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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted 5/14/2026 is noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement.
Response to Amendments
Status of Claims
The amendment, filed on 7/8/2026, is acknowledged.
Claims 18-20 are newly added.
Claims 1-20 are pending and under consideration in the instant Office Action, to the extent of the elected species:
The polyvinyl alcohol-based resin is polyvinyl alcohol-based resin having a modification degree of less than 10 mol%
The polyhydric phenol compound is tannic acid
Rejections Withdrawn
The provisional rejection of claims 1-7 and 11-17 as being unpatentable over claims 1-15 of copending Application No. 18/437,536 in view of Lerner et al (WO 99/04764, published 2/4/1999) is withdrawn in view of the approval of the Terminal Disclaimer
Maintained Rejections and Made Again
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.
The rejection of claims 1-7, 11-17 and now applied to newly added claims 18-20 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) is maintained and made again.
Note: The rejection pertaining to claims 1-7 and 11-17 is maintained but modified to address newly added claims 18-20.
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). This PVA material is in powder form, and ground into a fine particulate for use in developing the composition (col. 9 line 20), as in instant claim 18 and 19. This powder is then compressed into a final solid composition (col. 13 line 19), as in instant claim 18. 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 nor the powder form of tannic acid, as in instant claims 3, 12 and 20. 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 teaches that this composition may be in the form of a powdered precipitate that can then be pressed into a solid composition.
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.
Response to Arguments
The Applicant’s arguments, filed on 7/8/2026, have been fully considered but are not persuasive.
Applicant argues that the references cited in the rejection under 35 U.S.C. 103 “do not share any common required components” and “as a result, a person of ordinary skill in the art would not have had any motivation to combine the teachings of Furo and Lerner, and the subject matter of claim 1 would not have been obvious over Furo and/or Lerner.” Applicants arguments have been fully considered but are not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As both Furo and Lerner teach sustained-release compositions for the release of pharmaceutical actives, they would reasonably be combined to arrive at the instantly claimed invention. Both references relate to the development of tablet with sustained-release property, wherein the composition is comprised of a polymer. While the Examiner agrees that the polymers in each reference are different, there is no basis to suggest that inclusion of tannic acid would not have the same beneficial effects when applied to a synthetic polymer such as PVA. The incorporation of tannic acid is taught to impart benefit on a sustained-release composition, as Lerner teaches that the polymer-tannic acid composition possesses more ideal physical properties compared to other similar compositions taught in the art. This polymer-tannic acid benefit could obviously be applied to other types of polymers, such as PVA. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d at 1397. The teaching of Lerner that suggests incorporating tannic acid into a polymer for a sustained-dosage composition could therefore be reasonably applied to the teachings of Furo and a PVA-based sustained-dosage solid composition. Further, Furo teaches inclusion of other ingredients such as excipients, and names crystalline cellulose and gelatin as potential excipients. The inclusion of these ingredients further aligns the teachings of Furo and Lerner, as Lerner teaches that the polymer may be cellulosic (and crystalline cellulose is a cellulosic polymer), or proteinaceous (and gelatin is a proteinaceous polymer). The inclusion of these components into a composition as taught by Furo would align with the polymers taught by Lerner, and the inclusion of tannic acid with polymers that comprise the composition would be obvious based on the teachings described supra. Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Examiner
Further, Applicant has not shown that inclusion of tannic acid into a synthetic polymer such as PVA would not have success in developing a solid dosage form. One would reasonably expect success in incorporating tannic acid into a synthetic polymer such as PVA, as the application of the inventions described by the references clearly align.
Conclusion
No claims are allowed.
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 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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