DETAILED ACTION
Claims 8 and 10-28 are pending. Of these, claims 10 and 24-28 are withdrawn as directed to a nonelected invention. Therefore, claims 8 and 11-23 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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restriction
Applicant’s election of Group I with traverse is acknowledged. The basis of the traversal is that claim 8 as amended recites the presence of ilaprazole, which is not disclosed by JP’271, such that Groups I-III share a special technical feature over the cited art.
In response, the 103 rejection, infra, relies on Garst et al. for providing a disclosure of ilaprazole. Since the prior art as combined in the 103 rejection renders prima facie obvious all elements of claim 8 even as amended, there is still no special technical feature shared by Groups I-III. Therefore, the restriction requirement is still considered proper and is made FINAL.
Applicant’s election of chitosan as the species of cationic polymer and the combination of pectin and sodium alginate as the anionic gel is acknowledged. Since Applicant did not point to any alleged deficiencies in the election requirement, the election is treated as having been made without traverse. The election requirement is still considered proper and is made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/23/24 and 5/27/24 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.
Claim Objections
Claim 16 is objected to because of the following informalities:
“comprises” should be “comprise.” 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 8 and 11-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 8 recites “the suspension gel” and “the water-based medium,” but there is no antecedent basis for these limitations. Clarification is required. Since depend claims 11-23 do not clarify the point of confusion, they are also rejected.
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 8 and 11-23 are rejected under 35 U.S.C. 103 as unpatentable over CN107469652A (of record in IDS) as evidenced by the English translation thereof and in view of Meijlink et al. (EP 1232746; published 8.21.22), JP2001316271; of record in IDS) as evidenced by the English translation thereof, and Garst et al. (US Pat. Pub. 2010/0113524).
As to claims 8 and 11-23, CN107469652A discloses a pharmaceutical dosage form comprising gel suspension modified particles (“dry suspension granules”) and enteric pellets comprising an acid-sensitive proton pump inhibitor as active ingredient, and (paragraphs 2, 17, 23), the gel suspension modified particles comprising a thermosensitive gel material such as the polysaccharide chitosan (the elected species of “cationic polymer” of claim 8). CN107469652A discloses an embodiment comprising Poloxamer 407 as the thermosensitive gel material in the amount of 2.5 wt%, which is within the recited ranges of claims 8 and 13-15 (paragraph 52). CN107469652A discloses an embodiment wherein the composition is reconstituted as a suspension gel with a pH of 6.8, which is within the range of claim 8 (paragraph 79). CN107469652A teaches that “thermosensitive gel materials” are those that are temperature sensitive because when in solution can undergo a phase change to transform from a liquid state into a semi-solid gel (paragraph 7), and that the dosage form disclosed therein provides long term sustained release of the active and avoids undesirable low drug release early after administration (paragraph 15) with the gel suspension modified particles allow the introduction of an aqueous carrier to form a gel with the desired pH and stable viscosity Paragraph 23).
Regarding claims 16-19, the gel suspension modified particles further comprise an adhesive, a disintegrant, a diluent, and a pH regulator as recited by claim 16 (paragraphs 39-40), wherein the adhesive may be polyvinyl pyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, or starch of claim 17 (paragraph 31), the disintegrant may be croscarmellose sodium (“crosslinked sodium carboxymethyl cellulose”), pregelatinized starch, or microcrystalline cellulose of claim 18 (paragraph 35), the diluent may be mannitol of claim 19 (paragraph 33), and the pH regulator may be citric acid of claim 20 (paragraph 52).
As to claims 8 and 11-23, CN107469652A does not further expressly disclose the presence of an anionic gel of claims 8 and 12 that is the elected species (i.e., a combination of sodium alginate and pectin) and wherein the weight ratio of the anionic gel to cationic polymer is 1 to 10:1 as recited by claim 8 or the narrower ratio of claim 11, nor that the proton pump inhibitor is illaprazole or salt thereof such as the sodium salt as recited by claims 8 and 23 and which is present in the mass ratio relative to the dry suspension granules within the range of claim 22, or that the pH of a gel formed by the dry suspension granules in water is 3.0 to 5.0 (claim 21).
Mejlink discloses a pharmaceutical composition comprising a readily suspendible dry powder mixture comprising a gellant or thickener comprising xanthan and which further may comprise additional gellants including pectin and alginate (paragraph 30), which the skilled artisan would recognize are thermosensitive gel materials since they change from a liquid-like state to a gel at specific temperatures. Mejlink further teaches sodium alginate as a type of alginate (paragraph 38).
JP2001316271 discloses dry granules comprising chitosan and an anionic gel comprising a polysaccharide thickener such as pectin or sodium alginate (paragraph 6) and teaches that the thickening polysaccharide is present in the amount of most preferably 0.22 to 2 parts per 1 part by weight of the chitosan (paragraph 7), which overlaps the ranges of claims 8 and 11. JP2001316271 teaches that the purpose of the polysaccharide thickener is that when the dry granules are dissolved or dispersed in a liquid, the thickener increases the viscosity which helps in maintaining the dispersion stability of the chitosan, and that the amount of the thickener is selected from this perspective (paragraph 7). JP2001316271 further teaches that when chitosan is added to a beverage with a pH near neutral or higher, it can precipitate (paragraph 4).
Garst teaches that ilaprazole including salts thereof such as ilaprazole sodium is a known proton pump inhibitor (paragraphs 24 and 88).
As to claims 8 and 11-23, 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 thermoresponsive gel material-containing dosage form of CN107469652A by incorporating sodium alginate and pectin as polysaccharide thickeners in the gel suspension modified particles and in amounts that will result in weight ratios relative to the cationic polymer that are within the presently claimed ranges, because JP2001316271 teaches that the use of such thickeners in such amounts will help maintain the dispersion stability of the chitosan in the dry suspension granules, and additionally because the skilled artisan would recognize sodium alginate and pectin as additional examples of thermoresponsive gel materials, such that they reasonably would be expected to be able to serve as thermoresponsive materials in the particles of the CN107469652A dosage form.
It further would have been prima facie obvious to select ilaprazole sodium as the type of proton pump inhibitor, because CN107469652A does not limit the identity of the proton pump inhibitor and Garst teaches that ilaprazole sodium is a known proton pump inhibitor, such that the skilled artisan reasonably would have expected that it could be used as the proton pump inhibitor in the composition of CN107469652A.
As to claim 21, it further would have been prima facie obvious to select a pH for the suspension gel within the 3.0 to 5.0 recited range, because JP2001316271 teaches that chitosan can undesirably precipitate in aqueous medium at neutral or higher pH values, which would have motivated the skilled artisan to adjust the pH to values below 7, such as 5.0. 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 claim 22, it further would have been prima facie obvious to select an amount of the ilaprazole such that the mass ratio ofilaprazole to the dry suspension granules is within the range, because the amount of illaprazole is a result effective variable that will affect the therapeutic efficacy of the composition, and the amount of the dry suspension granules is a result effective variable that will affect their ability to form a gel with the desired pH and stable viscosity upon addition of an aqueous carrier, and with a reasonable expectation of arriving at the claimed ratio because the ilaprazole is serving the same function as in the claimed invention (as a therapeutic proton pump inhibitor) and the dry suspension granules are serving the same function (i.e., allowing for formation of a suspension having a stable viscosity s discussed at page 2, last paragraph of the present specification). 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).
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 on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examienr, Art Unit 1600
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