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 . Claims included in the prosecution are claims 1, 3, 5-9, 11, 13-18, 20, 22-25, 27 and 29-31.
Applicants' arguments, filed 09/19/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
Claims 22 and 29 recite b. an aromatic-substituted aliphatic alcohol in which the antifungal compound is soluble, c. a lower aliphatic alcohol in which the aromatic-substituted aliphatic alcohol is soluble., and d. a water-miscible solvent. These limitations are not supported in the specification and thus the claims fail to comply with the written description requirement. While the specification discloses alcohols and solvents, the specification discloses specific alcohols and solvents and does not disclose wherein composition may comprise any aromatic or aliphatic alcohols or any water-miscible solvents, which is what is encompassed by the claims.
Also, claim 22 recites delivering the compounds for at least 4 hours following a single application. This limitation is also not supported in the specification. At best the specification discloses on page 7 wherein the topical antifungal skin concentration of the specific antifungal, 24 hours after application, is equal to or greater than the MIC of the specific antifungal.
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 22 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 term “lower aliphatic alcohol” in claim 22 is a relative term which renders the claim indefinite. The term “lower aliphatic alcohol” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how many carbons or what molecular weight an aliphatic alcohol must have in order to be deemed as a “lower” aliphatic alcohol.
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.
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.
1. Claims 1, 3, 5-9, 11, 14-18, 20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Nimni (US 2005/0238672, Oct. 27, 2005) in view of Leyden et al. (Aluminum Chloride in the Treatment of Symptomatic Athlete’s Foot, Aug. 1975) (hereinafter Leyden) (of record).
Nimni discloses an antifungal composition for topical application to the skin and nails comprising (1) an allylamine antifungal compound, (2) an aliphatic alcohol substituted with an aromatic substituent in which the allylamine antifungal compound is soluble to a degree that a therapeutically effective concentration of the allylamine antifungal compound can be applied topically in solution (i.e., claimed excipient), (3) a lower aliphatic alcohol in which the aromatic alcohol is soluble, and (4) water or a water-compatible solvent mixture. The composition can further comprise an additional antifungal compound (abstract). Typically, the allylamine antifungal compound is terbinafine (¶ [0023]). Typically, the concentration of the allylamine antifungal compound is from about 1% to about 3% (¶ [0026]). The concentration of the additional antifungal compound depends on the specific additional antifungal compound (¶ [0037]). The composition may be used to treat Trichophyton rubrum (¶ [0038]). The composition can be applied by conventional methods, including the use of a roll-on applicator (¶ [0071]). The exact formulation, route of administration, and dosage can be chosen by the individual physician in view of the patient’s condition. The attending physician would also know to adjust treatment to higher levels if the clinical response were not adequate. Further, the application dose and perhaps the application frequency can also vary according to the age, body weight, and response of the individual patient, as well as other conditions affecting pharmacodynamic parameters (¶ [0073]). In a preferred embodiment, terbinafine is dissolved in benzyl alcohol (i.e., aliphatic alcohol substituted with an aromatic substituent) (i.e., claimed excipient). To this solution ethyl alcohol anhydrous (i.e., lower aliphatic alcohol) and distilled water are added (¶ [0060]). Since the water content of the nail ranges between 10 and 30%, the solvent carrier with the terbinafine in solution is able to traverse the nail plate and reach the subungual region, or nail bed. The material, which then begins to precipitate, is deposited in the interstices of the soft tissue and nail plate. It has been shown clinically and experimentally to act as a slow release active principle, thus providing a long-term bioactive function (¶ [0053]).
Nimni differs from the instant claims insofar as not disclosing wherein the composition comprises aluminum chlorohydrate.
However, Leyden discloses wherein aluminum chlorohydrate was more powerful in killing bacteria and fungi than aluminum acetate and aluminum chloride (abstract).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Nimni discloses wherein the composition may comprise an additional antifungal compound. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated aluminum chlorohydrate into the composition of Nimni since it is a known and effective antifungal compound as taught by Leyden.
In regards to instant claim 1 and 9 reciting an antibiotic-free composition or treatment, Nimni does not disclose wherein the composition comprises an antibiotic. Therefore, an antibiotic-free composition would have been obvious.
In regards to instant claim 1 reciting 5.0 to 30.0 wt. % anti-sweating agent, as discussed above, aluminum chlorohydrate kills fungi. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount of aluminum chlorohydrate based arriving at an amount that would kill a desired amount of fungi. Where 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. See MPEP 2144.05(II)(A).
In regards to instant claim 9 reciting wherein the specific antifungal, the anti-sweating compound, and the one or more excipient are all applied during a single administration event, this would have been obvious since Nimni discloses formulating the composition by adding all the components together.
In regards to instant claims 9 and 17 reciting wherein efficacious results can be achieved by only daily administrations and the duration of the treatment is between one and four weeks, respectively, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed application frequency since Nimni discloses wherein application frequency varies according to age, body weight, and response of the individual patient and can be determined by the individual physician. Where 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. See MPEP 2144.05(II)(A).
In regards to instant claims 15 and 16 reciting wherein applying results in a topical antifungal skin concentration of greater than or equal to the MIC of the antifungal and wherein the topical antifungal skin concentration 24 hours after application is equal to or greater than the MIC of the antifungal, respectively, these limitations would have been obvious since the claimed antifungal is terbinafine and since aluminum chlorohydrate (i.e., claimed anti-sweating agent) is a known antifungal as discussed above, it would have been obvious to one of ordinary skill in the art that the combination of terbinafine and aluminum chlorohydrate would be produce a greater effective than terbinafine alone.
In regards to the process steps in instant claim 18, it should be noted that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. Furthermore, even if the process steps had patentable weight, the claim would have still have been obvious since even though Nimni does not disclose adding the additional antifungal compound after terbinafine and the excipient, selection of any order of mixing ingredients is prima facie obvious. See MPEP 2144.04(II)(C).
In regards to instant claim 5 reciting treating a dermatophytic infection comprising T. rubrum, wherein the T. rubrum is strain MRL 666, this is merely a recitation of the intended use the claimed composition. Since T. rubrum is a fungal infection and the composition of Nimni comprises antifungal compounds, such as terbinafine, the composition of Nimni is capable of treating strain MRL 666 whether the prior art discloses such use or not.
2. Claims 5, 13 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Nimni (US 2005/0238672, Oct. 27, 2005) in view of Leyden et al. (Aluminum Chloride in the Treatment of Symptomatic Athlete’s Foot, Aug. 1975) (hereinafter Leyden) (of record), and further in view of Kingsbury et al. (Calcofluor White Combination Antifungal Treatments for Trichophyton rubrum and Candida albicans, Jul. 6, 2012) (hereinafter Kingsbury), as evidenced by ATCC (Trichophyton rubrum (Castellani) Sabouraud, 2025).
The teachings of Nimni and Leyden are discussed above. Nimni and Leyden do not disclose wherein the composition treats strand MRL 666 of Trichophyton rubrum.
However, Kingsbury discloses identifying novel therapeutic options for the treatment of skin infections by comparing the sensitivity of representative strains of dermatophyte Trichophyton rubrum and Candida albicans to CFW and a panel of fluorescent brighteners and phytoalexin compounds (abstract). Strains of T. rubrum include ATCC MYA-4438 (page 2, Materials and Methods: Strains, Media and Growth Conditions).
As evidenced by ATCC, the strain designation of ATCC MYA 4438 is MRL 666.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the composition of Nimni to treat strain MRL 666 of T. rubrum since the composition treats T. rubrum and strain MRL 666 is a known type of T. rubrum as taught by Kingsbury.
In regards to instant claim 22 reciting wherein the composition is formulated to deliver therapeutically effective concentrations of antifungal compound and aluminum chlorohydrate to the skin for at least 4 hours following a single application, since Nimni discloses wherein the solvent carrier affects long-term bioactive function, it would have taken no more than the relative skills of one of ordinary skill in the art through experimenting with different solvent carriers to have arrived at the claimed delivery rate depending on the length of long-term bioactive function desired. Where 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. See MPEP 2144.05(II)(A).
3. Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nimni (US 2005/0238672, Oct. 27, 2005) in view of Leyden et al. (Aluminum Chloride in the Treatment of Symptomatic Athlete’s Foot, Aug. 1975) (hereinafter Leyden) (of record), and further in view of Birnbaum et al. (US 2007/0092547, Apr. 26, 2007) (hereinafter Birnbaum).
The teachings of Nimni and Leyden are discussed above. Nimni and Leyden do not disclose wherein the composition is distributed on a wipe.
However, Birnbaum discloses compositions for the prevention and reduction of fungal diseases in man and animals by treating a substrate with at least one antifungal compound (¶ [0005]). Suitable delivery methods include spray and wipes (¶ [0053] and [0056]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have distributed the composition on a wipe since Nimni discloses wherein the composition can be applied by convention methods and wipes is a known method as taught by Birnbaum.
4. Claims 25, 27, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Nimni (US 2005/0238672, Oct. 27, 2005) in view of Leyden et al. (Aluminum Chloride in the Treatment of Symptomatic Athlete’s Foot, Aug. 1975) (hereinafter Leyden) (of record), and further in view of Ceve et al. (US 2010/0104633, Apr. 29, 2010) (hereinafter Ceve).
The teachings of Nimni and Leyden are discussed above. Nimni and Leyden do not disclose a kit comprising the composition.
However, Ceve discloses a topical antifungal formulation comprising terbinafine (abstract). Ceve further discloses a kit comprising one or more containers comprising the antifungal formulation. The kit may further comprise instructions for administrating the antifungal formulation as well as side effects and dosage information (¶ [0199]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated a kit comprising the composition of Nimni motivated by the desire to provide instructions for administering the antifungal composition of Nimni as well as provide side effects and dosage information as taught by Ceve.
In regards to instant claim 25 reciting an article and a storage container, it would have been obvious to one of ordinary skill in the art that the composition of Nimni would be in an article since it is in the form of a solution and a solution need something to hold it. It would have been obvious to one of ordinary skill in the art to have a storage container housing the article since, as discussed above, it would have been obvious to have the composition in a kit and a storage container is needed to provide for such kit.
In regards to instant claim 29 reciting treating a dermatophytic infection comprising T. rubrum, wherein the T. rubrum is strain MRL 666, this is merely a recitation of the intended use the claimed composition. Since T. rubrum is a fungal infection the composition of Nimni comprises antifungal compounds, such as terbinafine, the composition of Nimni is capable of treating strain MRL 666 whether the prior art discloses such use or not.
In regards to instant claim 29 reciting a sealed container, it would have been obvious to one of ordinary skill in the art that the composition of Nimni would be in a sealed container since it is in the form of a solution and a solution needs to be in a container to hold it and for the container to be sealed so the solution does not escape.
5. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Nimni (US 2005/0238672, Oct. 27, 2005) in view of Leyden et al. (Aluminum Chloride in the Treatment of Symptomatic Athlete’s Foot, Aug. 1975) (hereinafter Leyden) (of record), Ceve et al. (US 2010/0104633, Apr. 29, 2010) (hereinafter Ceve), and further in view of Kingsbury et al. (Calcofluor White Combination Antifungal Treatments for Trichophyton rubrum and Candida albicans, Jul. 6, 2012) (hereinafter Kingsbury), as evidenced by ATCC (Trichophyton rubrum (Castellani) Sabouraud, 2025).
The teachings of Nimni, Leyden, and Ceve are discussed above. Nimni, Leyden, and Ceve do not disclose wherein the composition treats strand MRL 666 of Trichophyton rubrum.
However, Kingsbury discloses identifying novel therapeutic options for the treatment of skin infections by comparing the sensitivity of representative strains of dermatophyte Trichophyton rubrum and Candida albicans to CFW and a panel of fluorescent brighteners and phytoalexin compounds (abstract). Strains of T. rubrum include ATCC MYA-4438 (page 2, Materials and Methods: Strains, Media and Growth Conditions).
As evidenced by ATCC, the strain designation of ATCC MYA 4438 is MRL 666.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the composition of Nimni to treat strain MRL 666 of T. rubrum since the composition treats T. rubrum and strain MRL 666 is a known type of T. rubrum as taught by Kingsbury.
6. Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Nimni (US 2005/0238672, Oct. 27, 2005) in view of Kolaei et al. (Antifungal activity of aluminum-containing salts against the development of carrot activity spot and potato dry rot, 2013) (hereinafter Kolaei), Kanlayavattanakul et al. (Body malodours and their topical treatment agents, 2011) (hereinafter Kanlayavattanakul) and Staniforth et al. (US 2003/0138503, Jul, 24, 2003) (hereinafter Staniforth).
Nimni discloses an antifungal composition for topical application to the skin and nails comprising (1) an allylamine antifungal compound, (2) an aliphatic alcohol substituted with an aromatic substituent in which the allylamine antifungal compound is soluble to a degree that a therapeutically effective concentration of the allylamine antifungal compound can be applied topically in solution (i.e., claimed excipient), (3) a lower aliphatic alcohol in which the aromatic alcohol is soluble, and (4) water or a water-compatible solvent mixture. The composition can further comprise an additional antifungal compound (abstract). Typically, the allylamine antifungal compound is terbinafine (¶ [0023]). Typically, the concentration of the allylamine antifungal compound is from about 1% to about 3% (¶ [0026]). The concentration of the additional antifungal compound depends on the specific additional antifungal compound (¶ [0037]). The composition may be used to treat Trichophyton rubrum (¶ [0038]). The composition can be applied by conventional methods, including the use of a roll-on applicator (¶ [0071]). The exact formulation, route of administration, and dosage can be chosen by the individual physician in view of the patient’s condition. The attending physician would also know to adjust treatment to higher levels if the clinical response were not adequate. Further, the application dose and perhaps the application frequency can also vary according to the age, body weight, and response of the individual patient, as well as other conditions affecting pharmacodynamic parameters (¶ [0073]). In a preferred embodiment, terbinafine is dissolved in benzyl alcohol (i.e., aliphatic alcohol substituted with an aromatic substituent) (i.e., claimed excipient). To this solution ethyl alcohol anhydrous (i.e., lower aliphatic alcohol) and distilled water are added (¶ [0060]).
Nimni differs from the instant claims insofar as not disclosing wherein the composition comprises an aluminum chlorohydrex compound.
However, Kolaei discloses wherein various aluminum-containing salts may provide an alternative to the use of synthetic fungicides to control fungal or fungus-like pathogens (abstract).
Kanlayavattanakul discloses wherein Aluminum salts are anti-bacterial. Aluminum salts prevent new sweat movement towards skin surface. However, they are not permanent, and the acidic nature of these salts can be irritating to the skin which limits their use. In an attempt to reduce skin irritation, salicylic acid was used in combination. Formulations consisting of aluminum salts and salicylic acid, had a reduced incidence of skin irritation and had good antibacterial and anti-fungal properties (page 302, right column).
Staniforth discloses a pharmaceutical formulation for topical administration (abstract). The formulation can be used as an antiperspirant (¶ [0082]). The antiperspirant comprises astringent salts such as inorganic salts of aluminum (¶ [0084]). Exemplary antiperspirant compounds include aluminum chlorohydrex PEG (¶ [0086]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Nimni discloses wherein the composition may comprise an additional antifungal compound. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated aluminum chlorohydrex PEG into the composition of Nimni since aluminum salts have anti-fungal properties as taught by Kolaei and Kanlayavattanakul, and aluminum chlorohydrex PEG is a known aluminum salt as taught by Staniforth.
Response to Arguments
Applicant argues that Leyden & Kligman attribute clinical efficacy to aluminum chloride’s astringency (drying), not to aluminum chlorohydrate’s antimicrobial effect. This distinction teaches away from simply substituting aluminum chlorohydrate into unrelated terbinafine systems.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, the composition of Nimni comprises terbinafine and can further comprise an additional antifungal compound. Leyden specifically discloses wherein aluminum chlorohydrate was more powerful in killing bacteria and fungi than aluminum acetate and aluminum chloride (abstract). Thus, aluminum chlorohydrate has antifungal properties. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated aluminum chlorohydrate into the composition of Nimni since it is a known and effective antifungal compound as taught by Leyden. Therefore, one of ordinary skill in the art would have incorporated aluminum chlorohydrate into a composition comprising terbinafine and Applicant’s argument is unpersuasive.
Applicant argues that the teachings of Benohanian et al. concern antiperspirant therapy for sweat-mediated odor and do not render obvious the presently claimed allylamine-based antifungal compositions, which are antibiotic-free and tuned to deliver ≥MIC antifungal levels for ≥ 24 hours.
The Examiner does not find Applicant’s argument to be persuasive. None of the rejections uses the teachings of Benohanian et al. As such, Applicant’s argument is unpersuasive.
Applicant argues that neither Kolaei or Kanlayavattanakul concerns human dermatophyte therapy using allylamine systems, nor do they provide a predictable path to the claimed human clinical regiments.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Applicant has not explained how the combination of references does not teach the claimed invention. As such, Applicant’s argument is unpersuasive.
Applicant argues that Kingsbury, Birnbaum, and Ceve do not address the functional requirements recited – e.g., specific antibiotic-free systems delivering therapeutic skin concentrations for at least 24 hours and daily-only dosing windows.
The Examiner does not find Applicant’s argument to be persuasive. None of the instant claims recite delivering therapeutic skin concentration for at least 24 hours. Instant claim 22 recites at least 4 hours. Also, as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Therefore, it is not necessary for Kingsbury, Bumbaum, or Ceve to teach the functional limitations. As discussed in the rejection, since Nimni discloses wherein the solvent carrier affects long-term bioactive function, it would have taken no more than the relative skills of one of ordinary skill in the art through experimenting with different solvent carriers to have arrived at the claimed delivery rate depending on the length of long-term bioactive function desired. In addition, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed application frequency since Nimni discloses wherein application frequency varies according to age, body weight, and response of the individual patient and can be determined by the individual physician. Where 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. See MPEP 2144.05(II)(A). As such, Applicant’s argument is unpersuasive.
Applicant argues that the cited art provides no guidance that combining an allylamine with aluminum chlorohydrate within the recited solvent system would sustain ≥MIC skin levels 24 hours post-dose while maintaining tolerability.
The Examiner does not find Applicant’s argument to be persuasive. The instant claims recite wherein the topical antifungal skin concentration 24 hours after application is equal to or greater than the MIC of the antifungal. The instant claims do not recite wherein the claimed composition would sustain ≥MIC skin levels 24 hours post-dose while maintaining tolerability. Therefore, it is not necessary for the prior art to suggested this. Also, Applicant has not shown wherein this is an unexpected result. Therefore, if Applicant was trying to make an argument of unexpected results, Applicant’s argument would be unpersuasive.
Applicant argues that the resulting compositions possess structural/functional characteristics distinct from generic mixtures cited in the art, including antibiotic-free status and the specified concentration/time performance requirements.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown with objective evidence wherein the product in the product-by-process claim is the same as or obvious from a product of the prior art, which is necessary for making the claim patentable. As such, Applicant’s argument is unpersuasive.
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 1, 3, 5-9, 11, 13-18, 20, 22-25, 27 and 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,251,822 and claims 1-14 of U.S. Patent No. 11,554,108. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional antifungals and a specific aluminum salt, respectively) and thus read on the instant claims.
Response to Arguments
The rejection is maintained due to the terminal disclaimers being disapproved. Please see the terminal disclaimer decision on 12/30/2024. Applicant has not filed a corrected terminal disclaimer.
Conclusion
Claims 1, 3, 5-9, 11, 13-18, 20, 22-25, 27 and 29-31 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/TRACY LIU/Primary Examiner, Art Unit 1614