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 .
Claim Status
Claims 1-17 are pending.
Election/Restrictions
Applicant’s election without traverse of group I ( in the reply filed on 3/13/2026 is acknowledged. Applicant’s species election without traverse for species A (polyvinyl alcohol-based resin having a modification degree of less than 10 mol%) and species B (tannic acid) in the reply filed on 3/13/2026 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method for producing, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/13/2026.
Claims 1-7 and 11-17 are under consideration to the extent of the elected species, e.g., the polyvinyl alcohol-based resin is polyvinyl alcohol-based resin having a modification degree of less than 10 mol% and the polyhydric phenol compound is tannic acid.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/3/2025 are noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 1-7 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Furo et al. (US10028915B2, published July 24, 2018) in view of Lerner et al. (WO 99/04764, published February 4, 1999).
Furo et al. teaches a composition of polyvinyl alcohol (PVA) fine particle that can be used in conjunction with a pharmaceutically active ingredient to produce a tablet form that can maintain good sustained release, high hardness, and friability. Furo teaches that in their preferred embodiments, the PVA-based resin has an average saponification of 70 to 100 mol% (col 8 line 60), and an average polymerization degree of 200 to 4,000 (col 8 line 39). The PVA-based resin taught by Furo is unmodified (i.e. modification degree of less than 10 mol%) (col 9 line 8) and has an average particle size of 1 to 200 micrometers after pulverization (col 9 line 37). Furo also teaches the addition of excipients, including crystalline cellulose (col. 12, lines 30-40), wherein the crystalline cellulose is exemplified in an amount of 30 parts by weight with respect to the PVA (col 16 line 12). In all, Furo teaches much of the instant claims, specifically claims 1(A), 4, 5, 7(A) and 7(C), 13, 14, 16, and 17. Furo’s teaching of an average polymerization degree of 200 to 4,000 also meets the requirement of resins having certain polymerization degrees, as in instant claims 6 and 15. It would be obvious to use a PVA-based resin mixture having the degrees of polymerization outlined in the instant claims based on the teachings of Furo. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Furo does not teach the introduction of tannic acid, as in instant claims 1(B), 2, 7(B), and 11. Furo also does not teach a ratio by weight of the tannic acid to the PVA-based resin, as in instant claims 3 and 12. These deficiencies are made up for in light of Lerner et al.
Lerner et al. teaches tannic acid-polymer compositions for the release of pharmaceutically active ingredients.
Lerner also teaches that in a polymer-tannic acid composition, an active ingredient, can be included from about 0.1% to 35% by weight of the final product (page 28 line 6). It is known in the art that tannic acid can act as an active ingredient. It is then prima facie obvious to include tannic acid in the stated percentage by weight as taught by Lerner, which corresponds to instant claims 3 and 12. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Furo and Lerner and thus produce the instantly claimed invention. A person of ordinary skill in the art would have been motivated to introduce 0.1% to 35% by weight tannic acid into a PVA-based resin having an average saponification of 70 to 100 mol% (col 8 line 60), an average polymerization degree of 200 to 4,000 and an average particle size of 1 to 200 micrometers and further includes 30 parts by weight of crystalline cellulose to produce a sustained-release solid dosage form. Furo combined with Lerner fully covers instant claims of PVA-based resin with the recited properties as a sustained-release solid dosage form combined with tannic acid, as Lerner teaches introduction of tannic acid to polymers, and Furo teaches said polymer composition. One with skill in the art may reason this addition as it is known that the addition of tannic acid can improve properties and capabilities of the polymer as the tannic acid acts as an additional crosslinker, leading to the conclusion that tannic acid incorporated to a PVA-based resin with the stated properties could have increased benefit when formulated a sustained-release solid dosage form. Furo also teaches the inclusion of crystalline cellulose in 30 parts by weight, as described above. A person of ordinary skill in the art would have had a reasonable expectation of success since PVA-based resin is commonly used in the art, and tannic acid is known to be incorporated with said resin to produce polymer-tannic acid compositions with amounts and properties as in the instant claims.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-7 and 11-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/437576 in view of Lerner et al (WO 99/04764, published February 4, 1999).
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 with or without crystalline cellulose. Claims 1-15 of copending ‘576 recite a composition for a sustained release pharmaceutical tablet that comprising a polyvinyl alcohol-based resin and crystalline cellulose, wherein the polyvinyl alcohol-based resin has an average particle size of 35µm or more and 100 µm or less and a viscosity greater than 44 mPa · s and 70 mPa · s or less in 4% aqueous solution and a saponification degree of 70 mol% to 100 mol%, wherein the crystalline cellulose has an average particle size of 250 µm or less and is either not greater than 0.5 times or not less than twice the size of the average particle size of the polyvinyl alcohol-based resin, wherein the weight ratio of the polyvinyl alcohol-based resin and the crystalline cellulose, polyvinyl alcohol-based resin/crystalline cellulose, is in the range of 100/200 to 100/1, or 2/1 to 50/1 and the blend has a tapped density of 0.50 to 0.68 g/mL.
PVA-based resin is recited where the PVA has an average particle size of 100 micrometers or less and a saponification degree of 70 mol% to 100 mol% (co-pending application claims 1, 7, 14). These claims align with the instant claims regarding the use of PVA-based resin. The instant claims also claim crystalline cellulose, which is claimed in co-pending application claim 1. However, copending ‘576 does not teach the addition of tannic acid. This deficiency is made up for in the teachings of Lerner et al.
Lerner et al has been described supra.
Instant claims 1-7 and 11-17 are an obvious variant of claims 1-15 of copending Application No. ‘576 because it would have been prima facie obvious to produce include 0.1% to 35% by weight tannic acid as taught by Lerner et al into a composition for a sustained release pharmaceutical tablet that comprising a polyvinyl alcohol-based resin and crystalline cellulose, wherein the polyvinyl alcohol-based resin has an average particle size of 35µm or more and 100 µm or less and a viscosity greater than 44 mPa · s and 70 mPa · s or less in 4% aqueous solution and a saponification degree of 70 mol% to 100 mol%, wherein the crystalline cellulose has an average particle size of 250 µm or less and is either not greater than 0.5 times or not less than twice the size of the average particle size of the polyvinyl alcohol-based resin, wherein the weight ratio of the polyvinyl alcohol-based resin and the crystalline cellulose, polyvinyl alcohol-based resin/crystalline cellulose, is in the range of 100/200 to 100/1, or 2/1 to 50/1 and the blend has a tapped density of 0.50 to 0.68 g/mL in view of claims 1-15 of copending Application No. ‘576 because Lerner et al teach that tannic acid inclusion benefits the overall polymeric structure by acting as an additional crosslinker.
Thus, instant claims 1-7 and 11-17 are drawn to an obvious variant of claims 1-15 of the co-pending application ‘576 because the claims teach the same polymer matrix as claimed in the instant application (PVA-based resin with specific saponification and polymerization degrees), and the introduction of tannic acid for enhanced properties would be obvious in the art as taught by Lerner et al to increase the overall quality of the polymer structure as tannic acid acts as an additional crosslinker.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW RYAN BURKE whose telephone number is (571)272-8949. The examiner can normally be reached Mon-Fri. 8am-5pm.
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/MATTHEW RYAN BURKE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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