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 .
Response to Amendments
Applicant’s amendments to the claims of June 12, 2026, in response to the Office Action of January 16, 2026, are acknowledged.
Response to Arguments
The § 112 Rejection of claim 21 is withdrawn in view of the Amendments to the claims.
Applicant argues that Brantley teaches away from using a single ryanodine receptor antagonist as a sole active agent.
The examiner notes that a teaching away requires a disparagement and not merely a preference for a combination, e.g. The prior art does not include a teaching away of using a single component. Further, the claims do not require a single active agent. While the claims are drafted to only include ryanodine receptor antagonists as the active agent, the claims are explicitly directed to one or a plurality of Ryanodine receptor antagonists. Thus, the examiner interprets ryanodine receptor antagonist to include a composition comprising nothing other than ryanodine receptor antagonists as a sole active agent. In other words, there are no active agents that are not ryanodine receptor antagonists.
The examiner notes that the Specification supports the language, “Ryanodine receptor antagonist” to include combinations thereof. See par. 85. As such, the examiner interprets this phrase to include one or a combination of the same.
Lidocaine is a ryanodine receptor antagonist. As noted previously, the prior art teaches using lidocaine as a short term anesthetic and a long acting anesthetic from a limited list of 8, including cinchocaine. The examiner notes that cinchocaine is also known as dibucaine and is also taught to be a ryanodine receptor antagonist. It is listed as a long term agent. Thus, Brantley, III et al. does not require anything other than a plurality of ryanodine receptor antagonists as the active agents.
Further, the use of a long term anesthetic and a short term anesthetic do exactly what they are defined to do. One alleviates short term pain almost immediately and the other provides slower and longer lasting relief. A POSA would understand that they each provide benefit when used alone. The purpose of Brantley, III, is to provide immediate relief that lasts. A POSA would also understand that immediate relief is still relief and longer term relief (while not immediate) would still provide relief over a period of time.
Applicant argues that Brantley, III, does not teach treating HSV-2, reducing ulcers, or inhibiting viral replication.
The examiner notes that the prior art teaches treating facial and genital lesions of HSV with the claimed agents. Doing so will have a claimed effect absent evidence to the contrary. As noted above, the claims include a plurality of agents and the use of each agent alone would be expected to be efficacious as they are taught to provide an additive effect with respect to activity time/period.
Applicant argues that the claimed ranges are not optimizable.
The examiner notes that the claimed ranges overlap that taught by the prior art. Moreover, the claimed agents are not shown to provide an unexpected feature or result. The prior art teaches the claimed agents as result effective variables and requires at least 5%. Without unexpected results, the amount of a known result-effective variable is optimizable and independent claim 1, e.g., does not include any concentration.
Applicant argues that there is no expectation of success that a ryanodine receptor antagonists would have an effect beyond pain management.
The examiner notes that the prior art motivates a POSA to administer the claimed agents to the claimed subject. This provides a reasonable expectation of success that the claimed result would occur. There is no requirement that such result would be recognized or described with particularity.
The examiner also notes that he also applies Jackson in a rejection under § 103. Jackson teaches using tetracaine, as a sole active agent, for treating herpes infections by providing topical relief and the relief can be included in a patch that can last for many days (i.e., continuous relief). Jackson further provides an indication that a POSA in view of the prior art would not think that multiple agents are required for treatment. A POSA would understand that a plurality of ryanodine receptor antagonists would treat herpes lesions, e.g., when topically applied. This is true for tetracaine or a combination of shorter and longer lasting agents.
Status of the Claims
Claims 1-16 and 21 are pending and examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brantley, III et al., (US2017/0056383) (“Brantley”).
Brantley teaches treating HSV virus lesion pain by applying a quick and long active anesthetic. See Abstract. HSV-2 is associated with lesions around the genitals and treatment often centers around pain management. See par. 6. When applied to a lesion, relief is immediate and can last for hours. See par. 8. Application of 5% to 95% short and long anesthetics can be formulated as a liquid to apply to human tissues. See par. 12. Tetracaine and procaine are listed as short term anesthetics. Cinchocaine is listed as one of a total of 8 long term anesthetics. See par. 28. In one example, a compositions is applied directly to a herpetic ulcer. See par. 37. There is no indication that an active agent other than a ryanodine receptor antagonist is used and there is no requirement that water be incorporated into the composition. Carriers include nonaqueous carrier including emulsifiers, viscosity modifiers, and others. The total anesthetic in the final composition can be between 15% and 90%. The anesthesia can be maintained in an example for 4-6 hours. This could mean that application could be required up to 4 time daily. See par. 37. Additives can includes many surfactants, penetration enhancers, preservatives, and other additives. These are not limited to any one in particular.
Claims 1-3, 5 and 13 are anticipated by the prior art.
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.
Claims 1-16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Brantley, III et al., (US2017/0056383) (“Brantley”), as evidenced by Martin et al., “The effect of local anaesthetics on the ryanodine receptor/Ca2’ release channel of brain microsomal membranes,” FEBS Vol. 328, number 1,2 77-81 (1993).
Brantley teaches treating HSV virus lesion pain by applying a quick and long active anesthetic. See Abstract. HSV-2 is associated with lesions around the genitals and treatment often centers around pain management. See par. 6. When applied to a lesion, relief is immediate and can last for hours. See par. 8. Application of 5% to 95% short and long anesthetics can be formulated as a liquid to apply to human tissues. See par. 12. Tetracaine and procaine are listed as short term anesthetics. Cinchocaine is listed as one of a total of 8 long term anesthetics. See par. 28. In one example, a compositions is applied directly to a herpetic ulcer. See par. 37. There is no indication that an active agent other than a ryanodine receptor antagonist is used and there is no requirement that water be incorporated into the composition. Carriers include nonaqueous carrier including emulsifiers, viscosity modifiers, and others. The total anesthetic in the final composition can be between 15% and 90%. The anesthesia can be maintained in an example for 4-6 hours. This could mean that application could be required up to 4 time daily. See par. 37. Additives can includes many surfactants, penetration enhancers, preservatives, and other additives. These are not limited to any one in particular.
Martin evidences dibucaine and tetracaine are both ryanodine receptor antagonists. See p78, 1st par.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 9, the result of administration would appear to follow as a product of the active steps of administration. Such steps are taught by the cited prior art. The burden has shifted to Applicant to show that this does not occur as a result of those steps rendered obvious by the cited prior art, but also that the specific limitations and/or requirements to achieve such results is claimed and distinguishes over that which is taught. This would also appear to be a result of an optimizable treatment regimen.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods over Brantley III. One would be motivated to do so because Brantley teaches a composition for topical application to a herpes lesion wherein the composition does not require water and the composition does not require any agent other than ryanodine receptor antagonists. However, Brantley also teaches tetracaine to be a short lasting API that can be topically applied to a herpes lesion to give immediate relief. As such, there is a reasonable and predictable expectation of success in arriving at the claimed method in view of the cited prior art. Thus, if a POSA is interested in a composition that provides immediate relief, they would consider using tetracaine without an additional secondary ryanodine receptor antagonist.
Claims 1-16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Brantley, III et al., (US2017/0056383) (“Brantley”), as evidenced by Martin et al., “The effect of local anaesthetics on the ryanodine receptor/Ca2’ release channel of brain microsomal membranes,” FEBS Vol. 328, number 1,2 77-81 (1993), and in view of Jackson et al., (U.S. Pat. No. 6,461,644).
Brantley teaches treating HSV virus lesion pain by applying a quick and long active anesthetic. See Abstract. HSV-2 is associated with lesions around the genitals and treatment often centers around pain management. See par. 6. When applied to a lesion, relief is immediate and can last for hours. See par. 8. Application of 5% to 95% short and long anesthetics can be formulated as a liquid to apply to human tissues. See par. 12. Tetracaine and procaine are listed as short term anesthetics. Cinchocaine is listed as one of a total of 8 long term anesthetics. See par. 28. In one example, a compositions is applied directly to a herpetic ulcer. See par. 37. There is no indication that an active agent other than a ryanodine receptor antagonist is used and there is no requirement that water be incorporated into the composition. Carriers include nonaqueous carrier including emulsifiers, viscosity modifiers, and others. The total anesthetic in the final composition can be between 15% and 90%. The anesthesia can be maintained in an example for 4-6 hours. This could mean that application could be required up to 4 time daily. See par. 37. Additives can includes many surfactants, penetration enhancers, preservatives, and other additives. These are not limited to any one in particular.
Martin evidences dibucaine and tetracaine are both ryanodine receptor antagonists. See p78, 1st par.
Jackson teaches anesthetic including tetracaine base for use with a polymer carrier at concentrations to topically treat pain. Tetracaine and dibucaine are taught to last longer following removal of a film patch and are thus more ideal. Anesthesia can work for subjects with herpes infections for topical pain relief. Prior art claim 1 provides for a drug delivery polymer and a drug, wherein the drug is a topical anesthetic in base form and the topical anesthetic can be selected from tetracaine as one of few API’s. Jackson teaches an anesthetizing plastic reservoir base that provides for a slower continued release and anesthetizing effect.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 9, the result of administration would appear to follow as a product of the active steps of administration. Such steps are taught by the cited prior art. The burden has shifted to Applicant to show that this does not occur as a result of those steps rendered obvious by the cited prior art, but also that the specific limitations and/or requirements to achieve such results is claimed and distinguishes over that which is taught. This would also appear to be a result of an optimizable treatment regimen.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods over Brantley III and Jackson. One would be motivated to do so because Brantley teaches a composition for topical application to a herpes lesion wherein the composition does not require water and the composition does not require any agent other than ryanodine receptor antagonists. However, Brantley also teaches tetracaine to be a short lasting API that can be topically applied to a herpes lesion to give immediate relief. As such, there is a reasonable and predictable expectation of success in arriving at the claimed method in view of the cited prior art. Moreover, Jackson teaches a composition for topical application to treat herpes lesions wherein the only API is tetracaine, e.g. Further, Jackson provides embodiments in which a carrier provides for longer delivery of the API. This would further highlight the ability to not require other anesthetics because a controlled and longer-term release of tetracaine can be achieved with a carrier when topically applied in a form taught by Jackson.
As such, no claim is allowed.
Conclusion
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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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