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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 5, 2026, has been entered.
Status of the Claims
Claims 1-16 and 21 are pending and examined.
Claim Rejections - 35 USC § 112
New claim 21 is 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. The phrase “fully treated” is used. The Specification at paragraph 58 defines treat, treating, treatment or variations thereof to include “clinical intervention in an attempt to alter the natural course of the individual, tissue or cell being treated….” Thus, the phrase “fully treated three days after topical administration” is not clear in light of the definition what is intended by the phrase. The examiner interprets this to mean that treatment is continued for a period of three days.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 does not allow for additional active agents. However, claim 7 includes PEG, which is taught by prior art of record to be an active agent. Thus, claims 7 and any claim include PEG is not further limiting nor within the scope of the independent claims, including claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Vitins (EP 2563374 B1) (of record) teaches application of PEG200 to PEG1000 can be topically administered up to 5 times daily to treat HSV-2 as an active agent.
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
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 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy 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