DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment to the claims, filed on August 8, 2025, is
acknowledged. This listing of the claims replaces all prior versions and listings of the
claims.
Claims 1-17 and 20-21 are pending and are being examined on the merits.
Claims 18-19 are cancelled.
Applicant’s remarks filed August 8, 2025 in response to the non-final rejection mailed February 10, 2025, is acknowledged and have been fully considered.
Previous rejections of claims 18-19 are withdrawn in view of the instant amendment to cancel these claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Drawings
The objection of the drawings because Figures 3-4 are illegible is withdrawn in view of replacement drawings filed August 8, 2025.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 6, 9, and 12-14 for being indefinite because of the use of the relative term “about” is withdrawn in view of the amendments to remove the term “about” in claims 6, 9, and 12-14.
The rejection of claims 6, 9, and 12 as indefinite because of the lack of clarify in the recitation of “U/g” is withdrawn in view of the amendment to claims 6, 9, and 12 to include the method by which the activity of SOD is determined (i.e., xanthine and xanthine oxidase-based colorimetric assay).
Claim Rejections - 35 USC § 101
The rejections of claims 1-20 under 35 U.S.C. 101 are withdrawn in view of the amendment to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm”, which distinguishes the claimed composition from naturally occurring organisms and extracts thereof comprising their cellular contents.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 13-17, and 20 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated Kabanov et al. (US 2013/0052154 A1, published February 28, 2013; cited on the attached Form PTO-892 mailed February 10, 2025; hereafter “Kabanov”) is withdrawn because the reference does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.”
The rejection of claims 1-3, 7-9, and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Kuwong et al. (Creighton University, published July 8, 2021; cited on the attached Form PTO-892 mailed February 10, 2025; hereafter “Kuwong”) is withdrawn because the reference does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.”
The rejection of claims 1-6 and 13-17 under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (Journal of Functional Foods, E-published July 16, 2019, No. 60, pg. 1-10; cited on the attached Form PTO-892 mailed February 10, 2025; hereafter “Xu”) is withdrawn because the reference does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.” The rejection of claim 6 is also withdrawn because the combination of cited references does not teach the newly added limitation to claim 6 to recite “wherein the standardized SOD content is measured by a xanthine and xanthine oxidase-based colorimetric assay.”
The rejection of claims 1-3, 10-12, and 14-19 under 35 U.S.C. 102(a)(1) as being anticipated by Ghahari et al. (Curr Microbiol, Published April 2017, E-published March 2, 2017,Vol. 74, No. 4, pg. 522-531; cited on the attached Form PTO-892 mailed February 10, 2025; hereafter “Ghahari”) is withdrawn because the reference does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.” The rejection to claim 9 is also withdrawn because the combination of cited references does not teach the newly added limitation to claim 9 to recite “wherein the standardized SOD content is measured by a xanthine and xanthine oxidase-based colorimetric assay.”
Claim Rejections - 35 USC § 103
The rejection of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Kabanov, in view of Kuwong, Xu, Ghahari, and Williams (Natural Product Communications, E-published March 1, 2009, Vol. 4, No. 3, p. 435-446; cited on the attached Form PTO-892 mailed February 10, 2025; hereafter “Williams”) is withdrawn because the combination of cited references does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.” The rejections of claims 6, 9, and 12 are also withdrawn because the combination of cited references does not teach the newly added limitation to claims 6, 9, and 12 to recite “wherein the standardized SOD content is measured by a xanthine and xanthine oxidase-based colorimetric assay.”
Claims 1, 13-17, and 20 are newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov et al. (Biophysical Journal, published April 12, 2016, Vol. 110, No. 7, p. 1499-1509; cited on the attached Form PTO-892; hereafter “Petrov”) and Sumiyoshi et al. (US 2010/0092446 A1; cited on the attached Form PTO-892; hereafter “Sumiyoshi”). This rejection is necessitated by the amendment to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.”
The claims are drawn to a composition, comprising: a combination of a therapeutically effective amount of superoxide dismutase (SOD) provided by a natural source with a stabilizing carrier wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.
Regarding claims 1, 15, 17, and 20, Kabanov teaches a composition comprising the enzymatic antioxidant SOD and at least one other therapeutic agent, such as an antioxidant, in order to inhibit, treat, and/or prevent oxidative stress associated disorders like inflammation (Title; para [0024 – 0026, 0032, 0038, 0055-0056, 0059, 0062, 0090, 0105, 0107- 0108]; Claim 6). Kabanov refers to “antioxidant” as compounds that neutralize the activity of reactive oxygen species or inhibit the cellular damage done by the reactive species or their reactive byproducts or metabolites, and also referred to “antioxidant” as compounds that inhibit, prevent, reduce, or ameliorate oxidative reactions (para [0045]). Kabanov further teaches the SOD is SOD1 is from a natural source of bovine erythrocytes (para [0080]). Regarding the limitation “therapeutically effective amount,” no condition or disease to be treated is recited in the claims and so any amount of SOD is considered to be therapeutically effective. As such, the composition taught by Kabanov is considered to comprise a “therapeutically effective amount” of SOD.
Regarding claim 16, Kabanov teaches the composition comprises a pharmaceutically acceptable carrier of water (para [0040, 0042, 0064]). Based on these teachings, an ordinary artisan would have recognized that the composition of Kabanov is water soluble.
Kabanov does not teach the claim 1 limitation wherein the carrier comprising water is deoxygenated water having a dissolved oxygen content of 2 ppm.
Petrov teaches that SOD1 is susceptible to oxidative damage (Abstract). Petrov teaches that when SOD1 experiences oxidative damage, the enzyme’s activity, stability, folding, and propensity to aggregate are altered (Abstract, p. 1500, col 1, para 2).
Sumiyoshi teaches producing a drug solution with a reduced dissolved oxygen content of 2 ppm in order to suppress the oxidative degradation of the drug solution so that the drug solution has high stability over time (Abstract; para [0011, 0022, 0014, 0041]).
In view of the combined teachings of Kabanov, Petrov, and Sumiyoshi, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising SOD in a pharmaceutically acceptable carrier of water taught by Kabanov such that the water is deoxygenated water wherein the water comprises a dissolved oxygen content of 2 ppm, thereby arriving at the invention of claims 1, 15-17, and 20.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to modify the composition comprising SOD in a pharmaceutically acceptable carrier of water taught by Kabanov such that the water is deoxygenated water wherein the water comprises a dissolved oxygen content of 2 ppm. This is because Petrov taught that when SOD1 experiences oxidative damage alters the enzyme’s activity and stability, and Sumiyoshi taught producing a drug solution with a reduced dissolved oxygen content of 2 ppm in order to suppress the oxidative degradation of the drug solution so that the drug solution has high stability over time stability. Therefore, modifying the water carrier to comprise 2 ppm dissolved oxygen content would reduce the likelihood of oxidative induced damage to SOD that decreases its effectiveness.
Regarding claim 13, the relevant teachings of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 15-17, and 20, are discussed above and incorporated herein.
Kabanov further teaches that antioxidants include vitamins (i.e., vitamin E, vitamin C, vitamin A) (para [0045]). Kabanov teaches antioxidants are therapeutic agents (para [0056]).
Kabanov does not teach the vitamin is present in an amount of from 1 wt% to 10 wt% as recited in claim 13. However, in view of the combined teachings of Kabanov, Petrov, and Sumiyoshi, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention for the content of the antioxidant consisting of vitamin E, vitamin C, vitamin A, or a combination thereof to be 1 wt% to 10 wt% of the composition. Since the prior art teaches the treatment of a plurality of oxidative damage related conditions, such as inflammation, with a composition comprising the bioactive agent and enzymatic antioxidant of SOD with at least one other bioactive agent like an antioxidant, an ordinary artisan would have recognized the content of the antioxidant vitamin E, vitamin C, vitamin A, or a combination thereof as a result effective variable ripe for optimization through routine experimentation in order to find a workable range (see MPEP 2144.05.II.A). Therefore, an ordinary artisan would have been motivated and had a reasonable expectation of success to discover through routine experimentation the workable range for the content of the antioxidant vitamin E, vitamin C, vitamin A, or a combination thereof to be 1 wt% to 10 wt% of the composition, thereby, arriving at the invention of claim 13.
Regarding claim 14, the relevant teachings of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13, 15-17, and 20, are discussed above and incorporated herein.
Kabanov further teaches that antioxidants include flavonoids (i.e., flavones, isoflavones, flavanones, flavonols) (para [0045]).
Kabanov does not teach the vitamin is present in an amount of from 1 wt% to 10 wt% as recited in claim 13. However, in view of the combined teachings of Kabanov, Petrov, and Sumiyoshi, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the antioxidant content of flavonoids such that through routine experimentation a workable range for flavonoids is discovered to be 0.0001 wt% to 25 wt% of the composition. Thereby, arriving at the invention of claim 14.Since the prior art teaches the treatment of a plurality of oxidative damage related conditions, such as inflammation, with a composition comprising the bioactive agent and enzymatic antioxidant of SOD with at least one other bioactive agent like an antioxidant, an ordinary artisan would have recognized the content of content of flavonoids as a result effective variable ripe for optimization through routine experimentation in order to find a workable range (see MPEP 2144.05.II.A). Therefore, an ordinary artisan would have been motivated and had a reasonable expectation of success to discover through routine experimentation the workable range for the content of flavonoids to be 0.0001 wt% to 25 wt% of the composition,
Consequently, the invention of claim 1, 13-17, and 20 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 2-5 are newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov and Sumiyoshi as applied to claims 1, 13-17, and 20 above, and further in view of Xu.
The relevant teachings of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20, are discussed above and incorporated herein.
Regarding claims 2-5, the combination he combination of Kabanov, Petrov, and Sumiyoshi does not teach or suggest wherein the SOD is from a botanical source.
Xu teaches Rosa roxburghii fruit comprises the highest amount of the antioxidant SOD (i.e., 54,000 U/ 100 ml), when compared to other common fruits (Abstract; p. 2, col 1, para 4; Tables 1 and 3; p. 3, col 1, para 5 - p. 5, col 1, para 1; p. 7, col 2, para 2).
In view of the combined teachings of Kabanov, Petrov, Sumiyoshi, and Xu, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the SOD in the composition taught by Kabanov with the SOD from Rosa roxburghii taught by Xu, thereby arriving at the invention of claims 2-5.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to substitute the SOD in the composition taught by Kabanov with the SOD from Rosa roxburghii taught by Xu because it is obvious to substitute SOD obtained from a natural source, like bovine erythrocytes, for another natural source of SOD, like Rosa roxburghii, to achieve a predictable result because they are equivalent enzymes with the same function.
Consequently, the invention of claim 2-5 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 2-3 and 7-8 are newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov and Sumiyoshi as applied to claims 1, 13-17, and 20 above, and further in view of Kuwong as evidenced by Williams.
The relevant teachings of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20 above, are discussed above and incorporated herein.
Regarding claims 2-3 and 7-8, the combination of Kabanov, Petrov, and Sumiyoshi does not teach or suggest wherein the SOD is from a botanical source.
Kuwong teaches the extraction of SOD from a source of plant cells, wherein the plant source comprises Silphium perfoliatun (p. 15, para 1). Barring evidence of the contrary, Silphium perfoliatun taught by Kuwong, is considered a typographical error as well as considered the same as Silphium perfoliatum because Silphium perfoliatum, but not Silphium perfoliatun, is the only species present in the limited-sized genus of Silphium L. (p. 435, col 2, para 2; p. 436, col 2, para 2 – p. 437, col 1, para 1; p. 442, col 2, para 1 – p. 443, col 1, para 1; Figure 1; Table 1-2) as evidenced by Williams. Kuwong teaches a composition comprising a stabilized SOD, from either bovine erythrocytes or a plant such as Silphium perfoliatum, encapsulated in Poly (D, L)-lactide (PLGA) nanoparticles is therapeutically effective as an antioxidant treatment studies to combat the harmful impact of ultraviolet light exposure on skin (Abstract; p. 14, para 2; p. 15, para 1; p. 21, para 2 – p. 23, para 1; p. 34, para 2 – p. 35, para 1). Kuwong teaches the bovine- and Silphium perfoliatum-based sources of SOD generate similar results as antioxidant treatments in studies to combat ultraviolet light skin damage (Abstract; p. 34, para 2).
In view of the combined teachings of Kabanov, Petrov, Sumiyoshi, and Kuwong, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the SOD in the composition taught by Kabanov with the SOD from Silphium perfoliatum taught by Kuwong, thereby arriving at the invention of claims 2-3 and 7-8.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to substitute the SOD in the composition taught by Kabanov with the SOD from Silphium perfoliatum taught by Kuwong. This is because it is obvious to substitute SOD obtained from a natural source, like bovine erythrocytes, for another natural source of SOD, like Silphium perfoliatum, to achieve a predictable result because they are equivalent enzymes with the same function.
Consequently, the invention of claim 2-3 and 7-8 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 2-3 and 10-11 are newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov and Sumiyoshi as applied to claims 1, 13-17, and 20 above, and further in view of Ghahari.
The relevant teachings of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20 above, are discussed above and incorporated herein.
Regarding claims 2-3 and 10-11, the combination of Kabanov, Petrov, and Sumiyoshi does not teach or suggest wherein the SOD is from a botanical source.
Ghahari teaches water-based extracts of Glycine Max seeds comprise the 1.32 U/mg of the antioxidant SOD (Abstract; p. 523, col 2, para 2 – p. 524, col 2, para 1; p. 525, col 1, para 1; p. 527, col 2, para 2; p. 527, col 2, para 5; Table 2).
In view of the combined teachings of Kabanov, Petrov, Sumiyoshi, and Ghahari, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the SOD in the composition taught by Kabanov with the SOD from Glycine Max taught by Ghahari, thereby arriving at the invention of claims 2-3 and 10-11.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to substitute the SOD in the composition taught by Kabanov with the SOD from Glycine Max taught by Ghahari. This is because it is obvious to substitute SOD obtained from a natural source, like bovine erythrocytes, for another natural source of SOD, like Glycine Max, to achieve a predictable result because they are equivalent enzymes with the same function.
Consequently, the invention of claim 2-3 and 10-11 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 6 is newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov, Sumiyoshi, and Xu as applied to claims 1-5, 13-17, and 20 above, and further in view of Woith et al. (Pharmazie, published August 2017, Vol. 72, No. 8, p. 309-314; cited on the attached Form PTO-892; hereafter “Woith”).
The relevant teachings of Kabanov, Petrov, and Sumiyoshi as applied to claims 1-5, 13-17, and 20, are discussed above and incorporated herein.
Regarding claim 6, the combination of Kabanov, Petrov, Sumiyoshi, and Xu does not teach or suggest wherein the SOD content is 1,000 U/g to 50,000 U/g as measured by a xanthine oxidase-based colorimetric assay.
Woith teaches determining the SOD activity from plant extracts using a xanthine/xanthine oxidase method wherein measuring absorbance at 450 nm superoxide detects the superoxide induced conversion of uncolored WST-1 to yellow WST-1 formazin (p. 310, col 1, para 7; p. 310, col 2, para ; p. 314, col 1, para 3). An ordinary artisan would immediately envision the xanthine/xanthine oxidase based-assay from Woith as a colorimetric assay.
In view of the combined teachings of Kabanov, Petrov, Sumiyoshi, Xu, and Woith, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to evaluate the activity of the SOD in the extract from Rosa roxburghii via the xanthine and xanthine oxidase-based colorimetric assay taught by Woith. Furthermore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the content of the extract such that through routine experimentation a workable range for the SOD activity in the Rosa roxburghii extract is discovered to be 1,000 U/g to 50,000 U/g.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success of evaluating the activity of the SOD in the extract from Rosa roxburghii via the xanthine and xanthine oxidase-based colorimetric assay. This is because Woith taught a xanthine and xanthine oxidase-based colorimetric assay to determine the SOD activity in plant extracts.
Since the prior art teaches the treatment of a plurality of oxidative damage related conditions, such as inflammation, with a composition comprising the bioactive agent and enzymatic antioxidant of SOD from Rosa roxburghii, an ordinary artisan would have recognized the content of the bioactive agent of SOD as a result effective variable ripe for optimization through routine experimentation in order to find a workable range (see MPEP 2144.05.II.A). Therefore, an ordinary artisan would have been motivated and had a reasonable expectation of success to discover through routine experimentation the workable range for the SOD activity in the Rosa roxburghii extract to be 1,000 U/g to 50,000 U/g, thereby, arriving at the invention of claim 6.
Consequently, the invention of claim 6 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 9 is newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov, Sumiyoshi, and Kuwong as applied to claims 1-3, 7-8, 13-17, and 20, and further in view of Woith as evidenced by Williams.
The relevant teachings of Kabanov, Petrov, Kuwong, Sumiyoshi as applied to claims
1-3, 7-8, 13-17, and 20, are discussed above and incorporated herein.
Regarding claim 9, the combination of Kabanov, Petrov, Sumiyoshi, and Kuwong and the claimed invention does not teach or suggest wherein the SOD content is 500 U/g to 50,000 U/g as measured by a xanthine oxidase-based colorimetric assay.
Woith teaches determining the SOD activity from plant extracts using a xanthine/xanthine oxidase method wherein measuring absorbance at 450 nm superoxide detects the superoxide induced conversion of uncolored WST-1 to yellow WST-1 formazin (p. 310, col 1, para 7; p. 310, col 2, para ; p. 314, col 1, para 3). An ordinary artisan would immediately envision the xanthine/xanthine oxidase based-assay from Woith as a colorimetric assay.
In view of the combined teachings of Kabanov, Petrov, Sumiyoshi, Kuwong, and Woith, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to evaluate the activity of the SOD in the extract from Silphium perfoliatum via the xanthine and xanthine oxidase-based colorimetric assay taught by Woith. Furthermore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the content of the extract such that through routine experimentation a workable range for the SOD activity in the Silphium perfoliatum extract is discovered to be 500 U/g to 50,000 U/g.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success of evaluating the activity of the SOD in the extract from Silphium perfoliatum, via the xanthine and xanthine oxidase-based colorimetric assay. This is because Woith taught a xanthine and xanthine oxidase-based colorimetric assay to determine the SOD activity in plant extracts.
Since the prior art teaches the treatment of a plurality of oxidative damage related conditions, such as inflammation, with a composition comprising the bioactive agent and enzymatic antioxidant of SOD from Silphium perfoliatum, an ordinary artisan would have recognized the content of the bioactive agent of SOD as a result effective variable ripe for optimization through routine experimentation in order to find a workable range (see MPEP 2144.05.II.A). Therefore, an ordinary artisan would have been motivated and had a reasonable expectation of success to discover through routine experimentation the workable range for the SOD activity in the Silphium perfoliatum extract to be 500 U/g to 50,000 U/g, thereby, arriving at the invention of claim 9.
Consequently, the invention of claim 9 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 12 is newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov, Sumiyoshi, and Ghahari as applied to claims 1-3, 10-11, 13-17, and 20 above, and further in view of Woith.
The relevant teachings of Kabanov, Petrov, Sumiyoshi, and Ghahari as applied to claims
1-3, 10-11, 13-17, and 20 above, are discussed above and incorporated herein.
Regarding claim 12, the combination of Kabanov, Petrov, Sumiyoshi, and Ghahari does not teach or suggest wherein the SOD content is 500 U/mg to 50,000 U/mg as measured by a xanthine oxidase-based colorimetric assay.
Woith teaches determining the SOD activity from plant extracts using a xanthine/xanthine oxidase method wherein measuring absorbance at 450 nm superoxide detects the superoxide induced conversion of uncolored WST-1 to yellow WST-1 formazin (p. 310, col 1, para 7; p. 310, col 2, para ; p. 314, col 1, para 3). An ordinary artisan would immediately envision the xanthine/xanthine oxidase based-assay from Woith as a colorimetric assay.
In view of the combined teachings of Kabanov, Petrov, Sumiyoshi, Ghahari, and Woith, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to evaluate the activity of the SOD in the extract from Glycine max via the xanthine and xanthine oxidase-based colorimetric assay taught by Woith. Furthermore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the content of the extract such that through routine experimentation a workable range for the SOD activity in the Glycine max extract is discovered to be 500 U/mg to 50,000 U/mg.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success of evaluating the activity of the SOD in the extract from Glycine max via the xanthine and xanthine oxidase-based colorimetric assay. This is because Woith taught a xanthine and xanthine oxidase-based colorimetric assay to determine the SOD activity in plant extracts.
Since the prior art teaches the treatment of a plurality of oxidative damage related conditions, such as inflammation, with a composition comprising the bioactive agent and enzymatic antioxidant of SOD from Glycine max, an ordinary artisan would have recognized the content of the bioactive agent of SOD as a result effective variable ripe for optimization through routine experimentation in order to find a workable range (see MPEP 2144.05.II.A). Therefore, an ordinary artisan would have been motivated and had a reasonable expectation of success to discover through routine experimentation the workable range for the SOD activity in the Glycine max extract to be 500 U/mg to 50,000 U/mg, thereby, arriving at the invention of claim 12.
Consequently, the invention of claim 12 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 21 is newly rejected under 35 U.S.C. 103 as being unpatentable over Kabanov in view of Petrov and Sumiyoshi as applied to claims 1, 13-17, and 20 above, and further in view of Liu et al. (CN112190698A; cited on the attached Form PTO-892; hereafter “Liu”). Reference is made to a machine translation of CN112190698A, which is provided by the Examiner and cited on the attached Form PTO-892.
The relevant teachings of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20 above, are discussed above and incorporated herein.
Regarding claim 21, Kabanov further teaches wherein the composition can be incorporated into liposomes (para [0042]).
The difference between the combination of Kabanov, Petrov, and Sumiyoshi and claim 21 is that the combination does not teach or suggest wherein the composition comprising SOD contains soy lecithin.
Liu teaches SOD protein encapsulated in a liposome comprising soybean lecithin in order to increase stability and performance (Abstract; p. 2 – “Superoxide dismutase (SOD)…”; p. 2, para 2-3 of “Background technique”; p. 5, para 4-8; Claim 3 and 6).
In view of the combined teachings of Kabanov, Petrov, Sumiyoshi, and Liu, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to stabilize the SOD taught by Kabanov in a liposome comprising soybean lecithin in order to increase the stability of the enzyme, thereby arriving at the invention of claim 21.
An ordinary artisan would have been motivated and would have had a reasonable expectation of success of to stabilize the SOD taught by Kabanov in a liposome comprising soybean lecithin because Kabanov taught wherein the composition can be incorporated into liposomes and Liu taught encapsulating SOD in a liposome comprising soybean lecithin in order to increase the stability of the enzyme.
Consequently, the invention of claim 21 would have been obvious to one of ordinary skill in the art before the effective filing date.
RESPONSE TO REMARKS: Applicant asserts none of the cited references teaches or suggests the newly added limitation "the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm."
Applicant’s arguments are not found persuasive. For the reasons set forth in the new rejections above, it would have been obvious to one of ordinary skill in the art to modify the composition comprising SOD in a pharmaceutically acceptable carrier of water taught by Kabanov such that the water is deoxygenated water wherein the water comprises a dissolved oxygen content of 2 ppm.
Double Patenting Rejections
The provisional rejections of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13-16, and 19 of copending Application No. 17/922,487 (hereafter “App’487”) in view of Kabanov, Kuwong, Xu, Ghahari, and Williams are withdrawn because the combination of cited references does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.” The rejections are also withdrawn because the combination of cited references does not teach the newly added limitation to claims 6, 9, and 12 to recite “wherein the standardized SOD content is measured by a xanthine and xanthine oxidase-based colorimetric assay.”
The provisional rejections of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 15, and 18 of copending Application No. 18/396,458 (hereafter “App’458”) in view of Kabanov, in view of Kuwong, Xu, Ghahari, and Williams are withdrawn because the combination of cited references does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.” The rejections are also withdrawn because the combination of cited references does not teach the newly added limitation to claims 6, 9, and 12 to recite “wherein the standardized SOD content is measured by a xanthine and xanthine oxidase-based colorimetric assay.”
The provisional rejections of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 17/922,452 (hereafter “App’452”) in view of Kabanov, Kuwong, Xu, Ghahari, and Williams are withdrawn because the combination of cited references does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.” The rejections are also withdrawn because the combination of cited references does not teach the newly added limitation to claims 6, 9, and 12 to recite “wherein the standardized SOD content is measured by a xanthine and xanthine oxidase-based colorimetric assay.”
The provisional rejections of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 23-24, 26-27 of copending Application No. 17/978,019 (hereafter “App’019”) in view of Kabanov, Kuwong, Xu, Ghahari, and Williams are withdrawn because the combination of cited references does not teach the newly added limitation to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.” The rejections are also withdrawn because the combination of cited references does not teach the newly added limitation to claims 6, 9, and 12 to recite “wherein the standardized SOD content is measured by a xanthine and xanthine oxidase-based colorimetric assay.”
Claims 1, 13-17, and 20 are newly, provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 21-22 of copending App’487 in view of Kabanov, Petrov, and Sumiyoshi. This provisional rejection is necessitated by the amendment to claim 1 to recite “wherein the stabilizing carrier is deoxygenated water having a dissolved oxygen content of 2 ppm.”
Regarding instant claim 1, claims 21-22 of App’487 recite a method of treating a condition with a composition comprising an active agent of SOD. Regarding the limitation “therapeutically effective amount,” no condition or disease to be treated is recited in the claims and so any amount of SOD is considered to be therapeutically effective. As such, the composition recited by App’487 is considered to comprise a “therapeutically effective amount” of SOD.
Regarding instant claim 15, claim 22 of App’487 further recites wherein the composition comprises an antioxidant.
Regarding instant claims 16-17, claims 13-15 of App’487 further recites the composition can comprise a stabilizing carrier comprising deoxygenated water. An ordinary artisan would immediately envision a composition with a water carrier is water soluble.
The difference between the claims of App’487 and the claimed invention is that App’487 does not recite wherein the SOD is from a natural source and wherein the deoxygenated water has a deoxygenated oxygen content of 2 ppm. Regarding instant claim 20, App’487 also does not recite wherein the SOD comprises SOD-1, SOD-2, SOD-3, or a combination thereof.
Kabanov teaches a composition comprising the enzymatic antioxidant SOD and at least one other therapeutic agent, such as an antioxidant, in order to inhibit, treat, and/or prevent oxidative stress associated disorders like inflammation (Title; para [0024 – 0026, 0032, 0038, 0055-0056, 0059, 0062, 0090, 0105, 0107- 0108]; Claim 6). Kabanov refers to “antioxidant” as compounds that neutralize the activity of reactive oxygen species or inhibit the cellular damage done by the reactive species or their reactive byproducts or metabolites, and also referred to “antioxidant” as compounds that inhibit, prevent, reduce, or ameliorate oxidative reactions (para [0045]). Kabanov further teaches the SOD is SOD1 is from a natural source of bovine erythrocytes (para [0080]).
Petrov teaches that SOD1 is susceptible to oxidative damage (Abstract). Petrov teaches that when SOD1 experiences oxidative damage alters the enzyme’s activity, stability, folding, and propensity to aggregate (Abstract, p. 1500, col 1, para 2).
Sumiyoshi teaches producing a drug solution with a reduced dissolved oxygen content of 2 ppm in order to suppress the oxidative degradation of the drug solution so that the drug solution has high stability over time (Abstract; para [0011, 0022, 0014, 0041]).
In view of the combination of App’487, Kabanov, Petrov, and Sumiyoshi, it would have been obvious for a person of ordinary skill to modify the composition comprising SOD in a pharmaceutically acceptable carrier of deoxygenated water recited by App’487 such that the SOD, such as SOD1, is from a natural carrier like bovine erythrocytes and that the water is deoxygenated water wherein the water comprises a dissolved oxygen content of 2 ppm, thereby arriving at the invention of claim 1, 15-17, and 20.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to substituting the SOD recited by App’487 with the SOD or SOD1 taught by Kabanov. This is because it is obvious to substitute SOD from once source with SOD from another source, like the natural source of bovine erythrocytes, to achieve a predictable result because they are equivalent enzymes with the same function.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to modify the composition comprising SOD in a pharmaceutically acceptable carrier of water recited by App’487 such that the water is deoxygenated water wherein the water comprises a dissolved oxygen content of 2 ppm. This is because Petrov taught that when SOD1 experiences oxidative damage alters the enzyme’s activity and stability, and Sumiyoshi taught producing a drug solution with a reduced dissolved oxygen content of 2 ppm in order to suppress the oxidative degradation of the drug solution so that the drug solution has high stability over time stability. Therefore, modifying the water carrier to comprise 2 ppm dissolved oxygen content would reduce the likelihood of oxidative induced damage to SOD that decreases its effectiveness.
Regarding instant claim 13, the combination of App’487, Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 15-17, and 20, are discussed above and incorporated herein.
Kabanov further teaches that antioxidants include vitamins (i.e., vitamin E, vitamin C, vitamin A) (para [0045]).
The difference between the combination of App’487, Kabanov, Petrov, and Sumiyoshi and the claimed invention is that the combination does not explicitly teach wherein the composition further comprises a vitamin selected from the group consisting of: vitamin A, vitamin B 1, vitamin B2, vitamin B6, vitamin B 12, vitamin C, vitamin D, vitamin E, vitamin H, vitamin K, folic acid, and a combination thereof in an amount of from about 1 wt% to about 10 wt% of the composition.
In view of the combination of App’487, Kabanov, Petrov, and Sumiyoshi, it would have been obvious for a person of ordinary skill in the art to include vitamin E, vitamin C, and/or vitamin A as the antioxidant in the modified composition and to furthermore optimize the content of the antioxidant consisting of vitamin E, vitamin C, or vitamin A, such that through routine experimentation a workable range for the vitamin is discovered to be 1 wt% to 10 wt% of the composition.
An ordinary artisan would have been motivated and had a reasonable expectation of success to substitute the antioxidant in the composition of App’487 with any one of the antioxidants consisting of vitamin E, vitamin C, or vitamin A. Since Kabanov teaches all of these vitamins are antioxidants, it is obvious to substitute one antioxidant with another antioxidant like one of the vitamins consisting of vitamin E, vitamin C, or vitamin A and to achieve a predictable result because they are all antioxidants with the same function.
Since App’487 recites a method of treating a condition responsive to a treatment comprising an active agent consisting of an antioxidant, an ordinary artisan would have recognized the content of the antioxidant as a result effective variable ripe for optimization through routine experimentation in order to find a workable range (see MPEP 2144.05.II.A). Therefore, an ordinary artisan would have been motivated and had a reasonable expectation of success to discover through routine experimentation the workable range for the content of the antioxidant vitamin consisting of vitamin E, vitamin C, or vitamin A to be 1 wt% to 10 wt% of the composition.
Regarding instant claim 14, the combination of App’487, Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 15-17, and 20, are discussed above and incorporated herein.
Kabanov further teaches that antioxidants include flavonoids (i.e., flavones, isoflavones, flavanones, flavonols) (para [0045]).
The difference between the combination of App’487, Kabanov, Petrov, and Sumiyoshi and the claimed invention is that the combination does not explicitly teach wherein the composition further comprises a polyphenol consisting of: a flavonoid, a tannin, and a combination thereof in an amount from 0.0001 wt% to 25 wt% of the composition.
In view of the combination of App’487, Kabanov, Petrov, and Sumiyoshi, it would have been obvious for a person of ordinary skill in the art to include flavonoids as the antioxidant in the modified composition and to furthermore optimize the content of the flavonoids such that through routine experimentation a workable range for the vitamin is discovered to be 0.0001 wt% to 25 wt% of the composition.
An ordinary artisan would have been motivated and had a reasonable expectation of success to substitute the antioxidant in the composition of App’487 for the antioxidant consisting of flavonoids. Since Kabanov teaches flavonoids are antioxidants, it is obvious to substitute one antioxidant with another antioxidant, like flavonoids, and to achieve a predictable result because they are all antioxidants with the same function.
Since App’487 teaches a method of treating a condition responsive to a treatment comprising an active agent consisting of an antioxidant, an ordinary artisan would have recognized the content of the antioxidant as a result effective variable ripe for optimization through routine experimentation in order to find a workable range (see MPEP 2144.05.II.A). Therefore, an ordinary artisan would have been motivated and had a reasonable expectation of success to discover through routine experimentation the workable range for the content of the flavonoids to be 1 wt% to 10 wt% of the composition.
For the reasons stated herein, claims 1, 13-17, and 20 of this application are unpatentable over claims 13-15 and 21-22 of App’487 in view of Petrov, Sumiyoshi, and Kabanov. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-5 are newly, provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 21-22 of copending App’487 in view of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20 above, and further in view of Xu.
Regarding instant claims 2-5, the relevant combination of App’487, Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20, are discussed above and incorporated herein.
The difference between the combination of App’487, Kabanov, Petrov, and Sumiyoshi and the claimed invention is that the combination does not teach or suggest wherein the SOD is from a botanical source.
Xu teaches Rosa roxburghii fruit comprises the highest amount of the antioxidant SOD (i.e., 54,000 U/ 100 ml), when compared to other common fruits (Abstract; p. 2, col 1, para 4; Tables 1 and 3; p. 3, col 1, para 5 - p. 5, col 1, para 1; p. 7, col 2, para 2).
In view of the combination of App’487, Kabanov, Petrov, Sumiyoshi, and Xu, it would have been obvious for a person of ordinary skill in the art to substitute the SOD in the composition taught by App’487 with the SOD from Rosa roxburghii taught by Xu, thereby arriving at the invention of claims 2-5.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to substitute the SOD in the composition taught with the SOD in the composition taught by App’487 with the SOD from Rosa roxburghii taught by Xu. This is because it is obvious to substitute SOD from once source with SOD from another source, like the natural source of Rosa roxburghii taught by Xu, to achieve a predictable result because they are equivalent enzymes with the same function.
For the reasons stated herein, claims 2-5 of this application are unpatentable over claims 13-15 and 21-22 of App’487 in view of Petrov, Sumiyoshi, Kabanov, and Xu. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-3 and 7-8 are newly, provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 21-22 of copending App’487 in view of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20 above, and further in view of Kuwong as evidenced by Williams.
Regarding instant claims 2-3 and 7-8, the relevant combination of App’487, Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20, are discussed above and incorporated herein.
The difference between the combination of App’487, Kabanov, Petrov, and Sumiyoshi and the claimed invention is that the combination does not teach or suggest wherein the SOD is from a botanical source.
Kuwong teaches the extraction of SOD from a source of plant cells, wherein the plant source comprises Silphium perfoliatun (p. 15, para 1). Barring evidence of the contrary, Silphium perfoliatun taught by Kuwong, is considered a typographical error as well as considered the same as Silphium perfoliatum because Silphium perfoliatum, but not Silphium perfoliatun, is the only species present in the limited-sized genus of Silphium L. (p. 435, col 2, para 2; p. 436, col 2, para 2 – p. 437, col 1, para 1; p. 442, col 2, para 1 – p. 443, col 1, para 1; Figure 1; Table 1-2) as evidenced by Williams. Kuwong teaches a composition comprising a stabilized SOD, from either bovine erythrocytes or a plant such as Silphium perfoliatum, encapsulated in Poly (D, L)-lactide (PLGA) nanoparticles is therapeutically effective as an antioxidant treatment studies to combat the harmful impact of ultraviolet light exposure on skin (Abstract; p. 14, para 2; p. 15, para 1; p. 21, para 2 – p. 23, para 1; p. 34, para 2 – p. 35, para 1). Kuwong teaches the bovine- and Silphium perfoliatum-based sources of SOD generate similar results as antioxidant treatments in studies to combat ultraviolet light skin damage (Abstract; p. 34, para 2).
In view of the combination of App’487, Kabanov, Petrov, Sumiyoshi, and Kuwong, it would have been obvious for a person of ordinary skill in the art to substitute the SOD in the composition taught by App’487 with the SOD from Silphium perfoliatum taught by Kuwong, thereby arriving at the invention of claims 2-3 and 7-8.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to substitute the SOD in the composition taught with the SOD in the composition taught by App’487 with the SOD from Silphium perfoliatum taught by Kuwong. This is because it is obvious to substitute the SOD from once source with SOD from another source, like the natural source of Silphium perfoliatum taught by Kuwong, to achieve a predictable result because they are equivalent enzymes with the same function.
For the reasons stated herein, claims 2-3 and 10-11 of this application are unpatentable over claims 13-15 and 21-22 of App’487 in view of Petrov, Sumiyoshi, Kabanov, and Kuwong. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-3 and 10-11 are newly, provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 21-22 of copending App’487 in view of Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20 above, and further in view of Ghahari.
Regarding instant claims 2-3 and 10-11, the relevant combination of App’487, Kabanov, Petrov, and Sumiyoshi as applied to claims 1, 13-17, and 20, are discussed above and incorporated herein.
The difference between the combination of App’487, Kabanov, Petrov, and Sumiyoshi and the claimed invention is that the combination does not teach or suggest wherein the SOD is from a botanical source.
Ghahari teaches water-based extracts of Glycine Max seeds comprise the 1.32 U/mg of the antioxidant SOD (Abstract; p. 523, col 2, para 2 – p. 524, col 2, para 1; p. 525, col 1, para 1; p. 527, col 2, para 2; p. 527, col 2, para 5; Table 2).
In view of the combination of App’487, Kabanov, Petrov, Sumiyoshi, and Ghahari, it would have been obvious for a person of ordinary skill in the art to substitute the SOD in the composition taught by App’487 with the SOD from Glycine Max taught by Ghahari, thereby arriving at the invention of claims 2-3 and 10-11.
An ordinary artisan would have been motivated to and would have had a reasonable expectation of success to substitute the SOD in the composition taught with the SOD in the composition taught by App’487 with the SOD from Glycine Max. This is because it is obvious to substitute the SOD from once source with SOD from another source, like the natural source of Glycine Max taught by Ghahari, to achieve a predictable result because they are equivalent enzymes with the same function.
For the reasons stated herein, claims 2-3 and 10-11 of this application are unpatentable over claims 13-15 and 21-22 of App’487 in view of Petrov, Sumiyoshi, Kabanov, and Ghahari. This is a pro