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 .
DETAILED ACTION
Claims 1-3, 6-8, 19-20, 29, 54-55, and 57-58 are pending.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/25/2025 has been entered.
Claim Rejections - 35 USC § 112
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 1-3, 6-8, 19-20, 29, 54-55, and 57-58 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 1 recites in lines 6-8 the limitation “a bioactive agent and lipid component comprising: a bioactive agent comprising at least one bilayer forming bioactive lipid selected from the group consisting of a cannabinoid and a steroid”. The claim is indefinite because it is not clear if cannabinoid and steroid refer to the bioactive agent or the one bilayer forming lipid. Cannabinoid and steroid are lipids but they are not bilayer forming lipids.
Claim 1 recites in lines 16-17 the limitation “ratio of the apolipoprotein to the bioactive agent and lipid component is in the range of 1:100 to 1:200 w/w”. This limitation is indefinite because there are three components (bioactive agent, lipid, apolipoprotein) but only two variables in the recited range.
Claims 2-3, 6-8, 19-20, 29, 54-55, and 57-58 which depend from claim 1 do not cure the indefiniteness and are also rejected.
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 1-3, 6-8, 19-20, 29, 54-55, and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (WO 2016032153, published 03/2016, reference is herein made to text in the corresponding English language machine translated application; see attached copy) in view of Hung (WO-0103668-A1, published 01/2001, of record in Office Correspondence mailed on 01/31/2025, hereinafter “Hung”).
Regarding claims 1, 29, 54-55, and 57-58, the limitation “ratio of the apolipoprotein to the bioactive agent and lipid component is in the range of 1:100 to 1:200 w/w” is interpreted as ratio of apolipoprotein: bioactive agent+lipid is in the range of 1:100 to 1:200 w/w
Cho teaches liposomes comprising bioactive agent minoxidil, DMPC (dimyristoyl phosphatidylcholine) or POPC (palmitoyl oleoyl phosphatidylcholine) (i.e., liposome forming lipid), and apolipoprotein A-I ([35]-[36]). Cho teaches a weight ratio of apolipoprotein to phospholipids of 0.01:1 (i.e., weight ratio of apolipoprotein to phospholipids of 1:100) to form the apolipoprotein-liposome ([35]-[36]), and teaches adding 5mg of minoxidil to 1mg of formed apolipoprotein-liposome ([38]).
Cho does not teach that a weight ratio of apolipoprotein to the bioactive agent and the lipid component is in the range of 1:100 to 1:200 w/w; and that the plurality of the particles comprises a majority having diameters between 220 nm and 2.2 µm.
However, Hung teaches a liposome comprising a bioactive agent THC and a liposome forming lipid, dipalmitoyl phosphatidylcholine (Abstract, page 5 line 16). Hung teaches the liposome comprises 0.3mg/ml of THC (Table 1). Hung teaches that the liposomes were uniform in size and contained the bioactive agent (page 12 lines 7-20). Hung teaches that the particles’ size is 366 nm to 888 nm (page 12 lines 10-16, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Cho by substituting 0.3mg/ml THC of Hung for the 5mg of minoxidil of Cho (i.e., a weight ratio of apolipoprotein to the bioactive agent and the lipid component of 1:129 (0.01 mg apolipoprotein + 0.99 mg phospholipid + 0.3 mg cannabinoid) and by modifying the size of the particles to 366 nm or 888 nm as suggested by Hung. One of ordinary skill in the art would be motivated to do so in order to form liposome with larger encapsulated volume and adequate dose of THC. Since Cho and Hung teach a desire for forming particles to deliver bioactive agents, there is a reasonable expectation of success.
Applicant discloses that the ratio of 1:100 to 1:200 of the present claims provides protein stabilized liposomes which necessarily comprise an internal aqueous compartment (Remarks filed on 09/25/2025 page 7 para. 4). Thus the limitation of “wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment” is understood as a characteristic of the apoAI-liposome-cannabinoid composition and will be found in the modified particles of Cho in view of Hung.
Regarding claims 2 and 3, Cho teaches using 1 mg/ml of apolipoprotein-liposome in 1 ml of water and teaches that the ratio by weight of apolipoprotein to phospholipid is 1:100 in the liposome ([38], [36]). Thus, it is understood that the amount of apolipoprotein in the 1 ml of solution is 0.01 mg/ml (i.e., 10 μg/ml) which falls within the instant limitations of between about 0.1 μg/mL to about 11 mg/mL by weight and between about 0.5 μg/mL to about 200 μg/mL.
Regarding claims 6-7, Applicant’s disclosure shows the stability of the particles are a characteristic of the claimed particles (FIG. 4). Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (See MPEP 2112.01 (I) and (II)). In addition, Applicant discloses in FIG. 5 the presence of an apolipoprotein confers stability to the particle. Thus, absence of evidence to the contrary, the characteristic of “the plurality of PSLs in solution share at least 80% identity with an initial particle size distribution profile for about one year at about 4oC or for about three months at room temperature”, and “the plurality of PSLs in solution share at least 80% identity with an initial particle size distribution profile for about two years at about 4oC or for about six months at room temperature” will also be found in the modified particles of Cho in view of Hung.
Regarding claim 8, Cho does not teach a temperature at which the PSL disassembles. However, Applicant’s disclosure evidences that “at 65°C PSLs disassemble, this is predominantly due to the thermal stability of apolipoproteins, which lose structural integrity at above 65°C” (Specification [0012]). Cho teaches particles comprise apolipoprotein A. Thus, absent evidence to the contrary, this limitation will be inherently found in the modified particles of Cho in view of Hung.
Regarding claim 19, the limitation of “wherein the plurality of PSLs in solution maintain the integrity of at least about 80% of the plurality of PSLs at room temperature for at least two days” is a characteristic of the claimed PSL. Thus, absence of evidence to the contrary, this limitation will be inherently found in the modified particles of Cho in view of Hung.
Regarding claim 20, the limitation of “wherein at least about 80% of the plurality of PSLs in solution retain their bioactive agent cargo after 48 hours” is a characteristic of the claimed PSL. Thus, absence of evidence to the contrary, this limitation will be inherently found in the modified particles of Cho in view of Hung.
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 1-3, 6-8, 19-20, 29, 54-55, and 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 35 of U.S. Patent No. 7,824,709 in view of Cho and Hung.
Regarding instant claims 1, 29, 54-55, and 57-58, patent claim 1 recites particle consisting essentially of at least one lipid binding polypeptide, a lipid bilayer, and one or more bioactive agents. Patent claim 7 recites wherein the apolipoprotein is human apolipoprotein A-I. Patent claim 35 recites wherein the phospholipids comprise dipalmitoylphosphatidylcholine (DPPC) or egg phosphatidylcholine.
Patent claims 1, 7, and 35 do not recite bioactive agent THC, the ratio of the apolipoprotein to the bioactive agent and the lipid is in the range of 1:100 to 1:200 w/w, wherein the plurality of synthetic PSLs comprises a majority having diameters between 220 nm and 2.2 µm, and wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment.
However, Cho teaches liposomes comprising bioactive agent minoxidil, DMPC (dimyristoyl phosphatidylcholine) or POPC (palmitoyl oleoyl phosphatidylcholine) (i.e., liposome forming lipid), and apolipoprotein A-I ([35]-[36]). Cho teaches a weight ratio of apolipoprotein to phospholipids of 0.01:1 (i.e., weight ratio of 1:100) to form the apolipoprotein-liposome ([35]-[36]).
Hung teaches a liposome comprising a bioactive agent THC and a liposome forming lipid, dipalmitoyl phosphatidylcholine (Abstract, page 5 line 16). Hung teaches the liposome comprises 0.3mg/ml of THC (Table 1). Hung teaches the particles’ size is 366 nm to 888 nm (page 12 lines 10-16, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the particle recited in patent claims 1, 7, and 35 by mixing phospholipid, ApoAI and 0.3mg/ml THC with a weight ratio of apolipoprotein to the bioactive agent and the lipid component of 1:129 (0.01 mg apolipoprotein + 0.99 mg phospholipid + 0.3 mg cannabinoid) and by modifying the size of the particles to 366 nm or 888 nm as suggested by Cho and Hung. One of ordinary skill in the art would be motivated to do so in order to form stable liposome as a vehicle to effectively deliver an adequate and effective dose of THC and to provide a rapid increase and sustained therapeutic plasma cannabinoid concentration and maintain a desired clinical effect, as taught by Hung (page 3 lines 18-20).
Applicant discloses that the ratio of 1:100 to 1:200 of the present claims provides protein stabilized liposomes which necessarily comprise an internal aqueous compartment (Remarks filed on 09/25/2025 page 7 para. 4). Thus, the limitation of “wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment” is understood as a characteristic of the apoAI-liposome-cannabinoid composition and will be found in the modified particles in view of Cho and Hung.
The examiner notes that patent ‘709 does not expressly use the term liposome. However, patent ‘709 claims DPPC and a lipid bilayer. Instant claim 1 discloses DPPC is a liposome forming lipid. Hung teaches lipids used for the preparation of liposomes primarily consisted of DPPC and cholesterol (page 11 lines 25-27). Thus, it is reasonable to conclude that the “particles” of patent ‘709 are liposomes since the phospholipids comprise dipalmitoylphosphatidylcholine (DPPC).
Regarding claims 2 and 3, Cho teaches using 1 mg/ml of apolipoprotein-liposome in 1 ml of water and teaches the ratio by weight of apolipoprotein to phospholipid is 1:100 in the liposome ([38], [36]).
Regarding instant claims 6-8 and 19-20, Applicant’s disclosure shows the stability of the particles are a characteristic of the claimed particles (FIG. 4). Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Applicant discloses in FIG. 5 the presence of an apolipoprotein confers stability to the particle. Thus, absence of evidence to the contrary, the limitations of “at least about 80% of the plurality of PSLs in solution are not substantially disassembled for about two years at about 4°C or for about six months at room temperature”, wherein the plurality of PSLs at 65oC do not share at least 80% identity with an initial particle size distribution profile at room temperature” and “wherein at least about 80% of the plurality of PSLs in solution retain their bioactive agent cargo after 48 hours” are characteristics of the claimed PSL, and these limitations will be inherently found in recited particles of patent claim 1.
Claims 1-3, 6-8, 19-20, 29, 54-55, and 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 10 of U.S. Patent No. 8,821,939 in view of Cho and Hung.
Regarding instant claims 1, 29, 54-55, and 57-58, patent claim 1 recites particle comprising a lipid binding polypeptide, a lipid bilayer, and wherein the lipid bilayer includes a lipid with one or more bound bioactive agents. Patent claim 6 recites wherein the apolipoprotein is an exchangeable apolipoprotein, apolipoprotein E or is human apolipoproteinA-I. Patent claim 10 recites wherein the phospholipids comprise dimyristoylphosphatidylcholine (DMPC) and dimyristoylphosphatidylglycerol (DMPG), dipalmitoylphosphatidylcholine (DPPC) or egg phosphatidylcholine.
Patent claims 1, 6, and 10 does not recite bioactive agent THC, the ratio of the apolipoprotein to the bioactive agent and the lipid is in the range of 1:100 to 1:200 w/w, and wherein the plurality of synthetic PSLs comprises a majority having diameters between 220 nm and 2.2 µm, and wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment.
However, Cho teaches liposomes comprising bioactive agent minoxidil, DMPC (dimyristoyl phosphatidylcholine) or POPC (palmitoyl oleoyl phosphatidylcholine) (i.e., liposome forming lipid), and apolipoprotein A-I ([35]-[36]). Cho teaches a weight ratio of apolipoprotein to phospholipids of 0.01:1 (i.e., weight ratio of 1:100) to form the apolipoprotein-liposome ([35]-[36]).
Hung teaches a liposome comprising a bioactive agent THC and a liposome forming lipid, dipalmitoyl phosphatidylcholine (Abstract, page 5 line 16). Hung teaches the liposome comprises 0.3mg/ml of THC (Table 1). Hung teaches the particles’ size is 366 nm to 888 nm (page 12 lines 10-16, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the particle recited in patent claims 1, 6 and 10 by mixing phospholipid, ApoAI and 0.3mg/ml THC with a weight ratio of apolipoprotein to the bioactive agent and the lipid component of 1:129 (0.01 mg apolipoprotein + 0.99 mg phospholipid + 0.3 mg cannabinoid) and by modifying the size of the particles to 366 nm or 888 nm as suggested by Cho and Hung. One of ordinary skill in the art would be motivated to do so in order to form stable liposome as a vehicle to deliver adequate and effective dose of THC and to provide a rapid increase and sustained therapeutic plasma cannabinoid concentration and maintain a desired clinical effect, as taught by Hung (page 3 lines 18-20).
Applicant discloses that the ratio of 1:100 to 1:200 of the present claims provides protein stabilized liposomes which necessarily comprise an internal aqueous compartment (Remarks filed on 09/25/2025 page 7 para. 4). Thus, the limitation of “wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment” is understood as a characteristic of the apoAI-liposome-cannabinoid composition and will be found in the modified particles in view of Cho and Hung.
The examiner notes that patent ‘709 does not expressly use the term liposome. However, patent ‘709 claims DPPC and a lipid bilayer. Instant claim 1 discloses DPPC is a liposome forming lipid. Hung teaches lipids used for the preparation of liposomes primarily consisted of DPPC and cholesterol (page 11 lines 25-27). Thus, it is reasonable to conclude that the “particles” of patent ‘709 are liposomes since the phospholipids comprise dipalmitoylphosphatidylcholine (DPPC).
Regarding claims 2 and 3, Cho teaches using 1 mg/ml of apolipoprotein-liposome in 1 ml of water and teaches the ratio by weight of apolipoprotein to phospholipid is 1:100 in the liposome ([38], [36]).
Regarding instant claims 6-8 and 19-20, Applicant disclosure shows the stability of the particles are a characteristic of the claimed particles (FIG. 4). Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Applicant discloses in FIG. 5 the presence of an apolipoprotein confers stability to the particle. Thus, absence of evidence to the contrary, the limitations of “at least about 80% of the plurality of PSLs in solution are not substantially disassembled for about two years at about 4°C or for about six months at room temperature”, wherein the plurality of PSLs at 65oC do not share at least 80% identity with an initial particle size distribution profile at room temperature” and “wherein at least about 80% of the plurality of PSLs in solution retain their bioactive agent cargo after 48 hours” are characteristics of the claimed PSL, and these limitations will be inherently found in recited particles of patent claim 1.
Claims 1-3, 6-8, 19-20, 29, 54-55, and 57-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,107,826 in view of Cho and Hung.
Regarding instant claims 1, 29, 54-55, and 57-58, patent claim 1 recites pharmaceutical composition comprising a bioactive agent delivery particle, wherein said bioactive agent delivery particle comprises ApoA-I, a lipid bilayer, a bioactive agent. Patent claim 2 recites wherein said lipid bilayer comprises two or more phospholipids selected from the group consisting of DMPC, DMPG, POPC, DPPC, DPPS, cardiolipin, DPPG, DSPG, phosphatidylcholine, phosphatidylinositol, phosphatidic acid, sphingomyelin, and cationic phospholipids.
Patent claims 1 and 2 do not recite bioactive agent THC, the ratio of the apolipoprotein to the bioactive agent and the lipid is in the range of 1:100 to 1:200 w/w, and wherein the plurality of synthetic PSLs comprises a majority having diameters between 220 nm and 2.2 µm, and wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment.
However, Cho teaches liposomes comprising bioactive agent minoxidil, DMPC (dimyristoyl phosphatidylcholine) or POPC (palmitoyl oleoyl phosphatidylcholine) (i.e., liposome forming lipid), and apolipoprotein A-I ([35]-[36]). Cho teaches a weight ratio of apolipoprotein to phospholipids of 0.01:1 (i.e., weight ratio of 1:100) to form the apolipoprotein-liposome ([35]-[36]).
Hung teaches a liposome comprising a bioactive agent THC and a liposome forming lipid, dipalmitoyl phosphatidylcholine (Abstract, page 5 line 16). Hung teaches the liposome comprises 0.3mg/ml of THC (Table 1). Hung teaches the particles’ size is 366 nm to 888 nm (page 12 lines 10-16, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the particle recited in patent claims 1-2 by mixing phospholipid, ApoAI and 0.3mg/ml THC with a weight ratio of apolipoprotein to the bioactive agent and the lipid component of 1:129 (0.01 mg apolipoprotein + 0.99 mg phospholipid + 0.3 mg cannabinoid) and by modifying the size of the particles to 366 nm or 888 nm as suggested by Hung. One of ordinary skill in the art would be motivated to do so in order to form stable liposome as a vehicle to effectively deliver an adequate and effective dose of THC and to provide a rapid increase and sustained therapeutic plasma cannabinoid concentration and maintain a desired clinical effect, as taught by Hung (page 3 lines 18-20).
Applicant discloses that the ratio of 1:100 to 1:200 of the present claims provides protein stabilized liposomes which necessarily comprise an internal aqueous compartment (Remarks filed on 09/25/2025 page 7 para. 4). Thus, the limitation of “wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment” is understood as a characteristic of the apoAI-liposome-cannabinoid composition and will be found in the modified particles in view of Cho and Hung.
The examiner notes that patent ‘709 does not expressly use the term liposome. However, patent ‘709 claims DPPC and a lipid bilayer. Instant claim 1 discloses DPPC is a liposome forming lipid. Hung teaches lipids used for the preparation of liposomes primarily consisted of DPPC and cholesterol (page 11 lines 25-27). Thus, it is reasonable to conclude that the “particles” of patent ‘709 are liposomes since the phospholipids comprise dipalmitoylphosphatidylcholine (DPPC).
Regarding claims 2 and 3, Cho teaches using 1 mg/ml of apolipoprotein-liposome in 1 ml of water and teaches the ratio by weight of apolipoprotein to phospholipid is 1:100 in the liposome ([38], [36]).
Regarding instant claims 6-8 and 19-20, Applicant disclosure shows the stability of the particles are a characteristic of the claimed particles (FIG. 4). Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Applicant discloses in FIG. 5 the presence of an apolipoprotein confers stability to the particle. Thus, absence of evidence to the contrary, the limitations of “at least about 80% of the plurality of PSLs in solution are not substantially disassembled for about two years at about 4°C or for about six months at room temperature”, wherein the plurality of PSLs at 65oC do not share at least 80% identity with an initial particle size distribution profile at room temperature” and “wherein at least about 80% of the plurality of PSLs in solution retain their bioactive agent cargo after 48 hours” are characteristics of the claimed PSL, and these limitations will be inherently found in recited particles of patent claim 1.
Response to Arguments
The affidavit under 37 CFR 1.132 filed 09/25/2025 is insufficient to overcome the rejection of claims 1-3, 6-8, 19-20, 29, 54-55, and 57-58 based upon non-obviousness in view of Ryan (US 7,824,709) as set forth in the last Office action because:
Dr. Oda argues that Ryan teaches a molar ratio on the order of about 1:100 (apolipoprotein: lipid) and not a weight ratio. Dr. Oda argues that Ryan’s weight ratio is 1:3.5 and that no prior art teaches the claimed weight ratio to yield stable liposome. Dr. Oda argues ApoA-1 and ApoE have substantially different physical properties.
In response to the argument, Ryan is not relied upon in this rejection. New reference Cho teaches liposomes comprising bioactive agent, DMPC (dimyristoyl phosphatidylcholine) or POPC (palmitoyl oleoyl phosphatidylcholine) (i.e., liposome forming lipid), and apolipoprotein A-I ([35]-[36]) and teaches a weight ratio of apolipoprotein to phospholipids of 0.01:1 (i.e., weight ratio of 1:100) ([36]).
Applicant argues that the weight ratio of 1:3.5 described in Ryan provides nanodisks which are necessarily planar and lack an internal aqueous compartment, that the ratio of 1:100 to 1:200 of the present claims provides protein stabilized liposomes-which necessarily comprise an internal aqueous compartment, and that Ryan uses ApoE and not ApoA-I.
New reference Cho teaches liposomes comprising bioactive agent, liposome forming lipid and apolipoprotein A-I and teaches a weight ratio weight ratio of apolipoprotein A-I: lipid of 1:100. Applicant discloses that the ratio of 1:100 to 1:200 of the present claims provides protein stabilized liposomes which necessarily comprise an internal aqueous compartment (Remarks filed on 09/25/2025 page 7 para. 4). Thus, the limitation of “wherein each PSL of the plurality of PSLs encapsulates an aqueous internal compartment” is understood as a characteristic of the apoAI-liposome-cannabinoid composition and will be found in the modified particles in view of Cho and Hung.
Applicant argues the references cited in the double-patenting rejections fail to provide an "apparent reason" that would have motivated a person of ordinary skill in the art to arrive to the ratio of apolipoprotein to bioactive agent and lipid component recited in claim 1 is a critical element of the liposomes-not micelles, as described in Nunez; and second the apolipoprotein A-I (ApoA-1) of claim 1 and the apolipoprotein E (ApoE) of Nunez are not functionally equivalent apolipoproteins which can be substituted to obtain a predictable result.
In response to the argument, Nunez is not relied upon in this rejection. New reference Cho teaches liposomes comprising bioactive agent, liposome forming lipid, and apolipoprotein A-I ([35]-[36]) and teaches a weight ratio of apolipoprotein to phospholipids of 0.01:1 (i.e., weight ratio of 1:100) ([36]). Hung teaches liposomes are good vehicles to deliver THC to a patient and teaches a concentration of THC in the liposome of 0.3 mg/ml. One of ordinary skill in the art would be motivated to modify the particles recited in the patent claims in order to form liposome as a delivery vehicle for THC in a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699