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 .
Priority
This application is a National Stage entry of PCT/JP2023/033846, International Filing Date: 09/19/2023; claims foreign priority to PCT/JP2023/030922, filed 08/28/2023; claims foreign priority to EP22196956.1, filed 09/21/2022; claims foreign priority to PCT/JP2022/034937, filed 09/20/2022.
Information Disclosure Statement
The IDS’s filed on 9/30/2026 and 3/19/225 have been considered. See the attached PTO 1449 form.
Claim Status
Claims 1-19 are currently pending and under examination.
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, the recitation “PVA-methylmethacrylate copolymer, polyvinylpyrrolidone (PVP)” should recite “PVA-methylmethacrylate copolymer and polyvinylpyrrolidone (PVP)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the white color colorant titanium oxide”. There is insufficient antecedent basis for this limitation in the claim which makes it unclear as to which previous component in the claim is a white color colorant.
Similarly, claim w recites the limitation “the white color colorant calcium carbonate”. There is insufficient antecedent basis for this limitation in the claim which makes it unclear as to which previous component in the claims is a white color colorant.
Claims 3-19 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-3, 7, 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Takubo (US20040234591A1) in view of Sato (US20210275404A1) and Nishimura (US20200155464A1).
Takubo throughout the reference teaches hard gelatin capsule and process for producing the capsule. Takubo teaches adding titanium oxide with a controlled particle size in a gelatin film (i.e. film forming polymer) used as a capsule base material, and further adding polyethylene glycol. Takubo teachs molding the dispersion obtained. Takubo also teaches employing a dipping method, dipping and drying are carried out to obtain hard gelatin capsules. Takubo teaches titanium oxide having light shielding property is added to the hard capsule. Takubo does not teach the capsule having any other layer besides this film and thus reads on wherein the capsule shell has only one layer which is the film layer. Takubo teaches a hard gelatin capsule which comprises gelatin and titanium oxide having a secondary particle size of less than 10 μm and a median diameter of 0.5 μm or less being dispersed in the gelatin. The amount of the titanium oxide is 10% by weight or less. The capsule further comprises 3% by weight or less of polyethylene glycol (i.e. plasticizer). The capsule comprises 89.6 to 96.99% by weight of gelatin. (see e.g. abstract; claims; summary of the invention; para 0006,0010, 0030; examples; entire document).
The teachings of Takubo have been set forth above.
Takubo does not teach the film comprises magnesium oxide and is free from titanium oxide. As such, Takubo does not teach the amount of magnesium oxide. Takubo also does not teach the shell/film comprises sorbitan monolaurate (i.e. a sorbitan fatty acid ester) and adding a colorant other than white color. However, Sato and Nishimura cure these deficiencies.
Sato discloses hard capsule containing a film forming polymer such as HPMC and gelatin and surfactant such as sorbitan monolaurate. Sato teaches that titanium oxide, commonly used whitening agent for providing light shielding properties, can have problems with formulation stability and is avoided from being incorporated into capsules due to concerns about carcinogenicity. Sato also teaches that other colorants can be incorporated to give a different color to the film/capsule. Sato teaches addition of a colorless surfactant such as sorbitan monolaurate can whiten the film during the formation and provide a beautiful appearance and light-blocking ability that are comparable to the one obtained by the dispersion of titanium dioxide. The level of whitening and that of the light blocking can be adjusted by changing the amount of the added surfactant. Whiteness of the film is adjusted by a total amount of the surfactant within a range from 0.5 parts by weight to 30 parts by weight while an amount, in dry weight, of the film-forming polymer is defined as 100 parts by weight. (see e.g. claims; examples; para 0001-0016, 0028-0029; 0037-0039, 0049-0050; entire document).
Nishimura also teaches capsule shell composition wherein the shell composition can include magnesium oxide as light shielding agent. (para 0047; abstract; claims; entire document).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Takubo, Sato and Nishimura and make a film which comprises magnesium oxide and is free from titanium oxide, further add sorbitan monolaurate and a colorant other than white color into the capsule film of Takubo. One would have been motivated to do so because Takubo teaches titanium oxide having light shielding property is added to the hard capsule. Sato teaches that titanium oxide, commonly used whitening agent for providing light shielding properties, can have problems with formulation stability and is avoided from being incorporated into capsules due to concerns about carcinogenicity. Sato teaches addition of a colorless surfactant such as sorbitan monolaurate can whiten the film during the formation and provide a beautiful appearance and light-blocking ability that are comparable to the one obtained by the dispersion of titanium dioxide. The level of whitening and that of the light blocking can be adjusted by changing the amount of the added surfactant. Nishimura also teaches capsule shell composition wherein the shell composition can include magnesium oxide as light shielding agent. Thus, one skilled in the art would have found it obvious to exclude titanium oxide (because of its adverse effects) and include sorbitan monolaurate and magnesium oxide as both of these provide light shielding properties, which is the intended purpose of adding titanium oxide in Takubo. Further, it would have been obvious to optimize the amount of magnesium oxide to achieve the optimal light shielding properties and color. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Sato also teaches that other colorants can be incorporated to give a different color to the film/capsule and thus, depending on the desired color of capsule, it would have been obvious to add a colorant other than white color.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Takubo (US20040234591A1) in view of Sato (US20210275404A1) and Nishimura (US20200155464A1) as applied claims 1-3, 7, 9-19 above, and further in view of Tomita (JP2009209048A).
The teachings of Takubo, Sato and Nishimura have been set forth above.
Takubo, Sato and Nishimura do not expressly teach the particle size of magnesium oxide as recited in instant claims. However, Tomita cures this deficiency.
Tomita teaches pharmaceutical magnesium oxide. Tomita teaches that pharmaceutical magnesium oxide used has an average particle size of 0.1 to 50 microns, which overlaps the particle sizes recited in claim 4-6. (see e.g. page 2; entire documents).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Takubo, Sato and Nishimura with Tomita and include magnesium oxide that has an average particle size of 0.1 to 50 microns. One would have been motivated to do so because Takubo, Sato and Nishimura are silent with respect to the particle size of magnesium oxide and, absence evidence of any unexpected effect, it would have been obvious to utilize the particle size of magnesium oxide which are known in the pharmaceutical formulations. Moreover, as discussed supra, magnesium oxide is taught to be used for having light shielding properties and it would have been obvious to manipulate the particle size and determine optimal particle size which would provide the desire/optimal light shielding properties.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Takubo (US20040234591A1) in view of Sato (US20210275404A1) and Nishimura (US20200155464A1) as applied claims 1-3, 7, 9-19 above, and further in view of Frank (https://www.ulprospector.com/knowledge/2735/fbn-8-uses-for-magnesium-oxide-food/; 2015).
The teachings of Takubo, Sato and Nishimura have been set forth above.
Takubo, Sato and Nishimura do not expressly teach wherein magnesium oxide is heavy magnesium oxide. However, Frank cures this deficiency.
Frank teaches magnesium oxide in foods. Light magnesium oxide has a density of roughly 40-50mL per 5g. Heavy magnesium oxide, which is denser at 10-20 mL per 5 g, is produced under more severe conditions. (see entire document).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Takubo, Sato and Nishimura with Frank and include heavy magnesium oxide. As discussed supra, magnesium oxide is taught to be used for having light shielding properties and Frank teach heavy magnesium oxide is more dense than light magnesium oxide, therefore, one skilled in the art would have expected that using a denser magnesium oxide would provide more light shielding than a less dense magnesium oxide. Further, Takubo, Sato and Nishimura teach using magnesium oxide and, absence any evidence of unexpected effect, it would have been obvious to one of ordinary skill in the art to substitute the known types of magnesium oxide as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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