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 .
Applicants amendment filed 12/4/2024 has been entered. Claims 17, 18, 22, 24 and 27 were amended. Claims 15, 16 and 20 were cancelled. New claims 71-74 were added. Claims 17-19, 21, 22, 24-27 and 71-74 are under examination.
Applicants amendment has necessitated a new rejection.
Withdrawn rejections
Applicant's amendments and arguments filed 12/4/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17-19, 21, 22, 27 and 71-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,161,666 (herein ‘666) in view of Hausler (WO 2007/038979). The patented claims disclose a method of promoting swallowing reflex in patients with dysphagia comprising administering a composition comprising cinnamaldehyde and zinc. Additional ingredients include thickeners, acidulants and agents for pH adjustment to form nutritional products (column 6, lines 41-63). The present claims require the presence of an effervescent composition comprising an acid compound, an alkaline compound, a thickening agent and optionally a trigeminal ingredient which is dissolved in water and administered to the patient. Hausler teach effervescent compositions comprising an acid compound, an alkaline compound, a thickening agent and optionally flavoring agents that encompass aldehyde compounds, that are administered in patients with dysphagia, wherein the composition are dissolved in water prior to administration (page 19, lines 27-31). Therefore, the present claims are prima facie obvious in view of teachings of ‘666 and Hausler.
Claims 17-19, 21, 22, 27 and 71-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,188,678 (herein ‘678) in view of Hausler (WO 2007/038979). The patented claims disclose a method of treating dysphagia comprising administering to a patient a composition comprising cinnamaldehyde and zinc in a food product. The ingredients for a supplement which may be in the form of a thickened liquid and nutritional compositions comprising thickeners, acidulants, pH adjustment agents and other excipients (column 6, lines 25-63). ‘678 teach ready-made drinks comprising the nutritional compositions, optionally as a soft drink and in the form of a tablet with dispersing agents (column 6, line 64 through column 7, line 23). The present claims require the presence of an effervescent composition comprising an acid compound and an alkaline compound which is dissolved in water and administered to the patient. Hausler teach effervescent compositions comprising an acid compound, an alkaline compound, a thickening agent and optionally flavoring agents that encompass aldehyde compounds that are administered in patients with dysphagia, wherein the composition are dissolved in water prior to administration (page 19, lines 27-31). Therefore, the present claims are prima facie obvious in view of teachings of ‘678 and Hausler.
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
Applicants request double patenting rejections be withdrawn or held in abeyance until otherwise allowable. The Examiner has maintained applicable ODP rejections for the reasons of record.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating dysphagia and preventing aspiration by administering an effervescent composition comprising an acid compound, an alkaline compound, a thickening agent and optionally, a trigeminal ingredient, dissolving the composition in a liquid and orally administering the product to the patient, does not reasonably provide enablement for an amount effective of the composition to prevent or treat any level of severity in swallowing and selecting an amount of the composition that corresponds to the swallowing disorder severity and trigeminal stimulation. The specification methods prophylactic prevention in a healthy person, but not in a person with a severe swallowing disorder, such as someone with a feeding tube. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims without undue experimentation.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the nature of the invention
2) the state of the prior art
3) the relative skill of those in the art
4) the predictability of the art
5) the breadth of the claims
6) the amount of direction or guidance provided
7) the presence or absence of working examples
8) the quantity of experimentation necessary
The nature of the invention.
The claimed invention is a method of preventing a level of swallowing severity in a patient with a swallowing disorder comprising identifying the amount needed is based on the level of severity of the swallowing disorder and determining, based on severity, an amount of the effervescent composition that is needed for preventing the swallowing disorder and cause trigeminal stimulation.
The state of the prior art & predictability of the art
The specification only details administering the effervescent compositions to treat dysphagia and to reduce aspiration. Only one device, a Bionix SafeStraw, that is described as configured to allow the healthcare provider to safely manage the swallowed liquid volume and help reduce aspiration risk by metering the amount of nutritional product dispensed to the patient [00156]. However, the device is only used in individuals suffering from dysphagia, not all swallowing disorders. The prior art reference Burbidge et al. teach that severity of dysphagia is classifiable and is done by using a standard videofluoroscopy techniques which determines whether aspiration occurs before, during or after the swallowing reflex [0039].
The breadth of the claims
The claims encompass any amount of composition needed prevent and identify swallowing severity in any swallowing disorder by administering the effervescent composition in any patient and identifying severity of any disorder. The claims also encompass any amount needed to provide trigeminal stimulation to improve swallowing safety. The specification teaches methods prophylactic prevention in a healthy person with swallowing dysfunction, but not in a person with a severe swallowing disorder that lack trigeminal stimulation, such as someone with a feeding tube.
The presence or absence of working examples
The specification provides no working examples to identify the level of severity of the swallowing disorder, how amounts of the compositions are selected to provide, supplemental nutrition, hydration and meal replacement or how a concentration of carbonic acid effectively provides a trigeminal stimulation to improve swallowing safety.
The quantity of experimentation necessary & relative skill in the art
To determine how to identify and select the amounts of ingredients needed to effectively identify severity of all swallowing disorders and to provide trigeminal stimulation cannot be deciphered.
Therefore, claims 24-26 require undue experimentation to determine amounts of ingredients needed to prevent and identify different swallowing disorder severity in any patient and amounts needed to provide trigeminal stimulation.
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
Applicant argues that a skilled person reading the specification would be able to identify the level of severity of the swallowing disorder without undue experimentation. The Examiner is not persuaded by this argument because that severity of dysphagia only known to be done by using a standard videofluoroscopy. Therefore, the claims are not commensurate in scope with the disclosure of the specification.
Applicant argues that a skilled person would be able to select doses appropriate to meet nutritional requirements. The Examiner is not persuaded by this argument because claim 25 depends on claim 24 which is not enabled for the reasons stated in the above response. The specification provides no working examples to identify the level of severity of the swallowing disorder.
Applicant argues that the specification discloses the preferred ratio of acid to base required to yield a concentration of carbonic acid effective to provide trigeminal stimulation. The Examiner is not persuaded by this argument because the only preferred ratio in detailed in the specification must comprise 1.3 grams of citric acid and 4 grams of sodium bicarbonate. Therefore, the claims are not commensurate in scope with disclosure of the specification.
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 24-26 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites selecting an amount of the effervescent composition for dissolving the liquid, wherein the amount of the effervescent composition is selected from a plurality of predetermined amounts that each corresponds to a different level of swallowing disorder severity. First, claim 24 recites the limitation "the effervescent tablet" in reference to the effervescent composition. The specification fails to detail a critical amount of effervescent composition needed to treat the levels of swallowing disorder severity. Therefore, the metes and bounds of the amounts cannot be deciphered.
Claim 25 recites the amount of the effervescent composition is an effective amount for administration of the nutritional product which is vague and indefinite. The specification fails to detail a critical amount of the composition that is required to provide nutrition, hydration or meal replacement. Therefore, the metes and bounds of the amount cannot be deciphered.
Claim 26 recites the amount of the effervescent composition provides an appropriate number, density and/or size of CO2 bubbles that in turn, when in contact with salivary carbonic anhydrase, yields a concentration of carbonic acid effective to provide trigeminal stimulation which is vague and indefinite. The specification fails to detail a critical amount of the composition that is required to provide a tingling sensation and/or produce acidification at the intracellular level that activates TRP1 channels to promote swallow reflex. Therefore, the metes and bounds of the amount cannot be deciphered.
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
Applicant argues that “a plurality of pre-determined amounts” is not indefinite and corresponds to the unit dosage forms. The Examiner is not persuaded by this argument because dosages are not clearly defined. Therefore, the metes and bounds of the claim are vague and indefinite.
Applicant argues that the specification discloses the preferred ratio of acid to base required to yield a concentration of carbonic acid effective to provide trigeminal stimulation. The Examiner is not persuaded by this argument because the only preferred ratio detailed in the specification must comprise 1.3 grams of citric acid and 4 grams of sodium bicarbonate however the claims are not commensurate in scope with disclosure of the specification and lack definiteness.
New 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.
Claim(s) 17-19, 21, 22, 26, 27 and 71-74 are rejected under 35 U.S.C. 103 as being unpatentable over Hausler (WO 2007/038979) in view of Michlig et al. (WO 2015/140124; published September 24, 2015).
Applicant claims a method of preventing, alleviating, and or compensating swallowing dysfunction in a patient comprising: providing an effervescent composition comprising an acid compound, an alkaline compound, a thickening agent and cinnamaldehyde and zinc as a trigeminal ingredient; dissolving the effervescent composition in a liquid to provide a nutritional product; and orally administering the nutritional product to the patient. (Claim 17)
Applicant claims a method of promoting swallowing safety and/or efficiency in a patient comprising: providing an effervescent composition comprising an acid compound, an alkaline compound, a thickening agent and cinnamaldehyde and zinc as a trigeminal ingredient; dissolving the effervescent composition in a liquid to provide a nutritional product; and orally administering the nutritional product to the patient. (Claim 27)
Claims 22 and 74 are drawn to inherent properties of the composition.
Hausler teach effervescent metformin tablets and granules (abstract). Treating dysphagia in elderly patients with type 2 diabetes is implied (page 2, lines 3-6). The formulations are powders or granules that are dissolved in water prior to administration (page 19, lines 27-31). The effervescent acids are selected from citric acid, succinic acid, adipic acid, tartaric acid, fumaric acid, malic acid and anhydrides (page 6, lines 7-14; limitation of claim 18). The alkaline compound is selected from potassium carbonate, sodium carbonate, sodium bicarbonate, potassium bicarbonate, sodium glycine carbonate, calcium carbonate and arginine carbonate (page 10, lines 4-15; limitation of claim 19). Hausler et al. teach other flavorants include aldehydes and esters such as benzaldehyde, citral, neral, decanal and C8-aldehyde which reads on cinnamaldehyde (page 24, lines 8-21; limitation of claim 20). Additional excipients used in the formulations include sodium carboxymethyl cellulose (page 25, lines 3-11; limitation of claim 21). Since Hausler et al. teach effervescent components are required to aid in treating dysphagia the limitation that the effervescent composition is in an amount that effectively provides trigeminal stimulation is inherent since the composition are taught to improve swallowing (limitation of claim 26).
Hausler et al. teach patients unable to swallow tablets, specifically elderly patients with type 2 diabetes, are prone to dysphagia. To overcome this issue the effervescent compositions allow for accurate dosing, high stability, easy to carry and easy to swallow formulations that disintegrate in water in less than 3 minutes with a palatable taste (page 3, lines 1-7).
Hausler et al. do not specify cinnamaldehyde and zinc as a trigeminal ingredient. It is for this reason that Michlig is joined.
Michlig teach a compositions comprising cinnamaldehyde supplemented with zinc to improve swallowing reflex (abstract). Michlig teach treating dysphagia and for preventing aspiration pneumonia [0018-21]. The combination of cinnamaldehyde and zinc unexpectedly have a synergistic effect and reduces the amount of cinnamaldehyde that is needed to be effective [0044].
Hausler and Michlig are both drawn to methods of treating dysphagia. Therefore, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Hausler and Michlig administer effervescent compositions comprising an acid component, an alkaline component and cinnamaldehyde and zinc to alleviate swallowing dysfunction in a patient unable to swallow tablets with a reasonable expectation of success. One of ordinary skill in the art would have been motivated at the time of filing to combine the teachings of Hausler et al. and Michlig to treating swallowing dysfunction with the dissolved compositions comprising cinnamaldehyde and zinc because Hausler et al. teach the effervescent compositions allow for accurate dosing and easy to swallow formulations that disintegrate in water in less than 3 minutes and are administered to patients with dysphagia and Michlig teach that the combination of cinnamaldehyde and zinc unexpectedly has a synergistic effect a of improving swallowing reflex.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hausler (WO 2007/038979) and Michlig et al. (WO 2015/140124; published September 24, 2015), as applied to claims 17-19, 21, 22, 26, 27 and 71-74, in view of Burbidge et al. (US 2016/0081923; March 24, 2016).
Applicant claims a method of preventing, alleviating, and or compensating swallowing dysfunction in a patient comprising: providing an effervescent composition comprising an acid compound, an alkaline compound, a thickening agent and cinnamaldehyde and zinc as a trigeminal ingredient; dissolving the effervescent composition in a liquid to provide a nutritional product; and orally administering the nutritional product to the patient. (Claim 17)
The teachings of Hausler and Michlig are addressed in the above 103 rejection.
With respect to claims 24 and 25, Hausler does not teach a method step of identifying severity of the swallowing disorder and selecting an amount of the composition to administer relative to the severity of the swallowing dysfunction. It is for this reason that Burbidge et al. is joined.
Burbidge et al. teach a method for treating swallowing disorder in a patient suffering from aspiration and a bolus for use in the treatment of a swallowing disorder (abstract). The bolus is selected from cohesive thin liquids having a shear viscosity of less than about 50 mPas when measured at shear rate of 50s-1 and a relaxation time of more than 10 ms at 20 degrees Celsius as determined by a capillary breakup extensional rheometry (CaBer) and cohesive thickened liquids having a shear viscosity of more than about 50 mPas, preferably 55-350, when measured at shear rate of 50s-1 and a relaxation time of more than 10 ms at 20 degrees Celsius as determined by a capillary breakup extensional rheometry (CaBer) [0010-11; limitation of claim 22]. The bolus comprises plant derived gums and mucilages selected from konjac, tara gum, locust bean gum, guar gum, pectins and cellulosics in an amount ranging from at least 0.01-25 wt% [0015-16]. The administrable form is selected from a nutritional supplement, a full meal, a pharmaceutical formulation or beverage [0017]. The severity of dysphagia may vary from minimal difficulty in safely swallowing liquid to the inability to swallow without significant risk of aspiration and therefore classifying the patient into a specific group is used [0036-38]. This is done by using a standard videofluoroscopy technique which determines whether aspiration occurs before, during or after the swallowing reflex [0039]. Therefore, Burbidge teach selecting and administering a bolus that is specifically suited for the type of aspiration occurring in the patient by using either the thin liquids or the thickened liquids [0040].
Hausler, Michlig and Burbidge et al. are drawn to methods of treating swallowing disorders. It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Hausler, Michlig and Burbidge et al. to include thickener in an amount that provides to the nutritional product, a relaxation time of more than 10 ms at 20 degrees Celsius and a shear viscosity up to about 2,000 mPas with a reasonable expectation of success. One of ordinary skill in the art would have been motivated at the time of filing to combine the teachings of Hausler, Michlig and Burbidge et al. and include thickener in this amount because Burbidge et al. teach liquids having a shear viscosity of less than about 50 mPas or preferably 55-350 mPas when measured at shear rate of 50s-1 and a relaxation time of more than 10 ms at 20 degrees Celsius as determined by a capillary breakup extensional rheometry (CaBer) aid in treating swallowing disorders in a patients suffering from aspiration.
It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Hausler, Michlig and Burbidge et al. to classifying the level of severity of dysphagia with a reasonable expectation of success. One of ordinary skill in the art would have been motivated at the time of filing to combine the teachings of Hausler, Michlig and Burbidge et al. and classifying the severity of dysphagia and adjusting the amount as necessary because Burbidge et al. teach selecting and administering a bolus that is specifically suited for the type of aspiration occurring in the patient by using either the thin liquids or the thickened liquids that enhance swallowing reflex and reduce aspiration.
Conclusion
No claims 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 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 DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617