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 .
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.
Previously presented rejection of product claims 17-21 and method claims 22-26 under 35 U.S.C. 103, is maintained for reasons of record, as being unpatentable over the combined teaching of Arnold, Arthritis & Rheumatism, Volume 64, Number 7, 2012, 2387–2397, Lawson K.. World J Pharmacology 2017; 6(1): 1-10, Wilding, US 20100104643, Holaday, US 20110245287, Zarmpi, European Journal of Pharmaceutics and Biopharmaceutics 111 (2017) 1–15, Nosb, Hydroxypropyl methylcellulose, Aug 26, 2002, Ghimire, Journal of Controlled Release volume 147, 2010 and Nokhodchi, BioImpacts, 2012, 2(4), 175-187.
Note that in the above Arnold, Lawson, Nosb, Ghimire and Nokhodchi are
now added in the ‘rejection statement’ to hammer-in previously presented rationale.
Applicant’s arguments focus on the amendment to base claim 17
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also that the
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with respect to method claims,
Applicant’s argument focuses on the
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ingredient esreboxetine not in the reference(s) as
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.
Response:
Applicant’s arguments are not persuasive:
At the outset, it is noted that none of the ingredients (active or inactive) in the claims or their intended use are applicant’s invention.
Applicant simply ignores the citations (see the previous action page 4 onto page 5) of relating to the above fact. According to MPEP 2144.03, Reliance on Common Knowledge in the Art or "Well Known" Prior Art [R-01.2024]: In certain circumstances where appropriate, an examiner may take official notice of facts not in the record or rely on "common knowledge" in making a rejection, however such rejections should be judiciously applied. Official notice unsupported by documentary evidence may be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art, are "capable of such instant and unquestionable demonstration as to defy dispute." In re Ahlert, 424 F.2d 1088, 1091, 165 USPQ 418, 420 (CCPA 1970) (citing In re Knapp Monarch Co., 296 F.2d 230, 132 USPQ 6 (CCPA 1961)).
Examiner went further than what is allowed as per the above MPEP guidance, he
made of record citations) to what are "Well Known".
With regard to ‘only active ingredient’:
Arnold teaches safety and efficacy of esreboxetine in patients with Fibromyalgia.
Arnold concludes at page 2397, column B,
“…study support the safety and efficacy of esreboxetine for the treatment of fibromyalgia, and, based on a benefit–risk assessment, the lack of a dose-response relationship in both the efficacy and safety analyses suggests that esreboxetine at a dosage of 4 mg/day would offer clinical benefit with the least risk of drug exposure. Lower doses of esreboxetine may also offer benefit, although further research Is needed to explore this possibility”.
Likewise,
Lawson teaches emerging pharmacological strategies for the treatment of fibromyalgia.
Lawson asserts that
esreboxetine modulate the bioamine system by targeting receptors, reuptake processes and neurotransmitter availability either individual or in various combination have demonstrated efficacy in the treatment of FM with a reduction in pain and fibromyalgia impact questionnaire scores (FIQ) (Table 2).
With regards to the limitation ‘hydroxypropyl methylcellulose’ the teachings of Nosb, Ghimire and Nokhodchi are invoked.
Nosb is a Review article teaches, lines 119-120, that
HPMC has many pharmaceutical uses, as a drug carrier, a coating agent, a tableting agent, an emulsifier in ointments HPMC has many other
uses as an emulsifier, thickening agent, stabilizer, gellant, and suspending agent.
And at lines 326-327.
HPMC has advantages over traditional gelatin capsules in that it is not chemically as reactive and eliminates problems of reaction between drugs and capsule shell. HPMC capsules have naturally low moisture content.
Likewise,
Ghimire teaches at page 70 column A,
Hydroxypropyl methylcellulose (HPMC), a semi-synthetic cellulose derivative, is widely used as a matrix former in oral controlled release tablet formulations. Its widespread use is mainly due to its generally regarded as safe (GRAS) status and biodegradable nature. Furthermore, it is compatible with numerous drugs, accommodates high levels of drug loading and can be easily incorporated to form matrix tablets by direct blending or granulation. The availability of a wide range of viscosity grades also allows the formulator to modify the release of drugs from HPMC matrix tablets according to therapeutic need.
In-vitro and in-vivo erosion profiles of hydroxypropyl methylcellulose (HPMC) matrix tablets
And Nokhodchi teaches the mechanism of drug release from HPMC matrices in
formulations that are able to control the release of drug have become an integral part of the pharmaceutical industry. In particular oral drug delivery has been the focus of pharmaceutical research for many years. This type of drug delivery has been at the centre of research due to its many benefits over conventional dosage. The focus of this review is on matrix tablets due to their widely use and simplicity of the formulation.
To avoid redundancy previously presented rationale is not entered here, but is very much part of this action.
Again the active ingredient esreboxetine and inactive ingredients hydroxypropyl methylcellulose, starch and magnesium stearate all being well-known (see claims of US 4415547) nothing unobvious is seen in the claims. Since all the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition (and method). Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. According to Examination guidelines “where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration (that is % amount as limited in the dependent claims here) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).”
Suggestion: MPEP 1204 Notice of Appeal [R-01.2024]
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.
Previously presented rejection of claims 17-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 13-17 of copending Application No. 17536669 (reference application) is maintained for reasons of record.
The reasons noted above those include are teachings discussed in section under Claim Rejections - 35 USC § 103 in their entirety. Applicant is encouraged to place on record that invoking arguments under different statue is improper!.
For motivation art made of record and not relied upon is considered pertinent to applicant's disclosure:
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
THIS ACTION IS MADE FINAL. 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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/ Primary Examiner, Art Unit 1625