Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges the filing of Applicants’ Amendment and Response on 27 January 2026. The Response comprised claims 1 – 9 and 11 – 17, and amended claim 1, and added new claims 16 and 17. Claim 6 remains withdrawn as being directed to a non-elected invention. Consequently, claims 1 – 5, 7 – 9, and 11 - 17 are available for active consideration, to the extent that the corticosteroid is budesonide and the dosage form is a lozenge.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 27 August 2025 is hereby withdrawn in light of Applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 – 5, 7 – 9, and 11 - 17 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2004/0253307 A1 to Hague, B. and L. Maland, cited on the Information Disclosure Statement (IDS) filed 2 June 2024, cite no. 6 (USPATAPP) (“Hague ‘307”), in view of US 8,679,545 to Dohil, R., et al., identified on the IDS filed 2 June 2024, cite no. 7 (USPAT) (“Dohil ‘545”), van Boven, J., et al., Drug Saf 36: 231 – 236 (2013) (“van Boven (2013)”), US 2009/0130232 A1 to Zahra, M, published 21 May 2009 (“Zahra ‘232”), and US 5,302,394 to Beahm, J., issued 12 April 1994 (“Beahm ‘394”), as evidenced by Takasuta, T., et al., Clin Oral Invest 12: 173 – 177 (2008) (“Takasuta (2008)”).
The Invention As Claimed
Applicants claim a method of treating, reducing, or alleviating esophageal inflammation in an individual comprising orally administering to the individual a medicated hard candy product, the medicated hard candy product comprising a hard candy base material, the hard candy base material containing no gluten, and forming a substantially rigid candy product after being heated and permitted to cool for a predetermined time period, and budesonide as a first medication intermixed with the base material, a second medication, said second medication being effective to treat a medical condition caused by budesonide, said second medication being provided in a dosage of between 400,000 to 600,000 international units (IU), and said second medication being provided with a flavoring substance, wherein the overall mass of the medicated hard candy product is between approximately 4.0 grams and approximately 17.0 grams, and wherein, after said medicated hard candy product is orally administered to said individual, said individual consumes said medicated hard candy product for an extended period of time of at least 15 minutes, wherein said second medication is in a form of an anti-fungal medication, wherein the step of orally administering said medicated hard candy product to said individual further comprises administering said medicated hard candy product to said individual twice per day, wherein the candy product is in the form of a lozenge, wherein the candy product comprises between approximately 0.25 milligrams and approximately 2.0 milligrams of budesonide, or between approximately 0.25 milligrams and approximately 1.0 milligrams, wherein the budesonide in the candy product is effective to treat esophageal inflammation and/or the symptoms associated therewith, wherein the base material comprises a sugar-free dry powder base, wherein the candy product contains no water after being heated and permitted to cool for a predetermined time period, wherein no water is used in the process of making the candy product, wherein the shelf life of the hard candy product is approximately 6 months, and wherein the step of orally administering said medicated hard candy product to said individual further comprises said individual self-administering said medicated hard candy product to himself or herself, wherein the hard candy base material comprises a blend of polyalcohols, wherein the hard candy base material is non-cariogenic, and wherein the hard candy base material contains no citric acid.
The Teachings of the Cited Art
Hague ‘307 discloses oral solid dosage forms that are sugar-free, and comprise a pharmaceutical agent and a suitable pharmaceutically acceptable excipient, and are bioequivalent to sugar-containing solid dosage forms, wherein bioequivalence is obtained by incorporating an ionizing agent in the form of a buffer system into the solid dosage forms (see Abstract), wherein a solid dosage unit can be designed to remain in the oral cavity for different periods of time and can be designed to remain in the oral cavity for about 10 to 15 minutes, when used as directed (see ¶[0008]), wherein, when such solid dosage forms comprise a sugar base, the solid dosage forms may be produced either mixing the drug into a molten sugar base, and allowing the base to solidify into a hard candy (see ¶[0015]), wherein it would be desirable to provide sugar-free oral solid dosage forms, with such dosage forms falling within the FDA labeling requirements for classifying a product as sugar-free (i.e., less than 0.5 grams sugar per serving), so that consumers would be able to recognize that the product was suitable for use by diabetic patients, suitable for use by others seeking to avoid dietary sugar, and others seeking to avoid cariogenic dosage forms (see ¶[0017]), wherein the dosage forms are for administering active ingredients by oral transmucosal delivery, which refers to the delivery of a pharmaceutical agent across a mucous membrane in the oral cavity, pharyngeal cavity, or esophagus (see ¶[0027]), wherein delivery involves administering the dosage forms to the oral cavity of a patient, which dosage form is held in the oral cavity and dissolved, thereby releasing the pharmaceutical agent for oral transmucosal delivery (id.), wherein the dosage form is a solid delivery form suitable for administering a pharmaceutical agent by oral transmucosal delivery, including patches, troches, lozenges, pastilles, sachets, sublingual tablets, lozenges-on-a-handle, and the like, preferably patches, lozenges, sublingual tablets, and lozenges-on-a-handle (see ¶[0028]), wherein the term “sugar-free” refers to compositions that are substantially free of “sugar” (less than 2% wgt or less than about 1% wgt) (see ¶[0031]), wherein the sugar free base can comprise polyhydric alcohols/sugar alcohols, or sugar derivatives of same, such as maltitol, lactitol, isomalt, and polyalditol (see ¶[0030]), wherein “pharmaceutical agent” refers to a substance that may be used in connection with an application that is therapeutic, such as pharmaceuticals, drugs, synthetic organic molecules, proteins, peptides, vitamins, and steroids for use in methods for the treatment of disease in a patient (see ¶[0036]), wherein the buffer systems may comprise any physiologically acceptable organic and inorganic acids and bases that may be combined in different proportions to produce a buffer having the desired buffering capacity and pH range (see ¶[0057], TABLE 5; see also ¶[0094]), wherein, in order to provide a good tasting medication, it may be necessary to add additional sweeteners to the composition, and because the compositions are sugar-free, an artificial sweetener, such as aspartame, acesulfame K, saccharin, sucralose, altitame, cyclamic acid and its salts, glycerrhizinate, dihydrochalcones, thaumatin, monellin, or any other non-cariogenic, sugar-free sweetener may be used, alone or in combination, although for compositions that contain a sugar alcohol-based excipient, additional sweeteners may not be necessary, due to the naturally sweet taste of these polyhydric alcohols (see ¶[0063]), wherein the dosage forms may be prepared by a wide variety of methods, including any methods for preparing medicated lozenges, troches, tablets, cough drops, etc. (see ¶[0070]), such as dry powder blending (see ¶[0071]), wherein the hard candy dosage forms are formed by a process where the pharmaceutical agent is dispersed in an excipient that is in liquid form, for example having been heated to a temperature above its melting point, or otherwise solubilized, and the liquid blend subsequently allowed to harden into a solid dosage form, the dosage forms so produced being referred to as hard candy oral transmucosal solid dosage forms (see ¶[0078]), and wherein the pharmaceutical agent is preferably present in amounts of from about 0.0005 to about 50% by weight (see ¶[0089]), and wherein, in an exemplified embodiment, a 2-g hard candy dosage form comprises an active (fentanyl citrate), isomalt [a polyol]/PEG 8000 (non-sugar base), a buffer system, berry flavor, and magnesium stearate (lubricant), wherein the purified water used to prepare the initial mixture of components was removed during curing of the dosage form (see, for example, EX. 2, ¶[0126]). The reference does not disclose the use of a sugar-free hard candy dosage form, wherein the steroid is budesonide (claim 1), or dosage forms further comprising a second medication for treatment of medical conditions caused by budesonide (claim 1), wherein the second medication is provided in a dosage of between 400,000 to 600,000 international units (IU), and is provided with a flavoring substance (claim 1), wherein the second medication is an anti-fungal medication (claim 17), or a dosage form that is administered twice a day (claim 16), or a dosage form wherein the budesonide is present at a loading of from approximately 0.25 mg to approximately 2.0 mg, or at approximately 0.25 mg to approximately 1.0 mg, or dosage forms with an overall mass of approximately 4.0 grams to approximately 17 grams, or dosage forms prepared without the use of water. The teachings of Dohil ‘545, van Boven (2013), Zahra ‘232, and Beahm ‘394, address these deficiencies.
Dohil ‘545 discloses methods for preventing or alleviating the symptoms of and inflammation associated with inflammatory diseases and conditions of the gastrointestinal tract, for example, those involving the esophagus, wherein the methods comprise the administration of useful pharmaceutical compositions (see Abstract), specifically orally administering a corticosteroid (see Col. 2, ll. 46 – 50), wherein an individual to whom the composition is administered may have been diagnosed with a disease or condition such as eosinophilic esophagitis, inflammatory bowel diseases involving the esophagus, Crohn' s disease, esophageal inflammation secondary to caustic/irritant ingestion, persistent/recurrent esophageal strictures of any cause and including caustic/irritant ingestion, pill-induced esophagitis, systemic diseases, congenital diseases, and post-surgery inflammation (see Col. 2, ll. 59 – 67; see also, Col. 6, ll. 64 - 67), wherein the corticosteroid is budesonide and the composition is in the form of a dissolving tablet, a dissolving wafer, a capsule, or a gel capsule (see Col. 3, ll. 6 – 14), wherein the compositions comprise an amount of the corticosteroid that is therapeutically effective to treat esophageal inflammation, such as delivering 1 - 3 mg of corticosteroid per day (see Col. 3, ll. 33 – 37), wherein the compositions comprise the corticosteroid in maltodextrin as a vehicle (see Col. 3, ll. 59 – 64), wherein the esophageal inflammation being treated is eosinophilic esophagitis and the amount of corticosteroid being delivered is about 0.25 mg to about 10 mg corticosteroid administered once a day, or no more than once a day (see Col. 4, ll. 12 – 17), wherein about 0.05 mg to about 50 mg or, more specifically, from about 0.25 mg to about 5 mg, of the corticosteroid is administered per day or per dose (see Col. 8, ll. 23 – 32), wherein the exact dosage administered will depend upon the route of administration, the form in which the composition is administered,
the subject to be treated, the age, body weight/height of the subject to be treated, and the preference and experience of the attending physician, as well as the specific corticosteroid used,
and the nature of the inflammation for which the treatment is sought (see Col. 11, ll. 12 – 22), wherein, more specifically, the amount of corticosteroid (e.g., budesonide) in the composition, or a dose of the composition, includes about 500 µg to about 2 mg (see Col. 11, ll. 49 – 53), wherein an effective amount is an amount sufficient to reduce inflammation or symptoms of inflammation associated with an allergic or caustic inflammatory disorder or condition of the esophagus, as compared to the level of inflammation or symptoms of inflammation associated with an inflammatory disease prior to administration of the effective amount (see Col. 14, ll. 17 – 23), wherein the budesonide is provided in the form of a lozenge that dissolves in the mouth, thus reaching and coating the esophagus (see Col. 15, ll. 28 – 31), wherein the compositions further comprise phosphate buffers, acetate buffers, combinations thereof, or the like (see Col. 19, ll. 60 – 66).
Van Boven (2013) discloses that oral candidiasis/oropharyngeal candidiasis (OPC) is thought to be a consequence of local immunosuppression at the oral mucosal surface by deposition of inhaled corticosteroid (ICS) particles in the higher respiratory airways (see p. 231, 2nd col., last para.), wherein oral candidiasis primarily leads to local discomfort such as altered taste sensation, but in immuno-compromised patients, the local infection may enter the bloodstream and develop into a potentially systemic life-threatening infection, with the condition most often treated with anti-fungals (see p. 232, 1st col., 1st para.), wherein the ICS’s comprise beclomethasone, budesonide, fluticasone, and ciclesonide, and medications for treatment of OPC comprise nystatin, miconazole, methylrosaniline, and amphotericin B (see p. 232, 2nd col., 4th para.; see also Fig. 1, Table 1, p. 234), and wherein a significant and clinically relevant increase in the number of patients receiving medication for oral candidiasis in the first year after initiation of therapy with corticosteroids, with the highest relative risk found in the first 3 months (see p. 235, 2nd col., 5th para.).
Zahra ‘232 discloses compositions for treating oral lesions, the compositions comprising a steroid composition and an antifungal composition (see Abstract), wherein the steroid composition comprises budesonide (see ¶[0017]), wherein the antifungal composition comprises nystatin, present at 100,000 unit/mL nystatin solution (see ¶[0016]), and wherein the compositions further comprise a flavoring agent (see ¶[0023]).
Beahm ‘394 discloses palatable medicated hard candy lozenges comprising a pharmaceutically active ingredient, such as dextromethorphan (see Abstract), wherein the lozenge size may be in the range of from about 2.4 grams to about 4.0 grams, yielding a loading of the active ingredient in the range of about 2.5 to about 20 mg (see Col. 6, ll. 46 – 47), and wherein auxiliary medicament ingredients may be added to the lozenges (see Col. 4, ll. 40 – 47).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare oral solid dosage forms that are sugar-free, and comprise a pharmaceutical agent, such as a corticosteroid, and suitable pharmaceutically acceptable excipients, wherein the term “sugar-free” refers to compositions that are substantially free of “sugar” (less than 2% wgt or less than about 1% wgt), wherein oral transmucosal delivery involves the administration of an oral transmucosal solid dosage form to the oral cavity of a patient, which is held in the oral cavity and dissolved, thereby releasing the pharmaceutical agent for oral transmucosal delivery, wherein the solid dosage form is designed to remain in the oral cavity for about 10 to 15 minutes, as directed, wherein the dosage forms include buffer systems that comprise any physiologically acceptable organic and inorganic acids and bases that may be combined in different proportions to produce a buffer having the desired buffering capacity and pH range, wherein the dosage forms are prepared by a wide variety of methods, including any methods for preparing medicated lozenges, etc., such as dry powder blending, wherein the hard candy dosage forms are formed by dispersing the pharmaceutical agent in a liquified excipient heated to a temperature above its melting point, and subsequently allowed to harden into a hard candy oral transmucosal solid dosage forms, and wherein a hard candy dosage form comprises an active, and a non-sugar base comprising maltitol, lactitol, isomalt, or polyalditol, a buffer system, berry flavor, and magnesium stearate (lubricant), wherein the purified water used to prepare the initial mixture of components is removed during curing of the dosage form, as taught by Hague ‘307, wherein the dosage forms are used to prevent, or alleviate, the inflammation associated with inflammatory diseases and conditions of the esophagus by orally administering a corticosteroid, wherein an individual to whom the composition is administered may have been diagnosed with a disease or condition such as eosinophilic esophagitis, inflammatory bowel diseases involving the esophagus, Crohn’s disease, esophageal inflammation secondary to caustic/irritant ingestion, persistent/recurrent esophageal strictures of any cause and including caustic/irritant ingestion, pill-induced esophagitis, systemic diseases, congenital diseases, and post-surgery inflammation, wherein the corticosteroid is budesonide, in place of, or in addition to, the steroids disclosed in Hague ‘307, and the composition is in the form of a lozenge that dissolves in the mouth, thus reaching and coating the esophagus, wherein the compositions comprise an amount of the corticosteroid that is therapeutically effective to treat esophageal inflammation, wherein the compositions comprise the corticosteroid in maltodextrin as a vehicle, wherein the esophageal inflammation being treated is eosinophilic esophagitis and the amount of corticosteroid being delivered depends upon the route of administration, the form in which the composition is administered, the subject to be treated, the age, body weight/height of the subject to be treated, and the preference and experience of the attending physician, as well as the specific corticosteroid used, and the nature of the inflammation for which the treatment is sought, wherein, more specifically, the amount of budesonide in the composition, or a dose of the composition, includes about 500 µg to about 2 mg, wherein an effective amount is an amount effective to reduce inflammation or symptoms of inflammation associated with an allergic or caustic inflammatory disorder or condition of the esophagus, as compared to the level of inflammation or symptoms of inflammation associated with an inflammatory disease prior to administration of the effective amount, as taught by Dohil ‘545, wherein the compositions of the dosage form comprises a second medication to treat OPC arising from treatment with budesonide, consistent with the teachings of van Boven (2013), wherein the anti-fungal composition comprises nystatin, an antifungal, present at a concentration of 100,000IU/mL, and a flavoring agent, as taught by Zahra ‘232, and wherein the lozenge dosage form has a mass of about 4.0 grams per lozenge, as taught by Beahm ‘394. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Dohil ‘545 to the effect that budesonide is a corticosteroid that is clinically effective in treating esophageal inflammation when administered in doses ranging from about 500 µg to about 2 mg (see Col. 11, ll. 49 – 53), by the teachings of van Boven (2013) to the effect that OPC is a frequent side effect of treatment with corticosteroids such as budenoside, and that the condition can be treated with anti-fungals, such as nystatin, present at a concentration of 100,000 IU/mL, as taught by Zahra ‘232, and by the teachings of Beahm ‘394 to the effect that tablets of about 4.0 g in mass can supply therapeutically effective amounts of the active ingredients.
With respect to the limitation recited in amended claim 1 directed to the hard candy base material not containing gluten, the Examiner notes that neither the primary reference, Hague ‘307, nor the secondary references, disclose base materials comprising gluten. Consequently, it is the Examiner’s position that such silence at least gives rise to a presumption that the base material does not contain gluten, thus reading on this limitation.
With respect to the newly-added limitation now recited in claim 1 directed to the second medication (a non-fungal: see claim 17) being present at a loading of 400,000 – 600,000 IU, the Examiner notes that Zahra ‘232 explicitly discloses compositions comprising budesonide (steroid) and nystatin (antifungal) for treating oral lesions, where the antifungal is at a concentration of 100,000 IU/mL. In this regard, the Examiner further notes that the limitation in question is directed to the total loading of the secondary medication (400,000 to 600,000 IU), while Zahra ‘232 expresses the content of nystatin, an anti-fungal medication, as a concentration (mg/mL). Therefore, to explicitly read on the limitation, the composition comprising nystatin would need to be present, or applied, at a volume of 4 – 6 mL, which would have been prima facie obvious to one of ordinary skill in the art.
With respect to claim 3, which claim recites a limitation directed to the dosage forms of the invention containing “no water after being heated and permitted to cool for [a] predetermined time period,” the Examiner notes that Hague ‘307 discloses exemplary embodiments in which any water content it driven off by heating during the process wherein the powder base components are rendered liquid, thus reading on this limitation.
With respect to claim 4, which claim recites a limitation directed to “no water [being] used in the process of making” the dosage forms, it is the Examiner’s position that such limitation is directed to process steps in the fabrication of the dosage form, and neither to the dosage forms themselves, not the manner of their use. Consequently, this limitation is not afforded patentable weight unless this process parameter affects the resulting dosage forms to the extent that they are not satisfactory for their intended purpose. See, analogously, MPEP § 2113.
With respect to claim 5, which claim recites a limitation directed to the dosage forms used in the practice of the method of the invention having a shelf life of “approximately 6 months,” the Examiner notes that the cited references do not expressly address the shelf lives of the disclosed dosage forms. However, it is the Examiner’s position that dosage forms consistent with the teachings of the cited references, comprising the same active ingredient (budesonide), at the same loadings (about 500 µg to about 2 mg), with the same type of non-sugar base materials, such as sugar alcohols, prepared by substantially similar processes, would necessarily display shelf lives that read on the limitation in question. Consequently, because the Patent and Trademark Office does not have the facilities for examining and comparing the compositions claimed for the methods of the invention with the compositions according to Hague ‘307 and Dohil ‘545, the burden of proof is upon the Applicants to show a distinction between the structural and functional characteristics of the compositions as sued and the compositions of the prior art. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, 10 USPQ 2d 1922 1923 (PTO Bd. Pat. App. & Int.).
With respect to claims 8 and 9, which claims recite limitations directed to the relative and absolute amounts of budesonide in the dosage forms used in the invention, the Examiner notes that the cited references do not expressly disclose amounts that are exactly congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches a range of loadings of the budesonide that significantly overlaps with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
More specifically, with respect to claim 1, which claim now recites a limitation directed to the total mass of the dosage forms being “between approximately 4.0 grams and approximately 17.0 grams,” the Examiner notes that Beahm ‘394 discloses lozenges of about 4.0 g mass. In addition, Hague ‘307 expressly discloses exemplary embodiments wherein the solid dosage form has a total mass of 2 grams. It is the Examiner’s position that one of ordinary skill in the relevant art would recognize, particularly in light of the teachings of Dohil ‘545: “The exact dosage will depend upon the route of administration, the form in which the composition is administered, the subject to be treated, the age, body weight/height of the subject to be treated, and the preference and experience of the attending physician. In certain embodiments, the optimal concentration of the corticosteroid in the composition depends upon the specific corticosteroid used, the characteristics of the patient, and the nature of the inflammation for which the treatment is sought,” (see Col. 11, ll. 12 – 22), that fabrication of solid, sugar-free lozenges with total masses within the claimed range would amount to nothing more than an optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Furthermore, given that the limitation in question is directed to the total mass of a hard candy dosage form, and not to the loading of an active ingredient, both the relative loading, and the total dosage of the active, would factor into the variables being applied to selection of the size or mass of the dosage form. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
With respect to claim 13, which claim recites a limitation directed to the hard candy base comprising a “blend” of polyalcohols, the Examiner notes that the cited references do not specifically disclose a non-sugar base comprising multiple polyhydric alcohols. However, Hague ‘307 discloses multiple examples of appropriate sugar alcohols that are suitable for the non-sugar base (see ¶[0030]). It is the Examiner’s position that it would be prima facie obvious to include any one, or any mixture of these components in the candy base due to the properties common to the disclosed polyhydric alcohols.
With respect to claim 14, which claim recites a limitation directed to the base material being non-cariogenic, the Examiner notes that the cited references do not address such a characteristic of the candy base. However, as evidenced by van Boven (2013), sugar alcohols such as maltitol are known to be non-cariogenic.
With respect to claim 15, the claim reciting a limitation directed to the base material not containing citric acid, the Examiner notes that Hague ‘307 discloses a number of buffer systems for the disclosed dosage form, including citric acid-based buffers. However, the reference also discloses buffer systems other than citric acid-based buffers (see ¶[0057], TABLE 5), thus reading on this limitation.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 5, 7 – 9, and 11 - 17 would have been obvious within the meaning of 35 USC § 103.
Response to Applicant’s Arguments
The Examiner has considered Applicant’s arguments in the Response filed 27 January 2026, but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. Applicant’s primary argument is that the previously cited references do not provide disclosures reading on the newly added limitations recited in claim 1. However, the new grounds of rejection set forth above address these limitations, thus rendering claim 1 obvious.
Applicant also argues that, with respect to the limitation recited in claim 1 directed to the dosage forms not comprising gluten, “mere silence [of the primary reference] with regard to an excluded element in a negative claim limitation is not enough to teach that limitation.” However, as addressed in the above rejection, neither Hague ‘307, nor any of the secondary references, teach the inclusion of gluten in the disclosed compositions. However, although silence may not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure. Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172). See MPEP § 2173.05(i). In the present case, where none of the five obviousness references disclose compositions comprising gluten, it is the Examiner’s position that the skilled artisan would be justified in concluding that the disclosures of the cited references support the negative limitation of being gluten-free. An opposite interpretation would simply not be logical.
As to Applicant’s argument with respect to a process of making the hard candy base without water “results in a novel product with a substantially longer shelf life, as compared to products made using water in the process,” the Examiner notes that the rejection of record relies on the disclosures of the cited references wherein the sugar-free base material does not comprise any water, and further relies on this disclosure to render the claims in question prima facie obvious. Furthermore, the fact that Applicants have 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).
Consequently, based on the above discussion, Applicant’s arguments are unpersuasive and claims 1 – 5, 7 – 9, and 11 - 17 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS 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.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see <http://pair-direct.uspto.gov>. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619