DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 07/28/2026 (Response After Final Action), is acknowledged.
Claims 1-8, 10-18, 20 are pending in this action. Claims 9, 19 have been cancelled. Claims 1, 4-5, 8, 12, 14-16, 18, 20 have been amended. Claims 1-8, 10-18, 20 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of objections and/or rejections presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/EP2022/056410, filed March 11, 2022, which claims benefit of foreign priority to EP21162444.0, filed March 12, 2021.
Claim Objections
Claims 2, 14 are objected to because of the following informalities:
It is suggested that in claim 2 the limitation “the aid comprises an International Dysphagia Diet Standardization Initiative (IDDSI) level from 1 to 4” should be corrected to “the aid has an International Dysphagia Diet Standardization Initiative (IDDSI) level from 1 to 4” for clarity.
Claim 14 recites the limitation “a capillary breakup extensional rheometer (CaBER)” that should be corrected to “CaBER” (see claim 1).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-8, 10-18, 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Newly amended claim 1 discloses “A method for promoting safe swallowing of a solid oral dosage form (SODF) in a patient in need thereof, the method comprising orally administering to the patient a liquid viscoelastic swallowing aid” that is not reasonably clear. In the present case, it is unclear when said liquid viscoelastic swallowing aid should be orally administered – before, together or after administering said solid dosage forms. Therefore, it is unclear what method/process the applicant is intended to encompass. Clarification is required.
Claim 1 discloses a liquid viscoelastic swallowing aid/composition comprising 0.1-10 wt% of a compound as instantly claimed and having a shear viscosity and an extensional relation time as measured by the applicant under specific conditions chosen by the applicant. First, as stated previously, it is noted that it is well known in the field that properties of multicomponent systems/compositions depend on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/formulation. “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Second, it is noted that it is well known in the field that a shear viscosity as well as an extensional relaxation time depend on the solvent used to measure it. Third, it is unclear if this claim discloses the use of any liquid comprising 0.1-10 wt% of compounds as instantly claimed and having recited properties, wherein said liquid may include other compounds even in large amounts (i.e., comprising). Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to claims 3-5, 14-16. Clarification is required.
Claim 12 (dependent on claim 1) recites the limitation “the method comprising: diluting a concentrated form of the liquid viscoelastic swallowing aid prior to said oral administration; reconstituting a powder form of the liquid viscoelastic swallowing aid prior to said oral administration;” that is not reasonably clear. In the present case, it is unclear if this is a sequence of steps, OR alternative steps of the preparation of claimed swallowing aid. Clarification is required.
Claims 2, 6-8, 10-11, 13, 17-18, 20 are rejected as being dependent on rejected independent claims 1 and14 and failing to cure the defect.
Claim Rejections - 35 USC § 103 - MAINTAINED
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.
Claims 1-8, 10-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burbidge et al., WO 2014/184329 (cited in IDS; hereinafter referred to as Burbidge’329), Popa Nita et al., WO 2016/012403 (cited in IDS; hereinafter referred to as Popa Nita), and Burbidge et al., WO 2020/120223 (cited in IDS; hereinafter referred to as Burbidge’223).
Burbidge’329 teaches a method of treating a swallowing disorder in a patient in need thereof (e.g., patients with dysphagia) by administering to the patient a cohesive thin liquid having (i) a shear viscosity of less than about 50 mPas, or 5-45 mPas, or 10-40 mPas, or 20-30 mPas, when measured at a shear rate of 50s-1; and (ii) a relaxation time, determined by a capillary breakup extensional rheometry (CaBER) experiment, of more than 10 milliseconds at 20 °C; and (iii) wherein said liquids may include 0.01-25 wt% of at least one food grade biopolymer selected from the group consisting of plant-extracted gums, plant-derived mucilages, or combinations thereof (Claims 1-3, 5, 7-8; Title; Abstract; Pages 3-4; Examples 1 as applied to claims 1, 3-4, 8, 10-11, 14-15, 18). Burbidge’329 teaches the use of (a) the plant-extracted gums selected from the group consisting of okra gum, konjac mannan, tara gum, locust bean gum, guar gum, fenugreek gum, tamarind gum, cassia gum, acacia gum, gum ghatti, pectins, cellulosics, tragacanth gum, karaya gum, or any combinations thereof; and/or (b) the plant-derived mucilages selected from the group consisting of kiwi fruit mucilage, cactus mucilage, chia seed mucilage, psyllium mucilage, mallow mucilage, flax seed mucilage, marshmallow mucilage, ribwort mucilage, mullein mucilage, cetraria mucilage, or combinations thereof (Claims 8, 16; Page 4 as applied to claims 6-7, 17). Further, Burbidge’329 teaches that said liquid compositions can be used as a part of pharmaceutical compositions (Claims 9, 17; Pages 5, 12 as applied to claims 1, 14).
Popa Nita teaches the use of nutritional compositions for promoting safer swallowing of food boluses for individuals having swallowing difficulties (e.g., patients with dysphagia), wherein said compositions comprise an aqueous solution comprising 0.01-10 wt% of beta-glucan, and wherein said aqueous solution is capable of providing to the nutritional product: (i) a shear viscosity of less than 200 mPas when measured at a shear rate of 50s-1; and (ii) a relaxation time of more than 10 milliseconds at a temperature of 20 oC as determined by a capillary breakup extensional rheometry (CaBER) experiment (Claims 1-20; Pages 7-8; Example 1 as applied to claims 1, 3-4, 8, 10-11, 14-15, 18). Popa Nita teaches that said products/compositions may also include acacia gum, guar gum (Page 12 as applied to claims 1, 6, 14, 17); and such optional ingredients as conventional food additives, acidulants, buffers or agents for pH adjustment, chelating agents, colorants, emulsifiers, excipient, flavor agent, minerals, osmotic agents, a pharmaceutically acceptable carrier, preservatives, stabilizers, sugars, sweeteners, texturizers, vitamins (Page 9 as applied to claim 13). Further, Popa Nita teaches that said solutions (i.e., liquid compositions) can be used as a part of pharmaceutical compositions (Claims 9, 20; Pages 15, 22 as applied to claims 1, 14).
Burbidge’223 teaches thickening powder promoting safe swallowing of a nutritional product by an individual with dysphagia, wherein said powder contains beta-glucan and at least one carrier ingredient in an amount that is neutral toward or enhances the extensional properties of the nutritional product (Title, Abstract). Burbidge’223 teaches that said powder can be diluted in a diluent to form an aqueous solution to improve the cohesiveness of the nutritional product, and wherein the resultant nutritional product has (i) a shear viscosity of 200-2,000 mPas when measured at a shear rate of 50s-1 at a temperature of 20° C, and (ii) a relaxation time determined by a Capillary Breakup Extensional Rheometry (CaBER) experiment of 10-2,000 milliseconds as measured at 20 °C (Claims 1-3, 14-17; Abstract; Para. 0022-0036 as applied to claims 1, 3-4, 8, 10-12, 14-15, 18). Burbidge’223 teaches that said products/compositions may also include acacia gum (Para. 0093 as applied to claims 1, 6, 14, 17); and such optional ingredients as conventional food additives, acidulants, buffers or agents for pH adjustment, chelating agents, colorants, emulsifiers, excipient, flavor agent, minerals, osmotic agents, a pharmaceutically acceptable carrier, preservatives, stabilizers, sugars, sweeteners, texturizers, vitamins (Claims 1, 6; Para. 0061 as applied to claim 13). Further, Burbidge’223 teaches that said liquid compositions can be used as a part of pharmaceutical compositions (Para. 0089 as applied to claims 1, 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try/use powder or liquid compositions as a part of a pharmaceutical composition(s) as taught by Burbidge and Popa Nita for treating a swallowing disorder in a patient in need thereof, e.g., patients with dysphagia. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach can be used to minimize the risk of swallowing impairments. Regarding the International Dysphagia Diet Standardization Initiative (IDDSI) level of 1-4 (claims 2, 14, 15), it is noted that the cited prior art teaches a treatment of patients with dysphagia. Therefore, it is expected that IDDSI criteria is also provided/met.
Response to Arguments
Applicant's arguments, filed 07/28/2026 (Response After Final Action), have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner comments are set forth next.
In response to applicant’s argument that instant independent claims clearly define compositions to be used in the claimed method, it is noted that said claims disclose liquid compositions comprising 0.1-10 wt% of compounds as claimed, i.e., may include other compounds even in large amounts (i.e., up to 99.9 wt%). Further, said claims recite the characteristics of the claimed compositions, i.e., a shear viscosity and an extensional relation time, as measured by the applicant under specific conditions chosen by the applicant. Given that recited characteristics of the claimed compositions depend on user’s choice (e.g., solvent, temperature, a shear rate, etc.), said claims are not sufficiently definite, because it refers to a variable. MPEP 2173.05(b)(ll). Therefore, clarification is required.
In response to applicant’s argument that the cited prior art does not teach the use of liquid viscoelastic swallowing aid for promoting safe swallowing of a solid dosage form (i.e., tablets, capsules), it is noted the cited prior art teaches the method for treating a swallowing disorder (Burbidge) and compositions to promote swallowing (Popa Nita) by using compositions as instantly claimed. Therefore, the examiner maintains the position that it would have been obvious to one of ordinary skill in the art to try/use liquid compositions as taught by Burbidge and Popa Nita for treating a swallowing disorder in a patient in need thereof, e.g., patients with dysphagia, because the cited prior art teaches that said approach can be used to minimize the risk of swallowing impairments. Further, it is noted that the optimization within prior art conditions or through routine experimentation (i.e., administering together with a solid dosage form or in a sequence/separately) does not support patentability absent comparative evidence of criticality of the claimed treatment. MPEP § 2144.05 (II). Optimization within prior art conditions or through routine experimentation is well within the purview of the skilled artisan for providing effective medical treatment with minimized negative side effects. Further, it is noted that “The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant is advised to clarify the claim language, the structure of the liquid composition to be used in the claimed method as well as method steps, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
