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 .
Priority
The instant application is a CON of Application No. 17/471,777, now U.S. Patent No. 12,090,404, filed on September 10, 2021 which claims benefit to domestic provisional application Nos. 63/223,835 filed on July 20, 2021 and 63/077,113 filed on September 11, 2020.
Status of Claims
Acknowledgement is made of cancelled (1-72) and new (73-92) claims filed on May 30, 2025. Claims 73-92 are pending in instant application.
Information Disclosure Statement
The information disclosure statement filed on June 4, 2025 has been considered.
Claim Interpretation
Regarding “porfimer sodium”, porfimer sodium is also known in the art as CAS# 87806-31-3, Photofrin, or Photofrin II as taught by STN1.
Regarding “humectant”, Applicant does not specifically define the term “humectant”, and provides one embodiment of “glycerin” (see instant spec. at p. 73 Table 18). A “humectant” is thus anything the prior art teaches to function as a “humectant” for any purpose. For example, glycerin is well-known in the art to be a humectant (as taught by Johnson2, see Johnson at p. 407 ¶1 “The principal function of glycerin in cosmetic products is its action as a humectant.”).
Regarding “solubilizer”, Applicant does not specifically define the term “solubilizer”. Based on a composition embodiment provided in the instant specification (see instant spec. at p. 73 Table 18 “Solvent” entries), a “solubilizer” is understood to be any solvent, including those acknowledge by Applicant (e.g. propylene glycol, hexylene glycol).
Regarding claims 78, 90, claim 90 depends from claim 89, claims 74 and 89 appear toonly require one component listed to be present (see below 35 USC 112 Rejections). Claim 90 is understood to specify the amount of the component or components present, if present. For example, if the composition comprises hydroxypropyl cellulose, the composition reads on claim 89 and only on claim 90 if the hydroxypropyl cellulose is present in the specified 0.5-2%. The composition need not comprise other components.
Claim Rejections - 35 USC § 112(b)
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.
Claims 74, 78, 89-90 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.
Claims 74, 89 recite “wherein the pharmaceutical composition further comprises one or more permeation enhancer, a humectant, a solubilizer, and a preservative”. It is unclear if “one or more” is referring to just the permeation enhancer component, or all the components listed. For the purposes of applying art, the claim is interpreted as: wherein the pharmaceutical composition further comprises one or more components selected from the list consisting of: a permeation enhancer, a humectant, a solubilizer, and a preservative. Claims 78 and 90 depend from claims 74, 89 and are thus included in instant rejection for not resolving the issue of indefiniteness (are all components required or just one?).
Claims 78, 90 recite the limitation "the polysorbate", “glycerin”, “benzyl alcohol”, “phenoxyethanol”, “hexylene glycol”, “hydroxypropyl cellulose”. There is insufficient antecedent basis for this limitation in the claim. It is also unclear if Applicant intended claim 78 to depend from 77 (which requires all components present) or 74. For the purposes of applying art, it is assumed Applicant meant for claims 78 and 90 to indicate the composition further comprises one or more alternative components at the respective amounts. For example, if a composition comprises hydroxypropyl cellulose, to read on claims 78 or 90 the composition must comprise 0.5-2% hydroxypropyl cellulose.
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.
Claims 73, 75 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over U.S. Patent No. 4,753,958 to Weinstein et. al.3
Regarding claims 73, 75 and a composition, Weinstein teaches topical compositions comprising photofrin, reading on instant porfimer sodium (see Claim Interpretation section), and EUCERIN™ with the final concentration of photofrin as 1% or 5% (see Weinstein at col 12 Example 4). Weinstein teaches EUCERIN™ serves as a viscous topical agent (see Weinstein at col. 7 lines 8-19), reading on instant gelling agent (see instant spec. at p. 13 ¶[0062], “any suitable substance that is used to modify the viscosity of the composition”).
Claim 73 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2008109424 A1 to Loebel et. al.4
Regarding claim 73, Loebel teaches an antifungal composition (see Loebel claim 1) comprising a photosensitizer such as photofrin (see Loebel claim 6), an anti-fungal agent, and a delivery system. Loebel teaches preferable embodiments comprise a gel-forming agent such as hydroxypropylcellulose or carboxymethylcellulose in a concentration of 1 to 5% (see Loebel at p. 8 ¶[0023] and claim 12), reading on instant gelling agent (see instant spec. at p. 13 ¶[0062] “cellulose derivatives”).
Claims 73 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2006/0265028 A1 to Houle et. al.5
Regarding claim 73, Houle teaches a formulation comprising a photosensitizer (see at p. 6 ¶[0067]) such as porfimer sodium (available as PHOTOFRIN™) (see at p. 3 ¶[0036]), a low molecular weight PEG such as PEG200 or diethylene glycol monoethyl ether, a high molecular weight PEG such as PEG3350, and a fatty alcohol such as oleyl alcohol (see at p. 6 ¶[0067]). Houle teaches the formulation should be viscous and can modify the viscosity with polyethylene glycols (see at p. 6 ¶[0065]), as included in the Houle preferred formulation, reading on instant gelling agent (see instant spec. at p. 13 ¶[0062] “used to modify the viscosity”).
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.
Claims 74, 76, 78-80 are rejected under 35 U.S.C. 103 as being unpatentable over Weinstein as applied to claims 73, 75 above.
Recall Weinstein teaches topical compositions comprising photofrin and a gelling agent.
Regarding claim 74, 79, Weinstein teaches it is preferred to include in the topical formulation a skin penetration such as DMSO (see Weinstein at col. 7 lines 26-29).
The prior art differs from the instant claims as follows: while Weinstein’s composition has a final concentration of photofrin as 1 or 5% and further comprising DMSO, Weinstein does not specify an embodiment wherein the final photofrin concentration is 0.5% or an amount of DMSO is 10-40%.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.05(II)(A), “[g]enerally, differences in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical.” Here, Weinstein provides varying concentrations of photofrin, an artisan would readily appreciate that the percent by weight of active agent would vary depending upon the amount of additional composition components (such as DMSO), and additionally the effective concentration of compound required for a patient and the volume of the application needed. Accordingly, it would amount to routine optimization to identify the optimal weight percentage of the components required to treat a condition via topical administration as taught by Weinstein. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
Furthermore, it is well-within the ordinary skill in art to optimize the amount of a known therapeutic component in a known composition.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 73-75, 81-82, 85-90 are rejected under 35 U.S.C. 103 as being unpatentable over Loebel.
Regarding claim 73, 81-82, Loebel teaches an antifungal composition (see Loebel claim 1) comprising a photosensitizer such as photofrin (see Loebel claim 6), an anti-fungal agent, and a delivery system. Loebel teaches preferable embodiments comprise a gel-forming agent such as hydroxypropylcellulose or carboxymethylcellulose in a concentration of 1 to 5% (see Loebel at p. 8 ¶[0023] and claim 12), reading on instant gelling agent (see instant spec. at p. 13 ¶[0062] “cellulose derivatives”), and overlapping with the instantly claimed range, see MPEP § 2144.05(I).
Regarding claim 74, Loebel teaches the composition may further comprise a pharmaceutical carrier or carrier combination which may be glycerin (see Loebel claim 9), reading on instant humectant, or water (see Loebel claim 9), reading on instant solubilizer. Loebel teaches the composition may further comprise a nail penetration enhancer (see Loebel claim 2), reading on instant permeation enhancer. Loebel also teaches the composition may comprise isopropyl palmitate (see Loebel claim 9), reading on instant permeation enhancer (see instant spec. at p. 15 ¶[0068] “isopropyl palmitate”). Loebel teaches the composition may comprise a preservative (see Loebel claim 10).
Regarding claim 75, Loebel teaches the photosensitizer is present in a range of 0.0001% to 10 % (see Loebel claim 7), which encompasses the instantly claimed range, see MPEP § 2144.05(I).
Regarding claim 85-87, Loebel teaches antifungal compositions for treating dermatophyte fungal infections (see Loebel claim 1) caused by Candida albicans (instantly claimed), Trichophyton rubrum, Trichophyton mentadrophytes, Aspergillus fumigatus, Epidermophyton floccosum, Microsporum canis, and Microsporum gypsum. Loebel teaches applying the composition to a nail, reading on instant “infected area”, beneath which the locus is situated, irradiating the locus with a light source at a wavelength absorbed by the photosensitizer of the composition, and repeating the steps daily over the treatment period (see Loebel at p. 10 ¶[0031]). Loebel teaches the preferred light wavelength is between 500 and 850 nm (see Loebel at p. 4 “2. Light”), encompassing the instantly claimed 630 nm, see MPEP § 2144.05(I).
Regarding claim 88-90, Recall Loebel teaches the photosensitizer such as photofrin (see Loebel claim 6) is present in the composition in a range of 0.0001% to 10 % (see Loebel claim 7), which encompasses the instantly claimed range, see MPEP § 2144.05(I). Recall Loebel teaches preferable embodiments comprise a gel-forming agent such as hydroxypropylcellulose in a concentration of 1 to 5% (see Loebel at p. 8 ¶[0023] and claim 12), overlapping with the instantly claimed range of 0.5-2%, see MPEP § 2144.05(I).
The prior art differs from the instant claims as follows: While Loebel teaches optional composition components and overlapping or encompassing ranges, Loebel does not specify an embodiment comprising multiple components or the same ranges.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding optional components to arrive at a composition, Loebel suggests to an artisan potential composition components for treating an infection with a photofrin composition. Accordingly, an artisan would have a reasonable expectation fo success when selected suggested composition components because the prior art teaches they are all suitable for the purposes of treating an infection such as an infection caused by Candida albicans.
Regarding ranges, per MPEP § 2144.05(II)(A), “[g]enerally, differences in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical.” Here, Loebel provides varying concentrations of photofrin, an artisan would readily appreciate that the percent by weight of active agent would vary depending upon the amount of additional composition components (such as hydroxypropyl cellulose), and additionally the effective concentration of compound required for a patient and the volume of the application needed. Accordingly, it would amount to routine optimization to identify the optimal weight percentage of the components required to treat an infection as taught by Loebel. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
Furthermore, it is well-within the ordinary skill in art to optimize the amount of a known therapeutic component in a known composition.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 83-84, 91 are rejected under 35 U.S.C. 103 as being unpatentable over Loebel. As applied to claims 73-75, 81-82, 85-90 and in further view of Huang et. al.6
The prior art differs from the instant claims as follows: While Loebel teaches a composition comprising porfimer sodium and a gelling agent for treating infection, Loebel does not specify further comprising potassium iodide.
However,
Regarding potassium iodide, Huang teaches antimicrobial photodynamic inactivation with a combination of a photosensitizer and visible light is a known technique for killing bacteria and fungi (see Huang at p. 320 left col. ¶1). Huang teaches this effect is potentiated by potassium iodide (see Huang at p. 320 right col. ¶2 – p. 321 left col. ¶1). Huang teaches a composition comprising potassium iodide (KI) at a concentration of 100 mM when added to microbial cells (108/mL) + photofrin (10 μM hematoporphyrin equivalent) + 415 nm light (10 J/cm2) can eradicate five different Gram-negative species (Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Proteus mirabilis, and Acinetobacter baumannii, bolded instantly claimed) (see Huang at Abstract). Huang teaches varying potassium iodide up to 10 mM and even up to 100 mM i(see Huang at p. 321 left col. ¶1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding the addition of potassium iodide, per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. It would have been obvious to include potassium iodide in a porfimer sodium composition meant for treating infection (as taught by Loebel) with an expectation of success because the prior art teaches adding potassium iodide to a porfimer sodium composition is known to improve the antimicrobial effects of the composition (as taught by Huang).
Regarding amounts of potassium iodide, per MPEP § 2144.05(II)(A), “[g]enerally, differences in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical.” Here, Huang provides varying concentrations of potassium iodide, an artisan would readily appreciate that the percent by weight of active agent would vary depending upon the amount of additional composition components (such as porfimer sodium), and additionally the effective concentration of compound required for a patient and the volume of the application needed. Accordingly, it would amount to routine optimization to identify the optimal weight percentage of the components required to treat an infection as taught by Loebel and Huang. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
Furthermore, it is well-within the ordinary skill in art to incorporate known compatible components into a known composition for the same purpose as taught by the prior art.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 74, 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Houle as applied to claim 73.
Recall Houle teaches a composition comprising porfimer sodium and a gelling agent.
Regarding claim 74, 79-80, Houle teaches the formulation may further comprise a solvent such as DMSO (see Houle at p. 6 ¶[0063]). Houle teaches the formulation to preferably be 1-75% solubilizer (see Houle at p. 6 ¶[0064]).
The prior art differs from the instant claims as follows: While Houle teaches a composition comprising porfimer sodium and a gelling agent, and optionally DMSO, Houlse does not specify and embodiment comprising porfimer sodium, a gelling agent, and DMSO.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding optional components to arrive at a composition, Houle suggests to an artisan potential composition components for a photofrin composition including a solubilizer such as DMSO. Accordingly, an artisan would have a reasonable expectation of success when selecting a suggested composition component such as DMSO because the prior art teaches DMSO is suitable for the purposes of acting as a solubilizer in a porfimer sodium composition.
Furthermore, it is well-within the ordinary skill in art to select a suggested composition component to add to a known composition.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim 77 is rejected under 35 U.S.C. 103 as being unpatentable over Loebel as applied to claims 73-75, 81-82, 85-90 and in further view of WO 03/035080 A2 to Kumar et. al.7
Recall Loebel teaches a composition comprising porfimer sodium and hydroxypropyl cellulose, and that the composition may further comprise a pharmaceutical carrier or carrier combination, or permeation enhancer, or preservative.
The instant claim differs from the prior art as follows: While Loebel teaches a porfimer sodium and hydroxypropyl cellulose composition, Loebel does not specify all the additional components of claim 77.
However,
Kumar teaches compositions for topical delivery (see Kumar at Abstract and claim 1). Kumar teaches compositions can comprise gelling agents such as hydroxypropyl cellulose (see Kumar at p. 8 lines 2-4 and claims 8-9), preservatives such as benzyl alcohol and phenoxyethanol (see Kumar at p. 12 lines 12-14 and claim 37), humectants such as glycerin (see Kumar at p. 12 lines 8-11 and claim 36), polysorbates such as TWEEN80® reading on polysorbate 80 (see Kumar at p. 9 lines 10-11 and claim 19), and non-volatile solubilizing agents such as hexylene glycol (see Kumar at p. 9 lines 4-7 and claim 20).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). The prior art directs artisans to select additional components (carriers, permeation enhancers, and preservatives) for the known topical porfimer sodium composition (as taught by Loebel). It would have been obvious to an artisan to select gelling agents, preservatives, humectants, polysorbates, and non-volatizing solubilizing agents such as hydroxypropyl cellulose, benzyl alcohol, phenoxyethanol, glycerin, polysorbate 80, and hexylene glycol (as taught by Kumar) for a topical composition comprising porfimer sodium (as taught by Loebel) with a reasonable expectation of success because the prior art teaches they are compatible and suitable components for a topical gel (as taught by Kumar).
Furthermore, it is well-within the ordinary skill in art to select known gel components to form a gel for the same purpose as taught by the prior art (treating an infection).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
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 73-84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52, 54-59, 61-64, 66-68, 70-73 of copending Application No. 17/869,448 (reference application)8. Although the claims at issue are not identical, they are not patentably distinct from each other.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis uses both an anticipation and obviousness (for amounts) analysis.
Regarding claims 73-84, App’448 claims a method for treating sun exposed skin in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising porfimer sodium, one or more gelling agents, one or more permeation enhancers, polysorbate 80, glycerin, benzyl alcohol, phenoxyethanol, and hexylene glycol, wherein the gelling agent is hydroxypropyl cellulose, and wherein the composition is applied to the sun exposed skin; and light is applied to the sun exposed skin, wherein the light ranges from about 380 nm to about 850 nm in wavelength (see App’448 claim 52). App’448 further claims wherein the composition comprises a potentiator of PDT such as potassium iodide (see App’448 claim 71). App’448 further claims wherein the composition comprises a permeation enhancer such as DMSO (see App’448 claim 70).
Further regarding claims 75-76, App’448 claims wherein the amount of porfimer sodium is 0.4 to 0.6% w/w (App’448 claim 68), encompassing the instantly claimed 0.5%, see MPEP § 2144.05(I).
Further regarding claim 84, App’448 claims wherein the amount of potassium iodide is 1.3-2 wt% (App’448 claim 71), encompassing the instant range of 1-2%.
App’448 thus inherently discloses a composition of instant claims 73-74, 77, 81, 83 for the clamed methods (see App’448 claims 52, 54-59, 61-64, 66-68, 70-73).
The copending claims differ from the instant claims as follows: while App’448 discloses a composition of instant claims, App’448 does not further specify the amounts of each component as in instant claims 78, 82.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.05(II)(A), “[g]enerally, differences in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical.” Here, App’448 provides varying concentrations of potassium iodide and DMSO (see App’448 claims 70-71). An artisan would readily appreciate that the percent by weight of each component (such as porfimer sodium or potassium iodide) would vary depending upon the amount of additional composition components (such as DMSO), and additionally the effective concentration of compound required for a patient and the volume of the application needed. Accordingly, it would amount to routine optimization to identify the optimal weight percentage of the components required to treat a condition via topical administration as claimed by App’448. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
Furthermore, it is well-within the ordinary skill in art to optimize the amount of a known therapeutic component in a known composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 73-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,090,204 B29. Although the claims at issue are not identical, they are not patentably distinct from each other.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an anticipation analysis.
As shown below, the patented claims significantly overlap in scope and are encompassed by the instant claims.
US’204 Claims
Instant Claims
Claim 1. A topical pharmaceutical composition comprising porfimer sodium, one or more gelling agents, one or more permeation enhancers, polysorbate 80, glycerin, benzyl alcohol, phenoxyethanol, and hexylene glycol, wherein the gelling agent is hydroxypropyl cellulose.
Claim 73. A pharmaceutical composition comprising porfimer sodium and one or more gelling agents.
Claim 74. The pharmaceutical composition of claim 73, wherein the pharmaceutical composition further comprises one or more permeation enhancer, a humectant, a solubilizer, and a preservative.
Claim 77. The pharmaceutical composition of claim 73, wherein the pharmaceutical composition further comprises polysorbate 80, glycerin, benzyl alcohol, phenoxyethanol, hexylene glycol, and hydroxyl propyl cellulose.
Claim 81. The pharmaceutical composition of claim 73, wherein the gelling agent is hydroxyl propyl cellulose.
Claim 2. The topical pharmaceutical composition of claim 1 wherein the porfimer sodium ranges from about 0.1% to about 1.0% w/w in the pharmaceutical composition.
Claim 75. The pharmaceutical composition of claim 73, wherein the concentration of porfirmer sodium ranges from about 0.1 % to about 1.0 % w/w in the pharmaceutical composition.
Claim 3. The topical pharmaceutical composition of claim 1 wherein the profimer sodium is about 0.5% w/w.
Claim 76. The pharmaceutical composition of claim 75, wherein porfimer sodium is about 0.5 % w/w in the pharmaceutical composition.
Claim 8. The topical pharmaceutical composition of claim 3 wherein the composition comprises one or more permeation enhancers selected from the group consisting of propylene glycol, polyethylene glycol 400 SR, polyethylene glycol 300 LA, diethylene glycol monoethyl ether, DMSO, and polysorbate 80 SR
Claim 79. The pharmaceutical composition of claim 74, wherein the one or more permeation enhancers is selected from the group consisting of propylene glycol, polyethylene glycol 400 SR, polyethylene glycol 300 LA, diethylene glycol monoethyl ether, DMSO, and Polysorbate 80 SR.
Claim 9. The topical pharmaceutical composition of claim 8 wherein the permeation enhancer comprises DMSO and the DMSO ranges about 10% w/w to about 40% w/w in the pharmaceutical composition
Claim 80. The pharmaceutical composition of claim 79, wherein the permeation enhancer comprises about 10% w/w to about 40% w/w DMSO in the pharmaceutical composition.
Claim 10. The topical pharmaceutical composition of claim 9, wherein the DMSO is about 40% w/w in the pharmaceutical composition.
See claim 80.
Claim 4. The topical pharmaceutical composition of claim 1 wherein the one or more permeation enhancers ranges about 0.5% to about 50% w/w in the pharmaceutical composition.
See claim 80.
Claim 5. The topical pharmaceutical composition of claim 1 wherein the one or more permeation enhancers is about 0.5% to about 50% w/w, the polysorbate 80 is about 1% to about 3% w/w, glycerin is about 10% to about 20% w/w, benzyl alcohol is about 1% to about 3% w/w, phenoxyethanol is about 0.5% to about 2% w/w, hexylene glycol is about 0.5% to about 2% w/w, and hydroxypropyl cellulose is about 0.5% to about 2% w/w in the pharmaceutical composition.
Claim 78. The pharmaceutical composition of claim 74, the one or more permeation enhancers is about 0.5% to about 50 % w/w, the polysorbate 80 is about 1 % to about 3 % w/w, glycerin is about 10 % to about 20 % w/w, benzyl alcohol is about 1 % to about 3 % w/w,phenoxyethanol is about 0.5 % to about 2 % w/w, hexylene glycol is about 0.5 % to about 2o% w/w, and hydroxy propyl cellulose is about 0.5 % to about 2 % w/w in the pharmaceutical composition.
Claim 82. The pharmaceutical composition of claim 81, wherein the gelling agent is in an amount ranging from about 0.5% to about 3.0% w/win the pharmaceutical composition.
Claim 6. The topical pharmaceutical composition of claim 5 wherein the composition additionally comprises potassium iodide (KI).
Claim 83. The pharmaceutical composition of claim 73, wherein the composition further comprises potassium iodide (KI).
Claim 7. The topical pharmaceutical composition of claim 6 wherein the KI is about 1% w/w to about 2% w/w in the pharmaceutical composition.
Claim 84. The pharmaceutical composition of claim 83, wherein the KI is about 1% w/w to about 2% w/w KI in the pharmaceutical composition.
Claim 12. A method for treating an infected area comprising administering to a subject in need thereof the topical pharmaceutical composition of claim 1, wherein the pharmaceutical composition is applied to the infected area; and light at about 630 nm in wavelength is applied to the infected area.
Claim 85. A method for treating an infected area, comprising administering to a subject in need thereof the pharmaceutical composition of claim 73, wherein the pharmaceutical composition is applied to the infected area; and light at about 630 nm in wavelength is applied to the infected area.
Claim 12. The method of claim 11 wherein the infected area is due to a microbial infection.
Claim 86. The method of claim 85, wherein the infected area is due to a microbial infection.
Claim 13. The method of claim 12, wherein the infected area is infected with Staphylococcus aureus(+), Staphylococcus aureus MRSA(+), Peptostreptococcus anaerobius(+), Proprionibacterium acnes(+), Bacillus thuringiensis(+), Bacillus atrophaeus(+), Streptococcus mutans(+), Streptococcus pneumoniae(+), Prevotella(-) , Porphyromonas gingivalis(-), Salmonella enterica(-), Escherichia coli(-), Yersinia intermedia(-), Acinetobacter baumannii(-), Neisseria gonorrhea(-), Haemophilus influenza(-), Fusobacterium nucleatum(-), Moraxella catarrhalis(-), Candida albicans, Candida glabrata, Candida parasilosis, Candida krusei, Candida tropicalis, or Candida guilliermondi.
Claim 87. The method of claim 86, wherein the infected area is infected with Staphylococcus aureus(+), Staphylococcus aureus MRSA(+), Peptostreptococcus anaerobius(+), Proprionibacterium acnes(+), Bacillus thuringiensis(+), Bacillus atrophaeus(+), Streptococcus mutans(+), Streptococcus pneumoniae(+), Prevotella(-) , Porphyromonas gingivalis(-), Salmonella enterica(-), Escherichia coli(-), Yersinia intermedia(-), Acinetobacter baumannii(-), Neisseria gonorrhea(-), Haemophilus influenza(-), Fusobacterium nucleatum(-), Moraxella catarrhalis(-), Candida albicans, Candida glabrata, Candida parasilosis, Candida krusei, Candida tropicalis, or Candida guilliermondi.
Claim 14. The method of claim 11, wherein the porfimer sodium ranges from about 0.1% to about 1.0% w/w.
Claim 88. The method of claim 86, wherein the porfimer sodium ranges from about 0.1 % to about 1.0 % w/w in the pharmaceutical composition.
Claim 15. The method of claim 11, wherein the one or more permeation enhancers ranges about 0.5% w/w to about 50% w/w, the polysorbate 80 is about 1% to about 3% w/w, glycerin is about 10% to about 20% w/w, benzyl alcohol is about 1% to about 3% w/w, phenoxyethanol is about 0.5% to about 2% w/w, hexylene glycol is about 0.5% to about 2% w/w, and hydroxypropyl cellulose is about 0.5 to about 2% w/w in the pharmaceutical composition.
Claim 89. The method of claim 88, wherein the pharmaceutical composition comprises one or more permeation enhancers, polysorbate 80, glycerin, benzyl alcohol, phenoxyethanol, hexylene glycol, or hydroxy propyl cellulose.
Claim 90. The method of claim 89, wherein the one or more permeation enhancers ranges about 0.5% w/w to about 50 % w/w, the polysorbate 80 is about 1 % to about 3 % w/w, glycerin is about 10% to about 20 % w/w, benzyl alcohol is about 1 % to about 3 % w/w, phenoxyethanol is about 0.5 % to about 2 % w/w, hexylene glycol is about 0.5 % to about 20% w/w, and hydroxy propyl cellulose is about 0.5 % to about 2 % w/w in the pharmaceutical composition.
Claim 16. The method of claim 15, wherein the pharmaceutical composition additionally comprises potassium iodide (KI), and the KI is about 1% w/w to about 2% w/w in the pharmaceutical composition.
Claim 91. The method of claim 90, wherein the pharmaceutical composition additional comprises potassium iodide (KI), and the KI is about 1% w/w to about 2% w/w KI in the pharmaceutical composition.
Claim 17. The method of claim 15, wherein the pharmaceutical composition comprises DMSO, and the DMSO is at about 10% w/w to about 40% w/w in the pharmaceutical composition
Claim 92. The method of claim 90, wherein the pharmaceutical composition comprises DMSO, and the DMSO is at about 10% w/w to about 40% w/w in the pharmaceutical composition.
Claim 18. The method of claim 17, wherein the DMSO is about 40% w/w in the pharmaceutical composition.
See claim 92.
The Examiner notes that while inconvenient as claim scope may change during prosecution, a double patenting rejection cannot be held in abeyance until allowable subject matter is established.
Conclusion
Claims 73-84 are rejected.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Photofrin (CAS 87806-31-3) CAS Registry File Accessed July 26, 2026 from STN, entered into STN November 16, 1984. Hereinafter STN.
2 Johnson, D. "Chapter 16 Alternatives to Glycerine in Cosmetics" in Glycerin, 1991, 407-433. DOI: 10.1201/9780203753071-16. Hereinafter Johnson.
3 Cite No 001 in the IDS filed 6/4/25. Patented June 28, 1988. Hereinafter Weinstein.
4 Patented September 12, 2008. Hereinafter Loebel.
5 Cite No. 008 in the IDS filed 6/4/24. Published November 23, 2006. Hereinafter Houle.
6 Cite No. 021 in the IDS filed 6/4/25. Huang et. al. "Potassium Iodide Potentiates Broad-Spectrum Antimicrobial
Photodynamic Inactivation Using Photofrin" ACS Infect. Dis. 2017, 3, 4, 320–328. DOI: 10.1021/acsinfecdis.7b00004. Hereinafter Huang.
7 Published May 1, 2003. Hereinafter Kumar.
8 CIP of PCT/US2021/049928 filed January 10, 2021. Rejection based of 12/15/25 claim set. Hereinafter App’448.
9 Patented September 17, 2024. Hereinafter US’204.
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