Prosecution Insights
Last updated: October 25, 2026
Application No. 18/426,213

Topical anesthetic agent-clay composite compositions

Final Rejection §102§103§112
Filed
Jan 29, 2024
Priority
Sep 09, 2021 — nonprovisional of PCTCN2021117393
Examiner
ALSTRUM ACEVEDO, JAMES HENRY
Art Unit
1622
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Andros Pharmaceuticals Co. Ltd.
OA Round
2 (Final)
41%
Grant Probability
Moderate
3-4
OA Rounds
1y 6m
Est. Remaining
21%
With Interview

Examiner Intelligence

Grants 41% of resolved cases
41%
Career Allowance Rate
180 granted / 441 resolved
-19.2% vs TC avg
Minimal -20% lift
Without
With
+-19.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 3m
Avg Prosecution
1 currently pending
Career history
444
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
36.4%
-3.6% vs TC avg
§102
11.1%
-28.9% vs TC avg
§112
26.9%
-13.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 441 resolved cases

Office Action

§102 §103 §112
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 . Claim Status Claims 1-20 are pending. Applicant amended claims 1-2 and 13-14. Claims 1-20 are under consideration in the instant office action. Withdrawn Claim Objections The claim objections of claims 1-2 and 13-14 set forth in the Non-Final Office Action mailed on April 8, 2026 are withdrawn in light of Applicant’s claim amendments. 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. Claim 13 remains 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 13 remains ambiguous because the specification does not clearly redefine "pharmaceutically acceptable solvent vehicle" to include dichloromethane (at line 6 of claim 13) and toluene (at line 7 of claim 13), which are known to be class 2 solvents considered to be toxic, have low permitted daily exposure limits, and, which would not be considered to be pharmaceutically acceptable solvents suitable for incorporation into a pharmaceutical formulation. See Table 2, Class 2 solvents on page 5 of Grodowska et al. "Organic Solvents in the Pharmaceutical Industry", Acta Poloniae Pharmaceutica- Drug Research, Vol. 67, No. 1, pp. 3-12 (2010) (of record). Response to Arguments Applicant's arguments filed July 3, 2026 have been fully considered but they are not persuasive. At paragraph 2.2 of Applicant’s remarks, Applicant asserts that claim 13 has been amended to overcome this issue, however, claim 13 still recites dichloromethane and toluene, so the issue was not been overcome by amendment at this time. Claim Rejections - 35 USC § 102 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1-3, 5, 7, 11-13, and 20 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Inoo et al. US PG-PUB 2011/0160194 ("Inoo"; cited on the IDS filed December 6, 2024; Published on June 30, 2011 with a 371 filing date of March 2, 2011), as evidenced by the Wikipedia article entitled, "Oxybuprocaine" (last updated on 14 January 2025 at 03:20 (UTC)) (of record). Applicant claims an anesthetic composition for topical application comprising (a) therapeutically effective amount of at least one pharmaceutically active agent; (b) at least one pharmaceutically acceptable solvent vehicle; (c) at least one clay; wherein the pharmaceutically active agent is ester type or amide type anesthetic agent (claim 1). Applicant also claims a method of use of the composition of claim 1 comprising (a) providing the composition of claim 1 and (b) contacting an area of skin with the anesthetic composition. Inoo exemplifies the below composition on page 4 in Table 3 in paragraph [0061]: PNG media_image1.png 506 700 media_image1.png Greyscale Inoo's Table 3 composition is made by dissolving diclofenac sodium in N-methyl-2-pyrrolidone (i.e., a pharmaceutically acceptable solvent vehicle) and oxybuprocaine is separately dissolved in propylene glycol (i.e., a pharmaceutically acceptable solvent vehicle). The purified water of this composition also reads on a pharmaceutically acceptable solvent vehicle. The concentration of oxybuprocaine of 5% w/w meets the limitations of "the pharmaceutically active agent is ester type anesthetic agent" and the limitations of dependent claims 3 and 5 for the amount of the ester-type anesthetic agent of "about 1 to 10%" w/w and "an amount of 5%" w/w, respectively. The "kaoline" (spelled as kaolin in Applicant's dependent claim 11) of Inoo's Table 3 composition reads on a clay. Applicant's rejected claims use open "comprising" language and thus do not exclude additional components such as "diclofenac sodium". The other components of Inoo's Table 3 composition read on "the anesthetic composition of claim 1 further comprising at least one excipient", as recited in rejected claim 12. With respect to the form of Inoo's Table 3 composition, it is noted that in paragraph [0061] this composition is described as being a "drug-containing base" that was spread onto a woven fabric. Based on this description it is inferred that this composition is a semi-solid, such as a paste, which meets the limitations of rejected claim 2. Moreover, Inoo's Table 3 composition has all the required elements of claim 1, so it follows that it would also be a semi-solid, absent evidence to the contrary. With respect to rejected dependent claim 13, Inoo's Table 3 composition contains propylene glycol (also known as propyl glycol) and water, which are recited in rejected claim 13. Moreover, rejected claim 13 uses "comprising" language and as a result does not exclude other pharmaceutically acceptable solvents, such as, N-methyl-2-pyrrolidone . Inoo does not affirmatively describe oxybuprocaine as an ester-type anesthetic. The Wikipedia article entitled, "Oxybuprocaine" evidences that oxybuprocaine is an ester-type anesthetic, see below, and the ester functional group highlighted in the chemical structure of oxybuprocaine, PNG media_image2.png 125 309 media_image2.png Greyscale . PNG media_image3.png 256 970 media_image3.png Greyscale Inoo discloses that the external preparations of the invention are not particularly limited as long as its dosage form allows for direct administration of an active agent to the surface of an affected skin area. See paragraph [0040]. Thus, application of the Table 3 composition spread onto a non-woven fabric with a polypropylene liner applied thereto, as described in paragraph [0061], permits the ordinary skilled artisan to clearly envisage providing the Table 3 Inoo composition and application of it (i.e., contacting) to an area of skin. This disclosure meets the limitations of the method of rejected claim 20. Response to Arguments Applicant's arguments filed July 3, 2026, have been fully considered but they are not persuasive. At section 2, numbered page 7 of Applicant’s remarks, Applicant begins their traversal by commenting generally about Inoo’s teachings without specifically addressing the exemplified composition of Inoo cited in the rejection or explaining why it allegedly does not contain all the required elements of the rejected claims. Applicant tries to argue that Inoo is really focused on other things, but again fails to address the exemplified formulation cited in the office action and fails to identify a single thing in the exemplified formulation that does not anticipate any required limitation of the rejected claims. Thus, Applicant’s argument is unpersuasive and the rejection is maintained. Claims 1, 4, 6, 10-13, and 20 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ono et al. EP 0507160 A1 ("Ono"; Reference cited on the 12/6/2024 IDS; Published October 7, 1992). Applicant's claims have been generally described above and this description is incorporated herein by reference. Ono discloses external preparations for application to the skin containing lidocaine (i.e., an amide-type anesthetic), which comprises a drug-retaining layer placed on a support, wherein the drug-retaining layer comprises an adhesive gel base and 1-10% w/w of lidocaine, said base comprising a water-soluble high molecular weight substance, water (i.e., a pharmaceutically acceptable solvent vehicle), and a water-retaining agent that can release the active lidocaine gradually and constantly so that the lidocaine is transdermally absorbed for a long period of time (abstract). In Example 4 (bridging pages 5-6), Ono exemplifies the preparation of an aqueous base containing lidocaine (5% w/w), propylene glycol (5% w/w; also known as propyl glycol), kaolin (1% w/w), water (q.s.), and additional components that each read on an excipient. Example 4 also indicates that the base is spread onto a non-woven fabric at 1000 g/m² and to the base is adhered a liner made of polyethylene terephthalate processed with silicone. The effect rate of local anesthesis of the Example 4 lidocaine base is disclosed in Table 1 of Ono at page 9. It is the Examiner's position that Ono's disclosures set forth above permits the ordinary skilled artisan to clearly envisage providing the Example 4 lidocaine-containing base and apply it (i.e., contacting) to an area of skin. This disclosure meets the limitations of the method of rejected claim 20. Although Ono does not explicitly refer to lidocaine as being an amide-type anesthetic, Applicant admits that lidocaine is an amide-type anesthetic (See paragraph [079] of the specification filed on January 29, 2024). Response to Arguments Applicant's arguments filed July 3, 2026, have been fully considered but they are not persuasive. At section 2, numbered page 8 of Applicant’s remarks, Applicant begins their traversal by commenting generally about the technical purpose of Ono as being to control the pH of the matrix of a transdermal patch composition to prevent crystallization of the active ingredient, which Applicant asserts is fundamentally different from the technical teaching of the present invention. Applicant’s arguments do not address specifically the composition of Ono’s Example 4, cited in the rejection. Whether Ono’s invention has a different focus from what motivated Applicant is not relevant with respect to an anticipation rejection. Instead of focusing on the general motivation behind Ono’s disclosure, Applicant should focus on the composition disclosed by Ono vis-à-vis the claimed compositions and consider claim amendments that would distinguish Applicant’s claimed compositions from Ono’s Example 4 composition. Nonetheless, Applicant’s arguments are unpersuasive and this rejection is maintained. Claims 1-5, 7, 9-13, and 20 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kanios et al. (US Patent No. 5,719,197; "Kanios"; cited on the IDS filed December 6, 2024; Published on February 17, 1998 with a US filing date of June 7, 1995). The rejected claims are described generally above and incorporated herein by reference. Kanios discloses compositions for topical application comprising a therapeutically effective amount of (i) a pharmaceutical agent(s), (ii) a pharmaceutically acceptable bio-adhesive carrier, (iii) a solvent for the pharmaceutical agent(s) in the carrier, and (iv) a clay and methods of administering the pharmaceutical agents to a mammal (Abstract; col. 11, lines 11-29). In claim 23, Kanios claims a method of administering one or more pharmaceutically active agents to a subject comprising (a) providing the composition as set forth in claim 1 and (b) contacting an area of skin or mucous membrane with the composition to administer the pharmaceutically active agent. In claim 1, Kanios claims a flexible bio-adhesive composition for topical application comprising (a) a therapeutically effective amount of at least one pharmaceutically active agent; (b) a pharmaceutically acceptable solvent for the pharmaceutically active agent and a plasticizer; (c) in admixture with the pharmaceutically active agent in the solvent, a pharmaceutically acceptable bio-adhesive carrier in an amount from about 5-50% w/w and (d) a cohesive increasing amount of a clay, etc. In particularly preferred embodiments, the active agent is an anesthetic agent (col. 6, lines 1-2), including local anesthetic agents in free base form such as, lidocaine, procaine, prilocaine, etc. or local anesthetic agents in salt form, such as, prilocaine, tetracaine, bupivacaine, cyclonine, dibucaine, lidocaine, etc. Combination of local anesthetics with one in base form and another in salt form are contemplated (col. 8, lines 54-56). Contemplated pharmaceutical carriers include liquids and solids, such as bio-adhesive (col. 8, line 56-60). Particular solid and semi-solid forms contemplated include gels, plaster, pastes (col. 8, lines 60-65). Local anesthetic agents are specifically taught as being suitable pharmaceutically active agents and include amides, such as, lidocaine, prilocaine, mepivacaine, bupivacaine, etc. and esters, such as, procaine, tetracaine, propoxycaine, benzocaine, etc. (col. 3, lines 17-22; 42-48; claims 3, 6, 14-18, 19-22, and 24). The preferred local anesthetic base is lidocaine and the preferred local anesthetic salt is a salt of prilocaine, bupivacaine, dyclonine, mepivacaine, or tetracaine, preferably the HCl salt (col. 8, lines 17-20). Generally, the concentration of solubilized pharmaceutically active agent can range on a weight basis between about 1 and about 50%, preferably about 2.5 and about 40%, and more preferably between about 5 and 30% of the composition. (col. 8, lines 1-9). Various solvents are disclosed with polyhydric alcohols or combination thereof being preferred (col. 3, line 66 through col. 4, line 8; col. 4, lines 28-37; and claims 10-18, and 27), included in the preferred polyhydric alcohols are dipropylene glycol, glycerin, propylene glycol, butylene glycol, and sorbitol (col. 4, lines 33-37; col. 5, lines 24-36). Other contemplated solvents as being suitable include dimethylsulfoxide (i.e., DMSO) (col. 5, line 36). Contemplated bio-adhesives include gums and celluloses, including cellulose derivatives (e.g., methyl cellulose, propyl cellulose, hydroxyethylcellulose, and the like, etc.) (col. 10, lines 13-18, 32-38, and 39-44; claims 8-9). Suitable clays are disclosed at col. 4, lines 50-58 and include kaolinites, e.g., boalinite, anauxite, dickite, and nacrite; montmorillonites, such as, montmorillonite, bentonite, bordellite, and montronite; polygorshites, such as, attapulgite, galloysite; aluminum silicate clays, etc. Clays are used in amount of about 0.5 to about 20% w/w, preferably about 0.5 to about 10% w/w (col. 4, lines 62-63). Typical, preferred, and optimal amounts by % weight of adhesive, solvent (with plasticizer), Drug(s), and clay are disclosed in the table at col. 11, lines 1-10, including adhesives in amounts of 15-60% w/w (typical), 20-50% w/w (preferred), and 20-35 % w/w (optimal). Kanios exemplifies in Example 1 the following compositions and preparation thereof, wherein the compositions disclosed comprise in part lidocaine base (8% w/w), dipropylene glycol (5% w/w), 60% lecithin in propylene glycol (8% w/w), karaya gum (5% w/w), bentonite (2.0% w/w), glycerin (6% w/w) etc. PNG media_image4.png 374 628 media_image4.png Greyscale Response to Arguments Applicant's arguments filed July 3, 2026, have been fully considered but they are not persuasive. At section 2, numbered page 9 of Applicant’s remarks, Applicant begins their traversal by commenting generally about the technical purpose of Kanios without addressing specifically the composition of Kanios’ Example 1 composition, cited in the rejection. Whether Kanios’ invention has a different focus from what motivated Applicant is not relevant with respect to an anticipation rejection. Applicant’s arguments are unpersuasive and this rejection is maintained. Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 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 non- obviousness. 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. Claims 1-13 and 20 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Kanios et al. (US Patent No. 5,719,197; "Kanios"; cited on the IDS filed December 6, 2024; Published on February 17, 1998 with a US filing date of June 7, 1995). Applicant Claims Applicant claims an anesthetic composition and method of administering one or more pharmaceutical active agents, as generally described above, and incorporated herein by reference. Determination of the Scope and Content of the Prior Art (MPEP §2141.01) The teachings of Kanios are set forth above and incorporated herein by reference. Ascertainment of the Difference Between Scope the Prior Art and the Claims (MPEP §2141.012) Kanios does not exemplify a formulation comprising an amide local anesthetic (e.g., lidocaine) in an amount of 5% or 7%, as in instant claim 6, and does not exemplify a formulation comprising claim within the range recited in dependent claim 8. Thus, Kanios does not anticipate claims 6 and 8. These deficiencies are nonetheless fairly suggested by the teachings of Kanios. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious to obtain an anesthetic composition per the teachings of Kanios comprising 5% or 7% lidocaine, because the concentration of lidocaine exemplified by Kanios is very close in magnitude to the amount of lidocaine recited in dependent claim 6 and the person of ordinary skill in the art would have expected that formulations comprising 5%, 7%, and 8% lidocaine would exhibit the same or substantially similar properties. Moreover, Kanios teaches a suitable range for of pharmaceutically active agent, e.g., local anesthetics that encompasses the amounts recited in claim 6 of between about 1 and about 50%, preferably about 2.5 and about 40%, and more preferably between about 5 and 30% of the composition. It would have been prima facie obvious to optimize the amount of amide local anesthetic in Kanios' exemplified formulations with a reasonable expectation of success and to arrive at formulations comprising an amide local anesthetic in an amount of 5% or 7%. Similarly, with respect to the recited amount of clay in dependent claim 8, Kanios teaches an overlapping range of suitable amounts of clay of amount of about 0.5 to about 20% w/w. A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. A prima facie case of obviousness also exists wherein the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 227 USPQ 773 (Fed. Cir. 1985) (holding that a rejection of a claim directed to an alloy of titanium "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium was proper); MPEP § 2144.05. The Examiner notes Applicant's data present in various tables in the specification, however, this data is not presented with evidence of statistical significance and the rejected claims are not commensurate in scope with the compositions evaluated to obtain these data. Consequently, the rejected claims do not appear to have any secondary considerations present that could overcome the instant prima facie case of obviousness. Response to Arguments Applicant's arguments filed July 3, 2026, have been fully considered but they are not persuasive. At section 3, numbered page 9 of Applicant’s remarks, Applicant begins their traversal by commenting generally about the technical purpose of Kanios without addressing specifically the composition of Kanios’ Example 1 composition, cited in the rejection. Applicant also asserts that local anesthetics are only one optional category among many possible active gents and are not presented as preferred or an essential aspect of the invention of Kanios. Applicant also states that tetracaine appears only within a broad listing of potential anesthetic agents. Whether Kanios’ invention has a different focus from what motivated Applicant is not dispositive as to whether Kanios’ teachings and exemplified local anesthetic composition (See Example 1 of Kanios) renders the rejected claims obvious. The prior art is not required to teach the same rationale that may have motivated Applicant to arrive at their claimed invention. With respect to Applicant’s argument that local anesthetics represent only one optional category of many active agents, ignores the fact that Kanios has an exemplified local anesthetic composition comprising all the elements of rejected independent claim 1, for example. Applicant’s arguments are unpersuasive and this rejection is maintained. Concerning Applicant’s arguments regarding tetracaine, the Examiner notes that Kanios disclosure has a very short list of suitable local anesthetics (approximately 22) in column 3, at lines 43-53, wherein tetracaine is one of eleven specific ester local anesthetics identified as being suitable. Thus, selection of tetracaine from such a short list of ester local anesthetics would have been prima facie obvious, because the ordinary skilled artisan could at once envisage tetracaine as the selected ester local anesthetic. Additionally, Applicant’s arguments regarding tetracaine do not apply to claims 1-14 and 20, which do not require that the local anesthetic is tetracaine. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the local anesthetic is tetracaine) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In summary, Applicant’s arguments traversing the finding that the teachings of Kanios render instant claims 1-13 and 20 obvious are unpersuasive and the rejection is maintained. Claim 14-16 remain rejected under 35 U.S.C. 103 as being unpatentable over Kanios et al. (US Patent No. 5,719,197; "Kanios"; cited on the IDS filed December 6, 2024; Published on February 17, 1998 with a US filing date of June 7, 1995) as applied to claims 1-13 and 20 above, and further in view of Kulichikhin et al. (US PG-PUB 2003/0225356; "Kulichikhin"; published December 4, 2003). Applicant Claims Applicant claims an anesthetic composition comprising (a) 1-10% w/w of anesthetic agent, (b) 5-60% of talc, (c) 20-90% of a pharmaceutically acceptable vehicle, and/or (d) 1-5% of hydroxypropylcellulose (HPC). The Examiner notes that HPC is not a required component of the claimed formulation of rejected claim 14. Determination of the Scope and Content of the Prior Art (MPEP §2141.01) The teachings of Kanios are set forth above and incorporated herein by reference. Ascertainment of the Difference Between Scope the Prior Art and the Claims (MPEP §2141.012) Kanios does not teach the use of talc as the clay in his compositions. This deficiency is cured by the teachings of Kulichikhin, who teaches skin-contacting adhesive compositions (abstract) wherein clay particles impart many of the beneficial aspects of the invention. For example, the clay particles: help to provide a wicking action to remove moisture from the skin surface and store it; reinforce the yield behavior that prevents the cold flow; help the composition maintain its adhesive nature as well as providing structural support to supply the high elastic recoil at application of skin-contacting adhesive (SCA) on the sole of foot, etc. (paragraph [0079]). Suitable clay minerals include kaolite (i.e., kaolin), montmorillonite , talc, etc. paragraph [0084]. Kulichikhin also claims a wound dressing comprising about 2-30 wt. % of reinforcing clay particles (claim 80). Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) In light of the teachings of Kulichikhin, a person of ordinary skill in the art would have been motivated to use talc as a clay in Kanios' formulations, because like other clays recognized by Kanios as being suitable, like kaolite (i.e., kaolin) and montmorillonite, talc is recognized as providing desirable properties to adhesive skin compositions. An ordinary skilled artisan would have been motivated to combine the teachings of Kanios and Kulichikhin with a reasonable expectation of success because both references are in the same field of endeavor of providing skin adhesive compositions comprising pharmaceutical agents for delivery to the skin. Moreover, the person of ordinary skill in the art would have been motivated to use talc in the amounts taught by Kanios as being suitable for clays such in an amount of 2-30% w/w. With respect to the selection tetracaine as the local anesthetic, the Examiner notes that Kanios teaches tetracaine as a suitable local anesthetic to use, thus, inclusion of tetracaine in Kanios formulations within the range taught as being suitable would have provided PHOSITA ample motivation and a reasonable expectation of success of obtaining an anesthetic composition such as in rejected claim 15. With respect to rejected claim 16, the Examiner notes that Kanios explicitly contemplates the combination of local anesthetics and explicitly highlights the combination of a local anesthetic in base form and another local anesthetic in salt form in ratios as taught at col. 8, lines 10-17. The Examiner notes Applicant's data present in various tables in the specification, however, this data is not presented with evidence of statistical significance and the rejected claims are not commensurate in scope with the compositions evaluated to obtain these data. Consequently, the rejected claims do not appear to have any secondary considerations present that could overcome the instant prima facie case of obviousness. Response to Arguments Applicant's arguments filed July 3, 2026, have been fully considered but they are not persuasive. At section 4, numbered page 10 of Applicant’s remarks, Applicant begins their traversal by commenting generally about the technical purpose of Kulichikhin and argues specifically that Kulichikhin does not focus on any anesthetic-related function to the clay component of the composition, such as that talc improves the anesthetic efficacy, stability, onset, duration of action, or any other property associated with a local anesthetic. This appears to be an argument asserting unexpected results for compositions comprising talc as the clay component. This argument is unpersuasive because the data is not presented with evidence of statistical significance and the rejected claims are not commensurate in scope with the compositions evaluated to obtain these data. See MPEP §§ 716.02(b)-(d). Thus, the rejection is maintained at this time. Allowable Subject Matter Claims 17-19 remain objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not anticipate and does not fairly suggest the specific anesthetic compositions of dependent claims 17-19, which comprise specific components in specific amounts. Conclusion Claims 1-16 and 20 are rejected. Claims 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. THIS ACTION IS MADE FINAL. 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 JAMES H. ALSTRUM-ACEVEDO whose telephone number is (571)272-5548. The examiner can normally be reached Mon.-Wed. 10 AM to 7:00 PM EDT; Thur.-Fri. 10 AM to 5 PM EDT. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer “Jenni” K. Michener can be reached at (571) 272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. JAMES HENRY ALSTRUM-ACEVEDO Supervisory Patent Examiner Art Unit 1622 /JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Read full office action

Prosecution Timeline

Jan 29, 2024
Application Filed
Apr 08, 2026
Non-Final Rejection mailed — §102, §103, §112
Jul 03, 2026
Response Filed
Oct 05, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
41%
Grant Probability
21%
With Interview (-19.9%)
4y 3m (~1y 6m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 441 resolved cases by this examiner. Grant probability derived from career allowance rate.

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