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 .
Formal Matters
This office action is issued in the reply to Applicant’s response filed on 18 August 2026. Claims 9, 11-14, and 16-30 are pending. Claims 9, 11-14, and 16-30 are under consideration in the instant office action. Claims 1-8, 10, and 15 are canceled.
Information Disclosure Statement
The information disclosure statement (IDSs) submitted on 02 July 2024, 02 January 2025, 19 May 2025, and 18 August 2026 are noted and the submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the references. Signed copies are attached herein.
Election/Restriction
Applicant’s election of Group II (claims 9, 11-14, and 16-30) in the reply filed on 18 August 2026 is acknowledged. Additionally, Applicant’s election of HCO-40 as the polyoxyl lipid or fatty acid and Octoxynol-40 as the polyalkoxylated alcohol in the reply filed on 18 August 2026 is also acknowledged Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Objection to the title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the instant application is “TOPICAL FORMULATIONS AND USES THEREOF”. The title should be brief but technically accurate and descriptive and should contain fewer than 500 characters. The title does not reflect the main inventive concept of Applicant’s invention and the major components of the “TOPICAL FORMULATIONS AND USES THEREOF”. The title is generic and can be applicable to any “TOPICAL FORMULATIONS AND USES THEREOF”. The examiner advises Applicant to consider including major components of the method and composition in the title to precisely reflect the inventive concept. Inasmuch as the words "new," "improved," "improvement of," and "improvement in" are not considered as part of the title of an invention, these words should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Similarly, the articles "a," "an," and "the" should not be included as the first words of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues.
Claim Objections
Claim 24’s duplicated “about 0.5 to about 0.5” should be corrected to a single range (e.g., about 0.5 to about 1.5 wt %).
Claim 26 should recite “Octoxynol-40,” matching claim 25.
The recitation “pH of the formulation is about 5 to about 8” in claims 18 and 27 lacks “the” in one instance (“wherein pH” vs. “wherein the pH”)—minor, but should be uniform.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 9, 11–14, and 16–30 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.
Independent claims 9 and 22, and claims depending therefrom, claim a method of treating or preventing an ocular disease or condition by topical administration of a mixed-nanomicelle formulation that excludes organic solvent and excludes active agents. Claim 9 excludes a long Markush list of therapeutic classes (calcineurin inhibitors, mTOR inhibitors, peptides, eicosanoids, anti-inflammatory drugs, steroids, biologics, anti-infectives, RNAi, resolvins, lipoxins, oxylipins, etc.). Claim 22 goes further and requires that the formulation “does not comprise a lipoxin, an oxylipin, or any pharmaceutically active agent.”The claimed methods therefore cover vehicle-only (or essentially vehicle-only) topical nanomicelle compositions used to treat or prevent the full genus of ocular disease, expressly including, via claims 20–21 and 29–30, anterior-segment disease, posterior-segment disease, dry eye, allergic conjunctivitis, and AMD.
The specification, as originally filed, describes mixed nanomicelles of polyoxyl lipids/fatty acids and polyalkoxylated alcohols primarily as carriers for hydrophobic or poorly soluble ocular actives. Possession of a method in which the same surfactant system, stripped of essentially every recognized ocular active, itself treats or prevents posterior-segment disease such as AMD is not reasonably conveyed. A few working examples of a blank micelle vehicle, even if present, do not describe the full scope of “treating or preventing an ocular disease or condition,” nor AMD after topical administration. Negative limitations of this breadth also require written-description support for the absence of the excluded agents as an element of the invention, not merely silence. Claim 22’s “any pharmaceutically active agent” is a genus-wide negative limitation. The specification does not identify what the inventors regarded as “pharmaceutically active” versus inactive vehicle components, nor show possession of methods that treat ocular disease while containing no pharmaceutically active agent of any kind. Accordingly, the specification does not reasonably convey possession of the full scope of claims 9 and 22 and claims depending therefrom.
Claims 9, 11–14, 16–30 are also rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The specification does not enable any person skilled in the art to make and use the invention commensurate in scope with these claims without undue experimentation.
Wands factors of particular weight
Breadth of the claims: “Ocular disease or condition” is unbounded. Claims 20/29 add the entire anterior and posterior segments. Claims 21/30 specifically name AMD. Administration is topical only. The formulation is required not to contain the listed actives (claim 9) or any pharmaceutically active agent (claim 22).
Nature of the invention / state of the art / predictability: Posterior-segment disease, and AMD in particular, is not predictably treated by topical administration of surfactant micelles lacking an active. Topical delivery to the retina/choroid is recognized as difficult; the art relies on specific actives, implants, injections, or well-characterized vehicles with demonstrated pharmacokinetics. A claim that the blank mixed-nanomicelle system treats AMD is highly unpredictable.
Quantity of experimentation / presence of working examples: Even assuming the specification contains examples of mixed nanomicelles of HCO-type surfactants and Octoxynol-40 at the recited wt % and pH, those examples do not teach how to treat the claimed disease genus, or AMD, in the absence of an active. The skilled artisan would have to undertake a research program to determine which diseases, if any, respond to vehicle alone, at what dose/regimen, and with what effect size. Undue experimentation would be required to practice the full scope of the treatment/prevention claims. Enablement is lacking at least for posterior-segment disease and AMD as recited in claims 20, 21, 29, and 30, and for the “any pharmaceutically active agent” embodiment of claim 22.
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 9, 11–14, 16–21 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.
The term “mixed nanomicelles” in claims 9 and 22 is not defined by size, polydispersity, mixed-micelle composition ratio, or assay. It is unclear whether any association of the two surfactants in water meets the limitation, or only a particular nano-sized mixed micelle. The metes and bounds cannot be determined.
The exclusion clause in claims 9 and 22 reads, in part, “nACh receptor antagonists, resolvins or resolvin-like compounds, lipoxins, and oxylipins” after an “and” that already closed the “consisting of” list. It is unclear whether resolvins, lipoxins, and oxylipins are members of the excluded Markush or a separate exclusion. “Mixture drugs,” “photo sensitizers,” and “G-coupled protein receptor antagonists” are also ambiguous as to what species they cover. A skilled artisan cannot determine with reasonable certainty what actives are forbidden.
It is unclear whether “polyoxyl” in claims 9 and 22-24 modifies both “lipid” and “fatty acid,” or only “lipid.” A free fatty acid that is not polyoxylated may or may not be within the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically taught or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 9, 11-14, and 16-30 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra et al. (WO 2014032026, IDS reference, 07/02/2024).
Applicant Claims
Applicant claims a method of treating or preventing an ocular disease or condition comprising topically administering a mixed-nanomicelle formulation of a polyoxyl lipid or fatty acid and a polyalkoxylated alcohol, without organic solvent, and without the claim 9 list of actives (or, in claim 22, without a lipoxin, oxylipin, or any pharmaceutically active agent). Examined as HCO-40 and Octoxynol-40, including the recited wt % and pH ranges and dry eye /allergic conjunctivitis/AMD.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Mitra et al. teaches topical ophthalmic formulations and methods of using them. The formulations may include a polyoxyl lipid or fatty acid and/or a polyalkoxylated alcohol and may include nanomicelles, and include methods of treating or preventing ocular diseases or conditions (abstract; paragraph 0006). Mitra teaches that the formulations dissolve and deliver ingredients without a need for organic solvents (such as propylene glycol) that can irritate the eye ( paragraph 0006). Nanomicelles are taught to improve ocular tissue distribution and to be suitable for anterior eye delivery, posterior eye delivery, or both (paragraph 0006). Mitra teaches polyoxyl lipid or fatty acid is a polyoxyl castor oil, one or more of HCO-40, HCO-60, HCO-80 or HCO-100, present between 1 and 6%; 2 and 6%; 3 and 5%; about 4%; greater than 0.7%, 1%, 1.5%, 2%, 3%, or 4% by weight (paragraph 0007). Polyalkoxylated alcohol is octoxynol-40, present between 0.002 and 4%; 0.005 and 3%; 0.005 and 2%; 0.005 and 1%; 0.005 and 0.5%; 0.005 and 0.1%; 0.005 and 0.05%; 0.008 and 0.02%; or about 0.01% by weight (paragraph 0007). Those ranges overlap or encompass claim 12 (0.002–4% Octoxynol-40), claim 14 (0.5–2% polyoxyl lipid; 0.002–4% Octoxynol-40), claim 16 (0.5–5%; 0.02–4%), claim 17 (0.5–1.5%; 0.02–0.1%), claim 22 (0.5–5% and 0.002–4%), claim 24 (0.5–1.5%), and claim 26 (0.02–4%). The placebo contains HCO-40 and Octoxynol-40 at amounts within every pending concentration claim, pH 7 (claims 18–19, 27–28), no cyclosporine (a calcineurin inhibitor excluded by claim 9), and no other agent from the claim 9 Markush. No organic solvent is listed. Mitra states that an active agent can be any agent capable of affecting a biological process, and “in some embodiments” is an agent for treating an ocular disease (paragraph after 0007. Actives are optional. The listed classes in Mitra (calcineurin inhibitors, mTOR inhibitors, peptides, eicosanoids, steroids, resolvins, lipoxins, oxylipins, etc.) are the same classes claim 9 excludes. Teaching those classes as optional cargo does not require their presence. Mitra teaches a method of treating or preventing an ocular disease comprising topically administering a formulation of any of the preceding embodiments, wherein the disease is one or more of dry eye syndrome, Sjögren’s, uveitis, allergic conjunctivitis, keratitis, AMD, DR, DME, ocular neovascularization, PVR, etc (claim 96). “Any of the preceding embodiments” includes vehicle/nanomicelle embodiments and the Table 5 placebo architecture. Mitra therefore teaches topical administration of an HCO-40 / Octoxynol-40 nanomicelle formulation, including a 0% active version, for dry eye, allergic conjunctivitis, and AMD (claims 20–21, 29–30).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Mitra et al. teach the instant invention in obvious manner as different permutations of especially the negative limitations exist in Mitra et al. The prima facie argument set forth below provides the analysis and the rational behind the obviousness rejection. Mitra does not in one sentence recite the exact claim 9 negative Markush or claim 22’s phrase “does not comprise … any pharmaceutically active agent.” Mitra’s working emphasis is often on loading a hydrophobic active. The placebo and the “may include”/ “in some embodiments” language supply the corresponding vehicle. Claim 22’s “capable of forming mixed nanomicelles” is functional; Mitra expressly teaches nanomicelles of these two surfactants.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing of the instant invention to topically administer Mitra’s HCO-40/Octoxynol-40 nanomicelle formulation, including the Table 5 placebo (1.0% HCO-40, 0.05% Octoxynol-40, pH 7, no CsA, no organic solvent), to treat or prevent dry eye, allergic conjunctivitis, or AMD. One of ordinary skill in the art would have been motivated to do so because Mitra already points the skilled artisan to that composition and to those indications. Reasons to use the vehicle without the listed actives include: (i) Mitra’s own placebo column; (ii) avoiding irritant organics (paragraph 0006); (iii) using the nanomicelle system for anterior/posterior distribution (paragraph 0006); (iv) routine vehicle/artificial-tear type use of nonionic surfactant systems in dry eye. Combining two surfactants Mitra already combines, at concentrations Mitra already recites, for diseases Mitra already lists, is the use of a known composition for its known purpose. KSR, 550 U.S. 398. One of ordinary skill in the art would have had a reasonable chance of success because in Mitra Table 5 is a complete, pH-adjusted ophthalmic solution of the elected pair. Mitra states the same platform is suitable for the claimed diseases. No new chemistry is required. Regarding amounts Mitra’s 1–6% (and “greater than 0.7% / 1%”) HCO-40 and 0.002–4% Octoxynol-40 overlap the claimed ranges. Furthermore, in the case where the amount of ingredients and actives "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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, 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. "[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).
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
Statutory Type Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 9, 11–14, 16–22, and 23–30 are rejected under 35 U.S.C. 101 as claiming the same invention as claims 1, 3, 5–10, 14, 15, 17, and 19 of US 12,053,528.
A statutory (same-invention) double-patenting rejection is proper when the instant claim and the patented claim are coextensive—identical subject matter, not merely obvious variants. In re Vogel, 422 F.2d 438 (CCPA 1970); MPEP § 804.
Claim 22 recites topical treatment or prevention of an ocular disease or condition with about 0.5–5 wt % polyoxyl lipid or fatty acid and about 0.002–4 wt % polyalkoxylated alcohol, capable of forming mixed nanomicelles, no organic solvent, and no lipoxin, oxylipin, or any pharmaceutically active agent.
Patented claim 1 is the same method limited to dry eye, 0.5–2% polyoxyl lipid (Markush including HCO-40), octoxynol, mixed nanomicelles actually present, no organic solvent, and the identical “lipoxin, oxylipin, or any pharmaceutically active agent” exclusion.
Patented claim 19 is the same vehicle used to treat “an ocular disease or disorder,” with the same negative limitations plus an express cyclosporine exclusion.
Dry eye is an ocular disease. The elected species (HCO-40 + Octoxynol-40) is inside both Markush groups. “Capable of forming mixed nanomicelles” (claim 22) and “comprises mixed nanomicelles” (’528 claim 1) cover the same composition on this record. The 0.5–5% band in claim 22 encompasses the 0.5–2% band of claim 1; the overlapping subject matter is the same invention. Anticipation is not the test; identity of the claimed invention is. Where the instant claim is only a different wording of the patented method of using the same active-free HCO-40 / Octoxynol-40 nanomicelle drop for ocular disease/dry eye, statutory double patenting applies.
Claims 21 and 30 name dry eye syndrome (also allergic conjunctivitis and AMD). As to dry eye, they are the same invention as claims 1 and 17 of the patent.Instant claims 11–14, 16–17, 23–26 correspond t patented claims 3, 5–10. Octoxynol-40, the HCO-40 Markush, and the overlapping amount ranges (0.5–2%, 0.5–5%, 0.5–1.5%, 0.002–4%, 0.02–4%, 0.02–0.1%) are already patented as methods of using that vehicle. Instant claim 14 is coextensive with patented claims 5+7. Instant claim 16 is coextensive with patented claim 9. Instant claim 17 is coextensive with patented claim 10. Regarding instant claims 18–19 and 27–28 vs. patented claims 14-15 recite same pH limitations on the same method.
If Applicant contends any of these pairs are not identical, the claims remain subject to obviousness-type double patenting below. A terminal disclaimer does not overcome statutory double patenting; the conflicting claim must be amended or canceled. MPEP § 804.02.
Nonstatutory Obviousness-Type 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 9, 11–14, and 16–30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1–20 of US 12,053,528.
The nonstatutory double-patenting rejection is based on a judicially created doctrine grounded in 35 U.S.C. 101 to prevent unjustified extension of exclusivity. In re Berg, 140 F.3d 1428 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); MPEP § 804.
Although the claims at issue are not identical in every word, they are not patentably distinct.Instant claim 9 versus patented claims 1, 17, and 19: claim 9 is a method of treating or preventing an ocular disease or condition by topical administration of a formulation comprising a polyoxyl lipid or fatty acid and a polyalkoxylated alcohol, mixed nanomicelles, no organic solvents, and none of a listed set of actives (calcineurin inhibitors, mTOR inhibitors, peptides, eicosanoids, anti-inflammatories, steroids, resolvins, lipoxins, oxylipins, etc.).
Patented claim 1 already claims topical administration of the same two-surfactant mixed-nanomicelle vehicle, with no organic solvent and no lipoxin, oxylipin, or any pharmaceutically active agent, to treat dry eye. Claim 19 already claims that vehicle to treat an ocular disease or disorder. Claim 17 claims the same vehicle as an artificial tear for dry-eye symptoms.An “ocular disease or condition” (claim 9) is anticipated by, or is an obvious genus around, patented “dry eye syndrome” and “ocular disease or disorder.” The claim 9 negative Markush is a species of the broader patented exclusion of “any pharmaceutically active agent.” Omitting actives that the patent already forbids is not a patentable distinction. Adding leftover language (“the formulation of any of the preceding claims”) does not distinguish the invention.It would have been obvious to practice the patented method for ocular disease generally, or for the diseases listed in instant claims 20–21 and 29–30. The patent already claims ocular disease (claim 19) and dry eye (claim 1). Allergic conjunctivitis and AMD are obvious members of that genus on the face of the commonly owned disclosure; even without looking at the specification, expanding a patented dry-eye / ocular-disease method to closely related anterior- and posterior-segment indications using the same active-free drop is an obvious variant. Geneva Pharms., 349 F.3d 1373 (Fed. Cir. 2003) (species/genus ODP).
Instant claim 22 versus patented claims 1, 9, and 19: claim 22 recites 0.5–5% polyoxyl lipid or fatty acid and 0.002–4% polyalkoxylated alcohol, “capable of forming” mixed nanomicelles, no organic solvent, no lipoxin/oxylipin/any pharmaceutically active agent.Patented claim 1 recites 0.5–2% / 0.002–4%, actual mixed nanomicelles, and the same negative clause. Patented claim 9 recites 0.5–5% polyoxyl lipid and 0.02–4% Octoxynol-40 in the same method. The amount ranges overlap or are identical. “Capable of forming” mixed nanomicelles is obvious over a claim that already requires mixed nanomicelles of those surfactants. Treating “an ocular disease or condition” is obvious over patented claims 1 and 19.
Claims 11–13 of the patent add NaCl, PVP-K90, EDTA, BAK, phosphate, and water at pH 7—the exact placebo. Instant claims that do not recite those excipients are broader than patented claims 11–13 and 18/20 and are therefore obvious over them (removing an excipient from a patented method claim is not a patentable distinction when the independent patented claims do not require those excipients). One of ordinarsy kill in the art would have been motivated to follow the patented claims to produce the instant invention because the reference claims already cover topical use of the elected HCO-40 / Octoxynol-40 mixed-nanomicelle, active-free, organic-solvent-free formulation to treat dry eye and ocular disease. The instant claims change only: (i) the disease clause from “dry eye” / “ocular disease or disorder” to “ocular disease or condition,” anterior/posterior, or a short list that includes dry eye; (ii) the width of an overlapping surfactant range; (iii) “comprises” versus “capable of forming” nanomicelles; and (iv) a longer written exclusion of actives that is already swallowed by “any pharmaceutically active agent.” Those are obvious variants of the patented methods. No unexpected result is required to be considered for ODP, and none commensurate with the full instant scope is of record. A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or (d) may overcome this nonstatutory rejection.
Conclusions
No claims are allowed.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
