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 .
Priority
This application filed 08/13/2024 is a national stage application of PCT/US2022/034932, filed 06/24/2022, which claims the benefit of provisional application 63/214,567, filed 06/24/2021.
Information Disclosure Statement
No information disclosure statement (IDS) has been filed.
Claim Objections
Claims 2 and 13 objected to because of the following informalities:
Claim 2 needs a period ,“.” at the end of the claim.
Claim 13 states “is administered is administered”, should state “is administered” only once.
Appropriate correction is required.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Edelson (Jonathan Edelson, “Methods to Treat, Prevent, And Improve Skin Conditions”, US 20150313819 A1, Pub. Date: 2015-11-05) in view of Bencherif (Merouane Bencherif et al., “Methods of Treating Bladder Disorders”, US 20130253067 A1, Pub. Date: 2013-09-26).
Regarding Claims 1-12, Edelson teaches nicotinic antagonists of acetylcholine receptors for the treatment of skin conditions (Abstract). Mecamylamine is disclosed as a nicotinic acetylcholine receptor antagonist (Pg.1 [006]).
Acne, excess sebum production, seborrhea, sebaceous hyperplasia, seborrheic dermatitis, sebaceous adenoma, sebaceous carcinoma, sebaceous cysts, wrinkles, oily skin, and enlarged pores are disclosed in Edelson as skin conditions that can be treated with antagonists of acetylcholine receptors (Pg. 1 [0006]).
Regarding Claim 13, Edelson discloses “topical, injected, oral and transmucosal administration” of the acetylcholine receptor antagonist (Pg. 1 [0006]).
Edelson does not teach dexmecamylamine as a nicotinic acetylcholine receptor antagonist.
Bencherif teaches Dexmecamylamine, substantially free of exo-R-mecamylamine, used as a nicotinic acetylcholine receptor to treat bladder disorders, and discloses topical administration (Pg. 2 [0014] and Pg. 9 [0103])).
Because Bencherif teaches Dexmecamylamine administered topically, it is understood to be suitable for applications to human skin.
Regarding Claims 1-13, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to take the known method of administering mecamylamine to treat skin conditions disclosed in Edelson, and substitute dexmecamylamine disclosed in Bencherif because dexmecamylamine and mecamylamine are both known nicotinic acetycholine receptor antagonists, and dexmecamylamine is known in the art for its application for human skin. One of ordinary skill in the art could have substituted one known element for another to yield predicable results, because both compounds have the same mechanism of action and are suitable for human skin, so they can be used dermalogically.
Regarding Claims 21 and 22, they recite the intended biological test results of the method of Claim 1, but do not provide further limitations. The court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Therefore, if the method of Claim 1 is rejected as obvious over the prior art, the limitations of Claims 21 and 22 that recite the intended results of the method of claim 1 are also rejected as obvious over the prior art.
Claim 16 is are rejected under 35 U.S.C. 103 as being unpatentable over Edelson (Jonathan Edelson, “Methods to Treat, Prevent, And Improve Skin Conditions”, US 20150313819A1, Pub. Date: 2015-11-05) in view of Bencherif (Merouane Bencherif et al., “Methods of Treating Bladder Disorders”, US 20130253067 A1, Pub. Date: 2013-09-26) as applied to claim 1 above, and further in view of Gupta (Deepak Gupta et al., “Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations”, Molecules, Volume 23, Issue 7, Pub. Date: 7/14/2018, Pgs. 1-15).
In addition to the teachings of Edelson and Bencherif above, Regarding Claim 16 Bencherif teaches dexmecamylamine or a pharmaceutically acceptable salt (Pg. 2 [0016]).
The combination of Edelson and Bencherif does not disclose administering hydrochloride as a pharmaceutically acceptable salt of dexmecamylamine to treat the claimed skin conditions.
Gupta teaches hydrochloride salt as a known pharmaceutically acceptable salt, that increases the solubility of the parent drug (Pg. 6, 2.8 Solubility and Dissolution Rate).
Regarding Claim 16, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to administer a pharmaceutically acceptable salt of dexmecamylamine as disclosed in Bencherif, to arrive at the hydrochloride salt of dexmecamylamine in instant Claim 16 because Gupta teaches hydrochloride salts as pharmaceutically acceptable salts and teaches they increase the solubility of the parent drug. One of ordinary skill in the art would be motivated to increase the solubility of the parent drug to boost bioavailability, therefor rendering Claim 16 obvious.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Edelson (Jonathan Edelson, “Methods to Treat, Prevent, And Improve Skin Conditions”, US 20150313819A1, Pub. Date: 2015-11-05) in view of Bencherif (Merouane Bencherif et al., “Methods of Treating Bladder Disorders”, US 20130253067 A1, Pub. Date: 2013-09-26) as applied to claim 1 above, and further in view of Endly (Dawnielle Endly et al., “Oily Skin: A review of Treatment Options”, Journal of Clinical and Aesthetic Dermatology, volume 10, Issue 8, Pub. Date: 8/1/2017, Pgs. 49-55).
Edelson does not teach a quantity of sebum production that qualifies as excessive, for treatment with mecamylamine, a nicotinic acetylcholine antagonist and Bencherif does not teach treatment of skin disorders with decamylamine, a nicotinic acetylcholine antagonist.
Endly teaches “when sebum production exceeds 1.5mg/10cm2 every three hours, it is considered excessive and results in seborrhea or oily skin” (Pg. 50, Sebaceous Gland Anatomy and Physiology). Sebum production of 1.5 mg/10cm2, is equivalent to 150 µg/cm2.
Regarding Claims 19 and 20, it would have been prima facie obvious for one of ordinary skill in the arts before the effective filing date to treat a patient with the amount of excess sebum disclosed in Endly, because Edelson teaches nicotinic acetylcholine antagonists for treating skin conditions and Bencherif teaches dexmecamylamine as a nicotinic acetylcholine antagonist. Therefore, it would have been obvious to treat a subject having excess sebum production in the range disclosed in Endly, because Edelson and Bencherif teach a method of treating excess sebum production with dexmecamylamine.
Claim 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Edelson (Jonathan Edelson, “Methods to Treat, Prevent, And Improve Skin Conditions”, US 20150313819 A1, Pub. Date: 2015-11-05) in view of Bencherif (Merouane Bencherif et al., “Methods of Treating Bladder Disorders”, US 20130253067 A1, Pub. Date: 2013-09-26) as applied to claim 1 above, and further in view of Peters (Dan Peters et al., “Novel Azabicyclic Aryl Derivatives and Their Medical Use”, US 2007029982 A1, Pub. Date: 12/27/2007).
Edelson and Bencherif do not teach an oral dosage amount for mecamylamine or dexmecylamine for the treatment of skin conditions like acne.
Peters teaches “ligands and modulators are useful for the treatment of diseases or disorders related to the cholinergic receptors, and in particular the nicotinic acetylcholine
receptor (nAChR)” (Pg.5, [0090]).
Peters also teaches the compounds of the present invention can be antagonists of the nicotinic acetylcholine receptor (Pg. 5, [0091]).
Peters teaches antagonists of the nicotinic acetylcholine receptor for the treatment of acne and inflammatory skin diseases (Pg.6, [0097]).
Peters teaches a pharmaceutical composition containing 0.1 to about 500 mg of active ingredient per dose (Pg. 6, [0107]).
The dosage range of nicotinic acetylcholine antagonists disclosed in Peters overlaps with the dosage range of 0.1 mg to 16 mg of dexmecamylamine disclosed in instant Claim 14.
The courts found that, 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.
Regarding Claim 14, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to optimize the dosage range of 0.1 mg to 500 mg of nicotinic acetylcholine antagonists as disclosed in Peters, to arrive at the claimed dosage range of 0.1 mg to 16 mg in instant Claim 14, because Peters and instant claim 14 use the same method of treating skin conditions like acne, and dexmecamylamine is a known nicotinic acetylcholine antagonist. Also, the dosage range of the current invention overlaps with the range disclosed in Peters therefore Claim 14 is rendered obvious.
Regarding Claim 15, Edelson teaches “In some embodiments, a therapeutically effective agent may be formulated and/or administered in a plurality of doses, for example, as part of a dosing regimen” (Pg. [0026]), but does not teach a specific time period for dosage administration.
Regarding Claim 15, it would have been obvious for one of ordinary skill in the art before the effective filing date to use the dosage disclosed in Peters and combine it with the method disclosed in Edelson for treating skin conditions with nicotinic acetylcholine antagonists as part of a dosing regimen to arrive at the dosage duration of two weeks or more in instant claim 15, because dosage duration is considered obvious to optimize for one of ordinary skill in the art based on the severity of the conditions you are treating.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIERRA M ROCHELLE whose telephone number is (571)272-9962. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/C.M.R./Examiner, Art Unit 1627 /Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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