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 .
Response to RCE
A request for continued examination under 37 CFR 1.114, including the fee set forth in
37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible
for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has
been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37
CFR 1.114.
Priority
The instant application is a 371 National Stage Entry of PCT/CA2020/050546 filed on April 24, 2020 which claims priority to domestic provisional application No. 62/838,216 filed on April 24, 2019.
Status of Claims
Acknowledgement is made of original (5, 12, 18, 21-22, 24, 33), previously presented (1-2, 4, 6-11, 14-17, 19-20, 23, 28-29, 31-32, 34-35), amended (26), new (36), and cancelled (3, 13, 25, 27, 30) claims filed April 6, 2026. Claims 1-2, 4-12, 15-24, 26, 28-29, 31-36 are pending. Claims 1-2, 4-12, 14-24, 33 remain withdrawn.
Claims 26, 28-29, 31-32, 34-36 are presently examined.
Election/Restrictions
The elected compound species is understood as follows:
Cannabinol, CAS Registry No. 521-35-7
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139
229
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cannabinol, also known as CBN or 6,6,9-Trimethyl-3-pentyl-6H-dibenzo(b,d)pyran-1-ol, with CAS Registry No. 521-35-7.
Following extensive search and examination, the elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to non-elected species have been withdrawn.
During the search and examination of the originally elected species, art pertinent to other non-elected species was incidentally discovered. Although examination has not been extended beyond the non-elected species identified above per MPEP § 803.02, as a courtesy to the Applicant, this art has been applied below.
Response to Arguments
Applicant’s arguments filed April 6, 2026 have been fully considered but are not persuasive.
The following rejections have been withdrawn in light of claim amendments:
The 35 USC 101 Rejection of claims 26, 28-29
The following rejections have been modified in light of claim amendments:
The 35 USC 101 Rejection of claim 35
The 35 USC 103 Rejection of claims 26, 28-29, 31-32, 35 over WO’022 in view of Kabiri
The 35 USC 103 Rejection of claim 34 over WO’022 in view of Kabiri in further view of Rapino.
The NSDP Rejection of claims 26, 28-29, 31-32, 34-35.
The following rejections are new in light of claim amendments:
Claim 36 is now included in the prior art rejections.
Regarding the 35 USC 101 Rejection
Regarding the 35 USC 101 Rejection, Applicant states “Claim 35 claims a neuroprotective compound when it is in contact with a retinal neuron in vivo” (see 4/6/26 Remarks at p.12 lines 17-18). This clarification brings up the issue that a human being (i.e. retinal neuron in vivo) is encompassed by the composition claim.
Regarding the 35 U.S.C. 103 Rejection
Regarding WO’022 and a pharmacologically active agent (see 4/6/26 Remarks at p. 17), WO’022 suggests to an artisan a cannabinoid is a suitable active agent, and provides a finite list cannabinoids, including all of the instantly claimed species: cannabinolic acid, cannabinol, cannabinol methyl ether, cannabinol-C4, cannabinol-C2, cannabinvarin, and cannabiorcol (WO’022 claim 10). While CBGA may be a preferred embodiment disclosed by WO’022, per MPEP §2123(II), disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). In instant case, WO’022 informs artisans that the instantly claimed cannabinoids are suitable active ingredients for the composition disclosed. Accordingly, an artisan would predict success in formulating an ophthalmic cannabinoid solution as taught by WO’022 with the disclosed cannabinoids.
Accordingly, an artisan would reasonably expect success in formulating an ocular drug delivery composition when selecting one of the listed cannabinoid species.
Regarding WO’022 and cell type (see 4/6/26 Remarks at p. 18), WO’022 states:
the neuroprotective properties of cannabinoids have been extensively studied in different neurodegenerative pathologies such as Parkinson's disease, Huntington's disease and multiple sclerosis. Cannabinoids have low aqueous solubility which results in poor bioavailability. Hence, neuroprotection as a therapeutic strategy in eye disorders has not been pursued due to the difficulties associated with the targeted delivery of cannabinoids to intraocular tissues…It is known that when the drugs are delivered as drops, less than 5% of the dose penetrates the cornea after eye drop administration (see WO’022 at p. 1 ¶[004]).
An artisan would readily appreciate that an ocular cannabinoid drug delivery composition formulated for penetrating the cornea in order to the treat a neurodegenerative disease is targeting a retinal neuron.
Regarding WO’022 and concentration (see 4/6/26 Remarks at p. 18), WO’022 teaches the cannabinoid may be present in any amount suitable for a desired application, including 0.1 wt% to 5 wt% (see WO’022 at p.11 ¶[061]). Applicant argues an artisan is not guided to the instant wt % by WO’022. The Examiner disagrees, as brought up in previous Office Actions, weight percent is a variable limitation and can read on different dosages in different compositions. For example, a composition with 2 mg cannabinoid in a composition weighing 100 mg is 5 wt % cannabinoid, but so is a 5 mg cannabinoid in a composition weighing 250 mg. Further muddying the waters is a composition that is 2 mg cannabinoid but the total composition weighs 2 grams, which would be 0.01% cannabinoid despite containing the same amount of active ingredient as the 2 mg/100mg composition.
Composition A
Composition B
Composition C
Amount of Cannabinoid
2 mg
5 mg
2 mg
Total Composition Weight
100 mg
250 mg
2 g
wt % Cannabinoid
5%
5%
0.01%
WO’022’s discussion of weight percent is not not guiding an artisan, but merely recognizing the inconsistency of reflecting amounts of active ingredients in this known variable limitation (weight percent). Combined with WO’022 teachings that corneal penetration is low, an artisan would appreciate that the amount of cannabinoid present in the initial composition must be optimized for the desired exposure of the retinal neuron to the cannabinoid to achieve therapeutic benefit for treating a neurodegenerative disorder.
In sum, WO’022 teaches an overlapping wt % and a suggestion to optimize. Absent evidence of criticality, the instantly claimed range is obvious over the prior art.
Regarding surprising results, The Examiner notes that the evidence of criticality is in reference to CBN only at 5-10 uM concentrations, which is not necessarily the same as the instantly claimed limitation of 0.1 to 0.5 w/w% for all of Formula I. Applicant notes that even at 5-10 uM CBD, CBGA, CBDA, CBND and THC are cytotoxic (see 4/6/26 Remarks at p. 23). The unexpected results are only relevant to CBN, the only instant species of Formula I Applicant has provided data for, and only in regards to uM amounts of CBN with no reference to w/w% and are thus not commensurate in scope with the claims as written.
Applicant argues CBGA, a cannabinoid studies in WO’022 does not work with the presently claimed technology (see 4/6/26 Remarks at p. 23). Applicant notes unpredictability and cites instant Fig 2 for comparing cannabinoids, but it is still not apparent what separates the instant invention from the prior art based on the claim limitations. The Examiner notes that the claims as presently written are still obvious over WO’022’s teachings because they do not substantially differentiate the instantly claimed composition from the prior art.
Claim Interpretation
Claim 26 is interpreted as a composition comprising 0.1-0.5 w/w% of a compound of Formula I and a condensation product of ethylene oxide with a partial ester derived from a fatty acid and hexitol. The structural limitations are understood to be capable of achieving the necessary molar amounts to inhibit degeneration in a retinal neuron. Prior art teaching the claimed structural limitations and teaching application to the eye is thus understood to be capable of reaching the retinal neuron.
Claim Objections
Claim 26 is objected to because of the following informalities:
Claim 26 recites “compound in contact when measured in vivo with a target retinal neuron” which reads as if the retinal neuron is doing the measuring. Alternative phrasing is proposed based on other claim wording: “compound in contact with a target retinal neuron when measured in vivo”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 recites “A neuroprotective compound in an amount sufficient to inhibit neurodegeneration”. It is unclear if the claim is a compound claim or a composition claim. Is the compound mixed with something? Is it intended use of the structure? What is the amount sufficient to inhibit? The concentration recited in contact with the neuron is a result-effective variable. It is unclear how much of the compound is in the tangible composition itself.
Furthermore, claim 35 recites “wherein the neuroprotective compound is in contact with” a “target retinal neuron” or a “target neuron in vivo” which could be interpreted as method steps.
Claim 35 also recites “wherein the neuroprotective compound is in contact with a target retinal neuron”. It is unclear if the neuron is included in the composition or not. Furthermore, the claim recites “in vivo” which would indicate the neuron is part of a living organism and raises 35 U.S.C. 101 issues, as applied below.
The pressing questions that remain are 1. how much of the neuroprotective compound is present in the composition? and 2. what are the structural limitations in the tangible claimed composition? Measuring the amount of the compound in contact with a retinal neuron in vivo is still a result-effective variable. Describing where the composition is does not add a structural limitation to the composition itself, only a desired intended use.
For the purposes of applying art, claim 35 is interpreted as a compound claim, and the products of claim 35 simply needs to be capable of being placed in contact with a target neuron in the claimed amounts. The patentability of claim 35 thus rests in the structure of Formula I itself, and not how it is used.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 35 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 35 states “wherein the neuroprotective compound is in contact with a target neuron in vivo” which is understood read on a compound as part of a living being such as a human (see also instant spec. at p. 13 ¶51 and 4/6/26 Remarks at p. 16). See also MPEP § 2105(III).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 26, 28-29, 31-32, 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/205022 A11 in view of Yamaguchi et. al.2 as evidenced by Ravichandran et. al.3 and STN4.
Regarding claims 26, 28, 29, 32, 35 and a pharmaceutical composition comprising a compound of Formula I including cannabinol, WO’022 teaches an ocular drug delivery formulation comprising a delivery carrier comprising a cellulosic polymer and an anionic polysaccharide and nanoparticles comprising an amphiphilic non-ionizable block copolymer and a cannabinoid with a gel point of about 30-37 °C, (see WO’022 claims 1, 4, and 7) wherein the cannabinoid may be CBN (see WO’022 claim 10). In view of the recitation of a gel point by WO’022, an artisan would readily appreciate that the formulation of WO’022 was a hydrogel (see WO’022 at claim 1, p.7 [041], [070]-[071]).
Regarding comprising a condensation product of ethylene oxide with a partial ester derived from a fatty acid and hexitol, WO’022 teaches the composition comprises amphiphilic non-ionizable block copolymers (see WO’022 claim 1), which may be poly(ethylene oxide-b-lactide) (see WO’022 at p. 1 ¶[0017]).
Regarding 0.1 to 0.5 w/w% of cannabinoid, WO’022 teaches that the cannabinoid may be present in any amount suitable for a desired application, including ranging from 0.1 to 5 wt% (see WO’022 at p. 11 [061]).
Regarding claims 31 and 32 and an eye drop formulation, WO’022 teaches the compositions may be formulated as eye drops which form hydrogels on the surface of the eye (see WO’022 at claim 1, p.7 [041], [070]-[071]).
Regarding claim 36 and further comprising, WO’022 teaches suitable solvents such as ethanol or DMSO (see WO’022 at p. 8 ¶[050]). WO’022 teaches aqueous solutions such as buffered saline (see WO’022 p. 8 [051]). WO’022 teaches additional pharmacological agents may be added such as penicillin (an antibiotic) or fungal medications (antimycotics) lists (see WO’022 at p. 13 ¶[067]).
Regarding administering to a retinal neuron or glaucoma, WO’022 teaches use of the disclosed compositions to treat eye disorders (see WO’022 claim 19) including glaucoma (see WO’022 claim 18).
WO’022 states:
the neuroprotective properties of cannabinoids have been extensively studied in different neurodegenerative pathologies such as Parkinson's disease, Huntington's disease and multiple sclerosis. Cannabinoids have low aqueous solubility which results in poor bioavailability. Hence, neuroprotection as a therapeutic strategy in eye disorders has not been pursued due to the difficulties associated with the targeted delivery of cannabinoids to intraocular tissues…It is known that when the drugs are delivered as drops, less than 5% of the dose penetrates the cornea after eye drop administration (see WO’022 at p. 1 ¶[004]).
The prior art differs from the instant claims as follows: While WO’022 teaches a composition comprising poly(ethylene oxide b-lactide), WO’022 does not specify a condensation product of ethylene oxide with a partial ester derived from a fatty acid and hexitol.
However,
The instantly claimed condensation product of ethylene oxide with a partial ester derived from a fatty acid and hexitol encompasses polysorbates such as polyoxyethylene sorbitan monooleate (see instant spec. at p. 26 ¶[0091]). WO’022’s composition comprises an amphiphilic non-ionizable block copolymer (see WO’022 claim 1). Exemplary reference Ravichandran teaches polysorbates are non-ionizable amphiphilic copolymers (see Ravichandran at p. 261 left col. ¶1).
Yamaguchi teaches ophthalmic lipid emulsions enhance the intraocular penetration of drugs (see Yamaguchi at Abstract). Yamaguchi teaches polyoxyethylene sorbitan monooleate, also known in the art as polysorbate 80 or TWEEN-80® (see evidentiary reference STN), is a non-ionizable ophthalmic-safe agent for drug delivery (see Yamaguchi at Abstract and at p. 124 right col. “3.2 Appearance of DFBA ophthalmic lipid emulsion”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding overlapping ranges, per MPEP § 2144.05(I), a prima facie case of obviousness exists for ranges that "overlap or lie inside ranges disclosed by the prior art". WO’022 teaches a composition comprising a cannabinoid such as cannabinol in 0.1-5% w/w which encompasses the instantly claimed 0.1-0.5% w/w range.
Regarding contacting a retinal neuron, an artisan would readily appreciate that an ocular cannabinoid drug delivery composition formulated for penetrating the cornea in order to the treat a neurodegenerative disease (as taught by WO’022) is targeting a retinal neuron.
Regarding a polysorbate, per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. In addition, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to ones skilled in the art to substitute WO’022’s non-ionizable amphiphilic copolymer such as poly(ethylene oxide-b-lactide) with another non-ionizable amphiphilic copolymer such as polyoxyethylene sorbitan monooleate for an ophthalmic composition, because the prior art teaches polyoxyethylene sorbitan monooleate is ophthalmic-safe and enhances intraocular penetration (as taught by Yamaguchi).
Furthermore, it is well-within the ordinary skill in the art to:
optimize an initial dosage to result in a desired concentration,
administer a known composition to a known target,
substitute one known delivery carrier for another,
Accordingly, claims 26, 28-29, 31-32, 35-36 are rendered obvious.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/205022 A1 in view of Yamaguchi as evidenced by Ravichandran and STN as applied to claims 26, 28-29, 31-32, 35-36 above and in further view of Rapino et. al.5
The prior art differs from the instant claim as follows: While WO’022 teaches a composition comprising 0.1-0.5% w/w CBN capable of contacting a retinal neuron, WO’022 does not specify formulating for IVT administration.
However,
Regarding intravitreal administration, Rapino teaches intravitreal administration of a cannabinoid for protecting retinal cells (see Rapino at p. 962 right col. lines 22-26).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding intravitreal formulated composition, one skilled in the art would recognize IVT as a suitable formulation for targeting a retinal neuron because Rapino teaches IVT administration of a cannabinoid for protecting retinal cells.
Furthermore, it is well-within the ordinary skill in the art to formulate a known composition for use in a known method of treating a known condition via a known route of administration.
Accordingly, claim 34 is rendered obvious.
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 26, 28-29, 31-32, 34-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,083,229 B26 in view of Kabiri7 and Yamaguchi as evidenced by Ravichandran and STN. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claim sets are directed to the same or overlapping compositions.
Regarding instant claims 26, 28-29, 35 and a pharmaceutical composition comprising cannabinol or a cannabinol derivative, US’229 claims an ocular drug delivery formulation comprising a cannabinoid (US’229 claim 1), wherein the cannabinoid may be cannabinol (see US’229 claim 2). US’229 claim 2 further lists all the instantly claimed species that are encompassed by the instant Formula I cannabinol derivatives: cannabinolic acid, cannabinol methyl ether, cannabinol-C4, cannabinol-C2, cannabivarin, and cannabiorcol.
Regarding the recitation of a 0.1% w/w to 0.5% w/w, MPEP § 2144.05(I) states a prima facie case of obviousness exists when claimed ranges “overlap or lie inside ranges disclosed by the prior art”. Here, the range recited at instant claim 26 lies inside the range explicitly and expressly taught by the prior art (compare instant claim 26 with US’229 at claims 1 and 5). Accordingly, an artisan would readily appreciate that such amounts could be predictably and credibly utilized to practice the prior art invention exactly as taught and claimed by the prior art.
Regarding instant claims 31, 34 and an eye drop formulation or IVT, US’229 claims a method of treating an eye disorder by administering the formulation directly to the eye (see US’229 claim 6), wherein the eye disorder may be glaucoma (see US’229 claim 7). In addition, US’229 clearly teaches and discloses an “ocular drug delivery formulation”. Accordingly, in view of claims directed to ocular formulations and direct administration to eyes, an artisan would at once envisage “eye drop” or “IVT” formulations in view of the issued claims of US’229.
Regarding instant claim 32 and a hydrogel comprising a) a delivery carrier comprising a cellulosic polymer and an anionic polysaccharide and b) nanoparticles comprising an amphiphilic non-ionizable block copolymer and the neuroprotective compound, wherein the formulation has a gel point of about 30°C to about 37°C, US’229 claims a delivery carrier comprising methyl cellulose (a cellulosic polymer) and hyaluronic acid (an anionic polysaccharide), and poly(ethylene oxide-b-lactide) nanoparticles (an amphiphilic non-ionizable block copolymer) with a gel point of about 30 °C to about 34 °C (see US’229 claim 1). In view of the recitation of a gel point, an artisan would readily appreciate that the claim scope of US’229 encompassed hydrogels.
Regarding instant claim 32 and the recitation of a gel point of “about 30° to about 37°C”, MPEP § 2144.05(I) states a prima facie case of obviousness exists when claimed ranges “overlap or lie inside ranges disclosed by the prior art”. Here, the range recited at instant claim 32 lies inside the range explicitly and expressly taught by the prior art (compare instant claim 32 with US’229 at claim 1). Accordingly, an artisan would readily appreciate that such amounts could be predictably and credibly utilized to practice the prior art invention exactly as taught and claimed by the prior art.
The pending claim scope differs from US’229 as follows: US’229 does not specify an embodiment having the concentration of cannabinoid 0.15 to 15 uM in contact with a target retinal neuron or 0.1 to 0.5 w/w% in the pharmaceutical composition, or a condensation product.
However,
Regarding a condensation product, the instantly claimed condensation product of ethylene oxide with a partial ester derived from a fatty acid and hexitol encompasses polysorbates such as polyoxyethylene sorbitan monooleate (see instant spec. at p. 26 ¶[0091]). US’229’s composition comprises an amphiphilic non-ionizable block copolymer (see US’229 claim 1). Exemplary reference Ravichandran teaches polysorbates are non-ionizable amphiphilic copolymers (see Ravichandran at p. 261 left col. ¶1).
Yamaguchi teaches ophthalmic lipid emulsions enhance the intraocular penetration of drugs (see Yamaguchi at Abstract). Yamaguchi teaches polyoxyethylene sorbitan monooleate, also known in the art as polysorbate 80 or TWEEN-80® (see evidentiary reference STN), is a non-ionizable ophthalmic-safe agent for drug delivery (see Yamaguchi at Abstract and at p. 124 right col. “3.2 Appearance of DFBA ophthalmic lipid emulsion”).
Accordingly, one skilled in the art would recognize that:
Regarding 0.15 to 15 uM in contact with a target retinal neuron and or 0.1 to 0.5 w/w% in the pharmaceutical composition, US’229 claims administering an effective amount to the eye of a subject (see US’229 claim 6). The amount of a drug in contact with a retinal neuron administered to the eye is a result-effective variable. Kabiri teaches that the drug dosage in eye drops is typically much higher than what is required due to less than 5% of the drug administered penetrating the cornea, which then must diffuse through the aqueous and vitreous humors before interacting with receptors on the surface of retinal neuron (see Kabiri at p. 485, left col., ¶1), teaching administration to the eye results in contact with a retinal neuron after diffusion. While Kabiri does not report the concentration in contact with the neuron, Kabiri readily informs an artisan that the concentrations utilized must be optimized to account for the barriers of ocular drug delivery. Accordingly, the concentration of the active agent of a cannabinoid would be art-recognized as a result-effective variable, which would need to be optimized to accommodate corneal penetration in different patient populations to improve the efficacy of drug administration.
US’229 teaches a highly similar pharmaceutical composition, for ocular delivery, comprising the same compounds (i.e., CBN), and the composition is taught for the treatment of the same or overlapping conditions (e.g., glaucoma), administered in the same or overlapping routes (e.g. ocular), it is reasonably understood that the concentrations necessary to treat the same conditions using the same compounds in the same way would necessarily require the usage of the same concentrations. Accordingly, although the two claim sets are not identical, they are not patentably distinct because they are reasonably understood to be directed to patently indistinct compositions.
Furthermore, it is well-within the ordinary skill in the art to:
optimize the concentration of a result-effective variable (see MPEP § 2144.05(II)), and
substitute one suitable delivery carrier for another.
Accordingly, instant claims 26, 28-29 and 31-32, 34-35 are rejected.
Conclusion
Claim 26 is objected to.
Claims 26, 28-29, 31-32, 34-36 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Corresponding to PCT/CA2018/050548, priority date May 8, 2017, Cite No. 14 in the IDS filed 12/5/24, hereinafter WO’022. The applied reference has a common assignee 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).
2 Yamaguchi et. al. "Formulation of an ophthalmic lipid emulsion containing an anti-inflammatory steroidal drug, difluprednate" Int J Pharm 2005, 301, 121-128. DOI: 10.1016/j.ijpharm.2005.05.036. Hereinafter Yamaguchi.
3 Ravichandran et. al. "Non-ionic polysorbate-based nanoparticles for efficient combination chemo/photothermal/photodynamic therapy" Journal of Industrial and Engineering Chemistry 2020, 88, 260-267. DOI: 10.1016/j.jiec.2020.04.023 Hereinfter Ravichandran.
4 (CAS 9005-65-6) CAS Registry File Accessed May 7, 2026 from STN, entered into STN November 16, 1984.
5 Rapino et. al. "Neuroprotection by (Endo)Cannabinoids in Glaucoma and Retinal Neurodegenerative Diseases" Current Neuropharmacology, 2018, 16, 959-970. DOI: 10.2174/1570159X15666170724104305
6 Corresponding to PCT/CA2018/050548, WO 2018/205022, and U.S. Application No. 16/611,837, patented September 10, 2024, hereinafter US’229.
7 Kabiri et. al. “A stimulus-responsive, in situ-forming, nanoparticle-laden hydrogel for ocular drug delivery” Drug Deliv Transl Res, 2018, 8, 3, 484-495. DOI: 10.1007/s13346-018-0504-x. Published March 5, 2018, Cite No. 21 in the IDS filed 12/5/24. Cited in previous Office Action. Hereinafter Kabiri.
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