gullion, and Dut Jasuja, discussed in greater detail above, suggest kits containing a non0viscous artificial tear and a viscous gel containing cannabidiol combined with non-steroidal antiinflammatory agents, polyphenols, alpha tocopherols, antioxidants, alkaloids, sitosterol, linalool, and alpha terpeineol for use in the treatment of dry eye disease.
Neither Gunther, Gullion, and Dut Jasuja indicates that additional agents such as methyl salicylate may be used in these compositions.
This is cured by the teachings of Doroudian, which teaches cannabinoid compositions useful for topical, which includes ocular, administration. [0106]. Cannabidiol is enumerated as one of the many cannabinoids suitable for formulation in such a manner. [0074]. Treatment of dry eye disease is listed among the various uses to which these cannabinoid compositions may suitably be put. [0113]. Doroudian indicates that the methyl salicylate of Claim 81 is known to be useful as a penetration enhancing agent in these formulations. [0129]. While the particular concentrations of methyl salicylate of Claim 81 is not recited, by indicating that this component is included to provide a particular property, namely increased penetration, to the compositions containing them, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Gunther. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
It therefore would have been prima facie obvious to have included a penetration enhancing agent such as methyl salicylate in the topical ophthalmic compositions in the kits suggested by the teachings of Gunther, Gullion, and Dut Jasuja, owing to the expectation that such inclusion would increase the absorption, and therefore efficacy, of compositions so formulated.
Response to Arguments
Applicant's arguments filed 7 January 2026 have been fully considered but they are not persuasive.
Applicants assert that a skilled artisan reading Gunther would be convinced that viscous ophthalmic formulations are suitable only for use as artificial tears and not as carriers for pharmaceutical agents. This conclusion is unsupported by the Gunther disclosure. Even the portion of Gunther reproduced by applicants indicates that the management of KCS relies on both non-pharmacological and pharmacological approaches to treatment. This flexible and expansive consideration of the entirety of the Gunther disclosure is further bolstered throughout the Gunther disclosure, which explicitly indicates that the object of the invention is to provide pharmaceutical compositions for the treatment of a broad variety of ophthalmic diseases including KCS containing cannabinoids such as are required by the claims (Pg.8), which are provided in a variety of viscosities. (pg.17, L.25-26). Because Gunther explicitly indicates that viscous ophthalmic compositions are known to be useful for the treatment of dry eye diseases like KCS, while also describing the use of suitably viscous ophthalmic compositions containing cannabinoids for the treatment of dry eye disorders including KCS, the use of viscous cannabinoid containing ophthalmic compositions is prima facie obvious. To this knowledge the teachings of Gullion add the understanding that compositions of varying viscosities can usefully be employed to provide treatment of dry eye diseases like KCS by permitting a more viscous composition to be used at one time of day, and a less viscous composition for another period of the day. Applicants are reminded that it is not possible to establish the non-obviousness of an invention rendered obvious by the combined teachings of multiple prior art references by arguing that each of the references relied upon fails to teach the entirety of the invention which has been claimed; the absence of a single anticipatory reference is implied by both the reliance on the combined teachings of multiple references as well as the fact that the rejection being made is one of obviousness under 35 U.S.C. 103 rather than any of the subsections of 35 U.S.C. 102. MPEP § 2145(IV), see In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981) (citing Application of Young, 403 F.2d 754, 757 (C.C.P.A. 1968) (indicating that "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references"). As such, it is irrelevant that neither Gunther nor Gullion teach the entirety of the invention claimed; the Examiner at no point in time has asserted they do. The Examiner instead concludes that nothing of the present claims falls outside what a skilled artisan would conclude is little more than the use of prior art elements, each according to their established functions, with the result nothing more than a skilled artisan would expect given the scope of knowledge provided by the combined teachings of Gunther and Gullion, either alone or in further consideration of the teachings of Dut Jasuja and Doroudian.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614