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
Claims 26-29 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/20/2026.
Applicant's election with traverse of Group I, claims 16-25 and 30, in the reply filed on 04/20/2026 is acknowledged. The traversal is on the ground(s) that Uzbelger Feldman does not specifically disclose the osmolarity and pH of the anesthetic solution. This is not found persuasive because Uzbelger Feldman teaches a local anesthetic solution with the same components as the instant application. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II). Identical compositions will have identical properties including pH and Osmolarity. Purely en arguendo, were the properties not considered inherent they would be able to be routinely optimized by one of ordinary skill in the art. One of ordinary skill in the art of anesthetic solutions would be capable of optimizing an injectable to have the properties of pH and Osmolarity fit for injection into a specific physiological system like oral tissue, muscle tissue or intravenous injection. See MPEP 2144.05(II). Uzbelger Feldman (US Patent Application Publication 20200206351 A1) is drawn to a local anesthetic solution for dental treatment comprising: an anesthetic agent; a bitterness suppressant that includes an amino acid and at least one of dextrose, fructose, sucrose, and saccharin; a buffering agent that includes a lactated Ringer's solution; a stabilizer that includes lecithin or sodium hydroxide; and an anesthetic solution vehicle in an aqueous form or hydrogel form; wherein the amino acid includes at least one of arginine, glycine, and glutamic acid (Uzbelger Feldman at claim 37). Uzbelger Feldman recites wherein the anesthetic agent includes one or more anesthetic agents selected from the group consisting of: lidocaine; tetracaine; mepivacaine; prilocaine; bupivacaine; etidocaine; ropivacaine; and articaine (Uzbelger Feldman at claim 38). Uzbelger Feldman recites further comprising one or more vasoconstrictors selected from the group consisting of: adrenaline; epinephrine; norepinephrine; phenylephrine; felypressin; and levonordefrin (Uzbelger Feldman at claim 39).
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application claims foreign priority to EP21305567.6 filed 04/30/2021. The instant application claims domestic priority to PRO 63/182,097 filed 04/30/2021. The instant application is a 371 of PCT/EP2022/061597 filed 04/29/2022.
Information Disclosure Statement
The information disclosure statements (IDS) dated 05/06/2026 and 10/30/2023 both comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Drawings
The drawings are objected to because the images are too pixelated or blurry to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the use of the term “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
The claims are objected to because of the following informalities: punctuation. Semicolons are used wherein another form of punctuation would be more appropriate. Appropriate correction is required.
Claim Interpretation
With regards to the term “derivates” in lines 2-4 of claim 16, the instant specification states:
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The instant specification further recites “According to one embodiment, the anesthetic agent is selected from: lidocaine derivates; tetracaine derivates; xylocaine derivates; mepivacaine derivates; prilocaine derivates; bupivacaine derivates; etidocaine derivates; ropivacaine derivates; articaine derivates; and any combinations thereof. According to one embodiment, the anesthetic agent is lidocaine or its derivates. According to one embodiment, the anesthetic agent is lidocaine hydrochloride. In the present invention, the term "X derivates" where X is the name of an anesthetic agent, includes the anesthetic agent X itself and any chemical substitutions made on the backbone of said anesthetic agent X or any pharmaceutically
acceptable salts of said anesthetic agent X.” (Instant Specification at [0052]).
As such, the Examiner is interpreting the term “derivatives” as the term "X derivates" where X is the name of an anesthetic agent, includes the anesthetic agent X itself and any chemical substitutions made on the backbone of said anesthetic agent X or any pharmaceutically acceptable salts of said anesthetic agent X, as specified in the instant specification (Instant Specification at [0052]).
With regards to the term “optionally” in line 5 of claim 16, the term optionally is interpreted as referencing only the term on the same line, a vasoconstrictor, and not the lines following.
Claim Rejections - 35 USC § 112
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 16-25 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.
Regarding claims 16-19, 21-22, and 24-25 the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05. Claims 20, 23, and 30 all depend from claim 16 and are therefore indefinite.
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.
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.
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(s) absent any evidence to the contrary. Applicant is advised of the obligation under 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.
A) Claims 16-20, 23-24 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Uzbelger Feldman (US Patent Application Publication 20200206351 A1).
Uzbelger Feldman is drawn to a local anesthetic solution for dental treatment comprising: an anesthetic agent; a bitterness suppressant that includes an amino acid and at least one of dextrose, fructose, sucrose, and saccharin; a buffering agent that includes a lactated Ringer's solution; a stabilizer that includes lecithin or sodium hydroxide; and an anesthetic solution vehicle in an aqueous form or hydrogel form; wherein the amino acid includes at least one of arginine, glycine, and glutamic acid (Uzbelger Feldman at claim 37). Uzbelger Feldman recites wherein the anesthetic agent includes one or more anesthetic agents selected from the group consisting of: lidocaine; tetracaine; mepivacaine; prilocaine; bupivacaine; etidocaine; ropivacaine; and articaine (Uzbelger Feldman at claim 38). Uzbelger Feldman recites further comprising one or more vasoconstrictors selected from the group consisting of: adrenaline; epinephrine; norepinephrine; phenylephrine; felypressin; and levonordefrin (Uzbelger Feldman at claim 39). Uzbelger Feldman recites a local anesthetic solution for dental treatment comprising: an anesthetic agent; a bitterness suppressant that includes an amino acid and at least one of dextrose, fructose, sucrose, and saccharin; a buffering agent; a stabilizer; and an anesthetic solution vehicle in an aqueous form or hydrogel form (Uzbelger Feldman at claim 42). Uzbelger Feldman recites wherein the anesthetic agent includes one or more anesthetic agents selected from the group consisting of: lidocaine; tetracaine; mepivacaine; prilocaine; bupivacaine; etidocaine; ropivacaine; and articaine (Uzbelger Feldman at claim 43). Uzbelger Feldman recites wherein the buffering agent includes one or more buffering agents selected from the group consisting of: Hartmann's solution; Ringer's solution; lactated Ringer's solution; acetated Ringer's solution; and bicarbonated Ringer's solution (Uzbelger Feldman at claim 44). Uzbelger Feldman recites wherein the stabilizer includes one or more stabilizers selected from the group consisting of: citric acid, sodium hydroxide; lecithin; fatty acid emulsions; and polysorbate 80 (Uzbelger Feldman at claim 45). Uzbelger Feldman recites wherein the bitterness suppressant further includes one or more amino acids selected from the group consisting of: lysine; glutamic acid; leucine; arginine; alanine; valine; isoleucine; aspartic acid; phenylalanine; glycine; serine; histidine; threonine; ornithine monohydrochloride; proline; methionine; tryptophan; cysteine; taurine; and tyrosine (Uzbelger Feldman at claim 46). Uzbelger Feldman recites further comprising one or more vasoconstrictors selected from the group consisting of: adrenaline; epinephrine; norepinephrine; phenylephrine; felypressin; and levonordefrin (Uzbelger Feldman at claim 47).
Uzbelger Feldman teaches that the anesthetic agent may be selected from the group consisting of: lidocaine derivates; tetracaine derivates; xylocaine derivates; mepivacaine derivates; prilocaine derivates; bupivacaine derivates; etidocaine derivates; ropivacaine derivates; articaine derivates; and combinations of any of the foregoing. In a variation of this feature, the anesthetic agent may be present in the solution in a mass percentage that ranges from about 0.1% to about 10% (Uzbelger Feldman at [0020]). Uzbelger Feldman teaches the bitterness suppressant may include a sweet compound selected from the group consisting of: stevia; aspartame; sucralose; neotame; acesulfame potassium; saccharin; sodium saccharin; advantame; cyclamates; lyzozyme, alitame; lactisole; corn syrup; high fructose corn syrup; sugar alcohols; thaumatin; glycosides; terpenoid glycosides; polyhydric alcohols; dipeptide derivatives; N-sulfonylamides; sulfamates; proteins; dihydrochalcones; chlorodeoxysugars; polychlorodeoxysugars; monodeoxysugars; polydeoxysugars; and combinations of any of the foregoing (Uzbelger Feldman at [0022]).Uzbelger Feldman teaches the bitterness suppressant may include an amino acid selected from the group consisting of: lysine; glutamic acid; leucine; arginine; alanine; valine; isoleucine; aspartic acid; phenylalanine; glycine; serine; histidine; threonine; ornithine monohydrochloride; proline; methionine; tryptophan; cysteine; taurine; tyrosine; amino sugars; and combinations of any of the foregoing (Uzbelger Feldman at [0024]). Uzbelger Feldman teaches the additional agent may include a vasoconstrictor selected from the group consisting of: adrenaline; epinephrine; norepinephrine; phynylephrine; felypressin; levonordefrin; and combinations of any of the foregoing. In a variation of this feature, the vasoconstrictor may be present in a concentration ranging from about 1:10,000 to about 1:500,000 milligrams of vasoconstrictor per milliliter of solution (Uzbelger Feldman at [0029]). Uzbelger Feldman teaches the additional agent may include a buffering agent selected from the group consisting of: one of the combinations of alkaline, neutral or acid substances of sodium bicarbonate; Hartmann's solution; Ringer's solution; lactated Ringer's solution; acetated Ringer's solution; bicarbonated Ringer's solution; colloids based agents; and combinations of the foregoing (Uzbelger Feldman at [0028]).Uzbelger Feldman teaches the solution may be contained within an anesthetic vial with a capacity ranging from about 0.3 milliliters to about 5 milliliters; and/or the solution may be administered with a dental syringe, a nasal spray, a needle-free injection system, or a hydrogel method (Uzbelger Feldman at [0033]).Uzbelger Feldman teaches that bitterness suppressant sugars for use in accordance with an improved local anesthetic solution for dental use as described herein are generally made from one or a combination of two or more monosaccharides, disaccharides or polysaccharides, in amounts ranging from 0.0001 to 1,000 mg per milliliter. Contemplated saccharides include, but are not limited to: dextrose; fructose; galactose; glyceraldehydes; lactose; maltose; sucrose; starch; glycogen; and combinations thereof. Bitterness suppressant sweet-tasting compounds include one or more compounds from the group that includes, but is not limited to: stevia; aspartame; sucralose; neotame; acesulfame potassium; saccharin; sodium saccharin; advantame; cyclamates; lyzozyme, alitame; lactisole; corn syrup; high fructose corn syrup; sugar alcohols; thaumatin; glycosides; terpenoid glycosides; polyhydric alcohols; dipeptide derivatives; N-sulfonylamides; sulfamates; proteins; dihydrochalcones; chlorodeoxysugars; polychlorodeoxysugars; monodeoxysugars; and polydeoxysugars. Other sugars and sweet compounds are likewise contemplated. Bitterness suppressant amino acids and/or L-form amino acids for use in accordance with an improved local anesthetic solution as described herein include one or more amino acids from the group that includes, but is not limited to: lysine; glutamic acid; leucine; arginine; alanine; valine; isoleucine; aspartic acid; phenylalanine; glycine; serine; histidine; threonine; ornithine monohydrochloride; proline; methionine; tryptophan; cysteine; taurine; and tyrosine. Amino sugars and other amino acids are likewise contemplated (Uzbelger Feldman at [0071-0073]). Uzbelger Feldman teaches A lactated Ringer's solution is a solution that is generally isotonic with blood and commonly used for intravenous administration. It is also commonly administered subcutaneously. Lactated Ringer's solution is grouped with intravenous fluids known as crystalloids, which include saline and dextrose solutions. Lactated Ringer's solution has an osmolarity of 273 mOsm/L. The lactate is metabolized into bicarbonate by the liver, which can help correct metabolic acidosis. Advantageously, lactated Ringer's solution and its variants are safe for use in the human body. (Uzbelger Feldman at [0081]). Uzbelger Feldman teaches Ringer's saline solution of inorganic salts was invented in the early 1880s by Sydney Ringer, a British physician and physiologist. Years later, the original Ringer's solution was further modified by American pediatrician Alexis Hartmann for the purpose of treating acidosis. Hartmann added lactate, which mitigates changes in pH by acting as a buffer for acid. (Uzbelger Feldman at [0080]). Uzbelger Feldman teaches the additional agent may include a preservative compound selected from the group consisting of: paraben derivatives; sodium bisulfites or metabisulfites; ascorbic acid; benzyl alcohol; phenylethyl alcohol; phenol; meta-cresol; chlorobutanol; thimerosal; phenylmercuric salts; and combinations of any of the foregoing (Uzbelger Feldman at [0030]).Uzbelger Feldman teaches an improved local anesthetic solution for dental use as described herein may have an aqueous or a non-aqueous form. In contemplated embodiments, the anesthetic solution vehicle includes one or more solution vehicles from the group that includes, but is not limited to: water; hypotonic, isotonic or hypertonic crystalloids solutions; colloids solutions; hydrophilic polymer chains networks; and plasma (Uzbelger Feldman at [0076]).
Uzbelger Feldman differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Uzbelger Feldman teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Uzbelger Feldman to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 16, Uzbelger Feldman teaches that the anesthetic agent may be selected from the group consisting of: lidocaine derivates; tetracaine derivates; xylocaine derivates; mepivacaine derivates; prilocaine derivates; bupivacaine derivates; etidocaine derivates; ropivacaine derivates; articaine derivates; and combinations of any of the foregoing. In a variation of this feature, the anesthetic agent may be present in the solution in a mass percentage that ranges from about 0.1% to about 10% (Uzbelger Feldman at [0020]).
Uzbelger Feldman teaches the use of water (Uzbelger Feldman at [0076]).
Uzbelger Feldman teaches the bitterness suppressant may include a sweet compound selected from the group consisting of; saccharin; sodium saccharin; and combinations of any of the foregoing (Uzbelger Feldman at [0022]).Uzbelger Feldman teaches the bitterness suppressant may include an amino acid selected from the group consisting of: serine; histidine; threonine; amino sugars; and combinations of any of the foregoing (Uzbelger Feldman at [0024]). Uzbelger Feldman teaches the use of the buffer Lactated Ringer's solution has an osmolarity of 273 mOsm/L (Uzbelger Feldman at [0081]), which overlaps the instantly claimed range of 250 to 500 mOsm/L. Uzbelger Feldman further teaches the use of buffers to maintain a steady pH (Uzbelger Feldman at [0079-0082]). One of ordinary skill in the are would be capable of optimizing a pH for an injectable depending on the specific components of the solution. See MPEP 2144.05(II).Uzbelger Feldman teaches a local anesthetic solution with the same components as the instant application. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (II). Identical compositions will have identical properties including pH and Osmolarity. Purely en arguendo, were the properties not considered inherent they would be able to be routinely optimized by one of ordinary skill in the art. One of ordinary skill in the art of anesthetic solutions would be capable of optimizing an injectable to have the properties of pH and Osmolarity fit for injection into a specific physiological system like oral tissue, muscle tissue or intravenous injection. See MPEP 2144.05(II).
Regarding instant claim 17, Uzbelger Feldman teaches the additional agent may include a vasoconstrictor selected from the group consisting of: adrenaline; epinephrine; norepinephrine; phynylephrine; felypressin; levonordefrin; and combinations of any of the foregoing. In a variation of this feature, the vasoconstrictor may be present in a concentration ranging from about 1:10,000 to about 1:500,000 milligrams of vasoconstrictor per milliliter of solution (Uzbelger Feldman at [0029]).
Regarding instant claim 18, Uzbelger Feldman teaches that the anesthetic agent may be selected from the group consisting of: lidocaine derivates; tetracaine derivates; xylocaine derivates; mepivacaine derivates; prilocaine derivates; bupivacaine derivates; etidocaine derivates; ropivacaine derivates; articaine derivates; and combinations of any of the foregoing. In a variation of this feature, the anesthetic agent may be present in the solution in a mass percentage that ranges from about 0.1% to about 10% (Uzbelger Feldman at [0020]).
Regarding instant claim 19, Uzbelger Feldman teaches an improved local anesthetic solution for dental use as described herein may have an aqueous or a non-aqueous form. In contemplated embodiments, the anesthetic solution vehicle includes one or more solution vehicles from the group that includes, but is not limited to: water; hypotonic, isotonic or hypertonic crystalloids solutions; colloids solutions; hydrophilic polymer chains networks; and plasma (Uzbelger Feldman at [0076]).
Regarding instant claim 20, Uzbelger Feldman teaches the bitterness suppressant may include a sweet compound selected from the group consisting of: stevia; aspartame; sucralose; neotame; acesulfame potassium; saccharin; sodium saccharin; advantame; cyclamates; lyzozyme, alitame; lactisole; corn syrup; high fructose corn syrup; sugar alcohols; thaumatin; glycosides; terpenoid glycosides; polyhydric alcohols; dipeptide derivatives; N-sulfonylamides; sulfamates; proteins; dihydrochalcones; chlorodeoxysugars; polychlorodeoxysugars; monodeoxysugars; polydeoxysugars; and combinations of any of the foregoing (Uzbelger Feldman at [0022]).Uzbelger Feldman teaches the bitterness suppressant may include an amino acid selected from the group consisting of: lysine; glutamic acid; leucine; arginine; alanine; valine; isoleucine; aspartic acid; phenylalanine; glycine; serine; histidine; threonine; ornithine monohydrochloride; proline; methionine; tryptophan; cysteine; taurine; tyrosine; amino sugars; and combinations of any of the foregoing (Uzbelger Feldman at [0024]).
Regarding instant claim 23, Uzbelger Feldman teaches the additional agent may include a preservative compound selected from the group consisting of: paraben derivatives; sodium bisulfites or metabisulfites; ascorbic acid; benzyl alcohol; phenylethyl alcohol; phenol; meta-cresol; chlorobutanol; thimerosal; phenylmercuric salts; and combinations of any of the foregoing (Uzbelger Feldman at [0030]).
Regarding instant claim 24, Uzbelger Feldman teaches the additional agent may include a preservative compound selected from the group consisting of: paraben derivatives; sodium bisulfites or metabisulfites; ascorbic acid; benzyl alcohol; phenylethyl alcohol; phenol; meta-cresol; chlorobutanol; thimerosal; phenylmercuric salts; and combinations of any of the foregoing (Uzbelger Feldman at [0030]).
Regarding instant claim 30, Uzbelger Feldman teaches that the components described herein are mixed and contained within an anesthetic vial with a capacity ranging from 0.3 ml to 5 ml. The anesthetic vial can be placed in a dental syringe made of stainless steel, disposable plastic or other material. Contemplated syringes include a conventional dental syringe, an intraligamentary syringe or gun, and an intraosseous system, with a needle 12 having a 10 to 40 gauge range and different sizes from 5-40 mm (Uzbelger Feldman at [0089]).
B) Claims 16-25 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Uzbelger Feldman (US Patent Application Publication 20200206351 A1) as applied to claims 16-20, 23-24 and 30 above, and further in view of Shenoy et al (US Patent Application Publication 20180333493A1).
The teachings of Uzbelger Feldman are discussed above.
The teachings of Uzbelger Feldman differ from the instant claims insofar as they do not specifically teach the amount of amino acid or sodium saccharin the composition. The teachings of Shenoy cure this deficit.
Shenoy teaches that excipients are used in a range of between 0.01% and 10% (w/v) (Shenoy at [0295]). Shenoy teaches the use of sodium saccharin and sorbitol, and sterile vehicles (e.g. bacteriostatic water for injection), water for injection, sterile water for injection, sterile water for irrigation and purified water) (Shenoy at [0260]). Shenoy teaches the use of threonine and serine (Shenoy at [0210]) and in a range of 0.1mM to 1000mM ([0234]). Shenoy teaches the composition has an osmolarity in the range may be between 200 mOsm/L to about 500 mOsm/L (Shenoy at [0269]). Shenoy teaches that the composition may have a pH of between 3 and about 6 (Shenoy at [0274]). Shenoy teaches the use of lidocaine (Shenoy at [0044, 0220,0227]).
Shenoy differs from the instant invention insofar as it does not teach the use of epinephrine. The teachings of Uzbelger Feldman cure this deficit.
It would have been prima facie obvious to have used the ranges for sodium saccharin and serine taught in Shenoy as the amounts used in Uzbelger Feldman as Shenoy teaches that they are useful ranges for injectables comprising sodium saccharin, serine, water, and lidocaine. One would have a reasonable expectation of success because both teach injectable compositions comprising sodium saccharin, serine, water and lidocaine. It would be reasonable to use the amounts taught in Shenoy as they are performing their intended purpose as an amino acid and a sweetener. See MPEP 2144.07.
Regarding instant claim 16, Uzbelger Feldman teaches that the anesthetic agent may be selected from the group consisting of: lidocaine derivates; tetracaine derivates; xylocaine derivates; mepivacaine derivates; prilocaine derivates; bupivacaine derivates; etidocaine derivates; ropivacaine derivates; articaine derivates; and combinations of any of the foregoing. In a variation of this feature, the anesthetic agent may be present in the solution in a mass percentage that ranges from about 0.1% to about 10% (Uzbelger Feldman at [0020]). Shenoy teaches the use of lidocaine (Shenoy at [0044, 0220,0227]).
Uzbelger Feldman teaches the use of water (Uzbelger Feldman at [0076]). Shenoy teaches the sterile vehicles (e.g. bacteriostatic water for injection), water for injection, sterile water for injection, sterile water for irrigation and purified water) (Shenoy at [0260]).
Uzbelger Feldman teaches the bitterness suppressant may include a sweet compound selected from the group consisting of; saccharin; sodium saccharin; and combinations of any of the foregoing (Uzbelger Feldman at [0022]).Uzbelger Feldman teaches the bitterness suppressant may include an amino acid selected from the group consisting of: serine; histidine; threonine; amino sugars; and combinations of any of the foregoing (Uzbelger Feldman at [0024]). Shenoy teaches the use of sodium saccharin and sorbitol, and sterile vehicles (e.g. bacteriostatic water for injection), water for injection, sterile water for injection, sterile water for irrigation and purified water) (Shenoy at [0260]). Shenoy teaches the use of threonine and serine (Shenoy at [0210]) and in a range of 0.1mM to 1000mM ([0234]).
Uzbelger Feldman teaches the use of the buffer Lactated Ringer's solution has an osmolarity of 273 mOsm/L (Uzbelger Feldman at [0081]), which overlaps the instantly claimed range of 250 to 500 mOsm/L. Shenoy teaches the composition has an osmolarity in the range may be between 200 mOsm/L to about 500 mOsm/L (Shenoy at [0269]), which overlaps the instantly claimed range of 250 to 500 mOsm/L. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Shenoy teaches that the composition may have a pH of between 3 and about 6 (Shenoy at [0274]), which overlaps the instantly claimed range of 2.3 to 5.5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Uzbelger Feldman further teaches the use of buffers to maintain a steady pH (Uzbelger Feldman at [0079-0082]).
Regarding instant claim 21, Shenoy teaches the use of threonine and serine (Shenoy at [0210]) and in a range of 0.1mM to 1000mM ([0234]), which overlaps with the instantly claimed range of 1% to 6%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 22, Shenoy teaches the use of sodium saccharin and sorbitol (Shenoy at [0260]), which are excipients. Shenoy teaches that excipients are used in a range of between 0.01% and 10% (w/v) (Shenoy at [0295]), which overlaps the instantly claimed range of 0.1% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 25,
Uzbelger Feldman teaches that the anesthetic agent may be selected from the group consisting of: lidocaine derivates; tetracaine derivates; xylocaine derivates; mepivacaine derivates; prilocaine derivates; bupivacaine derivates; etidocaine derivates; ropivacaine derivates; articaine derivates; and combinations of any of the foregoing. In a variation of this feature, the anesthetic agent may be present in the solution in a mass percentage that ranges from about 0.1% to about 10% (Uzbelger Feldman at [0020]), which overlaps the instantly claimed range of 0.01% to 5%.
Uzbelger Feldman teaches the additional agent may include a vasoconstrictor selected from the group consisting of: adrenaline; epinephrine; norepinephrine; phynylephrine; felypressin; levonordefrin; and combinations of any of the foregoing. In a variation of this feature, the vasoconstrictor may be present in a concentration ranging from about 1:10,000 to about 1:500,000 milligrams of vasoconstrictor per milliliter of solution (Uzbelger Feldman at [0029]), which overlaps the instantly claimed range of 0.0001 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Uzbelger Feldman teaches an improved local anesthetic solution for dental use as described herein may have an aqueous or a non-aqueous form. In contemplated embodiments, the anesthetic solution vehicle includes one or more solution vehicles from the group that includes, but is not limited to: water; hypotonic, isotonic or hypertonic crystalloids solutions; colloids solutions; hydrophilic polymer chains networks; and plasma (Uzbelger Feldman at [0076]).
Shenoy teaches the use of sodium saccharin and sorbitol (Shenoy at [0260]), which are excipients. Shenoy teaches that excipients are used in a range of between 0.01% and 10% (w/v) (Shenoy at [0295]), which overlaps the instantly claimed range of 0.1% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Shenoy teaches the use of threonine and serine (Shenoy at [0210]) and in a range of 0.1mM to 1000mM ([0234]), which overlaps with the instantly claimed range of 1% to 6%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Conclusion
No claims are presently allowable.
Correspondence
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
