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, 230-235, and 237-246 are pending. Acknowledgment is made of the amendment of claims 224, 230, 234, 235, and 240-244, and the cancellation of claims 225-229 and 236, in the reply filed 04/13/2026.
Information Disclosure Statement
The information disclosure statement filed 04/20/2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because references JP 2019502719 and JP 2008505177 do not have direct English translations provided. It has been placed in the application file, but the information referred to in these references only has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Withdrawn Rejections/Objections
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the objection to claims 234 and 236 for minor informalities. The objection to claims 234 and 236 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224, 231-234, 236, 237, 240, and 241 under 35 U.S.C. 102(a)(1) as being anticipated by Woodward et al. (U.S. 9,827,225 B2). The rejection of claims 224, 231-234, 236, 237, 240, and 241 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224-226, 231-233, 235, 236, 240, and 241 under 35 U.S.C. 102(a)(1) as being anticipated by, and 227-230, 242, and 243 under 35 U.S.C. 103 as being unpatentable over, Dobak (US 20210038503 A1). The rejection of claims 224-233, 235, 236, and 240-243 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224, 231-233, 235-237, 240, and 241 under 35 U.S.C. 102(a)(1) as being anticipated by Woodward et al. (U.S. 9,820,954 B2). The rejection of claims 224, 231-233, 235-237, 240, and 241 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224, 231-233, 235, 236, and 241 under 35 U.S.C. 102(a)(2) and claim 240 under 35 U.S.C. 103 as being anticipated by Woodward et al. (WO 2020251926 A1). The rejection of claims 224, 231-233, 235, 236, 240, and 241 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224, 231-234, 236, 237, 240, and 241 on the ground of nonstatutory double patenting over U.S. Patent No. 11,857,537 B2. The rejection of claims 224, 231-234, 236, 237, 240, and 241 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224-229, 232, 233, 236, 237, 240, and 241 on the ground of nonstatutory double patenting over U.S. Patent No. 11,478,437 B2. The rejection of claims 224-229, 232, 233, 236, 237, 240, and 241 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224, 231-234, 236, 237, 240, and 241 on the ground of nonstatutory double patenting over U.S. Patent No. 9,827,225 B2. The rejection of claims 224, 231-234, 236, 237, 240, and 241 has been withdrawn.
Applicant’s amendments to the claims, filed 04/13/2026, overcomes the rejection of claims 224, 231-233, 235-237, 240, and 241 on the ground of nonstatutory double patenting over U.S. Patent No. 9,820,954 B2. The rejection of claims 224, 231-233, 235-237, 240, and 241 has been withdrawn.
Applicant’s arguments, filed 04/13/2026, are persuasive regarding the rejection of claims 224-233, 235-237, 240, 241, and 243 on the ground of nonstatutory double patenting over Application No. 18/687,258. The rejection of claims 224-233, 235-237, 240, 241, and 243 has been withdrawn.
Maintained/Modified Rejections
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, 230-235, and 237-246 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, age-related macular degeneration, conjunctivitis, keratitis, uveitis, scleritis, episcleritis, blepharitis, acanthamoeba keratitis, and iritis using DHA, does not reasonably provide enablement for promoting ocular health or the prevention or treatment of all ocular diseases listed in instant claims 224 comprising administering DHA. 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 all ocular diseases listed in instant claim 224 in a patient, comprising administering DHA.
Nature of the invention
The nature of the invention is the performance of a method of treating or preventing an ocular disease listed in instant claim 224 in a patient comprising administering DHA.
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 and stress; chemical burn; anterior segment dysgenesis; cataract; iritis; pterygium; keratoconjunctivitis; keratitis; conjunctivitis; keratoconus; ectatic disorders including keratoglobus and pellucid marginal degeneration; pseudophakic bullous keratopathv; aphakic bullous keratopathv; episcleritis; corneal ulceration; corneal dysplasia; Fuchs' endothelial dystrophy; corneal dystrophies including lattice, granular, macular, and map-dot fingerprint; ocular cicatricial pemphigoid; Stevens Johnson syndrome; acute and chronic uveitis including anterior uveitis and intermediate uveitis; trauma to the cornea; conjunctiva and anterior segment including iris trauma; penetrating ocular trauma; blepharitis; blepharospasm; chalazion; ptosis; coloboma; dermatochalasis; ectropion; entropion; trichiasis; stye; meibomianitis; Meibomian Gland Dysfunction; lacrimal gland obstruction; seborrheic keratitis; actinic keratitis; bacterial infection; viral infection; dry and wet age-related macular degeneration; dry and wet macular degeneration; macular hole; macular pucker; lattice degeneration; retinal tear; retinal detachment; retinal artery occlusion; retinal vein occlusion; central retinal vein occlusion; intraocular tumors; pediatric, neonatal or inherited retinal disorders; hereditary retinal dystrophies; geographic atrophy; retinitis pigmentosa including Leber congenital amaurosis; cytomegalovirus (cmv) retinal infection; infectious retinitis; retinoblastoma; endophthalmitis; chorioretinitis; myopic macular degeneration; normal-tension glaucoma; retinal degeneration in glaucoma; retinopathies including diabetic retinopathy, retinopathy of prematurity, Sickle cell retinopathy, radiation/solar retinopathy, central serous retinopathy, hypertensive retinopathy, peripheral retinopathy and neuropathy; macular edema; retinal hemorrhage; diabetic macular edema; diabetic macular ischemia; geographic atrophy; Stargardt disease; refractive errors including myopia, hyperopia, and astigmatism; lymphatic malformations of the orbit (orbital lymphangiomas); thyroid eye disease (Graves' Eye Disease); or acute and chronic uveitis including intermediate uveitis, posterior uveitis, and panuveitis”. See In re Hokum, 226 USPQ 353 (ComrPats 1985).
In fact, the prior art shows that DHA is not capable of preventing or treating retinitis pigmentosa (Berson et al., Clinical Trial of Docosahexaenoic Acid in Patients With Retinitis Pigmentosa Receiving Vitamin A Treatment, Arch. Ophthalmol., 2004, Vol. 122, pages 1297-1305).
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 docosahexaenoic acid (DHA) 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 DHA.
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). As discussed above, it has been shown that DHA is not capable of preventing or treating retinitis pigmentosa. Therefore, the physiological activity of DHA in the treatment of various eye diseases would be considered unpredictable in the absence of any physiological tests, such as in vivo or in vitro assays or clinical trials.
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 DHA.
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 from instant claim 224 in a patient, comprising administering DHA.
Similarly, according to the claims and specification, DHA is capable of treating a variety of ocular diseases in a patient, including, but not limited to, “dry eye disease; ocular discomfort, irritation, pain and stress; chemical burn; anterior segment dysgenesis; cataract; iritis; pterygium; keratoconjunctivitis; keratitis; conjunctivitis; keratoconus; ectatic disorders including keratoglobus and pellucid marginal degeneration; pseudophakic bullous keratopathv; aphakic bullous keratopathv; episcleritis; corneal ulceration; corneal dysplasia; Fuchs' endothelial dystrophy; corneal dystrophies including lattice, granular, macular, and map-dot fingerprint; ocular cicatricial pemphigoid; Stevens Johnson syndrome; acute and chronic uveitis including anterior uveitis and intermediate uveitis; trauma to the cornea; conjunctiva and anterior segment including iris trauma; penetrating ocular trauma; blepharitis; blepharospasm; chalazion; ptosis; coloboma; dermatochalasis; ectropion; entropion; trichiasis; stye; meibomianitis; Meibomian Gland Dysfunction; lacrimal gland obstruction; seborrheic keratitis; actinic keratitis; bacterial infection; viral infection; dry and wet age-related macular degeneration; dry and wet macular degeneration; macular hole; macular pucker; lattice degeneration; retinal tear; retinal detachment; retinal artery occlusion; retinal vein occlusion; central retinal vein occlusion; intraocular tumors; pediatric, neonatal or inherited retinal disorders; hereditary retinal dystrophies; geographic atrophy; retinitis pigmentosa including Leber congenital amaurosis; cytomegalovirus (cmv) retinal infection; infectious retinitis; retinoblastoma; endophthalmitis; chorioretinitis; myopic macular degeneration; normal-tension glaucoma; retinal degeneration in glaucoma; retinopathies including diabetic retinopathy, retinopathy of prematurity, Sickle cell retinopathy, radiation/solar retinopathy, central serous retinopathy, hypertensive retinopathy, peripheral retinopathy and neuropathy; macular edema; retinal hemorrhage; diabetic macular edema; diabetic macular ischemia; geographic atrophy; Stargardt disease; refractive errors including myopia, hyperopia, and astigmatism; lymphatic malformations of the orbit (orbital lymphangiomas); thyroid eye disease (Graves' Eye Disease); or acute and chronic uveitis including 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 DHA, 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 ocular diseases would be capable of being treated and prevented by DHA. 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.
Applicant Argues:
Applicant states, in the Remarks filed 04/13/2026, that the potential application of DHA in the treatment of ocular diseases is evidenced in the prior art by the treatment of dry and wet macular degeneration comprising administering DHA. Applicant states that the ocular diseases in instant claim 224 “are well-known to a person having ordinary skill in the art as being treatable with DHA.”
Examiner Responds:
Evidence 4 and 5, cited by Applicant in the Remarks filed 04/13/2026, show the treatment of age-related macular degeneration comprising administering DHA, and therefore, Applicant would be enabled for the treatment of age-related macular degeneration.
The prevention and treatment of other ocular diseases listed in the instant claims would not be “well-known …as being treatable with DHA” in the absence of any evidence of such a statement. As cited in the above rejection, it has been shown that DHA is not capable of treating retinitis pigmentosa, which is listed in instant claim 224. One in the art would need to determine which of the ocular diseases are treatable with DHA, since it is clear from the prior art that not every ocular disease is treatable with DHA. Therefore, Applicant is not enabled for the prevention and treatment of the diseases listed in claim 224, and the quantity of experimentation needed to determine the scope of preventable or treatable diseases with DHA is high.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 224, 231-233, 235, 237, 240, and 241 are rejected under 35 U.S.C. 102(a)(2) as being obvious over Behl et al. (US 20210085603 A1), with an effective filing date of 22 December 2017.
Behl et al. teaches, in claims 1-2, a composition comprising an omega-3-fatty acid wherein the omega-3-fatty acid comprises α-linolenic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), or combinations thereof (paragraph [0012]).
MPEP 2131.02 states: “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In Kennametal, the challenged claim was to a cutting tool requiring a ruthenium binding agent with a physical vapor deposition (PVD) coating. The reference described all the elements of the claimed coated cutting tool but did not explicitly disclose the specific combination of ruthenium binding agent with a PVD coating. However, the reference disclosed that ruthenium was one of five specified binding agents and PVD was one of three suitable coating techniques. The Federal Circuit stated that the reference’s "express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required." Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted).”
Therefore, since the prior art only teaches three omega-3-fatty acids to be used in the composition, the prior art anticipates the instant claims, as one would “at once envisage” using DHA in such a limited grouping of alternatives.
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, 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 claim 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. It is taught, in paragraph [0066], that administration is once per day, as in instant claim 240.
Applicant Argues:
Applicant states, in the Remarks filed 04/13/2026, that Behl does not teach DHA to treat ocular diseases, and that the “laundry list merely mention DHA” in paragraph [0012].
Examiner Responds:
As discussed in the above rejection, the “laundry list” consists of only three compounds, one of which is DHA. Additionally, the claims teach using one of these three omega-3-fatty acids in the treatment of ocular diseases. Therefore, Applicant’s arguments are unpersuasive.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 230, 242, and 243 are rejected under 35 U.S.C. 103 as being obvious over Behl et al. (US 20210085603 A1), with an effective filing date of 22 December 2017, as applied to claims 224, 231-233, 235, 237, 240, and 241 above.
Behl et al. teaches a composition comprising DHA for the treatment of ocular 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 DHA 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.
Applicant Argues:
Applicant states that DHA is listed in the prior art as part of a non-specific list of materials. Applicant argues that the present invention which delivers DHA via periorbital administration is nonobvious over the prior art.
Examiner Responds:
As discussed above in the 35 U.S.C. 102 rejection, DHA is listed as one of three compounds to be used in the prior art invention. Additionally, the prior art also teaches the periorbital administration route. Therefore, Applicant’s arguments are not persuasive.
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, 230-233, 235, 237, 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 DHA. See above rejection.
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. MPEP 2144.06 states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”.
Although the methods are not being combined to form a single composition, one of ordinary skill in the art would still have a reasonable expectation of success combining two separate treatment methods taught to be used for the same purpose, since they are taught in the prior art to have the same purpose individually.
Applicant Argues:
Applicant states that the teachings by McDonnel fail to remedy the deficiencies of Behl, since McDonnell does not teach DHA as an active ingredient.
Examiner Responds:
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive. Applicant, in the instant claims, merely combines two separate prior art methods, with two separate administration techniques, and two separate active agents, which are both taught independently in the prior art to be used for the same purpose. Therefore, as discussed above and as shown in MPEP 2144.06, combining separate methods taught in the prior art to be used for the same purpose is prima facie obvious.
New Objections
Necessitated by Claim Amendment
Claims 224 and 241 are objected to because of the following informalities:
In the list of diseases in claim 224, in order to be consistent, “;” should be changed to “,” throughout the list.
Claim 241 reads “The method of claim 224, further administering…” and should read “The method of claim 224, comprising administering…”.
Appropriate correction is required.
New Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim 234 is rejected under 35 U.S.C. 103 as being unpatentable over Behl et al. (US 20210085603 A1) as applied to claims 224, 230-233, 235, and 237-246 above, and further in view of Woodward et al. (U.S. 9,827,225 B2), hereinafter referred to as patent ‘225.
Behl et al. teaches a composition comprising DHA for the treatment of ocular diseases, specifically dry eye disease. See above rejection.
Behl et al. fails to teach the composition further comprising the compound of instant claim 234.
However, Patent ‘225 teaches, in Example 1 and claim 6, a method of treating dry eye disease 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. The composition is taught, in claim 3, to be an emulsion, suspension, or gel. Table 2 teaches the composition comprising an anti-oxidant, humectant, and thickener.
MPEP 2144.06 states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)”.
Therefore, it would be prima facie obvious to combine two methods of treatment for the same purpose, since both methods are taught to have the same administration techniques, and both methods are taught to be used in the treatment of dry eye disease. One would have a reasonable expectation of success in using two methods that are taught to be used for the same purpose in order to treat dry eye disease.
Conclusion
Claims 224, 230-235, and 237-246 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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