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 .
This application is a domestic application, filed 27 June 2024; and claims benefit as a CON of 17/856,537, filed 01 July 2022, issued as Patent 12,030,908; which claims benefit as a CIP of 17/234,430, filed 19 April 2021, issued as Patent 11,377,468; which claims benefit as a CIP of 16/941,627, filed 29 July 2020, issued as Patent 10,981,943; which claims benefit as a CON of 16/505,497, filed 08 July 2019, issued as Patent 10,752,651; which claims benefit as a CON of 15/919,138, filed 12 March 2018, now abandoned; which claims benefit of provisional application 62/470,025, filed 10 March 2017; and claims benefit of provisional application 62/470,039, filed 10 March 2017.
Claims 23-42 are pending in the current application and are examined on the merits herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 23-24, 26-28, and 41-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,752,651.
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-14 are drawn to a compound of formula (I) as claimed. Reference claim 5 recites the pharmaceutically acceptable sodium salt corresponding to claims 41-42. Reference claim 12 recites the pharmaceutical composition includes at least one additional active ingredient, corresponding to claim 28. Reference claims 13-14 recite the pharmaceutical composition is adapted for topical administration such as lotion, gel, cream, ointment, oil, solution, or suspension, corresponding to claims 24 and 26-27.
The specification of U.S. Patent No. 10,752,651 also provides a method of treating otitis externa in a patient in need thereof. In some embodiments, the method comprises administering an effective amount of a compound of the present disclosure to the patient (column 26, lines 60-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to look to the disclosed utility in the reference disclosure to determine what method of using the claimed compound would have been obvious. MPEP 804 at II.B.1. provides “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).” and “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.” Further, Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003) provides “[t]he [reference] patent’s claim describes a compound, and [the reference patent’s] written description discloses a single utility of that compound … The [later expiring] patent claims nothing more than [the reference patent’s]disclosed utility as a method of using the [reference patent’s] compound. Thus, the claims of the [reference patent] and [later expiring] patents are not patentably distinct.” 349 F.3d at 1386. In this case, the reference patent’s specification discloses the uses of the claimed compound such as the method of treating otitis externa, and for analogous reasoning the disclosed method of using the reference claim compound would have been obvious over the claimed compound.
Claims 25 and 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,752,651 in view of Dale (US 2011/0135713, published 09 June 2011, provided by Applicant in IDS mailed 27 June 2024).
Reference claims 1-14 recite as above.
Reference claims 1-14 do not specifically recite the method wherein the administration is topical administration directly into the patient's external ear canal (claim 25). Reference claims 1-14 do not specifically disclose the dosing regimen (claims 29-39). Reference claims 1-14 do not specifically disclose the patient is a human (claim 40).
Dale teaches protonated compounds having antiviral and antimicrobial activity (abstract). Dale teaches compounds such as structure 3A or 3B (page 2, paragraph 15). The invention provides the use of the described protonated compounds as active ingredients in a topical skin cream (page 4, paragraph 37). The specific topical delivery system used depends on the location of the bacteria, and it is well within the skill of one in the art to determine the location of the bacteria and to select an appropriate delivery system (page 10, paragraph 107). Administration of the composition will introduce the compounds of the invention to the mammal in a diluted amount. Exemplary unit dosages for oral, injectable, aerosol, or topical administration may be more than about 0.01, 0.05, 0.1, 0.5, 1, or 5 mg/kg, and/or less than about 10, 5, 1, 0.5, 0.1, or 0.05 mg/kg (page 11, paragraph 127). When topically administered, one dosage unit may be administered once every 10,9,8,7,6, 5, 4, 3, 2, or one day, or 1,2,3,4,5,6,7,8,9, 10, or more than 10 times per day until relief is achieved or until the symptoms disappear or are satisfactorily attenuated (page 12, paragraph 130). Animal hosts that may be treated using the compositions of the present invention include particularly humans (page 12, paragraph 140).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Reference claims in view of Dale in order to select the administration and dosing regimen through routine experimentation. One of ordinary skill in the art would have been motivated to combine Reference claims in view of Dale with a reasonable expectation of success because both the Reference claims and Dale teach a compound within the scope of structure 3A or 3B for topical treatment of a bacterial infection, and Dale suggests it would have been obvious to one of ordinary skill in the art to select the appropriate location and regimen for treatment through routine experimentation.
Claims 23-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,981,943 in view of Dale (US 2011/0135713, published 09 June 2011, provided by Applicant in IDS mailed 27 June 2024) and Klein (Klein, J.O. in Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, 2018, Eighth Edition, volume 1, pages 767-773.e1, cited in PTO-892).
Reference claims 1-20 recite a method of treating an infection in a patient in need thereof, the method comprising administering to the patient an effective amount of a compound having the claimed formula (I). Reference claims 3 and 5-6 recite the administration is topical, corresponding to limitations of claims 24 and 26-27. Reference claim 8 recites the patient is administered at least one additional active ingredient, corresponding to claim 28. Reference claims 9-17 recite the administration regimen, corresponding to claims 29-39. Reference claim 18 recites the patient is a human, corresponding to claim 40. Reference claims 19-20 recite the salt is a sodium salt, corresponding to claims 41-42.
Reference claims 1-20 do not specifically recite the infection is otitis externa (claim 23). Reference claims 1-20 do not specifically recite the method wherein the administration is topical administration directly into the patient's external ear canal (claim 25).
Dale teaches as above. Dale further teaches examples of bacterial organisms against which the methods and compositions of the invention are effective include gram positive bacteria, gram negative bacteria, and acid-fast bacteria, and include members of the Staphylococcus, Streptococ-cus, and Pseudomonas genera, and particularly, Staphylococcus aureus (paragraph 141 spanning pages 12-13). Dale further teaches in the background of the invention that bacterial infections of concern include otitis media (page 1, paragraph 4).
Klein teaches the level of skill in the art regarding otitis externa, otitis media, and mastoiditis. Klein teaches localized infections of otitis externa can be treated with antibiotic solutions (page 767, abstract). Infection of the external auditory canal (otitis externa) is similar to infection of skin and soft tissue elsewhere (page 767, left column). In acute localized otitis externa S. aureus is the most frequent pathogen. Erysipelas caused by group A Streptococ-cus may involve the concha and the canal. Gram-negative bacilli, mainly P. aeruginosa, may play a significant role in acute diffuse otitis externa (page 768, left column, paragraph 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-20 in view of Dale and Klein in order to select the method of treating an infection to be a method of treating otitis externa, and to select the route of administration through routine experimentation. One of ordinary skill in the art would have been motivated to combine Reference claims 1-20 in view of Dale and Klein with a reasonable expectation of success because the Reference claims and Dale teach a compound within the scope of structure 3A or 3B for topical treatment of an infection, Dale teaches the pertinent field of art includes ear infections such as otitis media and suggests one of ordinary skill in the art would have selected the appropriate location for treatment, and Klein teaches otitis externa is caused by bacterial infections taught to be treated by the compound by Dale. Therefore it would have been obvious to one of ordinary skill in the art to select the infection treated according to the Reference claims to be otitis externa based on the suitability of treating that specific type of infection taught by Dale and Klein.
Conclusion
No claim is currently in condition for allowance.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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