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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 15, 2026, has been entered.
Response to Arguments
The anticipation rejection in view of Brantley is withdrawn in view of the Amendments to the claims.
Applicant’s arguments and allegations of unexpected results of January 5, 2026, are addressed below.
Claims 5 and 6 are newly rejected for improperly depending from canceled claim 4. Claim 6 depends from claim 5.
The applicability of Martin as an evidentiary reference is withdrawn. Applicant claims specific agent in independent claim 3. Thus, the mode of action of, concentrations discussed in Martin and the teachings of Martin are moot. Similarly, the attack on a motivation to combine Brantley with Martin is misplaced. An evidentiary reference is not combined, but rather provided as a further indicator of what a reference already teaches. This attack is similarly moot.
Applicant argues that Brantley fails to teach a reduction of ulcers or inhibition of viral replication. Applicant also indicates that Brantley is an abandoned application.
The examiner notes that Brantley and Jackson teaches administration of a claimed agent to a claimed subject population. Examination is based on the active steps of administration. If Applicant contends that the claimed result of administration was not occurring as a result of those methods taught by Brantley and Jackson, Applicant should indicate that specific active step that is a distinction over these claimed. Further, Applicant should limit the claims to the specific steps that give rise to such results.
The examiner notes that whether or not Brantley is abandoned or not is not relevant to the applicability of Brantley’s teachings. As stated in MPEP § 2121.01, “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989).
As noted in the previous Office Action, the prior art motivates a POSA to administer the claimed agents to the claimed subject through a claimed route of administration. 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.
Applicant argues that the previous unexpected results were not considered.
The examiner notes that to constitute unexpected results, those results must show an unexpected advantage not provided by the methods taught by the prior art and must be commensurate in scope with the claims, among other requirements. Further, unexpected results cannot be used to overcome anticipation rejections. In this case, Brantley and Jackson each independently teach administration of the claimed agents to the claimed subject through the same route of administration. There is no distinction in active steps of the instant claims over those of Jackson. Further, Brantley administers combination therapy with a long and short-active anesthetic. There has been no comparison to the closest prior art that highlights specific steps or limitations in the claims that provides any distinction over the active steps taught by Jackson. Further, the requirement to show unexpected results as compared to the closest prior art requires a statistically significant and unexpected advantage over the prior art. It is not clear what specific steps or limitations provides any distinction let alone one yields a required result. Even further, unexpected results must be commensurate in scope with the claims. Here, there is no dosage claimed and the agents claimed includes an extensive list of agents. Unexpected results must be shown for those agents alleged to yield such result. No showing has even been alleged for each of the claimed agents.
More specifically, the declaration notes that tetracaine is “highly effective.” To show unexpected results, data must be provided. Such data must be compared to the closest prior art. However, tetracaine is taught by the prior art. Moreover, the claims are not limited to tetracaine- even if tetracaine were shown to be unexpectedly advantageous. Efficacy is not unexpected superiority which is required for a showing of unexpected results. The prior art teaches tetracaine and procaine as one of 12 active agents for treating herpes infections as a sole active agent. Further, at the time the declaration was filed an anticipation rejection was of record. As noted above, unexpected results do not obviate anticipation rejections because they are not unexpected as compared to the closest prior art. As such, the Declaration of Dr. Turner does not obviate the prior art of record.
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 also claims and teaches a total of 12 agents and tetracaine and procaine are each included in the instant claims. See prior art claims 6 and 8. Thus, a POSA would immediately envisage use of these agents.
In view of Jackson, 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 as expected.
Unexpected results that are commensurate in scope with the breadth of the claims and are unexpectedly superior as compared to the closest prior art have not been provided. A prima facie showing is established because multiple references teaches treating herpes with the topical application of agents, including tetracaine. Brantley and Jackson each teach such use.
Status of the Claims
Claims 2, 3, 5, 6, 9-16, and 31 are pending and examined.
Claim Rejections - 35 USC § 112
Claims 5 and 6 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.
Claim 5 depends from canceled claim 4. Claim 6 depends from claim 5.
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 2, 3, 5, 6, 9-16, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over 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.
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 2, 3, 5, 6, 9-16, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Brantley, III et al., (US2017/0056383) (“Brantley”), 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 (i.e., dibucaine) 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.
Brantley teaches using multiple active agents for long and short term relief, respectively.
Jackson teaches anesthetics including tetracaine base for use with a polymer carrier at concentrations for topical pain relief, including for painful or itching skin conditions. 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 3, 5, 6, 9-16, and 31are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,740,960, over Brantley, III et al., (US2017/0056383) (“Brantley”), in view of Jackson et al., (U.S. Pat. No. 6,461,644).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘960 patent are directed to treating herpes-type lesion by topically applying a composition consisting of tetracaine as a sole active ingredient (claim 17). The instant claims are directed to the same topical administration including tetracaine as sole active agent to treat herpes lesions. A motivation to undertake those active steps include pain and irritation alleviation. Further, while the instant claims are directed to herpes of the genital region, herpes zoster can be of the genital region. Moreover, the purpose of Brantley and Jackson is to alleviate pain and irritation at the site of a lesion. This would be necessary and an obvious step as a result of a herpes lesion.
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
