DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 02/20/2026, is acknowledged. Amendments to the specification have been entered. Amendments to the drawings have been withdrawn.
Claims 1-20 are pending in this action. Claims 1-19 have been amended. New claim 20 has been added. No new matter was added. Claims 1-20 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Any rejection or objection not reiterated in this action is withdrawn.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.
Information Disclosure Statement
The information disclosure statements, filed 04/03/2026 and 05/19/2026, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
Claim Objections
Claims 1, 4-5, 8, 14-16, 18, 20 are objected to because of the following informalities:
Claim 1 comprises the typographic error “total amount from 0.1 to” that needs to be corrected to “total amount of from 0.1 to”. Similar is applied to claims 8, 14, 18.
Claim 1 recites the limitation “shear viscosity from 10-1,000 mPa.s” that needs to be corrected to “shear viscosity of 10-1,000 mPa.s” or clarified.
Claim 4 (dependent on claim 1) recites the limitation “as measured by a CaBER” that needs to be corrected to “as measured by the CaBER” or clarified. Similar is applied to claims 5, 15, 16.
Claim 14 comprises the acronym “SODF” and the full term. The acronym should be given once in parenthesis after the first use of the full term (see claim 1) and then the acronym is used alone thereafter if needed.
Claim 16 recites the limitation “at room temperature (25 oC)” that needs to be corrected to “at room temperature 25 oC” (see claim 3) or clarified.
Claim 20 comprises the typographic error “seprately” that needs to be corrected to “separately” or clarified.
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 1-20 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 provides for “A method for promoting safe swallowing of a solid oral dosage form (SODF) in a patient in need thereof, the method comprising administering to the patient a liquid viscoelastic swallowing aid” that is not reasonably clear. To this point, it is noted that said claim is not clear, because it merely recites an administering/use without any active, positive steps delimiting how this administering/use is actually practiced. MPEP 2173.05(q). Therefore, it is unclear what method/process the applicant is intending to encompass. Similar is applied to new claim 20. Clarification is required.
As stated previously, 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, 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. Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Second, given that recited characteristics of the claimed compositions depend on user’s choice (e.g., a shear rate, temperature, solvent, etc.), said claim is not sufficiently definite, because it refers to a variable. MPEP 2173.05(b)(ll). Therefore, given that the scope of the claim is not limited by claim language that does not limit a claim to a particular structure (MPEP 2111.04), one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to claim 2 regarding “IDDSI level”, as well as to claims 3-5, 14-16. Clarification is required.
Claim 12 (dependent on claim 1) recites the limitation “the liquid viscoelastic swallowing aid is provided in a concentrated form to be diluted prior to use or is provided in a ready-to-use form, or is provided as a powder to be reconstituted prior to use” that is not reasonably clear. In the present case, it is not clear how said limitation clarifies the method of administering the claimed aid, i.e., how said claim narrows the scope of the claim upon which it depends. Clarification is required.
Claims 6-11, 13, 17-19 are rejected as being dependent on rejected independent claims 1 and14 and failing to cure the defect.
Claim Rejections - 35 USC § 103- MAINTAINS
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 1-20 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 02/20/2026, 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 “The definiteness of the language employed in a claim must be analyzed not in a vacuum, but in light of the teachings of the particular application. In re Moore, 439 F.2d 1232, 1235 (CCPA 1971)”, it is noted that “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). Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).”
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, it is noted that the cited prior art teaches the use of compositions as instantly claimed that can be used as a part of pharmaceutical compositions and can be used for promoting safer swallowing of food boluses for individuals having swallowing difficulties. Further, it is noted that the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Furthermore, it is noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that: (i) the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ; (ii) the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents; (iii) it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed; (iv) it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton); (v) it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”. Therefore, the examiner maintains the position that 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 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, 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. Applicant is advised to clarify the claim language, the structure of the liquid composition to be used in the claimed method, 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.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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