DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/24/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 02/13/2026, is acknowledged.
Claims 1, 11-12, 14-15, 18 are pending in this action. Claims 2-10, 13, 16-17 have been cancelled previously. Claims 1, 18 have been amended. Claims 1, 11-12, 14-15, 18 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection or objection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application is a 371 of PCT/JP2019/024874, filed June 24, 2019, which claims benefit of foreign priority to JP 2018-119467, filed June 25, 2018.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 comprises the typographic error “amount from 5% to” that needs to be corrected to “amount of from 5% to”.
Claim 1 the typographic error “the talc” that needs to be corrected to “talc”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 11-12, 14-15, 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As stated previously, claim 1 defines the polyvinyl alcohol polymers by their properties (i.e., a viscosity of a specific solution), and not by the polymer chemical structure essential for claimed compositions, i.e., a degree of polymerization, a type of backbone (i.e., liner, branched, etc.), distribution of monomeric units (i.e., random, microblocks, blocks, etc.). In the present case, independent claim 1 discloses polyvinyl alcohol polymers to be used in the claimed composition/product by “what they do under specific conditions”, and not by “what they are”, i.e., a chemical structure essential for the claimed composition/product. Given that said properties/characteristics depends on user’s choice, said claim is not sufficiently definite, because it refers to a variable. MPEP 2173.05. Therefore, said limitation does not clearly define the PVA polymers to be used in the claimed compositions/products. Given that there is no clear-cut indication of the scope of the subject matter covered by the claim, one of ordinary skill in the art would not know from the claim terms what structures are encompassed by the claim. MPEP 2173.05(g). Clarification is required.
Newly amended claim 1 recites the limitation “the polyvinyl alcohol has a vinyl acetate unit and a vinyl alcohol unit” that is unclear. In the present case, it is unclear what does the term “unit” imply. Neither the claims nor the specification provides a definition for said term. Therefore, it is unclear if said term implies a monomer unit, or a (micro)block unit, etc. Therefore, the metes and bounds of the claim are not reasonably clear. Clarification is required.
Newly amended claim 1 further recites the limitation “water vapor transmission rate of 100-µm thick film formed by the composition is 90g/m2 ∙ day or less” that is not reasonably clear. In the present case, it is unclear what the limitation “90g/m2 ∙ day or less” does imply. This limitation was interpreted as best understood as “water vapor transmission rate of 100-µm-thick film formed by the composition is 90 g/m2 or less per day”. Clarification is required.
As stated previously, claim 1 recites the limitation “relative humidity difference of 75%” that is unclear, because the relative humidity difference is not clearly delineated. Does this limitation refer to measurements that are performed under variable humidity (i.e., that changes by 75%), OR disclose the water vapor transmission rate under different relative humidity? Neither the claims nor specification provide a definition for the term “relative humidity difference”. Clarification is required.
Newly amended claim 1 further recites the limitation “a ratio of the polyvinyl alcohol to the talc is from 70:30 to 30-70” that is unclear, because the recited numerical limitation is not clearly delineated. Is it a mass ratio, OR a mole ratio, etc.? Clarification is required.
Claims 11-12, 14-15, 18 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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, 11-12, 14-15, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al., US 2013/0189325 (cited in IDS; hereinafter referred to as Hayashi), in view of Matono et al., US 2020/0268671 (filing date 03/31/2016; hereinafter referred to as Matono), Pilgaonkar et al., US 2019/0262268 (hereinafter referred to as Pilgaonkar), Choi et al., US 2013/0171248 (hereinafter referred to as Choi).
Hayashi teaches coatings for oral solid pharmaceutical formulations, wherein said coatings can be used for improving stability of drugs in said formulations against oxygen and water vapor, and also teaches a method of applying said coatings to solid medicines (Abstract; Para. 0002, 0022, 0040). To this point, Hayashi teaches that said coating formulations/compositions may include:
polyvinyl alcohol (PVA) and/or derivatives thereof, wherein PVA is obtained by saponification of polyvinyl acetate, and wherein the saponification degree of PVA is 70-97 mol%, and the average polymerization degree of PVA is 200-3,000 (Para. 0034, 0035; Examples as applied to claim 1);
sucrose fatty acid ester, e.g., sucrose/saccharose stearate (C18), etc. (Para. 0046, 0047. 0091, 0092 as applied to claims 1, 18);
talc to improve the stability of solid formulations, e.g., in the amount of 0.5 mass% (Para. 0005, 0068, Example as applied to claim 1)
coloring agents, e.g., titanium oxide/pigment (i.e., an additional component; Para. 0051; 0068), e.g., in the amount of 2 mass% (Example; Para. 0068 as applied to claim 1, 12).
Hayashi provides examples of preparing aqueous solutions comprising said coating compositions and applying said solutions to a solid formulation (Para. 0011-0022, 0067, 0068 as applied to claims 14, 15).
Hayashi teaches that the coating compositions comprising bentonite/swelling clay allow decreasing the oxygen permeability coefficient and the water vapor permeability of the coating film compare to compositions comprising talc (Examples), and also teaches that said coating material becomes highly viscous, so that spraying thereof may become difficult (Para. 0045). Hayashi does not teach a use of 50 mass% or less of talc (claim 1), and/or PVA polymers having viscosity as claimed in claim 1.
Matono teaches coating layer composition provided on a surface of a tablet core by spaying and providing a high chemical stability of active agent even when stored under humid conditions (Title; Abstract; Para. 0011, 0013, 0044; 0101-0103), wherein said coating layer composition may include: (i) PVA polymers, copolymers, derivatives (Para. 0009, 0030) fully or partially saponified and providing viscosity at 20 oC in a 4 wt% aqueous solution in a range of 2-40 mPa*s, more preferably in a range of 3-30 mPa*s. (Para. 0042); (ii) sucrose fatty acid esters (Para. 0058); (iii) 0.1-50 wt% of talc (Para. 0043); (iv) coloring agents, titanium oxide/pigment (Para. 0043-0044).
Pilgaonkar teaches oral modified release compositions (Abstract), and specifically teaches the use of PVA as a polymeric release controlling agent (Claim 8; Para. 0019), and sucrose fatty acid esters, e.g., sucrose palmitate (C16), sucrose stearate (C18), sucrose behenate (C22) as non-polymeric release controlling agents (Claims 9, 10; Para. 0021, 0022), wherein said compositions may further include a colorant, talc, and other additives (Claim 12; Para. 0024, 0037).
Choi teaches oral compositions comprising PVA in combination with sucrose fatty acid esters, e.g., sucrose palmitate, sucrose stearate, sucrose behenate, talc to be used for controlled drug delivery (Claims 2, 3, 8, 9; Para. 0008, 0013, 0039, 0052, 0068).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use/try PVA polymers with controlled viscosity in combination with sucrose fatty acid ester, talc and other additives as taught by Matono, Pilgaonkar, and Choi preparing coating compositions as taught by Hayashi without swelling clay. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach would provide coating compositions providing high chemical stability of active ingredient that can be applied by spaying to a solid formulation comprising an active ingredient, e.g., to uncoated tablets (Matono), and also teaches that a combination of PVA and sucrose fatty acid esters such as sucrose palmitate, sucrose stearate, sucrose behenate can also be used for providing a controlled release/delivery of active agents (Pilgaonkar, Choi).
With regard to the relative concentrations as instantly claimed (claims 1, 11), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. One skilled in the art would have understood that properties of multicomponent systems depend on compounds included as well as on concentrations of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. The determination of suitable or effective concentrations/compositions can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2011/0256189 (cited in IDS), US 8,900,606 - teaches coatings for solid pharmaceutical formulations, wherein said coatings formulations/compositions may include (i) PVA obtained by saponification of polyvinyl acetate, wherein the saponification degree of PVA is 70-97 mol%, and the average polymerization degree is 200-3,000; (ii) sucrose fatty acid ester, e.g., sucrose stearate; (iii) talc; (iv) coloraing agent/titanium oxide/pigment; and wherein an aqueous solution of said coating compositions can be applied to a solid medical preparation.
US 2008/0311203 – teaches coating compositions for pharmaceutical formulations that may include PVA in combination with: 10-50% of opacifier and colorant/titanium dioxide; 5-30% of lubricant/talc; 0.5-5% of plasticizer; 0.1-3% of thickening agent/bentonite; 0-20% of filler agent.
US 2017/0354608 (cited in IDS) - teaches coating compositions that can be applied to a solid medicine, wherein said coating compositions allow improving a coating film strength, enhancing a storage stability of drugs, and comprise PVA, Tween or Span (i.e., fatty acid esters of polyols having 3 or more OH groups, e.g., Span 80, Tween 80, etc.; biophoretics.com/polysorbates-sorbitans), talc powder, coloring agent/titanium powder, pigments (Claim 1; Para. 0003; 0007, 0020, Examples 1, 5).
Response to Arguments
Applicant's arguments, filed 02/13/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and rejections have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant’s argument that recited dynamic viscosity limitation clearly identifies the polyvinyl alcohol to be used in the instant invention, it is noted that it is well known in the field that dynamic viscosity of a polymer solution reflects flow resistance but does not uniquely identify the chemical structure, branching, or polydispersity of the polymer, and different polymer architectures can yield the exact same viscosity value (Wikipedia). In the present case, the applicant defines the claimed component/PVA/polymer by what it does under specific condition chosen by the applicant, and not by the chemical structure of the said claimed compound. Given that said recited/claimed properties/characteristics depends on user’s choice, said claim is not sufficiently definite, because it refers to a variable. MPEP 2173.05. Therefore, clarification of PVA polymers to be used in the claimed product is required.
In response to applicant's arguments that disclosed coating compositions provide unexpected results, i.e., the specific ratio of PVA to talc (i.e., from 70:30 to 30:70) provides significantly better moisture resistance, the examiner maintains the position that one skilled in the art would have understood that properties of multicomponent systems depend on compounds included as well as on concentrations of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, it is expected that different compositions might have different properties. The determination of suitable or effective concentration/composition (for providing/controlling properties of compositions) can be and usually is determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Further, it is noted that the applicant shows that same compositions works better than others, but does not explain what is unexpected. Furthermore, it is noted that the fact that the applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant is advised to clarify the claim language, the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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