DETAILED ACTION
Claims 1-3, 6, 8-14, and 17-21 are pending. Of these, claim 21 is withdrawn as directed to a nonelected invention. Therefore, claims 1-3, 6, 8-14. and 17-20 are 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 5/8/26 has been entered.
Status of the Rejections
The 112(a) rejection is withdrawn in view of the amendment.
The 102 rejections are withdrawn in view of the amendment.
The 103 rejection over Motoune is maintained and the remaining 103 rejections are withdrawn in view of the amendment and Applicant’s arguments.
A new claim objection is applied.
Notice of Subject Matter Free of the Prior Art
Claims 6, 14, and 20 are free of the prior art. The prior art does not teach or suggest a hard capsule of claim 6 comprising one of the salts of claim 6 and wherein the amount of the salt is within the 0.5 to 40 parts by weight range recited by claim 1 as amended. CN102499910A (of record) discloses a hard shell capsule comprising pullulan and 0.001-0.1 wt% of a moisture retaining stabilizer such as dipotassium hydrogen phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, or sodium pyrophosphate, but the range taught by this reference for the salt is 5-fold less than the lower end of the range recited by base claim 1 and the salt is not used for the same purpose as in the present claims (i.e., as an opacifier), and there is no teaching, suggestion, or motivation to modify the amount of the salt to arrive at the claimed range.
The prior art also does not teach or suggest a hard capsule comprising gelatin and the film forming polymer in combination with one of the specific salts recited by claims 14 and 20.
Claim Objections
Claims 6, 14, and 20 are objected to as depending from a rejected base claim, but would be in condition for allowance if rewritten in independent form and incorporating all limitations of the base claim and any intervening claims.
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 1-3, 8-13, and 17-19 are rejected under 35 U.S.C. 103 as unpatentable over Motoune et al. (US Pat. Pub. 2005/0112189).
As to claims 1-3, 8-13, and 17-19, Motoune discloses hard capsules comprising a cellulose derivative (paragraph 26), a gelling agent such as gelatin (a “film forming polymer” of claims 1 and 3)(paragraph 29), and a gelling aid such as ammonium chloride, magnesium sulfate, or sodium citrate (a water soluble salt of claims 1, 13, and 19) (paragraph 30). Regarding claims 8-9, the sodium citrate salt is used in the amount of 0.01-1 wt% (paragraph 30), which reads on the range of claims 1 and 8 and which is slightly below the 2 wt% range of claim 9. The capsules are two piece comprising a body and cap (paragraph 34).
As to claims 10, 12, and 18 the capsule may contain a colorant (paragraph 14) such as caramel (a “color other than white” of claim 10)(paragraph 21), and while Motoune teaches that the colorant may be titanium oxide (a “white pigment”)(paragraph 31), Motoune nowhere requires the presence of the white pigment, thereby meeting the negative limitation of claims 12 and 18.
Regarding claims 11 and 17, the capsules may be #0 capsules (paragraph 39), which are used for oral delivery.
As to claims 1-3, 8-13, and 17-19, Motoune does not further expressly disclose a specific embodiment wherein the gelling aid is gelatin and the water soluble salt is a salt within the scope of claims 1, 13, and 19 such as the sodium citrate, or that the amount of the sodium citrate salt is within the range of claim 9, or that more than one water soluble salt/gelling aid is used in combination (claim 2).
As to claims 1-3, 8-13, and 17-19, 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 select gelatin as the gelling agent and sodium citrate as the gelling aid, because Motoune expressly teaches a list of gelling agents that includes gelatin and a list of gelling aids that includes sodium citrate. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." (325 U.S. at 335, 65 USPQ at 301). MPEP § 2144.07.
Regarding claim 2, it further would have been prima facie obvious to use more than one water soluble salt gelling aid in combination, for example, sodium citrate and ammonium chloride, because both sodium citrate and ammonium chloride are taught by Motoune as useful for the same purpose as gelling aids, such that the skilled artisan reasonably would have expected that a combination of sodium citrate and ammonium chloride also would be useful as a gelling aid. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Regarding claim 9, the 2 wt% amount that is within the scope of the range recited by claim 9 is close enough to the 1 wt% taught by Motoune that the skilled artisan would have expected the Motoune composition and the claimed composition to have substantially the same properties. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Response to Applicant’s Arguments
Applicant argues that claim 1 as amended recites that the film forming component is selected from gelatin or pullulan and excludes a cellulose derivative, while Motoune is focused solely on capsules that require a cellulose derivative as the film forming polymer. Applicant argues there is no suggestion in Motoune to replace its cellulose derivative with gelatin as the film forming polymer.
In response, claim 1 recites open-ended “comprising” language in the preamble, which allows for the presence of additional ingredients not recited by the claims, such as a cellulose derivative. Therefore, while claim 1 recites a film forming component that is gelatin or pullulan and excluding a cellulose derivative, the language of the claim does not exclude the presence of a cellulose derivative. While claim 1 specifies that the gelatin or pullulan is a “film-forming component” and Applicant argues that the gelatin in the Moutone composition is being used as a gelling agent, the Moutone composition nevertheless comprises gelatin in the hard capsule film and therefore reads on the structure recited by the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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