DETAILED ACTION
Claims 1-12 and 42-44 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/13/23 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Status of the Rejections
The 103 rejections are withdrawn in view of the amendment, but new rejections are applied over new references as detailed below.
The 112(b) rejections are withdrawn in view of the amendment.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10-12, and 43 are rejected under 35 U.S.C. 102(a)(1) as anticipated by JP6964369B (published November 2021) as evidenced by the English translation thereof (of record in IDS of 12/13/23).
JP6964369B has a common inventor with the present application, and was published within one year of the earliest date to which the present application claims foreign priority (i.e., 5/23/2022). Applicant has not, however, submitted any English translations of the foreign priority documents. Therefore, the claims are currently given a priority date equivalent to the International Filing Date (i.e., 5/11/2023). As a result, JP6964369B is treated as prior art to the present application.
As to claims 1-8, 10-12, and 43, JP6964369B discloses a rapidly disintegrating gel film/coating composition comprising an undercoat comprising an acidic substance and a gel coat comprising a carbonate and a polymer that gels upon contact with water (Title and paragraphs 1, 8)(claims 1 and 7). The function of the polymer is to gel upon contact with water to make a tablet coated by the gel film easier to swallow (paragraph 8). Erthryitol is disclosed as one of many excipients or sweeteners that can be included in the film (paragraphs 21 and 28), but its presence is not required, thereby meeting the negative limitation of base claims 1 and 7.
As to claims 2 and 10, the carbonate is present in the amount of 1-25 wt% (paragraph 16) which overlaps the recited range to such a significant extent that the claimed artisan immediately could have envisaged the claimed range from the prior art range, such that the prior art range discloses the claimed range with sufficient specificity to be anticipating.
As to claims 3 and 11, the acidic substance is present in the amount of 0.1-20 wt% (paragraph 18) which overlaps the recited range to such a significant extent that the claimed artisan immediately could have envisaged the claimed range from the prior art range, such that the prior art range discloses the claimed range with sufficient specificity to be anticipating.
Regarding claims 4 and 12, the foregoing amounts of carbonate and acidic substance taught by JP6964369B read on the claimed ratios. For example, the use of 10 wt% of both carbonate and acidic substance would be within the ranges taught by JP6964369B and would be a ratio of 1:1.
Regarding claims 5-6 and 43, JP6964369B teaches an oral solid composition comprising the rapidly disintegrating gel film coated on an oral solid preparation in the form of a tablet (paragraph 9).
As to claim 8, the polymer that is gelable upon contact with water may be a polysaccharide (paragraph 13).
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 1-12 and 43 are rejected under 35 U.S.C. 103 as unpatentable over JP6964369B (published November 2021) as evidenced by the English translation thereof (of record in IDS dated 12/13/2023).
The teachings of JP6964369B are relied upon as discussed above, but JP6964369B does not further expressly disclose the concentration of the polymer that is gelable on contact with water is within the range of claim 9.
As to claim 9, 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 teachings of JP6964369B by selecting an amount of the gelable polymer to arrive at an amount within the recited range, because JP6964369B expressly teaches that the function of the polymer is to gel upon contact with water to make the a tablet coated by the gel film easier to swallow, such that the amount of the polymer is a result effective variable that will affect the ability of the film to gel and therefore the degree to which the tablet is easier to swallow, and there would be a reasonable expectation of success in arriving at the claimed range because the function of the gelable polymer is the same as its function in the claimed composition (i.e., to gel upon contact with water). Differences in concentration generally 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).
Claims 1-12 and 42-44 are rejected under 35 U.S.C. 103 as unpatentable over Gruber (US Pat. Pub. 2002/0068088).
As to claims 1-12 and 42-44, Gruber discloses an easy to swallow pharmaceutical composition comprising particles comprising a coating layer (“gel film”) comprising a hydratable pharmaceutically acceptable polymer such as sodium carboxymethylcellulose, alginate, or pectin (a “polymer gelable on contact with water” of claim 1 that is a polysaccharide of claim 8)(paragraphs 1, 16, 36, and claim 3 of Gruber), and that forms a gel upon contact with moisture in saliva (paragraph 64). The coating layer further may comprise a carbonate as a pore-former (paragraph 38) and an acidic substance as a salivation promoting agent (paragraph 26). Gruber does not disclose the use of erythritol in the gel coating, thus meeting the negative limitation of claims 1 and 7.
Regarding claims 5-6 and 43, the composition may be in the form of tablets (an “oral solid preparation”) that is coated with the gel film (paragraph 41).
Regarding claim 9, the polymer is present in the amount of 0.25-35% by weight of the coating layer, which overlaps the claimed range (paragraph 39).
Regarding claims 3 and 11, Gruber discloses an embodiment wherein the acid (citric acid) is present in the amount of about 17% by total weight of the coating solid composition, which is within the recited range (paragraphs 172-178).
As to claim 42, the gel film may be a single layer (paragraph 37).
Regarding claim 44, Gruber teaches a method of producing an oral solid composition comprising mixing the ingredients of the coating layer into a solvent followed by coating onto an oral solid preparation (paragraph 65).
As to claims 1-12 and 42-44, Gruber does not further expressly disclose a single embodiment comprising a carbonate, an acidic substance and the gelable polymer in combination as recited by base claims 1 and 7. Nor does Gruber expressly teach the amount of carbonate relative to the total amount of the gel film (claims 2 and 10) nor the amount of the acidic substance relative to the carbonate (claims 4 and 12).
As to claims 1-12 and 42-44, 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 teachings of Gruber by incorporating a carbonate and an acidic substance in combination with the gelable polymer in the gel coating film, because Gruber expressly teaches that the coating film may comprise a carbonate and an acidic substance. "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.
As to claims 2, 4, 10, and 12, it further would have been prima facie obvious to select amounts of the carbonate and amounts of the acid relative to the carbonate that are within the claimed ranges with a reasonable expectation of success, because Gruber teaches that the polymer is present in the amount of 0.25-35% by weight and that the acidic substance may be used in the amount of 17 wt% as discussed above, which leaves sufficient room for the carbonate to be used in amounts within the range of claims 2 and 10. For example, the use of the upper limit of 35% gelable polymer and the amount of 17% acidic substance leaves up to 48 wt% available for the carbonate, which is within the recited range. Additionally, since Gruber teaches that the acid is useful to promote salivation and the carbonate is useful to form pores in the composition, the amounts of these substances would be viewed by the skilled artisan as result effective variables that will affect the degree to which salivation is promoted and pores are formed, such that they would be subject to an optimization process to determined the optimum amount of the acid relative to the carbonate. Differences in concentration generally 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).
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.
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 on M-F 9AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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