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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/12/2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, TLR7 agonist combined with at least one more API that modulates an immune response (Genus A) and release from the composition after administration to a human or animal body at comparable rates (Genus B) in the reply filed on 6/21/2024 is acknowledged.
Claims 19-27, 29-32, 34, 36-37, and 40-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I and species of Genus A & B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/21/2024. In the reply filed on 6/21/2024, Applicant did not elect a species from Genus C. Applicant will be required to elect a species in the future as prosecution advances.
Status of Claims
Cancelled: 5, 7-9, 15
Withdrawn: 19-27, 29-32, 34, 36-37, 40-43
New: 47-49
Examined Herein: 1-4, 6, 10-14, 16-18, 28, 33, 35, 38-39, 44-49
Priority
Priority to SE1950699-7 filed on 6/12/2019 and PCT/EP2020/066403 filed on 6/12/2020 is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/28/2022 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Drawings
The drawings filed on 12/13/2021 are accepted.
Withdrawn Rejections
The rejections of claim 2 under 35 U.S.C. 112(b) and 112(d) is hereby withdrawn in view of Applicant’s amendments to claim 2 which removes the limitation "the hydrophobic saccharide is an iodinated disaccharide comprising iodinated benzyl groups,” thereby rendering the rejections moot.
The rejection of claim 3 under 35 U.S.C. 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 3 which removes the trademark/trade name Lipiodol, thereby rendering the rejection moot.
The rejection of claim 35 under 35 U.S.C. 112(b) is hereby withdrawn in view of Applicant’s amendments to claim 35 which removes the phrase "such as," thereby rendering the rejection moot.
The rejection of claims 1-2, 4, 6, 10-14, 16-18, 28, 33, 35, 38-39, 44-46 under 35 U.S.C. 103 over Andresen, Ahmad, and Fukagawa is hereby withdrawn in view of Applicant’s arguments challenging the motivation to combine Andresen and Fukagawa, which are directed to different technical fields.
The rejection of claims 1-4, 6, 10-14, 16-18, 28, 33, 35, 38-39, 44-46 under 35 U.S.C. 103 over Andresen, Ahmad, Fukagawa, and Jeong is hereby withdrawn in view of Applicant’s arguments challenging the motivation to combine Andresen and Fukagawa, which are directed to different technical fields.
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.
Claims 13 and 14 rejected under 35 U.S.C. 112(b) 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.
Claims 13 and 14 contain the trademark/trade name Lipiodol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a lipid oil and, accordingly, the identification/description is indefinite.
Claim 14 recites the limitation “SuBen:GTO:EtOH (60:25:15 w/w), LacBen: Lipiodol: EtOH (60:25:15 w/w), LacBen:Ethyl-palmitate: EtOH (60:25:15), CLA-8:SuBen:GTO:EtOH (20:40:25:15).” SuBen:GTO:EtOH and LacBen:Lipiodol:EtOH are defined by the units w/w. However, the units for LacBen:Ethyl-palmitate:EtOH and CLA-8:SuBen:GTO:EtOH are not defined. As a result, it is unclear what units of measurement the ratios for LacBen:Ethyl-palmitate:EtOH and CLA-8:SuBen:GTO:EtOH are based on. Appropriate correction is required. Applicant may consider amending the claim to specify the unit of measurement for LacBen:Ethyl-palmitate: EtOH and CLA-8:SuBen:GTO:EtOH.
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, 2, 4, 6, 10-12, 16-18, 28, 35, 38, 39, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Andresen (US 2018/0325819 A1, Published 11/15/2018) and Albrechtsen (US 2016/0089454 A1, Published 3/31/2016).
With respect to claim 1, Andresen discloses a composition comprising;
A) a hydrophobic saccharide, lactose acetate:propionate (1:1) (78% w/w)
B) a solvent, propylene carbonate (5% w/w) and EtOH (10% w/w)
C) a lipid oil, glycerol trioctanoate (5% w/w); and
D) an active pharmaceutical ingredient (API), imiquimod. [Andresen, 0344 and Figure 17]
Andresen implicitly discloses the composition is homogenous at 20°C. Andresen discloses (1) the composition is injected and (2) in order for the composition (or gel forming system) to be
injectable it should be in a sol state with a sufficiently low viscosity of less than 10,000 cP at 20°C. [Andresen, 0100, 0329, 0345] A sol state is a homogenous distribution. Thus, since Andresen discloses the composition is injected/injectable, it is reasonable to conclude the composition is necessarily in a homogenous distribution at 20°C.
With respect to claim 4, Andresen discloses the composition may comprise an iodinated derivative of lactose. [Andresen, 0097]
With respect to claim 6, Andresen discloses the composition comprises a lipid oil, glyceryl
trioctanoate. [Andresen, 0344, Figure 17d]
With respect to claim 10, Andresen discloses about 78% of the composition is a hydrophobic
saccharide. [Andresen, 0344, Figure 17d]
With respect to claim 11, Andresen discloses the composition comprises 2% PLGA. [Andresen, 0344 and Figure 17]
With respect to claim 12, Andresen discloses the solvent constitutes 15% of the composition.
[Andresen, 0344, Figure 17d]
With respect to claim 16, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Imiquimod is chemically stable for more than 7 days at 20°C.
With respect to claim 17, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Imiquimod is a drug that modulates an immune response.
With respect to claim 18, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Imiquimod is a TLR7 agonist. Andresen further discloses the composition may comprise a combination of two drugs, including resiquimod, imiquimod, R850, R851, TMX-101, TMX-201, TMX-202, which are TLR7 agonists that modulate an immune response. [Andresen, 0119, 0123]
With respect to claim 28, Andresen discloses the API, imiquimod, is dissolved at a concentration of about 2.6 mg/g. [Andresen, 0344] Andresen implicitly discloses the APIs are dissolved at 20°C. For the reasons described above, it is reasonable to conclude the composition is homogenous at 20°C. In a homogenous mixture, solutes are completely dissolved. Thus, since the composition comprises a solute, imiquimod, and is homogenous at 20°C, then said solute must be completely dissolved. Therefore, it is reasonable to conclude the API is dissolved at 20°C.
With respect to claim 35, Andresen discloses the composition may comprise contrast agents that make the composition visible in x-ray imaging including one or more iodinated polymers, iodinated oligomers, iodinated lipids, iodinated saccharides, iodinated disaccharides, iodinated polysaccharides, iodinated peptides, or a derivative or a combination thereof. [Andresen, 0097]
With respect to claim 39, Andresen discloses the composition may comprise iodinated saccharides, iodinated disaccharides, iodinated polysaccharides, or a derivative or a combination thereof. [Andresen, 0097]
With respect to claim 44, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Less than 10% of imiquimod changes chemical structure within 7 days at less than 20°С.
With respect to claim 45-46, Andresen discloses the solvent is EtOH and propylene carbonate. [Andresen, 0344 and Figure 17d]
Moreover, Anderson discloses the composition may comprise iodinated derivates of sucrose acetate isobutyrate (SAIB). [Andresen, 0095, 0097, 0098]
Andresen does not disclose the composition comprises a hydrophobic saccharide being sucrose benzoate (SuBen).
However, with respect to claim 1 and 49, Albrechtsen discloses the following iodinated sucrose benzoate compounds are SAIB derivatives. [Albrechtsen, 0061]
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[Albrechtsen, Figure 7]
Modifying the composition disclosed by Andresen by adding iodinated sucrose benzoate to the composition results in the composition of claim 1 and 49, wherein the composition comprises a hydrophobic saccharide being sucrose benzoate (SuBen).
In which case, and with respect to claim 33, Andresen and Albrechtsen disclose a composition identical to instant claim 1. If the prior art teaches the identical chemical structure of a chemical composition, the properties applicant claims are necessarily present because a chemical composition and its properties are inseparable. Therefore, the APIs in the composition disclosed by Andresen and Albrechtsen are necessarily released from the composition after administration to a human or animal body at comparable rates. It is reasonable to conclude that this property necessarily flows from the teachings of the applied prior art because Andresen discloses the API, imiquimod, is released in vitro from the composition at a comparable rate to a similar composition after administration to small aliquots of PBS, under conditions mimicking a human body. [Andresen, 0110, 0344, Figure 31b and 31d; See also 0341 and Figure 31b] Therefore, since Andresen and Albrechtsen disclose a composition identical to instant claim 1 and said composition exhibits the claimed property under conditions mimicking administration to a human body, the limitations of instant claim 33 are necessarily present.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Andresen by adding iodinated sucrose benzoate to the composition and have a reasonable expectation of success. Andresen discloses a composition which may comprise iodinated derivates of sucrose acetate isobutyrate (SAIB). Albrechtsen discloses iodinated sucrose benzoate compounds are SAIB derivatives. Thus, the combined teachings of Andresen and Albrechtsen suggest the composition disclosed by Andresen may comprise iodinated sucrose benzoate compounds. Therefore, it is reasonable to expect the composition disclosed by Andresen may be modified by adding iodinated sucrose benzoate to the composition. One would have been motivated to do so because Andresen provides an express rationale to modify the composition, as Andresen discloses the composition may comprise iodinated derivates of SAIB. Therefore, one would have been motivated to add iodinated sucrose benzoate compounds to the composition because Albrechtsen discloses that they are SAIB derivatives. Moreover, it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Andresen discloses including iodinated derivatives of SAIB in the composition enables the composition to be used as an x-ray contrast agent. [Andresen, 0097] Therefore, one would have been motivated by the expectation that the aforementioned modification would enable the composition to be used as an x-ray contrast agent.
Claims 1, 2, 4, 6, 10-12, 16-18, 28, 35, 38, 39, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Andresen and Chung (US 2008/0249296 A1, Published 10/9/2008).
With respect to claim 1, Andresen discloses a composition comprising;
A) a hydrophobic saccharide, lactose acetate:propionate (1:1) (78% w/w)
B) a solvent, propylene carbonate (5% w/w) and EtOH (10% w/w)
C) a lipid oil, glycerol trioctanoate (5% w/w); and
D) an API, imiquimod. [Andresen, 0344 and Figure 17]
Andresen implicitly discloses the composition is homogenous at 20°C. Andresen discloses (1) the composition is injected and (2) in order for the composition (or gel forming system) to be
injectable it should be in a sol state with a sufficiently low viscosity of less than 10,000 cP at 20°C. [Andresen, 0100, 0329, 0345] A sol state is a homogenous distribution. Thus, since Andresen discloses the composition is injected/injectable, it is reasonable to conclude the compositions is necessarily in a homogenous distribution at 20°C.
Moreover, Anderson discloses the hydrophobic saccharide, lactose acetate:propionate (1:1), is a derivative of lactose and functions as the non-water soluble carbohydrate of the composition. However, Andresen further discloses the non-water soluble carbohydrate may be a derivative selected from derivatives of lactose, maltose, trehalose, raffinose, glucosamine, galactosamine, lactosamine, or derivatives of disaccharides with at least two pyranose saccharides. [Andresen, Abstract and 0012]
With respect to claim 4, Andresen discloses the aforementioned compositions may comprise an
iodinated derivative of lactose. [Andresen, 0097]
With respect to claim 6, Andresen discloses the composition comprises a lipid oil, glyceryl
trioctanoate. [Andresen, 0344, Figure 17d]
With respect to claim 10, Andresen discloses about 78% of the composition is a hydrophobic
saccharide. [Andresen, 0344, Figure 17d]
With respect to claim 11, Andresen discloses the composition comprises 2% PLGA. [Andresen, 0344 and Figure 17]
With respect to claim 12, Andresen discloses the solvent constitutes 15% of the composition.
[Andresen, 0344, Figure 17d]
With respect to claim 16, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Imiquimod is chemically stable for more than 7 days at 20°C.
With respect to claim 17, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Imiquimod is a drug that modulates an immune response.
With respect to claim 18, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Imiquimod is a TLR7 agonist. Andresen further discloses the composition may comprise a combination of two drugs, including resiquimod, imiquimod, R850, R851, TMX-101, TMX-201, TMX-202, which are TLR7 agonists that modulate an immune response. [Andresen, 0119, 0123]
With respect to claim 28, Andresen discloses the API, imiquimod, is dissolved at a concentration of about 2.6 mg/g. [Andresen, 0344] Andresen implicitly discloses the APIs are dissolved at 20°C. For the reasons described above, it is reasonable to conclude the composition is homogenous at 20°C. In a homogenous mixture, solutes are completely dissolved. Thus, since the composition comprises a solute, imiquimod, and is homogenous at 20°C, then said solute must be completely dissolved. Therefore, it is reasonable to conclude the API is dissolved at 20°C.
With respect to claim 35, Andresen discloses the composition may comprise contrast agents that make the composition visible in x-ray imaging including one or more iodinated polymers, iodinated oligomers, iodinated lipids, iodinated saccharides, iodinated disaccharides, iodinated polysaccharides, iodinated peptides, or a derivative or a combination thereof. [Andresen, 0097]
With respect to claim 39, Andresen discloses the composition may comprise iodinated saccharides, iodinated disaccharides, iodinated polysaccharides, or a derivative or a combination thereof. [Andresen, 0097]
With respect to claim 44, Andresen discloses the API is imiquimod. [Andresen, 0344, Figure 17d] Less than 10% of imiquimod changes chemical structure within 7 days at less than 20°С.
With respect to claim 45-46, Andresen discloses the solvent is EtOH and propylene carbonate. [Andresen, 0344 and Figure 17d]
Andresen does not disclose the composition comprises a hydrophobic saccharide being lactose benzoate (LacBen) or the hydrophobic saccharide is α,B-Lactose iodobenzoate or the composition comprises an iodinated lactose derivative
However, with respect to claim 1, 2, and 4, Chung discloses lactose octabenzoate is a lactose derivative. [Chung, 0128]
Modifying the composition disclosed by Andresen by replacing the hydrophobic saccharide, lactose acetate:propionate (1:1), with lactose octabenzoate results in the composition of claim 1, wherein the composition comprises a hydrophobic saccharide being lactose benzoate (LacBen).
In which case, with respect to claim 38, Andresen and Chung disclose the lactose benzoate is lactose octabenzoate.
Further modifying the composition disclosed by Andresen and Chung by iodinating lactose octabenzoate, results in the composition of claim 2 and 4, wherein the hydrophobic saccharide of the composition is an iodinated saccharide, lactose iodobenzoate.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Andresen by replacing the hydrophobic saccharide, lactose acetate:propionate (1:1), with lactose octabenzoate and have a reasonable expectation of success. Andresen discloses a composition comprising lactose acetate:propionate (1:1), which is a derivative of lactose and functions as the non-water soluble carbohydrate of the composition. However, Andresen further discloses the non-water soluble carbohydrate may be a derivative of lactose. Chung discloses lactose octabenzoate is a lactose derivative. Thus, the combined teachings of Andresen and Chung suggest the non-water soluble carbohydrate in the composition disclosed by Andresen may be lactose octabenzoate. Therefore, it is reasonable to expect the composition disclosed by Andresen may be modified by replacing the hydrophobic saccharide/non-water soluble carbohydrate, lactose acetate:propionate (1:1), with lactose octabenzoate. One would have been motivated to do so because Andresen provides an express rationale to modify the composition. Andresen discloses the non-water soluble carbohydrate of the composition may be a derivative of lactose. Therefore, one would have been motivated to replace lactose acetate:propionate (1:1), with lactose octabenzoate because Chung discloses that lactose octabenzoate is a derivative of lactose. Moreover, the selection of a known material based on its suitability for its intended use is prima facie obvious. Therefore, the selection of lactose octabenzoate based on its suitability as a derivative of lactose for its intended use as the non-water soluble carbohydrate of the composition disclosed by Andresen is prima facie obvious.
It would be obvious to one of ordinary skill in the art to further modify the composition disclosed by Andresen and Chung by iodinating lactose octabenzoate and have a reasonable expectation of success. Andresen and Chung disclose a composition comprising lactose octabenzoate. Lactose octabenzoate is a derivative of lactose. Andresen further discloses the composition may comprise iodinated derivatives of lactose. Thus, the combined teachings of Andresen and Chung suggest the derivative of lactose, lactose octabenzoate, present in the composition may be iodinated to yield an iodinated derivative of lactose. Therefore, it is reasonable to expect the composition disclosed by Andresen and Chung may be further modified by iodinating lactose octabenzoate. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Andresen discloses including iodinated derivatives of lactose in the composition enables the composition to be used as an x-ray contrast agent. [Andresen, 0097] Therefore, one would have been motivated by the expectation that the aforementioned modification would enable the composition to be used as an x-ray contrast agent.
Claims 1-4, 6, 10-14, 16-18, 28, 35, 38, 39, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Andresen and Chung, as applied to claims 1, 2, 4, 6, 10-12, 16-18, 28, 35, 38, 39, and 44-46 above, and further in view of Jeong (US 2004/0087567 A1, Published 5/6/2004).
With respect to claim 1, Andresen and Chung disclose the teachings above.
Recall, Andresen and Chung disclose the composition comprises a lipid oil, glycerol trioctanoate.
With respect to claim 3, 47, and 48, Andresen and Chun disclose the composition may comprise iodinated lipids for use as an x-ray contrast agent. [Andresen, 0097]
With respect to claim 13, Andresen and Chun disclose the composition comprises LacBen:EtOH. [Andresen, 0344]
With respect to claim 14, Andresen and Chun disclose the composition comprises LacBen:EtOH and the API, imiquimod, is dissolved. [Andresen, 0344] Andresen further discloses the composition may comprise 49-80 % gel forming carbohydrate (e.g., LacBen), 0-50 % additive (e.g., glycerol trioctanoate or an x-ray contrast agent), and 20-30% non-toxic water miscible solvent (e.g., EtOH). [Andresen, 0082, 0132, 0135, 0329]
Andresen and Chung do not disclose the lipid oil is an ethiodized oil.
However, with respect to claim 3, 47, and 48, Jeong discloses Lipiodol (ethiodized oil) is an iodinated lipid and contrast medium. [Jeong, 0004] Lipiodol (ethiodized oil) is a combination of iodine and ethyl esters of poppy seed oil.
Modifying the compositions disclosed by Andresen and Chung by replacing glycerol trioctanoate with an ethiodized oil results in the composition of claim 3, 47, and 48.
In which case, with respect to claim 13, the composition disclosed by Andresen, Chung, and Jeong comprises LacBen:Lipiodol:EtOH.
Further modifying the composition disclosed Andresen and Chung by adjusting the amount of LacBen:ethiodized oil:EtOH to 60:25:15 (w/w) results in the composition of claim 14.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Andresen and Chung by replacing glycerol trioctanoate with an ethiodized oil and have a reasonable expectation of success. Andresen and Chung disclose a composition comprising a lipid oil, glycerol trioctanoate. Andresen discloses glycerol trioctanoate functions as an additive in the composition.
Andresen further discloses the composition may comprise iodinated lipids, which may also function as an additive in the composition and enable the composition to be used as an x-ray contrast agent. Jeong discloses Lipiodol (ethiodized oil) is an iodinated lipid and contrast medium. Thus, the combined teachings of Andresen/Chung and Jeong suggest Lipiodol (ethiodized oil) may function as the lipid oil and additive in the composition disclosed by Andresen and Chung. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Andresen discloses including iodinated lipids in the composition enables the composition to be used as an x-ray contrast agent. [Andresen, 0097] Therefore, one would have been motivated by the expectation that the aforementioned modification would enable the composition to be used as an x-ray contrast agent.
It would be obvious to one of ordinary skill in the art to further modify the composition disclosed by Andresen and Chung by adjusting the amount of LacBen:ethiodized oil:EtOH to 60:25:15 w/w and have a reasonable expectation of success through routine optimization. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. The general conditions of the instant composition are disclosed by Andresen and Chung, as described above, thus it is not inventive to discover the optimum or workable ratio of LacBen:ethiodized oil:EtOH by routine experimentation. MPEP 2144.05(II)(A) It would have been routine optimization to arrive at the claimed invention because Andresen and Chung disclose a composition comprising LacBen:Lipidol:EtOH. Andresen further discloses the composition may comprise 49-80 % gel forming carbohydrate (e.g., LacBen), 0-50 % additive (e.g., glycerol trioctanoate or an x-ray contrast agent such as lipidol), and 20-30% non-toxic water miscible solvent (e.g., EtOH) relative to the total composition. Thus, the teachings of Andresen establish the gel forming carbohydrate (Lactose octabenzoate), the additive (lipiodol/ethiodized oil), and the solvent (EtOH) may be present in varied amounts and by extension, varied relative proportions including the claimed ratio of 60:25:15 (w/w). A person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range because the claimed ratio lies within the ranges disclosed by the prior art. Therefore, it is prima facie obvious to modify the composition disclosed by Andresen and Chung by adjusting the components within the amount disclosed by the prior art.
Response to Arguments
Applicant’s arguments filed 9/29/2025 with respect to the rejection of claims 1-2, 4, 6, 10-14, 16-18, 28, 33, 35, 38, 39, and 44-46 under 35 U.S.C 103 over Andresen, Ahmad, and Fukagawa have been fully considered and are persuasive. Specifically, Applicant’s arguments challenging the motivation to combine Andresen and Fukagawa in view of their different technical fields are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the references cited above.
Throughout the remarks of 9/29/2025 Applicant states that the instant composition is drawn to a non-aqueous gel. However, the instant claims are not limited to this embodiment. The instant claims do not exclude the addition of an aqueous component to the composition and the presence of an aqueous component does not preclude the composition from being homogenous at 20°C (as the composition may exist as a single-phase at 20°C but exhibit phase separation under other conditions/temperatures).
Conclusion
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618