DETAILED ACTION
Status of Application
Claims 1-17 are presented for examination on the merits. The following rejections are made.
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 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of co-pending Application No. 18/368219.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims in all the applications are drawn to tablet formulations comprising PVA and crystalline cellulose. The co-pending application is directed to a sustained-release formulation/tablet that comprises PVA having an average saponification of 78-96 mol% and a polyhydric phenol compound. The co-pending application states that a 4% PVA solution has a viscosity of 15-70 mPas. The PVA is to have a particle size of 40-200 microns (see claim 5). The co-pending application teaches that the composition may comprise crystalline cellulose (see [0021] and claim 7) having a size less than 150 microns wherein the cellulose to PVA is in a ratio of 100:1 to 100:50 (see [0053]). Methods of making the tablet is described by claim 8 of co-pending application. Although the conflicting claims are not identical, they are not patentably distinct from each other. The scope of the claims in the cited applications are overlapping and the differences are considered to be obvious over each other. For example, the major difference between the two applications is that the copending application requires polyhydric phenol but as the present claims are comprising such compounds would be encompassed. All other limitations are essentially identical in that the compositions contain the same components in relative ratios. Thus, the claims of the co-pending application are not patentably distinct over the instantly claimed subject matter.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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.
Claims 1-6, 8-13, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ognibene et al. (US 2017/0216213).
Ognibene is directed to tablet formulations comprising a mixture of microcrystalline cellulose (‘MC’) and polyvinyl alcohol (‘PVA’) (see abstract and claim 1) (see instant claim 1). Ognibene describes PVA as a ‘resin’ (see [0019]) (see instant claim 1).
The average particle size of the PVA is dependent on the molecular weight of the PVA and how the PVA is dispersed. However, [0125] teaches that PVA used in the reference tablet formulation has an average particle size of between 110 and 155 microns. More broadly, Ognibene teaches that the PVA is to have an average particle size between 50-260 microns (see [0064]) (see instant claim 10). A 4% aqueous PVA solution possesses a viscosity of between 3-70 mPa-s (see [0009] and claim 6) (see instant claims 1, 8 and 16). Although Ognibene does not disclose a PVA that has an average molecular weight of less than 100 microns and a 4% PVA solution as having a viscosity of greater 44 mPa-s, such would have been obvious both parameters are generally taught to be overlapping with the range instantly claimed. See MPEP 2144.05(I) regarding obviousness of overlapping/similar ranges and proportions.
Ognibene teaches the MC is to have an average particle size of 60-250 microns, preferably in the range of 90-140 microns (see claim [0015, 0050] and claim 17) (see instant claim 2). Regarding the limitation that the “crystalline cellulose” be “either not greater than 0.5 times or not less than twice the size of the average particle size of the polyvinvyl alcohol-based resin”, this is considered obvious. The reference teaches an average particle size of PVA to be between 50-260 microns and the average particle size of MC to be between 60-250 microns. Ratioing the lower bounds with each other and the upper bounds with each other yields a MC:PVA average particle size ratio of 6:5 (60 microns: 50 microns) and 25:26, respectively. Both of these ratios lie within that set forth by instant claim 2.
The weight ratio of MC to PVA is taught to be in the range of 2:1 to 1:2 (see claim 9) (see instant claims 3, 4, 6, 10, 11 and 13). The combination of MC and PVA has a tapped density of 0.55-0.63 g/mL (see [0010] and claim 10) (see instant claims 5 and 12).
The tablet comprising the blend of MC and PVA is to include a therapeutic active belonging to BCS class I (see [0013, 0021] and claim 17) (see instant claim 8). The resulting tablet is to be an extended-release (i.e. sustained-release) formulation (see instant claim 15).
Ognibene describes a method of producing the tablet by compressing (i.e. tabletting) a mixture of the pharmaceutical ingredient, MC and PVA together (see [0064]) (see instant claim 16).
The only difference between Ognibene and the instant claims is that Ognibene is not sufficiently specific with respect to a PVA having an average particles size of less than 100 microns and a viscosity of the PVA producing an aqueous solution with a viscosity of greater than 44 mPa-s. Although Ognibene discloses that the PVA used to produce their tablet is to be capable of producing a solution having a viscosity of between 3-70 mPa-s and have an average particle size of 50-260 microns, such is not considered anticipatory. However, as the claimed viscosity and claimed particle size are within the ranges described by the prior art, one of ordinary skill in the art would have been working within the framework set forth by the reference and if one identified PVA with an average particle size of 100 microns or less and a 4% aqueous solution having a viscosity of 44 mPa-s, that result would have been the product of ordinary skill and common sense rather than innovation. See MPEP 2141.05(I) which states that a claimed range which lies inside ranges disclosed by the prior art is supportive of obviousness. See also MPEP 2144.05(II)(A) which states that where the general conditions of a claim are disclosed, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ognibene et al. (US 2017/0216213) as applied to claims 1-6, 8-13, 15 and 16 above, and further in view of Kawada et al. (US 2021/0395507).
Ognibene fails to teach the PVA as having a saponification degree of 70mol% or more to 100% or less.
Kawada, like Ognibene, is directed to tablet formulations. The tablets of Kawada are to comprise a saponified PVA binder, such that the PVA has a saponification degree of between 85-89mol% (see [0009, 0022, 0026]). Kawada teaches that employing PVA with such a saponification value is desired as the resulting tablets exhibit reduced water solubility, improved moisture-proofing, improved appearance/moldability and reduced tackiness between tablets (see [0006, 0007, 0020, 0028]). Thus, one of ordinary skill in the art would have been motivated to use the saponified PVA of Kawada in Ognibene’s tablet formulation with a reasonable expectation for success as the saponified PVA produces tablets having improved moisture-proofing, appearance and moldability. See MPEP 2143(I)(A) which states that combining prior art elements according to known methods to yield predictable results is evidence of obviousness.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ognibene et al. (US 2017/0216213) as applied to claims 1-6, 8-13, 15 and 16 above, and further in view of Grattan (US 2004/0170681).
Ognibene fails to teach the pharmaceutical ingredient being in the form of a granule granulated using a binder.
Grattan is directed to paracetamol tablets wherein the tablet is made by a method of granulating excipients and the pharmaceutical actives to produce a therapeutic granule, the therapeutic granule is then combined with tabletting excipients and compressed to produce the final tablet composition (see [0018]). It would have been obvious to modify Ognibene’s method such that the pharmaceutical agent is formulated as a granule prior to tabletting with the tabletting materials (e.g. PVA, MC, etc). See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611