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 .
Status of the Claims
Claims 224-246 are pending.
Domestic Benefit
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Instant application is a U.S. National Stage Entry of PCT/US2022/020803, filed 03/17/2022. PCT/US2022/020803 claims benefit of U.S. Provisional Application Nos. 63/283,117, filed 11/24/2021, 63/219,336, filed 07/07/2021, and 63/162,960, filed 03/18/2021. Therefore, the effective filing date is 03/18/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 234 and 236 is objected to because of the following informalities:
Claim 234 reads “…imadazol…” and should read “…imidazol…”.
Claim 236 reads “…Sickel cell retinopathy…” and should read “…Sickle cell retinopathy…”.
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 224-246 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating dry eye syndrome, conjunctivitis, keratitis, uveitis, scleritis, episcleritis, blepharitis, acanthamoeba keratitis, and iritis using ALA, DHA, EPA, or combinations thereof , or treating corneal nociception comprising administering (4,5-dihydro-N-[4-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-1H-imadazol-2-amine or a pharmaceutically acceptable salt thereof, does not reasonably provide enablement for promoting ocular health or the prevention or treatment of any ocular disease comprising administering any active agent or any pharmaceutically acceptable esters thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the present invention, are summarized as follows:
Breadth of the claims
The breadth of the claim includes a method of treating or preventing any ocular disease in a patient, comprising administering any “active agent”.
Nature of the invention
The nature of the invention is performance of a method of treating or preventing an ocular disease in a patient, comprising administering an active agent.
State of the prior art
No single drug has been discovered that is effective in treating or preventing the myriad of ocular diseases in a patient, including, but not limited to, “dry eye disease, ocular discomfort, irritation, pain, stress, chemical burns, anterior segment dysgenesis, cataract, iritis, pterygium, keratoconjunctivitis, keratitis, conjunctivitis, keratoconus, ectatic disorders, Pseudophakic and aphakic bullous keratopathy , episcleritis, corneal dysplasia, corneal ulceration, Fuchs' endothelial dystrophy, corneal dystrophies, ocular cicatricial pemphigoid, Stevens Johnson syndrome, acute and chronic uveitis, anterior uveitis, intermediate uveitis, trauma to the cornea, conjunctiva and anterior segment, iris trauma, penetrating ocular trauma, blepharitis, blepharospasm, chalazion, ptosis, coloboma, dermatochalasis, ectropion, entropion, trichiasis, stye, meibomianitis, Meibomian Gland Dysfunction, lacrimal gland obstruction, lacrimal gland obstruction, seborrheic keratitis, actinic keratitis, bacterial infection, viral infection, age-related macular degeneration, dry and wet macular degeneration, lattice Degeneration, macular hole, macular pucker, lattice degeneration, retinal tear, retinal detachment, retinal artery occlusion, retinal vein occlusion, central retinal vein occlusion, intraocular tumors, pediatric retinal disorder, inherited retinal disorders, hereditary retinal dystrophies, geographic atrophy, retinitis pigmentosa, Leber congenital amaurosis, cytomegalovirus retinal infection, infectious retinitis, retinoblastoma, endophthalmitis, chorioretinitis, myopic macular degeneration, normal-tension glaucoma, retinal degeneration in glaucoma, retinopathies, diabetic retinopathy, retinopathy of prematurity, Sickle cell retinopathy, radiation/solar retinopathy, central serous retinopathy, hypertensive retinopathy, peripheral retinopathy, neuropathy, macular edema, retinal hemorrhage, diabetic macular edema, diabetic macular ischemia, geographic atrophy, Stargardt disease, refractive errors, myopia, hyperopia, astigmatism, lymphatic malformations of the orbit, orbital lymphangiomas, thyroid eye disease, Graves' Eye Disease, acute uveitis, chronic uveitis, intermediate uveitis, posterior uveitis, and panuveitis”. See In re Hokum, 226 USPQ 353 (ComrPats 1985).
The prior art teaches (Behl et al., US 20210085603 A1, paragraph [0060]) a composition comprising α-linolenic acid that can be used to treat “dry eye syndrome (keratoconjunctivitis sicca); conjunctivitis; keratitis; uveitis; scleritis; episcleritis; blepharitis; acanthamoeba keratitis; and iritis; or combinations thereof”. It is taught by Behl et al. in in paragraph [0012], that α-linolenic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), or combinations thereof can be used to treat the above listed diseases. Therefore, the Applicant would be enabled for treating dry eye syndrome, conjunctivitis, keratitis, uveitis, scleritis, episcleritis, blepharitis, acanthamoeba keratitis, and iritis using ALA, DHA, EPA, or combinations thereof.
Alternatively, the prior art teaches (Woodward et al., U.S. 9,827,225 B2, claims 1 and 8) that (4,5-dihydro-N-[4-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-1H-imadazol-2-amine can be used to treat corneal nociception, including ocular discomfort and ocular pain.
Level of one of ordinary skill in the art
The artisans performing the inventor’s or joint inventor’s method of treating or preventing an ocular disease in a patient, comprising administering any active agent, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
Level of predictability in the art
Synthetic organic chemistry is quite unpredictable. See In re Marzocchi and Horton 169 USPQ at 367 ¶3. Similarly, it is well established that “[T]he scope of enablement varies inversely with the degree of unpredictability of the factors involved, and physiological activity is generally considered to be an unpredictable factor”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Amount of direction provided by the inventor
The invention lacks direction with respect to making and/or using (performing) a method of treating or preventing an ocular disease in a patient, comprising administering any active agent.
Existence of working examples
The disclosure is insufficient to allow extrapolation of the limited examples to enable performing the instantly recited method of treating or preventing an ocular disease in a patient, comprising administering any active agent.
Similarly, according to the specification, any active agent is capable of treating a variety of ocular diseases in a patient, including, but not limited to, “dry eye disease, ocular discomfort, irritation, pain, stress, chemical burns, anterior segment dysgenesis, cataract, iritis, pterygium, keratoconjunctivitis, keratitis, conjunctivitis, keratoconus, ectatic disorders, Pseudophakic and aphakic bullous keratopathy , episcleritis, corneal dysplasia, corneal ulceration, Fuchs' endothelial dystrophy, corneal dystrophies, ocular cicatricial pemphigoid, Stevens Johnson syndrome, acute and chronic uveitis, anterior uveitis, intermediate uveitis, trauma to the cornea, conjunctiva and anterior segment, iris trauma, penetrating ocular trauma, blepharitis, blepharospasm, chalazion, ptosis, coloboma, dermatochalasis, ectropion, entropion, trichiasis, stye, meibomianitis, Meibomian Gland Dysfunction, lacrimal gland obstruction, lacrimal gland obstruction, seborrheic keratitis, actinic keratitis, bacterial infection, viral infection, age-related macular degeneration, dry and wet macular degeneration, lattice Degeneration, macular hole, macular pucker, lattice degeneration, retinal tear, retinal detachment, retinal artery occlusion, retinal vein occlusion, central retinal vein occlusion, intraocular tumors, pediatric retinal disorder, inherited retinal disorders, hereditary retinal dystrophies, geographic atrophy, retinitis pigmentosa, Leber congenital amaurosis, cytomegalovirus retinal infection, infectious retinitis, retinoblastoma, endophthalmitis, chorioretinitis, myopic macular degeneration, normal-tension glaucoma, retinal degeneration in glaucoma, retinopathies, diabetic retinopathy, retinopathy of prematurity, Sickle cell retinopathy, radiation/solar retinopathy, central serous retinopathy, hypertensive retinopathy, peripheral retinopathy, neuropathy, macular edema, retinal hemorrhage, diabetic macular edema, diabetic macular ischemia, geographic atrophy, Stargardt disease, refractive errors, myopia, hyperopia, astigmatism, lymphatic malformations of the orbit, orbital lymphangiomas, thyroid eye disease, Graves' Eye Disease, acute uveitis, chronic uveitis, intermediate uveitis, posterior uveitis, and panuveitis”.
However, the specification fails to set forth any convincing in vitro and/or in vivo assays corroborating the alleged activity in association with any of the aforementioned diseases. The specification only provides drug concentration levels of JV-DE1 and DHA after administration. There are no examples which include the prevention or treatment of any disease or disorder. There is insufficient disclosure to reasonably conclude that the method of preventing or treating an ocular disease in a patient, comprising administering any active agent, as recited, would contribute to treatment of any the aforementioned diseases. The inventor or joint inventor has neither provided convincing data for any patient population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claim.
Quantity of experimentation needed
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use (perform) the full scope of the claimed invention without undue experimentation. See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
One skilled in the art, such as a medical doctor, would be required to perform hundreds of clinical trials and in vivo or in vitro assays in order to determine which of the infinite number of “active agents” would be capable of treating and preventing which ocular diseases. Even in vitro and in vivo assays do not always correlate to efficacy in humans and are not generally predictive of clinical efficacy.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404. These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for a method of treating or preventing an ocular disease in a patient, comprising administering an active agent, is clearly justified.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 224, 231-234, 236, 237, 240, and 241 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woodward et al. (U.S. 9,827,225 B2), hereinafter referred to as patent ‘225.
Patent ‘225 teaches, in Example 1, a method of treating ocular discomfort and pain and corneal scarification comprising administering (4,5-dihydro-N-[4-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-1H-imadazol-2-amine topically to the ocular surface, as in instant claims 224, 233, 234, 236, and 241. It is taught, in claim 2, that the composition is administered once a day, as in instant claim 240. The composition is taught, in claim 3, to be an emulsion, suspension, or gel, as in instant claim 231. Table 2 teaches the composition comprising an anti-oxidant, humectant, and thickener, as in instant claim 232. Patent ‘225 teaches, in claim 6, a method for the treatment of dry eye disease comprising administering the above described composition, as in instant claim 237.
Claims 224-226, 231-233, 235, 236, 240, and 241 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dobak (US 20210038503 A1).
Dobak teaches, in claims 34, 46, and 48, a method of treating an ocular condition wherein the composition is administered to the eyelid, wherein the ocular condition is ocular itch, ocular inflammation, a scratched cornea, conjunctivitis, an eye infection, or a combination thereof, as in instant claims 224, 233, 236, and 241. It is taught, in claims 44 and 45, that the composition comprises a suitable carrier and is in the form of an aqueous-oil emulsion, as in instant claims 231 and 232. Dobak teaches, in paragraph [0129] that the active ingredient comprises an omega-3 fatty acid, as in instant claims 225 and 226. In Example 7, paragraph [0175], it is taught that the composition was administered twice daily with an eye dropper, as in instant claims 235 and 240.
Claims 224, 231-233, 235-237, 240, and 241 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woodward et al. (U.S. Patent No. 9,820,954 B2), hereinafter referred to as patent ‘954.
Patent ‘954 teaches, in claims 1, 8, and 9, a method of treating high intraocular pressure comprising administering a composition to the periorbital skin of at least one eye, wherein the composition is administered to the skin above and below the eyelid, as in instant claims 224, 236, and 241. The composition is taught, in claims 10 and 11, to be applied once daily, as in instant claim 240. The composition is taught, in claims 12,13, 15, and 24, to be in the form of a solution, emulsion, dispersion, suspension, topical cream, or hydrogel, and delivered through a delivery device which is a “roller device”, as in instant claims 231-233, and 235.
Claims 224-229, 231-233, 235-237, 240, and 241 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Behl et al. (US 20210085603 A1), with an effective filing date of 22 December 2017.
Behl et al. teaches, in claim 1-3, a composition comprising α-linolenic acid. The microemulsion composition is taught, in claims 1, 22, and 35, to be used in the prevention or treatment of an eye disorder, where the composition is administered to the eyelid, as in instant claims 224-227, 231, 233, and 241. It is taught, in claim 36, that the composition is administered using an eye drop dispenser, as in instant claim 235. The eye disorder is taught, in paragraph [0060], to be “dry eye syndrome (keratoconjunctivitis sicca); conjunctivitis; keratitis; uveitis; scleritis; episcleritis; blepharitis; acanthamoeba keratitis; and iritis; or combinations thereof”, as in instant claims 236 and 237.
Behl et al. teaches, in claim 8 and paragraph [0022], that the composition contains a co-surfactant which acts as a penetration enhancer, as in instant claim 232. Behl et al. teaches, in paragraph [0012], that in one embodiment, the omega-3-fatty acid comprises α-linolenic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA); or combinations thereof, as in instant claims 228 and 229. It is taught, in paragraph [0066], that administration is once per day, as in instant claim 240.
Claims 224, 231-233, 235, 236, and 241 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Woodward et al. (WO 2020251926 A1), with an effective filing date of 10 June 2019.
Woodward et al. teaches, in claims 1 and 11, a method of treating a vision disorder, wherein the administration of the composition comprises topical administration to the periorbital skin, as in instant claims 224, 233, and 241. It is taught, in claims 4, that the composition is used to treat a vision disorder associate with Grave’s disease, as in instant claim 236. It is taught, on page 19 lines 21-22, that the composition is in the form of a topical cream, gel, foam, or solution, as in instant claim 231. It is taught, on page 19 lines 11-15 and in claim 33, that the vehicle of administration can be an eye drop, and that the composition can contain penetration enhancers such as polyethylene glycol, as in instant claim 232 and 235.
The applied reference has a common inventor and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 227-230, 242, and 243 are rejected under 35 U.S.C. 103 as being unpatentable over Dobak (US 20210038503 A1), as applied to claims 224-226, 231-233, 235, 236, 240, and 241 above.
Dobak teaches a method of treating an ocular condition wherein the composition is administered to the eyelid, wherein the active ingredient is an omega-3 fatty acid. See above rejection.
Dobak fails to teach a specific embodiment containing the omega-3 fatty acids listed in claims 227-229, and the specific amounts contained in claims 230, 242, and 243.
However, Dobak teaches, in paragraph [0129], that the omega-3 fatty acid can be “hexadecatrienoic acid (HTA), α-Linolenic acid (ALA), … eicosapentaenoic acid (EPA), … docosahexaenoic acid (DHA), …”.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to select ALA, EPA, DHA, or combinations thereof, as they were explicitly listed as potential omega-3 fatty acids to use in this invention, as in instant claims 227-229.
Regarding the specific amounts of omega-3 fatty acids in claims 230, 242, and 243, MPEP 2144.05 II, which discusses routine optimization, states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Therefore, since the composition of Dobak is taught to contain the same elements and be used for the same purpose as the instant invention, the concentration of omega-3 fatty acid described in instant claims 230, 242, and 243 would constitute as routine optimization, and it is not patentable to discover optimum ranges.
Claims 230, 242, and 243 are rejected under 35 U.S.C. 103 as being unpatentable over Behl et al. (US 20210085603 A1), as applied to claims 224-227, 233, 235-237, and 241 above.
Behl et al. teaches a composition comprising α-linolenic acid used in the treatment of eye conditions and diseases. See above rejection.
The composition is taught, in claim 27, to contain the therapeutic agent at 0.01 mg/mL to 2 mg/mL, which overlaps with instant claims 230 and 243. MPEP 2144.05 I states: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. Therefore, instant claims 230 and 243 are rendered prima facie obvious in view of the prior art.
Regarding claim 242, Behl et al. fails to teach that the composition comprising α-linolenic acid results in a tissue concentration of 110 micrograms/gram of the α-linolenic acid in the retina 30 minutes after administration.
However, MPEP 2144.05 II, which discusses routine optimization, states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Therefore, the optimized working conditions are not patentable in view of the prior art, since Behl et al. teaches the same composition being used for the same purpose as the instant claims.
Claims 238, 239, and 244-246 are rejected under 35 U.S.C. 103 as being unpatentable over Behl et al. (US 20210085603 A1) as applied to claims 224-233, 235-237, and 240-243 above, and further in view of McDonnell et al. (U.S. 9,566,242 B2).
Behl et al. teaches a method of treating eye conditions and diseases comprising administering a composition comprising α-linolenic acid. See above rejections.
Behl et al. fails to teach the subsequent administration of an ocular injection to treat diabetic retinopathy or macular degeneration.
However, McDonnell et al. teaches, in claims 16, 23, and 31, a method for treating macular degeneration or diabetic retinopathy in a patient comprising administering an intravitreal injection into the eye of a patient, wherein the injection comprises an anti-VEGF agent, as in instant claims 238, 239, and 244-246.
Therefore, it would be prima facie obvious to combine the two methods of treating an eye disease, since the methods are taught in the instant claims to be administered separately for the same purpose, and the prior art also teaches the methods separately, but used for the same purpose.
One of ordinary skill in the art would have a reasonable expectation of success combining two separate treatment methods taught to be used for the same purpose.
Claim 240 is rejected under 35 U.S.C. 103 as being obvious over Woodward et al. (WO 2020251926 A1), as applied to claims 224, 231-233, 235, 236, and 241 above.
The applied reference has a common inventor and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Woodward et al. teaches a method of treating a vision disorder, wherein the administration of the composition comprises topical administration to the periorbital skin. See above rejection.
Woodward et al. fails to teach that the composition is administered from once to four times daily.
However, Woodward et al. teaches, on page 11 lines 17-22, that “The dose will vary depending on a number of factors, including the range of normal doses for a given therapy, frequency of administration; size and tolerance of the individual; severity of the condition being treated; risk of side effects; and the route of administration. One of skill will recognize that the dose can be modified depending on the above factors or based on therapeutic progress.”
Therefore, it would routine optimization to determine the most effective administration technique in a patient. MPEP 2144.05 II states that “it is not inventive to discover the optimum or workable ranges by routine experimentation”.
One of ordinary skill in the art would have a reasonable expectation of success in determining the optimum administration technique of the above described composition through routine experimentation.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Nonstatutory 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 224, 231-234, 236, 237, 240, and 241 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 9, 12, and 13 of U.S. Patent No. 11,857,537 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘537 teaches, in claims 1, 2, 5, and 9, a method of treating dry eye disease comprising periorbitally administering a topical ophthalmic formulation of 4,5-dihydro-N-[4-[[4-(1-methylethoxy)phenyl]methyl]-1H-imidazol-2-amine, as in instant claims 224, 231-234, 236, and 237. The composition is taught, in claims 3 and 4, to be administered once up to four times per day, as in instant claim 240. The composition is taught, in claims 9, 12, and 13 to be administered topically to the front of the eye or periorbital skin, as in instant claim 241.
Claims 224-229, 232, 233, 236, 237, 240, and 241 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,478,437 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘437 teaches, in claim 1, a method of treating dry eye comprising administering a naturally occurring oil to the eyelid, wherein the formulation is free of preservatives, as in instant claims 224, 232, 233, 236, 237, and 241. The naturally occurring oil taught in claim 1 also overlaps with the scope of instant claims 225-229.
Claims 224, 231-234, 236, 237, 240, and 241 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, and 8 of U.S. Patent No. 9,827,225 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘225 teaches, in claim 1, a method of treating corneal nociception comprising administering (4,5-dihydro-N-[4-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-1H-imadazol-2-amine topically to the ocular surface, as in instant claims 224, 233, 234, 236, and 241. It is taught, in claim 2, that the composition is administered once a day, as in instant claim 240. The composition is taught, in claim 3, to be an emulsion, suspension, or gel, as in instant claims 231 and 232. Patent ‘225 teaches, in claim 6, a method for the treatment of dry eye disease comprising administering the above described composition, as in instant claim 237.
Claims 224, 231-233, 235-237, 240, and 241 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-13, 15, and 24 of U.S. Patent No. 9,820,954 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘954 teaches, in claims 1, 8, and 9, a method of treating high intraocular pressure comprising administering a composition to the periorbital skin of at least one eye, wherein the composition is administered to the skin above and below the eyelid, as in instant claims 224, 236, and 241. The composition is taught, in claims 10 and 11, to be applied once daily, as in instant claim 240. The composition is taught, in claims 12,13, 15, and 24, to be in the form of a solution, emulsion, dispersion, suspension, topical cream, or hydrogel, and delivered through a delivery device which is a “roller device”, as in instant claims 231-233, and 235.
Claims 224-233, 235-237, 240, 241, and 243 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 16-18, 20-22, and 24 of copending Application No. 18/687,258 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘258 teaches, in claims 1-4, a method of preventing or treating disease in the central nervous system comprising administering a composition to the periorbital skin or eyelid, wherein the composition comprises alpha-linolenic acid, eicosatetraenoic acid, docosahexaenoic acid, or any combination thereof, as in instant claims 224-229 and 241.
Regarding claims 236 and 237, MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” Therefore, administering the same composition (from application ‘258) by the same administration route would inherently treat the diseases from instant claims 236 and 237.
It is taught, in claims 16 and 17, that the omega-3 fatty acid is administered in an amount from 0.1mg to 3000 mg or from 5 to 200 mg, as in instant claims 230 and 243. The formulation is taught, in claim 18, to be in the form of a cream, emulsion, oil, gel, or foam, and optionally includes an emollient, preservative, thickening agent, antioxidant, or combinations thereof, as in instant claims 231-233. It is taught in claims 20 and 21 that the composition contains or does not contain a preservatives, as in instant claim 233. The method of administration is taught, in claim 22, to be a roller ball, click pen brush, pump bottle, eye drop bottle, or an eye pad, as in instant claim 235. The composition is taught in claim 24 to be administered from one to four times daily, as in instant claim 240.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 224-246 are rejected.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624