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 .
Applicants' arguments, filed May 26, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
In view of the amendments to the claims, Uzbelger Feldman (US 2018/0193462) no longer qualifies as prior art and the rejections based upon this reference have been withdrawn.
In view of the amendments to the claims, new grounds to rejection are set forth below that use many of the previously applied references that still qualify as prior art. Applicants arguments regarding those references still used in the new grounds of rejection below are addressed below.
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, 39, 40, 44 and 47 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 Sohi et al. (Drug Dev Ind Pharm, 2004).
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. Sodium hydroxide and hydrochloric acid are also present in examples 3 and 4. Epinephrine is not disclosed as a required ingredient so compositions free of epinephrine are disclosed.
The use of hydrochloride salts of the local anesthetic such as lidocaine, reading on a derivate of lidocaine, is not disclosed.
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]).
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 is taught by both Anaebonam et al. and Abrahamsohn and one of ordinary skill in the would know that citric acid can act as a buffer with agents such as sodium hydroxide and hydrochloric acid being used to adjust the overall pH of the solution.
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.
The presence of amino acids is not disclosed by any of the above references.
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 and Muni. 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.
Regarding the previously applied references that are still used in the rejection set forth above, Applicants argue that Anaebonam et al. fails to teach lactated Ringer’s solution and at least one of the amino acids from the claimed Markush group. There is no evidence of record as to how one of ordinary skill in the art would interpret the other cited references as curing these defects. Abrahamsohn explicitly utilizes sodium bicarbonate and therefore fails to suggest a composition free of sodium bicarbonate and does not disclose amino acids from the recited group. Muni and Loiselle [no longer used in the rejections of record] fail to cure the defects of Anaebonam et al. and Abrahamsohn since neither reference discloses or otherwise suggests an amino acid such as one or more of those recited in the claims.
These arguments are unpersuasive. "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference .... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413,425 (CCPA 1981) MPEP 2145(III). As shown succinctly in claims 1 and 2 of Abrahamsohn, the method disclosed by Abrahamsohn has one step in which a local or regional anesthetic is administered and a separate step that administers the bicarbonate such as near the completion or immediately following the surgical or dental procedure. Therefore, compositions comprising both anesthetic and sodium bicarbonate are not disclosed by this reference as these ingredients are administered in separate steps and the anesthetic containing compositions are free of sodium bicarbonate. The failure of Anaebonam et al., Abrahamsohn and Muni to disclose the presence of amino acids is remedied by the previously applied reference Sohi which discloses the use of glycine and alanine for bitterness control. This reference was previously applied and Applicants present no specific arguments regarding this reference for the Examiner to address herein.
Claim(s) 37, 39 – 41, 44 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Anaebonam et al., Abrahamsohn, Muni and Sohi as applied to claims 37, 39, 40, 44 and 47 above, and further in view of Gowthamarajan et al. (Resonance, 2004).
Anaebonam et al., Abrahamsohn, Muni and Sohi are discussed above.
The use of a combination of multiple amino acids from the Markush groups of claims 37 or 41 is not disclosed.
Gowthamarajan et al. discloses that masking the bitter taste of drugs is a potential tool for the improvement of patient compliance with many techniques developed to improve the taste of the product and also the stability and performance of the product (p 25, ¶ 1). Amongst the taste-masking technologies for bitter drugs disclosed is the use of amino acids and protein hydrolysates (p 32, ¶ 2), the latter which would comprise all of the amino acids that were present in the protein prior to hydrolysis. Preferred amino acids for taste masking including alanine, glutamic acid and glycerin (p 32, ¶ 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 use more than one amino acid such as the combination of the preferred amino acids glutamic acid and glycine for taste masking as disclosed by Gowthamarajan 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 amino acids are known in the art for taste masking bitter substances and glutamic acid and glycine are among the amino acids explicitly discloses in the prior art for this purpose. The use of more than one taste masking ingredient can provide improved taste masking and there is no evidence of record as to unexpected results arising from the presence of multiple amino acids from the claimed Markush group.
Claim(s) 46 is rejected under 35 U.S.C. 103 as being unpatentable over Anaebonam et al., Abrahamsohn, Muni, Sohi and optionally Gowthamarajan et al. as applied to claims 37, 39 – 41, 44 and 47 above, and further in view of Benn (WO 2012/151464).
Anaebonam et al., Abrahamsohn, Muni, Sohi and Gowthamarajan 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]). 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, Sohi and optionally Gowthamarajan 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.
Applicants present no arguments regarding Benn for the Examiner to address herein.
Conclusion
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 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
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