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 .
Information Disclosure Statement
The information disclosure statement filed on December 5, 2024 has been considered.
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), amended (1-2, 4, 6-11, 14-17, 19-20, 23, 26), previously presented (28-29, 31-32), cancelled (3, 13, 25, 27, 30), and new (34-35) claims filed September 5, 2025. Claims 1-2, 4-12, 14-24, 26, 28-29, 31-35 are pending in instant application. Claims 1-2, 4-12, 14-24, 33 remain withdrawn.
Claims 26, 28-29, 31-32, 34-35 are presently examined.
Election/Restrictions
The elected compound species is understood as follows:
Cannabinol, CAS Registry No. 521-35-7
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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 Per MPEP § 803.02(III), claims directed to non-elected species have been withdrawn.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 September 5, 2025 have been fully considered but they are not persuasive.
The following rejections have been withdrawn in light of claim amendments:
The rejection of claims 26-29 and 31-32 under 35 U.S.C. 112(b).
The following rejections have been maintained in light of claim amendments:
The rejection of claims 26, 28-29 under 35 U.S.C. 101.
The following rejections have been modified in light of claim amendments:
Prior art rejections over claims 26, 28-29, 31, 32 are now under 36 U.S.C. 103 over WO’022 andKabiri.
The following rejections are new in light of claim amendments:
Claims 26, 28-29 and 35 is rejected under 35 U.S.C. 112(b).
Claim 35 is rejected under 35 U.S.C. 101.
Claims 35 and 34 are included in the prior art rejection over claims 26, 28-29, 31, 32 are now under 36 U.S.C. 103 over WO’022 in view of Kabiri and new reference Rapino et. al.1
Regarding the 35 U.S.C. 101 Rejection, Applicant argues the claims as written are now significantly more due to the recitation of a “carrier, adjuvant, vehicle, or excipient” (see 9/5/25 Remarks at p. 14), however the claims as written still do not exclude naturally occurring vehicles such as water which is known in the art. Applicant also states the amount of the neuroprotective in contact with a target retinal neuron is a critical range (See 9/5/25 Remarks at p. 15). However, the teachings of Kabiri still show the amount of cannabinoid in contact with a neuron is a result-effective variable, and Applicant does not explain how the claimed composition as a product itself is markedly different, only it’s intended target.
Regarding Colasanti, Applicant arguments regarding Colasanti are moot because the reference is no longer relied upon.
Regarding Kabiri, Applicant argues Kabiri fails to teach the instant composition (see 9/5/25 Remarks at p. 25). Examiner agrees, WO’022 teaches the composition. Kabiri is relied upon as a reference to inform artisans that the concentration in contact with a retinal neuron is a result-effective variable, providing motivation to one in the art to experiment with parameters such as initial concentration or administration route to achieve a desired effect (see also MPEP § 2141.02(V) and 2144.05(II)). Kabiri also teaches a composition comprising a cannabinoid is capable of contacting a target retinal neuron.
Regarding cannabinoid selection, Applicant argues a POSITA would not select cannabinol from the teachings of WO’022 (see 9/5/25 Remarks at pp.28-29). Examiner disagrees. WO’022 teaches fully defined species in a finite list that recites cannabinol (see WO”022 claim 10). A POSITA would be able to reasonably select an option from a finite list (see MPEP § 2143(I)(E)).
Regarding unexpected results/critical range, in response to applicant’s argument that the concentration is critical (see 9/5/25 Remarks at p. 20), 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 even at 5-10 uM CBD, CBGA, CBDA, CBND, and THC are cytotoxic (see 9/5/25 Remarks at p. 21). The unexpected results are only relevant to CBN, 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.
Regarding modifying WO’022, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (see 9/5/25 Remarks at pp.30-31), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, WO’022 teaches a composition comprising cannabinol and a carrier for treating glaucoma (an eye disease). Kabiri informs artisans that targeting the retinal with a cannabinoid is a result-effective variable in eye administration. One skilled in the art seeking to treat an eye disease with a cannabinoid would reasonably look to other studies pertaining to cannabinoid administration in the eye.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26, 28-29, 31-32, 34-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
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 (see teachings of Kabiri below). It is unclear how much of the compound is in the tangible composition itself.
Furthermore, claims 26 and 35 recite “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 26 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 would raise 35 U.S.C. 101 issues.
Claim 26 recites “wherein the amount sufficient to inhibit neurodegeneration is a concentration of from about 0.15 uM to less than 15 uM of the neuroprotective compound in contact when measured in vivo with a target retinal neuron” and “wherein the pharmaceutical composition is in contact with a target retinal neuron” and “wherein the neuroprotective compound is present in the pharmaceutical composition at a concentration of from 0.1% w/w to 0.5% w/w”. It is unclear exactly how much of the neuroprotective compound is present. The claim describes 0.15-15 uM of the compound in contact with the neuron, but then additionally states the composition is touching the neuron and has 0.1-0.5 % w/w of the compound. Is it 0.15-15 uM? Is it 0.1-0.5% w/w? Are both these ranges referring to the same amount of compound? How would an infringer know if a composition comprising 2 mg or 10 g of a neuroprotective compound of Formula I infringes on the claim or not?
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 (see teachings of Kabiri below). Describing where the composition is does not add a structural limitation to the composition itself, only a desired intended use.
Claims 28-29, 31-32, 34 do not rectify these issues of indefiniteness and are thus included in the instant rejection.
For the purposes of applying art, claim 35 is interpreted as a compound claim, and the products of claims 26 and 35 simply need 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. The patentability of claim 26 rests in a composition comprising a compound of Formula I in a concentration of 0.1-0.5% w/w and a carrier, adjuvant, excipient, or vehicle; the wherein clause of “a concentration of about 0.15 uM to less than 15 uM of the neuroprotective compound” is being interpreted as an inherent property of a “neuroprotective compound is present in the pharmaceutical composition at a concentration of from 0.1% w/w to 0.5% w/w”.
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.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Claims 26, 28-29 and 35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 35 has been rejected as indefinite, but is reasonably understood to be directed to a cannabinoid, without explicitly requiring any additional components. Claims 26 and 28 have been rejected as indefinite, but are reasonably understood to be directed to a cannabinoid (specifically cannabinol or cannabinolic acid) and an excipient.
MPEP § 2106 discusses the applicable analysis (see esp. MPEP § 2106(III)).
Step 1: Here, the claims are directed to a composition of matter (Step 1: Yes).
Step 2A: The claims are directed to a natural phenomenon, namely a product of nature. For example, claims 26 and 35 encompasses cannabinol (see, e.g., Formula I, wherein R1 and R2 are H and R3 is n-C5H11) (Step 2A, Yes).
Step 2B: The claims explicitly recite the natural product of cannabinol. Although the claims ostensibly recite concentration-based limitations, these limitations do not amount to significantly more than the judicial exception, at least because:
Claims 26, 28-29 have been rejected as indefinite because it is unclear how much of the cannabinoid is present in the composition, but have reasonably interpreted as a composition comprising 0.1-0.5% w/w cannabinoid and a carrier, adjuvant, excipient, or vehicle (see, e.g., rejection under 35 USC 112(b), above). The claims as written does not exclude naturally occurring components as a carrier, adjuvant, excipient, or vehicle. The instant specification defines excipients as “a substance that aids in the administration of an active agent to the subject and/or absorption by a subject. Pharmaceutical excipients useful in the present invention include, but are not limited to binders, fillers, disintegrants, lubricants, coatings, sweeteners, flavors, and colors (see instant spec. at p. 15 ¶[0057]). Remington et. al.2 teaches water is a common vehicle used in medicinal preparations (see Remington at p. 746 “Water”). (Step 2B: No).
Claim 35 has been rejected as indefinite because it is unclear if the claim is a compound, composition, or method but is reasonably interpreted as a compound (see, e.g., rejection under 35 USC 112(b), above).
Furthermore, even considered in the light most favorable to the Applicant, the differences in concentration fail to differentiate the claimed compositions from the naturally occurring product of a cannabinoid because, there is no indication that the cannabinoid as presently claimed has any characteristics (structural, functional, or otherwise) that are different from naturally occurring cannabinoid. Rather, the indefinite concentration limitations at claims 26-28 and 35 appear to capture a cannabinoid at various stages of purification from natural cannabis plants. Accordingly, the instant claims are understood to be directed to cannabis plants and cannabinol (i.e., naturally occurring products), without significantly more (Step 2B: No).
In summary, the claim 35 recites a compound reading on naturally occurring cannabinol, which is not markedly different from its naturally occurring counterpart because it is found in the natural plant cannabis. Claims 26, 28-29 recite a compound reading on a naturally occurring cannabinol, further encompassing a natural product such as water. This judicial exception is not integrated into a practical application because the pharmaceutical composition comprising cannabinol does not add any meaningful limitations to distinguish it beyond the naturally occurring product; varying concentrations does not change the presence of the cannabinol or add to the compound beyond the naturally occurring cannabinol, and the intended use to contact with a target neuron does not alter the compound contents. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they only distinctly recite naturally occurring cannabinol.
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 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/205022 A13 in view of Kabiri et. al. 4
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 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 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).
The prior art differs from the instant claims as follows: While WO’022 discloses compositions comprising cannabinoids such as cannabinol for retinal diseases in 0.1 to 5 w/w%, it does not specify if the composition is capable of being in contact with a retinal neuron.
Regarding contacting a retinal neuron, 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. Kabiri teaches delivery of CBGA through a cornea (see Kabiri at p. 488 “corneal penetration study”) an controlled-release of cannabinoids into the eye (see Kabiri at p. 493 “Conclusions”). While Kabiri does not report a 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.
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 a composition capable of contacting a retinal neuron, one skilled in the art would readily recognize that the composition disclosed by WO’022 would be capable of contacting a retinal neuron through administration to an eye because Kabiri teaches drugs must diffuse through the aqueous and vitreous humors before interacting with receptors on the surface of retinal neuron, and teaches administration of cannabinoids into the eye.
Furthermore, it is well-within the ordinary skill in the art to optimize an initial dosage to result in a desired concentration. Furthermore, it is well-within the ordinary skill in the art to administer a known composition to a known target.
Accordingly, claims 26, 28-29, 31-32, 35 are rendered obvious.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/205022 A15 in view of Kabiri et. al. 6 as applied to claims 26, 28-29, 31-32, 35 above and in further view of Rapino et. al.7
The prior art differs from the instant claim as follows: While WO’022 and Kabiri teach 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 B28 in view of Kabiri. 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.
However, 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)).
Accordingly, instant claims 26, 28-29 and 31-32, 34-35 are rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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 Rapino et. al. "Neuroprotection by (Endo)Cannabinoids in Glaucoma and Retinal Neurodegenerative Diseases" Current Neuropharmacology, 2018, 16, 959-970. DOI: 10.2174/1570159X15666170724104305
2 Remington's Pharmaceutical Sciences (21st Ed) New York, NY: Lippincott Williams and Wilkins 2005. Select pages. Hereinafter Remington.
3 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).
4 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, hereinafter Kabiri.
5 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).
6 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, hereinafter Kabiri.
7 Rapino et. al. "Neuroprotection by (Endo)Cannabinoids in Glaucoma and Retinal Neurodegenerative Diseases" Current Neuropharmacology, 2018, 16, 959-970. DOI: 10.2174/1570159X15666170724104305
8 Corresponding to PCT/CA2018/050548, WO 2018/205022, and U.S. Application No. 16/611,837, patented September 10, 2024, hereinafter US’229.