DETAILED ACTION
Claims 2-4, 7-16, and 18 are pending and under consideration on the merits.
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 .
Status of the Rejections
The 102 and 103 rejections are withdrawn in view of the amendment and new 103 rejections are applied incorporating the teachings of a new primary reference, Fuji’069, as detailed below.
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 2-4, 7-16, and 18 are rejected under 35 U.S.C. 103 as unpatentable over Fuji et al. (US Pat. Pub. 2016/0271069; hereinafter “Fuji’069”) in view of Fuji (JP2009-28544; of record in IDS) as evidenced by the English translation thereof (of record in IDS).
As to claims 2-4, 7-16, and 18, Fuji’069 discloses a soft capsule such as a seamless capsule comprising a shell, the shell comprising one or more gelatinizers that may include gellan gum and alginate (a salt of an alginic acid of claim 8), and further comprising glycerin and sorbitol (“plasticizers” of claim 11 wherein glycerin is a “polyhydric alcohol” of claim 11 and sorbitol a “sugar alcohol” of claim 11) along with starch or dextrin (a “shell-forming base material” of claim 10)(paragraphs 1, 14-16, 18, 26). The gelatinizer is present in the amount of most preferably 10-24 wt% excluding solvent, which overlaps the greater than 15% range for the gellan as recited by claim 2 (paragraph 19). The starch or dextrin is present in the amount of most preferably 10-60 wt% (paragraph 17), such that the amount of the starch relative to the gellan may be within the 100 parts by mass or less range of claim 10. For example, the use of 10 wt% for each of the starch and the gellan would be within the disclosed ranges and result in a mass ratio of 100 parts by mass to 100 parts by mass. The shell further may comprise a buffer such as sodium phosphate (a “monovalent metal compound” of claim 2) in the amount most preferably of 1-4 wt% (paragraph 23), which means it is present in an amount of less than 120 parts by mass relative to 100 parts by mass of the gellan gum, which is within the range of claim 2, as well as within the 0.1 part by mass or more relative to 100 parts gellan gum recited by claim 9. The shell does not comprise gelatin or a multivalent metal ion, thus meeting the negative limitations of claim 2.
Regarding claim 15, Fuji’069 teaches that the capsules comprise a content within the shell (paragraph 15).
As to claims 2-4, 7-16, and 18, Fuji’069 does not further expressly disclose a specific embodiment wherein the gelatinizer comprises gellan gum and a monovalent metal compound is present as recited by claim 2 or that the alginate is in the form of an alkali salt within the scope of claims 7-8. Nor does Fuji’069 disclose that the capsule has a disintegration time of 60 minutes or less in water as recited by claim 3 and/or has a ratio of crush strength (g) to an outer diameter (mm) of 210 or more as recited by claim 3 or five or more as recited by claim 18 and within the standard deviations for crush strength recited by claim 16, nor a ratio of crush deformation to outer diameter within the range of claim 4. Additionally, Fuji’069 does not expressly disclose the percentage of the shell in the capsule relative to the total mass of the soft capsule comprising the shell and the capsule content (claims 14-15), nor the outer diameter of the capsule (claim 13). Nor does Fuji’069 expressly teach forming the capsule by a drop method followed by drying the capsule as recited by claim 18.
Fuji discloses a soft, seamless capsule for use in pharmaceuticals comprising a shell comprising gellan gum (paragraphs 1, 8, 17). The English translation of record does not provide a translation of the tables, but the Office has obtained the following translation of Table 2:
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743
925
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Formulation M discloses a capsule shell comprising 1.0 wt% gellan gum, 0.15% calcium lactacte, 0.5% carrageenan (a “shell forming base material” of claim 10 that is also a polysaccharide plasticizer of claims 11-12), 0.05% potassium chloride (wherein the potassium chloride comprises “a monovalent metal compound” of claim 1 and an “alkali metal halide” of claim 7), and water to balance. Disregarding the water (since claim 2 specifies that the recited weight percents are “excluding any solvent”) results in a gellan content of 58.8 wt% by total weight of the solids, which is within the “15% by mass or more” range recited by claim 2, and 2.94 wt% of the potassium chloride, resulting in a mass ratio of the monovalent compound that is less than 120 parts relative to 100 parts of the gellan gum as recited by claim 2 and a mass ratio of the monovalent metal ion that is 0.1 part by mass or more relative to 100 parts by mass of the gellan gum as recited by claim 9, and 29.4% of the carrageenan base material which is an amount that is 100 parts by mass or less relative to 100 parts by mass of the gellan gum as recited by claim 10. Formulation M does not comprise gelatin, thus meeting the negative limitation of claim 2. Fuji further discloses that alginate can be used instead of carrageenan in the shell (paragraph 31) which will result in the formation of an alkali metal salt of alginic acid with the potassium. Fuji additionally discloses a method of producing the capsule using a drop method followed by drying as recited by claim 18 (paragraphs 17, 24), and discloses that in an embodiment the capsule has a water content of more than 95 wt% (paragraph 11), which is within the 80% or more range of claim 18.
As to claims 2-4, 7-16, and 18, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the seamless soft capsule of Fuji’069 by selecting a combination of gellan and a monovalent metal compound, because Fuji’069 expressly teaches that the shell may comprise gellan as a gelatinizer and a sodium or potassium salt as a buffer, and further because Fuji expressly teaches a specific embodiment of a very similar soft seamless capsule comprising gellan as a gelatinizer in combination with an alkali salt, which would have provided the skilled artisan with an additional motivation to select out this combination of ingredients from the disclosure of Fuji’069.
Regarding claims 7-8, it further would have been prima facie obvious to select an alkali metal salt of alginic acid as the type of alginate, because Fuji expressly teaches that an alkali metal salt of alginic acid is a suitable type of alginate for use in the shell of a soft seamless capsule, such that the skilled artisan reasonably would have expected that it could be used as the type of alginate in the Fuji’069 soft seamless capsule.
Regarding the disintegration time of 60 minutes or less in water as recited by claims 2 and 3, the ratio of crush strength (g) to an outer diameter (mm) recited by claims 3 and 18 and with the standard deviations of claim 16, and the ratio of crush deformation to outer diameter of claim 4, the Fuji capsule comprises the same ingredients recited by the claim and in the same amounts and therefore will possess the properties recited by the foregoing claims since a product cannot be separated from its properties. MPEP 2112.01. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01. Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 13 and 14-15, it further would have been prima facie obvious to select a diameter of the capsule within the recited range of claim 13, because the diameter of a capsule is a result effective variable that will affect the amount of a composition that can be loaded into the capsule. The skilled artisan further would recognize that the diameter of the capsule will affect the amount of a composition that can be loaded into the capsule, thereby affecting the weight percentage of the shell of the capsule relative to the total weight of the capsule, e.g., a larger amount of the loaded composition would result in a lower weight percentage of the shell of the capsule, such that the wt% of the capsule shell is also considered a result effective variable that will vary by the weight of the contents of the capsule. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claim 18, it further would have been prima facie obvious to form the capsule of Fuji’069 by a drop method followed by drying the capsule, because Fuji expressly teaches that such a method is a suitable way of forming seamless soft capsules comprising a shell comprising gellan and a monovalent metal compound, such that the skilled artisan reasonably would have expected that the Fuji’069 seamless soft capsules comprising a shell comprising gellan and a monovalent metal compound also could be made using this method.
Response to Applicant’s Arguments
Applicant’s arguments have been considered carefully but are moot in light of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/ Primary Examiner, Art Unit 1600
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