DETAILED ACTION
Claims 1-8 are currently pending. Claims 1-5 are currently under examination.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/17/2025 has been entered.
Withdrawn Rejections
The prior rejection of claims 1-5 under 112(b) is withdrawn in light of Applicant amendment instant claim 1 to specify the additives refer back to the additives being prepared.
Examiner’s Note
Applicant's amendments and arguments filed 06/17/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 06/17/2025, it is noted that claims 1-5 have been amended and no new matter or claims have been added.
Modified Rejections:
The following rejections have been modified based on Applicant’s claim amendments.
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2016-124861 (previously applied) in view of JP 2014-224079 (previously applied).
Regarding claim 1, the limitation of manufacturing an orally disintegration tablet comprising performing fluid bed granulation while spraying or dropping a liquid including hydroxypropyl cellulose on additives is met by the ‘861 publication teaching orally disintegrating tablet containing Olmesartan medoxomil [0001]. The binder is taught to include hydroxypropyl cellulose [0018]. The mixture of active ingredient, carmellose and if necessary, the above-mentioned additives is subjected to fluid bed granulation while being spraying with a solvent containing a binder ([0024], [0030]) wherein the Olmesartan medoxomil of the embodiment may further contain additives such as excipients [0016] wherein various additives are added to the granules obtained by wet granulation to obtain the orally disintegrating tablet [0024]. The ‘861 publication teaches Example 9 in which bitterness was suppressed [0061] is taught to be a combination of carmellose and low substituted hydroxypropyl cellulose [0053]. The ‘861 publication teaching an aqueous solution comprising HPC and sucralose being sprayed on a mixture of active agent, mannitol, carmellose, crystalline cellulose [0030] wherein additives used are taught to include excipients such as crystalline cellulose [0017] and excipients added to the dried granules is taught to include cropovidone ([0031], [0048]) and a combination of carmellose and low substituted hydroxypropyl cellulose is taught, therefore teaching the claimed disintegrant being used.
Regarding claims 2-3, the limitation of wherein the liquid including hydroxypropyl cellulose is sprayed or dropped on the additives so that a content of the HPC with respect to 100 wt% of the orally disintegrating tablet is 0.2 wt% or more and 5% or less, 0.2 wt% or more and 2 wt% of less is met by the ‘861 publication teaching fluid bed granulator containing 40 g active, 213 g D-mannitol, 35 g carmellose, 10 g crystalline cellulose and an aqueous solution containing 1 g HPC, 3 g sucralose sprayed onto the mixture [0030] leading to 0.33% (1/ (40+213+35+10+1+3) x 100 = 0.33 wt%). The ‘861 publication teaches ranges of the ingredients in the tablet, thus leading to an optimizable parameter ([0008], [0014]). As MPEP 2144.05 recites “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 optimization”.
Regarding claim 4, the limitation of the liquid including the hydroxypropyl cellulose is prepared by dissolved hydroxypropyl cellulose and a sweetener and the additives are prepared by mixing an excipient and a disintegrant is met by the ‘861 publication teaching an aqueous solution comprising HPC and sucralose being sprayed on a mixture of active agent, mannitol, carmellose, crystalline cellulose [0030].
Regarding claim 5, the limitation of wherein the pharmaceutically active ingredient is mixed with the additives is met by the ‘861 publication teaching the ‘861 publication teaching an aqueous solution comprising HPC and sucralose being sprayed on a mixture of active agent, mannitol, carmellose, crystalline cellulose [0030] wherein additives used are taught to include excipients such as crystalline cellulose [0017] and a combination of carmellose and low substituted hydroxypropyl cellulose is taught.
The ‘861 publication does not specifically teach hydroxypropyl cellulose having a viscosity in a 2% aqueous solution g at 20 degrees C of 150 mPa s or more and 400 mPa s or less (claim 1).
The ‘079 publication teaching granules for tableting and a method for producing the same [0001]. Granules of D-mannitol which containing candesartan cilexetil (active agent) is taught [0010]. The drug substance dispersion is dispersion of the drug substance in water or a mixture of water and ethanol and may contain a binder such as hydroxypropyl cellulose. HPC is particularly preferred and among these HPC-M (viscosity 150 to 400 mPa s at 20 degree C in a 2% aqueous solution) [0012]. The active granules are produced by charging D-mannitol granules into a fluid bed granulator spraying with the drug substance dispersion and drying [0016]. The active granules are mixed with convention auxiliary ingredients such as excipients to form an orally disintegrating tablet [0018].
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, hydroxypropyl cellulose sprayed on an expedient and disintegrant to form particles wherein the particles are further mixed with crospovidone) from within the prior art disclosure of the ‘861 publication, to arrive at the instantly claimed implantable drug depot “yielding no more than one would have expected from such an arrangement”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known HPC concentrations and viscosities in a spray liquid for fluid bed granulation as taught by the ‘079 publication in the fluid bed granulation as taught by the ‘861 publication because the ‘079 publication and the ‘861 publication are both directed to formation of disintegrating tablets formed by spraying HPC solutions for fluid bed granulation. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use know HPC as the ‘079 publication teaches specific HPC-M to be a particularly preferred binder for forming the disintegrating tablets, thus providing motivation to use HPC-M for the HPC liquid taught by the ‘861 publication to form a disintegrating tablet.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘861 publication example 1 after mixing olmestartan medoxomil, d-mannitol, carmellose and 10 g of crystalline cellulose in a fluidized ed granulator an aqueous solution of hydroxypropylcellulose and sucralose was sprayed on the fluidized granulation. The dried granules were sieved and then crospovidone, Neusilin and calcium stearate was added to the sieved product and mixed with a plastic bag to obtain a pre-tablet powder. However in Example 9, which indirectly refers to example 5, crospovidone was not added after granulation, by the same manner as in Example 1. Example 9 the Examiner points to teaches away from “mixing granules with crospovidone to obtain a pre-tableting powder recited in claim 1.
In response, the rejection is made under 103 and does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. Applicant teaching examples wherein crospovidone is not combined with the granulation mixture does not constitute a teaching away from the use of crospovidone combined after granulation, as the ‘861 publication does not discourage such use and in fact uses crospovidone to be combined after granulation in Example 1. The ‘861 publication teaching orally disintegrating tablet the binder is taught to include hydroxypropyl cellulose [0018]. The mixture of active ingredient, carmellose and if necessary, the above-mentioned additives is subjected to fluid bed granulation while being spraying with a solvent containing a binder ([0024], [0030]) wherein the Olmesartan medoxomil of the embodiment may further contain additives such as excipients [0016] wherein various additives are added to the granules obtained by wet granulation to obtain the orally disintegrating tablet [0024]. The ‘861 publication teaches Example 9 in which bitterness was suppressed [0061] is taught to be a combination of carmellose and low substituted hydroxypropyl cellulose [0053]. The ‘861 publication teaching an aqueous solution comprising HPC and sucralose being sprayed on a mixture of active agent, mannitol, carmellose, crystalline cellulose [0030] wherein additives used are taught to include excipients such as crystalline cellulose [0017] and excipients added to the dried granules is taught to include cropovidone ([0031], [0048]).
Conclusion
No claims are allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613