DETAILED ACTION
Claims 1-16 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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/15/2024 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Claim Objections
Claims 6-7, 11, 14, and 16 are objected to because of the following informalities:
Claims 6-7 and 16 recite the abbreviations THC and CBD, and claims 11 and 14 recite the abbreviation ALS, without identifying what these abbreviations stand for. The first instance of any abbreviation in the claims should be accompanied by the fully spelled out term. Correction is required.
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 7, 11-12, and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 7 recites “the ratio,” which is indefinite because it is unclear what type of ratio is being referenced, e.g., is it a weight ratio? Clarification is required. For the purpose of examination, the claim has been interpreted as referring to a weight ratio.
Claim 11 recites “in particular” in line 3, which renders the metes and bounds of the claim indefinite, because it is unknown whether the following clause is a required or optional element of the claims. See MPEP 2173.05(d). Clarification is required. Since claim 12 depends from claim 11 but does not clarify the point of confusion, it is also rejected.
Claim 14 recites “said treatment.” There is no antecedent basis for this limitation. Clarification is required.
Claim 15 recites “a biocompatible polymer” in steps (a), (b), and (c), but base claim 1 already recites a biocompatible polymer. Is the “biocompatible polymer” of claim 15 the same as the biocompatible polymer of claim 1? If so, claim 15 should recite “the biocompatible polymer” since there is already antecedent basis in claim 1. Clarification is required. For the purpose of examination, the claim has been interpreted as referring to the same biocompatible polymer recited by claim 1.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
Claim 15 recites a method of preparing the patch of claim 1 comprising the steps of providing a solution of a biocompatible polymer and providing a liquid comprising the active, followed by electrospinning the biocompatible polymer to produce a fiber comprising the polymer. The claim fails to recite, however, what happens to the liquid comprising the active. Base claim 1 recites that the patch comprises electrospun fibers comprising a biocompatible polymer and a pharmaceutical active ingredient, but the method of claim 15 as written produces only a patch comprising electrospun fibers comprising the biocompatible polymer, and therefore fails to produce the patch of claim 1. Additionally, the method of claim 15 produces “a fiber comprising said polymer” in the singular in the final step, while the patch of base claim 1 comprises “electrospun fibers” in the plural. Therefore, claim 15 fails to produce the patch of claim 1 for this additional reason. Consequently, the method of claim 15 is missing essential steps. Clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 recites only that that the active is “a cannabinoid or an opioid or a cannabinoid and an opioid,” but this limitation is already present in base claim 1. Therefore, claim 3 fails to further limit claim 1, which is improper.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3 and 10-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Hansen et al. (US Pat. Pub. 2019/0254985; of record in IDS).
As to claims 1-3 and 10-15, 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).
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).
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), 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).
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 1-4 and 8-15 are rejected under 35 U.S.C. 103 as unpatentable over Hansen et al. (US Pat. Pub. 2019/0254985).
The teachings of Hansen are relied upon as discussed above. Hansen further teaches that the electrospun fiber patch may comprise more than one drug (paragraph 165), but Hansen does not further expressly disclose a specific embodiment wherein an opioid is used in combination with an additional active, and which is not an opioid or a cannabinoid as recited by claim 4. Additionally, 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), but Hansen does not further expressly disclose a specific embodiment wherein such polymers are used in combination with an opioid as the active as required by claims 8-9 via their dependence from claim 1.
As to claim 4, 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 selecting an opioid as the active in combination with an additional active that is not an opioid or a cannabinoid, because Hansen expressly 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 paragraph 236).
As to claims 8-9, 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 selecting an opioid as the active and methacrylic acid-ethyl acrylate copolymers or ethylcellulose as the biocompatible polymers so as to produce a patch reading on claim 8 or claim 9, because Hansen expressly teaches that these polymers may be used as the biocompatible polymer and that the active may be an opioid. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." (325 U.S. at 335, 65 USPQ at 301). MPEP § 2144.07.
Claims 5-7 and 16 are rejected under 35 U.S.C. 103 as unpatentable over Hansen et al. (US Pat. Pub. 2019/0254985) as applied to claims 1-4 and 8-15 above, and further in view of Sela et al. (US Pat. Pub. 2020/0170994; published 6.4.2020).
The teachings of Hansen are relied upon as discussed above, but Hansen does not further expressly disclose that the active comprises a cannabinoid (claim 5) such as 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 5-7 and 16, 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 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.
Conclusion
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