DETAILED ACTION
Claims 1-17 are pending and under consideration on the merits.
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 Rejections
The claim objections are withdrawn in view of the amendment.
The112(b) rejections are withdrawn in view of the amendment.
The 102 rejection is withdrawn in view of the amendment.
The 103 rejection over Hansen is withdrawn in view of the amendment, and the rejection over Hansen in view of Sela is revised in view of the amendment and expanded to include newly added claim 17.
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.
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 1-17 are rejected under 35 U.S.C. 103 as unpatentable over Hansen et al. (US Pat. Pub. 2019/0254985) in view of Sela et al. (US Pat. Pub. 2020/0170994.
As to claims 1-17, Hansen discloses a transmucosal patch comprising electrospun fibers comprising a biocompatible fiber-forming polymer, the patch further comprising a therapeutically effective amount of a drug substance as an active pharmaceutical ingredient that may be an opioid of claims 1 and 3 (see Abstract, paragraphs 45-47, 284, and 290). Hansen teaches that the release rate of drug from the patch may be immediate release or modified release and that a slower release may be obtained by using coaxial injection during the manufacturing method instead of a simple needle nozzle (paragraphs 137 and 145), and paragraph 102 of the present specification as filed discloses that the use of coaxial injection results in a core shell structure with the active forming the core covered by a polymer shell as recited by claim 1, and further teaches that this results in a patch that is particularly suitable for controlled release administration.
Regarding claim 2, Hansen teaches that the patch is suitable for application to the oral mucosa, which would involve either buccal or sublingual application as recited by the claim (paragraph 284).
Regarding claims 3-4, Hansen teaches that the active may comprise an opioid and that more than one drug may be used in combination, and further discloses examples of other drugs that may be used which are not opioids or cannabinoids, for example, other pain relieving agents such as NSAIDs (see paragraphs 236, 290)
As to claims 8-9, Hansen further teaches the use of biocompatible polymers that would dissolve upon contact with saliva (claim 8) such as methacrylic acid-ethyl acrylate copolymers (paragraphs 61-62), as well as biocompatible polymers that would not dissolve and would stay intact when in contact with saliva (claim 9) such as ethylcellulose (paragraphs 56-58).
As to claims 10-14, the recitations that the patch is for use as a medicament (claim 10) or for the treatment or prophylaxis of symptom burden in a patient suffering from a symptoms generating disease (claim 11) such as one of the symptoms of claim 12 such as pain (claim 13), or as a second or third line or adjunctive/add-on treatment of cancer or ALS (claim 14) or wherein the disease is ALS (claim 17), are all merely intended uses of the claimed composition, and as such are not granted any additional patentable weight since the Hansen transmucosal patch is capable of being used for any of these purposes and the recited uses do not place any additional structural limitations on the patch.
Regarding claim 15, Hansen teaches a process for preparing the patch comprising dissolving the biocompatible polymer in a solvent to obtain a solution, providing a liquid containing a dissolved drug, and electrospinning the solutions to obtain a patch comprising electrospun fibers comprising the drug active (paragraphs 204-208). Hansen further teaches that the electrospun fibers may be formed by coaxial electrospinning and discloses that doing so can alter the release of the drug from the fibers from immediate release to modified release (paragraphs 137, 145, 157, 172).
As to claims 1-17, Hansen does not further does not expressly disclose that the electrospun fibers have a core-shell structure with the biocompatible polymer forming the shell and the active pharmaceutical ingredient forming the core, nor that the active comprises a cannabinoid, all as recited by claims 1 and 5, such as the active consisting of a cannabinoid and an opioid (claim 3) or a combination of THC and CBD (claim 6) in a weight ratio of 20:1 to 1:20 (claim 7) such as 1:1 (claim 16).
Sela discloses sublingual mucoadhesive compositions for the delivery of cannabinoids including THC and CBD (paragraph 18), and teaches that the compositions are useful for the treatment of neuropathic pain or inflammation such as may result from chemotherapy, as well as for the treatment of epilepsy, Parkinson disease, seizures, epilepsy and PTSD (paragraphs 22-25). Sela discloses a specific embodiment of a THC:CBD weight ratio of 1:1, which reads on the ranges of claims 7 and 16 (paragraph 101).
As to claims 1-17, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Hansen patch by incorporating by incorporating as actives THC and CBD in a weight ratio of 1:1 in addition to the opioid active taught by Hansen, because Sela teaches that THC and CBD are useful for the treatment of pain when delivered transmucosally in a weight ratio of 1:1, such that the skilled artisan reasonably would have expected that such a modification would provide pain relieving properties that are complementary to those of the opioid analgesic in the Hansen transmucosal patch.
The resulting composition will possess electrospun fibers having a core-shell structure with the biocompatible polymer forming the shell and the active pharmaceutical ingredient forming the core as recited by claim 1, because it comprises the same ingredients recited by the claims and is formed by a process comprising the same steps recited by process claim 15, and because Hansen expressly teaches achieving a controlled release delivery by using coaxial injection during the manufacturing process, and the present specification teaches that the use of coaxial injection results in electrospun fibers having a core-shell structure with the biocompatible polymer forming the shell and the active pharmaceutical ingredient forming the core as discussed above.
Response to Applicant’s Arguments
Applicant argues that none of the cited references disclose or suggest electrospun fibers with cannabinoids as active agent.
In response, the references must be considered not individually but rather for what they teach as a whole. The reference relies on Sela for its teaching that cannabinoids are useful for treating pain, and the rejection provides a motivation to incorporate cannabinoids as an active into the Hansen patch because the skilled artisan reasonably would have expected that such a modification would provide pain relieving properties that are complementary to those of the opioid analgesic in the Hansen transmucosal patch.
Applicant argues that the cited art does not suggest the core-shell configuration recited by the claim nor recognize the resulting controlled release behavior. Applicant acknowledges that Hansen mentions coaxial electrospinning as a possible technique, it does not associate this technique with the formation of a core shell structure for achieving controlled release. Applicant alleges that Hansen does not address controlled release via the architecture of the polymer fibers such that there would have been no motivation to modify Hansen’s fibers into a core shell system by using coaxial electrospinning.
In response, and as discussed in the revised rejection, Hansen does in fact address controlled release via the architecture of the polymer fibers by stating that controlled release can be obtained by using coaxial injection, and the present specification acknowledges that this will result in the claimed core-shell structure. The skilled artisan reading Hansen and wishing to obtain controlled release properties would therefore have been motivated to use coaxial spinning, and the resulting fibers will possess a core-structure configuration regardless of the fact that Hansen does not expressly teach that the fibers will have this configuration.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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