DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of group I and ingredients of dextrose, sodium saccharin, glycerin, citric acid, sodium hydroxide, lysine, glutamic acid, leucine, arginine, alanine, valine, isoleucine, aspartic acid, phenylalanine, glycine, serine, histidine, threonine, ornithine monohydrochloride, proline, methionine, tryptophan, cysteine, taurine, tyrosine, lidocaine hydrochloride, mepivacaine hydrochloride, articaine hydrochloride, prilocaine hydrochloride, bupivacaine hydrochloride, and organically bound iodine radiographic contrast medium organically bound iodine radiographic contrast medium in the reply filed on January 29, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
The elected species of a composition comprising all 32 of the elected ingredients is free of the prior art. Therefore the search and examination was expanded to a composition comprising an anesthetic salt as required by claim 37, Ringer’s type buffer and a sugar.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/376,099, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In independent claim 37, the full scope of pharmaceutically acceptable salts of the listed anesthetics is not supported as only lidocaine hydrochloride and mepivicaine hydrochloride are disclosed. While derivates of various local anesthetics are disclosed at ¶ [0020] of the specification as filed, that such derivates encompass any pharmaceutically acceptable salts of the recited anesthetics agents is not disclosed. While the use of Ringer’s solution and other forms such as lactated Ringer’s solution are discussed, there is not support in the disclosure for the full scope of Ringer’s-type buffer. There is also no support for the osmolality of the composition ranging from 500 – 700 mOsm/kg as the only values for osmolality given is that of lactated Ringer’s solution alone being 273 mOsm/L (¶ [0081] of the specification as filed), which does not provide support for the claimed range even if the value given was for the composition as a whole and not just one component.
The following dependent claims are not fully supported by the disclosure of the previously filed application:
Claim 39 - There is no disclosure of glycerin as an ingredient in the disclosed compositions generally or that such a compound falls within the scope of “sugar”.
Claim 40 – While citric acid and sodium hydroxide are supported as ingredients in the claimed composition, that these ingredients are present “in amounts effective to maintain the pharmaceutical composition at a preselected pH during storage and usage” is not disclosed.
Claim 42 – While the presence of amino acids in the composition is disclosed, the amino acids are disclosed as a subgenus within the genus of bitterness suppressants. That does not provide support the amino acids being “effective to modulate at least one of taste, buffering capacity and osmolality of the pharmaceutical composition”.
Claim 45 - While citric acid and sodium hydroxide are supported as ingredients in the claimed composition, that these ingredients “maintain a pH of about 6.0 to about 7.5” are not supported and there is no disclosure of the pH value of the claimed compositions.
Claim 46 – While organically bound iodine radiograph contrast medium is supported as an ingredient in the claimed composition, that this material is “configured to enhance radiographic visualization of an injection field of the pharmaceutical composition” is not disclosed.
If Applicant is in disagreement with the Examiner regarding support for the priority claim, Applicant is respectfully requested to point to page and line number in the prior filed application wherein support may be found for the instant invention.
As the claims under examination were added on the filing date of the instant application and all depend from claim 37 and are not limited to subject matter supported by the disclosure of the prior filed application, the effective filing date of all claims under examination is September 30, 2025.
This application repeats a substantial portion of prior Application No. 17/376,099, filed July 14, 2021, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: all of the material identified above that results in the instant claims not receiving the benefit of the prior filed application. All such subject matter must be added to the specification to provide proper antecedent basis for the claimed subject matter. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 37 and 39 – 47 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 37 requires the presence of “Ringer’s-type buffer” (emphasis added) and what renders something a Ringer’s type buffer is not clear. The specification references Ringer’s solution, which typically comprises sodium bicarbonate so could be a buffered solution depending on the pH. Does this mean alternate buffering agents can be present or any solution that contains the same type of buffering agent as is present in Ringer’s solution? Or does “type” only reference Ringer’s solution and versions containing additional ingredients such as lactated Ringer’s solution or dextrose lactated Ringer’s solution that were mentioned in the disclosure as originally filed?
Applicants may act as their own lexicographer but any special definition must be clearly set forth when the definition of a term differs from the plain and ordinary meaning it would otherwise possess (see MPEP 2111.01(IV)). No specific definition of sugar is given in the disclosure as originally filed although sections such ¶ [0021] of the disclosure as originally filed provides a Markush group of sugars with ¶ [0022] listing “sweet compound” as a possible bitterness suppressant followed by a list that includes sodium saccharin and polyhydric alcohols. There is no disclosure of glycerin in the disclosure as originally filed. The plain and ordinary meaning of sugar does not encompass the artificial sweetener sodium saccharin or glycerol. But for claim 39 to be a proper dependent claim, dextrose, sodium saccharin, glycerin and at least one additional compound must be part of the “sugar” component of claim 37. But as materials that do not fall within the plain and ordinary meaning of sugar are claimed as “sugars”, the scope of “sugar” as set forth in claim 37 is unclear as what other compounds outside the plain and ordinary meaning of “sugar” are within the scope of sugar as used in the instant claims.
The dependent claims fall therewith.
Please clarify.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 37 – 44, 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Uzbelger Feldman (US 2018/0193462) in view of Abrahamsohn (US 2008/0292731) and Loiselle et al. (Anesthesia Progress, 1966).
Uzbelger Feldman discloses improved local anesthetic solutions that comprise an anesthetic agent, an anesthetic solution vehicle and a bitterness suppressant that can be a sugar, sweet-tasting compounds and/or amino acids (whole document, e.g., abstract). Amongst other classes of compounds that can also be included are buffers and contrast media agents (abstract). The anesthetic agent may be lidocaine derivates; mepivacaine derivates; prilocaine derivates; bupivacaine derivates; and articaine derivates (¶ [0020]). Dextrose as a sugar (¶ [0021]) and sodium saccharin a sweet compound for the bitterness suppressant (¶ [0022]) are disclosed. The use of Ringer’s solution, lactated Ringer’s solution, acetated Ringer’s solution and bicarbonate Ringer’s solutions, all reading of Ringer’s-type buffer, are disclosed as buffering agents that can be used (¶ [0028]) and lactated Ringer’s solution is used in the examples beginning at ¶ [0102]. Lactated Ringer’s solution has an osmolality of 273 mOsm/L (¶ [0081]). The amino acids lysine; glutamic acid; leucine; arginine; alanine; valine; isoleucine; aspartic acid; phenylalanine; glycine; serine; histidine; threonine; ornithine monohydrochloride; proline; methionine; tryptophan; cysteine; taurine; and tyrosine are also disclosed as suitable bitterness suppressants (¶ [0024], reading on modulating the taste of the composition as required by instant claim 42. Citric acid is disclosed as an acid for bitterness suppressant (¶ [0023]) and a stabilizer (¶ [0031]). Combinations of the various subgenera of bitterness suppressants are also contemplated (claim 1). Sodium hydroxide is also disclosed as a stabilizer (e.g., ¶ [0031] and [0093]). Contrast media agents such as ionic iodine or non-ionic iodine can be added (¶ [0032]) and example 6 (¶ [0107]) discloses the uses of organically bound iodine. Epinephrine is not disclosed as a required ingredient so compositions that are free of epinephrine are disclosed. The solution may be contained within a vial about 0.3 to about 5 mL in size and administered with a dental syringe (¶ [0033]). The examples (¶ [0102] onward) use a 1.7 mL vial.
Uzbelger Feldman does not disclose salts such as the hydrochloride salt and an overall osmolality of the composition being in the range of 500 – 700 mOsm/kg
Abrahamsohn discloses methods for providing post-operative pain relief by administering bicarbonate such as during, near completion or immediately following a dental procedure that was previously administered a regional or local anesthetic (whole document, e.g., abstract). The anesthetics can be a hydrochloride acid-addition salt (¶ [0013]) with hydrochloride salts of lidocaine, prilocaine or bupivacaine being either commercially available or typically used (¶ [0015]). The desired pH can be maintained using buffers such about 7 to 8.5 using buffers such citrate (¶ [[026]).
Loiselle et al. discloses the osmolality of various local anesthetic solutions used in dentistry (title). The values range from 109 – 433 for the mean osmolality in millimoles with 2% lidocaine HCl formulation having a value of 309 (p 95). There is a correlation between the post-injection tissue response with the pH and osmolality of the injected solution (¶ bridging p 95 and 96).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the hydrochloride salt of the anesthetic present in the compositions of Uzbelger Feldman that can be placed the vial portion of a dental syringe. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Uzbelger Feldman discloses that anesthetics such as lidocaine, prilocaine or bupivacaine can be used in the disclosed solutions and Abrahamsohn discloses that such local anesthetics are commercially available or typically used in the hydrochloride salt form. The selection of a known salt form of the local anesthetic from those that are known and available in the art does not patentably distinguish the instant claims over Uzbelger Feldman. It also within the skill of those of ordinary skill in the art to select specific ingredients such as bitterness suppressants that can be sugars, dextrose, sodium saccharin, citric acid and/or amino acids from the disclosed by Uzbelger Feldman. There is no evidence of record as to the criticality of the claimed compositions. The osmolality would be at least that of what would typically be used and then increase further as the total solute concentration is considered. The additional ingredients present for bitterness suppressant and other functions will increase the osmolality over something such as the 2% lidocaine HCl solution disclosed by Loiselle et al. and will be affected by the amounts of those additional ingredients used. There is no evidence of record as to the criticality of the claimed osmolality. The presence of citric acid, that also functions as a buffer that acts to maintain the composition at a preselected pH, is taught by Abrahamsohn and the suitable pH range of about 7 to about 8.5 overlaps with the presently claimed range and such ranges are prima facie obvious (see MPEP 2144.05) and there is no evidence of record as to the criticality of the claimed range.
Claim(s) 37 – 40, 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Anaebonam et al. (US 5,763,449) in view of Abrahamsohn (US 2008/0292731), Muni (US 2009/0048349) and Loiselle et al. (Anesthesia Progress, 1966).
Anaebonam et al. discloses a liquid pharmaceutical composition with a pharmaceutically effective amount of a bitter tasting drug dissolved or dispersed in an aqueous medium that is transparent and has a pleasant taste (whole document, e.g., abstract). Exemplified bitter tasting drugs include lidocaine (col 1, ln 23 and claim 11). The aqueous medium comprises polyvinylpyrrolidone (PVP), a C3-C6 polyol and ammonium glycyrrhizinate and one or more flavorants (abstract). PVP is added to assist in dissolving or dispersing the bitter tasting drug in the medium as well as masking the taste of the bitter tasting drug (col 3, ln 40 – 43). The C3-C6 polyol can be fructose and the like (col 3, ln 57 – 60). Further debittering agents in addition to the PVP and C3-C6 polyol are required to suitably mask the bitter taste as even compositions with 0.05-2 wt% sodium saccharin or about 0.1-about 2 wt % aspartame still requiring the presence of a further debittering agent such as ammonium glycyrrhizinate to produce the desired composition with a pleasant taste (col 4, ln 15 – 49). Example 3 comprises the bitter tasting drug trimethoprim; water as part of the aqueous vehicle system and the bitterness masking agents/sweet-tasting compounds ammonium glycyrrhizinate, maltitol (a sugar alcohol) and liquid fructose (a sugar; col 7, ln 35 onward). Example 1 comprises the bitter tasting drug guaifenesin; water; PVP; sodium benzoate; and at least ammonium glycyrrhizinate, maltitol and liquid fructose as bitterness masking/sweet-tasting agents; and citric acid and sodium citrate, which read on stabilizers (see claim 40). Sodium hydroxide and hydrochloric acid are also present in examples 3 and 4. Epinephrine is not disclosed as a required ingredient so compositions that are free of epinephrine are disclosed.
The use of pharmaceutically acceptable salts of lidocaine such as the hydrochloride salt and the pH of the solution is not disclosed.
Abrahamsohn is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the hydrochloride salt of the anesthetic present in the composition of Anaebonam et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Abrahamsohn discloses that such local anesthetics are commercially available or typically used in the hydrochloride salt form. The selection of a known salt form of the local anesthetic from those that are known and available in the art does not patentably distinguish the instant claims over the applied prior art. The presence of citric acid, that also functions as a buffer that acts to maintain the composition at a preselected pH, is taught by Abrahamsohn and the suitable pH range of about 7 to about 8.5 overlaps with the presently claimed range and such ranges are prima facie obvious (see MPEP 2144.05) and there is no evidence of record as to the criticality of the claimed range.
The presence of lactated Ringer’s solution is not disclosed.
Muni discloses compositions and methods for providing unit-of-use compounded formulations (whole document, e.g., ¶ [0007]). Liquid bases are recommended for orally administered pharmaceuticals (¶ [0047]). Aqueous carries include water, saline and buffered media with parenteral vehicles including sodium chloride solutions, Ringer’s dextrose, dextrose and sodium chloride and lactated Ringer’s (¶ [0049]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate materials such as dextrose and/or sodium saccharin and lactated Ringer’s as part of the formulations of Anaebonam et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because such liquids can be used as liquid bases for pharmaceutical formulations and there is no evidence of record as to the criticality of the liquid used. Anaebonam et al. discloses various ingredients that can be added for debittering purposes including various sugar compounds and also artificial sweeteners such as sodium saccharin to aid in masking the unpleasant taste of drug and there is no evidence of record as to the criticality of claimed combination of ingredients.
An overall osmolality of the composition being in the range of 500 – 700 mOsm/kg.
Loiselle et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the osmolality of the claimed composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the osmolality should be optimized given the correlation between post-injection tissue response and the pH and osmolality of the injected composition. The osmolality of the local anesthetic composition would be at least that of what would typically be used and then increase further as the total solute concentration is considered. The additional ingredients present for bitterness suppressant and other functions will increase the osmolality over something such as the 2% lidocaine HCl solution disclosed by Loiselle et al. and will be affected by the amounts of those additional ingredients used. There is no evidence of record as to the criticality of the claimed osmolality.
Claim(s) 41 – 43 are rejected under 35 U.S.C. 103 as being unpatentable over Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. as applied to claims 37 – 40, 44 and 45 above, and further in view of Sohi et al. (Drug Dev Ind Pharm, 2004).
Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. are discussed above.
The presence of amino acids is not disclosed.
Sohi et al. discloses bitterness reduction and inhibition are important characteristics of a good oral dosage form and various techniques are available for masking bitter taste of drugs including sweeteners, amino acids, and taste masking with lecithin (p 430, col 1, ¶ 2). Artificial sweeteners and flavors are generally used along with other taste-masking techniques to improve efficiency (p 430, col 1, ¶ 3). Table 1 shows various taste masking with flavors, sweeteners and amino acids. The amino acids glycine and alanine along with flavors are used for bitterness control of anticholesterolemic saponin-containing foods, beverages and pharmaceuticals (p 431, col 2, ¶ 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to additional ingredients such as the amino acid glycine to improve the sweetness/flavor of the formulations of Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Sohi et al. discloses that many different ingredients can be used to mask bitterness in pharmaceutical formulations and the efficiency of artificial sweeteners and flavors is improved by using other techniques. Additionally, “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Claim(s) 46 is rejected under 35 U.S.C. 103 as being unpatentable over Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. as applied to claims 37 – 40, 44 and 45 above, and further in view of Benn (WO 2012/151464).
Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. are discussed above.
The inclusion of an organically bound iodine contrast agents in the anesthetic formulation is not disclosed.
Benn discloses a method of imaging dental caries, diagnosing or monitoring periodontal disease and evaluating the 3D shaped of dental root canals using a topical intraoral solution comprising a contrast agent (¶ [0004]). The contrast agent can be a variety of iodide compounds including those that comprise iodine bound to an organic molecule such as iopamidol and iotrolan (¶¶ [0026] – [0027]). The constant agent is delivered using a pharmaceutically acceptable carrier with typical carriers including solvent or solvent like solutions such as water (¶ [0034]). Excipients such as buffers, flavor modifying agents, sweeteners and taste masking agents can be included as will be appreciated by a skilled artisan (¶ [0036]). All customary buffers are suitable for use in the composition, including sodium hydrogen carbonate buffer (sodium bicarbonate; ¶ [0040]). PVP can be included as a thickener (¶ [0043]). Sugars and polyhydric alcohols can be included as diluents or sweeteners (¶ [0045] and [0047]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a contrast agent such as the organically bound iodine contrast agents of iopamidol and iotrolan in a bitterness masked lidocaine preparations as in Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Benn discloses that solutions used during various dental procedures can also include a contrast agent. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. A solution containing a contrast agent allows for visualization of the anatomy as disclosed by Benn while also providing an anesthetic effect to the area. The selection of which optional ingredients to include in the formulation from those that are known in the art as suitable for inclusion in liquid compositions for use during oral or dental procedures does not patentably distinguish the instant claims.
Claim(s) 47 is rejected under 35 U.S.C. 103 as being unpatentable over Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. as applied to claims 37 – 40, 44 and 45 above, and further in view of Talonn et al. (US 5,088,988).
Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. are discussed above.
A dental syringe comprising the local anesthetic solution of Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. is not disclosed.
Talonn et al. discloses a safety dental syringe adapted to receive a medication cartridge with a protective needle shield (whole document, e.g., abstract). The medication cartridge has an injectable medication therein and the example given is a 1.8 mL cartridge containing 2% lidocaine HCl with epinephrine (col 9, ln 38 – 44).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to load a dental syringe with a medication cartridge as disclosed by Talonn et al. loaded with the anesthetic composition of Anaebonam et al., Abrahamsohn, Muni and Loiselle et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because injectable medications must be injected, which requires specialized equipment such as that disclosed by Talonn et al. Commercially available cartridges may vary in size but the one disclosed by Talonn et al. reads on about 1.7 mL and depending on the volume of solution to be injected, one of ordinary skill in the art can select an appropriately sized medication cartridge for use in the dental syringe to provide adequate solution for use while minimizing waste solution left over after injection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618