DETAILED ACTION
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 .
Claim Status
Claims 1-15 are pending.
Claims 11-15 are withdrawn.
Claims 1 and 4-6 are currently amended.
Claims 1-10 are currently under consideration.
Claims 1-10 are rejected.
Acknowledgement of Receipt
This Office Action is in response to amendments and remarks filed 07/28/2025.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) submitted on 05/01/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this IDS has been considered by the Examiner.
Withdrawn Rejections
In light of the new amendments, the rejection of claims 4-6 under 35 U.S.C. § 112(b) as being indefinite are withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Action dated 02/28/2025 since the art that was previously cited continues to read on the newly amended limitations.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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 1-2 and 4-10 are rejected under 35 U.S.C. § 103 as being unpatentable over Doi (WO 00/06122, cited on IDS) in view of Dairaku (WO 2010/150400). Citations from Dairaku are from the machine translation document previously provided.
Doi discloses a pharmaceutical composition comprising a gelling agent and a drug-containing substance in which the unpleasant taste of the drug is masked; wherein said pharmaceutical composition is converted into a jelly-like preparation containing the above drug-containing substance dispersed therein by dissolving in water (abstract, claims 1-2). Doi clearly teaches gel beads (pg. 16, lines 11-12, 16; pg. 17, lines 4-5, lines 13 and 15; claim 7) and provides embodiments thereof (pg. 26, line 17; pg. 39, lines 12 and 15, Example 12).
Doi teaches that the content of the drug can be usually set within a range from 10 to 90% by weight based on 100% by weight of the drug-containing substance (pg. 16, lines 13-15). Here the prior art range overlaps with the claimed range of at least 50%. MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art. Further, Doi suggests that the limits of the range advantageously provide an enhanced controlled release of the drug (pg. 16, lines 15-17). Doi states that it would be discerning enough to mix, adjust and optimize the drug to gelling agent ratio to achieve the desired results (pg. 24, lines 1-9). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Doi teaches that drug-containing substance has a form of fine particles (pg. 14, line 9; claims 4, 7) to read on the dry weight limitation. In addition, Doi discloses a dry syrup to be reconstituted upon administering (pg. 1, lines 19 and 22; pg. 3, line 25; pg. 4, line 1). Doi teaches that in the case of the drug which is freely soluble in water, the content is not less than 30 to 80% by weight (pg. 16, 18-21,) with embodiments (pg. 26, lines 18-21).
Doi does not teach isosorbide.
Dairaku discloses a preparation of a jelly formulation preparation comprising a gelling agent and isosorbide in an amount of 65-75 mass % ([0008], [0013], claim 1). Dairaku teaches that the jelly preparation can be produced by powder-mixing (i.e., dry) isosorbide, carrageenan and other prescription components, then heating and stirring and dissolving the mixture into purified water, dispensing and filling the purified water, and solidifying it by cooling ([0021]). Dairaku teaches a content range of 0.4 to 0.8% mass % of gelling agent (i.e., carrageenan) relative to the total amount of the formulation the formulation and that outside the range, the formulation is either too hard (above the upper limit) or not solidified enough (less than the lower limit) ([0010], [0014]). Dairaku teaches that the formulation may comprise sodium alginate as an additional gelling agent thickener; the content of the gelling agent and the thickener other than the carrageenan is 0.01 mass % or less ([0018], claim 4).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate or combine the isosorbide taught by Dairaku in the composition of Doi with expected results. One would be motivated to incorporate the isosorbide of Dairaku with a reasonable expectation of success because Dairaku provides an improvement to the administering of the drug, by providing a composition with a good palate feeling, improved texture, to foster better patient compliance particularly among those (e.g., elderly) with heightened organoleptic sensitivity ([0039]). Dairaku improves upon Doi by providing an answer to the problem of when mixing ratio of the drug-containing substance to the gelling agent may result in a “jelly” that has a “rough feel to the tongue” (pg. 24, lines 1-9).
Regarding the claim 2 (i.e., at least 60%), as stated above, Doi teaches the range 10 to 90% (pg. 16, lines 13-15). In addition, Dairaku teaches isosorbide in an amount of 65-75 mass % relative to the total amount of the formulation ([0008], claim 1).
Regarding claim 4 (i.e., alginate), Doi discloses sodium alginate and a calcium salt as the gelling agent (claim 12). Doi teaches that the polymer capable of causing crosslinking gelation by an action of the polyvalent metallic ions includes, for example, alginate and that alginate is preferred (pg. 18, lines 12-15) with exemplary embodiments (see Examples 1-18, pgs. 29-47). Doi teaches that sodium alginate is widely used as a viscous agent or a gelling agent in the consumables (i.e., food) industry and are commercially available (pg. 18, lines 21-24).
Regarding claim 5 (i.e., gelling agents, 0.1%, ≤ 5.0%), Doi teaches 2 w/v% solution of sodium alginate resulting in beads described in Example 12 (pg. 39, lines 6-18). Doi further teaches the gelling agents of the gelling powder in the same example at about 4% of the resulting composition (pg. 39, line 20). Additionally, as mentioned above, Dairaku teaches 0.01 mass % or less of sodium alginate ([0018]) with 0.4 to 0.8% mass % carrageenan (i.e., gelling agent) ([0014]).
Regarding claim 6 (i.e., isosorbide/gelling agents ≤ 40:1), Doi teaches a weight ratio of the drug-containing substance to the gelling agent from 1:0.01 to 1:2, (pg. 24, lines 16-21) and provides embodiments (pg. 27, lines 15-19). Dairaku discloses a content ratio of isosorbide and carrageenan is 70:0.4 to 70:0.8 ([0015]). Here the prior art meets the limitation of isosorbide/gelling agent of at least 40:1. MPEP 2144.05 states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Further, MPEP 2144.05 states that where 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. Evidence of the criticality of the claimed ranges has yet to be provided.
Regarding claim 7 (i.e., ≤ 30%), although Doi does not explicitly teach water content; resulting beads (of drug) are dried to obtain particles (drug-containing substance) (pg. 17, line 6) wherein the content of the drug is 60 w/w% (pg. 39, lines 15-17). Doi teaches that the drug-containing particles are mixed with the gelling agent powder (pg. 39, lines 20-25) to obtain a composition for jelly preparation (pg. 40, lines 1-4). Looking to Dairaku, the jelly preparation uses water is disclosed as being the amount that is the remainder after preparing isosorbide, carrageenan, and other prescription components, specifically 15 to 29% mass% ([0016]). Thus the prior art renders the claimed gelled beads having a water content of less than or equal to 30% as prima facie obvious.
Regarding claim 8 (i.e., mean diameter ≤ 5.0 mm), Doi teaches that it is possible to use the drug-containing substance having a particle diameter of up to about 2 mm (pg. 13, line 24 through pg. 14, line 4). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art. Further, Doi discloses that when a large drug containing substance having a particle diameter of larger than 500 μm (0.5 mm) is prepared, a drug in gel beads such as water-insoluble alginate beads is used (pg. 16, lines 8-12; pg. 26, line 17; claim 7).
Regarding claim 9, Applicants define “pharmaceutical composition” to mean a composition in the final dosage form of isosorbide to be administered (see Spec., [0035]). Applicants disclose that the pharmaceutical composition may also only consist of the gelled beads and that the gelled beads may be administered with other substances, for example in the form of a suspension of the gelled beads in a syrup (see Spec., [0036]). Doi discloses an orally administered jelly pharmaceutical composition to a patient (pg. 49, lines 2, 8). The claim recites “comprising” and as such, Doi teaches a composition to be administered while in combination with water in a proper amount (pg. 53, line 4) which therefore meets the limitation of the claim.
Regarding claim 10, Applicants disclose an objective to mask (bitte) taste, particularly for medicaments intended for pediatric and geriatric populations, for whom oral administration can be challenging (see Spec., [0002]). The teachings of Doi resonates with the instant disclosure because Doi provides an improved drug delivery system to infants, the elderly and those suffering from dysphagia (pg. 53, lines 7-10). As Applicants describe the claimed invention for use as medicament, in particular for treating Meniere's disease (see Spec., [0040]), Dairaku provides medicament for the same (see “Menial’s” [sic] disease in para. [0002]) with an improved structure that makes for easier removal from the package, delivers an agreeable organoleptic profile, while maintaining excellent drug elution properties ([0008]) to suggest improved safety and enhanced and consistent patient compliance.
Response to Arguments
Applicants’ arguments have been fully considered but they are not persuasive.
Gelled beads
Applicants argue that the particles of active ingredient of Doi may optionally be in the form of alginate beads (Example 12). Applicant argues that the particles disclosed in Doi, such as the alginate beads of Example 12, are always mixed with a powder comprising a gelling agent (Remarks, pg. 5, para. 4).
In response, the Examiner respectfully submits that Doi clearly teaches gelled beads (pg. 16, lines 11-12, 16; pg. 17, lines 4-5, lines 13 and 15; claim 7). Regarding Applicants’ argument that beads are mixed with a powder comprising gelling agent, the rejected claims recite comprising language and are product claims. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Isosorbide
Applicant admits that the list of active ingredients taught by Doi is considered useful but argues that the reference does not mention isosorbide (Remarks, pg. 5, last para.). Applicant argues that the active ingredient used in the examples of Doi is grepafloxacin and different from isosorbide. Applicant argues that the pharmaceutical compositions of Doi comprise low amounts of active ingredients (Remarks, pg. 5, last para.). Applicant argues that Sutriyo et al. does neither teach nor suggest isosorbide (Remarks, pg. 6, para. 1).
Previously used evidentiary references are no longer used. Dairaku is brought in to teach isosorbide. Doi does not exclude isosorbide. Regarding low amounts of active ingredients, Dairaku is brought in to teach isosorbide. Further Dairaku explains that a drug having a large amount of drug such as isosorbide needs to reduce volumes as much as possible in order to reduce the burden on the patients’ administration ([0005], [0013]). This focus complements that of Doi as Doi states that it would be discerning enough to mix, adjust and optimize the drug to gelling agent ratio to achieve the desired results (pg. 24, lines 1-9). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Taste masking strategy
Applicant argues that the taste masking strategy disclosed in Dairaku is not based on microencapsulation via incorporation of isosorbide inside gelled beads but based on flavors and sweeteners that eliminate the strong bitter taste of isosorbide (Remarks, pg. 6, para. 2). Applicant argues that Dairaku teaches flavors and sweeteners to mask the bitter taste of isosorbide when used in high concentration (Remarks, pg. 8, para. 2). Applicant argues the prior art teaches that one would necessarily include sweeteners and flavors in the composition of the beads in order to efficiently mask the bitter taste of isosorbide as in the case of isosorbide in high concentrations (i.e. above 50% by dry weight) in Dairaku (Remarks, pg. 8, last para. – pg. 9, para. 1). Applicant argues that the cited references taken alone or in any combination, provides any teaching, suggestion or other guidance that would motivate the skilled artisan to use isosorbide in the gelled beads of Doi without adding sweetener and flavor to obtain the desired taste masking effect (Remarks, pg. 9, last para.).
First, the Examiner reiterates that the previously used evidentiary references are no longer used. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., taste masking strategies) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Dairaku provides an improvement to the administering of the drug, by providing a composition with a good palate feeling, improved texture, to foster better patient compliance particularly among those (e.g., elderly) with heightened organoleptic sensitivity ([0039]). Dairaku improves upon Doi by providing an answer to the problem of when mixing ratio of the drug-containing substance to the gelling agent may result in a “jelly” that has a “rough feel to the tongue”(pg. 24, lines 1-9).
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
All claims under consideration remain rejected; no claims are allowed. 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 extension fee 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 Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614