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 .
Acknowledgement of Papers Received: Amendment/Response dated 1/07/26.
Claim Objections
Claim 1 are objected to because of the following informalities: 2-methyl-5-((2R,4S)-2-((((R-1-(naphthalen-1-yl)ethyl)amino)methyl)chroman-4-yl)benzoic acid hydrochloride is misspelled as “2-mehtyl-5-((2R,4S)-2-((((R-1-(naphthalen-1-yl)ethyl)amino)methyl)chroman-4-yl)benzoic acid hydrochloride. Appropriate correction is required.
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.
Claim(s) 1, 6, 7, 10-12, 14, 16-24, 26-36 and 45-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Skula et al (US 9,987,249 hereafter Skula) in view of Weibel et al (US 9,561,251 hereafter Weibel).
Skula discloses a pharmaceutical composition comprising a pharmaceutically effective amount of 2-methyl-5-((2R,4S)-2-((((R-1-(naphthalen-1-yl) ethyl) amino) methyl) chroman-4-yl)benzoic acid hydrochloride (col. 10, lin. 55), with suitable excipients such as magnesium stearate, talc, hydroxy methylcellulose and polyvinylpyrrolidone (col. 25, lin. 10-19). The dosage can be in the form of tablets or capsules for oral administration (col. 25, lin. 10-19). The formulation can be used to treat chronic kidney disease with a secondary hyperparathyroidism where a formulation comprising the active compound and a vehicle comprising polyglycol and polyethylene glycol (col. 219, lin. 25-45). The formulation is found to reduce PTH levels greater than 80% (col. 219, lin. 50-55).
While the reference discloses the active compound of the instant claims, along with suggestions of excipients of the instant claims, the reference does not disclose the concentrations of the instant claims. These ranges in formulations useful in treating hyperparathyroidism in a patient.
Weibel discloses a solid formulation for treating hyperparathyroidism where the dosage form can be a coated tablet where the coating includes ethyl cellulose and hydroxypropylmethylcellulose (abstract, col. 3, lin. 52-57; col. 4, lin. 1- 9; col. 9, lin. 10-15). The tablet comprises starches, present from 5-30% (col. 5, lin. 20-27). The tablet comprises glidants like magnesium stearate and talc in a range from 1-% (col. 8, lin. 19-24). It would have been obvious to combine these components with the solid dosage form of Skula as they solve the same problem of treating hyperparathyroidism with solid dosage forms.
Regarding the concentration of the active agent, dose titrating and post administration adjustment, it is the position of the Examiner that such limitations do not distinguish over the prior art. Skula discloses a solid tablet or capsule formulation comprising from 0.1-30 mg/kg. The reference is silent to post administration adjustment or dose titration and as such the reference would meet the limitation of claims 32. Regarding claims 34 and 45-47 and the reduction of iPTH levels, the prior art combination discloses that up to 80% of the PTH plasma levels are suppressed due to administration of the active compound (col. 219, lin. 45-55). The general conditions of the claims, the concentration of the active compounds and the combination of those compounds with commonly known excipients are met by the prior art combination and as such any modifications and optimizations would be obvious to those of ordinary skill in the art. Where 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind, it would have been obvious to combine the prior art in order to produce a stable solid dosage form for treating chronic kidney disease and associated disorders. It would have been obvious to follow the teachings and suggestions of Skula to produce a solid dosage form with common excipients and use the compounds of Weibel as they solve the same problem. One of ordinary skill would have been motivated to combine these excipients of Weibel into the formulation of Skula as Skula discloses similar compounds and Weibel discloses the specific ranges and forms useful for treating parathyroid conditions. One of ordinary skill in the art would have been motivated to combine the prior art with an expected of a stable solid dosage form.
Response to Arguments
Applicant's arguments filed 1/7/26 have been fully considered but they are not persuasive. Applicant argues that the combination of the prior art does not render the claims obvious because Skula does not meet the limitations of newly amended claim 1 and as such cannot be used to render the claim obvious.
Regarding this argument, it remain the position of the Examiner that the prior art continues to rendered the claims obvious. First, Skula discloses the exact active agent, excipients and forms of claim 1, and a broad range covering claim 10. Skula further discloses a method meeting claims 14. No further conditions were disclosed, so the treatment method would so at least cover claims 22 and 23. Skula discloses the lowering or suppression of claims 24 and the reduction that covers claims 33 and 34. Skula does not disclose the exact excipients range of claim 1, however disclose that the excipients would be present as vehicles for delivery of the drug. Weibel disclose a formulation for treating the same condition where the dosage form is a tablet with similar excipient to that of Skula, only with the ranges of claim 1. The tablet is coated as in claim 6 and coated with the composition of claim 7. With these aspects in mind, it would have been obvious to combine the prior art in order to produce a stable solid dosage form for treating chronic kidney disease and associated disorders. It would have been obvious to follow the teachings and suggestions of Skula to produce a solid dosage form with common excipients and use the compounds of Weibel as they solve the same problem. One of ordinary skill would have been motivated to combine these excipients of Weibel into the formulation of Skula as Skula discloses similar compounds and Weibel discloses the specific ranges and forms useful for treating parathyroid conditions. One of ordinary skill in the art would have been motivated to combine the prior art with an expected of a stable solid dosage form.
Conclusion
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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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