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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claim amendments on 11/6/2023. Claims 1-40 has been cancelled. Claim 41-57 have been added new. Claims 41-57 are examined based on the merits herein.
Application Priority
This application filed on 11/06/2023 is a National Stage entry of PCT/EP2022/ 062266, International Filing Date: 05/06/2022, claims foreign priority to 21172686.4, filed 05/07/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 11/6/2023 (2), 01/04/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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.
Claim(s) 41-52, 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson & Johnson (IDS: https://www.jnj.com/media-center/press-releases/fda-approves-nucynta-er-tapentadol-extended-release-oral-tablets-for-the-management-of-neuropathic-pain-associated-with-diabetic-peripheral-neuropathy, Aug 29 2012) in view of Odriozola (Diabetes Research and clinical Practice, 2021, available online Dec 2020) and Ozdag Acarli et al. (Arch Neuropsychiatry 2020;57:154−159).
Johnson & Johnson (J&J) teach NUCYNTA® ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (See para 1, page 1). Tapentadol is a centrally-acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act. NUCYNTA® ER was approved by the FDA in August 2011. It is an oral analgesic available by prescription only for the following indications: the management of moderate to severe chronic pain in adults and the management of neuropathic pain associated with DPN in adults, when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. NUCYNTA® ER is taken twice daily and available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths (See p 3, para 1).
The reference is not explicit in teaching the patient population, patient infected with COVID) as claimed.
Odriozola teach that diabetic patients hospitalized with severe COVID-19 infection had developed severe neuropathic symptoms. Severe COVID-19 infection with hypoxemia is associated with neuropathic symptoms and widespread sensory dysfunction in patients with DM (See Abstract). It is taught that diabetic polyneuropathy (DPN) affects over 50% of the diabetic population and affects large and small nerve fibers (p 2, para 2) and neuropathic pain is associated in patients with COVID-19 pneumonia (See p1, para 1, lines 6-7). In conclusion a proportion of patients with diabetes and severe COVID-19 may develop or show worsening of peripheral neuropathy characterized by neuropathic symptoms and small and large fibre dysfunction in the feet and face (see p 6, col. 1, para 2). Odriozola teach treating a COVID-19 patient with lopinavir-ritonavir (see p 4, col. 2, 3.2).
Ozdag Acarli is explicit in teaching that acute severe respiratory failure syndrome (SARS), coronavirus 2 (SARS-Cov-2) are known as coronavirus disease, COVID-19 (see p 154, Introduction, lines 1-2). It is reported that a variety of symptoms and syndromes such as headache, dizziness, confusion, ataxia, epilepsy, ischemic stroke, neuropathic pain (detected in 19 COVID patients, see p 155, col. 2, lines 12-13) and myopathy are common especially in more severe COVID-19 patients (See Abstract).
From the prior art teachings a person skilled in the art before the effective filing date of the invention would have found it obvious to administer an effective amount of tapentadol in subjects with COVID-19, e.g. diabetes to treat neuropathic pain because (i) Johnson and Johnson teach the effects of tapentadol in treating neuropathic pain in diabetic peripheral neuropathy subjects (ii) Odriozola teach that (i) neuropathic pain is associated with COVID-19 (ii) diabetic patients hospitalized with severe COVID-19 infection had developed severe neuropathic symptoms (iii) severe COVID-19 infection with hypoxemia is associated with neuropathic symptoms and widespread sensory dysfunction in patients with diabetes and diabetic polyneuropathy (DPN) affects over 50% of the diabetic population and (iv) Ozdag Acarli teach neuropathic pain is associated with SARS-Cov-2. A person skilled in the art would have been motivated to administer an effective amount of tapentadol in subjects with COVID-19 and diabetes to relieve the symptoms of COVID-19 e.g. neuropathic pain symptoms with a reasonable expectation of success. As to the effective amount, the instant specification in [0058] and [0063], 50-250 mg of tapentadol. The prior art J&J teach 50-250 mg of tapentadol for neuropathic pain treatment. Thus a skilled artisan would have found it obvious to administer an effective amount for e.g. 50-250 mg of tapentadol to treat neuropathic pain in COVID-19 subjects. Thus claims 41-42 are addressed.
As to claim 43, Odriozola teach that severe COVID-19 may develop or show worsening of peripheral neuropathy characterized by neuropathic symptoms. Hence peripheral neuropathy is treated by administration of tapentadol to COVID-19 patients. As to claim 44, neuropathic pain includes chronic pain to be treated.
As to claims 45-47, Odriozola teach treating a COVID-19 patient with lopinavir-ritonavir (see p 4, col. 2, 3.2). Hence a skilled artisan would have found it obvious to administer anti-viral drugs like ritonavir to subjects with COVID-19 to treat viral symptoms. A person skilled in the art would have found it obvious from Ozdag Acarli teachings that SARS Cov-2 is COVID-19.
As to claims 48, a person skilled in the art would have found it obvious to administer an effective amount of tapentadol in a subject suffering from SARS and COVID-19 to treat neuropathic pain because the prior art is explicit in teaching that neuropathic pain is associated with COVID-19 patients. A person skilled in the art would have been motivated to administer an effective amount of tapentadol in subjects with COVID-19 to relieve the symptoms of COVID-19 e.g. neuropathic pain symptoms with a reasonable expectation of success.
As to claims 49-51, 56-57 a person skilled in the art would have found it obvious to administer tapentadol and additional medicament, e.g. lopinavir-ritonavir in treating coronavirus symptoms and neuropathic pain in COVID-19 subjects from the combined teachings of the prior art. A person skilled in the art would have found it obvious to arrive at the claimed method with a reasonable expectation of success and to derive therapeutic benefits. As to claim 52, it would have been obvious to a skilled artisan to treat the neuropathic pain in COVID-19 subjects with acute phase still ongoing for the subject to recover from the symptoms completely.
Claim(s) 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson & Johnson (J&J) (IDS: https://www.jnj.com/media-center/press-releases/fda-approves-nucynta-er-tapentadol-extended-release-oral-tablets-for-the-management-of-neuropathic-pain-associated-with-diabetic-peripheral-neuropathy, Aug 29 2012) in view of Odriozola (Diabetes Research and clinical Practice, 2021, available online Dec 2020) and Ozdag Acarli et al. (Arch Neuropsychiatry 2020;57:154−159) in view of Fame et al. (Annals ATS Volume 17 Number 10| October 2020).
Johnson & Johnson, Odriozola and Ozdag Acarli teachings as discussed above. The above rejections are incorporated herein.
The above references are not explicit in teaching the select agents remdesivir, chloroquine and dexamethasone as the additional active agents in the method.
Fame teach that coronavirus disease (COVID-19) is the illness resulting from syndrome coronavirus 2 (SARS-CoV-2) (See p 1189, col. 1, lines 1-3). The reference teaches that drugs such as remdesivir, chloroquine and dexamethasone can be repurposed to treat COVID-19. It is taught that a case series of 61 hospitalized patients treated with remdesivir off license reported a clinical improvement (p 1187, col. 2); chloroquine or hydroxychloroquine might be effective both early and late in the disease owing to their antiviral and anti-inflammatory effects (See p 1189, col. 2, lines 23-26); dexamethasone and remdesivir have been shown to be effective in the treatment of COVID-19 (See Abstract).
A person skilled in the art before the effective filing date of the invention would have found it obvious to add remdesivir, chloroquine and dexamethasone as additional active agents in combination with tapentadol to treat the viral symptoms in COVID-19 subjects. A person skilled in the art would have been motivated to do so is in expectation of treating the COVID-19 viral symptoms and neuropathic pain with a reasonable amount of success. Thus claims 53-55 would have been obvious over the prior art teachings.
Claim Objections
Claims 41, 46, 48-50 are objected to because of the following informalities:
Claims 41, 46, 48, 49 (in line 2), recite a limitation of ‘corona virus’. It is suggested that the term be changed to ‘coronavirus’, as it is the standard term. Also claim 41 recites a limitation of ‘effective amount therefor of’. It is suggested that the claim be amended to ‘effective amount of’.
Claim 50, line 2 ‘coronavirus 2’ has been misspelled as ‘coronavirus 42’. For examination purposes it has been interpreted as coronavirus 2.
Appropriate correction is required.
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 41-52, 56-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of the following U.S. Patent(s) and or application(s) (see p 11-13 below) in view of Johnson & Johnson (IDS: https://www.jnj.com/media-center/press-releases/fda-approves-nucynta-er-tapentadol-extended-release-oral-tablets-for-the-management-of-neuropathic-pain-associated-with-diabetic-peripheral-neuropathy, Aug 29 2012) in view of Odriozola (Diabetes Research and clinical Practice, 2021, available online Dec 2020) and Ozdag Acarli et al. (Arch Neuropsychiatry 2020;57:154−159).
The instant claims are directed to:
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The dependent claims are limited to specific subject population, pain type, additional medicament, specific additional medicament(s).
The teachings of the reference patent(s) or the reference co-pending application claims as shown below.
Patent/Application
Claims
Representative Claims
1
US 8309060
1, 31-34
An abuse-proofed, thermoformed dosage form comprising one or more active ingredients with abuse potential (A) optionally together with physiologically acceptable auxiliary substances (B), at least one synthetic or natural polymer (C), wherein the polymer (C) has a molecular weight of at least 0.5 million according to rheological measurements, and optionally at least one wax (D), wherein the dosage form exhibits a breaking strength of at least 500 N, wherein A is selected from oxymorphone, oxycodone, tapentadol and the physiologically acceptable salts thereof.
2
US 9675610
1, 14
A solid dosage form for oral administration with reduced potential for parenteral abuse, said dosage form comprising: (a) one or more active ingredients with potential for abuse selected from the group consisting of hydrocodone, morphine, oxycodone, tramadol, tapentadol, and pharmaceutically acceptable salts and/or solvates thereof
3
US 9750701
1-11
A pharmaceutical dosage form with controlled release of a pharmacologically active compound (A) contained therein, the pharmaceutical dosage form wherein the pharmacologically active compound (A) is tapentadol or a physiologically acceptable salt thereof and/or the pharmaceutical dosage form comprises a polyalkylene oxide. Claims 75-77 are to a method of treating pain in a patient in need of such treatment, said method comprising administering to said patient an effective amount therefor of a pharmaceutical dosage form.
4
US 9872835
1-16
An oral pharmaceutical dosage form comprising a pharmacologically active ingredient embedded in a matrix material, wherein: the pharmacologically active ingredient, is selected from the group consisting of oxycodone, oxymorphone, hydrocodone, hydromorphone, tramadol, tapentadol, morphine, buprenorphine, and the physiologically acceptable salts thereof. Claim 14 is to a method for treating pain in a patient in need thereof, said method comprising administering to said patient an effective amount therefor of a dosage form of claim 1.
5
US 9980927
1-13
A method of treating or inhibiting depression and/or anxiety in a subject in need thereof, said method comprising administering to the subject a therapeutically effective amount of tapentadol, wherein the subject further suffers from chronic pain, diabetic neuralgia, monoradiculopathies, trigeminal neuralgia, post-herpetic neuralgia persistent postoperative or posttraumatic pain, hyperalgia etc.
6
US 9913814
1-13
A tamper resistant pharmaceutical capsule comprising a capsule filling and a capsule shell, wherein said capsule filling is encapsulated by said capsule shell and comprises: (a) Tapentadol or a physiologically acceptable salt thereof. Claims 12-13 are to a method for treating pain or for preventing parenteral abuse of Tapentadol in a patient in need of such treatment, said method comprising administering to said patient at least one capsule according to claim 1.
7
US 10064945
1-18 and 24
A thermoformed, tamper-resistant pharmaceutical dosage form comprising: a) a pharmacologically active ingredient selected from the group consisting of opioids, stimulants, tranquilizers, and narcotics, the physiologically active ingredient is tapentadol (claim 24) and its use in a method of treating pain or reducing the incidence of drug abuse.
8
US 10300141
1, 6, 21-22, 14
A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N and comprising: a pharmacologically active ingredient , tapentadol (claims 6, 21, 22), and its use in a method of treating pain (claim 14).
9
US 10695297
1-13
A tamper-resistant tablet comprising (i) a matrix material in an amount of at least 40 wt. % of a total weight of the tablet; and (ii) a plurality of particulates in an amount of not more than 60 wt. % of the total weight of the tablet; wherein said particulates comprise (a) a pharmacologically active compound, tapentadol and its use in a method of treating pain.
10
US 10813891
1-6
A method of treating or inhibiting migraine in a subject suffering therefrom, said method comprising administering to said subject a medicament comprising an effective migraine treating or inhibiting amount of tapentadol, wherein tapentadol is the only therapeutically active ingredient in said medicament.
11
US 11013701
1-22
An aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt thereof and a buffer.
12
US 11344512
1-3
A method of treating pain with a lower incidence of somnolence in a subject in need thereof, said method comprising orally administering to said subject: (i) a first dose of tapentadol.
13
US 11547678
1-13
An aqueous pharmaceutical composition comprising: (a) water; (b) a buffer; (c) tapentadol or a physiologically acceptable salt thereof and its use to a method of treating pain in a subject in need thereof, the method comprising administering to the subject a pharmaceutically effective amount of an aqueous pharmaceutical composition.
14
US 10398657
1-17
A method of treating pain in a subject suffering from pain chronification or for inhibiting pain chronification in a subject suffering from pain and at risk for pain chronification, said method comprising administering to said subject an effective pain alleviating or pain chronification inhibiting amount of tapentadol.
15
US 10898452
1-21
An aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt thereof.
16
US 9642801
1-22
A dosage form comprising at least one form of tapentadol and at least one opioid antagonist, wherein the at least one form of tapentadol is present in the dosage form and its use to a method of treating pain (claim 18).
17
US 9446008
1-14
A pharmaceutical composition comprising water and tapentadol or a physiologically acceptable salt thereof, and its use in a method of treating pain in a subject in need thereof.
18
US 8383152
1, 52, 57, 77-19
A pharmaceutical dosage form with controlled release of a pharmacologically active compound (A) contained therein, the pharmaceutical dosage form wherein the pharmacologically active compound is tapentadol and its use in a method of treating pain in a patient in need of such treatment (claims 77-79).
19
19/005104
1-18, 21, 22
An oral pharmaceutical dosage form comprising a plurality of coated particles, wherein said coated particles comprise a core which comprises a Tapentadol component and its use in a method of treating pain in a patient in need thereof.
The above reference patent(s) or the co-pending application teach tapentadol dosage form and/or its use in treating pain. The reference claims do not teach treating neuropathic pain in the subject population with tapentadol as instantly claimed.
Johnson & Johnson, Odriozola and Ozdag Acarli et al. teachings as above.
From the prior art teachings a skilled artisan would have found it obvious to administer an effective amount of tapentadol or its pharmaceutical dosage form taught by the reference claims to treat neuropathic pain in coronavirus disease subjects with a reasonable expectation of success because (i) Johnson and Johnson teach the effects of tapentadol in treating neuropathic pain in DPN subjects (ii) Odriozola teach that (i) neuropathic pain is associated with COVID-19 (ii) diabetic patients hospitalized with severe COVID-19 infection had developed severe neuropathic symptoms (iii) severe COVID-19 infection with hypoxemia is associated with neuropathic symptoms and widespread sensory dysfunction in patients with diabetes and diabetic polyneuropathy (DPN) affects over 50% of the diabetic population and (iv) Ozdag Acarli teach neuropathic pain is associated with SARS-Cov-2. As to the effective amount, the instant specification in [0058] and [0063], 50-250 mg of tapentadol. The prior art J&J teach 50-250 mg of tapentadol for neuropathic pain treatment. A skilled artisan would have found it obvious to administer an effective amount for e.g. 50-250 mg of tapentadol dosage form of the reference claims to treat neuropathic pain in COVID-19 subjects. Thus claims 41-42 are addressed.
As to claim 43, Odriozola teach that severe COVID-19 may develop or show worsening of peripheral neuropathy characterized by neuropathic symptoms. Hence peripheral neuropathy is treated by administration of tapentadol to COVID-19 patients. As to claim 44, neuropathic pain includes chronic pain to be treated.
As to claims 45-47, Odriozola teach treating a COVID-19 patient with lopinavir-ritonavir (see p 4, col. 2, 3.2). Hence a skilled artisan would have found it obvious to administer anti-viral drugs like ritonavir to subjects with COVID-19 to treat viral symptoms. A person skilled in the art would have found it obvious from Ozdag Acarli teachings that SARS Cov-2 is COVID-19.
As to claims 48, a person skilled in the art would have found it obvious to administer an effective amount of tapentadol in a subject suffering from SARS and COVID-19 to treat neuropathic pain because the prior art is explicit in teaching that neuropathic pain is associated with COVID-19 patients. A person skilled in the art would have been motivated to administer an effective amount of tapentadol in subjects with COVID-19 to relieve the symptoms of COVID-19 e.g. neuropathic pain symptoms with a reasonable expectation of success.
As to claims 49-51, 56-57 a person skilled in the art would have found it obvious to administer tapentadol and additional medicament, e.g. lopinavir-ritonavir in treating coronavirus symptoms and neuropathic pain in COVID-19 subjects from the combined teachings of the prior art. A person skilled in the art would have found it obvious to arrive at the claimed method with a reasonable expectation of success and to derive therapeutic benefits. As to claim 52, it would have been obvious to a skilled artisan to treat the neuropathic pain in COVID-19 subjects with acute phase still ongoing for the subject to recover from the symptoms completely.
Note: As to co-pending application, 19/005104, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627